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Do Birth Control Pills Cause Gallbladder Damage? Bayer Will Find Out -- in Court

Bayer (BAYRY) faces 4,200 lawsuits on its Yaz contraceptive franchise, more than double the number previously thought, an indicator of how fast the potential liabilities are piling up around the company's tentpole revenue driver. If a handful of "bellwether" trials go the wrong way for Bayer, that liability could spread to Teva (TEVA), which recently started making a generic version of Yaz and its sister birth control pills.

A scheduling order from the judge overseeing the federal multi-district litigation process indicated that the first of 3,700 cases in the MDL were scheduled to face juries in September 2011. Plaintiffs' lawyers say there are another 485 cases scattered through the state court system. Of the 24 bellwether cases, 12 will be gallbladder claims.

Until recently, it was believed that the cases mostly alleged that Yaz and similar Bayer pills (Yasmin, Beyaz, Natazia, Angeliq and Teva's Ocella generic) caused excessive blood clots in women, triggering pulmonary embolisms, strokes, and heart attacks, some of them fatal. But federal judge David Herndon noted that gallbladder injuries made up a significant portion of the claims. It is not clear how birth control pills might cause gallbladder disease. Historically, pills have been associated with blood clots and embolisms because the estrogen-progestin combination in them triggers clotting. Gallbladder problems are not commonly associated with blood clotting, however.

Gallbladder problems are usually associated with the five F's: Female, fat, fertile, forty, and fair. Younger women and teenagers are the main users of birth control, which should make excess risk of gallbladder problems in hormonal contraceptive users easy to demonstrate, statistically. Here's the judge's breakdown of allegations:

  • Gallbladder injuries: 43 percent
  • Venus thromboembolisms, (including pulmonary embolisms and deep vein thromboses): 40-41 percent.
  • Strokes and heart attacks: 9-10 percent
The plaintiffs lawyers don't seem to be too clear about the Yaz-gallbladder link either. In this typical complaint, the lawyer gives chapter and verse on potential causes of clotting from Yaz's specific ethinyl estradiol-drospirenone combo, and cites various studies showing greater risk for that ingredient mix. But there's zero information in the claim describing how Yaz may have triggered the eventual removal of the girl's gallbladder. Bayer denies the claims, in part because the allegations are too vague. If there's a management lesson here, it's that there is no end to the inventiveness of product injury lawyers.

With Yaz now facing generic competition, sales of the drug slipped 15 percent in Q2 2010 to €289, although it's still Bayer's second-biggest brand. Bayer has responded by rushing yet more new birth control pills to the market, including Natazia and Angeliq -- which contain similar estrogen-progestin combinations -- and Beyaz, which is Yaz plus folic acid.


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