Ocella is a fourth generation oral contraceptive consisting of a combination of the synthetic female hormones drospirenone and ethinyl estradiol. Manufactured by Teva Pharmaceutical Industries, Ocella is a chemically identical generic version of Yasmin, a popular birth control pill sold by Bayer. In addition to being prescribed as an oral contraceptive, Ocella is also used to treat a number of symptoms associated with premenstrual dysphoric disorder (PMDD) such as depression, anxiety, sleep disorders, and trouble concentrating. It is estimated that PMDD affects three to eight percent of menstruating women.
What are the risks related to drospirenone use?
Drospirenone is an artificial progesterone (progestin) used in Yasmin, Yaz and Ocella. It has been linked to a number of serious health risks, including the following:
- Pulmonary embolism (blood clots in the lungs)
- Deep vein thrombosis (blood clots in the legs)
- Heart attack
- Gall bladder disease
Have there been any FDA warnings?
Yes. On May 31, 2011, the FDA issued a safety communication reporting a number of studies that had found a greater risk of blood clots among women using birth control pills containing drospirenone than those using other forms of oral contraceptives. The FDA followed-up with a safety announcement on September 26, 2011, in which the agency advised while it had “not yet reached a conclusion”, it remained “concerned” over the possible increased risk of blood clots in women using drospirenone products.
On April 10, 2012, the FDA announced it had completed its review of the studies reporting a heightened risk of blood clots among women using drospirenone-containing birth control pills, concluding that the pills may be associated with a higher risk for blood clots than pills containing other progestins. The FDA directed that warning labels for drospirenone-containing pills were to report that some studies have suggested as much as a 300% increased risk of blood clots for women using drospirenone products as compared to other progestins.
Have there been any lawsuits filed for drospirenone injuries?
Thousands of lawsuits have been filed against drug manufacturers for injuries allegedly caused by drospirenone products, including generic Ocella. Many of these lawsuits have been consolidated into multidistrict litigation in the United States District Court for the Southern District of Illinois. As of August 15, 2013, there were 9,868 cases pending in the Ocella lawsuit MDL.
Injuries from blood clots, such as stroke and heart attack, are the primary focus of the pending Ocella lawsuit litigation. In addition to these injuries, plaintiffs are alleging birth control manufacturers failed to adequately warn about the risks of drospirenone use. In 2013, Bayer announced it had set aside $1.5 billion to settle future suits. At the time, the company had already paid approximately $1 billion in drospirenone settlements.
How can the manufacturer be held liable?
The Ocella lawsuit falls within the realm of product liability law. Under product liability law, all manufacturers, dealers, and distributors may be held liable for defective products that enter the marketplace. A product is deemed “defective” if it is unreasonably dangerous for its intended use, or if the manufacturer failed to adequately warn consumers about the risks associated with the product. Liability may be imposed regardless of any fault by the manufacturer or seller. This is called strict liability and it makes product liability law unique in personal injury law. Consequently, in order to succeed in an Ocella lawsuit, a plaintiff need only demonstrate that the product is unreasonably dangerous, and that the plaintiff was injured by the defect.
Should I contact an attorney?
If you suspect you have been injured by a drospirenone product and want to be compensated for your injury, you should contact an experienced attorney who is knowledgeable about drospirenone litigation to review your case. Don’t delay, though, because each state has its own sets of laws that limit the time in which you may file a product liability lawsuit.