St. Louis, MOLast December, all Yasmin and Yaz lawsuits were consolidated and transferred to a federal court in East St. Louis, where the US Judicial Panel on Multidistrict Litigation (MDL) appointed US District Judge David Herndon to preside over suits from federal courts nationwide. Last month Judge Herndon ordered Yasmin/Yaz sales representatives who had any contact with plaintiffs' doctors to produce all their files for national litigation.
Bayer Health Care Pharmaceuticals, Bayer Schering Pharma, Barr Laboratories and Teva Pharmaceuticals have all been ordered to produce records from their facilities, third party storage vendors, or homes and automobiles of sales representatives, including "all written materials, video and or audio tapes in the possession of the sales representative." Defendants must produce files of sales representatives no later than 60 days before plaintiffs start taking depositions.
Meanwhile, plaintiff lawyers are submitting individual fact sheets, and defendants must respond with their own fact sheets within 45 days. Herndon has also ordered sales reps to produce:
Training materials related to "physician detailing and obstacle handling," including workbooks and forms representatives completed.
E-mails, bulletins, memoranda, activity reports, call notes, belief notes, tactical plans, voice mail transcripts, and summaries of meetings.
Materials from national, regional or district sales meetings.
Physician prescribing data and ratings.
Incentive plans and goal attainment reports.
Promotional and cross promotional marketing materials.
All documents representatives signed reflecting business and ethics practices and policies.
Documents representatives provided to doctors.
Budgets and materials for speaker's programs.
Materials relating to tests representatives took.
All communications between representatives and managers.
On October 1, 2009 the United States Judicial Panel on MDL entered an order transferring litigation involving claims against the manufacturers of the oral contraceptives to the US District Court for the Southern District of Illinois (in re: Yasmin and Yaz [Drospirenone] Marketing, Sales Practices and Product Liability Litigation, MDL no. 2100.) Lawsuits claim that Bayer and Barr Pharmaceuticals failed to adequately research their products, fraudulently concealed and negligently failed to warn users of the risks associated with the drugs and misrepresented the safety of these drugs compared with that of other birth control pills.
Sadly, a number of women who took Yasmin or Yaz women and suffered adverse side affects, including blood clots and stroke, didn't need to take the birth control in the first place. Young women were prescribed Yasmin and Yaz off-label to treat acne or to have lighter, shorter and less painful periods. Women post-menopause were prescribed the drug for migraines and even weight loss. No wonder Yasmin and Yaz quickly became the top-selling oral contraceptive in the US.
It certainly didn't hurt sales when the FDA supported Bayer, saying that as long as a woman is primarily taking Yasmin for oral contraception, the drug may also help with acne and serious premenstrual syndromes.
Of course Bayer is defending its blockbuster birth control pill, even after more than a thousand lawsuits have been filed about deaths and serious injuries.
FD (Fair Disclosure) Wire reported on 4/29/10 that Arthur Higgins, Chairman of Bayer Healthcare, said during the 2010 Bayer Earnings Conference Call: "We are clearly disappointed that good science and good medicine have been trumped by opportunistic fear-mongering by litigation lawyers. We are, as you mentioned, doing our best to address this. We believe the measures that we have in place [a new drug called Yaz Plus] will make a difference... unfortunately we still see a lot of this negative [Yaz] advertising by litigation lawyers. "
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