According to documents unsealed in litigation involving the YAZ birth control product made by Bayer, former FDA head David Kessler stated Bayer didn’t include an analysis “that demonstrated an increase in the U.S. reporting rate” for venous thromboembolism, or clots, in a 2004 review of Yasmin’s safety provided to the agency.
According to Kessler “Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin.” Kessler also indicated that the company also promoted the oral contraceptive for unapproved uses, particularly for treatment of premenstrual syndrome. Kessler’s 196-page report was one of several such expert opinions that were released by a federal court in Illinois, where some thousands of lawsuits are pending over alleged injuries and deaths relating to Yaz and Yasmin, as well as generics. Kessler’s report was submitted on behalf of women suing the manufacturer, and he was compensated for his time.
Dr. Kessler wrote: “In my opinion, had I, or a medical review officer, known these facts prior to approval, further investigation would be warranted before a decision on Yasmin’s NDA could be made. These facts would impact the Agency’s risk-benefit equation about the drug and whether it could be approved”.
Women who used YAZ for birth control and who later suffered clots from YAZ obviously were not advised of the increased risk thereby enabling the company to maintain its competitive edge in the market. If the truth were told, sales would have decreased, doctors would have made fewer recommendations for YAZ, and more and more women would not have been exposed to costly life changing risks.
But the whole truth was not told and women and their families suffered needlessly while profits continued to roll in.
Attorneys at The Brandi Law Firm have long been involved in drug and device litigation, from the Dalkon Shield, Fen-Phen, Vioxx, Avandia, YAZ, to POP (pelvic organ prolapse) surgeries from Transvaginal mesh, bladder cancer from Actos, femur fractures from Fosamax, to toxic poisoning and revisions from De Puy ASR metal on metal hip implants. For more information contact Thomas Brandi or the Brandi Law Firm Pharmaceutical Attorneys.