Johnson & Johnson and Ethicon, Inc., manufacturers of the recalled transvaginal mesh device, ProLift, have been ordered to pay for not preserving evidence in a pelvic systems product liability litigation. The litigation comes after the Food and Drug Administration (FDA) received hundreds of reports from women who suffered severe complications after having the recalled product implanted.
Ethicon, a subsidiary of Johnson & Johnson, claimed to have lost or disposed of thousands of files – related to its Gynecare ProLift transvaginal mesh device – that were ordered to be retained by the company.
“We Plaintiffs’ attorneys are beginning to notice a pattern and practice of drug and medical device companies losing or destroying files that reasonably could contain important facts that are contested in these claims,” commented Robert Price, a drug and medical device attorney with the Levin, Papantonio law firm and a member of the TVM Plaintiffs Steering Committee. “These companies tend to cry ‘inadvertence’ or ‘mistake,’ but the behavior that comes to light is very suspect, and these companies deserve to be reprimanded for their behavior that obstructs complete discovery of the facts at hand.”
In 2008, the FDA issued a letter to physicians regarding complications associated with the placement of transvaginal surgical mesh. Over the past 3 years, the agency has received over 1,000 adverse event reports from 9 surgical mesh manufacturers. In 2011, the FDA issued an updated safety warning on the placement of transvaginal surgical mesh.
Transvaginal mesh is used for the treatment of pelvic organ prolapse (POP) and stress urinary incontinence in women. In September, a study conducted by a team of researchers from Georgetown University found that transvaginal mesh has no benefit over traditional treatments for POP.
Last year, a jury reached a $2 million verdict in another transvaginal mesh trial. The jury found the manufacturer, C.R. Bard, guilty of failure to warn about the dangers associated with its surgical mesh product and found the product defective. The case of Cisson v. C.R. Bard was just one of over 23,000 transvaginal mesh lawsuits filed against the manufacturer.
Other lawsuits have been filed against Boston Scientific and American Medical Systems. Severe health complications arising from the implantation of transvaginal surgical mesh products include organ erosion, urinary incontinence, infection, bleeding, and pain.
Transvaginal mesh products were approved by the FDA under the 510(k) expedited approval process, which allows for drugs and products that are deemed similar to existing FDA-approved products to enter the market as FDA-approved, without extensive trials or testing. Only last year did the FDA order over 30 manufacturers of transvaginal mesh products to conduct post-market safety tests to better examine the dangers of their products.
Alisha is a writer and researcher with Ring of Fire. You can follow her on Twitter @childoftheearth.