10,000 Yaz and Yasmin Lawsuits Just a Cost of Doing Business?

East St. Louis, ILIt could be said that a majority of businesses fear the possibility of a lawsuit that could wipe them out - and not so much the settlement, but the rise in liability insurance premiums they would have to face. So imagine facing almost 10,000 lawsuits. That’s what Bayer Corp. is facing with regard to Yaz lawsuits and similar actions over Yasmin, contraceptives that have been on the market since 2006 and 2001, respectively.

For major pharmaceutical companies like Bayer, litigation appears to be the cost of doing business. And for Bayer, the potential need for settling nearly 10,000 cases is not reason enough to pull two allegedly unsafe products from the market.

It suggests that revenue from Yasmin birth control, and its sister contraceptive Yaz, eclipses any costs associated with legal action.

As of January 15, there were 9,781 cases pending in the Yasmin/Yaz Multidistrict Litigation (MDL 2100, US District Court, Southern District of Illinois). Bayer has long maintained that Yasmin side effects and those of Yaz are no worse than other oral contraceptives on the market, including older products, as birth control pills have always posed a risk for blood clots.

That may be true. However, the risk for Yasmin blood clots and Yaz side effects in kind has been identified through various studies to pose a higher risk. Other studies have not identified a higher risk, and for its part, the US Food and Drug Administration (FDA) is content with denoting the potential for higher risk, but remains satisfied that the benefit in prevention of unwanted pregnancies outweighs any risk posed by estrogen and drospirenone, a fourth-generation progestin that forms the basis for Yasmin and Yaz.

Meanwhile, many a Yasmin lawsuit continues to roll in. One lawsuit filed in November alleges a stroke the plaintiff suffered was due to her use of Yasmin/Yaz. Another lawsuit filed in October alleges the plaintiff suffered a pulmonary embolism (Yasmin blood clot) from her use of drospirenone. The plaintiff claims she suffered the Yasmin side effects within a few months of starting Yasmin in 2008.

It should also be pointed out that Yasmin DVT (deep vein thrombosis) is not the only adverse health issue posed by use of Yasmin and Yaz. There have also been reports of Yasmin gallbladder problems. However, it can be reported that Bayer was cut some slack recently when it was relieved of more than 60 lawsuits in New Jersey state court with regard to gallbladder issues linked to Yasmin and Yaz.

Regardless of the injuries allegedly suffered by the plaintiffs in relation to their use of the Yasmin pill (and Yaz), the lawsuits were reportedly set aside from pending multicounty litigation after a special master recommended the dismissals due to a failure to file preservation notices.

The report noted that Special Master Stephen A. Saltzburg recommended the action after the defendant was not served with notices requiring Bayer to preserve records pertaining to future claims in a timely fashion. A total of 66 cases alleging Yasmin gallbladder problems, and similar problem relating to Yaz, were dismissed based on Saltzburg’s recommendation.

That leaves 405 cases still pending, alleging Yasmin side effects with regard to gallbladder. In March, Bayer agreed to a $24 million settlement with plaintiffs alleging Yaz side effects and similar gallbladder problems with Yasmin and Ocella, another contraceptive in the drospirenone class (In re: Yaz, Yasmin and Ocella Litigation, case number L-11775-10, in the Superior Court of the State of New Jersey, County of Bergen).

It appears Bayer, akin to other major players in the pharmaceutical industry, is not adverse to spending millions to settle lawsuits as the cost of doing business in what pundits assume to be a wildly profitable sector.