What comes first: will Bayer issue a recall of Yasmin/Yaz or will the drug company simply stop making its wildly popular and extremely dangerous birth control pill? For Bayer, the decision likely boils down to cost: can more claims be settled by taking the drug off the market? Poor Bayer has plenty to worry about these days. Not only are Yasmin/Yaz lawsuits related to life-threatening side effects stacking up, it was also served a warning letter from the FDA regarding quality control problems.
If and when Yasmin is taken off the market it will surely affect Bayer’s bottom line: In 2008 Yaz brought in $616 million for the company and Yasmin sales brought in $382. And sales increased from the previous year, mainly due to aggressive marketing campaigns that have since been called “deceptive” and “misleading” by the FDA. Advertising is a powerful tool: according to numerous Yasmin users I have spoken with, they had no knowledge of these side effects nor did they hear of any warnings: after all, if you knew Yasmin was life-threatening, you certainly wouldn’t be taking it!
So what’s taking the FDA so long to issue a recall? The agency must act on the countless reports of thrombosis, heart attack and stroke and even gallbladder disease associated with Yasmin and Yaz.
It wasn’t long ago that several fatalities were directly linked to the Ortho Evra birth control patch and it never did get recalled, even though last May the Public Citizen Health Research Group filed a petition on behalf of 80,000 consumers urging the FDA to recall Ortho Evra within six months. I wonder how many deaths it will take to remove Yasmin and Yaz from the market…
So we just posted about Kerry Sims, the woman who’s recently filed a lawsuit against Bayer’s Yaz birth control pills. Ms. Sims alleges she suffered a blood clot in her lung and an infection surrounding the clot while on Yaz.
But here’s the interesting twist—the one that brings “shotgun style” to mind. In true git ’em all fashion, she’s not just suing Bayer, the maker of Yaz and Yasmin oral contraceptives, she’s also naming Walgreen’s in her suit. As reported in the Madison Record yesterday,
“In selling, Yaz/Yasmin to plaintiff, Walgreens expressly and impliedly warranted that Yaz/Yasmin was safe for its intended use, was free from manufacturing or production defects, and would perform as indicated,” Sims’s suit states.
While this is not unusual practice—i.e., to include other seemingly uninvolved or not-at-fault parties into a lawsuit—it does paint an interesting picture when the focus of the lawsuit is Read the rest of this entry »
Another young woman has suffered a blood clot while using Yaz/Yasmin.
She is alive. Thankfully.
And apparently once she put two and two together, she got pissed off enough that she’s now suing Bayer.
Kerry Sims was prescribed Yasmin for birth control. She alleges she suffered a blood clot in her lung and an infection surrounding the clot while on the pill. The complaint reportedly alleges that between 2004 and 2008 Yaz caused in excess of 50 deaths in women taking the pill, some as young as 17. Sims maintains that had she known the risks associated with Yaz/Yasmin she would not have taken it. Those “risks” refer to the likelihood of deep vein thrombosis (DVT); pulmonary embolism (PE); gallbladder complications and gallbladder disease; stroke; heart attack and death.
The evidence is mounting—evidence that shows the risk for developing potentially lethal blood clots such as deep vein thrombosis (DVT) in women taking new generation hormonal contraception is much higher than in women taking older generation oral contraceptives.
Two new studies published on the British Medical Journal’s website this month point to a higher incidence of DVT in women taking pills containing desogestrel (e.g., Cyclessa from Organon) and drospirenone (e.g., Yaz from Bayer Healthcare).
In one of the studies, conducted in the Netherlands, the researchers found a 6.3 fold increased risk for venous thrombosis (VT) associated with drospirenone—one of the hormones in Yaz/Yasmin—compared with rates for VT in non-users. That means the risk for VT increases 6 times above that seen in women not taking drospirenone.
Researchers involved in the second study, from Denmark, found a 1.64 increased risk for VT associated with drosperinone.
The researchers from the Netherlands concluded: Read the rest of this entry »
The media has been full of reports of lawsuits filed against Bayer recently, all related to the company’s oral contraceptives Yaz and Yasmin.
This week alone six lawsuits were filed in Toledo. The allegations in these suits focus on misrepresentation of the adverse effects associated with the pill. Those adverse effects would include stroke, embolism and other life-threatening events. According to the suits, Bayer did not advertise proper warnings and did not adequately disclose the potential risks. One of the suits was brought by the family of a 25-year old mother who died from a stroke in 2006, allegedly while taking Yaz.
Between the first quarter of 2004 and the third quarter of 2008 reports indicate that more than 50 Yasmin- or Yaz-related incidences of death were filed with the FDA, one involved a 17-year old woman. The causes of death allegedly involved pulmonary embolisms, stroke and cardiac arrests. Read the rest of this entry »