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Our team of attorneys are now investigating claims and prepared to file Mirena lawsuitsinvolving the intrauterine contraceptive device Mirena®. Manufactured by Bayer Healthcare Pharmaceuticals, Inc., Mirena is an IUD device [intrauterine device] that must be inserted by a trained health care provider and is intended to provide contraceptive protection for up to five years. Some women have experienced serious adverse side-effects and potentially life-threatening complications following the implantation of theMirena device, including perforation of or imbedment in the uterus.
Perforation of the Uterus Claims are possible says Mirena Lawyer
The Mirena device is manufactured by Bayer Pharmaceuticals. Bayer Pharmaceuticals was formerly known as Berlex, Inc. which was formerly known as Berlex Laboratories. Nevertheless, Bayer is the holder of the new drug application for the contraceptive device Mirena.
Mirena is an intra-uterine contraceptive system made of flexible plastic that is inserted by a healthcare provider during an office visit. The Federal Food and Drug Administration (FDA) approved Bayer’s new drug application for Mirena in December 2000. Today, more than two million women in the United States use Mirena. It has been used by more than 15 million women worldwide. The system releases levonorgestrel, a synthetic progestogen directly into the uterus for birth control. Bayer admits that “it is not known exactly how Mirena works” but provides that Mirena may thicken cervical mucus, thin the uterine lining, inhibit sperm movement and reduce sperm survival to prevent pregnancy.
The Mirena Intra-Uterine System (IUS) is designed to be placed within seven (7) days of the first menstruation and approved to remain in the uterus for up to five (5) years. If continued use is desired after five (5) years, the old system must be discarded and a new one inserted. The package labeling recommends that Mirena be used in women who have at least one child, suggesting that carrying a child to term may be complicated after Mirena’s use.
Mirena’s label does not warn about spontaneous migration of the IUS device but only states that migration may occur if the uterus is perforated during insertion. Bayer has a history of overstating the efficacy of Mirena while understating the potential safety concerns. In or around December 2009, Bayer was contacted by the Department of Health and Human Services Division of Drug Marketing, Advertising and Communications regarding a consumer-directed program entitled “Mirena Simple Style Statements Program” a live presentation designed for “busy moms.” The Simple Style Program was presented in a consumer’s home or other private setting by a representative from “Mom Central” a social networking internet site and Ms. Barb Dehn, a nurse practitioner. The Simple Style Program represented that Mirena would increase the level of intimacy, romance, and emotional satisfaction between sexual partners. The Government determined these claims were unsubstantiated and, in fact, pointed out that Mirena’s package insert states that at least five percent (5%) of clinical trial patients reported a decreased libido after use. The simple style program strip also intimated that Mirena use can help patients “look and feel great.” Again, the Government noted these claims were unsubstantiated and that Mirena can cause a number of side effects, including weight gain, acne, and breast pain or tenderness. The portion of the simple style script regarding risks omitted information about serious conditions, including susceptibility to infections and the possibility of miscarriage if a woman becomes pregnant on Mirena. Bayer falsely claimed that its program required no compliance with a monthly routine.
Lawsuits have been filed on behalf of women who received the Mirena device and who have experienced a spontaneous perforation of the uterine lining / uterine wall by their Mirena IUD / IUS. It is alleged in lawsuits that have been filed that Bayer placed Mirena into the stream of commerce with wanton and reckless disregard for the public safety. It is alleged that Bayer knew and, in fact, advertised and promoted the use of Mirena despite their failure to test or otherwise determine the safety and efficacy of such use. In deed, despite the fact that evidence existed that the use of Mirena was dangerous and likely to place users at serious risk to their health, it is alleged that Bayer failed to disclose and warn of the health hazards and risks associated with the Mirena and in fact acted to deceive the medical community and public at large, including all potential users of Mirena, by promoting it as safe and effective. It is alleged that Bayer knew or should have known that physicians and other healthcare providers began commonly prescribing the Mirena product as a safe and effective contraceptive device despite its lack of efficacy and potential for serious permanent side effects.
Lawsuits also allege that the Mirena was manufactured, marketed, promoted and sold by Bayer without substantial change in the condition in which it was sold. The foreseeable risks associated with the Mirena device are alleged to be more dangerous than a reasonably prudent consumer would expect when used in an intended reasonably foreseeable manner. It is therefore alleged that defendants defectively designed the Mirena device especially considering that the devices are known to spontaneously perforate the uterine wall and cause serious permanent side effects, medical bills, lost work, and otherwise pain and suffering to patients at large.
Lawsuits also allege that Bayer failed to use reasonable care in designing Mirena and that the company failed to properly and thoroughly test Mirena before releasing the drug to the market, failed to properly and thoroughly analyze the data resulting from the pre-marketing test of Mirena, failed to conduct sufficient post-market testing and surveillance of Mirena, designed/manufactured/marketed/advertised/distributed/sold Mirena to consumers without an adequate warning of the significant and dangerous risks, failed to exercise due care, and negligently continued to manufacture and market the device after it knew of adverse effects.
Likewise, it is alleged that the manufacturers of Mirena had a duty to warn consumers and the medical community of the dangers associated with Mirena and by negligently and/or wantonly failing to adequately warn of these dangers breached their duty of care owed to plaintiffs. It is alleged that a spontaneous perforation of the uterus by a Mirena device can cause severe pain, infections, surgical procedures, medical treatment, and result in the occurrence of medical expenses both past and future.
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