The Recall Lawyers

What's a gallbladder worth? This is the question that I've heard over and over and over again as it relates to the Yas, Yasmin and Ocella settlement discussions currently taking place across the country. Bayer (the maker of Yaz, Yasmin and Ocella) says a gallbladder is worth zero, nothing, nada, zip. Bayer says that the woman who lost their gallbladders were fat, out of shape, old, and generally unhealthy. Bayer says that they are not responsible for gallbladder losses because there are no epidemiological studies showing an increased risk of gallbladder disease in Yaz, Yasmin and Ocella users.

What do I say? Bring it on. A gallbladder removal is a very serious injury. I represent teenagers, as well as middle-aged women, in the Yaz, Yasmin and Ocella litigation. They aren't all fat or old or out of shape. Indeed, there are thousands of young woman (pretty, thin, and in shape) who have lost their gallbladders. These women had no prior health history that would suggest gallbladder disease. These women never knew that they were at risk. The women never knew that a Canadian Medical Association published a study that found that there was a "statistically significant" increase in gallbladder disease for Yaz, Yasmin and Ocella users when compared to other oral contraceptives.

So what's it worth? I'm an experienced trial lawyer. I can try these cases. I can't imagine that a jury would not award six figure verdicts. So when Bayer comes knocking at my door, they better be ready to negotiate reasonable settlements. If not, I'll go to court and try my cases on behalf of my gallbladder clients. We don't plan on letting them get away with endangering our daughters, moms, aunts, and nieces who have used Yas, Yasmin and Ocella.

Evidence is mounting that Bayer's birth control pills are unreasonably dangerous, particularly in light of safer alternatives. Yasmin, Yaz, Beyaz and Safyral are fourth generation contraceptive drugs that contain drospirenone, a new type of synthetic progestin. During the month of December, several FDA advisory groups met to review Bayer's warnings for these birth control pills.

Bayer's first drospirenone birth control pill, Yasmin, was developed and released in May 2001. With the approval of Yaz in 2006, Bayer's heavy marketing campaign took off. Bayer's advertisements targeted women's sense of freedom and individuality. It also directed Yaz and Yasmin for uses not FDA approved, including bloating, muscle fatigue, aches, and PMS. The campaign proved a huge success. In 2008 Bayer's Yaz and Yasmin profits were a staggering $998 million.

Then the problems surfaced. Women began having strokes and heart attacks due to venous thromboembolisms (blood clots) and pulmonary embolisms. Many healthy and young women with no other risk factors had their gallbladders removed. A significant number of studies and other evidence suggest a link between drospirenone and these gallbladder injuries. Additionally, these women share a common denominator: they all took a birth control pill in the Yaz-family. In response to the rising number of adverse events, the FDA ordered Bayer to spend $20 million on corrective advertising.

Continue reading "Yaz/Yasmin: FDA Reviews Bayer's Warnings" »

A U.S. Food and Drug Administration advisory committee recommended stronger warning labels for Bayer's birth control pills Yaz and Yasmin. By a 21 to 5 vote, the panel recommended changing the contraceptives' labels to reflect the possibility that the pills could lead to a higher risk for blood clots or deep vein thrombosis (DVT). Currently, the labels suggest the risk of blood clot is similar to those of other contraceptives that combine estrogens and progestins.

FDA spokeswoman Morgan Liscinsky said the panel acknowledged the conflicting data but "definitely felt that stronger labels were needed, that the labels need to be updated to reflect current data." While some physicians do not believe this risk is enough to change their prescribing habits, others, including members of the FDA advisory committee, disagree. In an interview with the Wall Street Journal, committee member Sean Hennessy of the University of Pennsylvania stated physicians should use an abundance of caution because "these drugs ought to be rarely used."

Continue reading "FDA Panel Recommends Stronger Warning for Yaz and Yasmin" »

The U.S. Food and Drug Administration (FDA) remains concerned about the potentially higher risk of blood clots in women taking newer forms of birth control pills, such as Yaz, Yasmin and Ocella. These "fourth generation" contraceptive drugs contain drospirenone, a new type of synthetic progestin.

An FDA-funded study indicates that women taking contraceptive drugs containing drospirenone have a 50 percent increased risk of blood clots. Earlier this year two other studies appearing in the British Medical Journal found double to triple the risk. An FDA advisory committee is scheduled to meet in December after which the full findings of the study will be released.

A deep vein thrombosis (DVT) is a serious condition where a blood clot forms inside a vein. DVTs are very serious and can be deadly. These clots typically form in the lower leg or thigh, but can travel to other areas of the body. A pulmonary embolism (PE) is a potentially fatal condition where the clot breaks loose and travels to the lung blocking a lung artery. DVTs and PEs are also known as venous thromboembolic events, or VTEs.

Continue reading "FDA Warns Yaz, Yasmin and Ocella Contraceptives Could Increase Clot Risk " »

Recent studies have confirmed that thousands of lawsuits regarding Yaz, Yasmine and Ocella over gallbladder disease, blood clots and heart related trouble have merit.

According to the Canadian Medical Association Journal, a survey of health databases show that the risk to women on Yaz and Yasmin is double that of other birth control drugs of having to have their gallbladder removed. Researchers analyzed a database of more than 2.7 million women who used birth control pills. The analysis showed that newer birth control brands had increased risk of gallbladder disease when compared to previous generations, but that the increased risk of Yaz and Yasmin for gallbladder removal and disease was twice as much as any other.

In addition, a recent study published in the British Medical Journal showed that the risk of blood clotting disorders was twice as much for users of Yaz and Yasmine than other drugs. To make that determination, researchers from the Boston Collaborative Drug Surveillance Program at the BU School of Medicine analyzed about 900 women on birth control since the year 2002. For women taking Yaz or Yasmin, the rate of blood clots was 30.8 per 100,000 person-years. For women talking levonorgestrel-based pills, the rate was only 12.5 per 100,000 person-years.

Continue reading "Yaz, Yasmin Studies Show Double Gallbladder, Clot Risk" »