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The Heparin DisasterA running commentary on the contaminated heparin disaster caused by Baxter Healthcare's distribution of contaminated heparin from Scientific Protein Lab's API, and the deaths and injuries resulting therefrom.Thursday, May 14, 2009 Bad Chinese Heparin Supplier Cited by FDA AgainDespite 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. Labels: Baxter, Baxter Heparin, Chinese heparin, FDA, Heparin, heparin attorney, Heparin Class Action, heparin disaster, heparin lawsuit, heparin lawyer, Scientific Protein, SPL
Monday, May 11, 2009 More Problems with Baxter Heparin?
Last weekend, two Delaware patients died and a third suffered medical complications after taking Baxter heparin, sparking concern of a repeat of last year’s contamination that killed hundreds of Americans. (See 05/11/09, Wall Street Journal, “Two Delaware Deaths Prompt Review of Baxter’s Heparin.”)
Although there is not specific evidence tying heparin to the illnesses, a spokesman for the Medical Center where the reactions occurred stated, "We don't know what's going on, but heparin is the only commonality that we were able to see ourselves. (Id.) Baxter claims that unlike last year’s deadly contamination, the bulk material in the recent cases did not come from China and did not involve the counterfeit additive, over-sulfated chondroitin sulfate, (“OSCS”). However, testing is still ongoing. Labels: Baxter, Baxter Heparin, China, Chinese heparin, FDA, Heparin, heparin attorney, heparin disaster, heparin lawsuit, heparin lawyer, OSCS, over sulfated chondroitin sulfate
Friday, May 8, 2009 The Games Drug Companies PlayElsevier, the publisher of many medical journals relied upon by experts in drug litigation, made a chilling announcement yesterday: 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. Labels: Baxter, Baxter Heparin, Heparin, heparin attorney, Heparin Class Action, heparin disaster, heparin lawyer, OSCS, over sulfated chondroitin sulfate, vioxx
Wednesday, May 6, 2009 FDA Pushed for Answers Regarding Bad Chinese Heparin
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. Labels: Barton, Baxter, Baxter Heparin, Celsus, Chinese, Chinese heparin, Eschenbach, FDA, Heparin, heparin attorney, Heparin Class Action, heparin disaster, heparin lawsuit, heparin lawyer, OSCS, Sharfstein
Monday, May 4, 2009 Baxter Files its Trial Proposal - Seeks to delay trials until 2011
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. Labels: Baxter, Baxter Heparin, Heparin, heparin attorney, Heparin Class Action, heparin disaster, heparin lawyer
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