What Will 2013 Hold For Yasmin Birth Control?

St. Clair County, ILIt's been a year since US District Judge David Herndon decided to postpone the trial associated with a Yasmin lawsuit in an effort to have the thousands of cases mediated instead, with the view of reaching a settlement.

That effort with regard to Yasmin birth control, as well as Yaz lawsuits, resulted in the November 2012 settlements of nearly 3500 lawsuits. The bill to Bayer Pharmaceuticals, the manufacturer of the controversial contraceptives, was $750 million.

But that's nothing compared to what could be ahead, with more the 8,000 lawsuits remaining to either be settled, or handled through trial. There is speculation the final cost to Bayer to settle all outstanding lawsuits over alleged Yasmin blood clots and Yaz side effects could exceed $1.5 billion.

That's about what Bayer earned in sales for all of its contraceptives, worldwide, in 2010.

The Yasmin lawsuit that served as the catalyst for the basket of mediated settlements announced in November of last year was that of Kerry Sims. According to the Madison-St Clair Record (8/24/09), Sims filed her lawsuit August 18th 2009, with Bayer and Walgreens listed as defendants.

The plaintiff developed a Yasmin blood clot in her lung, together with a subsequent infection.

While all oral contraceptives carry a slight risk for blood clot, first-generation contraceptives developed and introduced in the 1960's contained a combination of estrogen and progestin that was found to carry too high a risk for blood clot.

The development of second-generation progestins, which lowered the amount of estrogen, helped reduce the risk of blood clots and DVT (deep vein thrombosis), as well as cardiovascular events such as heart attack and stroke.

Then along comes Yasmin birth control and its cousin Yaz??"both introduced in the first decade of the new millennium and both containing the synthetic hormone drospirenone.

However, rather than further reduce the risk for Yasmin DVT and Yaz side effects, drospirenone appears to increase that risk??"an observation stemming from the federal drug regulator itself. The US Food and Drug Administration (FDA) is reported to have examined data on more than 835,000 women who were known to have taken oral contraceptives containing drospirenone.

The result of that examination was an FDA communiqué warning about the possibility of Yasmin DVT or blood clots, with a rate of risk pegged at 74 percent over women who took other low-estrogen drugs, or none at all.

Bayer says studies damning its Yasmin pill are inconclusive, maintaining that Yasmin and Yaz pose no greater risk for blood clots than any other oral contraceptive on the market.

The association between Yasmin and DVT--as well as Yaz--was never a part of a slick advertising campaign issued by Bayer to launch Yasmin and Yaz to women under 35. The campaigned claimed that using Yaz or Yasmin would protect against unwanted pregnancy, but also reduce the potential for bloating and water retention, could help clear up acne, and reduce the effects of PMS.

Women across America responded to the launch in droves--as plaintiff did Kerry Sims. However, Sims was not impressed when the FDA found inaccuracies in Bayer's marketing campaign and demanded from the manufacturer a retraction.

"You may have seen some Yaz commercials recently that were not clear," the retraction says. "The FDA wants us to correct a few points in those ads." It was reported that Bayer spent $20 million on the updated campaign in an attempt to correct the misleading information. Sims decided to sue.

"Plaintiff Kerry Sims reasonably relied upon Defendants' representations to her and/or her healthcare providers that Yaz/Yasmin was safer than other types of oral contraceptives for human consumption and/or use and that Defendants' labeling, advertisements and promotions fully described all known risks of the product," Sims's Yasmin lawsuit states.

The suit referenced reports to the FDA's Adverse Events Reporting System (AERS) that revealed more than 50 deaths, some of which occurred in women as young as 17.

The Bayer product has also been linked to Yasmin gallbladder problems, which were experienced by a young mother who posted her story on You Tube.

The lawsuit is Kerry Sims v. Bayer et al No. 3:09-cv-10012-DRH-CJP and was filed in the United States District Court for the Southern District of Illinois, East St. Louis Division.