A Charleston, West Virginia jury recently awarded a Georgia woman a total of $2 million against C. R. Bard Industries, one of the manufacturers of transvaginal mesh (TVM) products, in one of the first cases to go to trial.
Finding the company guilty of “fraud, malice or wantonness,” the jury awarded plaintiff Donna Sisson $250,000 for her pain and suffering from the defective Avaulta mesh device implanted in her in 2009 to correct pelvic organ prolapse (POP). It further punished Bard by awarding $1.75 million in punitive damages against Bard.
Sisson, a public health nurse from Georgia, had pain, bleeding and bladder spasms after the device was implanted, requiring several corrective surgeries to remove the mesh. The jury rejected the company’s claims that Sisson’s injuries were not caused by the plastic device. Sisson claimed Bard continued to market Avaulta, made of plastic, even after it knew that it should not be permanently implanted in humans, and jurors agreed that Bard not only defectively designed the product, but also failed to warn doctors and women of its dangers.
Bard claimed the product complied with industry standards, and did not cause Sisson’s injuries. However, the product was taken off the market last year after the Food and Drug Administration (FDA) requested all TVM product manufacturers to study organ damage, infection and pain during intercourse associated with their products.
Bard, facing more that 5,000 TVM claims, is only one of several TVM manufacturers facing a tidal wave of lawsuits maintaining that these devices, once implanted, can shrink, causing a multitude of injuries. Other manufacturers include Johnson & Johnson, Endo Health Solutions, Inc., and Boston Scientific Corp.
TVM products have been used to correct pelvic organ prolapse (POP), in which a woman’s pelvic organs drop into the vagina, and stress urinary incontinence (SUI), a condition in which urine is leaked involuntarily.
Jurors have not been sympathetic to TVM device manufacturers’ claims that their products are safe. Last year, a California jury awarded $5.5 to a woman, and earlier this year, a New Jersey jury awarded another woman $11 million for her injuries.
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