The popular birth control pills, YazÂ and Yasmin, have been linked to a wide array of adverse health effects. Now, over 50 more women have alleged in lawsuits that they suffered strokes, heart attacks, and a variety of other significant health problems as a result of taking the medications, said the IndyStar.
These lawsuits were filed in Indianapolis. Scores of others have been filed nationwide by dozens of women over the past recent months, said IndyStar; all claim similar problems. Plaintiffs allege Yaz was not subjected to adequate testing, and that Bayer failed to provide adequate warnings about its potential side effects. According to Bayer, Yaz and Yasmin are safe when used according to directions; furthermore, said Bayer, all oral contraceptives contain warnings for potential side effects, said the IndyStar.
These birth control pills are associated with various dangerous Yaz side effects, including blood clots, heart attacks, strokes, andâ€”most recently, gallstones, gallbladder disease, the need to undergo surgical removal of the gallbladder, and development of a condition called postcholecystectomy syndrome. The lawsuits filed in Indianapolis concern complaints such as blood clots and pulmonary embolisms in the plaintiffsâ€™ legs and lungs; some underwent surgery to remove gallbladders and others suffered strokes that left permanent disabilities, explained the IndyStar, citing attorneys involved in the lawsuits.
Meanwhile, according to the IndyStar, the drugs contain a so-called “fourth generation” steroidal formulation for birth control pills; drospirenone, according to the lawsuits, could lead to potentially high potassium levels. These levelsâ€”a condition called hyperkalemiaâ€”can lead to a host of health issues such as â€œarterial blood clots, gallbladder disease, pancreatitis, liver and kidney failure, rapid heartbeat, arrhythmias and other conditions, including death,â€ said the IndyStar, citing the lawsuits. Yasmin has been marketed since 2001 and, Yaz, since 2006.
In response to the filings, Bayer argued, â€œâ€¦ the complaints we have reviewed so far pertain to side effects that are warned about in the labeling of all oral contraceptives, including ours,” said spokeswoman Rose Talarie, quoted the IndyStar. “Bayer’s oral contraceptives are safe and effective when used according to product labeling.”
In August 2008, the Food and Drug Administration (FDA) sent Bayer a warning letter over two Yaz televisions ads that misled consumers into believing Yaz could help relieve symptoms associated with Pre-Menstrual Syndrome (PMS) and could help in the treatment of specific types of acne. The FDA never approved Yaz for either of these issues; Bayer was mandated to implement a $20 million dollar campaign to â€œremedyâ€ the misinformation it promoted, submit all subsequent television advertisements to the FDA for pre-approval, comply with the FDA on TV and print advertisement suggestions, and â€œclearly and conspicuouslyâ€ disclose for what the FDA has approved when discussingâ€”in its print adsâ€”those symptoms Yaz can treat, said BizJournal, previously.
Recently, all lawsuits involving Yaz, as well as its precursor, Yasmin, currently pending in federal court were consolidated for centralized and coordinated pre-trial proceedings in the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation in the United States District Court for the Southern District of Illinois before Judge David R. Herndon (MDL No. 2100). In December, Judge Herndon discussed scheduling a series of â€œbellwetherâ€ trials for the lawsuits, which will serve as a guideline for other cases. Some legal experts believe that as many as 25,000 lawsuits involving Yaz and similar medications could ultimately be filed in the multidistrict litigation. It could take more than two years to resolve all of the Yaz lawsuits on Judge Herndonâ€™s docket.