The pharmaceutical division of the German company Bayer declined in 2012, by over 43 percent. This is due to the $1.5 billion Bayer has in reserve to deal with the legal issues revolving around its products Yaz, Yasmin, and the generic Ocella, all oral contraceptives.
The Basis of Bayer’s Legal Difficulties
The legal issues involve drospirenone, a synthetic hormone that is used as the primary active ingredient in Bayer’s Yaz, Yasmin, and Ocella products. After an April 2012 study by the U.S. Food and Drug Administration (FDA), consumers were told that drospirenone may be connected to a higher risk of blood clots, which can potentially be deadly.
There are now nearly 10,000 pending actions about Yaz and Yasmin causing blood clot-related health concerns, with over 1,000 more claims waiting in the wings until the court filing process is complete.
Legal Claims Against Bayer
Legal claims against the company go back as far as 2009, claiming that the drugs’ side effects were known to Bayer or should have been known. The company never warned its customers about their birth control drugs being associated with a higher blood clot risk. Claimants say this leaves them entitled to compensation if they used the drug and had complications.
The U.S. federal courts have consolidated the many currently pending cases into a multidistrict litigation. Chief Judge David R. Herndon, of the U.S. District Court for Illinois’ Southern District, is responsible for those cases.
Yaz, Yasmin and Ocella are not the only products causing Bayer difficulty these days. Mirena, an intrauterine device, has also been found to cause severe health complications. Lawsuits regarding Mirena are also going against the company. In this case, however, the lawsuits haven’t hurt sales yet. Mirena’s sales went up nearly 9 percent last year.
Blood Clot Risk Among Yaz Patients
The Yaz lawsuits’ claimants are citing serious health issues that began after taking Yaz or the contraceptive’s sister drugs. Some of these health issues were fatal. The FDA’s ruling on the drug is backed up by the British Medical Journal. The Journal warns that drospirenone can greatly raise an individual’s risk of blood clots, along with related clotting issues like pulmonary embolism and deep vein thrombosis. In some patients, the study found that taking Yaz increased their risk nearly 74%.
The FDA reviewed this study, as well as other studies that indicated no added risk. In the end, the FDA ruled that the safety labels for Yaz, Yasmin, and Ocella had to be revised. The labels now indicate that blood control products with drospirenone can triple the risk of blood clots. Birth control products containing progesterone or other synthetic hormones have been found to have no such added risk.
Bayer’s Plans for the Future
Currently, nearly $1 billion has gone to settle almost 5,000 claims against Bayer. The company does not admit liability in any of these cases. Their 2012 annual report states that any future blood clot claims will be reviewed on a case-by-case basis. 3,200 claims remain unsettled, however, and the company does expect continued lawsuits. The $1.5 billion set in reserve will be used for future settlements and legal fees.
Authored By: Renee Simmons. Renee is a journalist/blogger who contributes new legal information across different websites and organizations.
Photo source: http://www.flickr.com/photos/epsos/8463683689/