The Heparin Disaster

Congress Vows to Continue Contaminated Heparin Investigation

2011-07-21T13:04:00.001-07:00

Just weeks after the pharmaceutical giant, Baxter and its supplier, SPL lost the first contaminated heparin trial in Chicago for their role in the contaminated heparin crisis that killed hundreds of Americans, Congress has indicated that it has not given up on its three-year investigation to identify the original contamination source. (06/29/11 Press Release from the House Energy and Commerce Committee)

It is now well-known that in order to increase corporate profits, Baxter and SPL decided to purchase their heparin (referred to in the companies’ own internal records as “the cheap stuff”) from an overseas Chinese facility that the companies knew had never been inspected by the U.S. FDA or any Chinese regulatory officials. (When the Chinese plant was finally inspected by the FDA after the heparin contamination crisis, multiple violations were found, resulting in an import ban.) It was also uncovered that Baxter and/or SPL completely failed to establish and conform with quality/purity specifications, including an impurity profile, failed to understand, let alone control, their supply chain, and did not conduct the testing that they promised the FDA they would conduct. The specific individuals who added the contaminant to over half of the nation’s supply of heparin, however, have never been identified.

On June 29, 2011, the House Energy and Commerce Committee indicated that it “firmly believe[s] discovering the root cause of the heparin crisis is an urgent matter of public health and that the public deserves long-overdue answers about the contamination of this widely used blood-thinning drug in order to prevent similar dangers in the future.” As a result, the Committee announced that it was expanding its investigation as to the original contamination source.

Committee Chairman Fred Upton, R-Mich., Chairman Emeritus Joe Barton, R-Texas, Health Subcommittee Chairman Joe Pitts, R-Penn., Health Subcommittee Vice Chairman Dr. Michael Burgess, R-Texas, and Oversight and Investigations Subcommittee Chairman Cliff Stearns, R-Fla., said they contacted 10 pharmaceutical companies because documents provided by the FDA indicated that they had information related to the Chinese heparin industry and Chinese heparin supply chains.

The leaders are seeking documents and information from Amphastar Pharmaceuticals, Momenta Pharmaceuticals, Siegfried USA, Inc., Sagent Pharmaceutical, APP Pharmaceuticals, Sanofi Aventis, Drug Source Company LLC, Global Pharma Sourcing LLC, Pacific Rainbow International, and Sandoz.

In their press release, the Committee leaders wrote, “We believe there is substantial public interest in solving this case. More than 80 percent of the U.S. unfractionated heparin supply is sourced from China and more than 16 percent of U.S. pharmaceutical ingredients are imported from China. There is reason to believe all or some of the individuals responsible for the adulteration are still actively engaged in the Chinese pharmaceutical supply chain and pose a continuing threat to pharmaceutical products imported to the U.S. How the heparin came to be contaminated and the exact nature of the contaminant remain unknown. It is important to determine how the adulteration happened so that industry and government can take more effective proactive measures to reduce the risk of such adulteration in the future.”

The Committee also faulted the FDA, whom the Committee indicated it has been “pressing” since 2008 “for answers about the agency’s handling of the investigation into the contaminated heparin.” As the Committee noted in its press release, “The U.S. Government Accountability Office also faulted some of the FDA’s efforts, including the decision to continue allowing drugs to be imported from Chinese facilities that refused to allow inspections.”

Responses from the companies are due July 29, 2011.

We commend the continued efforts of Congress to obtain additional answers, which are not only important to those who lost loved ones from contaminated heparin, including our clients, but those who may still be in danger from foreign-made pharmaceuticals.

However, we also continue to lobby for additional efforts and regulation to address the significant risk posed to Americans from foreign-made pharmaceuticals. As a senior Food and Drug Administration regulator warned just a few months ago, another public health crisis may be inevitable because the FDA can't guarantee the safety of many drugs and food products manufactured overseas. (CNNMoney.com, March 14, 2011.) "The safety of America's food and medical products is under serious challenge," John Taylor, FDA's acting principal deputy commissioner, said in an interview with CNN in March. Decades ago, Taylor said the agency had a better grip on ensuring the safety of those products because most of them were made in the United States. But today, he said, the agency is crippled in its mission to protect the health of Americans since a lot of medicine sold in the U.S. is made abroad and outside of strict FDA oversight. As a result, Taylor admitted that the safety agency must reinvent itself to operate more effectively globally, or "another public health crisis like Heparin seems inevitable."

Cook County Judge authorizes Punitive Damages in Contaminated Heparin

2011-07-14T15:21:00.000-07:00

Yesterday Judge Duncan Brice handed down her decision in the Cook County litigation on Plaintiffs' Motion for Leave to amend to add claims for Punitive Damages. The Judge ruled that Plaintiffs may amend their complaints to allege punitive damages against SPL, finding that there is a reasonable likelihood that Plaintiffs can prove facts at trial that will support an award of punitive damages.

In making her ruling, the Judge found that there was evidence that SPL acted with such "gross negligence as to indicate a wanton disregard of the rights of others." Although she found that there was evidence on the part of Baxter of negligence, she unfortunately did not find that the Baxter negligence rose to the level of wanton disregard for safety as to permit an additional award, like that of SPL.

The Court focused on the willingness of SPL to sell lots that failed galactosamine testing, the failure of CZSPL to pass a Sanofi Aventis audit in 2005 (which was 2 years before Baxter even audited), the failure to audit its crude suppliers, the failure of SPL to investigate the catastrophic failures of contaminated heparin sold to Beckman Coulter, the failure to investigate high galactosamine levels in heparin api intended for Momenta, the resale of these failed lots to other customers such as B Braun, Covidien and Medifil, and the failure to investigate the rejection of contaminated lots of 1060 contaminated heparin by Leo Pharma, which contained levels of contamination over 16%.

Judge Duncan Brice further rejected the Defendants' pleas to bifurcate the punitive damages aspects of the trials from the liability portion, ruling instead that the evidence is so intertwined that it would be prejudicial to plaintiffs to have to present the same evidence twice, and to incur the added expense and time that bifurcation would cause.

SPL is owned by American Capital (ACAS), which has $37 billion under management. ACAS has been named as a responsible party in some of the pending cases. Motions involving ACAS are pending in the MDL.

We will be posting the 27 page decision shortly. We believe there is additional evidence which, once reviewed in more detail, will also support a further extension of the right to seek punitive damages against Baxter and intend to continue pushing for an award of punitive damages against Baxter as well as SPL.

Baxter gets yet another warning letter

2011-06-29T08:20:00.000-07:00

Baxter's inability to make quality products and comply with FDA and GMP requirements was once more documented by the release of a Warning Letter:

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

January 20, 2011

Mr. Robert L. Parkinson
Chairman, President, and CEO
Baxter Healthcare Corporation
One Baxter Parkway
Deerfield, IL 60015-4633

Dear Mr. Parkinson:

During our July 14 to August 26, 2010 inspection of your pharmaceutical manufacturing facility, Baxter Healthcare Corporation, located at No. 250 Road No. 144 Jayuya, Puerto Rico, investigators from the Food and Drug Administration (FDA) identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug product(s) to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351(a)(2)(B)] in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP.

The inspection at Jayuya, Puerto Rico, also identified that your products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].

In addition, the inspection at Jayuya, Puerto Rico, and our September 21 - 30, 2010 inspection at the Baxter Healthcare Corporation, located at Route No. 3 KM 142.5 Guayama, Puerto Rico, identified your firm’s failure to submit NDA Field Alert Reports (FARs) to the FDA as required by 21 C.F.R. § 314.81(b)(1)(i) and (ii), and section 505(k) of the Act [21 U.S.C. § 355(k)].

We have reviewed your firm’s response of September 15, 2010, and October 20, 2010, and note that they lack sufficient corrective actions.

Incredibly, when Baxter made drug products that were discolored and at risk of being cross-contaminated, instead of a recall it sent out a color chart, and instructed health care personnel to discard any products that failed to have the correct color! The FDA refused to permit Baxter to shift the burden onto its customers of insuring Baxter's quality control. The Letter stated "It is unacceptable to rely upon the health care professional to fulfill your Quality Control Unit responsibilities."

The end user should not be expected to make a determination of product safety and effectiveness based on a color chart that was not reviewed and approved by the Agency. It is your responsibility to ensure that your products comply with their predetermined specifications to ensure their quality, safety, and effectiveness."

The FDA found that the Baxter products were Misbranded under the Act. The FDA also found evidence of dirt and insects in Baxter products.

It gets worse
Not only did Baxter's manufacturing practices and products fail, Baxter also continues to be unable to comply with the duty imposed upon drug manufacturers to monitor products in the field after distribution:

A. Post Marketing Reports

1. Your firm failed to submit NDA Field Alert Reports (FARs) within three (3) working days of receipt of information concerning a product defect. This includes any bacteriological contamination, any significant chemical, physical, or other change, any deterioration in the distributed drug product, or any failure of one or more distributed batches of drug product to meet the specifications established for it in the application [21 C.F.R. §314.81(b)(1)(ii)].

Drug manufacturers have a serious obligation to not only make safe and effective products, but to also monitor those products in the field and report failures, adverse events, or other issues to the authorities. Baxter continues to profit from its failures by making or purchasing drug products in facilities that do not comply with GMP, by not tracking its products to the end users, and by not recalling products completely and effectively when they do fail. Again, the quality failures here are the same quality failures that lead to the contaminated heparin debacle.

The full letter is available at FDA Website.

We continue to work towards obtaining the full release of all trial transcripts and exhibits from the recent trial. The victims of the Heparin Disaster, and the public, need to know the truth.

UPDATE: At Fierce Pharma there is the following comment:
Both the Jayuya and Guayama facilities fell down on reporting product defects to the FDA, the agency maintains. Inspectors found 43 consumer complaints concerning discoloration of an amino acid injection--varying from dark yellow to dark brown--dating to February 2010. Yet no report was filed with the FDA. And despite receiving some 40 complaints regarding particle contamination in another product, which initiated a health hazard assessment, Baxter neglected to file a field report.

Read more: Baxter gets warned on missing field reports - FiercePharma Manufacturing

Jury Finds Against Baxter Healthcare In Nation’s First Contaminated Chinese Heparin Case

2011-06-09T14:36:00.000-07:00

FOR IMMEDIATE RELEASE

(Chicago, June 9, 2011) Today a Cook County jury awarded $625,000 to the estate of a 63 year old Chicago area man, Steven Johansen, who was administered Baxter blood thinner that contained a contaminated ingredient Baxter sourced from China. This was the first of hundreds of pending lawsuits on Baxter contaminated Chinese heparin to go to trial. The lawsuits are pending in the Circuit Court of Cook County in Chicago, Illinois before Judge Jennifer Duncan-Brice and in the U.S. Northern District Court in Toledo, Ohio before Judge James G. Carr. The contaminated heparin crisis and resulting lawsuits received national attention and sparked congressional investigation as they exposed deficiencies in the regulatory oversight of drugs imported from China and other developing countries, and the failure of American drug companies, eager to increase profits by outsourcing, to monitor those foreign suppliers.

The blood thinner was manufactured in part in China and sold by the U.S. drug company, Baxter Healthcare Corporation and its supplier, Scientific Protein Laboratories, L.L.C. (SPL). It was recalled in early 2008 following an alarming and unexpectedly high rate of reported adverse events and deaths that resulted in a national healthcare crisis. The contaminate was determined to be a man-made “fake heparin” called over-sulfated chondroitin sulfate (OSCS), causing among other effects, potentially fatal allergic-like reactions.

The active pharmaceutical ingredient in the contaminated heparin received by Mr. Johansen and other Americans was obtained from Baxter/SPL’s Chinese supplier, Changzhou SPL (a joint venture with SPL). This heparin api was referred to in the companies’ own internal records as “the cheap stuff.” Baxter and SPL knew that the plant had never been inspected by the U.S. FDA (which the FDA later attributed to clerical error) or Chinese regulatory officials. When the Chinese plant was finally inspected by the FDA after the heparin contamination crisis, multiple violations were found resulting in an import ban. Additional evidence also brought to light during the trial established that Baxter and SPL failed to establish and comport with quality/purity specifications, including an impurity profile, and failed to trace and control their supply chain. At trial, the Court granted partial directed verdict in favor of Mr. Johansen holding that the product sold by Baxter and SPL was defective as a matter of law.

Plaintiffs contended Mr. Johansen received low doses of contaminated heparin during dialysis and a bolus dose during a subsequent hospitalization at Palos Community Hospital on December 12, 2007. Following a code, Mr. Johansen died a day later, on December 13, 2007. Baxter and SPL argued that Mr. Johansen died from sepsis and that he was already in poor health. As noted by co-lead attorney David Zoll from Zoll, Kranz & Borgess in Toledo, Ohio (co-counsel with Chicago attorney Donald Nolan of Nolan Law Group), “Heparin is supposed to be a life-saving drug, not a life-taking drug. Baxter’s defense is that these people were already sick. However, this is all the more reason why they needed a life-saving drug. The medical needs of a patient don’t excuse their failures.”

----
To our blog readers
Because of the power of the internet we took this blog down during the trial to avoid the influence of any jurors. We will begin publishing our past blogs shortly, and will be adding new information that, up until now, we have been forced to hold in confidence. The trial exhibits and testimony will soon be public knowledge. We look forwards to publishing the documents that reveal the facts behind the shoddy quality controls and workmanship of Baxter and SPL that, in part, lead the Judge to award a partial directed verdict in favor of Plaintiffs.

Sadly Illinois law does not permit an award of punitive damages in a wrongful death case; however there are other cases yet to be tried that will permit us to pursue these damages.

We thank the brave members of the Johansen family for their perserverance in the face of a sophisticated and extensive defense, and our expert witnesses who did so well under fire.

The Nolan Law Group is one of the premier law firms in the country and we were deeply honored to work side by side with them on this important case.
David & Pamela

Update: Chicago Tribune story: Baxter loses first Heparin case.

Wall Street Journal (subscription required): Jury Rules Against Baxter in First Contaminated Heparin Case.

FDA: Another tainted drug crisis seems inevitable

2011-03-15T05:21:00.000-07:00

The following article came out today in CNN Money and shows why it is so important that drug companies be held accountable for tainted drugs that they choose to manufacture overseas in order to increase corporate profits.

A senior Food and Drug Administration regulator warned that another public health crisis may be inevitable because the agency can't guarantee the safety of many drugs and food products manufactured overseas.

"The safety of America's food and medical products is under serious challenge," John Taylor, FDA's acting principal deputy commissioner, said Monday.
He said the safety agency must reinvent itself to operate more effectively globally, or "another public health crisis like Heparin seems inevitable."

In 2008, contaminants in Heparin, a blood thinner being produced in China, led to more than 100 deaths in the United States.

The FDA is responsible for overseeing the safety and manufacturing quality of food, drugs, medical devices, vaccines, cosmetics and tobacco products.

Speaking at the Pew Health Group conference in Washington D.C., Taylor said the FDA can't keep up with how quickly manufacturing has shifted overseas.

Decades ago, Taylor said the agency had a better grip on ensuring the safety of those products because most of them were made in the United States.

But today, he said, the agency is crippled in its mission to protect the health of Americans since a lot of medicine sold in the U.S. is made abroad and outside of strict FDA oversight.

40% of drugs consumed in the United States are imported, while 80% of the ingredients used in U.S. drugs come from other countries.

And food imports have grown on average 10% each year for at least 7 years, he said.
"Today, there are more than 130,000 importers of record and more than 300 ports of entry in the United States," he said.

Taylor said the FDA's difficulty in monitoring imports is also leading to more counterfeit and adulterated products entering the U.S.

One recent high-profile incident was the contaminated Heparin from China that killed more than 140 people in the United States. Other incidents include toothpaste from China containing Diethylene Glycol -- used in antifreeze -- counterfeit Lipitor from Central America and counterfeit glucose monitor test strips.

The next few years, he said, are critical for the agency to transform itself to adapt to the global challenges.

Taylor provided a glimpse of what he called the FDA's "global strategy and action plan."

Among his key points: the FDA will partner with its foreign counterparts to create a global coalition of regulators; it will boost intelligence gathering and the agency will encourage consumers and the private sector to help in its efforts.
"Regulators cannot do it alone," said Taylor.

“60 Minutes” Program on Counterfeit Drugs, Including Contaminated Heparin, to Air this Sunday, March 13, 2011

2011-03-11T07:40:00.000-08:00

CBS’ news program, 60 Minutes, will air a program on counterfeit drugs including, contaminated heparin, this Sunday, March 13, 2011 at 7 p.m. ET/PT.

60 Minutes’ website describes the program as follows:

“In this program, Dr. Sanjay Gupta investigates the counterfeit drug trade, revealing an international web of manufacturers and distributors whose dangerous and often deadly products are extremely hard to keep out of the world's drug supply.
The nine-month "60 Minutes" investigation begins by reporting on a special global security team assembled by American pharmaceutical firm Pfizer. The team contains former federal law enforcement agents and tracks counterfeiters and their products around the world with the help of local police. Pfizer's team identifies a fake drug factory in Lima, Peru, and Gupta and "60 Minutes" cameras accompany a raid by Peruvian police.

The factory was producing hundreds of thousands of counterfeits of real brands with convincing labels and imprints. Some are so exact, technicians at the pharmaceutical companies whose brands they are counterfeiting cannot tell them apart without using sophisticated tests. The fakes usually find their way into people's medicine cabinets via illegitimate Internet pharmacies, from which an estimated 36 million Americans have purchased medicines.

From Peru, "60 Minutes" goes to the computer command center of Immigration and Customs Enforcement, which tracks the intricate web of counterfeit-drug producers and distributors around the world. The investigation then follows packages of suspicious medicines through U.S. Customs and FDA inspection at JFK international airport and visits the FDA laboratory where they are tested.

The fakes sometimes have small amounts of the right active ingredient, but often contain substances like sugar or chalk - dangerous enough because it is useless against the illness. But counterfeits have also made their way into the legitimate drug supply and have been found in bulk raw ingredients sold to companies making legitimate drugs with them. The FDA has linked American deaths to a blood thinner found in 2008 to contain a raw ingredient from China that was counterfeit.

Three years after those deaths, Gupta asks FDA commissioner Margaret Hamburg how the crime was perpetrated and by whom. "We do not know the answer to that question," she responds. Assuring him that the vast majority of the drug supply is safe, Hamburg allows there is still reason for concern.

"We do know that in certain countries, somewhere between 30 and 50 percent of really important drugs...are in fact, counterfeit," she says. "Just consider that 40 percent of drugs taken in this country come from other countries. Eighty percent of the active pharmaceutical ingredients in drugs taken in this country actually come from other countries," she tells Gupta.”

To view a clip of this program, click here.

Money Well Spent? Baxter lobbies for advantages

2011-01-14T05:23:00.000-08:00

Bloomberg reported yesterday that Baxter spent $930,000 in the third quarter of last year on lobbying efforts, which included efforts opposing tracking drug ingredients manufactured overseas. Bloomberg noted:

The Deerfield, Ill., company lobbied on bills that would increase tracking of drug ingredients manufactured overseas. In 2008, Baxter was forced to recall all of its blood-thinning heparin drugs because of contamination that was later traced to a Chinese plant.

Baxter has lobbied against requirements for tracking of drugs since at least 2006. Baxter's inability to track lot numbers to institutions that bought its contaminated product is now being used as a defense by Baxter to avoid responsibility for death and injury caused by its contaminated products.

The term ‘drug pedigree’ refers to a record of the chain of custody of a product as it moves through the supply chain from manufacturer to pharmacy. On February 24, 2007, Baxter submitted its official opinions in a letter to FDA to comment on the FDA’s proposed regulations regarding prescription drug pedigree. Baxter’s letter to FDA, Docket Number: 2005N-0510, was signed by J. Andrew Harrison, Manager, Global Regulatory Affairs, Baxter.

In Baxter’s letter to the FDA, Baxter argued for exemptions to be made from proposed pedigree requirements for drugs when in “normal chain of distribution.” Baxter urged FDA to consider the consequences of pedigree requirements on cost to consumers. Baxter also argued against use of new technology and RFID tags to facilitate pedigree record-keeping for drugs. Baxter did support a limited and/or phased-in, risk-based approach to track and trace technology.

According to Bloomberg, Baxter spends about $900,000 a quarter, or over $3.5 million a year, in its efforts to seek favorable treatment from Congress and the FDA.

Yet more safety problems, including contamination, in Baxter products reported today

2010-12-17T09:17:00.000-08:00

More bad news today for patients using Baxter products.

Reuters and other news agencies reported today that according to the European Medicines Agency, current stocks of Baxter International's peritoneal dialysis solutions should be immediately replaced because of possible contamination. (“Update 1 – EU Regulator Warns on Baxter Dialysis Solution,” Reuters, 12/17/10.) Specifically, three normally sterile solutions (Dianeal, Extraneal and Nutrineal) used in patients who have to undergo dialysis because of kidney failure, may be contaminated with endotoxins, (toxic substances from bacterial cell debris), which may cause patients to develop aseptic peritonitis and develop shock among other deadly complications. The contamination is allegedly due to cracked tanks in the production process, which apparently came to light after a number of batches contained unexpected levels of endotoxins.

It was also reported today that U.S. FDA inspectors found serious failures by Baxter Pharmaceuticals Solutions, who used a syringe lot that was supposed to be on a quality assurance hold during filling activities. (“Baxter 483 Notes Hold, Investigation Problems,” FDAnews Drug Daily Bulletin, 12/17/10, Vol. 7 No. 245.) As a result, the FDA issued a Form 483 (a warning letter that lists significant deviations from required “current good manufacturing practices” [cGMPs]). Specifically, Baxter did not initiate a review to see if additional component lots placed on hold had all physical locations included in the hold, the corrective and preventive action associated with this and a similar event was not initiated until more than two months later, and FDA inspectors also found that a syringe lot placed under electronic quality hold was still used by Baxter in the production of a product batch a month later!

Even though it has been 3 years, Baxter has yet to acknowledge any responsibility for deaths of hundreds of Americans in 2007 and 2008 from the tainted Chinese heparin that the company knowingly purchased from an unregulated and uninspected foreign facility in order to save money. Unfortunately, until and unless Baxter is held responsible by the American public and its Justice System, these problems will continue and more innocent lives will be taken.

Judge Finds Contaminated Heparin Unreasonably Dangerous

2010-11-28T09:57:00.000-08:00

Earlier this month Judge Jennifer Duncan-Brice held that Baxter's contaminated heparin was unreasonably dangerous and defective as a matter of law. The Wall Street Journal reported on the ruling.

It may seem self-evident that contaminated heparin was unsafe and dangerous, particularly in light of the massive recall and the deaths caused by the product. Yet Baxter opposed this motion, arguing that the risk utility test made even contaminated heparin safer than no heparin. This argument was soundly rejected by the Judge.

Currently there are about 700 claims pending against Baxter, most for wrongful death. About 400 of the cases are in federal court and about 300 in Cook County, Illinois. While the ruling applies technically only to two cases in Illinois, the reasoning supports the application of the ruling to all cases.

Baxter Sells Heparin Plant

2010-11-28T09:47:00.000-08:00

Earlier this month Baxter announced that it has sold the Cherry Hill plant where it manufactured the contaminated heparin that killed hundreds of people. It also announced that it had reorganized its Medical Delivery unit. The sale of this facility by Baxter continues its efforts to divorce itself from its heparin product. Baxter never relaunched its vial heparin product following the total heparin recall in early 2008.

Baxter had purchased the Cherry Hill facility from ESI Lederle / Wyeth in 2002. According to published reports, Baxter will receive $112 million from generic drug maker Hikma Pharmaceuticals. The sale will also include the Memphis distribution facility that stored and distributed the contaminated heparin to distributors around the country.

Hikma was founded in Amman, Jordan and is listed on the London Stock Exchange.

Baxter announces departure of Peter Arduini, President Med. Del.

2010-10-13T14:54:00.000-07:00

Baxter has just announced that Peter Arduini, corporate vice president and president, Medication Delivery, which was the division that manufactured and sold contaminated heparin, is leaving "to pursue other opportunities." (Press release)

Previously Cheryl White, corporate vice president in charge of Quality, left, following two of her underlings who were, like her, responsible for heparin quality.

Yet Baxter continues to dodge responsibility and deny liability for the hundreds of deaths and injuries caused by its contaminated heparin. Today we filed a brief asking for the deposition of Robert Parkinson, CEO, in the hopes that we can ask him what he meant when he told Congress that Baxter accepted responsibility and that Baxter's contaminated heparin was neither safe nor effective. His congressional testimony has been in sharp contrast to the statements made by his underlings in deposition.

Baxter and its partner SPL continue to live in a state of denial, rejecting responsibility for those who have lost lives, limbs and loved ones to their contaminated products. Yet their intransigence simply solidifies and strengthens our commitment to justice.

Earlier this week we filed the expert report of our China expert, Paul Midler, author of "Poorly Made in China: An Insider's Account of the Tactics Behind China's Production Game." Mr. Midler's insights and opinions are based on years of first hand experience in dealing with the Chinese culture of counterfeiting. After reading his book, we knew we had to get him on board. His book tracks precisely the pattern of misconduct found in this case. I urge everyone to read it. If only Baxter had hired someone like Mr. Midler before buying the cheap stuff.

Baxter Nailed for $500 Million in Punitive Damages from Hepatitis C

2010-05-14T13:42:00.000-07:00

Once again Baxter has put profits over patient safety. First it was pumps, then heparin. Now a Jury has found that Baxter encouraged the use of the more profitable multi-use vials of propofol, resulting in the spread of diseases such as Hepatitis C. Over the past few years there have been large outbreaks of Hepatitis C. Some of these, including an outbreak that infected 100's of people in Las Vegas, Nevada, were traced to the practice of using large multi-dose vials of an anesthetic known as propofol for multiple patients.

Propofol is used as an anesthetic in performing endoscopies. Baxter and Teva made more profits by selling the larger vials of Propofol. However this resulted in endoscopy centers using the same vial of propofol on multiple patients, thereby spreading diseases among patients.

Plaintiff argued the 50-milliliter vials had no place in endoscopy centers, where a fraction of that amount is required for the routine procedures performed there.

The jury agreed, and on Wednesday found both companies liable for failure to warn and for breach of warranty. They awarded more than $5 million in compensatory damages. They also agreed that punitive damages were warranted, ultimately deciding during deliberations Friday that Teva Parenteral Medicines should pay $356 million and Baxter Healthcare Corp. should pay $144 million.

The brave men and women of Nevada who served on this jury have sent Baxter and Teva a pretty strong message. Jury service is the highest duty of citizenship, and the last bulwark against corporate misconduct and injustice. Apparently Baxter didn't get the message. According to the Las Vegas Sun, Baxter's public relations person, Erin Gardner, blamed the doctors and the endoscopy centers for "misusing" the products Baxter distributed.

Baxter has tried to spin its misconduct in the heparin litigation in a similar fashion. In a motion filed recently Baxter had the temerity to blame the health care facilities for using contaminated heparin, even though Baxter kept most of its product on the market and told the FDA it should stay on the market. Even though Baxter botched the recall, it blames the health care facilities for using its defective products.

Some people may have contracted hepatitis C as a result of Baxter and Teva's misconduct and still are unaware they are carrying the disease or how they got it. There are many more cases set for trial. I spoke with Robert Eglet, the Las Vegas attorney who brought Baxter and Teva to justice. He confirmed that Baxter refused to offer a penny to settle the case. Mr. Eglet believes there are many more people who have contracted Hepatitis C from the same improper use of multi-use vials and who are unaware of either the fact that they are ill, or the source of the disease.

Baxter CEO received $8.6 million in 2009

2010-03-21T10:43:00.000-07:00

According to the latest proxy statement filed by Baxter International Inc., CEO Robert Parkinson was paid $8.6 million in 2009.

Though the bonus was more than $2.5 million and reflected the "company's strong financial performance" last year, it was lower than the prior year in part because "the company continues to address certain quality issues," the company said in the proxy statement.
According to an online story by Bruce Japsen:

Baxter has been dogged by quality issues with its Colleague infusion pumps and has yet to begin selling its blood thinner heparin again on the U.S. market due to manufacturing issues uncovered two years ago at a plant in China.

This is somewhat accurate. While it is true that Baxter has been unable to get its heparin vial products back on the market, it was continuing to sell its premix products until recently, when they were withdrawn due to the inability of the premix to meet the new standards.

A recent report online described problems Baxter has been having with its premix:

The drugmaker has since been grappling with a new problem, an updated test that gives potency readings for the drug that are 10% higher than an older version, according to Baxter spokeswoman Kellie Hotz.

“It's taking us a bit longer than anticipated to meet the requirements of the new test. We've been having some challenges, and we've been talking with the FDA on how we can achieve this new USP standard, to adjust the drug amount to get within the range that's required,” Hotz said.

Hotz clarified that the heparin currently being tested is a pre-mixed product, and is not the concentrated vial product that was at the center of the FDA's investigation last year. “That's not something we're producing anymore,” she said.

This ModernHealthcare article fails to articulate whether or not Baxter is continuing to try to get back on the market with its vial heparin. The statement from Hotz seems to imply that Baxter has finally given up its efforts to requalify for the manufacture of heparin.

The Baxter 2010 Shareholder Proxy showed that the total value of the CEO's compensation, including stock options and pension, dropped slightly to $14.3 million from $14.8 million in 2008. It also shows the compensation for each of the directors and confirms that General Counsel Susan Lichtenstein resigned.

FDA Testifies before Congress

2010-03-13T14:56:00.000-08:00

Two separate Congressional Committees heard testimony this week from FDA officials. In both hearings the specter of Baxter's contaminated heparin loomed large. Sadly, two years later the FDA has done nothing to control scofflaws like Baxter Healthcare and SPL from acting responsibly to control supply chains and track their products.
Baxter sourced its heparin in China but failed to control or even understand its supply chain. Nor did it keep track of where the specific lots of contaminated heparin ended up.
Both of these issues came before Congress this week.

The hearing in the House of Representatives was held before the House Committee on Energy and Commerce. The opening statement of Chairman Henry Waxman deserves wider attention:

We cannot forget the lessons of the 2007 heparin contamination catastrophe which resulted in numerous severe allergic reactions and the deaths of at least 80 Americans. In that case, the active ingredient was manufactured in China. Thanks to the excellent work of the Subcommittee on Oversight and Investigations in 2008, we know that this is not a unique situation: the U.S. drug supply is increasingly sourced from abroad.
In order to market a drug in the U.S., FDA must ensure that the drug meets our appropriately high safety standards. So when ingredients or finished drug products are manufactured abroad, FDA needs to expand its reach if the Agency is to meet its responsibilities.
As heparin illustrated, FDA clearly needs more authorities and more resources to do a better job policing the safety of imported products. But what heparin also demonstrated is that we cannot expect FDA alone to do this job. We need to place a greater onus on all manufacturers to oversee the safety of their own products. ...

...
I hope FDA will tell us today about what the Agency believes it needs to protect us from another heparin disaster.

So what did the FDA state? Joshua M. Sharfstein, M.D., Principal Deputy Commissioner for the FDA provided the agency's testimony. While the FDA has opened more offices overseas and intends to institute a trace program to identify the location of prescription drugs, these steps appear to me to be more about helping big pharma make more money than patient safety.

Here is what the Pugh Prescription Project had to say about the hearing:

Two years after dozens of Americans lost their lives to contaminated heparin, we are still not able to protect U.S. consumers from many of the risks of pharmaceuticals manufactured in foreign factories. It is time for Congress to take action to better protect health. FDA must be given the tools it needs to protect our drug supply, which enters the home of nearly every American each day. Congress is right to focus on this important issue and today's drug safety hearing is a step in the right direction.

The FDA has received reports of 149 Americans who died after receiving heparin, all of whom suffered one or more symptoms associated with a known contaminant. The deaths occurred over a 17-month period in 2007 and 2008. Heparin, a blood thinner contaminated during manufacture in China, is an example of the movement of pharmaceutical manufacturing to the developing world and the increased risk that American consumers will be exposed to sub-standard and harmful drugs. A 2007 report by the U.S. Government Accountability Office estimated that 80 percent of the active ingredients in U.S. drugs are now made overseas, and that FDA has little ability to inspect foreign manufacturing sites. Health and Human Services Secretary Kathleen Sebelius and FDA Commissioner Margaret Hamburg have both said that the agency needs additional authority and resources to protect Americans.

The Senate hearing was before U.S. Senator Herb Kohl. Senator Kohl held a hearing on the Food and Drug Administration (FDA) budget and heard testimony from FDA Commissioner Dr. Margaret Hamburg about the agency’s priorities for the next fiscal year. Kohl is the chairman of the Senate Agriculture Appropriations Subcommittee which has jurisdiction over funding for the FDA.
The FDA claimed it plans to provide increased protection for patient safety, increases are proposed to improve the safety of imports and high-risk products, expand partnerships with public and private entities, and to slightly increase FDA’s capacity to review generic drug applications. The increased costs will come from taxpayers of course.
Why should taxpayers pay the addtional costs to inspect foreign based factories set up overseas by companies like Baxter and SPL who are trying to make more profits by flying under the regulatory radar and using cheap products? I submit that the costs of inspecting these foreign operations ought to be born by the companies who import these drugs. Simply impose a tax on imports to finance the costs of inspections overseas. Taxpayers could continue to fund the costs of domestic inspections. This would protect U.S. jobs and place the costs where they belong.

Similarly, the FDA and Congress should require each manufacturer to bear the cost of tracking the end use of each product it manufactures. This is simply good safe distribution practice. While we will be able to painstakingly prove that the contaminated heparin ultimately was distributed to each of the facilities where so many patients became ill and many died, for purposes of prompt recall and patient safety manufacturers like Baxter ought to be required to trace each lot to the end user.

Hope for the Holidays

2009-12-24T08:21:00.000-08:00

As the holiday season quickly approaches, we remember the victims of the heparin tragedy that occurred almost two years ago this winter. In a season that is supposed to be filled with joy and peace, many of our clients still struggle with the emptiness left from the loss of their loved one, as well as frustration from Baxter’s ongoing refusal to acknowledge and take responsibility for the harm it caused these families.

However, the holiday season is one that is filled with hope. While taking on a powerful billion dollar drug company is not an easy or quick task, there is an amazing team of attorneys, doctors, scientists and other victim advocates, who are working every day to expose Baxter’s lies and to hold it accountable for its decision to put corporate profits over people’s lives. We will not waiver or tire in our quest for truth and justice for the hundreds who lost their lives. As Martin Luther King, Jr. said, “True peace is not merely the absence of tension: it is the presence of justice.”

As our important fight continues, we wish all of the families hope, strength and perseverance this holiday season.

Heparin Cases continue to be Filed

2009-12-08T17:14:00.000-08:00

As the two year anniversary of the discovery of the Heparin Disaster approaches more and more cases are being filed. At this point it appears that there will most likely be 700 - 1000 cases filed on behalf of those who literally lost life and limb as a result of the failure of Baxter Health Care to understand the product it was selling.

Many clients and other lawyers are interested in understanding what a typical case looks like.

1. Method of Administration. About 90% of the cases involve Intravenous administration of the heparin, while the other 10% of victims received their heparin subcutaneously. Typically a subcutaneous injection will, understandably, not involve as sudden or initally severe reaction as the reaction from a bolus intravenous dose, but the results can be just as fatal.

2. Purpose of Administration. About 85-90% of affected patients received heparin for preventive, or prophylactic, purposes, while therapuetic purposes accounted for 10-15% of the injuries. These can be further broken down to Dialysis patients (70-75%) and cardiac patients (10-15%).

3. Type of Injury. About 80% of the injuries involve Contact / Complement Anaphylactoid-type Reaction constellation of symptoms. These include the following:
i. Hypotension (drop in blood pressure)
ii. Diarrhea
iii. Nausea
iv. Vomiting

Another 15% involve Heparin Induced Thrombocytopenia (HIT).

5% of the cases are so called "Supra-additive Effect" cases, involving bleed out cases or other coagulation issues.

4. Degree of harm. Death is the injury in 75% of the cases. Of those not involving death, most are Serious Permanent Injury (mostly HIT) (15%).

5. Time Frame. The large majority of cases occurred after September 15, 2007 and prior to April 15, 2008.

If you believe a client or loved one died during this time frame from symptoms described here, while undergoing dialysis or cardiac surgery, you should immediately seek skilled review of the medical file. You can reach us during regular hours toll free at 888-841-9623. Or you can email me at david@toledolaw.com or our heparin paralegal Serenity at serenity@toledolaw.com.

Heparin Disaster Lawyer Update

2009-10-16T12:22:00.000-07:00

The Heparin Litigation continues to move ahead, in spite of the efforts of Baxter and SPL to avoid responsibility for their misdeeds. Recently I took the deposition of Dr. Francois Lebel, Vice President for Baxter. Next week we depose Ted Roseman, a former Baxter official also involved in the heparin investigation.

The overriding principle of the litigation so far has been the refusal of Baxter to accept responsibility for its product, and the refusal of Baxter to admit the obvious: that their contaminated heparin killed hundreds of people.

A recently published article on contaminated heparin authored by one of Baxter's own experts, Robert Linhardt, stated:

The presence of OSCS within heparin likely led to clinical manifestations, most prevalently, hypotension and abdominal pain, leading to the deaths of several dozens of patients.

The actual FDA count, which is only a fraction of the actual number, is well over 100 deaths associated with the contaminated heparin. Yet Baxter continues to deny that anyone died or became ill from their contaminated product. They claim they have no responsibility because their product met the then current specifications.

Other manufacturers were performing tests for purity and did in fact detect the contamination, saving the lives of their customers. Yet Baxter claims it had no duty to do so. Published literature shows that at least since 1989 the existence of contaminants such as dermatan sulfate in heparin were known and identified through NMR analysis. For years the literature has encouraged NMR analysis of heparin. But Baxter never tested any of its heparin by NMR.

Other recent articles and research by Dr. Fareed of Loyola and others have established that the contaminated heparin contained more contaminants than just oversulfated chondroitin sulfate (OSCS), and in fact that the contamination was done intentionally and by someone with a high level of knowledge about heparin anticoagulation properties and molecular structure.

The Lindhardt article quoted above was based on research done by Baxter in an effort by Baxter to prove that their supplier, SPL, did not manufacture the contaminant from heparin byproduct. Heparin byproduct is the waste material generated in the refining of heparin crude into heparin API (active pharmaceutical ingredient).

Heparin byproduct, like the heparin crude, contains a number of glycosaminoglycans (GAGs). These sugar molecules include heparin, heparan sulfate (HS), dermatan sulfate (DS) and chondroitin sulfate (CS). Some scientists have found evidence of all of these heparin byproducts in various lots of contaminated heparin, often in an oversulfated form.

The oversulfated forms are not found in nature. Rather they are created by chemical sulfation. It is also possible, and indeed likely, that the sulfation step was followed by a desulfation step, thus making the number of sulfation units on the various sulfated GAGs more uniform. This step would have made the contaminant even more difficult to detect, and may even assist in more uniform anticoagulation. As pointed out by Dr. Lindhardt and his coauthors (see page 5 of the article) partially sulfonated GAGs, especially heparan sulfate, are difficult to detect and separate from heparin, even using modern detection techniques. These experts should know. Some of them hold patents on the sulfation / desulfation of GAGs.

ZKB Partner to Moderate AAJ Seminar

2009-09-09T05:59:00.000-07:00

The American Association for Justice has honored our firm, by asking one of our partners and drug litigation attorneys, Pamela A. Borgess, to act as moderator for their annual “Litigating Toxic Tort, Pharmaceutical and Medical Cases” Seminar to be held on September 24-25, 2009 in Las Vegas at the Palazzo Hotel. Ms. Borgess will also present an update on the ongoing litigation involving the tainted Chinese heparin that killed hundreds of Americans in 2007 and 2008.

This well-regarded seminar is attended by Plaintiff Attorneys from across the country, who come to get inside information on innovative trial techniques, strategies, and practices that leading attorneys have used to take on industry giants. Agenda highlights also include the latest updates on hot topics such as Hydroxycut, Paxil Birth Defects and Avandia; Electronic Discovery, and new topics such as "Facebook and Other Social Networking—What They'll Find Out About Your Client." Attendees will also learn how to access and maximize the necessary resources to go up against negligent companies.

Plaintiff Attorneys who are interested in this seminar can get more information and register at www.justice.org/education/pharmaseminaror by calling AAJ Education at 800-622-1791 or 202-965-3500, ext. 612.

**Open Only to Plaintiff Attorneys**

Conflict of Interest at the FDA

2009-08-12T16:10:00.000-07:00

The Wall Street Journal reported today that the FDA was investigating conflict of interest allegations from a Momenta competitor, Amphastar.

The investigation of Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, stems from an ethics complaint filed by Amphastar Pharmaceuticals Inc., a California company that says it has been delayed in its six-year effort to win approval for a generic version of Lovenox, a multi-billion-dollar blood thinner.

Last February Woodcock co-authored a paper with Momenta scientists claiming that OSCS was the contaminant in heparin. It has never been made clear why Woodcock selected Momenta scientists to the special task force. The papers have been challenged as lacking scientific rigor and leave many questions unanswered.

There may be a lot more to this story and a lot more questions need to be asked. Contaminated heparin killed many people. There are many questions which no one has answered (or even asked) but which we are and will address in the litigation.

There are millions of people exposed to this contamination. Many of them died and have claims that have not been filed. Most of their families probably do not even realize their loved ones were exposed to this contaminant.

The statute of limitations is rapidly approaching for many people. The worst contamination was in heparin released after September 15, 2007. If you had a loved one who died after this date while on dialysis or while undergoing heart surgery you should immediately contact us or some other experienced attorney involved in the heparin litigation.

If you are an attorney with a client who died while undergoing dialysis or heart surgery between October 2007 and April of 2008 feel free to contact me at david@toledolaw.com. Or call toll free 888-841-9623.

What Exactly is an MDL?

2009-07-10T14:28:00.000-07:00

We are commonly asked by clients, referring attorneys and the media what is an MDL and how does it work? Therefore, the purpose of this blog is to help answer those questions.

Q. What is an MDL?

You may have heard of the Vioxx, Bextra, Celebrex and Heparin "MDLs" in the media recently. So what exactly is an "MDL"? MDL is an abbreviation for Multidistrict Litigation. It is not the same thing as a class action.

In a class action, one or more people or entities, called “Class Representatives,” sue on behalf of people who have similar claims. These latter people, called the “Class” or “Class Members,” are not individually named in the suit. For example, one person might sue on behalf of thousands of other people who were overcharged for a product as a result of an illegal price-fixing conspiracy, or by a member of a company for illegal hiring or salary practices. In a class action, if the named plaintiff (the “Class Representative”) wins at trial or resolves his/her claims, then all of the claims of the un-named Class members are likewise resolved, with the exception of those that exclude themselves from the Class.

Multidistrict litigation is very different from a class action. Although MDLs may involve a host of categories, such as airplane crashes, train wrecks, hotel fires, asbestos, fraud, and price fixing, many MDLs involve defective medical drugs and devices. To explain how multidistrict litigation works, it is easiest to give an example. Assume that a dangerous drug has just been pulled from market because it was contaminated or manufactured improperly, resulting in hundreds of injuries and/or deaths. As the news of the disaster spreads, attorneys begin filing suits all across the country on behalf of the victims. If enough suits involving the drug are filed in federal court against the same drug company, a federal court, the drug company and/or a plaintiff’s lawyer might ask the Judicial Panel on Multidistrict Litigation to “consolidate” all of the cases in an “MDL” before a single judge.

Although the Clerk of the Judicial Panel on Multidistrict Litigation is permanently stationed in Washington, D.C., the panel meets in different cities in the United States on a periodic basis to review requests that cases be consolidated. After an MDL request is made, a hearing will be held to determine whether to create the MDL proceeding.

If the panel agrees after the hearing to create an MDL, it will also decide where the MDL will be located. The judge who gets all the federal cases assigned to him is known as the "transferee judge." The judges throughout the United States who send cases to the MDL judge are known as the "transferor judges" or "transferor courts." The panel’s selection of the transferee court that is in charge of the MDL may affect the outcome of the litigation. There are friendly jurisdictions and not-so-friendly ones. Parties try to influence the panel by proposing various transferee courts.

Generally, the transferee court (also called the “MDL court”) will then set standing orders or pretrial orders informing the lawyers involved of the ground rules, deadlines and procedures that the Court expects the litigants to follow. Although there may be hundreds or even thousands of cases in an MDL, if the Court makes a ruling, it generally applies to all of the cases. Indeed, this is one of the purposes of the MDL, as it is much more efficient to have one ruling on a general issue than possibly hundreds of conflicting rulings by many judges across the United States on the exact same issue.

Typically hierarchies of plaintiff “executive” and/or “steering” committees made of leading and experienced drug litigation lawyers, such as our firm, are then appointed. These committees are often referred to simply as the “PEC” and/or the “PSC.” These PEC and/or PSC are responsible for representing all the claimants in the MDL and managing the substance of the litigation.

Under the supervision and direction of the PEC and/or PSC, volunteer lawyers will assist in reviewing documents, taking depositions, writing briefs, and developing and prosecuting the common aspects of the litigation. Ultimately, they prepare and provide to all MDL plaintiffs a trial package consisting of depositions, documents and other materials that the plaintiff’s attorney will need to take his or her case to trial.

In an MDL, all of the information-gathering and investigation is done at the same time on behalf of all of the plaintiffs. This is referred to as the “discovery” process and is designed to obtain the basic facts of the case. The MDL Judge also rules on discovery disputes and decides critical issues, including whether there is sufficient evidence for the claims to proceed to a jury trial.

During and/or at the conclusion of this process, the MDL Judge often works with both sides in an attempt to reach a global settlement (which if successful, is often a matrix based on various factors involved in each specific case and decided by neutral masters or arbiters who have experience in this area). To assist in trying to reach a settlement, the MDL Judge may even have a few jury trials on cases that were actually filed in his or her own court. Some MDL cases are settled individually, others as a group. Each claimant is typically free to accept or reject the award, but if they accept it, then they give up their claim and release the drug company of any further liability.

It is important to understand, however, that a settlement does not always occur in an MDL. If settlement cannot be reached, each of the cases is sent back for trial, to the court where it was originally filed. The only cases that would not be remanded are those cases originally filed in the court with the MDL Judge is seated. Unlike a class action where there is only one trial, MDL cases are tried individually. That is, each plaintiff gets his or her day in court.

Q. What experience does Zoll, Kranz & Borgess, LLC have with MDLs?

Our firm has been recognized on a national level for its work in MDLs. On February 14, 2008, Zoll, Kranz & Borgess, LLC was the first law firm in the nation to file suit against Baxter Healthcare Corporation and other related companies regarding contaminated batches of its drug, Heparin, and is now leading Heparin MDL 1953 in its position as Liaison Counsel and Chair of the Plaintiffs’ Executive Committee. In April of 2008, the firm was honored to have three of its clients speak before Congress at an investigational hearing on tainted Heparin entitled, “The Heparin Disaster: Chinese Counterfeits and American Failures.” Their stories have also been featured in news media, including on ABC Nightly News, Nightline, CNN, Bloomberg News and in Time Magazine.

Zoll, Kranz & Borgess, LLC was also one of the first firms to file suit this year regarding the birth control drugs, YASMIN and YAZ, and will likely also seek a leadership role in any national litigation.

Other MDL involvement includes, but is not limited to, the Plaintiffs’ Steering Committee for In Re: Yamaha Motor Corp. Rhino ATV, MDL No. 2016, acting as special counsel on behalf of Plaintiffs in In re: Inter-Op Hip Prosthesis Liability Litigation (Sulzer) MDL Docket No. 01-CV-9000, on the Discovery Committee in In re: Vioxx® Products Liability Litigation MDL Docket No. 1657, and involvement in Ford Crown Victoria, Bextra/Celebrex, and other mass tort litigation projects.

Q. What are the pros and cons of multi-district litigation?

Suing a billion dollar drug company with almost unlimited resources who will fight at every turn is expensive. A single victim would unlikely be able to finance such litigation alone. The combination of claims in a single forum increases the plaintiffs’ leverage by permitting counsel to pool their resources and to work for the plaintiffs’ common benefit. Thus, one purpose of an MDL is to make it cheaper for individual plaintiffs by spreading the costs of information gathering and trial preparation among hundreds or even thousands of plaintiffs. Although Zoll, Kranz & Borgess, LLC does not require its clients to reimburse it for costs if the case does not result in settlement or a favorable verdict, if there is a settlement or favorable verdict, costs come out of the settlement or verdict amount and an assessment is paid to the MDL. Thus, an MDL allows each plaintiff’s costs to be substantially reduced and avoids one client bearing a disproportionate share of the costs that benefit all such clients.

An MDL also promotes efficiency and consistency of rulings. Instead of 10, 100 or 1,000 cases pending in different courts across the county, the litigation is coordinated and important decisions are made by a single court saving substantial time and expenses.

However, there are disadvantages, too. The primary disadvantage is the length of time it takes to resolve an MDL. Although certainly litigation can resolve at any point, MDL litigation can often drag out for 4-5 years, or even more. Thus, MDL claimants should not have an expectation of a quick or guaranteed resolution of their case.

Q. Can a lawyer avoid having a case consolidated under multidistrict litigation rules?

Most plaintiff attorneys filing a case in state court against an out-of-state drug manufacturer may have no choice but to become part of an MDL proceeding, as the case will likely be pulled to federal court by the drug manufacturer.

However, if the attorney believes it is in his or her client’s best interests, there may be some appropriate state jurisdictions that may avoid being pulled into the MDL. (Although in an effort to be fair to the MDL lawyers who expend substantial time and effort for common-benefit work, some state court judges may order assessments in non-MDL cases to be paid to the MDL regardless.)

In every litigation, Zoll, Kranz & Borgess, LLC carefully considers all federal and state jurisdictional options to determine which is in their clients’ best interests.

If you have further questions or concerns about MDLs, please do not hesitate to contact us at our toll-free number (888) 841-9623 or or via email to pamela@toledolaw.com. (If you choose to correspond via email, please keep in mind that sometimes spam filters or computer problems block correspondence. Therefore, if you do not receive a response to your email by the next business day, please call us.)

Bad Chinese Heparin Supplier Cited by FDA Again

2009-05-14T07:21:00.000-07:00

Despite the deaths of hundreds of Americans last year from tainted Chinese heparin, Scientific Protein Laboratories (“SPL”) has still not cleaned up its act and has been cited again this month for violating safety regulations.

SPL supplied the component ingredients in the bad heparin, called “active pharmaceutical ingredients” ("API") to Baxter from its facility in China. However, despite Baxter and SPL's representations to the public that they were taking great care to assure the safety of their drugs, both companies knew that the Chinese facility had never been inspected by the FDA or any other governmental agency.

Last year, upon investigating the cause of the deaths, the FDA discovered the existence of the Chinese facility. When the International Compliance Team for the U.S. FDA performed an inspection of the Chinese facility from February 20 – 26, 2008, multiple and severe violations were found, including, but not limited to, the lack of any assurances that the processing steps used to manufacture heparin were capable of effectively removing impurities.

As a result, the FDA issued a “Form 483” to SPL last year. A Form 483 is referred to as “Notice of Inspectional Observations.” The 483 is issued by an FDA field investigator after an on-site inspection of a facility and documents significant and serious violations from regulations called “Good Manufacturing Practices” (“GMP”) regulations. These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations protect the consumer from purchasing a product which is ineffective, dangerous or contaminated.

After hundreds of Americans died from bad heparin supplied by its facility, you would think that SPL (who is now being defended by Baxter in the ongoing litigation), would have learned its lesson. You would think that the company would insist that its facilities strictly adhere to safety regulations to avoid something like this happening again. Unfortunately, such is not the case.

The FDA recently issued another Form 483 for SPL’s United States plant in Waunakee, Wisc. (See May 13, 2009, FDAnews Drug Daily Bulletin “Scientific Protein Laboratories Gets Form 483 for Heparin Plant,” Vo. 6 No. 93.) The FDA cited six violations of GMP regulations, including for example, incorrect or inadequate data and reports, and failure to follow safety protocols, including the cleaning of tanks used in the manufacture of heparin.

SPL’s ongoing and callous disregard for safety procedures is an absolute insult to every victim of the heparin disaster. The fact that Baxter is defending this company and asking that both itself and SPL not be held responsible for the deaths of innocent men, women and children, is likewise sickening. These companies must be held responsible. There must be consequences when companies balatantly ignore safety regulations, thereby sacrifing human lives for corporate profit. If not, as evidenced by SPL's refusal to learn from the heparin tragedy, history is bound to repeat itself.

The Games Drug Companies Play

2009-05-08T06:44:00.000-07:00

Elsevier, the publisher of many medical journals relied upon by experts in drug litigation, made a chilling announcement yesterday:

Philadelphia, PA, 7 May 2009 - Elsevier, one of the world’s leading publishers of scientific, technical, and medical (STM) information products and services, announced today that Michael Hansen, CEO of Elsevier’s Health Sciences Division, issued the following statement in light of recent allegations of improper Australia based sponsored journal publication practices between 2000 and 2005:

“Elsevier prides itself on operating its business in the most ethical, honest and transparent manner possible. We have been stewards of the scientific record for more than 125 years and we take our role in advancing medical and scientific research seriously.

It has recently come to my attention that from 2000 to 2005, our Australia office published a series of sponsored article compilation publications, on behalf of pharmaceutical clients, that were made to look like journals and lacked the proper disclosures. This was an unacceptable practice, and we regret that it took place.

We are currently conducting an internal review but believe this was an isolated practice from a past period in time. It does not reflect the way we operate today. The individuals involved in the project have long since left the company. I have affirmed our business practices as they relate to what defines a journal and the proper use of disclosure language with our employees to ensure this does not happen again.

We will continue to partner with all scientists and clinical investigators, including those in the pharmaceutical industry, to help communicate the findings of high-quality, peer-reviewed medical research. We have strict disclosure rules in place so that readers are aware of any financial interests behind a specific article or journal, or when entire compilation products are created for pharmaceutical marketing purposes.

I understand this issue has troubled our communities of authors, editors, customers and employees. But I can assure all that the integrity of Elsevier’s publications and business practices remains intact.”

The AP reported that "Those publications included one titled The Australasian Journal of Bone and Joint Medicine, which heavily favored Merck & Co.'s osteoporosis drug Fosamax and the painkiller Vioxx."

Why is this so troubling? For a number of reasons. First, because it shows how invidious the big drug companies are in pushing their products, even when they know or have reason to know that those drugs have dangers which have not been fully disclosed.

Second, because medical journals are used by expert witnesses in cases such as the Heparin Litigation to support claims or oppose claims that a particular drug causes harm, or that it has been improperly marketed or lacked necessary warnings.

In essence the drug companies use their massive propaganda machine to push doctors into prescribing their drugs and to prevent those who are injured or killed by the drugs to obtain fair compensation.

In Vioxx Merk paid out over $4.6 billion to settle the cases, even after they had succeeded in defending many of the cases at trial. Articles in medical journals about the efficacy of Vioxx and the risks of harm were relied upon by experts for both sides in those trials.

Similarly, in the Heparin Litigation, many of the articles that have been written to date on contaminated heparin include authors whom we know are on the payroll of Baxter. We have made that discovery from a review of the confidential documents produced by Baxter, even though the articles themselves fail to make those disclosures.

The truth can only be learned through vigorous, demanding and diligent review of documents and careful depositions of witnesses. It is possible that this latest revelation could lead to further challenges of the Vioxx settlement, particularly if any experts relied upon the challenged articles in their testimony.

We will continue to vigorously pursue Baxter and the other defendants to hold them responsible for the harm caused by the dirty Chinese Heparin they sold across the continent. On Monday we have a hearing to determine a trial schedule. The papers we filed yesterday asked the Court to set the first cases for trial in the Spring of 2010.

FDA Pushed for Answers Regarding Bad Chinese Heparin

2009-05-06T12:35:00.000-07:00

Like many Americans, including the families of hundreds of innocent victims killed from tainted Chinese heparin last year, Rep. Joe Barton, (R- Texas) is dissatisfied with the lack of information from the FDA regarding the heparin debacle.

Barton, (the ranking member on the House Energy and Commerce Committee), has asked the investigative arm of Congress, the Government Accountability Office, to investigate the FDA’s response to the heparin debacle. He has also sent a letter to Acting FDA Commissioner Joshua Sharfstein, demanding that the FDA turn over any databases relating to their investigation. (See 05/06/09 Article from NASDAQ, Jared A. Favole, “Rep. Barton Presses FDA for Information about Tainted Heparin.”)

An unidentified staffer for the Energy and Commerce Committee is quoted as saying, “We don’t seem to be any further along a year later from understanding [the heparin debacle]. What are they doing about it? Is this an acceptable practice in China?”

Last year, Barton also sent a letter to the former FDA Commissioner, Dr. Andrew von Eschenbach, seeking answers on why the agency took six months to confiscate 11 tainted batches of heparin from Celsus Laboratories (located in Cincinnati, Ohio) even though an inspection in April found that the company's recall was inadequate. (See Dec. 15, 2008 Blog, “Rep. Barton Questions FDA’s Six Month Delay in Seizure of Tainted Heparin.”) At the time, FDA officials said they could not give details because of "an ongoing investigation."

While we applaud these continuing efforts by Congress to get answers for the victims of the tragedy, similar inquiry should also be made of the responsible drug companies, including Baxter. It was Baxter who decided to purchase the cheaper, bad Chinese heparin from a Chinese plant that it knew had not been inspected by the FDA. Why? Corporate Greed. While the FDA certainly has a duty to provide information to the American public, we should not loose sight that it is ultimately the drug companies, including Baxter, who are responsible for ensuring the safety of their supply chains.

Barton wants the FDA to respond to his letter within two weeks. We will continue to keep you updated as to any response from the FDA.

Baxter Files its Trial Proposal - Seeks to delay trials until 2011

2009-05-04T10:46:00.000-07:00

Late last week Baxter filed a Scheduling Proposal with Chief Judge James G. Carr here in Toledo, seeking to delay any trial in the Heparin Disaster litigation until June 1, 2011. We will be filing our response later this week, and will present argument on the issue in a hearing set for May 11th in Cleveland.

In our filing we will try to push for a quick trial date so that the victims of the Heparin Disaster will get their day in court sooner rather than later.

Sadly the goal of Baxter and other big pharma companies whose drugs cause harm typically follow this same pattern of delay: Delay the date of reckoning, delay the date of payment as long as possible, and then pay as little as possible to those you have injured. The only tool we have to bring these big companies to justice is the hammer of a jury trial. So it is our task to prepare for that trial as quickly and diligently as possible.

While we now have received a million pages of documents from Baxter and SPL, almost all have been marked confidential. This prevents us from sharing the content of those documents until the time of trial.

What we can say is that there is nothing good in these documents for Baxter or SPL.

Once trials begin they will be primarily wrongful death cases. The most serious harm caused by the contaminated heparin were wrongful deaths of people who were undergoing dialysis therapy or heart surgery between October 1, 2007 and April 1, 2008. We expect that most of the early trials will focus on cases that meet these criteria.

If you lost a loved one during this period of time who was undergoing dialysis or heart surgery you should immediately seek legal counsel. Some states have one year statutes of limitation while other states may have 2 years, which means that if a claim isn't filed promptly it can be time barred.

Baxter Releases Live Avian Flu Virus

2009-04-29T16:26:00.000-07:00

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Baxter International, the company that brought us contaminated Chinese heparin, has struck again. The Toronto Sun reported earlier this year that it released live flu virus material in Austria.

The World Health Organization is closely monitoring the situation. The contaminated product was a mix of H3N2 seasonal flu viruses and unlabelled H5N1 live avian flu viruses. The viruses could have combined to create an even more dangerous hybrid.

People familiar with biosecurity rules are dismayed by evidence that human H3N2 and avian H5N1 viruses somehow co-mingled in the Orth-Donau facility. That is a dangerous practice that should not be allowed to happen, a number of experts insisted.

Accidental release of a mixture of live H5N1 and H3N2 viruses could have resulted in dire consequences.

While H5N1 doesn’t easily infect people, H3N2 viruses do. If someone exposed to a mixture of the two had been simultaneously infected with both strains, he or she could have served as an incubator for a hybrid virus able to transmit easily to and among people.

That mixing process, called reassortment, is one of two ways pandemic viruses are created.

Amazingly, Baxter refused to reveal information about how the accident happened because of fear of revealing “trade secrets.” According to the Toronto Sun:

Earlier this week [Baxter spokesman Christopher] Bona called the mistake the result of a combination of “just the process itself, (and) technical and human error in this procedure.”

He said he couldn’t reveal more information because it would give away proprietary information about Baxter’s production process.

The cavalier attitude of Baxter towards the release of live flu virus is the same attitude we see in the Heparin case. Baxter failed to secure its supply lines, failed to adequately test, failed to adequately inspect, and when the contamination was discovery, failed to perform an adequate recall. In its quest to grasp the low hanging fruits and profits it ignores the safety of those it should be protecting. It is the same attitude that has plagued Baxter for decades.

For some very interesting history of Baxter International, go to Wikipedia and read the history of Baxter International.

Grassley, Kennedy Introduce Bill to Protect Against Contaminated Imported Drugs

2009-04-27T07:13:00.000-07:00

Sens. Chuck Grassley (R-Iowa) and Edward Kennedy (D-Mass.) introduced new legislation in Congress last week that would broaden the FDA’s inspection and enforcement authority with respect to foreign drugs and medical devices. To view the press release on the proposed legislation, click here.

This legislation, referred to as “The Drug and Device Accountability Act of 2009,” would give the FDA money to conduct foreign drug plant inspections. As stated by Sen. Grassley, “An increasing number of drugs and ingredients for pharmaceuticals are being manufactured in other countries, yet studies show the FDA doesn’t know how many foreign plants are subject to inspection, and the FDA conducts relatively few foreign inspections each year. Our legislation is a practical solution to beefing up the FDA’s inspection work, both domestically and abroad, and holding the FDA accountable for its review of medical devices, where questions have been raised about the agency’s work.”

The proposed legislation would also give the FDA the power to detain products from foreign plants when inspectors believe that a drug, (such as the dirty Chinese heparin that recently killed hundreds of Americans), has been adulterated. This is important because the FDA currently has no alternative, but to rely on the overworked and unfunded U.S. Customs to handle the actual seizure of suspect imported goods.

The bill would also give the FDA the power to issue subpoenas allowing the agency to obtain internal business records from careless drug manufacturers who ship production of their drugs overseas in order to increase corporate profit and avoid regulation meant to protect the American public. As discussed previously in our May 21, 2008 blog, “FDA Needs Subpoena Power,” without this ability, the agency is powerless to obtain internal business records from a negligent company who has allowed contaminated drugs to be sold, (such as Baxter who sold the dirty Chinese heparin from a foreign plant that Baxter knew had never been inspected by the FDA or any other governmental agency).

The FDA is one of the few Federal agencies that currently lacks subpoena power. As previously noted by Rep. Bart Stupak, (Chairman of the investigations panel of the House Commerce Committee), in a letter last year to the former FDA Chief, “An integral part of ensuring the FDA can protect the American people is equipping the Agency with proper resources and enforcement authority it currently lacks….In some cases, the FDA does no testing of its own, and in making decisions it must rely entirely on the test results submitted by manufacturers. Without subpoena power, the only way the FDA can ensure it has the information it needs it to threaten criminal prosecution by the Justice Department if it finds critical data is withheld.”

Finally, the proposed legislation would also require certification of applications for drugs and devices needing FDA approval and establish civil and criminal penalties for false or misleading certifications.

To fund the new powers, the bill would levy fees on plant inspections, thus putting the cost on the drug manufacturers who decide to send production overseas.

This regulation would likely have prevented the Heparin debacle and saved the lives of hundreds of innocent Americans. As such, we commend and support this important legislation.

Sherrod Brown speaks out for Heparin Victims

2009-04-23T12:23:00.000-07:00

Ohio Senator Sherrod Brown struck a blow for victims of dirty Chinese Heparin yesterday in a speech in our nation's capital. Speaking before the Washington International Trade Association and the George Washington University Elliot School for International Relations, Senator Brown decried the importation of cheap drugs:

Our enormous trade deficit has resulted in our nation not only importing goods and services, but also importing the dangerous safety standards of our trading partners.
In Toledo, Ohio, patients died after taking contaminated Heparin to treat their heart conditions. The manufacturer of Heparin had outsourced the making of the drug, and as a result, did not know where the contamination occurred.
The patients in Toledo, or the factory workers in Reynosa, or the meatpackers in Nebraska illustrate that continuing our trade direction is not a ringing endorsement of our trade agenda. Their stories represent a continuation of a policy of broken promises. [Link to full text of speech]

I discussed the Heparin Disaster with Senator Brown last year in Toledo. He clearly heard the concerns of the victims of big pharma. Senator Brown understands that the big corporations like Baxter Healthcare put profits over people.

We have now received about one million pages of documents from Baxter. These documents show that Baxter went to China for its heparin because it could save a few dollars on its raw material costs. Baxter knew the Chinese facility had never been inspected by the FDA. It knew that there were no inspections being performed on the heparin workshops and consolidators.

Baxter showed reckless indifference even after the contamination was brought to light. We are now learning that Baxter was being criticized by the FDA in September of 2008 for an inadequate recall.

The more we learn, the worse the story. We will continue to uncover the unsavory details and fight in the courtroom for the victims. We ask you to all support Senator Brown as he fights for us in the halls of Congress.

Two Chinese Heparin Suppliers Cited by FDA

2009-04-19T18:11:00.000-07:00

The FDA just cited two Chinese-based drug suppliers, Qingdao Jiulong Biopharmaceuticals Co. and Shanghai No. 1 Biochemical & Pharmaceutical Co, who manufactured and sold at least 19 lots of contaminated heparin to the U.S. in 2008, despite the fact that the heparin was supposed to be quarantined. (See 04/18/09 Wall Street Journal Article, “FDA Cites Two Chinese Heparin Makers.”) To read the FDA’s letter to Qingdao click here. To read the FDA’s letter to Shanghai No. 1 click here.

The heparin was tainted with over-sulfated chondroitin sulfate (“OSCS”), the same contaminate that has been linked with numerous U.S. deaths.

During the FDA’s inspection of these companies, the FDA found “significant deviations from U.S. current good manufacturing practices (CGMP) requirements in the manufacture of drugs.” Further, one of the drug suppliers, Shanghai No. I Biochemical, was also was found to have lied to the FDA about the manufacture of its heparin. Specifically, the FDA found that the Chinese drug supplier “used two other manufacturers to produce heparin sodium, failed to notify FDA of this manufacturing arrangement, and affirmatively represented that ‘no contract firms are involved in the manufacturing of the drug substance, Heparin Sodium USP, that is the subject of th[e] Drug Master File.’”

PREEMPTION REJECTED!!

2009-03-04T09:05:00.000-08:00

As addressed periodically on this blog, powerful drug companies such as Baxter, have advocated for complete immunity from the majority of suits involving unsafe medical drugs and devices under a legal concept called “preemption.” Specifically, they have argued that regardless of misconduct or failures on their part, Americans injured by defective drugs should be stripped of their constitutional right to a trial by jury for most, if not all, legal claims, where the drugs are regulated or approved by the FDA.

It looked like for a time, the drug companies were winning in this battle against victims harmed by their defective drugs. This was particularly true a little over a year ago in February 2008, when the United States Supreme Court severely curbed the rights of injured victims in the case of Riegel v. Medtronic, which held that the Federal Food, Drug and Cosmetic Act (FDCA) preempts state-law claims seeking damages for injuries caused by medical devices with premarket approval from the FDA. (The harsh effects of this decision are now being sought to be reversed in a bill sponsored by Congressmen Pallone and Waxman.)

The United States Supreme Court then accepted a case, Wyeth v. Levine, that involved the labeling of a medical drug. Until this morning, the case had not been decided.
In the case, Diana Levine, a professional musician, went to the hospital to treat a migraine headache. However, after being injected with a drug manufactured by Wyeth, she was left with injuries that led quickly to the amputation of her right arm, harming her profession and lifelong passion to be a musician. The drug, Phenergan, was given to Ms. Levine using a method of administration that was permissible under Wyeth’s label instructions. However, Wyeth knew for decades that this method increased risk of contact with arteries and serious injuries, and specifically chose not to warn the medical community and the public of this danger.

After a trial in the case, a Vermont jury agreed with Levine's claim that Wyeth failed to provide a strong and clear warning about the risks of quickly injecting the drug into a vein. However, the drug company appealed and, backed by the Bush administration, argued that since the FDA had approved the drug’s labeling instructions, victims such as Ms. Levine are barred (i.e. “preempted”) from being able to hold them accountable, even where the company knew its warnings were not adequate.

In a 6-3 decision released this morning, the United States Supreme Court rejected Wyeth's claim that federal approval of its drug should have shielded the drug company from lawsuits like the one filed by Ms. Levine.

This is an important victory, particularly for the injured Americans who will not be denied their constitutional to seek and obtain justice in a court of law.

A copy of the decision is available by clicking here.

FDA Scientists Report Corruption to President Obama

2009-02-17T14:21:00.000-08:00

Last month, a group of nine FDA scientists wrote to the Obama transition team reporting widespread managerial misconduct in a division of the Food and Drug Administration. Specifically, in a letter written on FDA Center for Devices and Radiological Health letterhead, the FDA scientists complained that agency managers use intimidation to suppress scientific debate, leading to the approval of questionable medical devices that may not be safe for the American public.

Various quotes from the letter provided to The Associated Press by a Congressional official, include:

-"The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk."

-"[Top FDA officials] committed the most outrageous misconduct by ordering, coercing and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along."

-"Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices...have ignored serious safety and effectiveness concerns of FDA experts."

-"Managers have ordered, intimidated, and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid."

-"Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around."

This letter continues to confirm that the FDA, whose duty is to protect the safety of the American public, is in desperate need of repair. It also reflects the power of large medical drug and device companies, who care more about profits than people, to influence the highest levels of government. We continue to support lawmakers who are seeking to overhaul the current FDA and once again restore confidence in the agency, so that catastrophic failures such as the heparin debacle will not happen again.

New York Times Reports on Concern Over Drugs Produced Abroad

2009-01-21T12:21:00.000-08:00

According to a recent article in the New York Times, "experts and lawmakers are growing more and more concerned that the nation is far too reliant on medicine from abroad, and they are calling for a law that would require that certain drugs be made or stockpiled in the United States." (Gardiner Harris, The New York Times 01/19/09 “Drug Making’s Move Abroad Stirs Concerns.”)

In recent years, pharmaceutical companies like Baxter (who sold the majority of contaminated heparin that resulted in numerous U.S. deaths), have imported drugs and/or shipped production oversees in order to increase corporate profit and avoid regulation. Of the 1,154 pharmaceutical plants mentioned in generic drug applications to the FDA in 2007, the article reports that only 13 percent were in the United States. Forty-three percent were in China, and 39 percent were in India.

The article further reports that since drug makers often view their supply chains as trade secrets, the true source of a drug’s ingredients can be difficult or impossible to discover. Indeed, the FDA cannot even identify how many foreign entities ship drugs into the U.S.

As a result, and as made clear from the recent heparin contamination, oversees drug production with little or no government oversight, leaves Americans at risk for tainted drugs. We continue to support Ohio Senator Sherrod Brown, (who has held hearings on this issue), and other lawmakers who remain dedicated to ensuring that America’s drug supply is safe.

Heparin Debacle Tops Chicago Tribune’s Top 10 Local Business Stories of 2008

2009-01-05T07:10:00.000-08:00

On December 31, 2008, the Chicago Tribune reported on the top 10 local business stories of 2008. Heparin contaminated with oversulfated chondroitin sulfate (“OSCS”) that was manufactured and sold by Baxter Healthcare Corporation and Scientific Protein Laboratories, topped this list. (See 12/31/08 Chicago Tribune Article, “Top 10 Local Business Stories of 2008.)

As more and more scientific literature continues to be published linking the contaminate to the hundreds of reported deaths and other adverse events, we expect and hope that this will remain an important public concern this year, particularly for those families who still are awaiting answers whether their loved ones were in fact victims of the tainted heparin.

WORLDFOCUS NEWS STORY ON CONTAMINATED HEPARIN

2008-12-17T13:53:00.000-08:00

Today, Worldfocus editorial consultant Peter Eisner, the former deputy foreign editor of The Washington Post, reported on the deadly contamination of U.S. drugs produced overseas, including heparin.

This news program tells the story of a young couple, Alex and Ann Oryschak, whose infant son, Julien, may have been one of the hundreds of victims who died in late 2007 and early 2008 from tainted heparin that was produced overseas. Producing drugs overseas not only allows powerful drug companies, like Baxter (who sold much of the contaminated heparin), to fly under the FDA radar and avoid government regulation and oversight, but it is cheaper. However, when safety is sacrificed in order to increase corporate profits, there is still a price to be paid. It is Julien Oryschak, Bonnie Hubley, Randy Hubley, Dennis Staples, and the hundreds of others who have lost their lives, who have borne that cost.

We thank reporters like Knut Royce, Peter Eisner, legislators like Representative Bart Stupak, and others, who, like our firm, fight to publicly expose the dirty secrets of the drug industry and effectuate real change.

To view this latest news report by Worldfocus, click here. Also be sure to read Knut Royce's detailed story posted here.

Rep. Barton Questions FDA’s Six Month Delay in Seizure of Tainted Heparin

2008-12-15T14:08:00.000-08:00

On December 10, 2008, U.S. Rep. Joe Barton, (Republican on the House Energy and Commerce Committee), wrote to the Food and Drug Commissioner, Andrew von Eschenbach, asking for information about the six month delay in the FDA’s seizure of contaminated lots of heparin from a manufacturer in Cincinnati, Ohio, Celsus Laboratories Inc.

In November, U.S. Marshalls seized 11 contaminated lots of the blood thinner heparin from Celsus after an April inspection found that the company wasn't properly recalling the product.

The text of the Barton letter states as follows:

The FDA’s management of the heparin issue continues to be of great interest to me and others on the Committee on Energy and Commerce. I commend you for your recent seizure of contaminated heparin from a manufacturer in Cincinnati, Ohio.

However, your November 6, 2008, announcement accompanying the enforcement action indicates that you twice previously informed the manufacturer (during an April 2008 inspection and again in a May 8, 2008, letter) that the company’s actions regarding the contaminated heparin were insufficient to assure an effective recall. I am concerned about this six-month delay between FDA informing the company of its insufficiencies and FDA taking enforcement action, and respectfully request your response to the following:

1. Why did FDA wait until November 2008 to seize the contaminated lots?

2. When was the recommendation to seize this contaminated heparin first made? Who made
it? Was it a written recommendation? Please provide supporting records as appropriate.

3. Please provide all FDA regulations, policies and/or guidances that govern the standards for authorizing this type of seizure.

4. Please list the names, titles, and offices of the FDA officials involved in the recommendation for the seizure of the contaminated heparin.

5. Please list the names, titles, and offices of the FDA officials involved in the decision on whether to approve the recommendation for seizure.

The letter than requested a response in the next four weeks. We will continue to keep you updated.

CDC REPORT IN NEJM FURTHER SUPPORTS LINK BETWEEN OSCS-CONTAMINATED HEPARIN AND DEATHS

2008-12-10T13:51:00.000-08:00

The Centers for Disease Control and Prevention (“CDC”) recently issued a final report in the New England Journal of Medicine (“NEJM”) that confirms a definite link between the man-made contaminant found in heparin, (i.e. over-sulfated chondroitin sulfate, [“OSCS”]) and the patients who experienced reactions. Blossom, David, etc., “Outbreak of Adverse Reactions Associated with Contaminated Heparin,” N. ENGL. J. MED. 359:25, 2674-2684 (December 18, 2008), (available at http://content.nejm.org/cgi/content/full/NEJMoa0806450.)

The CDC was the first to investigate suspected reactions among hospital patients given heparin in November of 2007. Before the contaminant was discovered, the CDC collected data on possible reactions occurring from November 19, 2007 through January 31, 2008 that met its case definition (i.e. development of symptoms within one hour after administration of heparin or the initiation of a hemodialysis session). (In its report, the CDC explained that it used this early case definition as an attempt to reduce misclassification, but recognized that in light of what is being discovered about the contaminate, “some true cases may have been misclassified as noncases.”)

The study did not report or investigate the long term effects of contaminated heparin, the cumulative effect of receiving multiple contaminated doses, delayed onset of symptoms, or the contaminate’s effect on other conditions such as heparin induced thrombocytopenia (“HIT”). Instead, the report simply confirmed that the “reported clinical features” of the limited cases it investigated “further support the conclusion that contamination of heparin with OSCS was the cause of the outbreak.”

Washington Post Reports on Needed FDA Overhaul

2008-11-26T15:18:00.000-08:00

The Washington Post reported today that former officials, members of Congress, watchdog groups and various government reports are calling for an overhaul of the FDA, which “desperately needs an infusion of strong leadership, money, technology and personnel -- and perhaps a major restructuring.” (11/26/08 Washington Post, “Ailing FDA May Need a Major Overhaul, Officials and Groups Say.”)

The article is worth the read and discusses some of the FDA’s recent failures to monitor imported drugs and consumer products, including contaminated heparin, toothpaste, and pet food from China. As similarly opined in this blog recently, the article also discusses the view that more needs to be done than simply starting to open offices overseas, including sharply boosting inspections abroad, developing strict new regulatory standards, and updating and integrating the FDA's computer systems. To read a copy of this article, click here.

Another Step Closer to Synthetic Heparin

2008-11-25T13:36:00.000-08:00

Today, scientists at the University of North Carolina at Chapel Hill announced that they have discovered how to customize a key human enzyme responsible for producing heparin. (See NewsWise, “Scientists Teach Enzyme to Make Synthetic Heparin in More Varieties.") This important announcement brings researchers closer to developing a more effective synthetic anticoagulant, rather than using raw natural heparin from pigs. As a result, it would shorten the drug chain and make it less susceptible to contamination. This is important because as learned from the heparin debacle, companies such as Baxter and Scientific Protein Laboratories, who are more interested in saving a buck by purchasing product from China rather than protecting the American public, cannot be trusted to ensure the safety of their drug. As stated by Jian Liu, Ph.D., associate professor in the school’s medicinal chemistry and natural products division, “The pig stuff has served us well for 50 years and is very inexpensive, but if we cannot control the supply chain, we cannot ensure the safety of the drug.”

Questions Raised Over FDA's Investigation of Heparin Deaths

2008-11-23T17:57:00.000-08:00

In a letter to the Government Accountability Office (GAO) dated November 19, 2008, Rep. Joe Barton questioned the adequacy of the FDA's ongoing investigation and evaluation of the recent heparin deaths, casting doubt on whether the FDA in fact has used all available postmarket surveillance tools when determining the likelihood that contaminated heparin caused patient fatalities. Specifically the letter states, “Based on the available information …there is a serious and potentially troubling question about whether FDA availed itself [of] all of its tools to conduct comprehensive surveillance of heparin deaths.” The letter also questions "whether [the] FDA has confounding or conflicting information about Heparin death cases that has not been made public." A copy of this letter is available by clicking here.

As first described in our July 30, 2008 blog, we also have questions concerning the conclusions reached by the FDA as reported to the Chicago Tribune and Nightline. For example, is the FDA investigating or supporting scientific studies to determine whether the contaminate, OSCS, and its resulting symptoms can cause, contribute to, or leave an individual susceptible to other complications leading to death, such as heart failure? (To date, the FDA admits that it has limited knowledge “since the contaminant was only recently discovered” and that all effects are not yet known. (See FDA Questions and Answers, updated 7/3/08.)) Without such studies, the FDA's conclusions may be premature.

Likewise, if the FDA requires additional information to determine whether additional deaths are related, why isn’t this information being gathered or at least requested from the providers or others who filled out the reports to make an adequate determination? For example, as we stated in our July blog, while we have filed multiple adverse-event reports of clients, to date WE HAVE NEVER BEEN CONTACTED BY THE FDA REGARDING THESE REPORTS, NEVER BEEN ADVISED OF THE STATUS OF THEIR INVESTIGATION, OR TOLD THAT ADDITIONAL INFORMATION IS NEEDED.

We have been contacted, however, by many caring lawmakers, journalists, and scientists who have not forgotten the victims of the heparin disaster. We commend and support their ongoing efforts to obtain answers and accountability from the FDA, Baxter and SPL.

FDA Offices in China: A Baby-Step Toward Public Safety

2008-11-18T06:55:00.000-08:00

In response to the ongoing public outcry for protection from imported drugs and other products, the U.S. Food and Drug Administration is finally taking some action. This week, the FDA is opening three offices in China. (11/17/08, Washington Post, “FDA to open China Offices After Product Scares.”) The first office will be opened in Beijing on Wednesday, followed by one in Guangzhou and another in Shanghai. According to Health and Human Services (HHS) Secretary Mike Leavitt,13 employees will be assigned to work in the FDA offices in China, but he has not said what their role will be.

While this is certainly a good first step, it is only a baby-step. There are thousands of foreign companies who ship drugs into the United States, let alone other consumer products. Thus, additional presence and regulation is needed. Last year the FDA reported that it only had resources to inspect foreign pharmaceutical companies every 13 years. (U.S. Government Accountability Office, Drug Safety: Preliminary Findings Suggest Weakness in FDA’s Program for Inspecting Foreign Drug Manufacturer. Statement of Marcia Crosse, Director of Health Care, before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, U.S. House of Representatives, November 1, 2007.) It is unclear how much of an impact that three offices with only 13 employees, who must deal with multiple consumer products, (not just pharmaceuticals), will have on the undisputed inability of the FDA to ensure product safety of foreign products.

As often discussed on this blog, this inability to protect the American public underscores why preemption of lawsuits is wrong. Drug and medical device companies argue that Americans injured by defective drugs or medical devices should be barred from bringing suit, because the FDA can adequately protect the American public. The heparin disaster has made it clear that this assumption is inherently flawed.

Indeed, as also reported in this week's news, the House Committee on Oversight and Government Reform released a report showing "that historically the Food and Drug Administration has not sought to preempt state law claims, and that the agency 'viewed lawsuits brought by persons injured by a drug as a valuable complement to the agency's regulatory efforts.'" (11/17/08 Lawyers USA, "Report: FDA Staff Objected to Preemption Policies.") However, during the Bush administration the FDA made a dramatic reversal, adding preemption language to drug regulations. This language has now become "a cornerstone of drug industry preemption arguments."

According to the report, "key career officials" objected to the regulatory changes. The officials "repeatedly warned that the central factual justifications for the agency's new positions were false."

The American Association for Justice ("AAJ") "blasted the FDA over the report, noting that the findings were similar to those in an AAJ report released earlier this month." Geri Voss, Director of Regulatory Affairs at AAJ, said, "In a gift to big negligent corporations, the Bush Administration overrode the advice of career professionals, ignored the agency's history of respect for litigation and put consumer safety on the backburner." For a full copy of “Get Out of Jail Free: A Historical Perspective of How the Bush Administration Helps Corporations Escape Accountability” go to: www.justice.org/getoutofjailfree.

Hubleys and Staples Featured in Time Magazine

2008-11-14T13:38:00.000-08:00

This week our clients, the Hubley Family and Johanna Staples, were featured in Time Magazine regarding the heparin disaster. To read this article, click here. We continue to be proud and honored to represent these brave individuals, who have selflessly agreed to share their private losses and suffering with the public so that the extent and severity of this tragedy may be exposed and hopefully, prevented in the future.

Updated: FDA seizes OSCS Contaminated Heparin

2008-11-07T08:57:00.000-08:00

Yesterday, the FDA seized 11 lots of Heparin products, valued at approximately $112,000, which were found to be contaminated with over-sulfated chondroitin sulfate (OSCS) from Celsus Laboratories in Cincinnati, Ohio. All 11 lots were manufactured with material imported from China, although the FDA reported that the contaminated crude heparin entered the United States prior to the import ban in April 2008. The discovery was found as part of the cooperative efforts by manufactures and the FDA to perform additional testing on all heparin materials to ensure no OCSC contamination. In fact, Celsus informed CNN that these lots had been quarantined by Celsus since March 8, 2008.

The FDA previously reported recalls of heparin products from Celsus Laboratories because of finding that batches of crude heparin Celsus received from their supplier contained OCSC. Celsus was also reprimanded by the FDA earlier this year for insufficient efforts by Celsus to notify its customers about the contaminated heparin products.

Celsus is a private business that has been manufacturing heparin related products, among others, since 1987. It not only provides its products here in the U.S., but also exports to many other countries, such as Australia, Canada, the European Union, and Japan.

Correction to reflect updated information:

USA Today originally reported that the contaminated heparin was imported from Changzhou SPL, the Chinese arm of U.S. based Scientific Protein Labs. USA Today cited FDA Spokeswoman Karen Riley for that information. They have now corrected their story to eliminate SPL as the source of the contaminated heparin after I brought this claim to the attention of the SPL attorney. Celsus had never been listed before as a customer of SPL or CZSPL. It is not clear whether the FDA spokesperson was misunderstood by USA Today, or if the FDA spokesperson was simply wrong as to the source of the contaminated product. Certainly the FDA should clarify this and should announce, publicly, the source of the OSCS contaminated heparin utilized by Celsus.

The FDA says it inspected Celsus Laboratories in April and found that two of its heparin products were contaminated.

The company had sent a letter to its customers telling them its heparin was contaminated, but FDA wanted the company to physically recall the product because of the danger it presented to patients.

FDA sent a follow-up letter to the company again asking for a recall on May 8.

What the federal marshals did Thursday was to seize the contaminated heparin that remained at the company's facilities, Riley says.

Comment: There is nothing in this latest story to establish that importations of contaminated heparin have occurred since April of 2008. But the story does show a conscious disregard by Celsus for the health and safety of the consumer. The FDA should have more power so that they can enforce the recall of these products.

In my opinion the FDA should also focus on inspection of existing health care facilities in this country to insure that all the bad stuff is off the shelf. I am personally more concerned about seizure of existing product in the hands of health care providers than raids to recover product that has already been quarantined.

And I want to know if Celsus used any of the contaminated Heparin in any of the products it shipped since April.

It is going to take much more than this raid to convince Americans that the FDA is doing its job; however the fact that Celsus chose to ignore the FDA request for a recall shows that Celsus has failed to act responsibly and has instead shown callous disregard for the consumer.

UPDATE COMMENT: Celsus should immediately disclose the source of the contaminant. Was Celsus experimenting with the use of OSCS? Did it know the products it sold contained OSCS? Celsus, up to now, has had a very good reputation. Its web site, www.heparin.com states:

Celsus is pursuing the development of a proprietary complex carbohydrate comprising a rare disaccharide sequence that may be prepared by chemical synthesis, genetically modified organism or site selected 6-O-sulfation of dermatan sulfate for medical needs unmet by heparin or its low molecular weight derivatives.

Celsus owes the world an explanation.

Reports of Serious Injuries and Death Linked to Medications Hits a Record High

2008-11-06T07:04:00.000-08:00

On October 23, 2008, The Institute for Safe Medication Practice, (a nonprofit group that educates the healthcare community about safe medication practices), issued a report on the number of serious injuries and death reported to the U.S. Food and Drug Administration in the first quarter of 2008. (See Inst. For Safe Med. Practices: 10/23/08, “Quarter Watch: 2008 Q 1.”)

According to this report, the number of reports of serious injuries and death linked to medications hit a record high. In the first three months of 2008, there were 20,745 new cases of serious injury and 4,824 reports of death. This total was 38% higher than the average for the previous four quarters, and the highest for any quarter. Death cases also accounted for a larger share with 23% for the first quarter of 2008 as compared to a historical average of 16%. This represented a 2.6 fold increase from the previous quarter and the highest number of deaths in a calendar quarter since 2004.

Two drugs accounted for a disproportionate share, including Chantix, a new anti-smoking drug from Pfizer, Inc. (with 1001 cases of serious injury and 50 deaths), and Heparin imported from China, (with 779 cases of serious injury and 102 deaths). (The FDA has actually reported receiving 238 reports of death from contaminated heparin over a longer period, but 102 represent the first quarter.)

Even scarier for the American public is the fact that because reporting is voluntary, these reports represent “only a small fraction of the adverse drug events that occur.” Id. at 1.

As concluded by the Institute, “While prescription drugs bring great benefits to millions of patients and most are used safely, these data show the need for additional progress to better manage the risks to patients….It also underlines the importance of the nation’s system for assuring drug product stability and purity. The scale of injury--hundreds of deaths or serious injuries in a short period—underlines the importance of strengthening oversight of drug manufacture abroad.” Id. at 4.

Boston Globe Editorial on Preemption

2008-10-13T18:03:00.000-07:00

A recent editorial, “No Haven for Dangerous Drugs,” published in the Boston Globe emphasizes the importance of a case often discussed in this blog, Wyeth v. Levine (06-1249), which deals with federal preemption of state drug labeling law and is set to be argued before the U.S. Supreme Court on November 3, 2008.

The Boston Globe Editorial highlights the importance of the issue of preemption in our present times. Given the increasing number of dangerous and defective pharmaceutical drugs and medical devices, such as tainted heparin, and the significant number of Congressional Hearings exposing the shortcomings and clear limitations of the U.S. FDA, barring any claim simply because it received FDA approval is a mistake. Indeed, as noted in the editorial, the U.S. FDA itself is among the many groups who support the argument that federal preemption should not bar a victim’s right to redress.

This editorial is worth reading and is available by clicking here.

The Joint Commission Warns of Heparin Dosing Errors

2008-09-26T08:53:00.000-07:00

On September 24, 2008, the Joint Commission, an independent, not-for-profit organization that accredits and certifies more than 15,000 health care organizations and programs in the United States, issued a heparin safety alert. (See JOINT COMMISSION WEBSITE: 9/24/08 Sentinel Event Alert, “Preventing errors relating to commonly used anticoagulants.”)

According to this report, “anticoagulants have been identified as one of the top five drug types associated with patient safety incidents in the United States.” (Id.) From January 1997 through December 2007, the Joint Commission reported that there 446 medication-related sentinel events (9.3 percent of all events) reported in their event database, with 7.2 percent (32) of these involving anticoagulants; of those, two-thirds (21) involve heparin. (Id. See also the illustrative chart on the Joint Commission Website.) Further, according to the United States Pharmacopeia MEDMARX database, there were a total of 59,316 medication errors related to anticoagulants reported to their database from 2001 to 2006 (these data do not include errors involving heparin lock flush). (Id.) According to the report, “nearly 60 percent of these errors reached the patient and nearly 3 percent resulted in harm or death.” (Id.) Further, “performance error (e.g., administration) is the most common cause of adverse events relating to anticoagulant medications.” (Id.)

The Joint Commission explained in its report that “heparin and warfarin in particular have narrow therapeutic ranges and a high potential for complications, so there is a greater risk of patient harm.” (Id.) It also listed the following factors which also contribute to medication errors involving anticoagulants:

• Lack of standardization for the naming, labeling and packaging of anticoagulants creates confusion. For example, heparin flush syringes have been confused with LMW heparin syringes. In addition, other, lesser-known anticoagulant drug names exist (e.g., enoxaparin, dalteparin, tinzaparin) and are used less commonly, which can result in duplicate medication orders and erroneous dosing.
• Keeping current with different dosing regimens for various patient populations, newer assay methods, the expanding lists of drug interactions, and the potential reversal strategies can be a challenge for providers—especially those who infrequently prescribe or administer anticoagulants.
• The specific and individualized instructions and monitoring information (for example, dose adjustments, lab values, changing patient condition) that accompany the prescribing and administration of anticoagulants may fail to get documented or communicated during transfers and hand-offs.
• Neonates and other pediatric patients are problematic to treat, specifically because the medications are formulated and packaged primarily for adults.

(Id.) The Joint Commission offers suggestions on how to reduce these dangers.

What is missing from the report is the danger of contamination and the lack of updated and appropriate testing for imported drugs, which unfortunately, may have claimed as many lives in a just few months, as dosage errors have claimed in the past ten years.

Spiked Baby Formula: Yet Another Warning To U.S. Companies

2008-09-16T08:12:00.000-07:00

On Monday, Chinese health officials raised the total number of infants sickened by Sanlu brand milk powder to more than 1,200. (09/15/08 USA TODAY, “Tainted Milk Sickens More than 1,200 Babies in China.”)

The formula was spiked with the industrial chemical, melamine, a contaminate that causes kidney stones (which are otherwise rare in infants). (Id. See also 9/12/08 FDA PRESS RELEASE, “FDA Issues Health Information Advisory on Infant Formula.”) Like the Heparin scandal, the contamination was intentional and a result of corporate greed. Specifically, Chinese investigators say melamine was added to make the milk seem higher in protein and thus, fool quality tests after water was added to fraudulently increase the milk's volume. (Id.)

Unlike the Heparin tragedy, however, it appears that Americans might have missed this latest batch of contaminated products manufactured in China. The FDA has indicated “that there is no known threat of contamination” as “no Chinese manufacturers of infant formula have fulfilled the requirements to sell infant formula in the United States.” (9/12/08 FDA PRESS RELEASE, “FDA Issues Health Information Advisory on Infant Formula.”) Yet, the FDA has not completed its current investigation as to whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community. (Id.)

Regardless, this latest contamination is another example of why drugs and other products manufactured in poorly regulated foreign countries cannot be blindly accepted as pure. It should continue to serve as a warning to large U.S. companies who buy these cheaper products and pass them on to the unsuspecting American public…A warning, which unfortunately, was ignored by the big drug company, Baxter, in the heparin disaster that killed numerous Americans.

NEJM Opposes Preemption

2008-09-04T18:33:00.000-07:00

Recently, the New England Journal of Medicine (NEJM) voiced strong opposition to preemption of cases involving defective medical devices and drugs, which would strip Americans injured by defective medical devices or drugs of their constitutional right to a trial by jury for most, if not all, legal claims, where the drugs or medical devices are regulated or approved by the FDA.

In an Amicus Brief filed in a case pending before the United States Supreme Court, Wyeth v. Levine, the NEJM editors wrote that the “FDA alone simply lacks the ability to serve as the sole guarantor of drug safety'’ and that without the discoveries made by plaintiff’s lawyers as a result of defective drug lawsuits, “the FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decisions, and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct.'’

A copy of this compelling brief is available by clicking here. In addition, the recent NEJM article, “Why Doctors Should Worry about Preemption,” is available on the NEJM’s website, by clicking here.

Hospitals Still Not Removing Contaminated Heparin

2008-08-28T05:55:00.000-07:00

Last week, the Los Angeles Daily Journal reported that the California Pharmacy Board will be citing and fining 94 California hospitals and the head pharmacist at each facility for not removing (and in some cases actually dispensing) contaminated heparin from their hospital pharmacies. (George, Los Angeles Daily Journal, 8/20)

This failure is inexcusable, as these institutions have been warned in writing on numerous occasions, including, for example, the FDA’s April 25, 2008 “Update to Healthcare Facilities and Healthcare Professionals about Heparin and Heparin-Containing Medical Products.”

Patients receiving heparin therefore, should remain cognizant of the recall and demand assurances from their health-care providers that they have complied with the recall.

Researchers Closer to Developing Synthetic Heparin

2008-08-19T14:36:00.000-07:00

At the American Chemical Society’s national meeting on August 17, 2008, Robert J. Linhardt, a chemist with Rensselaer Polytechnic Institute (“RPI”) in Troy, New York, reported ongoing advances toward developing a safer, fully-synthetic version of heparin. (Am. Chem. Society 09/17/08 Press Release, “Chemists move closer toward developing safer, fully-synthetic form of heparin.”) Specifically, Linhardt said his team from RPI, along with the assistance of Jian Liu at the University of North Carolina, has been able to produce a tiny amount of synthetic heparin. (Id.) The researchers claim that this creation is the largest dose of heparin ever created in a lab. (RPI Website: “Researchers Create Safer Alternative to Heparin.”)

According to the American Chemical Society’s press release, researchers have been trying for years to develop heparin production methods. (Am. Chem. Society 09/17/08 Press Release, “Chemists move closer toward developing safer, fully-synthetic form of heparin.”) In 2003, the first so-called total synthesis of heparin was developed at the Massachusetts Institute of Technology (MIT). However, the result was not practical as it only produced minute batches of heparin — less than 0.000000035 ounces at a time. (Id.)

Linhardt, together with Jian Liu, discovered the synthetic “recipe” for heparin in 2006. (RPI Website: “Researchers Create Safer Alternative to Heparin.”) Since that time, they have worked to piece together the various molecules and grow a complex carbohydrate that is naturally created in the body in the lab. (Id.)

RPI claims that larger amount of fully synthetic heparin could be ready for use in patients in five years. (Id.)

Important Anti-Preemption Bill Introduced by Senators Kennedy and Leahy

2008-08-12T13:41:00.000-07:00

Sens. Edward Kennedy (D-Mass.) and Patrick Leahy (D-Vt.) have followed the lead of House lawmakers and introduced a Senate counterpart of the Medical Device Safety Act of 2008 to ensure individuals are not prevented from seeking legal recourse against devicemakers selling defective products under state tort laws. (FDAnews Device Daily Bulletin, Aug. 12, 2008, Vol. 5, No. 157, “Senators Introduce Their Version of Anti-Preemption Bill." See also 08/01/08 Statement of Senator Leahy.)

The bill seeks to reverse the United States Supreme Court’s February 20, 2008 decision in Reigel v. Medtronic in which the Supreme Court severely curbed the rights of injured victims. Specifically, this harsh decision held that the Federal Food, Drug and Cosmetic Act (FDCA) preempts state-law claims seeking damages for injuries caused by medical devices with premarket approval from the FDA.

Baxter and other drug manufacturers argue that Riegel should be even further expanded to include medical drugs. They argue that regardless of misconduct or failures on their part, Americans injured by defective drugs or medical devices should be stripped of their constitutional right to a trial by jury for most, if not all, legal claims, where the drugs or medical devices are regulated or approved by the FDA.

As discussed in previous blogs, this argument is not only legally and ethically problematic, but is based on the flawed assumption that the FDA has the resources, authority, and capability to ensure product safety. Unfortunately, as the heparin debacle as reminded us, such is not the case. Without accountability of companies who unapologetically put profits over people, innocent Americans will continue to die from unsafe drugs and medical devices.

To read Senator Leahy’s powerful statement regarding the bill and the dangers of preemption, click here.

We thank Senators Leahy and Kennedy for their efforts to protect the American public from unsafe drugs and medical devices.

NEW BAXTER DRUG PROMO MISLEADING

2008-08-07T09:52:00.000-07:00

In a letter dated July 7, 2008, the FDA warned that Baxter’s promotion for its bleeding treatment FEIBA VH misleads doctors about the drug’s safety and effectiveness. (Chicago Tribune/Bloomberg News 7/31/08: “Baxter Warned on Hemophilia Drug Promotion.”)

The FDA advised that the "clinical thank you e-mail" submitted for review by Baxter violates FDA policies and is misleading with respect to both the efficacy and the safety of the drug. Specifically, the FDA held that the promotion overstated the efficacy of the drug and minimizes the fact that serious thrombotic events can occur with the drug. In its letter, the FDA states:

"This Email makes false or misleading safety and efficacy claims for FEIBA VH. Therefore, this material misbrands FEIBA VH in violation of the Federal Food, Drug and Cosmetic Act (the Act) 21 U.S.C. §§ 352(a) and 321(n), and FDA implementing regulations. Cf. 21 CFR 202.1 (e)(6)(i) and (iv). These violations are concerning from a public health perspective because by promoting misleading safety and efficacy claims, you are potentially encouraging the unsafe use of FEIBA VH."

A complete copy of this letter is available by clicking here.

After the heparin debacle, one would hope that Baxter would not be so quick to overstate the safety of its drugs. Apparently, as the old idiom warns, a leopard can never change its spots.

HUBLEY FAMILY FEATURED ON NIGHTLINE

2008-07-31T06:28:00.000-07:00

Last night, our client, Leroy Hubley, and his family, were featured on ABC’s television news program, “Nightline,” which discussed the heparin disaster. (07/30/08 Nightline, “Pharmaceutical Companies Must Take Responsibility.”)

The Hubley family, like hundreds of others, lost loved ones as a result of the contaminated heparin sold by Baxter, and supplied by SPL. The Hubley family not only lost their mother, Bonnie Hubley, but their 47 year-old son, Randy Hubley.

Previously on April 29, 2008, the Hubley family, along with Johanna Staples, (another client of Zoll, Kranz & Borgess who lost her husband, Dennis Staples), were invited to tell their tragic stories to the U.S. House Commerce Committee on Energy and Commerce at a hearing entitled, “The Heparin Disaster: Chinese Counterfeits and American Failures.” Video of this hearing is available by clicking on the links below.

Panel I (Witnesses: David Nelson, Senior Investigator for the Committee on Energy and Commerce, Colleen Hubley, Leroy Hubley, and Johanna Marie Staples)

Panel II (Witnesses: Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, Deborah M. Autor, Director of FDA’s Office of Compliance, and Regina T. Brown, Consumer Safter Officer of the FDA’s Division of Field Investigations)

Panels III and IV (Witnesses: Robert Parkinson, CEO and President of Baxter International, Inc., David Strunce, CEO of Scientific Protein Laboratories, Yan Wang, Ph.D., Vice President of Business Development and Research at Scientific Protein Laboratories, and Clive Meanwell, CEO of The Medicines Co.)

In addition, the written statements submitted to Congress by Leroy Hubley, Colleen Hubley Johanna Staples, and other witnesses, are available by clicking on their name below:

• Leroy Hubley
• Colleen Hubley
• Johanna Staples
• David Nelson, Senior Investigator for the Committee on Energy and Commerce
• Janet Woodcock, Director of the FDA’s Center for Drug Evaluation
• Robert Parkinson, CEO and President of Baxter International, Inc.
• David Strunce, CEO of Scientific Protein Laboratories
• Clive Meanwell, CEO of The Medicines Co.

We are proud and honored to represent these brave individuals, who have selflessly agreed to share their private losses and suffering with the public so that the extent and severity of this tragedy may be exposed and hopefully, prevented in the future.

FDA Tells Chicago Tribune That It Can Only “Conclusively” Link 3 Fatalities So Far to Contaminated Heparin

2008-07-30T14:06:00.000-07:00

Today the Chicago Tribune reported that the FDA has only been able so far to "conclusively link" three fatalities to contaminated heparin manufactured by Baxter. (07/30/08 Chicago Tribune: Heparin Taint Tied to Deaths.)

According to the article, in an interview Tuesday with the Tribune, the FDA said it completed its review of 93 death reports related to heparin that the agency received from January 1 to March 31, 2008. (07/30/08 Chicago Tribune: Heparin Taint Tied to Deaths.) Of the 10 reports of death from severe shock known as anaphylaxis or hypotension, three of those could be traced to lot numbers of Baxter products that tested positive for oversulfated chondroitin sulfate (“OSCS”). Heparin lot numbers were not known for the other seven deaths from anaphylaxis or hypotension, so the FDA could not determine whether those 7 patients received heparin contaminated with the substance.

Of the remaining 83 reports, 13 were described as "potential complications of heparin use" such as bleeding; and 25 cases were due to causes unrelated to heparin use such as pneumonia, sepsis and kidney failure. (07/30/08 Chicago Tribune: Heparin Taint Tied to Deaths.) In the remaining 45 deaths, FDA spokeswoman Janet Woodcock stated, "clinical information in the adverse-event reports is insufficient to specify the cause of death with clinical certainty,” and that the FDA was missing information from providers or others who filled out the reports to make an adequate determination. She also added, "While some of these [reports] appear definitely related [to contaminated heparin] many are still in the gray zone…We have looked over all of these death reports and a number of them were probably not related to the contaminated heparin."

While it is good that the FDA has finally conclusively linked some of the deaths, many questions are still unanswered. The top five questions that immediately jump out to me are as follows:

1) If additional information is needed to determine whether additional deaths are related, why isn’t this information being gathered or at least requested from the providers or others who filled out the reports to make an adequate determination? For example, we have filed multiple adverse-event reports of clients, but to date WE HAVE NEVER BEEN CONTACTED BY THE FDA REGARDING THESE REPORTS, NEVER BEEN ADVISED OF THE STATUS OF THEIR INVESTIGATION, OR TOLD THAT ADDITIONAL INFORMATION IS NEEDED.

2) Is the FDA relying on death certificates to determine cause of death? If so, this analysis is suspect, as many individuals died before the public recall and before the medical community learned of the contaminated heparin. As such, a medical provider would not have known or appreciated that their patient could have died from an anaphylactic reaction from contaminated heparin.

3) Is the FDA investigating or supporting scientific studies to determine whether the contaminate, OSCS, and its resulting symptoms can cause or contribute to other complications leading to death, such as heart failure? To date, the FDA admits that it has limited knowledge “since the contaminant was only recently discovered.” (See FDA Questions and Answers, updated 7/3/08.) For example, the FDA admittedly does not know whether there are any long term health effects of the contaminant. (See FDA Questions and Answers, updated 7/3/08.) With the New England Journal of Medicine article (that had severely restricted testing parameters) being the only scientific study published to date regarding the effects of OSCS, it may be too quick to report that the only deaths caused by that contaminate are those from anaphylaxis or hypotension.

4) Why has the FDA failed to analyze any of the reports that were filed after March 31, 2008? Or if they have analyzed them, why have they failed to report on them?

5) Why did it take an interview with the Chicago Tribune to ferret out this important information?

Baxter, SPL and the FDA have each admittedly failed the American public with respect to Heparin. As such, it is in their best interests to minimize the national disaster that they allowed to occur. It is no wonder, therefore, that they are quick to try to limit the number of deaths. Speculation is worthless. What we need is science. We implore the scientific community to not accept the FDA’s and drug companies’ unfounded conjectures at face value, but to test and study this contaminate further. Only then will we reach the truth… something that the victims of this disaster and their loved ones deserve.

FDA links 149 deaths to contaminated Heparin

2008-07-24T06:13:00.000-07:00

The FDA recently increased the number of reported deaths in which one or more allergic / hypotensive symptoms occurred in correlation to the receipt of heparin to 149 deaths.

Here is the table from the FDA Report:

Number of Deaths of Patients Receiving Heparin Reported to FDA, January 1, 2007 through May 31, 2008
Month the Medical Event(s) Occurred	Number of Reported Deaths*	Reported Deaths with One or More Allergic/Hypotensive Symptom(s)
Jan-07	6	3
Feb-07	2	1
Mar-07	5	2
Apr-07	7	4
May-07	3	1
Jun-07	5	2
Jul-07	6	3
Aug-07	4	4
Sep-07	3	2
Oct-07	10	5
Nov-07	12	11
Dec-07	34	23
Jan-08	50	32
Feb-08	49	29
Mar-08	14	10
Apr-08	7	4
May-08	5	3
Unknown date	24	10
Total	246	149
*The reports in this table concern heparin produced by any manufacturer.

A review of this table shows a significant spike in events for the months of November 2007 through March of 2008. There is no doubt but that this spike is the result of deaths caused by the contaminant oversulfated chondroitin sulfate (OSCS), which was intentionally added to the raw heparin in China.

While there have been a few deaths related to products sold by other manufacturers, the overwhelming majority of the deaths arose from the administration of heparin manufactured and sold by Baxter.

There is also no question but that this table significantly underestimates the actual number of people who died from the contaminated heparin. The FDA adverse events reports only capture a relatively small percentage of the actual number of adverse events.

According to the FDA: "A small percentage of adverse reactions are reported to Centers for Deisease Control and Prevetnion and FDA by health care professionals and industry."

Therefore the actual number of deaths attibutable to the contaminated heparin is much larger.

Baxter Announces Profits up 26%

2008-07-23T14:05:00.000-07:00

Last Thursday, Baxter announced net income of $544 million for its second quarter ending on June 30, 2008, or 85 cents per share, due to higher sales of biotech drugs and vaccines. This is up from $431 million, or 65 cents per share, in the same period last year. (7/17/08 CNBC: “Biotech, Overseas Sales Push Baxter 2Q Profit Rise.”)

In response, Baxter shares rose $2.08, or 3.2 percent, to end at $67.96, and hit an all-time high of $69.66 earlier in the session. (7/17/08 CNBC: “Baxter Shares Hit High on 2Q Profit Growth.”)

In boasting of the company’s success during Thursday’s earnings release, Chairman and Chief Executive Officer Robert Parkinson, Jr., did not mention heparin or the increasing death count linked to its contaminated drug, nor did Baxter bother mentioning how much of these increased profits were a result of foreign manufacturing of drug or drug components in countries with lax regulation and cheaper production costs.

Chinese Authorities Still Doubt Deaths are a Result of Contaminated Heparin

2008-07-19T11:46:00.000-07:00

According to Chinese news, the Chinese Ministry of Health announced Friday that despite its “joint investigation” with U.S. drug authorities, it could still not conclude that the multiple U.S. deaths were a result of contaminated heparin sold by Baxter, who bought the raw ingredient supplied by SPL from its facility in China, SPL Changzhou. (07/18/08 China View News: “Cause of deaths still in doubt after Sino-U.S. Investigation on Blood Thinner.”)

As you may recall, China’s drug agency reported the same inability to link the reported deaths in May of this year. (See our May 7, 2008 Blog: China Points the Finger at Baxter and the FDA.”) At that time, the inability of China and the U.S. FDA to cooperate was evident. Chinese officials claimed that Baxter and the FDA failed to provide them with medical records, medical histories, and information on Baxter's manufacturing practices. The Chinese also complained that they had not been given samples of the contaminated product. The FDA complained that it was not provided records from Changzhou Techpool Pharmaceutical Co. (“CZTP”), a company who supplied SPL Changzhou with raw heparin and may have been a source for the contaminant.

U.S. researchers confirmed the link between the adverse events, including death, and the contaminant, OSCS, since at least April 23, 2008, when the results of the first study were reported in an article published online by the New England Journal of Medicine entitled, “Contaminated Heparin Associated with Adverse Clinical Events and Activation of the Contact System.” As reported on the FDA website, “The contaminant activates chemicals in the body called enzymes. These enzymes cause the body to make inflammatory mediators (chemicals that are released by immune cells). Inflammatory mediators can lead to some of the symptoms such as low blood pressure, abdominal symptoms and shortness of breath.” (FDA: Questions and Answers re Heparin.)

It seems, therefore, that the two agencies are still failing to cooperate and exchange pertinent information. Maybe someone should give the Chinese Ministry of Health a copy of the New England Journal of Medicine article.

New International Pilot Program to Facilitate Overseas Inspections

2008-07-15T14:16:00.000-07:00

Last week, the U.S. Department of Health and Human Services (HHS) announced a new program in conjunction with the U.S. Food and Drug Administration (“FDA”) to enhance the safety of medical drugs and food exported to the United States. (07/09/08 HHS Press Release.)

Specifically, the program is a pilot project with the European Union and Australian authorities “to jointly plan, allocate for and conduct inspections of drug-manufacturing facilities.” (07/09/08 HHS Press Release.) The program will initially focus on makers of active pharmaceutical ingredients, but will expand to other types of manufacturing facilities if successful.

Additional information about this import safety initiative, as well as other import safety news, reports and blogs are available at the HHS’ import safety website: http://www.importsafety.gov/.

Texas Hospital Quick to Raise Defenses to Heparin OD

2008-07-12T05:22:00.000-07:00

In a statement released July 10, 2008, Texas Hospital, Christus Spohn, indicated that the recent heparin overdose of 17 children in its Neonatal Intensive Care Unit, was a result of an error that occurred during the mixing process in its hospital pharmacy. (See 07/10/08 Christus Spohn Statement.) While the hospital claims this mistake in mixing was unrelated to product labeling or packaging, (which has recently resulted in similar deaths), it has not released details as to how the “mixing error,” occurred.

Likewise, in true defense fashion, the Texas Hospital is quick to speculate publicly that the heparin overdose of twins Keith and Kaylyn Garcia, (which was 100 times stronger than recommended), did not directly result in their deaths, before the conclusion of any autopsies. Relatives of the twins had planned a baby shower for their mother today, instead their funerals will be held. (7/11/08 ABC news, “Hospital Error Blamed for More Infant Overdoes.”)

If hospitals spent as much time figuring out ways to eliminate and reduce errors, as setting up defenses to protect themselves from anticipated future litigation, we would all be safer.

Fresenius to Buy APP Pharmaceuticals

2008-07-07T16:05:00.000-07:00

Yesterday, Fresenius SE, a German company and the largest worldwide provider of dialysis services, announced that it has agreed to buy the U.S. company APP Pharmaceuticals for $23 cash a share, plus as much as another $6 a share if APP's financial results meet certain targets, resulting in a purchase price ranging from $3.7 to $4.6 billion. (WSJ: Market Watch, 07/07/08, "APP to be Bought by Fresenius for up to $4.6 Billion.") In addition, Fresenius agreed to assume APP's $940 million of debt, net of the company's cash on hand. (Id.)

After the Baxter recall of contaminated heparin, APP became the leading producer of heparin. (WSJ, 02/19/08, "Baxer Rival APP Steps in Quickly to Supply Heparin.")

Analysts opine that the sale will allow Fresenius to "take control of heparin," and "curb the rise in its price." (Reuters, 07/07/08, "Fresenius to Enter World Drug Market with APP.") As a result, Fresenius' U.S. rival, DaVita, Inc., could "'ride the coattails' of that price moderation." (Id.)

The company will become part of the Fresenius Kabi division, a provider of infusion therapy services in Europe, Latin America and Asia.

THE HISTORY OF HEPARIN

2008-07-04T07:58:00.000-07:00

Scientists have long realized the need to deal with clotting when disturbing blood flow during dialysis or other procedures. In 1913, John Abel, a pharmacologist at Johns Hopkins University, reported the first successful performance of dialysis in a dog using “hirudin,” an anticoagulant extracted from leeches. (Mark J. Acierno, Vera Maeckelbergh “Continuous Renal Replacement Therapy,” Compendium, May 2008, Vol. 30, No. 5; Research Defence Society Website, “Anticoagulants,” (2008)). This early anticoagulant was unsuitable for human use, however, as it was expensive, difficult to extract and purify, and caused severe heart and lung problems, as well as allergic reactions. (Research Defence Society Website, “Anticoagulants.”)

Heparin, one of the oldest drugs currently still in widespread clinical use, was discovered in 1916 by a second-year medical student, Jay McLean (1890-1957), and his Professor of Pharmacology, William Henry Howell (1860-1945) at Johns Hopkins University in Baltimore. (Wikipedia: Heparin; Rutty, Christopher, Health Heritage Research Services, “Miracle Blood Lubricant: Connaught and the Story of Heparin, 1928-1937.”)

Allthough “the first description of heparin has been clouded in controversy,” it is reported that McLean, working under the direction of Howell, was investigating pro-coagulant preparations, when he isolated a fat-soluble phosphatide anti-coagulant from liver cells from dogs, (hence its name hepar or "ηπαρ," which is Greek for "liver"). (“Practical Haemodialysis Began with Cellophane and Heparin: The Crucial Role of William Thalhimer (1884-1961),” Nephrol. Dial. Transplant (200) 15: 1086-1091; Wikipedia: Heparin.)

Although it appears that “Howell initially seemed not to have welcomed this discovery, perhaps because [he] disagreed with [McLean’s] theories of coagulation,” most historians believe that McLean’s work lead to Howell’s later isolation of a water-soluble polysaccharide anticoagulant in the early 1920s. (“Practical Haemodialysis Began with Cellophane and Heparin: The Crucial Role of William Thalhimer (1884-1961),” Nephrol. Dial. Transplant (200) 15: 1086-1091; Wikipedia: Heparin.)

This early heparin, however, was expensive, toxic and not practically applied by doctors until the early 1930s when a research team lead by Dr. Charles H. Best at Connaught Medical Research Laboratories, (then part of the University of Toronoto), developed a method to make it into a “purified, plentiful and inexpensive supply safe for human use.” (Rutty, Christopher, Health Heritage Research Services, “Miracle Blood Lubricant: Connaught and the Story of Heparin, 1928-1937;” Wikipedia: Heparin.)

In 1928, Best, the head of University of Toronto’s Physiology Department and an Associate Director of Connaught, “decided to break the heparin stalemate and explore its practical value.” (Rutty, Christopher, Health Heritage Research Services, “Miracle Blood Lubricant: Connaught and the Story of Heparin, 1928-1937.”) Best then expanded his team in 1929 to include Drs. Arthur F. Charles (1905-1972), an organic chemist, David A. Scott (1892-1971), a scientist closely involved with insulin production, and Dr. Gordon Murray (1896-1976), a prominent surgeon at Toronto General Hospital. (Id.)

Charles and Scott turned to beef liver because it was cheaper than dog liver and readily available from local slaughterhouses. (Id.) When the price of beef liver increased, they turned to beef lung and intestines. (Id.) In conjunction with Murray’s experimental surgeries on animals using the more potent heparin, the team succeeded in purifying and then crystallizing heparin into a standardized dry form that could be administered in a salt solution. (Id.)

In May of 1935, the first human trials began and “by 1937, it was clear that Connaught's heparin was a safe, easily-available, and effective blood anticoagulant.” (Wikipedia: Heparin.)

FDA first approved heparin drug products for sale within the U.S. in the 1940s. (04/14/08 USP Press Release.)

Congress Demands Documentation Supporting the FDA’s Change in Position Regarding Preemption of Product Liability Lawsuits

2008-07-01T08:25:00.000-07:00

On June 26, 2008, Congressman and Chairman of the House of Representatives’ Committee on Oversight and Government Reform, Henry A. Waxman, sent a letter to the FDA Commissioner demanding production of documents that explain why under the Bush Administration, the FDA changed its position regarding whether FDA regulation should bar liability claims. (To view this letter, click here.)

Prior to the Bush Administration, the FDA had a long-standing position that despite its regulation of medical drugs and devices, “product liability lawsuits in state court complement the agency’s regulation of drugs and medical devices, providing an important additional layer of consumer protection against unsafe products.” (See 06/26/08 Letter to Eschenbach.) As such, the FDA did not interfere or challenge the constitutional right of innocent Americans injured by defective products to hold the drug companies responsible in a court of law.

On May 14, 2008, the House of Representatives Committee on Oversight and Government Reform, held a hearing on the issue of preemption of state liability claims related to FDA-approved drugs and medical devices. (We have previously blogged on this hearing and the problem with preemption. See prior blogs, “Should FDA Drug and Medical Device Regulation Bar State Liability Claims?” (05/14/08); “FDA Needs Subpoena Power” (05/21/08); “The Preemption Problem” (06/04/08); “Draft Bill Regarding Preemption To Be Introduced” (06/13/08)).

Despite the FDA’s long-standing position regarding preemption, the current FDA Deputy Commissioner for Policy, Randall Lutter, testified at the hearing that under the Bush Administration the FDA reversed its position and calls such suits a “challenge” to the agency that have “detrimental effects on the public health.” (For a transcript of this hearing, click here. For a video, click here.) As such, under the Bush Administration, the FDA now sides with drug manufacturers. They argue that regardless of any misconduct or failures on behalf of the drug companies, Americans injured by defective drugs should be stripped of their constitutional right to a trial by jury for most, if not all, legal claims, where the drugs are regulated or approved by the FDA, giving negligent drug companies almost complete immunity.

Ironically, this position comes amidst the heparin disaster, wherein the FDA has admitted that it does not have the resources, authority and capability to ensure product safety. (See 04/29/08 Video of House of Representatives’ Subcommittee on Oversight and Investigations Hearing, “The Heparin Disaster: Chinese Counterfeits and American Failures; 04/22/08 Video of House of Representatives’ Subcommittee on Oversight and Investigations Hearing, “FDA’s Foreign Drug Inspection Program: Weaknesses Place Americans at Risk.”) Indeed, the FDA currently does not even have subpoena power, which would allow the FDA to demand certain documents from companies who have sold contaminated drugs. Without this ability, the agency is powerless to obtain internal company documents that a company itself chooses to withhold. (See prior blog, “FDA Needs Subpoena Power” (05/21/08)).

The June 26, 2008 letter asks that the requested information/documents be produced by July 11, 2008.

The United States Pharmacopeia Announces Revised Heparin Monographs

2008-06-27T13:21:00.000-07:00

In response to the heparin contamination and resulting deaths, the FDA asked the United States Pharmacopeia (USP) on March 19, 2008 to assist in re-assessing current tests and developing new methods for detecting contaminants, such as over-sulfated chondroitin sulfate, in heparin. (See 04/14/08 USP Press Release.) The USP is an independent, science-based public health organization that sets the official public standards for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured and sold in the United States. (To learn what a “pharmacopeia” is, click here. To learn more about the USP itself, click here.)

Among other functions, the USP plays a critical role in developing “monographs” for drug substances, drug products, or “excipients,” (substances that act as a vehicle for a drug). A monograph is a written standard that describes the medical drug, device or product and provides a public standard by which to judge its quality or to test it in order to produce a high-quality and consistent product. (See July 2004 USP Monograph Backgrounder for more information.) These monographs may be updated. For example, heparin, which has been sold in the United States since the 1940s, has had a USP monograph since 1950 that has been updated several times. (04/14/08 USP Press Release.)

Monographs are published in the National Formulary (USP-NF), which was originally created in 1888 and contains more than 4,000 monographs for prescription and over-the-counter products, dietary supplements, medical devices and other health care products. (Feb. 2005 USP Program, “What is a Pharmacopeia?”) When a standard is published in the USP-NF, federal and state government agencies, such as the FDA, can recognize and enforce those standards to ensure product compliance and quality. Currently, there are monographs for two heparin drug substances in the USP-NF. (04/11/08 USP Heparin Statement.)

In April of 2008, the USP started working to develop more sensitive methods for detecting contaminants found in heparin. (04/14/08 USP Press Release.) This work was divided into two stages. Stage one would include revisions to the heparin monographs, and was “intended to address rapidly the immediate public health crisis associated with the drug and help ensure an unadulterated supply of heparin.” (06/23/08 USP Press Release.) The second stage would seek additional methods to test for over-sulfated chondroitin and other potential contaminants in heparin.

The USP conducted a “heparin web meeting with the industry” on April 11, 2008. (To view the power point presentation for that meeting, click here.) On April 25, 2008, the USP’s Heparin Advisory Panel provided written recommendations for the revision of the heparin sodium monograph. (To view these recommendations, click here.) An open microphone meeting regarding the recommendations was then held on June 11, 2008. (To view the agenda for this meeting click here. To view the presentation given at this meeting click here.)

As a result of these meetings and recommendations, on June 23, 2008, the USP announced that stage one had been completed and that the monographs for heparin sodium and heparin calcium had been revised and are now available on the USP Web site. (06/23/08 USP Press Release.) The two heparin monographs are posted on the USP Web site at http://www.usp.org/hottopics/heparin.html?hlc. These revised monographs are accompanied by new and updated official USP Reference Standards, that all drug manufacturers who market heparin in the United States are required to meet. (For additional information, see USP “Heparin Monograph Revision Frequently Asked Questions.”)

The USP indicates that it will now turn to “the second stage of revision,” which involves seeking out additional methods to test for over-sulfated chondroitin and other potential contaminants in heparin. (06/23/08 USP Press Release.)

Although these revisions are important and the USP should be thanked for its hard work, as recognized by the USP itself, they are only “one of a series of safety nets that work to assure that U.S. patients and practitioners have access to good quality medicines.” (Statement of USP executive vice president and CEO, Roger L. Williams, M.D., in the 06/23/08 USP Press Release.) These other critical safety nets must also include “dedicated and trusted drug ingredient and product manufacturers who follow good manufacturing practices (GMPs) and sound sampling protocols in support of batch release testing,” and “oversight from the FDA...” (04/14/08 USP Press Release.)

As we have unfortunately now learned from the heparin disaster, when these other safety nets are not in place, the ramifications can be devastating. Companies who do not use good manufacturing practices or purchase product from companies who do not use good manufacturing practices, and do not adequately test their drugs, should be held accountable when those defective drugs cause death and injury. At the same time, the FDA must be given the resources and power it needs to enforce compliance by powerful and wealthy drug companies, including those who want to save money by purchasing product from uninspected and substandard plants in foreign countries.

Who owns Scientific Protein Labs?

2008-06-26T19:12:00.000-07:00

The information in this post is based on information in the public domain.

We have written earlier about Scientific Protein Labs (SPL) and the role they played in providing Baxter with the heparin that had been cut with oversulfated chondroitin sulfate. But unlike Baxter, which is a publicly traded company, the stock in SPL is privately held. 89% of SPL was purchased about 2 years ago for the price of $135 million. The purchaser was American Capital Strategies, Ltd., ("ACAS") a private equity firm headquartered in Bethesda, Maryland, which is publicly traded under the symbol ACAS.

Area biotech sold again: Helps make heparin

The Capital Times

By Mike Ivey
August 23, 2006

A company founded 30 years ago to make use of pig intestines from the Oscar Mayer slaughterhouse has changed owners again.

Scientific Protein Laboratories of Waunakee has been acquired by American Capital Strategies, a Washington, D.C.-area buyout firm that is publicly traded on the Nasdaq stock exchange.

A sales price was not released but the company had sold for $81 million in 2004 to Arsenal Capital Partners, a New York-based private equity firm. Prior to that, the company was a wholly-owned subsidiary of Wyeth Pharmaceuticals.

SPL has 150 employees at its facility here, where it produces the active ingredient used in the manufacture of heparin, a common anti-blood clotting drug. The company also has a small facility in Changzhou, China, with about 30 employees.

Complete Article

ACAS had placed a fair value of $176M on SPL as of 12/31/2007. The total asset value of ACAS is about $11 Billion. Thus SPL represents about 1.6% of ACAS total assets. According to the New York Times story published earlier this week:

American Capital, which owns stakes in some 170 companies, booked $29.6 million in unrealized depreciation related to its investment in Scientific Protein in the first quarter [of 2008].

American Capital’s stock is down about $4 since February, but that appears more related to the company’s write-downs on some of its assets, including mortgage bonds. Jefferies, the investment bank, downgraded American Capital’s stock to underperform in April, but did not mention the tainted blood thinner in its report.

NYT Story May 23, 2008

An article today posted on The Street.com titled "Valuations Haunt American Capital" contains this information:

American Capital's investment in Scientific Protein Labs (referred to as SPL Acquisition in regulatory filings) had a fair value of $176 million on American Capital's balance sheet at the end of 2007. The valuation dropped to $141 million at the end of the first quarter, as American Capital wrote down the value of its preferred-stock investment from $41 million to $10 million. (The news story on the bad heparin broke in the first quarter).
But the firm's $131 million debt investment in SPL was essentially left untouched.
At American Capital's annual investor day last week, one audience member questioned the valuation of Scientific Protein.
"I'm trying to understand, as we're trying to get comfortable with valuations through the portfolio, how the debt of a company that is looking at lawsuits that could probably bankrupt it if even a fraction of them come to fruition, how that can possibly be marked at par?" the unidentified audience member asked a panel of American Capital officials, according to a webcast replay of the event.
American Capital CEO Malon Wilkus, who was in the audience and not on the panel, immediately grabbed the microphone from the questioner, according to an investor who attended the event.
Wilkus said the situation was very sad, but he called Scientific Protein a "very good company ... and we think it will do extremely well," according to the webcast.
He did point out that Scientific Protein had some insurance to cover itself from lawsuits but stopped short of saying how much.
"I think that is about all we can say about the company specifically," he said.

The ACAS public financials do not disclose what amount of money SPL made from the CZ-SPL and China imports. SPL continues to make heparin from domestic sources as well as some other products. But the FDA has blocked any imports of heparin from SPL's wholly owned subsidiary CZ-SPL.

Why Didn’t the Contaminated Heparin Affect Everyone Receiving It?

2008-06-24T19:16:00.000-07:00

Much is yet to be learned regarding the contaminate found in the recalled heparin, oversulfated chondroitin sulfate (“OSCS”). However, the first and only study published to date since the January 2008 heparin recall does shed some light on the relationship between the contaminate and the severe reactions, sometimes fatal, experienced by many Americans. (“Contaminated Heparin Associated with Adverse Clinical Events and Activation of the Contact System,” N. Engl. J. Med. 358:23, pgs. 2457-2467, June 5, 2008, available for a charge on the New England Journal of Medicine Website.) One of the issues addressed in this article is a question that we are often asked by our clients, why weren’t all patients who received tainted heparin from a particular lot affected?

In order to investigate this and related issues concerning the biologic link between the contaminant and the reported reactions, the researchers conducted animal testing. (6/5/08 N. Engl. J. Med. article, pg. 2464.) Pigs were chosen because unlike rabbits, horses and rats, only the pig plasma supported an appropriate level of response to the OSCS contaminated heparin, but not the uncontaminated control heparin. (This also may explain why early attempts by Baxter to provoke an allergic response with suspect lots of heparin failed. See Baxter 03/19/08 Press Update and 6/5/08 N. Engl. J. Med. article, pg. 2464.)

The pigs were given a single intravenous dose (5 mg per kilogram) of OSCS-contaminated heparin, uncontaminated heparin, or other substances. (06/05/08 N. Engl. J. Med. article, pg. 2466.) They were then monitored for 60 minutes. Two of six pigs treated with OSCS-contaminated heparin had at least a 30% drop in blood pressure over the first 30 minutes after infusion. One animal remained in a hypotensive state for more than 15 minutes. In contrast, none of the four animals treated with uncontaminated heparin showed any substantive changes in blood pressure. (Additionally, three pigs were given pure synthetic OSCS. All three of these pigs “showed a profound drop in blood pressure [maximal decrease, 45 to 59%] and a concurrent increase in heart rate within minutes after infusion.”)

Interestingly, while not all pigs who received OSCS-contaminated heparin exhibited clinical signs, the researchers found that “induction of kallikrein activity [kallikrein is an enzyme present in blood plasma and other body fluids which can lead to the generation of bradykinin that in turn, impacts the blood vessels leading to hypotension and other symptoms] was evident in all animals that received OSCS-contaminated heparin, even when no substantive changes in blood pressure were observed.” (06/05/08 N. Engl. J. Med. article, pg. 2466, with explanation and emphasis added by Zoll, Kranz & Borgess, LLC.) Based on these findings, the researchers concluded as follows:

“These findings suggest that activation of kallikrein does not always manifest as clinical symptoms, perhaps because of individual variations in control mechanism that regulate bradykinin activity…. The finding that hypotension did not develop in all animals treated with OSCS-contaminated heparin, even at a relatively high dose, is consistent with the observation that the majority of patients who received contaminated heparin did not experience an adverse event. However, it is important to note that all animals treated with OSCS-contaminated heparin showed evidence of kallikrein activation in vivo, even in the absence of clinical signs. Patients undergoing dialysis who are also receiving heparin therapy are already at high risk for hypotension because of their exposure to the dialysis membrane, which can also activate the contact system, and their treatment with angiotensin-converting-enzyme inhibitors, which inhibit bradykinin degradation. Exposure to OSCS-contaminated heparin may further increase the risk and could potentially trigger an adverse event.” (06/05/08 N. Engl. J. Med. article, pg. 2467.)

Thus, the scientific evidence to date suggests that while some patients may not exhibit clinical signs after receiving OSCS, this does not necessarily lead to the conclusion that those patients were “unaffected” by the OSCS, particularly those patients, including dialysis patients, who are already at greater risk.

Hopefully, researchers will continue to investigate the relationship between OSCS and the reported reactions, so that the families of those who have lost loved ones can understand how and why this happened, and continue to hope that it can and will be prevented in the future.

Sherrod Brown Challenges the FDA

2008-06-21T12:44:00.000-07:00

This week Ohio Senator Sherrod Brown sent a letter to the FDA challenging them to evaluate the level of outsourcing by U.S. Pharmaceutical companies, and the impact of that outsourcing on Drug Safety. He also asked Pfizer, who admitted outsourcing 17% of their API ("Active Pharmaceutical Ingredient"), to make public how much money they save by doing so. Sherrod Brown Press release and letters.

Now the FDA has announced that it will spend taxpayer money to set up inspection offices in China and India. (Three offices in China this year, followed by offices in India. Story here.) It seems to me that the drug companies that profit from overseas operations and the lax or total absence of controls and inspections should pay for these offices and the cost of inspecting the foreign operations.

Senator Brown is absolutely right to dig into this issue that is so critical to the health and safety of our citizens. As he stated to Janet Woodcock, head of the FDA:

You also asserted that FDA must have the tools to hold drug companies accountable when they outsource. What, in your opinion, is the best means of holding these drug companies accountable? All parties throughout the drug supply chain should be held accountable for the quality and integrity of the products they produce.

I seriously doubt that the current FDA will hold drug companies accountable. But they must do so. And those injured by the failure of the drug companies to perform their duties must be able to obtain full and fair compensation from the drug companies that have failed to provide products that are safe and effective.

Thank you Senator Brown. Please keep challenging the FDA, Pfizer, and the rest of the phamaceutical industry to do their duty. And please give those persons and families who are injured and killed the ability to seek full compensation. It is ridiculous to protect these companies from liability on the basis that the FDA is doing its job.

As we have seen in the Heparin Disaster, and as I pointed out in my blog yesterday, the Chinese operations, subcontractors and joint ventures of these drug companies are flying under the radar of the FDA. Even when the FDA tries to inspect these companies they cannot do so.

The FDA China Inspections

2008-06-20T07:20:00.000-07:00

The US FDA inspected, or rather attempted to inspect, three heparin manufacturing facilities between February 20th and February 29, 2008. The first facility was that of Changzhous SPL Company, Ltd., ("CZ-SPL") a wholly owned subsidiary of SPL. All of the CZ-SPL product was shipped to Baxter.

This inspection lasted 6 days. This was the first time the FDA had ever inspected the facility, in violation of FDA policy.

The inspection found that the process validation for the purification of Heparin Crude was inadequate . It further found a number of other deficiences, including:

process changes included removal of Heparin Crude quality attributes based on ease of procurement without adequate raw material evaluation.
No impurity profile had been established.
A discontinued workshop's crude heparin was included in lots sold to SPL.
Equipment was not cleaned.

The report states that, beginning in June of 2007, CZ-SPL started testing incoming lots by Polymerase Chain Reaction (PCR) for species verification. In other words, because SPL was worried about counterfeit sheep product being substituted for pig product, it started doing a basic PCR analysis. As a result of the inspection, the FDA issued a Form 483 report.

The second inspection began February 27, 2008. This inspection was of a facility located right next door to CZ-SPL. The neighboring factory is known as Changzhou Techpool Pharmaceutical Co. Ltd. ("CT"). CT is 45% owned by CZ-SPL. All of the product made by CT is sold to CZ - SPL. Importantly, the plant is not registered with the Chinese FDA because it does not make product for consumption in China. Nor is it registered with or inspected by the US FDA. The inspection lasted only 2 days. On both days the company refused to give the FDA copies of basic documents, including raw material crude specification, test methods, cards, certificates of analysis, blend records, and inventory records. The FDA did take photographs, which we are seeking to obtain.

The third inspection was even less successful. This inspection began the afternoon of February 28th and ended the next day when the FDA inspection team was refused reentry into the facility. This facility was located in Hangzhou, China. The name of the firm was Hangzhou Ruihua Biochemical Products Co. Ltd. This firm was a manufacturer and tester of crude heparin that was sold to CZ-SPL for further processing. A photograph of Dr. Wang, the general manager of CZ-SPL and an officer of SPL hung in the entryway of the facility.

The firm refused to provide copies of any records and no samples were collected. The firm is not regulated or inspected by the Chinese FDA or the US FDA. The owner of the firm, Mr. Ruihua, admitted that the firm had been unable to meet the needs of CZ-SPL because there was not enough heparin available. He indicated that CZ-SPL was his sole customer.

Ruiha collects raw heparin from the countryside and nearby provinces. The workshops are all on a list provided by CZ-SPL. However Mr. Ruiha refused to provide any documents, refused to permit the FDA to inspect the laboratory, refused to provide a list of the workshops from which they get the raw heparin, and would not even state the Provinces in which the workshops were located.

On April 21, 2008 the FDA issued a warning letter, which held that the deficiencies and deviations from current good manufacturing processes were so severe that CZ-SPL was barred from shipping product into the United States.

FDA revises information on Heparin

2008-06-19T07:12:00.000-07:00

The FDA has updated its website FDA Questions and Answers on Heparin

The latest version contains new questions and answers about Heparin and its uses, further details on the FDA investigation, and describes the contaminant, oversulfated chondroitin sulfate (OSCS) and its effect on the human body.

For example, the new article adds the following question and answer:

18. Why does the contaminant cause serious adverse events? (new question and answer added 6/18/2008)

The contaminant activates chemicals in the body called enzymes. These enzymes cause the body to make inflammatory mediators (chemicals that are released by immune cells). Inflammatory mediators can lead to some of the symptoms such as low blood pressure, abdominal symptoms and shortness of breath. This mechanism can explain many of the serious adverse events that occurred immediately after patients were given the contaminated heparin.

Tomorrow I will write about the FDA inspections of the Chinese facilities.

Heparin Death Reports Nearly Double

2008-06-17T07:58:00.000-07:00

The FDA issued an updated report yeseterday on the number of deaths reported after heparin administration that occurred and were submitted to the FDA from January 1, 2007 through May 31, 2008. (See FDA 06/17/08 “Information on Adverse Event Reports and Heparin.”)

According to the FDA, as of May 31, 2008, there have been 246 reports of death in patients receiving heparin since January 1, 2007. Out of the 246 reported deaths, 149 of the reports included one or more allergic symptoms or symptoms of hypotension. This report is nearly double the FDA's earlier report in April 2008, which advised of 131 reported deaths, with 81 of those reports including one or more allergic symptoms or symptoms of hypotension.

The FDA's Center for Devices and Radiological Health (CDRH) has also recently reported 11 deaths and 86 injuries since January 1, 2008, which have been linked to use of medical devices containing heparin. (06/03/08 FDA web update: "Questions and Answers on Heparin, Medical Devices and In-vitro Diagnostic Assays.") The heparin in the majority of these medical devices was found to be contaminated with OSCS.

Draft Bill Regarding Preemption To Be Introduced

2008-06-13T18:11:00.000-07:00

On February 20, 2008, the United States Supreme Court severely curbed the rights of injured victims in the case of Riegel v. Medtronic, which held that the Federal Food, Drug and Cosmetic Act (FDCA) preempts state-law claims seeking damages for injuries caused by medical devices with premarket approval from the FDA. (The problems with preemption have been discussed previously on this blog including, “The Preemption Problem” and “Should FDA Drug and Medical Device Regulation Bar State Liability Claims?”)

However, as reported in the 6/10/08 FDA news Device Daily Bulletin, prominent lawmakers are now seeking to introduce a bill in the next few weeks that would render this harsh U.S. Supreme Court decision moot. (FDAnews Device Daily Bulletin, Vol 5 No. 113, “Device Preemption Ruling Threatened by Draft Bill.”) This important bill would add a subsection to the FDCA stating, “Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State.” The draft bill is sponsored by Congressmen Pallone and Waxman and is available at: www.fdanews.com/ext/files/FinalBill.pdf.

As this legislation is critical to ensuring the accountability of medical drug and device manufacturers for the safety of their products, we support this new bill.

Heparin Timeline with Web-Links Now Available

2008-06-11T11:53:00.000-07:00

Zoll, Kranz & Borgess, LLC has just posted a detailed timeline relevant to the Heparin recall and subsequent litigation. This timeline created solely by Zoll, Kranz & Borgess, also features web-links to almost a hundred articles, videos, and other documents, including public documents from Baxter, SPL and the FDA. Please visit this timeline by clicking here.

Additional U.S. Deaths from Heparin Medical Devices

2008-06-09T07:08:00.000-07:00

On June 3, 2008, the FDA announced that there have been 11 deaths and 86 cases of harmful side effects since January 1, 2008 that have been linked to use of medical devices containing heparin. (See 06/03/08 FDA web update: "Questions and Answers on Heparin, Medical Devices and In-vitro Diagnostic Assays.") The heparin in the majority of these medical devices was found to have the same contaminate, oversulfated chondroitin sulfate (OSCS), as found in Baxter heparin multiple-dose vials often used in dialysis and other medical procedures. Products coated with, containing or manufactured with heparin include:

Heparin lock flush solutions in vials and solutions in pre-filled syringes;
Devices used during cardiopulmonary bypass procedures, including certain oxygenators, filters, reservoirs, and cannulae;
Catheters including certain vascular access catheters, drainage, retransfusion and thermodilution catheters, and oximetry probes;
Certain vascular stents and grafts;
Certain assisted reproduction media devices; and
Certain In-Vitro Diagnostic media and related devices

A list of other medical devices and diagnostic products that may contain or be coated with heparin can be found by clicking here. This list also includes the manufacturer or distributor.

In a media interview, the FDA said that these 11 deaths involving heparin medical devices are ``probably in addition'' to the 81 deaths stemming from Baxter heparin multiple-dose vials, though some of the reports to the FDA are ``very sketchy'' and there could be ``some minor overlap.'' (See 6/5/08 Blooomberg News, "Heparin in Medical Devices Linked to 11 U.S. Deaths.")

The majority of reports of death and injury from medical devices containing heparin were associated with use of heparin lock flush solutions in vials and solutions in pre-filled syringes, although reports have also been received for other medical devices listed above. (See 06/03/08 FDA web update: "Questions and Answers on Heparin, Medical Devices and In-vitro Diagnostic Assays.")

This contamination can also lead to inaccurate test results from diagnostic diagnostic devices that monitor heparin or use it as part of the device itself. (See 06/03/08 FDA web update: "Questions and Answers on Heparin, Medical Devices and In-vitro Diagnostic Assays.")

Heparin and medical devices containing heparin have been recalled by Baxter (01/25/08 Baxter recall notice and 02/28/08 Baxter recall notice), American Health Packaging (03/20/08 Am. Health Pkg recall notice), B. Braun (03/21/08 B. Braun recall notice), Covidien (03/28/08 Covidien recall notice), and Medtronic (05/14/08 Medtronic recall notice).

Heparin MDL Sent to Toledo, Ohio

2008-06-06T12:18:00.000-07:00

On May 29, 2008, Zoll, Kranz & Borgess, LLC argued before the United States Judicial Panel on Multi-District Litigation that the Heparin Products Liability Litigation be transferred to the Northern District of Ohio, before the Honorable Chief Judge James G. Carr. Other districts, including the Southern District of Illinois, District of New Jersey, Southern District of Florida, the District of Puerto Rico, and the Northern District of California, were suggested by Baxter Healthcare Corp., Scientific Protein Laboratories, LLC, and other parties.

Today the United States Judicial Panel on Multi-District Litigation issued a transfer order, transferring the Heparin Multi-District Litigation MDL No. 1953 to the Northern District of Ohio, before the Honorable Chief Judge James G. Carr.

A copy of the decision is available by clicking here.

Any inquiry regarding this or any other Heparin matter may be directed to either David Zoll or Pamela Borgess at (419) 841-9623.

We have invited all Plaintiff attorneys from across the nation to meet with us and organize for this important litigation. We are committed to working for the common benefit of all Plaintiffs in this action.

Update: Link to story in Toledo Blade

The Preemption Problem

2008-06-04T13:13:00.000-07:00

Baxter, along with other drug manufacturers, continues to advocate for complete immunity from the majority of suits involving unsafe medical drugs under a legal concept called “federal preemption.” (See Baxter’s “Response to Preemption Discussion to Quaid’s Lawsuit.” See also testimony of Dennis and Kimberly Quaid at the Committee on Oversight and Government Reform’s 5/14/08 hearing, “Should FDA Drug and Medical Device Regulation Bar State Liability Claims?” The full transcript and video of this hearing is available by clicking here.) Baxter and other drug manufacturers argue that regardless of misconduct or failures on their part, Americans injured by defective drugs should be stripped of their constitutional right to a trial by jury for most, if not all, legal claims, where the drugs are regulated or approved by the FDA.

This argument is not only legally and ethically problematic, but is based on the flawed assumption that the FDA has the resources, authority, and capability to ensure product safety. Unfortunately, as the heparin debacle as reminded us, such is not the case. Since the contaminated heparin recall, the significant shortcomings in the FDA’s ability to protect this county against unsafe drugs and medical devices, has been on the forefront of the news media, as well as the agenda of Congress. Reports exposing the depth of the problem continue. This week USA Today published an article entitled “Drug Companies Drain Scientific Brains from FDA,” which reports that the FDA continues to lose its most experienced scientific minds to major drug companies with more financial resources. This has led to staffing problems for the agency, which has a turnover rate twice that of other agencies.

A previous study conducted by USA Today and reported in an article entitled “FDA Advisers Tied to Industry,” found that “more than half of the experts hired to advise the government on the safety and effectiveness of medicine had financial relationships with the pharmaceutical companies that will be helped or hurt by their decisions.”

With their undeniable influence at this and other levels of our government, it is no wonder that drug companies have gained support for federal preemption of medical drug and device lawsuits. It is also no wonder that Americans continue to die from unsafe drugs and medical devices.

Yet, our constitution gives every-day Americans injured through no fault of their own, a powerful weapon against corporate corruption and greed, the right to a jury trial. In a United States court of law, a regular American can hold even the wealthiest and most powerful corporation accountable. Attempts by Baxter and others to sacrifice that constitutional right for protection of its corporate profits, should be not be permitted.

SPL story in Wisconsin State Journal

2008-06-02T13:14:00.000-07:00

The Saturday, May 31, 2008 edition of the Wisconsin State Journal ran a story on Scientific Protein Labs, the supplier of the contaminated heparin to Baxter. (SPL was formerly a division of Oscar Mayer, the hot dog company.) The story is worth reading for several reasons.

First, it describes the process involved in processing pig intestines into the raw sugar powder used to make heparin. This powder is called the api, or active pharmaceutical ingredient. Here in the United States, SPL controls its supply by actually processing the pig intestines. One 22 ton semi load of pig guts is processed down into just six pounds of heparin powder.

In China, SPL - Changzhou (SPL-CZL), an SPL joint venture, bought processed pig guts, rather than act as the parent company and purchase the raw pig guts. SPL-CZL purchased the material after some processing had been done. SPL - CZL then shipped the heparin powder in bags from China to Wisconsin. SPL did not even open the bags in Wisconsin, but simply forwarded them to Baxter's Cherry Hill, New Jersey plant. These bags contained material that had been "cut" with a counterfeit product that mimicked heparin. Up to 30% or more of the material was actually oversulfated chondroitin sulfate (OSCS).

What is new in this article is the admission that Baxter bought all of its raw heparin only from the China operation. The raw heparin that is made by SPL from domestic pigs is all sold to Sanofi Aventis, another drug company.

All of SPL's heparin was made in the United States until 2004, when it acquired the China operations. In China SPL purchases its raw materials from two different companies, and each of them obtain the processed raw material from 10 other workshops, which do the initial processing of the pig intestines. So the supply chain of SPL is much different than that here in the United States, a fact which should have been known by Baxter.

The most critical admission in the latest article is the admission by SPL that it feared suppliers would try to sell it counterfeit products because of the blue ear pig disease that was ravaging the pig supply in China. It started testing its incoming supplies to make sure that sheep intestines weren't being substituted. But amazingly it never utilized the common test of NMR until after it was too late.

It didn't even own an NMR machine.

CEO Strunce stated that he has learned a lesson. "The lesson is that you have to be constantly vigilant."

Mr. Strunce, that lesson was taught in drug manufacturing 101. You must have missed that class.

Where will the cases go? MDL update

2008-05-30T13:33:00.000-07:00

Yesterday I had the honor to present oral argument before the United States Judicial Panel on Multidistrict Litigation. This is a very distinguished panel of Federal Judges from around the country who meet once a month to decide if particular groups of cases should be consolidated before a single judge for purposes of discovery, and, if so, to decide which judge should hear the cases.

The Court sat yesterday in Asheville, North Carolina to decide several dozen matters. One of them was MDL 1953, the Heparin Disaster cases. The first attorney to argue asked the cases be transferred to San Francisco, even though there as yet are no cases pending there, because San Fran is closest to China, where some of the discovery needs to be done.

I argued second for Toledo. My reasons included the following:

Toledo has the best resources and is most convenient, and we were the first to file, had the most cases, and it would be best not to have the cases heard in Baxter's back yard of Illinios.

I pointed out that Chief Judge Jim Carr has the time, experience, dedication and resources to resolve these cases in a fair and expeditious manner, pointed out that our Toledo courthouse has state of the art equipment in the clerk's office and courtroom, run by tech savvy skilled personnel.

I indicated that Baxter's claim that all the witnesses were in either New Jersey or Illinois was really incorrect. The main issue in this case isn't what Baxter or SPL did, but what they didn't do. Why they failed to perform critical customary testing of incoming raw material for purity, and why they relied on Chinese subcontractors to perform this critical purity testing without documentation. NMR analysis is a basic fundamental test that is done for purity. It should have been used for Heparin.

Finally I concluded that Toledo was centrally located and convenient to the entire country. I pointed out that the federal courthouse in Toledo was only 45 minutes from Detroit Metro, which has a state of the art Northwest hub with connections throughout the world, and that it is much easier to drive from Detroit Metro to the Toledo courthouse than to go from OHare to downtown Chicago. I ended by mentioning that Northwest has just announced a new nonstop flight from Detroit to Shanghai, China.

After my argument other attorneys argued for Puerto Rico, Illinois and New Jersey. I am cautiously optimistic that the cases may be referred here. I expect a decision within thirty days.

HEPARIN FEDERAL FILINGS UPDATE

2008-05-23T12:05:00.000-07:00

To date there are twenty-four (24) heparin cases filed in Federal District Courts across the country. This number includes our seven (7) cases which are filed in the United States District Court for the Northern District of Ohio, Western Division. We expect to file additional cases shortly. Other Federal District Courts include:

· U.S. Dist. Ct., Southern District of Florida (1 case)
· U.S. Dist. Ct., Middle District of Florida (1 case)
· U.S. Dist. Ct., District of New Jersey (2 cases)
· U.S. Dist. Ct., Eastern District of Texas (2 cases)
· U.S. Dist. Ct., Northern District of Illinois (4 cases)
· U.S. Dist. Ct., Western District of Pennsylvania (1 case)
· U.S. Dist. Ct., Eastern District of Louisiana (1 case)
· U.S. Dist. Ct., District of Puerto Rico (3 cases)
· U.S. Dist. Ct., Eastern District of Tennessee (1 case)
· U.S. Dist. Ct., Eastern District of Pennsylvania (1 case)

There may be several other cases filed in state courts.

At the present time, the federal cases are being considered for multi-district litigation. Multidistrict litigation (“MDL”) is a procedure utilized in the federal court system to transfer to one federal judge all pending civil cases of a similar type, such as the heparin cases, filed throughout the United States. A panel of seven federal judges that are appointed by the Chief Justice of the United States Supreme Court decide on whether the cases should be transferred.

The judge who gets all the federal cases assigned to him is known as the "transferee judge." The judges from throughout the United States who send cases to the MDL judge are know as the "transferor judges" or "transferor courts."

At a hearing scheduled on May 29, 2008 in Asheville, North Carolina, we will be arguing that all of the federal cases should be transferred here to Toledo on the basis that our federal court has the time, resources and experience to handle the MDL and Toledo is conveniently and centrally located. Other attorneys are seeking a transfer to courts in Illinois, New Jersey, Pennsylvania, Florida and Puerto Rico. We hope to have a decision in the next few months.

-Submitted by Pamela A. Borgess

FDA NEEDS SUBPOENA POWER

2008-05-21T13:39:00.000-07:00

At the April 29, 2008 hearing entitled, “The Heparin Disaster: Chinese Counterfeits and American Failures,” Rep. Bart Stupak, Chairman of the investigations panel of the House Commerce Committee, asked FDA representatives if the FDA needs subpoena authority. This subpoena power would give the FDA the power to demand certain documents from companies who have sold contaminated drugs, such as Baxter and SPL. Without this ability, the agency is powerless to obtain internal company documents that a company itself chooses to withhold. Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, and Deborah Autor, Director of the FDA’s Office of Compliance, replied that this power “would be very helpful.”

Last week, Stupak followed up on his inquiry, sending a letter to the FDA Chief, Andrew C. von Eschenbach, M.D. This letter emphasized the importance of giving the FDA subpoena power and asked the FDA Chief to stand by the statement of Dr. Woodcock and Ms. Autor. (Wall Street Journal, 5/20/08, “Rep. Stupak Nudges FDA Toward Subpoena Power.”)

As noted by Stupak, the FDA is one of the few Federal agencies that lack subpoena power. In his letter, Stupak writes, “An integral part of ensuring the FDA can protect the American people is equipping the Agency with proper resources and enforcement authority it currently lacks….In some cases, the FDA does no testing of its own, and in making decisions it must rely entirely on the test results submitted by manufacturers. Without subpoena power, the only way the FDA can ensure it has the information it needs it to threaten criminal prosecution by the Justice Department if it finds critical data is withheld.”

After six years of debate whether Congress should give the FDA subpoena power, the most recent heparin disaster and the FDA’s inability to fully investigate what went wrong, should signal the importance and need to immediately provide this power. Stupak is correct. Without the ability to obtain all documents necessary for a full and fair investigation, we will likely never know the full truth as to how fake heparin was allowed to be sold and injected into hundreds of Americans. More importantly, we cannot ensure that it will not happen again.

-Submitted by Pamela A. Borgess

Promises of Safety

2008-05-16T13:15:00.000-07:00

On Monday, during an interview with The Associated Press, U.S. Health and Human Services Secretary, Mike Leavitt, represented that the heparin in the United States is now safe in light of tighter testing and controls. (5/12/08 Chicago Tribune Article: “U.S. Health Secretary: Chinese Heparin Now Safe.”) He discussed the additional guidelines regarding quality and safety that exporters must now meet. I hope he is right. I hope that after months of Americans dying from contaminated heparin, import alerts at the borders and proper testing, heparin and all drugs coming into the United States are now safe. (Although based on the evidence presented to the U.S. House Commerce Committee on Energy and Commerce at the April 29, 2008 hearing entitled, “The Heparin Disaster: Chinese Counterfeits and American Failures,” I doubt this is the case.) But what about what is on our shelves already?
Unfortunately, just a week ago, the FDA stepped up its heparin alert to hundreds of hospitals, medical societies and pharmaceutical organizations after learning that some medical facilities still had contaminated heparin among their supplies. (5/9/08 Wall Street Journal, “FDA Issues Update Heparin Alerts to Medical Facilities.”) The notice to the facilities read, "Please help FDA spread the word about recalls of injectable heparin products and heparin flush solutions that may be contaminated with oversulfated chondroitin sulfate (OSCS). Affected heparin products have been found in medical care facilities in one state since the recall announcement…Although product recall instructions were widely distributed, they may not have been fully acted upon at all sites where heparin is used.”
Indeed, many manufacturers and distributors of medical products containing or coated with heparin have only recently begun to identify and recall products containing the contaminant, as requested by the FDA last month. For example, on Monday, Atrium Medical Corporation recalled selected lots of HYDRAGLIDE™ Brand Heparin-Coated Thoracic Drainage Catheters that were manufactured with heparin that was contaminated with OSCS. Likewise, on May 7, 2008, Medtronic, Inc. recalled selected products with a “Carmeda BioActive surface” that were manufactured with heparin found to have been contaminated with OSCS. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs.
This delayed response is unfortunately consistent with the experience of our clients, some of whom we believe received recalled heparin after the date of recall, or who never received notice of the recall from their pharmacy or medical facility. Authorities must continue to focus not only on what is being imported, but what is already within our borders. A blanket promise of safety to the unsuspecting American public should only be made when it is certain that it is a promise that can be kept.

-Submitted by Pamela A. Borgess

Should FDA Drug and Medical Device Regulation Bar State Liability Claims?

2008-05-14T13:44:00.000-07:00

A hearing today before the House Committee on Oversight and Government Reform will address the question of immunity for drug companies. The drug companies want complete protection from lawsuits even when they fail to properly manufacture, market or package their drugs.

But a formerFood and Drug Administration commissioner told Congress today that FDA approval of a drug or medical device shouldn't bar suits against the product's manufacturer, saying the agency's lack of resources diminishes its ability to detect emerging risks.

"Even if the FDA's funding were doubled or tripled, its resources and ability to detect emerging risks on the thousands of marketed drugs and devices would still be dwarfed" by the resources of drug companies, according to David Kessler, FDA commissioner from 1990 to February 1997.

The Bush administration has followed a two-pronged strategy for protecting big pharma. First, seek legal immunity in the Supreme Court for companies on the basis that the FDA's approval amounts to a "preemption" of the rights of individuals injured or killed by the defective drugs to purse claims under state laws.

Second, the Bush administration intentionally underfunds the FDA, thereby preventing it from performing its obligation of inspection and enforcement.

Actor Dennis Quaid also testified today. His six-month-old twins, Thomas Boone and Zoe Grace, were accidentally given adult-doses of the blood thinner heparin in November 2007 because the product looked similar to another drug used to flush IV lines. The overdose of heparin was potentially lethal, but Quaid's children fully recovered.

Quaid said in opening testimony that the similarity of heparin to Hep-Lock, a weaker blood thinner used to flush IV lines, also led to the deaths of three infants in Indianapolis in 2006. Both Hep-Lock and heparin are made by Baxter International Inc. (BAX).

Quaid sued Baxter in November 2007, and the Deerfield, Ill., company has moved to dismiss the case, relying on the preemption doctrine.

Quaid said a federal ban on lawsuits "would relieve drug companies of their responsibility to make products as safe as possible, and especially to correct drug problems when they are most often discovered - years after their drugs are on the market."

Quaid and the former FDA Commissioner are right. Both the FDA and the manufacturers have absolute non-delegable duties to insure our drugs are safe. The preemption doctrine significantly diminishes the safety of our drugs, permitting companies to hide behind the fallacy that FDA approval amounts to a guarantee of safety.

We have learned the hard way that the FDA does not and cannot protect us from defective drugs. Drug companies that fail to perform their duties should be held to the same standard as every other corporation or person in America, and required to make good the harm caused by their breach of duty.

You can watch the hearing on C-Span here: Hearing: Should FDA Drug and Medical Device Regulation Bar State Liability Claims?

What is the status of the Litigation?

2008-05-12T13:18:00.000-07:00

Most of the Heparin cases have been either filed in or removed to federal court. The federal court system has jurisdiction over the cases because of diversity of citizenship between the Plaintiffs and Defendants.

A motion has been filed to consolidate all of the federal cases into a single case for purposes of discovery and related proceedings. This motion will be heard on May 29, 2008 before a special panel of federal judges who will sit in Asheville, North Carolina.

The Judicial Panel on Multi-District Litigation ("MDL") has two issues to decide. First, they must decide if the cases should all be consolidated. It is highly probably that they will agree that the cases should be consolidated. In fact no one has opposed the motion to consolidate so far.

The second issue for the Panel to decide is to which District the cases should be sent. So far there have been a number of options presented to the panel. Baxter and SPL have argued that the cases should be decided in the home districts of Baxter, namely, New Jersey or Illinois. We have argued that the cases should be sent to the Northern District of Ohio. At the hearing I will present the argument for Ohio while other attorneys will request the panel to send the cases to Pennsylvania, Florida or Puerto Rico.

I expect that the panel will act quickly on this matter. I do believe there is a fair chance that the cases will be sent to our district.

Once the cases are assigned to a particular judge the parties will begin the discovery process. This involves obtaining copies of all relevant documents and taking the depositions of the Baxter and SPL employees and officers, as well as experts in the relevant fields of specialty.

Other MDL's have resulted in settlements. For example, we have recently worked on the Vioxx and Sulzer Hip MDLs which resulted in negotiation of a universal settlement. At this stage, though, the primary goal is to lock in the liability of SPL and Baxter for this tragedy. Once the evidence has established their irrevocable responsibility we can start to focus on the other issues.

NMR would have detected OSCS

2008-05-09T14:44:00.000-07:00

One of the key issues in the Heparin Disaster litigation is whether Baxter and SPL should have taken reasonable steps to insure the safety and purity of the raw materials used in the finished heparin product.

We now know that a test called NMR Spectroscopy can easily distinguish over sufated chondroitin sulfate ("OSCS") contaminated heparin from the real thing. So what is NMR Spectroscopy?

According to Wikipedia:

Nuclear magnetic resonance spectroscopy, most commonly known as NMR, is the name given to a technique which exploits the magnetic properties of certain nuclei. This phenomenon and its origins are detailed in a separate section on nuclear magnetic resonance. The most important applications for the organic chemist are proton NMR and carbon-13 NMR spectroscopy. In principle, NMR is applicable to any nucleus possessing spin.

Many types of information can be obtained from an NMR spectrum. Much like using infrared spectroscopy to identify functional groups, analysis of a 1D NMR spectrum provides information on the number and type of chemical entities in a molecule.

The impact of NMR spectroscopy on the natural sciences has been substantial. It can, among other things, be used to study mixtures of analytes, to understand dynamic effects such as change in temperature and reaction mechanisms, and is an invaluable tool in understanding protein and nucleic acid structure and function. It can be applied to a wide variety of samples, both in the solution and the solid state.

Over the past 50 years NMR has become the preeminent technique for analysis of organic compounds. Here is a very good explanation (with pictures!) as to how NMR works from an undergraduate level course in Organic Chemistry at Michigan State University:

NMR Spectroscopy

While the science and theory maybe complex to a layman, NMR has been around a long time and is a very common analysis method taught at the undergraduate level. We intend to find out from Baxter and SPL why they failed to use this common test method in the analysis of raw materials from unknown sources before inclusion in such an important and sensitive product as heparin.

We continue to investigate cases from patients or their families around the country who have been killed or injured by this counterfeit product.

Baxter CEO questioned by Shareholders

2008-05-08T10:41:00.000-07:00

Baxter held its annual meeting yesterday in Chicago. According to press reports:

Although the hourlong meeting focused on Baxter's record sales last year and rising share price, about 15 minutes was devoted to the heparin imbroglio. One investor wondered whether Baxter has taken steps to "close the loopholes" in its supply chain to make sure such a situation did not happen again.

Parkinson acknowledged "challenges associated with managing the supply chain," but that Baxter and other companies were making changes for the better.

Parkinson said Baxter and other companies get heparin's raw ingredient from China because "that's where the pig population is," adding that the Chinese supply of hogs is five times larger than in the U.S.

Well it wasn't the Chinese pigs that added oversulphated chondroitin sulphate (OSCS) to their intestines. It was someone looking to substitue a counterfeit product that was 100 times cheaper than Chinese raw heparan made from pig intestines. Someplace between the workshop that received the raw intestines and the bottling of the finished heparin, someone substituted counterfeit OSCS.

We have obtained a translated copy of a Chinese patent for the manufacture of OSCS. The Chinese patent was filed December 20, 2005 by Shandong University in Shandong China. This patent claims that OSCS can be cheaply manufactured using the claimed technique and the resulting OSCS product "has anticoagulant activity of 10 IU/mg," "anti-inflammatory and pain killing activity," and "inhibits tumor growth and metastasis."

It doesn't take a great leap of imagination to figure out that this or a similar product might be used as a substitute for heparin, particularly when disease in China had caused a sharp increase in the price of the raw product.

I commend the responsible Baxter shareholders who are challenging their company to act responsibly and "close the loopholes" that let this counterfeit product into the Baxter products.

All manufacturers of food and drug products owe a non-delegable duty to the consumers to insure the safety of their products, even if this means they have to use only those raw materials that can be securely monitored.

China Points the Finger at Baxter and the FDA

2008-05-07T13:41:00.000-07:00

The director of China's "FDA" told a press conference that Baxter had failed to cooperate with Chinese experts sent to the U.S. to investigate the Heparin Disaster. The director, Jin Shauhong, also claimed that there was no "confirmed" link between the Over Sulfated Chondroitin Sulfate ("OSCS") and the deaths of patients in the United States.

Chinese representatives claimed that Baxter and the FDA failed to provide them with medical records, medical histories, and information on Baxter's manufacturing practices. The Chinese also complained that they had not been given samples of the contaminated product. Baxter now says it will give the Chinese samples of the product to test.

The FDA tried to inspect the Changzhou Techpool Pharmaceutical Co. ("CZTP") in Changzhou, China on February 27, 28 and 29, 2008. This company supplied SPL Changzhou with raw heparin and may have been a source for the contaminant.

During those inspections the FDA was accompanied by a representative of the U.S. Embassy from Beijing. This facility was NOT regulated by the Chinese because it did not sell any product within China. Instead its products were all made for export; therefore neither the Chinese nor the FDA inspected this plant.

Changzhou SPL, a defendant in the cases we have filed, owns 45% of CZTP. During the FDA inspection CZTP refused to provide the FDA with records for review.

Now the Chinese are complaining that U.S. companies are not cooperating with them in their investigation. What a surprise.

This illustrates a number of critical shortcomings in our drug system. First, as admitted by the FDA last week, the FDA is woefully underfunded and unable to inspect foreign manufacturers. Second, the manufacturers themselves cannot be relied upon to self-regulate their suppliers. Third, China and the United States have been unable to cooperate with each other to insure that good manufacturing practices are followed throughout the chain.

The only regulation that is truly reliable is that obtained by our common law. Companies that fail to insure the safety of ingredients in their products must be held strictly accountable for all injuries and deaths they cause. They must be held strictly accountable.

SPL used to be called Oscar Mayer. It used the small intestines of American grown hogs to make the raw heparin. There was no adulteration by counterfeit heparin because Oscar Mayer was an American company with a reputation to protect and a business to run. It would be unthinkable.

Yet somewhere along the way, through free trade agreements, the drive for ever higher shareholder return, corporate profits, deregulation, and business - friendly agencies we have lost our way. As we go through the documents and take the depositions of these corporate officers we are going to learn a lot more. And it isn't going to be a pretty picture.

By the way, if the Chinese are really worried about the relationship between the counterfeit heparin and the injuries and deaths, I suggest they read the recent article in the New England Journal of Medicine. We have a link to it on our web site. Maybe we should translate it into Mandarin.

The Heparin Disaster

2008-05-06T17:07:00.000-07:00

On February 14, 2008, Zoll, Kranz & Borgess, LLC was the first law firm in the nation to file suit against Baxter Healthcare Corporation and other related companies regarding contaminated batches of its drug, Heparin. We are continuing to lead the way with multiple cases filed in federal court and have ongoing investigations into possible cases both in and outside Ohio.

Recently, our law firm was honored when three of our clients, Leroy Hubley, Colleen Hubley and Johanna Staples, were invited by the U.S. House Commerce Committee on Energy and Commerce (one of the oldest standing committees of the U.S. House of Representatives) to speak on April 29, 2008, at a hearing entitled, “The Heparin Disaster: Chinese Counterfeits and American Failures.”

Please contact our law office by phone at 419-841-9623 or by email at pamela@toledolaw.com if you or someone close to you may have been given heparin during dialysis or during any other procedure, and experienced any of the following symptoms or death:

Oral swelling

Abdominal pain

Burning sensation

Chest pain

Diarrhea

Dizziness

Drug ineffectiveness

Painful, difficult, or disturbed digestion

Dyspnea [unpleasant or uncomfortable breathing]

Erythema [redness of the skin]

Flushing

Headache

Hyperhidrosis [excessive sweating]

Hypoesthesia [reduced sense of touch or sensation]

Increased lacrimation [production, secretion, and shedding of tears]

Loss of consciousness

Malaise [general discomfort or uneasiness]

Nausea

Pallor

Palpitations

Paresthesia [tingling, pricking, or numbness of a person's skin]

Pharyngeal edema [swelling in throat]

Restlessness

Vomiting/retching

Shortness of breath

Stomach discomfort

Tachycardia [rapid beating of the heart]

Thirst

Trismus [Inability to open the mouth fully]

Unresponsiveness to stimuli

Severe hypotension [abnormally low blood pressure]

The Heparin Disaster

Congress Vows to Continue Contaminated Heparin Investigation

Cook County Judge authorizes Punitive Damages in Contaminated Heparin

Baxter gets yet another warning letter

Jury Finds Against Baxter Healthcare In Nation’s First Contaminated Chinese Heparin Case

FDA: Another tainted drug crisis seems inevitable

“60 Minutes” Program on Counterfeit Drugs, Including Contaminated Heparin, to Air this Sunday, March 13, 2011

Money Well Spent? Baxter lobbies for advantages

Yet more safety problems, including contamination, in Baxter products reported today

Judge Finds Contaminated Heparin Unreasonably Dangerous

Baxter Sells Heparin Plant

Baxter announces departure of Peter Arduini, President Med. Del.

Baxter Nailed for $500 Million in Punitive Damages from Hepatitis C

Baxter CEO received $8.6 million in 2009

FDA Testifies before Congress

Hope for the Holidays

Heparin Cases continue to be Filed

Heparin Disaster Lawyer Update

ZKB Partner to Moderate AAJ Seminar

Conflict of Interest at the FDA

What Exactly is an MDL?

Bad Chinese Heparin Supplier Cited by FDA Again

More Problems with Baxter Heparin?

The Games Drug Companies Play

FDA Pushed for Answers Regarding Bad Chinese Heparin

Baxter Files its Trial Proposal - Seeks to delay trials until 2011

Baxter Releases Live Avian Flu Virus

Grassley, Kennedy Introduce Bill to Protect Against Contaminated Imported Drugs

Sherrod Brown speaks out for Heparin Victims

Two Chinese Heparin Suppliers Cited by FDA

PREEMPTION REJECTED!!

FDA Scientists Report Corruption to President Obama

New York Times Reports on Concern Over Drugs Produced Abroad

Heparin Debacle Tops Chicago Tribune’s Top 10 Local Business Stories of 2008

WORLDFOCUS NEWS STORY ON CONTAMINATED HEPARIN

Rep. Barton Questions FDA’s Six Month Delay in Seizure of Tainted Heparin

CDC REPORT IN NEJM FURTHER SUPPORTS LINK BETWEEN OSCS-CONTAMINATED HEPARIN AND DEATHS

Washington Post Reports on Needed FDA Overhaul

Another Step Closer to Synthetic Heparin

Questions Raised Over FDA's Investigation of Heparin Deaths

FDA Offices in China: A Baby-Step Toward Public Safety

Hubleys and Staples Featured in Time Magazine

Updated: FDA seizes OSCS Contaminated Heparin

Reports of Serious Injuries and Death Linked to Medications Hits a Record High

Boston Globe Editorial on Preemption

The Joint Commission Warns of Heparin Dosing Errors

Spiked Baby Formula: Yet Another Warning To U.S. Companies

NEJM Opposes Preemption

Hospitals Still Not Removing Contaminated Heparin

Researchers Closer to Developing Synthetic Heparin

Important Anti-Preemption Bill Introduced by Senators Kennedy and Leahy

NEW BAXTER DRUG PROMO MISLEADING

HUBLEY FAMILY FEATURED ON NIGHTLINE

FDA Tells Chicago Tribune That It Can Only “Conclusively” Link 3 Fatalities So Far to Contaminated Heparin

FDA links 149 deaths to contaminated Heparin

Baxter Announces Profits up 26%

Chinese Authorities Still Doubt Deaths are a Result of Contaminated Heparin

New International Pilot Program to Facilitate Overseas Inspections

Texas Hospital Quick to Raise Defenses to Heparin OD

Fresenius to Buy APP Pharmaceuticals

THE HISTORY OF HEPARIN

Congress Demands Documentation Supporting the FDA’s Change in Position Regarding Preemption of Product Liability Lawsuits

The United States Pharmacopeia Announces Revised Heparin Monographs

Who owns Scientific Protein Labs?

Why Didn’t the Contaminated Heparin Affect Everyone Receiving It?

Sherrod Brown Challenges the FDA

The FDA China Inspections

FDA revises information on Heparin

Heparin Death Reports Nearly Double

Draft Bill Regarding Preemption To Be Introduced

Heparin Timeline with Web-Links Now Available

Additional U.S. Deaths from Heparin Medical Devices

Heparin MDL Sent to Toledo, Ohio

The Preemption Problem

SPL story in Wisconsin State Journal

Where will the cases go? MDL update

HEPARIN FEDERAL FILINGS UPDATE

FDA NEEDS SUBPOENA POWER

Promises of Safety

Should FDA Drug and Medical Device Regulation Bar State Liability Claims?