Bayer: Former FDA Head is Not a Yaz Expert
Bayer Healthcare, manufacturer of the oral contraceptive Yaz, is doing all it can to ensure a former commissioner of the U.S. Food and Drug Administration (FDA) can’t be used as an expert witness in multidistrict litigation (MDL) against the drug maker.
Attorneys for Bayer said that Dr. David Kessler, who served as FDA commissioner from 1990 through 1997, doesn’t have the credentials to be an expert witness in the case.
Despite Kessler's former role with the FDA, he does not recite relevant facts, he gives legal opinions that he’s not qualified to proffer and doesn’t have a grasp of the most recent FDA rules, Bayer attorneys said.
Dr. David A Kessler - Former FDA commissioner
Kessler Notes Conflict of Interest
All of this comes amid Kessler’s harsh criticism of the company. Yaz is under fire for its ties to deadly blood clots, heart attacks and strokes, among other things.
Kessler said Bayer withheld vital information about the risks associated with Yaz during the approval process. He also said that an FDA advisory committee’s vote to keep Yaz on the market in December was tainted by conflicts of interest.
Thousands of women have joined the MDL, based in an Illinois federal court, making claims against Yaz for everything from heart attacks to pulmonary embolisms.
In December, Bayer's attorneys were unsuccessful in getting Kessler’s statements excluded from the trial. U.S. District Judge David Herndon, who is heading up the MDL, told Bayer that he considers Kessler an expert.
Yaz Blood Clot Risks Concealed
The first knowledge of Kessler’s attack against Bayer came in December when federal court documents were unsealed. In the documents, he said Bayer hid the blood clot risks for Yaz and sister drug Yasmin.
“By failing to disclose all thromboembolic event risk information and marketing Yaz and Yasmin off-label, Bayer needlessly exposed large numbers of women to risks of serious or fatal thromboembolic events," Kessler said in the opinion.
Later in December, Kessler blasted an FDA advisory committee as being biased. He said the advisory committee that narrowly recommended keeping Yaz on the market had several voting members who could not be impartial because of ties to Bayer.
“Due to the complex dynamics that are part of FDA advisory committee meetings, and in light of the fact that a reasonable person with knowledge of the relevant facts could question the above members’ impartiality, it is my opinion that the FDA advisory committee was not independent of Bayer, and its recommendations and votes need to be viewed as such,” Kessler wrote.