The complaint alleges seven counts against Bayer, including faulty design, failure to warn, fraudulent misrepresentation and breach of warranty.
St. Louis, MO (PRWEB) February 07, 2013
John J. Driscoll, a nationally recognized defective medical device attorney, has filed a lawsuit on behalf of seven plaintiffs who allege they were injured by use of the Mirena Intrauterine System (IUS), a product of Bayer HealthCare Pharmaceuticals, Inc.
Five women and two men are named plaintiffs in the lawsuit, which was filed in Missouri’s 22nd Judicial Court on February 1. (Case No. 1322-CC00276). The complaint alleges seven counts against Bayer, including faulty design, failure to warn, fraudulent misrepresentation and breach of warranty.
The plaintiffs claim injury and damages, including loss of consortium, which were caused by the Mirena IUS migrating from its intended location in the women’s bodies and requiring removal.
They allege that the Mirena IUS “was defectively designed, inadequately tested, dangerous to human health, and lacked proper warnings as to the true danger associated with its use.”
The Mirena IUS is called an “intrauterine system” by the manufacturer because it has multiple mechanisms of action. It may stop sperm from fertilizing an egg, but it may also stop a fertilized egg from implanting in the uterus. Otherwise, the device is the same T-shape and size of a standard intrauterine device, or IUD.
The Mirena IUS was approved for the U.S. market in 2000, and today, more than 2 million women in the U.S. use the device, according to the lawsuit.
The lawsuit says Bayer failed to warn the public that the Mirena IUS could embed itself and perforate the uterine lining and/or migrate through the uterine lining after its insertion.
The defendant disregarded multiple warnings from the Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications (DDMAC) that its advertising materials for Mirena constituted misbranding of the IUS in violation of the Federal Food, Drug and Cosmetic Act and Food and Drug Administration implementing regulations, the lawsuit alleges.
“Specifically, DDMAC pointed out that Bayer failed to communicate any risk information, inadequately communicated Mirena’s indications, and overstated the efficacy associated with the use of Mirena in Bayer-sponsored [advertising] on Internet search engines,” the complaint states.
“Despite knowing the extremely high incidence rate of uterine perforation and migration to women who use Mirena IUS, Bayer continues to downplay the risks and refuses to provide adequate information in its drug labeling and package inserts regarding the real scope and severity of the dangers,” the lawsuit says.
About The Driscoll Firm, P.C.
The Driscoll Firm, P.C., is dedicated to fighting for the rights of people and families injured by the wrongful acts of individuals and companies. The firm is currently investigating national injury claims involving product liability, defective drugs, dangerous medical devices, medical malpractice, car accidents, premises liability, spinal cord injuries, birth injuries, Cerebral Palsy, brain injuries, Erb's palsy and other circumstances that have caused serious injury or death. The Driscoll Firm, P.C., is based at 211 N. Broadway, 40th Floor, St. Louis, MO, 63102, and serves clients nationwide. To learn more, call (800) 305-9800 or use the firm’s online contact form. All initial consultations are free and confidential.