For the first time, a Texas jury has decided the pelvic mesh made by healthcare giant Johnson & Johnson was defectively designed. The jury awarded the 64-year-old Dallas woman $1.2 million following a two-and-a half week trial.
The case has implications for all pelvic mesh which is overwhelmingly made of polypropylene, a petroleum-based plastic. Hernia mesh is made of the same material and has a similar reaction in the body.
Linda Batiste was implanted with the TVT-O to treat incontinence in January 2011. Since then she has suffered pelvic and nerve pain due to mesh erosion. Lawyers for Batiste, showed Ethicon, a division of Johnson & Johnson, had been working on an improved mesh, lighter weight with larger holes and cut by laser not a machine, but that newer, improved mesh never made it to the TVT or TVT-O.
Ethicon, based in New Brunswick, New Jersey, is facing more than 25,000 similar lawsuits which allege the Women’s Health and Urology division makes a defectively designed polypropylene implant to treat prolapsing organs and incontinence. Most of those cases are consolidated in multidistrict litigation in Charleston, West Virginia.
Polypropylene mesh incites a foreign body response and encapsulates tissue and nerves as it shrinks. The plaintiffs’ attorneys showed the jury that response never stops.
Punitive damages in Texas must be unanimous and the jury was split 8-2 so there was no punitive award.
J&J told Bloomberg News it planned an appeal and noted the Dallas jury did not find the instructions for use were defective. A spokesman said:
“We emphasize with all women suffering from SUI, which can be a serious and debilitating condition, and we are always concerned when a patient experiences adverse medical events” …..”TVT-O has been deemed safe and effective by regulators and practitioners alike and it continues to be an important option for treating physicians to offer to women suffering from SUI.”
Last February, a jury in New Jersey awarded Linda Gross $11.1 million including $7.76 million in punitive damages over her polypropylene mesh implanted to treat prolapse. It too is made by Ethicon. The jury there did not determine the mesh was defectively designed.
In June 2012 the company decided it would stop selling some of its mesh kits following a number of lawsuits. The kit implanted in Linda Gross, Prolift, was among those removed from the market. Ironically, you can still buy it on eBay.
Meanwhile the TVT-O is still on the market as is its cousin version the TVT (transvaginal tape). It used the same mesh used for hernia repair, something scientists have called overengineered.
The Dallas trial was the second state case naming Ethicon over defective pelvic mesh. The only other similar case concluded in federal court in Charleston, WV with a directed version in Ethicon’s favor as the defendant was about to begin its case.