In a decision that may set a precedent for hundreds of remaining cases, a jury in California ruled against C.R. Bard (NYSE:BCR) that the company’s transvaginal mesh device was responsible for a patient’s injuries.
Plaintiff Christine Scott sued Bard in 2009 after a surgical procedure intended to treat occasional urinary incontinence left her entirely incontinent, in chronic pain and unable to have sex, according to the Bakersfield Californian. The jury awarded Scott $5 million for her injuries and awarded her husband $500,000 for the damage to their love life.
Scott claimed that 2 Avaulta Plus surgical mesh devices surgeons implanted, which remain in her body and can’t be removed safely, led to 8 additional surgeries and 9 other procedures to correct they damage the caused.
The jury decision may bode ill for Bard and other device makers, including Johnson & Johnson (NYSE:JNJ), Endo Pharmaceuticals Holdings (NSDQ:ENDP) and Boston Scientific (NYSE:BSX), which are in the midst of similar lawsuits against their mesh devices.
Bard plans to appeal Scott’s win and maintains that its mesh products, which it pulled from the U.S. market earlier this month, can be used “safely and effectively when used properly and when used with the right patient,” Bard attorney Michael Brown told the paper
“Throughout the case we clearly have empathized with Mrs. Scott’s injuries,” Brown added. “We just don’t feel that they were the result of the Avaulta Plus product or the conduct of our company.”
Bard continues to market the Avaulta products elsewhere in the world.
Johnson & Johnson last month pulled its mesh products off the shelves in response the more than 600 women who have filed lawsuits claiming personal injury as a result of having receiving the implants. The decision wasn’t made based on any safety or efficacy concerns, according to Johnson & Johnson, and the company didn’t issuing any warnings for women with the mesh already implanted.
The FDA warned patients and physicians in July 2011 that the surgical placement of mesh to repair pelvic organ prolapse may expose patients to unnecessary risk without any apparent clinical benefit over safer options.
“There are clear risks associated with the transvaginal placement of mesh to treat POP,” FDA devices deputy director Dr. William Maisel said at the time. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh.”
Late last year 3 U.S. Senators probed Bard on its management of the clamor surrounding its transvaginal mesh devices as part of a larger investigation into medical device recalls. Early this year the FDA asked a total of 33 mesh-makers to conduct 3 years of safety and effectiveness trials, collect and review all existing data on the safety and efficacy of the devices and the conduct a total 88 postmarket surveillance studies.
The 1st federal lawsuit against a clutch of mesh-makers will hit a federal court in West Virginia in February 2013.
U.S. District Judge Joseph Goodwin will oversee lawsuits claiming that Bard’s Avaulta line of mesh products were “rushed to the market without 1st being shown to be safe or effective” and resulted in “serious physical and emotional injuries.”
Bard found itself mired in a mess of lawsuits after dozens of patients asked to join a multi-district federal case against the company for allegedly selling defective and dangerous products – its Avaulta transvaginal mesh.
Consolidated from 21 individual lawsuits in October 2010, the lawsuit includes complaints from women implanted with three different types of Bard mesh: The Avaulta Biosynthetic, the Avaulta Plus and the Avaulta Solo mesh.
The complaints arose as transvaginal mesh gained visibility in the public eye over FDA concerns that it might do more harm than good. The devices are used to treat pelvic organ prolapse, which occurs when internal support structures become so weak or stretched that organs, like the uterus, bladder or bowels, sag from their normal position and bulge or prolapse into the vagina.
