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.

Serious injuries and death have been reported because of the failure of Baxter's HomeChoice and HomeChoice PRO dialysis machines.  The recall comes too late for some.  We are investigating and handling claims arising from the failure of these machines.  If you or a loved one has suffered injury or death while relying on any of the following Baxter products you should contact us immediately.

Company, Product(s): Baxter Healthcare Corporation HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems
Recall Class: Class I
Date Recall Initiated: January 8, 2010
Product Names:
Baxter Healthcare Corporation, HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems. These systems have been distributed since 1994.

Model	Product Code	Lot Number	Manufacturing Date
HomeChoice	5C4471	All	All
HomeChoice	5C4471R	All	All
HomeChoice	5C4474	All	All
HomeChoice	5C4474R	All	All
HomeChoice	T5C4441	All	All
HomeChoice	T5C4441R	All	All
HomeChoice	5C4474D	All	All
HomeChoice	5C4474DR	All	All
HomeChoice PRO	5C8310	All	All
HomeChoice PRO	5C8310R	All	All
HomeChoice PRO	R5C8320	All	All
HomeChoice PRO	R5C8320R	All	All
HomeChoice PRO	T5C8300	All	All
HomeChoice PRO	T5C8300R	All	All

Use: Automated peritoneal dialysis (PD) systems are prescription medical devices used to treat pediatric and adult patients with kidney failure.
In PD, a soft tube called a catheter is used to fill the abdomen with a cleansing liquid called dialysis solution. The walls of the abdominal cavity are lined with a membrane called the peritoneum, which allows waste products and extra fluid to pass from the blood into the dialysis solution. These wastes and fluid then leave the body when the dialysis solution is drained. Several fill – drain cycles are typically needed during a treatment. Automated PD systems, like the HomeChoice systems, can be programmed to deliver and remove several cycles of doctor-prescribed amounts of dialysis solution.
HomeChoice systems are used in conjunction with Baxter’s single use disposable tubing sets and bags of dialysis solutions.
The HomeChoice PRO model also has a small electronic data card, called a PRO card, which stores information from the nurse or doctor and automatically sets up the system for the patient

The injuries are caused by Increased Intraperitoneal Volume (IIPV), or overfill of the abdominal cavity, associated with HomeChoice and HomeChoice Pro peritoneal dialysis cyclers as a Class I recall. This action has been classified as a Class I recall because of the risk of serious injury or patient death that could be associated with the use of this device. Over the last two years, Baxter has received serious injury reports and at least one patient death report associated with this issue.


About IIPV
IIPV may result in serious injury or death from conditions such as: abdominal wall and/or diaphragmatic hernias, hydrothorax, heart failure, acute hypertension, pulmonary edema, decreased pulmonary function and pericardial effusion. Children and non-verbal patients may be at increased risk because of their smaller size and/or inability to communicate. Increased monitoring of these patients is recommended. Other vulnerable populations include critically ill patients and patients with pulmonary and hemodynamic instability.
Patients and caregivers should watch for the potential signs of IIPV. These include: difficulty breathing; vomiting or spitting up; a child complaining of a “funny feeling” in the abdomen; a child crying during therapy without other apparent reasons; difficulties feeding; feeling full, bloated, or overfilled after treatment; abdominal pain or discomfort; expanded or tense abdomen; localized swelling around the genital area (labia, scrotum) or groin region, belly button, the tunnel tract of the peritoneal dialysis catheter or the PD catheter exit site; leakage of fluid from the PD catheter exit site; and unexpected increase in blood pressure.

The cases that we have seen involved complaints of "sloshing" and fullness in the belly, bloating and similar feelings of fullness.  Skilled healthcare providers are typically unable to account for these symptoms and typically do not realized the cause is the failure of the Baxter product.

Many patients or their families have received recall notices and have been asked to ship the machines back to Baxter.  If you believe your machine has failed, and you have not previously shipped the machine back to Baxter, we urge you to hold on to the defective machine and seek alternate means of dialysis while the claims against Baxter are investigated.

It also appears that Baxter did not act promptly, efficiently and completely in instituting the recall, similarly to the mistakes they made in the heparin recall.

You can reach us toll free at 1-888-8419623 or by email at david@toledolaw.com or michelle@toledolaw.com.

Labels: Baxter HomeChoice, Baxter HomeChoice PRO, HomeChoice Dialysis, HomeChoice PRO, HomeChoice Recall, IIVP, Peritoneal Dialysis

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.

Labels: Baxter, Heparin

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.

Labels: Baxter, Baxter Heparin, contaminated heparin, FDA, foreign drugs, Heparin, Waxman.

Andy Zajac from the Chicago Tribune's Washington Bureau has an interesting blog out this week, entitled FDA: Questions of protocol, conflict.

Apparently when the FDA decides to make an announcement now, they call up a reporter. That is exactly what they did when they wanted to announce that Janet Woodcock was no longer handling the generic low molecular weight heparin dispute involving Momenta and Amphastar. The FDA is used to dealing like that. Their deals with Baxter involving life or death decisions are done behind closed doors and involve conference calls with Corporate lawyers and FDA officials from which the the public is locked out. The results of their "investigation" remain locked up in Rockville, MD.

Even though it knew its heparin was causing harm, Baxter, which had 50% of the market, continued to sell its contaminated wares, making profits in doing so while the FDA did nothing. How was it that fifty percent of this country relied on the heparin from one manufacturer that was made in a factory never inspected by the FDA, and not subject to purity standards?

In his latest blog Andrew Zajac points out that Amphastar was put to a higher purity standard than Janet Woodcock's friends at Momenta. And of course the purity standard was much higher than that required of Baxter, although when it finally inspected the Chinese facility the FDA shut it down for lack of a purity standard.

Meanwhile, apparently the New England Journal of Medicine has realized it has been conned as well. Ram Sasiskeharan, the Momenta Director and consultant to the contaminated API manufacturer, SPL, has now admitted, and the NEJM has disclosed, that he held a patent on the use of heparin modified by chondroitin sulfate, dermatan sulfate, and other "GAG" mixtures. The latest disclosure can be found here.

A fair reading of the patent makes it look awfully suspicious... but it was probably just a coincidence. SPL was selling mixtures of contaminated GAGs and Ram was claiming patent rights on how you could measure the affects of the GAGs on patients, including analphylactoid responses.

Also probably a coincidence that Baxter's consultant from RPI had published the recipe for OSCS in 1998. Of course both Ram and Dr. L told the FDA that it was something else entirely. Chitin. Chondroitin E. What would they know about NMR and CE? What would they know about sulfation of GAGs? What would they know about OSCS?

Zajac, like others, points out that the Heparin Contamination is still not resolved:

--The Chinese heparin crisis remains an open book. The source of the contaminant has never been identified, and the tainted drug, marketed by Baxter International, of Deerfield, Ill., has spawned at least 650 lawsuits which have yet to be tried. The crisis remains a powerful illustration of the FDA's inability to monitor an increasingly globalized drug ingredient supply chain.

When will the FDA publish its final report? If it does not intend to do so, it should at least release the results of its inspections and testing. Its failure to do so continues to protect powerful Big Pharma who continue to avoid responsibility while raking in the profits. Its failure to do so continues to permit and encourage Big Pharma to do as they please, the public be damned.

Is that a conflict of interest?

Labels: Baxter Heparin, contaminated heparin, FDA, Heparin, Zajac

Two years ago this month Baxter first recognized it had been selling contaminated heparin. We now know that this contamination was intentional, sophisticated, and deadly. Heparin is a sugar molecule, one of several glycosaminoglycans (GAGs) found naturally in the lining of the intestine of pigs. The contaminant also was a GAG. In fact, the contaminant may have been a combination of GAGs, all of which are found in crude heparin, the starting material for heparin.

Crude heparin consists of 4 GAGs, namely Dermatan Sulfate (DS), Chondroitin Sulfate (CS), Heparan Sulfate (HS) and Heparin. Responsible manufacturers have known of the requirement to test for the DS and CS to make sure their heparin is pure. If Baxter or its supplier, SPL, had been performing simple tests which were then in existence, they would have known and realized that their heparin was full of impurities.

These impurities, the contaminants, were easily distinguishable from heparin; yet Baxter failed to perform any testing to insure its heparin was free of common GAG impurities.

The contaminants included Chondroitin Sulfate which had been "sulfated", or chemically modified, to make it have anti coagulation properties. Heparin is an anticoagulant. So one of the purposes of adding the contaminant was to increase the anticoagulation properties.

The recipe for the contamination had been published by Robert Lindhardt in 1997 in a scientific journal, along with claims that this oversulfated chondroitin sulfated product had value as a heparin like compound:

It is possible that the anticoagulant activity can be
further increased by appropriate refinement of the
modification procedure for N-deacetylation–N-desulfonation
w26x of fully O-sulfonated chondroitin
sulfate. These possibilities point to new practically
feasible routes for the generation of heparin-like
compounds with various pharmacologically relevant
biological activities.

http://www-heparin.rpi.edu/

Unfortunately Baxter was too busy counting the profits from its cheap Chinese heparin to pay attention to what it was selling. Some one with a college education who was able to read scientific literature figured out that a cheap substitute for heparin could be made from the by product produced during the manufacture of heparin. All that had to be done was to follow the recipe published in 1997.

There are basically 2 classes of GAGs found in crude heparin. Heparin itself contains glucosamine. The contaminants included heparin byproducts that contain galactosamine. DS and CS both are galactosamines. Therefore the simple tests that had been used for decades to make sure the heparin had been properly purified to remove all of the galactosamine-containing GAGs would have also detected the contamination.

Recently published studies indicate that the contaminant was made from byproduct generated during the manufacture of heparin itself. http://ash.confex.com/ash/2009/webprogram/Paper17902.html

Neither the FDA nor the USP wants to admit that the contamination was a result of their inability to perform basic inspections and to require basic purity tests. However the failures of these organizations does not relieve Baxter or its supplier from responsibility.

The identity of the individuals and organizations responsible for intentionally contaminating Baxter's heparin remain a secret. But the list of suspects is actually pretty short. The FDA has still not finalized its investigation. Either the FDA has abandoned the hunt or they are closing in on the responsible party.

Meanwhile our civil justice system continues to grind ahead. Sooner or later Baxter and SPL will be held accountable. There are currently about 750 claims for death or permanent injury pending in federal and state courts. Hundreds more died without their survivors realizing they were victims of corporate greed.

The final chapter has yet to be written.

Labels: Baxter Heparin, Heparin, Heparin Class Action, heparin disaster, SPL

Labels: Baxter, Baxter Heparin, contaminated heparin, contamination, Heparin, heparin attorney, Heparin Class Action, heparin disaster, heparin lawyer; heparin safety, OSCS, Scientific Protein Labs, SPL