On March 26, 2012, Searcy Denney filed two additional individual lawsuits against Bayer Corporation, the manufacturer of Yasmin and Yaz.
One of the new cases was filed on behalf of a married Texas woman who works as a Head Start teacher. She started taking Yasmin in 2008, and quickly developed gallbladder disease, which required her to undergo surgery in December of 2008 at a hospital in North Central Texas.
The other case was filed on behalf of a Miami mother of two children who works in the insurance industry. She underwent surgery to have her gallbladder removed at Jackson Memorial Hospital in Miami-Dade County, Florida in May of 2008, after suffering gallbladder disease brought on by her use of Yaz and Yasmin for several years.
Both of these cases were direct-filed into the coordinated proceedings pending before federal judge David Herndon in East St. Louis, Illinois. Currently, there are nearly 10,000 lawsuits pending before Judge Herndon, with more than half of those case filings involving gallbladder injuries.
The year 2008 was one of great significance to the litigation involving oral contraceptives containing drospirenone, a class of drugs that now includes Yaz (brand name drug manufactured by Bayer), Yasmin (brand name drug manufactured by Bayer), Ocella (generic version of Yasmin sold by Barr Pharmaceuticals), Beyaz (Yaz plus folate sold by Bayer), Gianvi (generic version of Yaz marketed by Teva Generic), Safyral (Yasmin plus B vitamins), Syeda (generic Yasmin marketed by Sandoz), Loryna (generic version of Yaz sold by Sandoz Pharmaceuticals), and Zarah (manufactured by Watson Pharmaceuticals). Key events that occurred in 2008 include:
- Ocella, a generic version of Yaz, was first approved by the FDA in 2008. Bayer and Barr reached a licensing agreement to market this generic version of Yaz in June of 2008. Under this agreement, Bayer would provide the generic drugs to Barr in the future, depending on the outcome of patent lawsuits filed by Bayer against other generic drug manufacturers. Ocella contains 3 mg of drospirenone and a .03 mg dose of ethinyl estradiol. It is estimated that sales of Ocella topped $170 million in the United States in 2008 based upon IMS data (a private company that tracks information from pharmacies and prescribing physicians that is widely used by drug sales representatives for targeting and rewarding high-volume prescribers).
- By the third quarter of 2008, the FDA had received reports of more than 50 teenage girls and young women whose deaths were attributed to their use of Yasmin, Yaz, and/or Ocella. These avoidable patient deaths were caused by elevated potassium levels, cardiac arrhythmia, cardiac arrest, intracardiac thrombus, pulmonary embolus, and stroke. It is commonly accepted that the FDA may only receive reports of less than 1% of drug adverse reactions, so the total number of deaths caused by drospirenone-containing birth control pills may have easily topped 5,000 by mid-to-late 2008.
- Bayer Corporation was admonished by drug regulators on October 3, 2008, when the FDA sent a warning letter (not the first or last to be sent to this manufacturer) finding that the maker of Yaz and Yasmin had engaged in improper marketing practices. This particular warning letter focused on the “balloons” advertisement, which is set to the tune of “Goodbye to You” and shows a variety of women next to balloons marked “headaches,” “acne,” and “feeling anxious.” These balloons (and, by implication, these PMS symptoms) float away after taking Yaz. The problem with this advertisement is that Yaz and Yasmin were never approved for the treatment of PMS symptoms, even though the relief of PMS symptoms has been the focus of the drug company’s marketing efforts and the subject of numerous warning letters from the FDA. The FDA warning letter found that Bayer’s “TV ads misleadingly overstate the efficacy” of Yaz, which ultimately led to the requirement, somewhat unprecedented at the time, that Bayer run corrective TV advertisements pointing out its previous improper promotion of the drugs.
- Sales for Yaz in 2008 were particularly strong and rose to $616 million, a substantial increase from the $262 in sales for 2007.
- Sales for Yasmin were also strong in 2008, and reached $382 million (or about 11% of the market for oral contraceptives). These sales figures are a testament to the aggressive marketing of these drugs by Bayer Corporation, especially when you consider that there are more than 100 different formulations for birth control pills on the market and Yaz and Yasmin, as branded drugs, are generally more expensive than other competing oral contraceptives.
The total number of cases filed across the nation involving Yaz, Yasmin, and Ocella now exceeds 11,000 lawsuits. The first trial in the country was originally scheduled to occur in January of 2012, but was postponed for several months for settlement discussions. So far, however, less than 100 cases have been settled, so it is likely that trials will be rescheduled in the near future. Bayer’s settlement negotiations so far have focused on blood clot-related injuries (such as deep vein thrombosis and pulmonary emboli), so it is likely that thousands of cases will need to be litigated and tried in the coming months even if the settlement negotiations are successful in resolving some of the pending lawsuits. Trial preparations are already underway with regard to arterial blood clot-related claims (including heart attack, stroke, and sudden cardiac death (SCD) injuries) as well as cases involving gallbladder disease.