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Yasmin Lawsuit Documents Reveal Bayer Concealed Blood Clot Risks

Dec 6, 2011 | Parker Waichman LLP

More documents have been unsealed in the Yaz and Yasmin litigation, including an expert witness report that alleges Bayer AG hid evidence pointing to a higher risk of blood clots among Yasmin users from the U.S. Food & Drug Administration (FDA).  According to a Bloomberg News report, the allegations were made by David Kessler, a former FDA commissioner.

Kessler's statement was one of five expert opinions released yesterday by lawyers representing former users of Bayer’s Yasmin family of contraceptives in thousands of personal injury lawsuits. In his 121-page report, Kessler writes that Bayer had documented in the draft of an August 2004 white paper that Yasmin was 10 times more likely to cause serious side effects including deep vein thrombosis (DVT), a dangerous type of blood clot. But when the paper was submitted to the FDA, the statement mentioning the increased DVT risk was omitted. Also omitted was an earlier draft opinion by company researchers that “spontaneous reporting data do signal a difference in the VTE rates for Yasmin” compared with other oral contraceptives, Kessler said.

“Had I, or a medical review officer, known these facts prior to approval, further investigation would be warranted before a decision on Yasmin’s NDA (new drug application) could be made,” Kessler wrote.  “These facts would impact the agency’s risk-benefit equation about the drug and whether it could be approved,” Kessler continued.

The FDA has scheduled a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee for December 8 to discuss the safety of newer birth control pills, including Yaz and Yasmin.  Unfortunately, the FDA advisors won't have access to Kessler's report, because the agency refused to accept it for submission.   According to the agency, it wasn't  received prior to the November 23 cut-off date for submissions.

Yaz and Yasmin have been named in more than 10,000 lawsuits alleging Bayer neglected to appropriately warn patients and doctors about increased health risks associated with the drugs.  Thousands of those lawsuits have been consolidated the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100), currently pending before the Honorable Judge David R. Herndon in the United States District Court for the Southern District of Illinois.  Kessler's report was released by plaintiffs' attorneys involved in the consolidated litigation.
 



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