Articles Posted in Yasmin/Yaz

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We have been writing a lot about imminent Yaz settlements. Let’s be honest. We want to gin up traffic for the phase “Yaz settlements” because we want to get as many cases as possible.

But when I say “Yaz settlement” – okay, I’ll stop, I’m annoying even myself – I am talking about Yaz stroke, heart attack, blood clot, deep vein thrombosis, pulmonary embolism, and other similar Yaz injuries. For every one of these types of Yaz leads we have gotten, we have received 10 cases alleging a gallbladder injury.

Bayer is reportedly holding the line on these cases and have no intention of settling the Yaz/Yasmin gallbladder lawsuits that have been filed in the MDL. A new Boston University study concludes that there is no evidence in these data that drospirenone- or levonorgestrel-containing OC use brings an increased risk of gallbladder disease compared to women on birth control without drospirenone- or levonorgestrel. This is hardly game set and match for lawsuits that link gallbladder injury to Yaz/Yasmin, but you can expect this study to strengthen Bayer’s resolve to fight these cases out longer in the MDL.

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An advisory committee to the Food and Drug Administration has met to discuss popular birth control pills such Yas and Yasmin, and has concluded that the information on the labels should be strengthened.

Currently, the labels suggest that these contraceptives have blood clot risks similar to those of other birth control pills that combine estrogens and progestins. The panel, which voted 21 to 5 in favor of changing the labels, has said the labels should be strengthened to include more information about the possibility that the pills could lead to greater risk of blood clots. They stopped short of recommending that they warn that the drugs are more likely than other contraceptive pills to cause blood clots. Instead, the experts suggested that the labels note that the evidence about blood clots is conflicting.

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Like every plaintiff”s lawyer and their mother, we have been trying to attract potential Yaz lawsuit clients. I think the Yaz cases are going to be good and I think when all is said and done, Yaz/Yasmin is going to come off the market and Bayer is going to reach a global settlement in these cases.

The FDA may indirectly push that ball along. The FDA now says it will take another look at the risks that accompany Yaz/Yasmin. The big risk that Yaz lawsuits allege that are going to make up most of the larger Yaz settlements should these cases resolve are the deep vein thrombosis (DVT)/ pulmonary embolism (PE).

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Yaz-4-2010-press-release.jpgReviewing the YAZ website (“know the enemy”), it seems that Bayer is still contending that YAZ and Yasmin are no riskier than other drugs—that is, the drugs have “comparable” risks to other birth control pills on the market. Here’s the “News You Need To Know” (according to Bayer):

Do YAZ or Yasmin carry any greater risk for blood clots (VTE), than other birth control pills?

According to the product information, the scientific data indicates that the risk of developing blood clots while taking YAZ and Yasmin is comparable to other birth control pills.

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On November 10, 2009 we wrote that New Jersey state court Assignment Judge Donald Volkert, Jr. formally requested consolidation of the YAZ, Yasmin and Ocella birth control lawsuits in New Jersey state courts. In an order dated February 9, 2010 (and posted to the New Jersey website on February 18, 2010) , Chief Justice Stuart Rabner ordered that all pending and future state court actions regarding the birth control pills would be designated as a mass tort and assigned to Bergen County Judge Brian R. Martinotti. Furthermore, Judge Martinotti will oversee those cases and may return them to their original counties as he sees fit (presumably for individual trials after common work is completed).

More New Jersey YAZ Lawsuit Information

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Canada%20Yaz-02-12-10%29.JPGOne thing product liability lawyers look at when litigation medical device and pharmaceutical cases is the experiences of foreign countries with the product at issue. I ran across a story about YAZ in Canada that reminds us of the importance of investigating what goes on outside of our borders (hat tip: Girard Gibbs LLP & The Danko Law Firm)
Starting last year, Bayer was promoting YAZ in Canada through a young television actress, Lauren “Lo” Bosworth. MTV’s announcement is woefully inadequate. Granted, it is not marketing directly from YAZ manufacturer Bayer, but it seems that the actress is doing an end-run around the FDA’s restrictions by talking about the benefits of YAZ with regard to regular PMS symptoms. The article states:

Last week [actually, in 2009], the young actress spent a day in Toronto and then Vancouver doing media interviews, where she focused on the fact that Yaz can lead to fewer symptoms like headaches and cramps during that time of the month.

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Yaz-logo-02-09-10.jpgA new article on YAZ and Yasmin lawsuits in the IndyStar sheds a little light on manufacturer Bayer’s defense to the cases:

“But the complaints we have reviewed so far pertain to side effects that are warned about in the labeling of all oral contraceptives, including ours,” according to a statement from company spokeswoman Rose Talarie. “Bayer’s oral contraceptives are safe and effective when used according to product labeling. Health-care professionals prescribe oral contraceptives following a comprehensive evaluation of the risks and benefits for the individual woman.”

Bayer’s statement ignores two things:

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The 406 YAZ, Yasmin and Ocella cases filed or transferred to the Southern District of Illinois before Judge David R. Herndon are proceeding apace.

The Judge has been primarily concerned with case management and establishing procedures that will guide the litigation through to completion, including potentially bellwether trials (early trials that can reveal case strengths and weaknesses as viewed by juries, and which often promote settlement). Also on the Judge’s list has been finding a way to deal with several of the foreign entities. In litigation where foreign entities are involved (in this case, the Germany-based Bayer has several corporate offshoots), service is oftentimes required to be done following procedures set in the Hague Convention, which can include translating documents to the foreign language at issue. (Judge Polster dealt with this in the Gadolinium litigation, and decided that after the translation and service of one complaint following Hague guidelines, formal adherence to those rules were no longer necessary).

There are 393 filings to date, with most of them being the opening of “member cases.” Member cases are cases received from other federal courts, transferred to the Southern District of Illinois through MDL protocols. You can also see the following documents: