Civil trial begins over safety of vaginal mesh device
Jury selection began Tuesday in the civil trial of a lawsuit brought by a woman in Philadelphia Common Pleas Court against Johnson & Johnson, claiming that a vaginal mesh device made by the company failed after she had it surgically implanted, causing extreme pain and requiring multiple corrective surgeries.
Jury selection began Tuesday in the civil trial of a lawsuit brought by a woman in Philadelphia Common Pleas Court against Johnson & Johnson, claiming that a vaginal mesh device made by the company failed after she had it surgically implanted, causing extreme pain and requiring multiple corrective surgeries.
Thousands of lawsuits have been filed against J&J - one of the world's biggest makers of health-care products - and other pelvic mesh manufacturers contending that the devices were poorly tested and that the companies failed to disclose information showing the risks.
J&J withdrew some of its surgical mesh products from the market in 2012, including the Prolift product at issue in this suit, after an avalanche of complaints. At that time, the company said it properly warned all physicians and patients about possible risks. The Food and Drug Administration had warned in 2008 about the safety and effectiveness of the broad group of mesh products on the market.
The lawsuit, filed in July 2013 by Patricia Hammons of Indiana, is being tried before Judge Mark Bernstein. Opening arguments could begin as early as Wednesday.
Nationwide, there have been 16 verdicts in recent years against pelvic mesh manufacturers, including J&J, totaling $247 million. In May, a jury in Delaware awarded a woman $100 million in compensation for injuries caused by a pelvic mesh implant made by Boston Scientific. Overall, the exposure to mesh manufacturers could be in the billions of dollars, analysts say.
Philadelphia courts often are the venue of choice for plaintiffs lawyers pursuing mass torts cases, like the vaginal mesh lawsuits, because they have long experience with complicated civil claims, and Philadelphia juries are deemed sympathetic to plaintiffs. J&J and its subsidiary Ethicon, which marketed the vaginal mesh product, have facilities throughout the region, thus giving courts here jurisdiction.
"Contrary to J&J defendants' representations and marketing to the medical community and to the patients themselves, their pelvic mesh products ... have a high failure, injury, and complications rate, fail to perform as intended, require frequent and often debilitating re-operations, and have caused severe and irreversible injuries," according to Hammons' lawsuit.
Pelvic mesh implants came into wide use a decade ago for treatment of a condition where the bladder and other organs, weakened by childbirth, over time sag into the vagina, causing urinary incontinence, pain during intercourse, and other maladies.
Hammons had the pelvic mesh implant surgery in 2009, when she was 58.
After the surgery, Hammons complained of painful intercourse. Although Hammons underwent corrective surgery, the pain persisted, as did other problems, including incontinence. In subsequent surgeries to remove the mesh, her physician noted that the mesh was "bunched up" along the undersurface of the bladder and that the movement likely caused perforation to Hammons' bladder.
The multiple surgeries, moreover, caused Hammons to have a greatly shortened vaginal cavity, making it highly unlikely that she would ever be able to enjoy intercourse again, according to her complaint.
Hammons' Philadelphia lawyer, Shanin Specter, alleges that J&J rushed its vaginal mesh products to market, fearing competition from other makers, and in the process ignored evidence that the device might harm patients, particularly by shrinking over time.
In court papers in the case, J&J said both doctors and patients were adequately warned of the medical risks.
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