yaz-update

After the postponement of the first bellwether trial in January of 2012, Bayer began negotiations with individual law firms to evaluate and settle their clients’ claims in the Yasmin/Yaz litigation.  Since March of 2012, Burg Simpson has held regular monthly settlement meetings with Bayer.  To date, Burg Simpson has successfully negotiated settlement in well over 600 Yasmin/Yaz venous thrombosis cases.  Burg Simpson has meetings scheduled with Bayer’s settlement counsel throughout 2013.

Prior to the start of settlements of VTE cases, Burg Simpson’s imprint on the Yasmin/Yaz litigation was clear. Burg Simpson shareholders hold prominent leadership roles. Michael Burg is co-lead counsel, Seth Katz is chair of the Discovery Committee and Janet Abaray is co-chair of the Science Committee. In the event that these cases cannot be resolved and litigation continues, Burg Simpson’s leadership will continue and these three Burg Simpson shareholders will continue to lead the fight against Bayer on behalf of our injured clients.

While Bayer’s 2012 Annual Report is not scheduled for release until February 28, 2013, its most recent Quarterly Report provides a comprehensive overview of the global status of the Yasmin/Yaz settlement process.  In its Third Quarterly Report, Bayer states that as of October 15, 2012, it has reached settlement in approximately 3,490 Yasmin/Yaz claims, for a total payment of $750,000,000.00.  Bayer also confirms in its Quarterly Report that it is only entertaining settlement of Yasmin/Yaz claims involving venous thrombosis.  Thus, while Bayer reports approximately 12,400 pending lawsuits and an additional 720 unfiled injury claims, Bayer states that only 3,800 of the total remaining claims allege venous thrombotic injuries.  Therefore, less than one third of the pending claims as of October 15, 2012 allege the venous thrombosis injuries that Bayer states it is willing to negotiate.

Based upon the figures quoted in the Third Quarterly Report above, the average settlement value paid by Bayer for venous thrombosis claims is slightly under $215,000.  It should be noted, however, that the range of injuries among the settled cases includes some claims as minor as small DVTs treated in the emergency room, to cases of devastating pulmonary embolism and cerebral venous thrombosis.  Any assumption that each case or set of cases will command a value of $215,000 per case will prove highly inaccurate when actual negotiations are undertaken, and could be counterproductive. Each case must be evaluated individually and Burg Simpson has developed a system to do just that.

In addition to negotiating claims involving Yasmin/Yaz, Bayer has also agreed to consider claims asserted by women who used Ocella and Gianvi.  Ocella and Gianvi are generic versions of Yasmin and Yaz, respectively, which are marketed in the United States by Barr Laboratories, but manufactured by Bayer.  Bayer has accepted responsibility for Gianvi claims to the extent that the claims arise after Bayer reached a manufacturing agreement with Barr.

Bayer also markets Beyaz and Safyral, which are Yaz and Yasmin pills, respectively, supplemented with folate.  The marketing intention of adding folate to the birth control pills is to reduce the risk of neural tube defects in the offspring of women who subsequently become pregnant.  Folic acid supplementation, however, has no relevance to the risk of developing blood clots among women taking Yaz/Yasmin.  The product warnings for Beyaz and Safyral in terms of clotting risk to the product user therefore are the same as for Yaz and Yasmin, because no scientific basis exists to distinguish between clotting risks posed by the pills with or without folate.  Despite the lack of any rationale to distinguish clotting injuries suffered by women who ingest Beyaz or Safyral, as opposed to Yaz or Yasmin, Bayer has not yet agreed to negotiate Beyaz and Safyral cases.

Another category of significant cases not currently under negotiation involves those of arterial thrombosis.  The injuries caused by arterial thrombosis are often very traumatic.  In the case of strokes, the resulting blockage of blood flow to the brain can cause death or serious permanent injury.  Similarly, clotting in the heart can cause fatal cardiac arrest or heart damage.  In terms of the scientific and epidemiological evidence, however, clotting events that affect the arteries are studied separately from those that arise in the veins.  Therefore, published literature supporting an increased risk of venous thrombosis will not directly support claims of arterial thrombosis.  Moreover, the arterial clotting events are more rare in young women than the venous events, making it more difficult for researchers to assemble data sufficient to draw detailed conclusions regarding increased risk.  Nonetheless, it is well accepted that all oral hormonal contraceptives increase the risk of stroke and heart attack.  A recent study sponsored by the FDA found an increase in the risk of arterial strokes and heart attack among women taking Yasmin and Yaz as compared to those taking other oral contraceptives.  Bayer has sponsored its own studies with contrary results.

The number of Yasmin/Yaz cases alleging arterial clots, while not specifically addressed by Bayer in its Quarterly Report, is anticipated to be much smaller than the number of VTE cases.  Based upon the epidemiological evidence supporting general causation and the recent literature documenting an increased risk of arterial thrombosis, these serious injury cases would stand as strong cases for trial. It remains to be seen if Bayer will choose to settle or to try serious injury cases involving arterial clots.

It is also fair to assume based upon the figures released by Bayer in its Quarterly Report that at least 7,000 filed Yasmin/Yaz cases allege gall bladder injury.  Recently published epidemiology studies are being relied upon by Bayer to claim that Yasmin/Yaz does not increase the risk of gall bladder disease compared to use of other oral contraceptives, or compared to no use of oral contraceptives.  Unless additional studies are published, it is anticipated that Bayer will continue to deny liability in the gall bladder cases.

Burg Simpson’s Yasmin/Yaz team is led by Michael Burg, Kerry Jardine, Seth Katz and Janet Abaray. If you have any questions about the litigation, or are interested in discussing this litigation or entering into a co-counsel relationship to work on your Yasmin/Yaz cases, please contact one of our Yasmin/Yaz team members.

 

 

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