Female genital prolapse is a common problem that can occur for a variety of reasons. The collapse of the pelvic floor during childbirth is the most typical cause of genital prolapse, but forms of the condition can also occur after a hysterectomy and due to hormonal problems.
Transvaginal mesh implants are a treatment option for genital prolapse that has proven to be highly problematic. Vaginal mesh implants were promoted as a way to make up for weakened pelvic muscles, but these medical devices have been shown to have a high failure rate and very serious consequences. The Food and Drug Administration (FDA) has noted that transvaginal mesh implants do not conclusively provide better outcomes than nonmesh alternatives and many women find themselves with painful complications as a result of their defective mesh implants.
One patient recently filed several product liability-related claims against W.L. Gore & Associates Inc. after receiving a failed mesh implant. The patient received the implant to repair vaginal vault prolapse, genuine stress incontinence, prolapsed bladder and rectocele. The patient experienced shrinkage, erosion and extrusion issues with the implant, which resulted in multiple corrective surgeries, painful scarring and painful sexual intercourse.
The patient brought a variety of tort claims against W.L. Gore, including several fraud-based claims. Fraud is a particularly challenging type of claim to bring in the context of a medical device case because it has heightened pleading standards. Generally, to bring a fraud claim, a patient must plead the who, what, when, where and how of the misconduct charged. Even in situations where a company has engaged in fraudulent conduct, finding sufficient specific details of the fraud before discovery is a difficult undertaking.
The court found that in this case, the patient failed to sufficiently plead allegations that, if true, would show that the medical device manufacturer engaged in fraud. The court gave the patient leave to amend her complaint, but it is unclear whether she will abandon her fraud claim and focus on her strict product liability and negligence claims.
Source: Reiniger v. W.L. Gore & Associates Inc., 2010 WL 1948588, U.S. District Court, D. Arizona. May 12, 2010