A product liability lawsuit has been filed against Bayer by the mother of a New Jersey teen who died from a pulmonary embolism from Yaz birth control, which was prescribed to help control her acne.
The Yaz wrongful death lawsuit was filed on May 10 by Joan Cummins, whose 18 year old daughter, Michelle Pfleger, died on September 24, 2010.
The complaint alleges that Pfleger’s death was caused by side effects of Yaz birth control, which has been linked to an increased risk of blood clots that can result in a pulmonary embolism.
Pfleger was a student at Elon University in North Carolina. She was on her way to class when she collapsed due to cardiac arrest when a blood clot entered her lungs, causing a sudden and ultimately lethal drop in blood pressure.
Yaz is part of a family of birth control pills manufactured by Bayer that contain a combination of ethinyl estradiol and drospirenone, a new type of progestin. Other oral birth control pills that contain drospirenone include Yasmin, Yasminella, Beyaz, Ocella (a generic form of Yasmin) and Gianvi (a generic form of Yaz).
The birth control pills have been heavily marketed by Bayer, particularly to young women and teens. The drug maker has received FDA warnings over advertisements that stressed the potential benefits of Yaz to treat acne and symptoms of PMS, while minimizing the potential risk of blood clots from Yaz. As a result, Bayer was forced to run a $20 million advertising campaign in 2009 to correct misrepresentations about the safety of Yaz.
Bayer currently faces about 7,000 Yaz lawsuits and Yasmin lawsuits filed on behalf of women who allege that the drug maker failed to adequately warn about the increased risk of serious and potentially life-threatening injuries from the birth control bills, such as a stroke, heart attack, pulmonary embolism, deep vein thrombosis or gallbladder disease.
According to wrongful death complaints filed against the drug maker, more than 50 Yasmin or Yaz deaths were reported to the FDA between the first quarter of 2004 and the third quarter of 2008. The fatalities have involved many young women in their teens and included reports of cardiac arrest, pulmonary embolisms and strokes, with elevated levels of potassium in the blood frequently reported.
The use of drospirenone in the birth control pills is often cited as the cause of the increased risk associated with Yaz when compared to older oral contraceptives. Drospirenone impacts the body’s normal mechanism of regulating a balance between salt and water, which could result in elevated potassium levels. This can cause a condition known as hyperkalemia, which is linked to potentially life-threatening heart problems and other health issues.
The federal Yaz litigation has been consolidated and centralized for pretrial proceedings as part of an MDL, or multidistrict litigation, in the U.S. District Court for the Southern District of Illinois. There are also hundreds of cases filed at the state-court level in New Jersey and Pennsylvania.
The first Yaz trials are expected to begin early next year. A small group of cases, known as bellwether lawsuits, are being prepared for early trial dates to help parties to gauge the strengths and weaknesses of cases involved in the litigation. The outcome of the bellwether trials may help facilitate a possible Yaz settlement for other cases involved in the litigation.