Blood clots, stroke and other dangerous side effects associated with the use of Yaz and Yasmin birth control pills are driving more than 10,000 U.S. patients to file lawsuits against Bayer Pharmaceuticals.
The lawsuits stem from the serious number of heart and blood disorders experienced by Yaz users. Plaintiffs – former users of Yaz and Yasmin and their families – are bolstered in part with the U.S. Food and Drug Administration (FDA) rulings that Bayer trumped up some of the drugs’ uses in marketing and advertising campaigns and downplayed their side effects. The number of lawsuits grew to the point that multidistrict legislation (MDL) is now in place to handle all of the related claims.
In December 2008, an FDA panel voted in favor of strengthening warnings on YAZ birth control pill labels. The FDA’s most serious label, the black-box warning, appears on all Yaz and Yasmin packaging. It cautions women who smoke about an increased risk of serious cardiovascular side effects that may occur if they use either drug.
In 2012, Bayer agreed to pay $110 million to settle 500 lawsuits — about $220,000 per claim — to settle lawsuits claiming the drug caused pulmonary embolisms, strokes and heart attacks, Bloomberg reported.
Lawsuit Claims about Yaz
Plaintiffs in claims over Yaz and Yasmin include allegations that the drugs were marketed and advertised in a way that exaggerated benefits such as acne reduction and downplayed serious dangers associated with the drug. Thousands of injuries and about 100 deaths are linked to Yaz through these severe side effects. According to a study published in the British Medical Journal in October 2011, YAZ and Yasmin users experienced twice as much blood clot risk as women who used older contraceptives.
The claims also accuse Bayer of not doing enough research on the medications and of failing to issue a recall after reports indicated a risk of life-threatening side effects with Yaz and Yasmin. Bayer is also charged with failing to highlight the risks associated with the contraceptives.
Claims include negligence, strict product liability, breach of express and implied warranties, fraudulent and negligent misrepresentation, fraudulent concealment, medical monitoring, and fraud and deceit.
A judicial panel decided to transfer lawsuits filed in federal courts to the U.S. District Court for the Southern District of Illinois. Because the cases have similar claims against common defendants, one judge will manage them for greater efficiency.
According to Bayer, as of March 2014 it had settled 8,250 cases for $1.7 billion. More cases are pending in state and federal courts nationwide.
Injuries, Deaths because of Yaz Side Effects
Yaz gained widespread popularity in the United States after hitting the market in 2006. In addition to preventing pregnancy, Yaz was also marketed by Bayer as a treatment for acne and premenstrual syndrome (PMS). For these reasons, similar drugs Yasmin and Ocella also became popular.
Yasmin is Bayer’s lower-dose version of the pill. Ocella is the generic version manufactured by Barr Laboratories and marketed by Teva Pharmaceuticals. Despite the differences of the drugs and the dosages, the drugmakers find themselves in court because of the severe side effects patients say Yas, Yasmin and Ocella cause.
|They are linked to several complications. They include:|
|Heart attack||Deep vein thrombosis (blood clots in the legs)|
|Pulmonary embolism (blockages in the lungs)||Stroke|
The severe reactions to Yaz and Yasmin are linked to drospirenone, a new generation of synthetic progesterone. Drospirenone can cause elevated levels of potassium in the body, which may cause serious heart conditions and other health concerns.
The U.S. Food and Drug Administration (FDA) Adverse Events reporting system indicated serious side effects such as heart arrhythmias, electrolyte imbalance, hyponatremia, hyperkalemia, stroke, gallbladder problems, blood clots, embolisms and sudden death following the use of Yaz and Yasmin in some cases.
Bayer’s Marketing and Advertising of Yaz
Pharmaceutical companies are responsible for creating safe drugs that accurately warn about any risks. They are also responsible for accurately advertising a drug’s uses. Bayer has been criticized for allegedly failing to meet both of these responsibilities.
Consumers might remember the popular “Not Gonna Take It” and “Balloons” commercials advertising Yaz. They may also remember that the Yaz commercials later changed following an FDA ruling.
According to the FDA, the commercials wrongly suggested that Yaz was approved to treat PMS and acne at any level of severity. In actuality, the drug was only approved to treat premenstrual dysphoric disorder (PMDD) and moderate acne. The FDA also complained that Bayer overstated the effectiveness of the contraceptive to treat both conditions.
The FDA also told Bayer that the company had downplayed the drug’s risks. According to the FDA, the commercials’ audio and visual effects distracted viewers from the most important part of the commercial. Quickly changing scenes combined with background music took attention away from the part that disclosed the drug’s risks.
Although Bayer eventually changed its commercials, problems with how it disclosed information about YAZ continued. Three years after the FDA’s warning about the commercials, an FDA document acknowledged that studies raised questions about the safety of YAZ and its related contraceptives. Scientists have also recommended more testing and better labeling to warn about possible risks.