Suits Claim Bayer's Yaz Caused 50 Deaths; Novel Theory of Blood Clot Causation

Last Updated Jul 14, 2009 10:49 AM EDT

Bayer has been hit with four federal suits claiming its Yaz and Yasmin birth control pills caused 50 deaths, according to the National Law Journal.

The cases were brought by Janet G. Abaray (pictured) and others, the same lawyers who won $68 million to settle hundreds of cases brought by women who suffered blood clots while using Johnson & Johnson's Ortho Evra birth control patch back in October.

Abaray alleges Yaz and Yasmin have a higher rate of blood clots than older, safer pills. Her suit claims:

Indeed, during the brief time that Yasmin and Yaz have been sold in the United States, hundreds of reports of injury and death have been submitted to the FDA in association with Defendants' products.

In fact, in less than a five-year period, from the first quarter of 2004 through the third quarter of 2008, over 50 reports of death among users of Yasmin and Yaz have been filed with the FDA.

Yaz received FDA approval in 2006, Yasmin in 2001. The suit comes after the FDA state attorneys general demanded Bayer run an unusual $20 million corrective advertising campaign after it found false or misleading claims for Yaz in earlier TV ads. That campaign is still on the air.

Abaray's suit puts forth a novel theory regarding how Yaz causes clots. The pill uses a new, "fourth generation" progestin ingredient, drospirenone, the suit claims. No other contraceptive uses this progestin. This ingredient can cause a rise in blood potassium levels, causing hyperkalemia:

... hyperkalemia disrupts the normal heart rhythms, the flow of blood through the heart can be slowed to the point that it permits blood clots to form.

The cases are filed in Ohio and Wisconsin. A copy of the Wisconsin complaint -- in which the plaintiff, Marie Becker, suffered a stroke -- can be downloaded here.