› $4.85 Billion settlement in drug case
Another lawsuit has been filed against the Wisconsin-based heparin manufacturer, Scientific Protein Laboratories and one of its major distributors, Baxter International Inc., claiming the companies allowed contaminated batches of heparin to reach hospitals and medical facilities, where it led to the death of a 59-year-old hemodialysis patient, according to The News-Enterprise.
Rep. Joe Barton, a ranking member of the House Energy and Commerce Committee, appears to be fed up with the FDA’s reluctance to provide details of the tainted heparin scandal that first came into public light earlier this year, according to CNN Money. That scandal resulted in the deaths of more than 80 Americans and adverse reactions in hundreds more, and led to an agency recall of lots of the blood thinner manufactured in Baxter International’s Chinese facility.
The Associated Press reported today that Food and Drug Administration Commissioner Dr. Andrew von Eschenbach will resign from his post effective Jan. 20, the same day president-elect Barack Obama takes office.
Von Eschenbach was appointed by President Bush in 2005 after the agency’s previous commissioner resigned due to ethical issues, the AP reports. While under von Eschenbach’s helm, the FDA has undergone scrutiny by Congress and consumer groups over issues such as the tainted heparin scandal earlier this year.
A team of researchers from the Massachusetts Institute of Technology (MIT) has confirmed that over-sulfated chondroitin sulfate was, in fact, the contaminant in heparin that was manufactured in China and triggered serious allergic reactions that caused more than 80 Americans to die and hundreds more to be sickened earlier this year, according to ABC Action News.
A Washington lawmaker is raising concerns about the FDA’s handling of the tainted heparin scandal earlier this year, claiming that the agency misrepresented deaths tied to the product and didn’t thoroughly investigate the situation, according to CNN Money.
Following up on a story we brought you last month about the FDA setting up offices on foreign soil to provide guidance on U.S. food and drug quality standards, the FDA announced today that the first three of its offices will open this week in China, according to the Associated Press.
A recent Time magazine story gives us a glimpse into a family affected by the contaminated heparin tragedy: Leroy Hubley’s wife of 48 years, Bonnie, suffered from polycystic kidney disease, a genetic kidney disease in which cysts grow in the kidneys, causing them to fail. She received a kidney transplant in October 2007, but her body rejected it, leaving her in need of regular dialysis treatments.
ConsumerAffairs.com is reporting that doctors are outraged that recalled batches of heparin were found in a Cincinnati, Ohio lab.
“It’s really horrible for two reasons: one, that a company that knows that their product is not a good product that should be distributed and they’ve been told so,” said Dr. Lynne Wagoner, a Christ Hospital Heart Specialist, who was quoted in the story by WTOL-TV in Toledo, Ohio.
The U.S. Food and Drug Administration (FDA) issued and FDA NEWS release today informing the public that it has removed 11 lots of heparin from Celsus Laboratories, Inc., in Cinncinnati, Ohio. According to the release, the FDA has determined five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were contaminated with over-sulfated chondroitin sulfate (ASCS). The heparin products were manufactured from material imported from China.
The FDA ordered U.S. Marshals to seize the products today. Mike Chappell, acting associate commissioner for regulatory affairs for the FDA is quoted as saying, “This action will help prevent this contaminated heparin from finding its way into the marketplace.”
Earlier this year, heparin manufactured by Baxter International, Inc., was found to be contaminated with OSCS. That heparin also contained components manufactured in China, which is believed to be the source of the contamination. The Baxter contamination led to hundreds of injuries and 81 deaths.
The FDA news release states that the agency has initiated 13 recalls of multiple contaminated medical products containing heparin from several companies, to date this year.
Information in the news release indicates the Celsus heparin entered the United States before the establishment of FDA import controls for the drug, and was reviewed by the FDA after it was processed at Celsus as a part of the agency’s process to implement the controls.
The release also indicates that the FDA knew about the contamination in April 2008, when it warned Celsus Laboratories during an inspection that the company’s actions to notify customers about the contaminant were insufficient. The FDA says it warned Celsus again that it needed to step up its efforts to notify customers about the potential hazard in a May 8, 2008 letter. Finally, today the FDA seized the contaminated product from the lab.
Manufacturers who may have purchased heparin from Celsus are urged to contact the company immediately to make sure they are not using any heparin from the since-seized lots. The product does not meet acceptable quality standards, the release says.
