Bayer Covered Up Yasmin Blood Clot Risk: Ex-FDA Head
Law360, New York (December 05, 2011, 10:54 PM ET) — Bayer AG hid the significance of potentially serious side effects of its Yasmin contraceptives despite knowing they were more likely to cause blood clots than other oral contraceptives, according to a former U.S. Food and Drug Administration chief’s report unsealed Monday in multidistrict litigation in Illinois.
In a 121-page expert report, former FDA Commissioner David Kessler said the drugmaker 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, the formation of a clot in a deep vein.
But in the white paper it finally submitted to the FDA that month, it took out its statement alerting regulators about the increased risk of venous thromboembolisms, or clots, linked to Yasmin, according to the report.
“Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin,” Kessler said in the report. “In my opinion, Bayer had a duty to present a full and balanced view of all the data and analysis concerning Yasmin to the FDA and health care professionals and failed to do so.”
The FDA refused to accept Kessler’s report, filed in July, for its Dec. 8 advisory committee meeting on the contraceptives, saying it had missed their Nov. 23 deadline for written submissions, according to an email it sent to Ned McWilliams, an attorney for one of the plaintiffs in the multidistrict litigation over Yasmin and Yaz who emailed the report to the FDA.
“I think the American public would want to know why the FDA has refused to consider important safety information that Bayer did not consent to be released to the public or the FDA until after the submission deadline,” McWilliams said he had written in response to the FDA. “Surely there must be special circumstances like these, where confidential safety information was not available until after the submission deadline.”
Kessler also said Bayer had marketed its Yasmin and Yaz contraceptives for the treatment of premenstrual syndrome even though neither drug had the FDA’s approval for that purpose.
In addition, Kessler’s report emphasized that the FDA could not anticipate all the potential safety risks of a drug, saying it was the drug manufacturer’s responsibility to make sure its drugs adhered to consumer protection laws.
In its October motion to exclude Kessler’s testimony, Bayer argued Kessler had overstepped his boundaries as a medical expert in advancing such legal opinions as expert testimony.
“We have nothing further to add as these are matters of litigation,” Bayer spokeswoman Rose Talarico said in a statement Monday. “We expect them to be addressed further at trial.”
Representatives for the FDA could not immediately be reached for comment Monday.
The MDL is In re: Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation, case number 3:09-md-02100, in the U.S. District Court for the Southern District of Illinois.
— Article by Sindhu Sundar
–Editing by Elizabeth Bowen.