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On November 6, 2008, the U.S. government seized 11 lots of contaminated Heparin, a widely used blood thinner, from a company in Cincinnati as part of a broader effort to ensure tainted Heparin from China doesn’t harm patients. U.S. Marshals seized the Heparin at the request of the FDA, according to a press release. The FDA said the products from Cincinnati-based Celsus Laboratories Inc. were contaminated with over-sulfated chondroitin sulfate, a substance that mimics heparin’s blood-thinning activity. The company’s products were made from material imported from China.

Earlier in 2008, the FDA said contaminated Heparin from facilities in China was linked to 81 deaths in the U.S. and hundreds of allergic reactions. Baxter International Inc. is the largest supplier of Heparin. The FDA later said it received reports of 11 deaths and other adverse events associated with medical devices that contain Heparin.

Once again heparin is back in the new and there is new evidence that the Chinese government didn’t pursue an investigation into contaminated heparin sent to the U.S. in 2007 and 2008, despite repeated requests from the U.S. for help, according to a congressional probe, according to a recent New York Times news report.

Two House Republicans said Food and Drug Administration officials recently told them that the agency has been “severely hampered” by the lack of cooperation from China in finding those responsible. Contamination in the widely used blood-thinner was linked to at least 81 deaths in the U.S.

The probe by Reps. Joe Barton and Michael Burgess, both of Texas, comes as FDA Commissioner Margaret Hamburg prepares for her first trip to China since assuming her post last year.

“It is shocking to find out two years after Chinese-made heparin was killing Americans, the Chinese government still has done no investigating to find out why,” said Mr. Barton, the top Republican on the House Energy and Commerce Committee. He called on Ms. Hamburg to air the issue with Chinese officials.

Yan Jiangying, spokeswoman for China’s State Food and Drug Administration, said the congressmen’s accusations are “not true.”

Ms. Yan said her agency “did a very thorough investigation, including very detailed inspection and testing, and surveys of enterprises as well. We signed an agreement with the FDA on drug safety in the end of 2007, and strengthened the monitoring of heparin.”

A spokeswoman for the FDA said Wednesday that “there are serious limitations on what the FDA can do to pursue civil and criminal investigations in foreign countries, especially without the cooperation of the foreign government.”

In a June 16 letter to the congressmen, the FDA wrote that it was “denied full access” to manufacturers of raw heparin in China.

Mr. Barton and Mr. Burgess said the FDA told members of Congress that China hasn’t had any breakthroughs in the investigation, which they said left the “misleading impression” that “there was some kind of open investigation.”

In fact, Chinese security authorities told a U.S. official in Beijing on June 18, 2008, that China wasn’t investigating the heparin issue as either a criminal or administrative matter, according to the congressmen.

Baxter International Inc., recalled its blood thinner heparin amid reports of allergic reactions and deaths in 2008, faces at least 30 lawsuits in Chicago by injured people or their estates. According to Bloomberg, an estimated 300 product-liability complaints may be filed in the Illinois.

The FDA requested new manufacturing standards for the blood thinner in 2008 after the problems were linked to tainted ingredients from China. Baxter which at the time supplied about 50 percent of the blood thinner and anticoagulant used in the United States began a voluntary recall after its monitors noticed an increase in reports of allergic reactions to injections of the drug.

The company began a full recall after determining that other drug makers would be able to ensure an adequate national supply, according to Gardiner.

A key ingredient in heparin is made in China from pig intestines, the company said in a May 2008 statement. “The decision to source from China is based solely on supply the majority of the world’s supply of crude heparin comes from China, due to the large number of pigs required,” Baxter said then.

The complaints accuse Baxter and the supplier, Scientific Protein Laboratories LLC, of negligence, alleging their products were unsafe for their intended use. The suits seek money damages for those who were injured and for survivors of those who died.

A new study states that Heparin, a frequently prescribed blood thinner, can cause skin lesions that are harmless in most cases but could indicate a life-threatening condition induced by the drug.

Researchers examined 320 people who were given heparin injections at a German hospital. Of those, 7.5% developed skin lesions as a result of the treatment. That’s higher than the 2% rate the researchers had anticipated.

“During the study, we were surprised by the high number of patients with heparin-induced skin lesions,” the study authors wrote. “For most patients, the diagnosis was made because of our study.”

The researchers found that in most cases, the lesions resulted from an allergic reaction. Women were more likely to have the reaction, and three factors: pregnancy, obesity and long-term heparin use resulted in a higher likelihood of the condition, the study found.

The authors suggested that doctors be aware that skin lesions might occur and realize that they need to figure out the cause. The lesions could be a sign, they said, of a serious condition called “heparin-induced thrombocytopenia,” in which the number of platelets in the blood decreases.

The study results appear in the September 28, 2009 Canadian Medical Association Journal.