The reason: Bayer had reported the product was "within specification" when in fact it wasn't -- the company had taken a number of measures and averaged them together to get the number it needed.
And no one noticed. The reason you don't know anything about this is because the recall was buried in an "Enforcement Report" section of the FDA's website. The FDA's site is infamously confusing. The recall is significant for a number of reasons: First, it involved specifications for the dosage of drospirenone in the pill, which is the new ingredient that the lawsuits allege is more dangerous than the traditional recipe.
In Scott's case, it was just over a month. Tony Merchant, a lawyer representing 1, women outside Ontario — including Scott — is seeking to certify a second class-action lawsuit in Canada against Bayer this fall.
Merchant said the number of deaths potentially associated with Yasmin or Yaz may be largely underreported because doctors may not realize there is a link between the cause of death and the risks of the pills. Merchant said hundreds of patients who have approached his firm have had gallbladders removed, or have had strokes or blood clots and now must take blood thinners for the rest of their lives.
In a written statement to CBC News, Bayer said it is fighting the certification of the first Canadian class-action suit, the one in Ontario, which alleges women died or were injured by Yaz and Yasmin:.
No decision has been made on the merits of the case. We have filed a request with the Court for leave to appeal the decision and are evaluating our legal options At Bayer patient safety comes first and we fully stand behind, Yaz and Yasmin.
Health Canada summaries of reported adverse reactions for Yaz and Yasmin, where death was an outcome. Taken correctly, the pill is over 99 percent effective at preventing pregnancy. But with some brands of the contraceptive pill comes the risk of potentially deadly side effects. On Thursday, a court case against German pharmaceutical giant Bayer will open in the southern German town of Waldshut-Tiengen. The law suit was first filed in May by German native Felicitas Rohrer. The year-old claims she suffered a double pulmonary embolism as a result of taking Bayer's Yasminelle contraceptive pill, which uses the hormone drospirenone.
An embolism is caused by a blot clot obstructing the circulatory system. In , Rohrer, who was 25 at the time, suddenly collapsed and her heart stopped beating for 20 minutes. In emergency open-heart surgery, doctors found huge blood clots blocking the main artery to her lung. I've never smoked, I'm not overweight and I've always exercised," Rohrer wrote on her website. After finding no alternative explanation, doctors pointed the finger at Bayer's pill, which Rohrer had been taking for eight months when she collapsed.
Since her surgery six years ago, Rohrer has had to take an anti-coagulant which reduces her chances of conceiving a child. Rohrer's case will be the first of its kind in Germany, but in the US, such lawsuits are far from unheard of.
In alone, the company paid out million euros in cases connected with with its Yasmin contraception range, which includes Yaz, Yasmin and Yasminelle. According to several recent studies, birth control pills containing drospirenone, such as Bayer's Yasmin range or Jenapharm's Aida and Petibelle, were found to increase the risk of an embolism or thrombosis by up to three times compared to previous generations of contraceptive pill.
Researchers in a study that assessed the data of 1. Germany's Federal Institute for Drugs and Medical Devices BfArM also said they received reports from women in the last 15 years who suffered from thrombosis and were also taking a contraceptive pill containing drospirenone. Sixteen of the suspected cases resulted in death. Despite the studies, Bayer insists that its contraceptive pills are safe when taken correctly. In an interview with DW, Bayer's spokesperson for women's health, Dr Michael Diehl, said that all of the company's "combined oral contraceptives, even those containing drospirenone, have a positive user risk profile, when they're taken as indicated.
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