Thursday, June 6, 2013

Manufacturer and Implanting Physician of Vaginal Mesh Found Liable

                Bloomberg Businessweek

Currently, there are hundreds of lawsuits pending alleging that vaginal-mesh implants made by Murray Hill, New Jersey-based Bard, Boston Scientific Corporation and other companies have caused organ damage in women.

A jury in California has recently held C.R. Bard, Inc., manufacturer of the Bard Avulta Plus transvaginal-mesh implant, liable for injuries caused to plaintiff Christine Scott. The devises are used to treat pelvic organs that bulge, or prolapse, or to deal with incontinence. Scott was implanted with the device in 2008 and afterwards had to undergo as many as nine surgical procedures to deal with problems caused by the device.

In her complaint, Scott alleged that the Bard Avaulta Plus vaginal-mesh implant was defectively designed and that the manufacturer had failed to warn about its safety risks. Her attorney produced evidence in hopes of showing the jury that Bard did not properly test the device before putting it on the market. In its ruling, the California jury found that Bard officials knew or should have known that surgeons “performing pelvic-floor repair would not realize the potential risks” posed by the implant. As a result, the jury ruled that Bard was 60% at fault and Christine Scott’s implanting surgeon, Dr. Tillakarasi Kannannan, 40% liable for the injuries Scott sustained as a result of the vaginal-mesh device.

In their verdict, the jury ruled that together, C.R. Bard, Inc. and Dr. Tillakarasi Kannannan are to pay $5.5 million to Scott and her husband. The damages awarded are in order to compensate both plaintiff and her husband for their financial and emotional suffering caused by the vaginal-mesh device Christine had implanted back in 2008.

In an e-mail statement, Scott Lowry, a Bard spokesman, stated that “while we empathize with the complications suffered by the plaintiff, those complications are not the fault of any conduct by the company.” Lowry went on to say that “[the company] believe[s] the evidence establishes that our Avaulta mesh products, cleared by the FDA, are safe and effective and provide significant benefits to patients.”

A 2011 report by the U.S. Food and Drug Administration found that vaginal mesh products should be classified as posing high risk to patients based on a review of side-effect reports from January 2008 to December 2010. In January of this year, in attempt to investigate the safety of vaginal mesh implants, the FDA ordered 31 manufacturers to study the rates of organ damage and other complications occurring as a result of the implants. Both Bard and Johnson & Johnson were included in the manufacturers required to conduct these studies. These studies must be conducted over the period of three years.