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The Heparin DisasterFriday, October 16, 2009 Heparin Disaster Lawyer Update
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. Labels: Baxter Heparin, Chinese heparin, Heparin, heparin attorney, Heparin Class Action, heparin disaster, heparin lawsuit, heparin lawyer
Wednesday, August 12, 2009 Conflict of Interest at the FDA
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. Labels: Chinese heparin, FDA, Heparin, heparin attorney, Heparin Class Action, heparin disaster, Janet Woodcock, momenta
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
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
Wednesday, April 29, 2009 Baxter Releases Live Avian Flu VirusBaxter International, the company that brought us contaminated Chinese heparin, has struck again. The 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.
Amazingly, Baxter refused to reveal information about how the accident happened because of fear of revealing “trade secrets.” According to the
Labels: Baxter, Baxter Heparin, Chinese heparin, Heparin, heparin lawsuit, heparin lawyer
Monday, April 27, 2009 Grassley, Kennedy Introduce Bill to Protect Against Contaminated Imported DrugsSens. 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. Labels: Baxter, Baxter Heparin, China, Chinese, Chinese heparin, FDA, Grassley, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, Kennedy, OSCS, Stupak
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