The first Yaz trial, which involves a plaintiff who suffered a pulmonary embolism after taking the drospirenone-containing birth control pill, was set to begin on January 9th. However, the federal judge overseeing thousands of Yaz, Yasmin and Ocella venous thromboembolism lawsuits, instead ordered that all involved parties meet with a special mediator in order to negotiate a settlement for the litigation.
Judge Herndon’s December 31st order has delayed the start of a trial that was likely going to help both the prosecution and the defense gauge how juries would react and respond to the evidence presented in many of the cases. Stephen Saltzburg, a professor at the George Washington School of Law, was the Special Master appointed to mediated the entire litigation.
To date, more than 10,500 women have filed product liability lawsuits against Bayer AG, alleging that they suffered injuries as a result of Bayer’s failure to properly warn users of the potentially dangerous side effects of Yasmin, Yaz and other drospirenone-containing birth control pills.
According to a recent report by the U.S. Food and Drug Administration, birth control pills that contain drospirenone, a new kind of synthetic progestin, may increase the risk for blood clots by as much as 75 percent over older-generation birth control pills.
Joan Cummins, mother of Michelle Pfleger, the Elon University freshman who died suddenly last fall as a result of a blood clot in her lungs, has filed a wrongful death suit against the drug manufacturer, Bayer Corp. The suit targets the company’s birth control product, Yaz, which Pfleger consumed between September 2009 and September 2010 and alleges that Bayer and its partners concealed the dangers associated with use of their drug, failed to properly warn consumers of these dangers and ultimately misrepresented the drug and violated consumer protection laws.
The class-action lawsuit further cites that the specially formulated progestin in Yasmin, Yaz and its generic counterparts is potentially fatal. The drugs, which have been linked to at least 50 reported deaths between 2004 and 2008, may potentially be responsible for “10 to 100 times more” deaths than those which were previously reported.
Plaintiffs are asking for a jury trial, damages, as well as coverage of the cost of the suit.
After a thorough search of the FDA’s adverse events database, a German research group found there have been 190 Yaz or Yasmin related deaths in the United States alone.
Most of the women were young and healthy when they started taking the oral contraceptive. They then suddenly developed blood clots, pulmonary embolisms, suffered a stroke or gallbladder disease.
Currently, there are about 7000 lawsuits against Bayer, the makers of Yaz and Yasmin. The German research group called Coalition against Bayer Dangers, or CBG would like to have women who suffered a Yaz side effect speak out at a Bayer shareholder meeting; Because of the high number of injuries, CBG aims to ask the drug makers to recall their best-selling birth control pill.
Bayer HealthCare Pharmaceuticals worked with the FDA to update the prescribing Information for YAZ after the interim results of a safety study revealed that a woman’s risk of developing blood clots is greatest during the first six months of taking a birth control prescription. “This risk is greatest when first starting the Pill and when restarting the same or a different Pill after a four week or greater break.” (PR Newswire.com)
The information comes from the ongoing, “Long-Term Active Surveillance Study for Oral Contraceptives,” an international study that collects data, and performs follow up on women taking birth control.
Many young women across the US have suffered blood clots of the leg and/or lungs after taking YAZ. Lawsuits against Bayer suggest that these dangerous side effects are more common and frequent with YAZ than with other birth control pills
Pharma News Online reports that Bayer, the German company that makes Yaz birth control, has seen an increase in sales for 2010– 35.1 billion euros, up 13% from the prior year. This is their highest sales record in the company’s history. The article went on to note that growth was “dragged down by sales in North America, hit by generic competition for the YAZ.” It did not mention the more than 1000 US lawsuits filed against Bayer. Users of Yaz contraception involved in the lawsuits have developed serious and life threatening side effects. Certainly, all birth control prescriptions carry a risk of side effects. However, it’s believed that the risk of developing side effects is greater when taking Yaz, and that Bayer knew or should have known that.
Yaz is a top-selling birth control pill with a flashy marketing campaign that speaks to young women, teens and college students. The pills even come with a blue suede case and fun stickers that turn birth control into a craft project. It’s also a drug with dangerous side effects.
There are a growing number of lawsuits across the country from women and families of women who been harmed by Yaz.
In Nashville, TN a twenty-year old college student was one of the many who suffered the side-effects of Yaz. She developed blood clot in her lung and died.
Blood-clots are one of the side-effects of Yaz.
She was in her junior year at Tennessee Tech and had been using Yaz for six months. The official cause of death was a pulmonary embolism.
The woman’s family has since filed suit against Bayer, makers of Yaz. Attorneys can’t bring their daughter back, but they are seeking justice, and hope to warn others about the dangers associated with Yaz.
Yaz has been called “A Birth Control that Promised too Much” by the New York Times. In 2007, Yaz became the first oral contraceptive approved by the FDA for three distinct indications. It was approved to treat moderate acne, premenstrual dysphoric disorder (PMDD), and birth control. Marketing campaigns then produced by Bayer, makers of Yaz were misleading. The advertising campaign suggested that Yaz could treat PMS, which is different than PMDD, for which Yaz has FDA approval. In addition, the ads didn’t specify Yaz’s capacity for acne treatment. Yaz cannot treat all forms of acnes. After a crackdown, Bayer came to an agreement with the FDA and 27 State Attorneys General regarding the deceptive marketing campaign. Mayer was required submit all ads to the FDA for approval, and they were required to allocate $20 million toward a marketing campaign clearing up the misleading ads. The follow-up TV commercials point out errors in their previous advertising and alert people that Yaz cannot treat PMS or “cure pimples.” Yaz has since been the subject of lawsuits across the USA, claiming dangerous side effects such as blot clots. Lawyers suing Bayer claim their clients experienced blood clots, heart attacks and other health problems and that Bayer knew or should have known that the pills were riskier than other contraceptives. The New York Times reports the effect of Yaz and its marketing campaign on a history teacher from Ohio: She developed blood clots in both lungs and lost partial use of her right lung. “To be perfectly honest,” she said “I asked my doctor about Yaz because I had seen the commercial. It mentioned helping control your period symptoms and acne, which was very attractive to me. I didn’t think it was going to be worse than any other pill.” Legal cases continue to be filed against the makers of Yaz. Continue reading “Yaz: Promised too Much” »