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

In Second Bellwether Trial, NJ Jury Awards $15M in Ethicon Mesh Case

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.

AU "living nightmare" with J&J Prolift pelvic mesh!

'We've lost so much': Senate urged to act on failures over mesh device implants

April 13, 2016 - 8:15PM

Joanne McCarthy (FiDA highlights)

EXCLUSIVE

Five years ago Gai Thompson warned Australia's peak health bodies of a looming disaster involving women receiving mesh device implants to treat common problems after pregnancy, birth and hysterectomies.

This week Mrs Thompson and others are speaking publicly for the first time as they plan a rally in Canberra and call for a formal inquiry into the health regulators and medical bodies they say have failed them.

They are the women who, in many cases, can no longer have sex, have lost their jobs, have had to mortgage or sell their homes, have travelled overseas for surgery to remove the mesh, have suffered excruciating chronic pain, are resistant to some antibiotics because of chronic infections, and have suffered in isolation and silence – often for years.

"We've lost so much that I can't believe in this day and age this can happen to women, that our lives are being destroyed and no one cares," Mrs Thompson said.

In America tens of thousands of mesh victims have taken manufacturers and doctors to court and been awarded damages of up to $12.5 million. In Australia the response from women has been slower because of fewer numbers and isolation, but it is growing, says Australian Pelvic Mesh Support Group founder Caz Chisholm.

A planned rally by her group in Canberra in late May will target one of Australia's peak health regulators, the Therapeutic Goods Administration (TGA), which approved the first of more than 40 different mesh devices for transvaginal (through the vagina) surgery to treat prolapse in 2005. Prolapse is where pelvic muscles and ligaments are weakened after pregnancy, birth or hysterectomy.

The TGA approved the devices despite no evidence of their safe use in prolapse cases and clear warnings in 2003 of the need for controlled trials on related mesh devices.

Eleven years later, in a letter to a patient advocate in 2014, the TGA conceded its assessment process for mesh devices had not been "mature" and lacked "rigour". The letter coincided with belated TGA action requiring clinical evidence from manufacturers of the safety and efficacy of transvaginal mesh devices.

Mrs Thompson's life after mesh surgery in February, 2008, is reduced to a one-page incident report on the TGA website.

She is the woman whose adverse event report to the TGA in October, 2011 about the Johnson & Johnson Prolift mesh device, noted she could no longer have sex and her life after February, 2008 had become "a living nightmare".

The report noted multiple urinary tract infections leaving her resistant to some antibiotics, chronic and severe pelvic pain, chronic bowel problems, incontinence, multiple areas where the mesh had eroded into her vagina, and that she was unable to stand for any length of time, suffered constant fatigue and stress, and had needed successive surgeries and treatments.

She was unable to work and as a consequence she and her husband had been forced to sell their home, Mrs Thompson said.

It took almost exactly three years for the TGA to complete its investigation of Mrs Thompson's October, 2011 complaint, until it placed her adverse event report on its website in October, 2014.

This week she said she first contacted the TGA by phone in 2010, after two years of seeing different medical specialists to deal with the consequences of the surgery.

"You don't know where to complain when something like this happens. When I first phoned the TGA they said they'd had no other complaints. I kept ringing them. I kept saying to them 'What else have I got to do to get you to do something'?" she said.

"They just kept saying sorry, but I was the only complaint they had."

A Senate inquiry into Australia's health care complaints processes will consider a submission by a patient advocate arguing the complaints process has spectacularly failed women given transvaginal mesh devices to treat prolapse surgery.

While it is mandatory for manufacturers to report adverse events to the TGA, they have to be made aware of any adverse events experienced by women. The TGA has confirmed it is not mandatory for doctors to report adverse events experienced by patients.

Ms Chisholm and Mrs Thompson say the majority of women were completely unaware they could complain to the TGA, or even that mesh was classed as a "device" that came under the TGA.

When Mrs Thompson was told three or four years ago that she had irreversible nerve damage in her pelvis because of the mesh, she was advised she could try morphine patches to cope with the pain.

She rejected the idea. Her life is about managing pain and the stress that flows from it.

"I can't get up and down steps. I can't go out for a walk. I feel like I have barbed wire in my pelvis and every time I move it causes me pain," she said.

"To have one day pain free, when you've had years and years of chronic pain, is something I can't even imagine now."

The Therapeutic Goods Administration said it started monitoring urogynaecological meshes in 2008, with a review in 2010 that found complications were closely linked to the skill and training of surgeons.

By August 2014 after a clinical review it reassessed the clinical evidence for devices and took action against some manufacturers, including the cancellation of devices.

In a statement to the Newcastle Herald the TGA said it had strengthened its oversight of new applications for mesh approvals, including conducting its own clinical assessment of the evidence rather than relying solely on European approvals as the basis for approval in Australia.

Johnson & Johnson was contacted for comment.

Newcastle Herald

http://www.smh.com.au/federal-politics/political-news/weve-lost-so-much-senate-urged-to-act-on-failures-over-mesh-device-implants-20160413-go5obe.html

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Harmed patient not healed by $3.35M verdict.

J&J Failed to Warn of VaginalMesh Risks, Jury Says

By David Voreacos - Feb 25, 2013 11:44 AM CT  FiDA highlight

           

           

Johnson & Johnson (JNJ)’s Ethicon unit failed to properly warn of the risks of a vaginal mesh implant and made fraudulent misrepresentations to a South Dakota nurse who sued, a New Jersey jury ruled in the first verdict in more than 2,100 lawsuits filed over the device.

Jurors ordered J&J to pay $3.35 million to the nurse, Linda Gross, and her husband. Gross, 47, had 18 operations after the device was implanted.

J&J, the world’s biggest seller of health-care products, didn’t defectively design the mesh and didn’t make fraudulent misrepresentations to Gross’s doctor, the jury ruled. Jurors decided that the company failed to warn Gross’s implanting surgeon. The verdict in Atlantic City state court came in the first trial of claims Ethicon’s Gynecare Prolift injured women.

“This verdict establishes that Johnson & Johnson and Ethicon failed to tell physicians and women the truth about the catastrophic complications that can result from the Prolift,” Gross attorney Adam Slater said in an interview.

Slater argued to jurors that company documents and e-mails showed Ethicon knew the mesh would cause pain and harm women. Gross blamed the mesh for constant pain that makes it hard to sit and for subsequent operations to remove mesh that hardened.

‘Doctors Knew’

J&J claims the Prolift is safe and effective and it warned of the risks.

“Our position is that the Prolift is a safe and effective product, that Ethicon adequately warned doctors of the risks, that doctors knew of the risks,” J&J attorney Christy Jones said in her closing arguments on Feb. 15.

Superior Court Judge Carol Higbee is considering whether to allow Gross’s attorneys to pursue punitive damages, which are intended to punish the company. If so, the same jury would hear evidence and decide whether to award such damages. New Jersey caps punitive damages at five times compensatory damages, which in this case would be $16.75 million. Jurors delivered their verdict on the fifth day of deliberations.

Gross sought $3.38 million for lost earnings and past and future medical expenses. She also sought unspecified damages for pain and suffering.

Difficult Removal

The Prolift, made of a polypropylene mesh, was inserted through an incision in the vagina. In August, J&J stopped selling four mesh devices in the U.S., including the Prolift. J&J, based in New Brunswick, New Jersey, said in June that it would end sales worldwide because the products lacked commercial viability, not because of their safety and effectiveness.

Slater claimed that Gross’s chronic pain and other health problems were risks Ethicon knew about before first selling Prolift in March 2005. Slater said Ethicon knew the device caused pain and often became exposed through the vaginal skin. He said it hardened in women’s bodies and was difficult for surgeons to remove.

Gross, of Watertown, South Dakota, testified on Jan. 31 that her life has changed dramatically for the worse since her mesh was implanted. She said she is in constant pain and can no longer sit comfortably, and she has prescriptions for 20 different medicines to help with her pelvic problems.

“Who you see standing here now is not who I was,” Gross told jurors. “I was eager and energetic, loved to go to work, loved to participate in church activities, school activities.”

Little Risk

Kevin Benson, the South Dakota surgeon who implanted her Prolift on July 13, 2006 to shore up pelvic muscles, was “so gung-ho” about the Prolift that she thought she needn’t worry. She understood from talking to Benson and reading a company brochure that she faced little risk and that the mesh could be removed easily, she said. Had she known all the risks, she said, she wouldn’t have chosen the Prolift.

Gross said she has had more than 400 visits to doctors and physical therapists for treatment, exams and tests, which have been “horrific.”

“I am fearful of dying because this pain is so bad,” she said.

On cross-examination, Jones sought to establish that before many of her surgeries, doctors warned that they may not help her pain. At one point, Gross shouted at Jones: “You’re trying to blame it on me, and it’s not right.”

Jurors saw the video deposition of Benson, who did three follow-up surgeries to remove portions of the mesh to help her with her pain. Other doctors also removed parts of her mesh.

During jury deliberations, the jury reheard testimony from both Gross and Benson. During the trial, which began Jan. 10, jurors also heard from 11 company witnesses and several experts on each side.

Johnson & Johnson shares fell 2 cents to $76.23 at 12:40 p.m. in New York Stock Exchange trading.

The case is Gross v. Gynecare Inc., Atl-L-6966-10, Superior Court of Atlantic County, New Jersey (Atlantic City).

To contact the reporter on this story: David Voreacos in Atlantic City, New Jersey, at dvoreacos@bloomberg.net

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net

Accessing justice is a high barrier for patients who experience failed implanted medical devices. they are hurt and medically impoverished. The surgeons are not legally required to report "adverse events" to the FDA unless there is a fatality.  Registry of the devices (if there is any) is held in a proprietary silo and data of implants success/failure is obscured for patients making life-changing decisions.  The monumental failure of Johnson & Johnson both for DePuy MoM (metal on metal hips) and Ethicon surgical mesh were preventable if marketing had not led science.  Why is this not criminal?  It is defrauding the government because taxpayers absorb the expen$ive accountability that the industry does not. FiDA Failed Implant Device Allicance  Joleen Chambers