Recently it has been made apparent that the FDA hearing that was was recently held, may have been a sham hearing owing to undisclosed conflicts of interests among the FDA panel. Read the Wall Street Journal article.
In early December 2011, a hearing was convened to hear evidence on the safety of drospirenone containing oral contraceptives. In a narrow 15-11 vote, the panel elected to keep these contraceptives on the market. Read full opinion of FDA here.
Women plaintiffs who are suing Bayer over serious injuries from drospirenone containing contraceptives, Yaz and Yasmin and others are 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, the plaintiff steering committee, overseeing the federal litigation, opposed a motion to exclude opinions of former FDA commissioner David Kessler about the current FDA.
Kessler claims conflicts of interest had stymied a joint meeting of two advisory committees that decided not to remove Yaz and Yasmin from the public market or issue a black box warning.
The FDA advisors voted on two questions. The first asked whether benefits of Yaz and Yasmin outweigh the risk.
The second question asked whether current labels adequately reflect the risk benefit profile for the product. 21 committee members voted no and five voted yes.
At the outset of the meeting, FDA made clear that all members and temporary voting members were subject to federal conflict of interest laws.
Kessler reviewed documents pertaining to backgrounds of Paula Hillard, Anne Burke, Melissa Gilliam, and Julia Johnson.
Kessler believes they have conflicts such that a reasonable person with knowledge of relevant facts could question their impartiality.
Kessler 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."
Kessler cited documents identifying a committee member as a "huge advocate" for Yasmin and a "Bayer trained speaker."
Kessler opined that either Bayer hid from its experts its connections to these individuals or its experts intentionally omitted the connections from their reports.
Bellwether Trials Abated, Mediation Ordered
Herndon plans to start the first of nine trials on April 30, if mediation fails. Read court orders here.
Herndon's bellwether trials would shape mass settlement of more than 10,000 claims including deep vein thrombosis, pulmonary embolisms, stroke and gall bladder damage.
Herndon explained his descision 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."
"Since there are a variety of alleged injuries involved in this court, a number of bellwether trials were contemplated."
He wrote that mediation was an alternative method for achieving that end.
Shezad Malik is an Internal Medicine and Cardiology specialist, a Texas Medical Doctor (retired) and Defective Medical Device and Dangerous Drug Attorney. Dr. Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.
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