Bayer Acknowledges, Agrees to Settle Yasmin Gallbladder Problems

Mountain View, CAIn moves that will only serve to baffle the everyman, Bayer AG is set to pay $1.1 billion to acquire a California-based contraceptive manufacturer, while at the same time setting aside $24 million to settle a series of Yasmin birth control gall bladder claims. This, on top of the $1 billion Bayer set aside to settle 4,800 claims of Yasmin blood clots.

If there were any doubts that pharmaceutical companies make huge profits, there should be none now.

By its own admission, according to the Bayer AG 2012 Annual Report and Consolidated Financial Statement, Bayer has spent $1 billion to settle lawsuits thus far with regard to Yaz blood clots inherent with Yasmin and Yaz. Additional settlements will be on a case-by-case basis. And blood clots, until recently, have been Bayer’s focus.

But now, according to Thomson Reuters (3/20/13), Bayer has acknowledged Yasmin gall bladder problems and corresponding adverse reactions tied to Yaz birth control pills, and in March, reached a deal to settle gall bladder claims in three state courts, as well as gall bladder injury claims consolidated in the US District Court for the Southern District of Illinois (In Re: Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation, U.S. District Court for the Southern District of Illinois, No. 09-md-2100).

According to the report, there are some 8,000 claims with regard to gall bladder problems allegedly triggered by use of Yasmin and Yaz, and there could be more. Compared against the $24 million set aside by Bayer, the typical payout per plaintiff could be in the neighborhood of a few thousand dollars each. A statement issued by Bayer and appearing in the Thomson Reuters article noted that Bayer holds fast in its belief that Yaz birth control pills (and Yasmin) containing drospirenone, a synthetic hormone, do not cause gall bladder problems.

“Nevertheless, the company has agreed to this settlement, without admission of liability, in order to avoid protracted and expensive litigation and to resolve the vast majority of pending gallbladder claims,” the statement read.

Oral contraceptives containing drospirenone are widely held as carrying a greater risk for blood clot. Yasmin and DVT, or deep vein thrombosis, have proven problematic for scores of women and have represented a serious health issue for others - sometimes fatal.

Research conducted by the University of Copenhagen and published in the British Medical Journal (10/25/11) suggested drospirenone-based contraceptives such as Yaz and Yasmin birth control can increase risk for blood clot, DVT and pulmonary embolism by as much as 74 percent. The US Food and Drug Administration (FDA) has cautioned consumers preferring Yasmin and Yaz that they are facing an increased risk for blood clot. The agency mandated a black box warning to that effect.

Meantime, while offering $24 million to Yasmin gall bladder victims as a means to avoid costly litigation, Bayer is poised to acquire Conceptus, of Mountain View, California, for $31 per share. Conceptus is the manufacturer of Essure, an irreversible birth control method in which small metal and polyester coils are inserted to block a woman’s fallopian tubes. The deal is reported to be worth about $1.1 billion.