Lawsuits Mount Against Yaz Birth Control

Thousands of women throughout the United States have filed a Yaz lawsuit or Yasmin lawsuit against Bayer, alleging that the drug maker failed to adequately research the risks associated with the medication or warn women that they may be exposed to an increased risk of serious and potentially fatal side effects when using the birth control pills. Lawsuits also allege that Bayer engaged in deceptive and misleading advertisements that were directed to consumers and the medical community. Still, the researchers described the overall risk as low, with rates for blood-clotting cases in U.S. study of 30.8 per 100,000 women years on drospirenone versus 12.5 in the control group. Bayer said in a statement that the methodology used showed "significant flaws."

In 2010 Bayer took in $1.6 billion of sales from drospirenone-based pills such as Yasmin, down 13 percent from a year earlier, still making it Bayer's second-best-selling pharmaceutical product after multiple sclerosis drug Betaseron. Yasmin revenue is slipping because of cheap generic copies on sale in the United States but also in part because of concern about a heightened risk of thrombosis. Thromboembolism is the medical term for a blood clot in the veins, often in the legs, that gets dislodged and can cause fatal clogging in the lungs' arteries. Countless women are experiencing Yaz blood clots, which are hugely detrimental to one's health.

The mother of 18-year-old, Michelle Pfleger has openly blamed the birth control for a blood clot that killed her daughter. Michelle was on her way to Elon University on September 14, 2010 to attend her morning classes when she collapsed. She died shortly after arriving at the hospital. According to the North Carolina Office of the Chief Medical Examiner, the official cause of death was recorded as a pulmonary thromboembolism. Alberto Estrada from Phillipsburg's Warren Hospital vascular lab, stated that it is rare for an 18-year-old girl to die as a result of a pulmonary thromboembolism, but there is no certainty that the birth control pill is related to the cause of death. However, the birth control pill could be a contributing factor if the conditions were right at the time of her death. Victims suffering from Yaz side effects should contact a Yaz lawyer as soon as possible.

Women Voice Concern Over Yaz Side Effects

Bayer held its annual shareholder meeting on April 29 in Cologne, Germany. About 4,000 shareholders participated in the meeting and voted on the future of the company. According to the group Coalition against Bayer Dangers (CBG), based in Germany, several women spoke out at the meeting about the dangers posed by health problems from Yaz and Yasmin, which included countermotions by CBG to rein in what it considers to be irresponsible corporate activity by Bayer. CBG claims that the FDA has logged at least 190 reports of Yaz and Yasmin deaths in the United States that were reportedly linked to the use of the two popular birth control pills. However, that number is likely only a fraction of the actual number of deaths from Yasmin and Yaz, as it is widely acknowledged that only about 1% to 10% of all adverse events associated with the use of medications are ever reported. More and more women are speaking out against the adverse Yaz side effects that are changing their lives.

Allegations in these cases have been that drospirenone, a diuretic, causes an increase in potassium to unsafe levels, which can disrupt heart rhythms and slow the flow of blood, leading to clotting. Bayer Healthcare Pharmaceuticals is the maker of Yaz/Yasmin. Last spring, the FDA required Bayer to update its ads and promotional materials after the company changed its warning label to include new information about the risk of thromboembolism compared to other contraceptives. Despite serious allegations and detrimental side effects, Yaz recall has not been administered.

  Studies, published in the British Medical Journal, found that drospirenone, the new progestin component in the contraceptives, carries a two to three times greater risk of blood clots than previous types of birth control pills containing an older progestin ingredient called levonorgestrel. There are hundreds of Yaz lawsuits pending across the country that allege that contraceptives that include: Yaz, Yasmin and Ocella, cause blood clots, as well as heart attacks, strokes and gallbladder failure.  These findings have stand as a direct contradiction to Bayer’s claims that drospirenone poses no greater risk than other drugs used in contraceptives.

Yaz Lawsuits Over Generic Forms

            Many of the thousands of Yaz lawsuits that have been filed in state an federal courts are related to generic forms of the medication that are produced by drugmakers other than Yaz’s manufacturer Bayer Pharmaceuticals. The popular fourth-generation drospirenone birth control pill has been reproduced by many companies wanting to capitalize on the popularity and profitability of the oral contraceptive. Gianvi is a drug similar to Yaz that was introduced by Teva Pharmaceuticals in June of last year. Yasmin, Yaz’s “sister” drug that is also produced by Bayer Pharmaceuticals, has two generic forms – Ocella and Zarah, both involved in Yaz litigation.

            Also linked to the cases are Safyral and Beyaz. These are similar to Yaz and Yazmin but include metafolin that can reduce the risk of birth defects in women who get pregnant shortly after discontinuing the birth control treatment.

            Most recently, a new Yaz-like drug has been approved by the Food and Drug Administration. Sandoz has introduced a birth control called Loryna, which contains drospirenone and ethinyl estradiol, like Yaz. Because it is incredibly similar in composition to Yaz it is likely that patients of this new birth control will experience similar Yaz side effects, which include gallbladder disease, stroke, blood clots, pulmonary embolism, and deep vein thrombosis.

            A British study published in the British Medical Journal in April of this year showed that women taking birth control containing drospirenone – including Yaz and all of its generic forms – are more than twice as likely to develop Yaz blood clots than women who are taking other forms of birth control, although almost all oral contraceptives come with some risk of blood clotting.

            Although Yaz and similar products are netting Bayer millions of dollars, ther is a significant drop in the profitability of the products, especially due to increased use of generic forms of the drug.

Yaz Blood Clots Cause Multitude of Problems

Women who take Yaz, Yasmin, and other drospirenone birth control pills experience blood clots at a rate six times higher than that of women who take other forms of oral contraceptive without the synthetic hormone. Yaz blood clots are linked to several problems, including deep vein thrombosis, thromboembolism, and pulmonary embolism.

Although all methods of birth control that contain estrogen increase the risk of blood clots, drospirenone-based birth control pills like Yaz, Yasmin, Zarah, Gianvi, Safyral, Beyaz, and Ocella may contribute to hyperkalemia, which is an elevated level of potassium in the bloodstream. This in turn could cause the blood to pool and clot in the bloodstream, increasing the risk of blood clots significantly.

Some blood clots dissolve on their own and don’t put a patient’s life at risk or require medical attention. However, there are some forms of blood clot that are extremely serious – and even, in some cases, can be fatal. Deep vein thrombosis is a painful condition in which a blood clot forms in a major vein. This usually occurs in the leg and may require medical treatment in the form of a blood thinner or anticoagulant.

Any Yaz blood clot has the potential to travel to the lungs, causing perhaps the most serious Yaz blood clot related side effect – pulmonary embolism. 60,000 Americans die of pulmonary embolism a year. While it is unclear how many of these deaths are related to Yaz or other forms of birth control, there is significant risk to a patient taking Yaz of developing the potentially fatal condition.

There are currently more than 7,000 plaintiffs who have filed suit against Bayer Pharmaceuticals, the company responsible for the manufacture and distribution of Yaz and Yasmin. These plaintiffs have been consolidated into a multidistrict litigation case that deals with many different Yaz side effects – blood clotting problems, heart attack, stroke, and gallbladder disease. Despite the legal and public backlash against side effects associated with the product, Yaz continues to be an extremely popular birth control product.

Yaz Lawsuits: Status Update

As the lawsuits surrounding popular birth control medication Yaz are continuing to make their way through the legal system, the status of the cases are likely to change at any given moment. Over seven thousand plaintiffs have already filed suit against the German-based pharmaceutical brand that manufacturers the drospirenone-based fourth generation birth control pill due to side effects that have been experienced by an unprecedented number of women. These side effects include pulmonary embolism, gallbladder disease, stroke, deep vein thrombosis, blood clots, and heart attack.

Judge David Herndon was named as the overseeing judge in the Yaz multidistrict litigation case during the U.S. Judicial Panel’s move to consolidate the Yaz lawsuits in 2009. Multidistrict litigation, a process similar to class action, is intended to streamline and speed up the litigation process for cases that are similar to one another – but in this case, depositions have not been as efficient as expected due to disputes among representatives of each side.

Yaz lawyers on both sides of the debate argued whether or not to require foreign documents to be produced earlier this year. This, and other conflicts, led to Judge Herndon to appoint a special master to help deal with some of the issues at hand in the Yaz cases.
Bellwether trials in Yaz multidistrict litigation are set to begin next year, and will help both plaintiffs and defendants know what to expect when their Yaz trial reaches court. These trials will test the legal waters in regards to possible settlements and other issues within the trial, and the earliest bellwether trial could begin as early as the beginning of 2012.

Plaintiffs are looking for settlements from the pharmaceutical giant Bayer in order to help pay past and future medical bills and other expenses related to their Yaz side effects. Although it may take a while for each plaintiff’s case to see its day in court, it is likely that many eligible patients will receive compensation.