What was initially an American legal sensation has made its first step abroad.
Bayer pharmaceuticals, famous for manufacturing many over-the-counter products such as Aspirin, Midol, and Aleve, has been sued in Germany over claims that the birth control drug Yasminelle is too dangerous to prescribe to women. The case opened Thursday, December 17th, 2015.
The drug maker is no stranger to legal action; it has been sued in the past over numerous defective and dangerous products, such as its Mirena IUD and the blood thinner Xarelto.
In the United States, Bayer is still facing litigation based on the claims that women who have been taking Yaz have experienced life-threatening conditions such as blood clots, deep vein thrombosis, pulmonary embolisms, myocardial infarctions, and even death.
The company also faces claims that its marketing campaign was fraudulent and misleading, convincing women that taking Yaz would cause any side effects of their menstrual cycles to magically disappear.
Felicitas Roehler is the main plaintiff in the landmark German case against Bayer. Before age 31, she suffered a pulmonary embolism allegedly caused by taking Yaz. Doctor’s orders prevent her from heavy lifting, and because she has difficulty breathing, she had to abandon her veterinary training to take a desk job. She has to wear compression stockings on car journeys of any length to avoid future potential clotting issues; other types of travel are difficult.
Roehler believes that her case will deliver a significant blow to Bayer, a German company. It is the first such lawsuit filed on Bayer’s home turf. She is suing the company for €200,000 ($220,000), but hopes that the in addition to a settlement, the company will pull Yasminelle from the market.
Scientists are divided on the level of severity of health risks associated with Yaz and similar drugs. Though the FDA did note that taking Yaz could lead to a 74% increased risk in developing blood clots, they did not determine that this was enough risk to issue a recall.
Patients who have been taking the drug disagree with the FDA’s assertion, and many have demanded another hearing on whether Yaz should be removed from the market.
To date, Bayer has paid over two billion dollars to settle cases related to Yaz side effects and marketing errors, but only in the United States. Roehler’s case in Germany may bring more international awareness — and justice — to women who have suffered as a result of taking Yaz.
Written by David Smethie, Senior Marketing Director of Balanced Bridge Funding.