Judge Requests Mass Tort Status for Yaz, Yasmin and Ocella

Passaic, NJDue to the increasing number of Yaz/Yasmin and Ocella lawsuits alleging that the oral contraceptives have caused strokes and other serious health problems, the New Jersey judiciary is considering a judge's request for mass tort status against the manufacturer, Bayer Corp., located in Wayne, NJ.

Plaintiffs in these lawsuits claim that Bayer overstated the benefits of the "fourth generation" Yaz/Yasmin contraceptive and failed to adequately warn of their risks.

Litigation "would place a fairly substantial strain on our already limited resources," wrote Assignment Judge Donald Volkert Jr. Currently there are 13 suits filed in Volkert's vicinage alone and 26 suits pending in other counties. Plaintiffs' lawyers expect the number could reach 1000.

The Courts will accept public comments until December 31, 2009 on the proposal to centralize the cases in Atlantic, Bergen or Middlesex counties, where mass torts are heard. Volkert said the benefit of mass tort includes:

- geographic dispersement of parties;
- consolidation by the Judicial Panel for Multidistrict Litigation of federal litigation over the three drugs in the Southern District of Illinois;
- risk of redundancy and inconsistent filings by different judges, resulting in undue delay and expense;
- existence of common issues of law and fact, as found by the MDL panel; and
- increased efficiency by having one judge oversee the issues.

Without mass tort status, similar complaints would be filed separately, which could mean different judgments on the same issue.

According to the mass tort application, 10 women from Texas and Tennessee suffer from deep vein thrombosis, pulmonary embolism, and other problems they attribute to Yasmin, Yaz and Ocella.

Yasmin, which was approved by the FDA in 2001, and its sister drug Yaz, approved in 2006, are fourth generation combination oral contraceptives that combine estrogen and progestin to prevent pregnancy. The term "fourth generation" refers to the fact that unlike other birth control drugs, Yasmin and Yaz contain a progestin component called drospirenone.

Drospirenone is associated with health risks not seen with other forms of the hormone. It can increase the levels of potassium in the blood, which in rare cases causes hyperkalemia. This condition may result in potentially serious heart and health problems, including fatal cardiac arrhythmias. High potassium levels are especially dangerous for people who are obese or who have diabetes or high blood pressure.

In August 2009, the British Medical Journal (BMJ) published two studies showing that drospirenone, more than any other oral contraceptive, puts women at risk for developing venous blood clots. The Journal cited 40 cases of venous thrombosis, including one that resulted in the death of a 17-year-old. According to the BMJ, the Dutch College of General Practitioners recommends that its members prescribe older second generation birth control pills rather than Yaz/Yasmin.

Between 2004 and 2008, more than 50 deaths linked to Yaz and Yasmin were reported to the FDA. On August 5, 2009 the FDA issued a warning letter to Bayer for using low-quality batches of drospirenone from a plant in Germany.