Product News and Recalls

Yasmin maker agrees to illegal marketing settlement

Bayer, maker of the Yasmin line of birth control pills, has agreed to pay $15 million to settle a lawsuit alleging that it illegally marketed aspirin mixed with supplements, Bloomberg reports.

Consumers sued a unit of the company, Bayer Healthcare LLC, in 2008 over its Bayer Women’s Low Dose Aspirin + Calcium and Bayer Aspirin with Heart Advantage, containing the supplement phytosterols.

The U.S. Food and Drug Administration warned the company the same year that it considered the aspirin mixtures “unapproved new drugs,” which were being sold illegally. According to Bloomberg, over-the-counter drugs don’t typically require FDA approval as long as they conform to pre-approved formulas.

Bayer is facing additional legal action from thousands of plaintiffs who claim they or their loved ones have been injured by the Yasmin line of oral contraceptives. A number of studies indicate that birth control pills with the compound drospirenone carry up to three times the risk of potentially fatal blood clots as other oral contraceptives on the market.

Birth control pills with drospirenone include Yaz, Beyaz and Ocella.

In December, an FDA panel evaluating the risks of pills with drospirenone voted narrowly to keep this type of birth control on the market. It was later revealed that several members of the panel had professional and financial ties to the pills’ manufacturer.

The Bloomberg report says a federal judge in Brooklyn, New York, gave preliminary approval to the settlement between the unit, Bayer Healthcare LLC, and U.S. consumers.

“Clearly, this was a hard-fought case,” Judge Brian M. Cogan said at a hearing. “The settlement negotiations were extensive. Significant compromises were made by both sides.”

The settlement would include all U.S. consumers who purchased the drugs within predetermined timeframes. The deal requires final approval by the court.

Patients should consult their doctors before making any changes in their medication. A consultation with a Beyaz lawyer is also important if there are significant injuries while on Beyaz or similar birth control pills.

See the story here:

http://www.businessweek.com/news/2012-07-11/bayer-to-pay-15-million-to-settle-aspirin-marketing-suit