Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Friday, December 15, 2017

Slow Justice: A Slap on the Wrist of J&J Corporate Perpetrators

A Bergen County jury returned a $15 million verdict Thursday against Johnson & Johnson subsidiary Ethicon in a suit over alleged defects in its Prolift pelvic repair product.
By Charles Toutant | December 14, 2017 at 07:15 PM
Ethicon mesh
A Bergen County jury returned a $15 million verdict Thursday against Johnson & Johnson subsidiary Ethicon in a suit over alleged defects in its Prolift pelvic repair product.
The verdict, for $4 million in compensatory damages to plaintiff Elizabeth Hrymoc, $1 million in compensatory damages to her husband, Tadeusz Hrymoc, and $10 million in punitives, was awarded after a three-week trial before Superior Court Judge Rachelle Harz.

Johnson & Johnson has promised to appeal and says it stands by its pelvic mesh products.
Thursday’s verdict is the second in a bellwether pelvic mesh case in New Jersey. It follows another for $11 million that was awarded in 2014. That verdict was later upheld by the Appellate Division, and the Supreme Court declined to take up the case.
Hrymoc, 71, who suffered vaginal pain after surgery to implant the product in 2008, is unable to have sexual intercourse or undergo a pelvic exam as a result of her injuries, said plaintiffs lawyer Adam Slater of Mazie Slater Katz & Freeman in Roseland.
The jury found that the Prolift pelvic repair system was defectively designed and failed to contain adequate warnings, and that the TVT-O system for treatment of stress urinary incontinence failed to contain adequate warnings. The punitive damages were awarded based on a finding that the Prolift design and warnings demonstrated willful and wanton disregard for the health and safety of the plaintiff. The jury, including one attorney and numerous others with master’s degrees, was “very sophisticated,” Slater said.
The resolution of the Hrymoc case means that “every single important legal ruling has been made, so trying these cases going forward is going to be very streamlined,” according to Slater. Those legal issues include what evidence is admissible on particular issues, and what jury charges are allowed, he said.
“Those orders now apply in every case. It’s going to be much easier and much more efficient. That’s very, very significant,” said Slater.
Also of note is that punitive damages have been awarded in both New Jersey Prolift suits, which requires a finding, by an enhanced, clear-and-convincing evidence standard, that the defendant showed a wanton disregard for the plaintiffs’ safety and health, Slater said.
Johnson & Johnson spokeswoman Mindy Tinsley said in a statement in response to Thursday’s verdict: “Ethicon intends to appeal this verdict, as we believe the evidence showed that the company appropriately informed surgeons of the pertinent complications and that the products were properly designed and studied.”
About 2,000 pelvic mesh suits against Ethicon are still pending in Bergen County, and in 2018 the court is likely to begin trying those cases two or three at a time, according to Slater.
About 150 pelvic mesh cases against Bard are also pending in New Jersey, he said.
In September, a Philadelphia jury returned a $57.1 million verdict against Ethicon in Ebaugh v. Ethicon. That verdict was composed of $7.1 million in compensatory damages and $50 million in punitive damages.
Tinsley’s statement continued: ”All surgeries to treat pelvic organ prolapse and stress urinary incontinence have risks, including Prolift and TVT-O, and Ethicon is always concerned when a patient experiences surgical complications. The majority of surgeons around the world continue to agree that midurethral slings like TVT-O are a suitable first line surgical option to treat stress urinary incontinence. Many surgeons also continue to support the use of pelvic mesh to treat prolapse as an important treatment option for women because the vast majority of women experience improvement in their symptoms and quality of life. Ethicon stands by, and will continue to defend, our pelvic mesh products in litigation.”
Slater was joined at trial by his firm’s David Mazie, David Freeman, Cheryll Calderon, Karen Kelsen and David Estes.

Ethicon’s lawyers included William Gage of Butler Snow in Ridgeland, Mississippi; Judith Wahrenberger of Ruprecht Hart Weeks Ricciardulli in Westfield; Kelly Crawford of Riker Danzig Scherer Hyland & Perretti in Morristown; and Philip Combs of Thomas Combs & Spann in Charleston, West Virginia.

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