Yaz lawyers want Herndon to examine conflicts of interest at FDA

Steve Korris Jan. 19, 2012, 11:56am



EAST ST. LOUIS – Women suing Bayer over injuries from contraceptives Yaz and Yasmin urge U.S. District Judge David Herndon to examine evidence of conflicts of interest at the U.S. Food and Drug Administration.

On Jan. 17, a plaintiff steering committee opposed a motion to exclude opinions of former FDA commissioner David Kessler about the current FDA.

Kessler claims conflicts of interest tainted a joint meeting of two advisory committees that decided not to remove Yaz and Yasmin from the public market.

Steering committee leader Roger Denton of St. Louis wrote that on Dec. 8, the FDA advisors voted on two questions.

The first asked whether benefits of Yaz and Yasmin outweigh the risk.

Denton wrote that 15 committee members responded yes and 11 responded no.

The second question asked whether current labels adequately reflect the risk benefit profile for the product.

Denton wrote that 21 committee members voted no and five voted yes.

He wrote that at the outset of the meeting, FDA made clear that all members and temporary voting members were subject to federal conflict of interest laws.

He wrote that Kessler reviewed documents pertaining to backgrounds of Paula Hillard, Anne Burke, Melissa Gilliam, and Julia Johnson.

He wrote that Kessler believes they have conflicts such that a reasonable person with knowledge of relevant facts could question their impartiality.

He quoted Kessler's opinion 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."

Denton wrote that Kessler cited documents identifying a committee member as a "huge advocate" for Yasmin and a "Bayer trained speaker."

He wrote that either Bayer hid from its experts its connections to these individuals or its experts intentionally omitted the connections from their reports.

Herndon plans to start the first of nine trials on April 30, if mediation fails.

He had planned to start it on Jan. 9, but canceled it on Dec. 31.

He presides over suits from many federal courts by appointment of the U.S. Judicial Panel on Multi District Litigation.

His "bellwether trials" would shape mass settlement of more than 10,000 claims including gall bladder damage and embolisms.

He canceled trial a day after Bayer challenged Kessler's opinions about the FDA.

Lawyers sought clarification and Herndon supplied it on Jan. 10, writing that the process had completely broken down.

"The underlying rationale of ordering bellwether trials was that such trials would provide the parties with a representation of the value of the mill run case in this litigation," he wrote.

"Since there are a variety of alleged injuries involved in this court, a number of bellwether trials were contemplated," he wrote.

He wrote that mediation was an alternative method for achieving that end.

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