This year, the U.S. Food and Drug Administration (FDA) mandated Bayer—maker of the birth control pill, Yaz—to run a correction to its Yaz marketing that cost some $20-million. Bayer must also submit its ads to the agency for approval resulting from a legal settlement obtained by some state attorneys general and the agency.
Now, Yaz and Yasmin lawsuits originating in New Jersey might be deemed a mass tort. According to Law.com, a Passaic County request is being considered by the judiciary in that state for the mass tort status.
Allegations linked to strokes and other significant adverse health reactions are growing with respect to Yaz, Yasmin, and Ocella, said Law.com. After receiving filings on over one dozen cases on the matter, Assignment Judge Donald Volkert Jr. wrote to the Acting Administrative Director of the Courts Glenn Grant on last month stating that “the case management and potential trial of this particular litigation would place a fairly substantial strain on our already limited resources,” quoted Law.com.
In addition to these 13 cases, there are also 26 more lawsuits pending in other New Jersey counties, said Law.com, which noted that, citing plaintiffs’ attorneys, the total is expected to top 1,000.
Bayer Healthcare Pharmaceuticals, which is located in Wayne, New Jersey manufacturers Yaz; Barr Pharmaceuticals, located in Montvale, New Jersey and owned Israel’s Teva Pharmaceuticals, manufactures the generic Ocella, said Law.com.
Yaz was approved in the U.S. in 2006 and is a low-estrogen pill made with a type of progestin called drospirenone. As we’ve reported previously, drospirenone is known to carry some health risks not seen with other forms of the hormone. Most notably, it can increase the levels of potassium in the blood, which can lead to a disorder called hyperkalemia in high-risk patients. This condition may result in potentially serious heart and health problems, including fatal cardiac arrhythmias. High potassium levels are especially dangerous for people who are obese, or who have diabetes or high blood pressure.
According to the mass tort application, 10 women from Texas and Tennessee allege suffering from deep vein thrombosis, pulmonary embolism, and other problems they have attributed to the medications, said Law.com. It is stated in the Yaz lawsuit that “defendants should have known that Yaz, Yasmin and Ocella created a higher risk of pulmonary embolism than other oral contraceptives on the market”.
Since early 2004, the FDA has received over 50 reports of deaths in women who were taking Yaz and other drospirenone-containing contraceptives. Many of the reported deaths involved elevated potassium levels. The deaths were caused by a variety of ailments, including cardiac arrhythmia, cardiac arrest, intracardiac thrombus (blood clots in the heart), pulmonary embolism (blood clot in the lungs) and stroke in women in their childbearing years.
Scores of lawsuits have been filed nationwide on behalf of plaintiffs who claim they suffered serious Yaz side effects and its sister drug, Yasmin. Plaintiffs in these lawsuits claim Bayer overstated the benefits of these drugs and failed to adequately warn of their risks.