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Woman sues manufacturer of alleged defective medical device

Product liability refers to that legal principle or tort that imposes liability on a manufacturer or seller of a product that is unreasonably dangerous and defective, and which causes injury to the user or consumer. Some of the theories of recovery universally recognized are failure to warn, negligence, defect in the product's design, and strict liability. In the reported case from a state neighboring West Virginia, a woman has filed a lawsuit in federal court against Bayer Healthcare, the manufacturer of an allegedly defective medical device known as the Mirena birth control device.

She alleges that the device was medically placed in her body in 2010. The lawsuit claims that by sometime in 2011 the device perforated her uterus and traveled into other sections of her body. She asserts that she suffered from numerous severe physical and emotional symptoms after the product was implanted.

To make matters worse, she became pregnant and went to the doctor to have the apparently faulty medical device removed. However, the doctors couldn't find it, advising her that she must have expelled it from her body. She continued to suffer symptoms and eventually obtained x-rays that showed the product at another location. She had surgery to have it removed. She subsequently filed the lawsuit in the U.S. District Court for the Western District of Pennsylvania.

The damages claimed include pain and suffering, loss of life's pleasures, physical pain, involuntary surgery and numerous mood changes and emotional conditions. With respect to liability, she alleges a failure to warn adequately of the possibility of perforation and migration of the device after the implantation procedure is completed. She also includes other counts, including for strict liability, negligence, fraud, and breach of warranty.

West Virginia law recognizes the same legal theories for recovery as are asserted in most jurisdictions. Strict liability is a useful theory in most cases because it relieves the victim of having to prove negligence in the manufacture of the defective medical device. If a defect is proved, and there was no warning of the defect given, then liability for injury applies regardless of how careful the manufacturer might have been.

Source: The Pennsylvania Record, Pa. woman files Mirena products liability complaint against Bayer Healthcare, Jon Campisi A, Nov. 5, 2013

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