Lawyers for Yaz, Yasmin Plaintiffs want to Present Evidence on FDA Conflicts

Lawyers representing thousands of women injured by the oral contraceptives Yaz or Yasmin have asked a federal judge overseeing consolidated litigation to not dismiss key evidence showing conflict-of-interest played a key role in a regulatory decision on the safety of the drugs.

The lawyer heading up the Plaintiffs’ Steering Committee asked Judge David Herndon to include evidence showing that four members of an independent advisory panel to the Food and Drug Administration had received considerable sums of money from Bayer and Barr Pharmaceuticals, manufacturers of Yaz, Yasmin and a generic form of the birth-control pills.

The drug companies are likely to include the recent findings of that advisory panel, which voted last week to advise the FDA to keep Yaz, Yasmin and other drosperinone-containing drugs on the market, as evidence at trial to show its drugs are safe. What the drugs companies are looking to strike from the record is evidence showing that conflict-of-interest on that advisory panel, specifically the testimony from former Food & Drug Administration (FDA) Commissioner David Kessler, who believes that panel was tainted by drug company money and influence.

That FDA advisory committee voted 15-11 on the question of whether the benefits of taking Yaz outweighed the risks of suffering life-threatening pulmonary embolism (blood clots) and gall bladder disease. Considering the amount of people on that advisory panel also on the payrolls of these pharmaceutical companies, it’s not a stretch to suggest that money may have had some influence. That panel also voted 21-5 on the matter of the warning labels of these drugs not being strong enough to warn of these side effects.

The agency stands behind the validity of its independent panel is not bound to act as the panel votes but it often does. Had that panel voted to say the risks of Yaz, Yasmin and Ocella did outweigh the benefits, it would have been a boon to the cases of the thousands of women already injured by these contraceptives.

The PSC lead attorney wrote to Herndon that a “person with knowledge of relevant facts could question (those specific panel members’) impartiality,” according to the journal report. Kessler has testified that, in his opinion, “the FDA advisory committee was not independent of Bayer, and its recommendations and votes need to be viewed as such.” The former Commissioner said that one member of that panel, specifically, was a “huge advocate” of Yaz.

Herndon has recently ordered both sides of this case to meet with an appointed mediator to possibly reach a settlement. If no settlement is reached, the first trial of Yaz side effects is expected to begin on April 30.

The thousands of women who’ve filed lawsuits against the makers of these contraceptives claim they’ve suffered severe and life-threatening side effects. One European study believes as many as 200 deaths could be blamed on Yaz, Yasmin or a similar drosperinone-containing contraceptive.

This entry was posted in Pharmaceuticals, Yaz / Yasmin. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.