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New document says Bayer withheld information from FDA

There are new developments in a product liability case against a leading pharmaceutical company. In a previous blog, we discussed the allegations against pharmaceutical giant Bayer in regards to two of its contraceptives. In a federal court in Illinois, a document has now been unsealed that is telling the court that Bayer withheld information its researchers had uncovered from the U.S. Food and Drug Administration in 2004.

According to the former commissioner of the FDA, Bayer did not disclose an analysis that showed an increase in the occurrence of venous thromboembolisms -- also known as blood clots -- for American users of Yasmin. The company is now in court because several consumers have filed product liability suits against them because of their widely used contraceptive.

Allegedly, the company withheld the aforementioned data as well as a document that showed the opinion of its researchers. According to this document, there was a difference between the rates of blood clots in Yasmin users and those who were using other oral birth control products. The former commission of the FDA alleged that Bayer picked and chose what data it wanted the FDA to see for its 2004 review of the product, making the agency's understanding of the product's potential dangers less than clear.

Lawsuits have alleged that the company also falsely advertised their product, suggesting that it could work as a treatment for premenstrual syndrome. More than 10,000 lawsuits have been filed against the company. Many of the attorneys representing the suing parties have also pointed towards reports made by the FDA that associate at least 50 deaths with Yasmin between 2004 and 2008.

If the allegations are true, the company may find itself in a serious amount of trouble. But, according to an individual with the FDA's Division of Advisory Committee and Consultant Management, no written submissions will be accepted after the deadline, which was on Nov. 23. This means that the unsealed document has not been accepted as part of the current trial against Bayer.

Source: Bloomberg, "Bayer Withheld Yasmin Data From U.S., Former Agency Chief Tells Court," Margaret Cronin Fisk and Jef Feeley, Dec. 6, 2011

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