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.

Reasonable jury verdict: J&J pays $3M for surgical mesh patient harm

No retrial for Ethicon in $3m pelvic mesh loss

AUGUST 19, 2015 BY BRAD PERRIELLO 

A federal judge today shot down a bid by Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon to overturn a $3.3 million judgment in a pelvic mesh product liability lawsuit and denied the company’s move for a new trial.

A jury in the U.S. District Court for Southern West Virginia awarded Jo Huskey and her husband damages of $3.2 million, finding in September 2014 that Ethicon’s TVT-O transvaginal sling caused her injuries and that the company failed to warn about the stress urinary incontinence treatment’s risks.

Ethicon asked Judge Joseph Goodwin, who’s overseeing 10s of thousands of product liability lawsuits brought over pelvic mesh products, to overturn the verdict or, alternatively, to grant a new trial.

But Goodwin today declined to disturb the jury’s verdict, finding that “[t]he evidence on the defective design claim is particularly strong and is capable of upholding the verdict on its own.”

A reasonable jury, Goodwin ruled, could conclude that the risks of the TVT-O product “are not justified by the benefits, and as a result, the TVT-O cannot, as a matter of law, qualify as an unavoidably unsafe product.”

“In short, while Ethicon produced evidence of the TVT-O’s usefulness and benefits, the plaintiffs countered with evidence of the TVT-O’s high risks of injury and how Ethicon could have mitigated those risks through alternative designs,” Goodwin wrote, according to court documents. “Taking the evidence as a whole and viewing it in the light most favorable to the plaintiffs, it is clear that reasonable persons could balance the risks and benefits against Ethicon. As a result, I cannot displace the jury’s verdict on these grounds.”

Goodwin also cited evidence produced at trial that Huskey’s physician would not have used the TVT-O device had she been warned that it was contra-indicated for active patients like Huskey. The doctor was also unaware of other risk factors from the product, the judge ruled, including that the mesh itself could cause infection and that the amount of mesh material in the product could cause more complications.

“The plaintiffs presented sufficient evidence on Ethicon’s knowledge of dangerous propensities of the TVT-O and failure to warn about those propensities such that a reasonable jury could conclude that Ethicon was negligent,” Goodwin wrote.

http://www.massdevice.com/no-new-trial-for-ethicon-in-3m-pelvic-mesh-loss/

Surgical Mesh: Scandal Deepens in Scotland

Mesh surgeryscandal: Doctor hired to lead mesh probe used to work for manufacturers

         Jun 15, 2014 12:33

         By Marion Scott  Daily Record  FiDA highlight

        

MESH victims have become concerned over the news that Dr Fred Milani, who worked for one of the mesh manufacturers will be investigating safety issues.

A doctor who was once a consultant to one of the world’s biggest mesh manufacturers has been appointed by the European Commission to investigate safety issues.

The appointment of Dutch urogynaecologist Dr Fred Milani has sparked concern among mesh victims, who say they would have preferred someone with no ties to the industry that they blame for their injuries.

We can reveal that, less than two years ago, Dr Milani stated in medical papers that he had a “consultancy agreement” with Ethicon, the Johnson & Johnson company who produce mesh implants to treat pelvic organ prolapse and bladder problems.

The firm also manufactured the TVT-O mesh implant device which was ruled as defective in a US court of law two months ago.

Milani co-authored a number of medical studies and papers with some of Ethicon’s high-profile management team including Dr Piet Hinoul, former medical director of Ethicon’s Gynecare women’s health and urology.

He has also written medical papers with Ethicon’s clinical director in Scotland, Judi Gauld, and Vanja Sikirica, another ex-associate director at Ethicon.

And in his report to Holland’s Health Care Inspectorate into mesh complications last year, it was noted Milani’s research was partially financed by Ethicon.

Campaigner Olive McIlroy, 57, of Scottish Mesh Survivors, said: “This investigation will have a huge influence across European countries in how they deal with the emerging mesh injury crisis.

“We already feel let down by doctors because so very few of them bothered reporting adverse incidents, allowing the mesh industry and medical watchdogs to continue saying the benefits outweigh the risks. It is vital that the victims have complete confidence in what happens from now on.”

Despite 328 women having repeat surgeries to correct damage, just 12 cases were reported by Scottish doctors.

Dutch health experts have delivered new guidelines on mesh surgery but said a ban on products was not in the best interests of patients.

However, mesh will only be used in patients where traditional methods fail.

A spokeswoman for European Commissioner for Health Tonio Borg said: “Strict rules are in place to assure an independent, excellent and transparent 

SCANDAL: Surgical mesh in Scotland

            News

            Scottish News

            Mesh surgery scandal

Labourhealth spokesman Andy Burnham accuses the Government of failing women living inagony because of mesh implants

         Apr 27, 2014 14:18

         By Marion Scott

THE health spokesman says the Government must act now to end the devastating injuries and enduring agony suffered by hundreds of Scots women.

Mesh victim Caroline Tait outside Scottish Parliament

LABOUR'S health spokesman Andy Burnham has accused the Government of failing women living in agony because of mesh implants.

He criticised SNP health secretary Alex Neil over his refusal to suspend the use of the controversial treatments.

It follows a Sunday Mail campaign which has highlighted devastating injuries and enduring agony suffered by hundreds of Scots women.

Burnham said: “The evidence from health boards is shocking and clearly shows thousands of women have been affected by these products which can have life-altering consequences.

“Some of the cases revealed by the Sunday Mail are heart-breaking when what should be a simple procedure has left women disabled.

“I’m surprised by the lack of action or leadership being shown by the Scottish Government.”

Burnham backs Scotland’s shadow health secretary Neil Findlay who has called on Alex Neil to suspend the use of mesh until an inquiry can properly assess the scale of the scandal.

Pressure on Neil is growing after a US court decision found one of the most widely used vaginal mesh implants, produced by Johnson & Johnson subsidiary Ethicon, was defective.  (Batiste v. McNabb/J&J Ethicon in Dallas, TX)

Findlay said: “After the US ruling, Alex Neil should have suspended the use of mesh in Scotland and instructed health boards to 
contact every woman given this implant to check whether they are experiencing any problems.”

Hundreds of thousands of women around the world have reported injuries inflicted by mesh eroding in their bodies.

Many have faced a series of ops as surgeons struggle in vain to remove the mesh used to treat prolapse and bowel conditions.

American courts have already awarded damages of millions of pounds to the victims.

More than 400 cases are lodged in Scotland. The Scottish Government said: “We continue to work with professional organisations to improve 
reporting and monitoring of procedures using mesh.”

Johnson & Johnson are considering appealing last month’s judgment that their TVT-O device was defective.

Spokeswoman Lucinda Macari said: “The verdict is disappointing and we believe we have strong grounds for an appeal.”

Leslie McGlinchey, 33, of Drumchapel, Glasgow, who was forced to use a wheelchair after a mesh implant three years ago, said: “Politicians continue to ignore this scandal at their peril.

“When things go wrong, the damage is so devastating, it affects whole families.

“We’re calling on everyone to sign our petition and get this stuff out of our hospitals.”

The Hear Our Voice petition closes on Wednesday.

www.scottish.parliament.uk/gettinginvolved/petitions/scottishmeshsurvivors

Plaintiff awarded $1.2M by Texas jury for defective surgical mesh product

Jurysays Johnson & Johnson must pay $1.2M over defective vaginal-mesh implant

By Bloomberg News

 April 04, 2014 at 11:38 AM

Johnson & Johnson was ordered by a Texas jury to pay $1.2 million to a woman who alleged one of the company’s lines of vaginal-mesh implants to treat incontinence was defectively designed, in the first verdict against the company over those devices.

Jurors in state court in Dallas concluded the design of the TVT-O mesh sling implanted in Linda Batiste was flawed and the 64-year-old woman deserved $1.2 million in compensatory damages, her lawyers said. They argued Batiste suffered pelvic pain when the device eroded inside her.

J&J, based in New Brunswick, faces more than 12,000 lawsuits accusing its Ethicon unit of making improperly designed vaginal inserts, such as the slings, that damaged women’s organs and made sex painful. Most of the cases have been consolidated before a federal judge in West Virginia for pretrial information exchanges while other cases are being heard in state courts.

The U.S. Food and Drug Administration has ordered J&J, C.R. Bard Inc. and 31 other vaginal-implant makers to study rates of organ damage and complications linked to the implants after manufacturers faced a wave of lawsuits over the devices.

Doctors inserted more than 70,000 mesh devices in the U.S. in 2010 alone, threading them through incisions in the vagina to fortify pelvic muscles that failed to support internal organs or to treat incontinence, according to court filings.

Appeal Planned

J&J officials noted the Dallas jury rejected Batiste’s claims that Ethicon didn’t provide proper warnings about the slings’ health risks and declined to award punitive damages.

“The jury’s verdict on design defect is disappointing, and we believe we have strong grounds for appeal,” Matthew Johnson, an Ethicon spokesman, said yesterday in an e-mailed statement.

J&J officials decided in 2012 to stop selling some lines of vaginal-mesh implants after being hit with a wave of lawsuits over the devices. The TVT-O sling Batiste, a former nurse, received is still on the market, Thomas Cartmell, one of her lawyers, said in a phone interview.

“This verdict represents the first time an impartial jury had the opportunity to decide whether Ethicon’s sling products are defective and they found exactly that,” Bryan Aylstock, a plaintiffs’ lawyer helping to oversee cases gathered before U.S. District Judge Joseph Goodwin in West Virginia, said in a phone interview. “We believe this is the first of many more verdicts to come over this dangerous product,” he added.

NJ Verdict

Last year, a New Jersey jury ruled J&J must pay $11.1 million in damages to a woman who blamed a Prolift device for her injuries in the first case over any of the company’s implants to go to trial. The Prolift implants help support sagging organs.

Lawyers for J&J, the world’s biggest maker of medical products, argued in court papers that the TVT-O slings are safe and effective and the company properly warned consumers about their risks.

In February, Goodwin threw out a woman’s claims that another line of the company’s sling inserts was def


Updated April 24, 2014

WOMAN WITH SURGICAL MESH STILL SUFFERING, YEARS AFTER SURGERY  (Video)  

FiDA Highlights

by JANET ST. JAMES

WFAA TV  Dallas, TX

Posted on April 24, 2014 at 10:37 PM

Updated yesterday at 10:43 PM

DALLAS — It's not just walking that's painful for 64-year-old Linda Batiste. Life, in general, is a physical struggle.

"I have pelvic pain," she said through tears. "It actually does feel like a scouring pad in your body. You can feel in your women parts, what it is. It's there."

The condition that brought Batiste to tears is embarrassing for her discuss. That feeling comes from a product left inside her body to fix urinary incontinence.

More than 20-million women in the United States suffer from urinary incontinence and/or pelvic prolapse. In thousands of cases — including Batiste's — doctors use a pliable, gauze-like mesh sling to support the bladder and other organs.

But what Batiste got from her 2011 procedure was not relief.

"I have never been pain-free since then,” she said.

Surgical mesh is a synthetic material manufactured by several companies and routinely used for urinary incontinence, pelvic prolapse, and hernia operations.

Attorney Tim Goss, a parner at the Dallas law firm Freese & Goss, represented Batiste in a product liability case against the Johnson & Johnson subsidiary Ethicon. It was the first mesh cast to go before a Texas jury.

"The polypropylene mesh, it degrades, it disintegrates, it extrudes, it frays, it ropes, and it has particle loss,” he said. “And all of those problems cause other problems — like scarring, chronic pain, for example."

The American Urogynecologic Society says mesh is "safe, effective, and has improved the quality of life for millions..."

Three years ago, Hal Samples described the side-effects of his mesh hernia surgery as "torture."

"It can be a bend-over pain, where it will be a sharp stab," he said.

Samples was forced to travel out of state for surgery to remove the mesh. The procedure was not a complete success, and Samples continues to have some pain, even now.

The FDA first issued a "Public Health Notification" in 2008, saying it had received "over 1,000" reports of "adverse events" "for surgical mesh devices."

In 2011, The FDA sent out another warning, saying "serious complications associated with surgical mesh" "are not rare" and that mesh "may expose patients to greater risk" than traditional procedures.

Since then, women across the country have formed organizations and online support groups trying to get mesh removed from the market.

Linda Batiste won a $1.2 million judgment against the maker of her mesh, Ethicon.

"It's significant because there are almost 100,000 other cases pending around the country regarding this type of product,” said Goss, who represents 9,000 mesh cases.

Goss said the lawsuits have the potential to become the largest mass-tort in history — bigger than the Phen-Fen diet drug mess.

A statement from Ethicon spokesman Matthew Johnson called the Dallas verdict mixed:

"A jury in the 95th Judicial District Court of Dallas County, Texas, returned a mixed verdict today in a product liability trial concerning Ethicon’s TVT-O pelvic mesh, which is used as a minimally invasive treatment for women suffering from stress urinary incontinence (SUI).

"The jury found Ethicon properly informed of the known risks associated with TVT-O. The jury also found that the product was defectively designed. The jury awarded $1,200,000 in compensatory damages. The jury declined to award punitive damages.

“We believe the evidence showed Ethicon’s TVT-O pelvic mesh was properly designed and that Ethicon acted appropriately and responsibly in the research, development and marketing of the product. The jury’s verdict on design defect is disappointing, and we believe we have strong grounds for appeal.

“We empathize 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,” Johnson continued. “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.”

In the meantime, Linda Batiste has had several surgeries to try to remove the mesh, which is embedded in her tissue. Her original problem of incontinence is back.

"And it's compounded the pain that I normally would have had,” she said. “I never wish for any other woman to feel this way or to have it happen to them."

E-mail jstjames@wfaa.com