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Yaz, Yasmin Judge Asked To Allow Evidence Of FDA Conflicts

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The judge overseeing the Yaz and Yasmin multidistrict litigation has been asked to allow evidence concerning a U.S. Food and Drug Administration (FDA) conflict of interest. Women suing Yaz, Yasmin maker, Bayer, for injuries they alleged to have suffered from the controversial birth control pills, have urged U.S. District Judge, David Herndon, to review evidence pointing to conflicts of interest at the agency, wrote The Madison Record.

The Plaintiffs’ Steering Committee has opposed a January 17 motion by the defense to exclude former FDA commissioner, David Kessler’s, opinions about the current FDA. Kessler, an expert witness for the plaintiffs, noted panel conflicts in an expert opinion in which he stated, after reviewing internal Bayer documents, that Bayer wrongfully withheld safety information from the agency, said Pharmalot.

More than 10,000 lawsuits claiming the birth control pills caused young women to suffer serious blood clots and other serious side effects, are pending in the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100) in federal court in Illinois. Plaintiffs’ lawyers have cited at least 50 reports of death linked to the drugs from 2004 to 2008.

According to Kessler, it was conflicts of interest that corrupted a meeting with two FDA advisory committees whose findings kept Yaz and Yasmin on the public market, said The Madison Record. On December 8, FDA advisors voted on two issues: If Yaz and Yasmin’s benefits outweighed its risks and if current labeling sufficiently presented the drugs’ risk benefit profile, said The Madison Record.

The FDA advisory committee voted, 15-to-11, that Yaz and Yasmin’s benefits outweigh its risk, said The committee also voted, 21-to-11, that the drugs’ risk benefit profile was not adequately presented. Denton indicated that the agency advised the members and temporary voting members at the start of the meeting that they were subject to federal conflict of interest laws, The Madison Record, said. The decision to allow Yaz and Yasmin to remain on the market, but with some additional information about blood clot risks,.

According to plaintiffs attorneys, Kessler analyzed paperwork on the backgrounds of committee members Paula Hillard, Anne Burke, Melissa Gilliam, and Julia Johnson and opined that, “Due to the complex dynamics that are part of the 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,” The Madison Record reported.

According to plaintiffs’ attorneys, Kessler cited documents that identified one committee member as a “huge advocate” for Yasmin and a “Bayer trained speaker,” noting that either Bayer hid its connections to these individuals from its experts or that Bayer experts “intentionally omitted” these associations from their reports, The Madison Record said.

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