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The Yaz/Yasmin litigation has been consolidated into one court, the United States District Court for the Southern District of Illinois. A pre-trial conference will take place on January 21, 2010. It is anticipated that Chief Judge David Herndon will proceed with several bellwether trials in this matter. Bellwether trials are advisory only trials in which the jury’s decision does not bind the parties but is used to help the parties see how the case will fair before a jury and ultimately assist in placing a settlement value on the case.
The number of lawsuits which may be ultimately included in the multi-district litigation is anticipated at approximately 25,000. This is reported to make the Yaz litigation the largest multi-district litigation assigned to this District Court.
A large number of women who have taken Yaz or Yasmin, both manufactured by Bayer allege that the contraceptive pills which contain dropspirenone have caused a various of illnesses, strokes and even death. Women allege in their litigation that Bayer failed to properly warn consumers of the dangers involved.
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- Yaz Litigation Update (tammyheff.wordpress.com)
The lawsuits alleging product liability claims as to both Yasmin and Yaz from all over the country have been consolidated. On October 1st, the United States Judicial Panel on Multidistrict Litigation entered an order consolidating all the lawsuits into one case in the United States District Court for the Southern District of Illinois.
This will make the management of the various lawsuits easier and more streamlined, since one court will be overseeing all aspects of the discovery and if necessary, the trial. Here is the link to the minutes of the initial conference.
Little else has been said in the news as of late. It will be interesting to see how things progress in the weeks to come. Another status conference is scheduled for December 17th.
The much awaited results of the Swiss study on the risks of Yaz and Yasmin has evidently been released. There is some controversy over the results of the study. Bayer is stating that the results show no difference between the risk of developing potentially fatal venous thromboembolisms associated with its two products and similar contraceptive pills. Meanwhile, other authorities are stating that the study doesn’t say exactly that, and the Bayer products are not off the hook from a liability perspective. The problem evidently stems from the fact that the results of the study are in German and translations (like your mileage) appear to vary. According to bnet.com the risk associated with the so-called third generation birth control pills such as Yaz may be double those of 2nd generation birth control pills and can be affected by a woman’s weight, smoking history and genetics.
To date there have been approximately 125 court cases filed in the United States alleging injuries from Yaz and Yasmin. Advocates on behalf of these litigants were awaiting the results of the study, which was commissioned following the death of a Swiss woman after she started taking the Bayer birth control product.
Until the document is completely released in English, it appears that the actual wording of the results of the study are open to interpretation here in the United States depending upon your translation.
Yaz, a birth control pill manufactured by Bayer (the aspirin people) has been all over the news and blog world in the past few days. It appears that Bayer has caught a great deal of bad press due to the fact that approximately 70 lawsuits have been filed against the manufacturer alleging injuries resulting from consuming the pill and its sister pill, Yasmin. Litigants report that the birth control pills containing the novel progestin, drospirenone (which was approved by the FDA in 2001 in Yasmin), cause increased risk of strokes, blood clots and heart problems. In fact on Friday, the news was replete with a Swiss investigation of the death of an otherwise healthy young woman earlier this month from a pulmonary embolism after beginning the use of Yaz ten months earlier and the death of a 16-year-old girl after she began taking Yaz earlier this year. Pulmonary embolisms are scary stuff since they are usually fatal and strike with little or no, warning. The New York Times published an article on Friday outlining one woman’s illness following ingesting Yaz as well as a recount of the difficulties Bayer has encountered both early on and more recently as a result of its’ top selling products. There is also evidence that the use of Yaz can cause devastating gall bladder disease requiring surgical removal of the gallbladder according to Dr. Shezad Malik. Early on, both Yaz and Yasmin were advertised as drugs to not only provide contraceptive relief, but also to provide acne treatment and treatment for pre-menstrual syndrome and other pre-menstrual mood and emotional issues suffered by many women. Bayer was admonished by the FDA and agreed to launch a new advertising campaign downplaying its earlier advertising and warning women of the risks inherent in the use of any birth control pill. Bayer has endured the wrath of the FDA recently also when it was issued a warning letter regarding quality control issues at the German manufacturing plant where drospirenone is produced for the birth control line. This called into question in some fronts the effectiveness of the birth control pills that were manufactured with this product. The FDA and Bayer both advised that there was no need to recall the drugs and their effectiveness as a contraceptive should not be affected by the quality issues addressed by the FDA.
Today, my friend Tracy Station, who writes for FiercePharma devoted her article to the Yaz and Yasmin controversy and gives the reader a good overview of both sides of the controversy.
The buzz in legal circles is whether the FDA will cause Bayer to recall Yaz given the frenzy of claims and allegations. There are presently cases filed in federal courts in Georgia, Pennsylvania, Ohio, Puerto Rico and Wisconsin alleging product liability claims against Bayer for alleged Yaz and Yasmin related injuries. The United States Judicial Panel on Multidistrict litigation scheduled a hearing on the consolidation of all Yaz litigation into one forum under the auspices of one federal judge on September 24th. No decision has been released as of yet regarding the outcome of that hearing. This is in addition to any state court claims, such as the Illinois case, which has been filed.
My interest in this is both intellectual and personal. I have taken Yaz since September 2006.
Earlier this year, I went online scouring forums and blogs for information about Yaz and a possible link to rashes or contact dermatitis. At the time, I was suffering from a horrendous rash on various parts of my body that lasted well over a year and corresponded from a time perspective to my switch to Yaz. I was amazed to read the horror stories conveyed by hundreds of women (and some men on their women’s behalf) relating to health issues and problems which seemed to surface after commencing a Yaz or Yasmin regime. I discounted a large amount since some of the posters seemed to have a penchant for complaining. I found nothing on “official” medical sites regarding a link between the two on my issue despite spending a great deal of time looking for one. My concern stemmed solely from the coincidence of the appearance of a rash that was stubborn and did not subside despite removal of multiple possible allergens from both my environment and my diet and my switch-over to Yaz.
I must admit that the news these last few days is alarming and rest assured that I will be monitoring what goes on and make an informed decision after discussing the whole issue with my doctor if the investigations that are underway in Switzerland reveals a definite link between the ingestion of Yaz and the embolism which killed a 16-year-old girl early this year and killed another woman earlier this month.