Hernia Mesh JPML (Georgia,federal) and MCL (NJ, state)

Ethicon Hernia Mesh Lawsuits May Be Consolidated in New Jersey MCL

Posted by Eric T. Chaffin

May 15, 2018 12:45 PM

http://newyork.legalexaminer.com/medical-devices-implants/ethicon-hernia-mesh-lawsuits-may-be-consolidated-in-new-jersey-mcl/

Eric T. Chaffin

Attorney • (888) 480-1123

In May 2016, Ethicon released an urgent field safety notice alerting hospitals, surgeons, and medical center personnel worldwide to stop using their “Physiomesh” mesh products because recurrence and revision rates after laparoscopic repair were “higher than the average rates of the comparator set of meshes among patients in these registries.”

In June 2017, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federally-filed Ethicon Physiomesh lawsuits into one court in the Northern District of Georgia. Currently, about 750 cases are pending there, filed by plaintiffs who claim that their Ethicon Physiomesh implants caused them to suffer from serious injuries.

U.S. District Judge Richard Story is overseeing the MDL, and, currently, the parties are working toward preparing a small number of cases for early “bellwether” trials. The plaintiffs and the defendants are actively identifying potential cases for early trial, from which a final 10 cases will be chosen.

The first bellwether trial is expected to begin in September 2019. Meanwhile, many additional cases involving plaintiffs who claim that they were injured by multi-layered hernia mesh products have been filed in New Jersey state court. In a recent Notice to the Bar, acting administrative director of New Jersey state courts Glenn A. Grant noted that the state Supreme Court had received an application to consolidate all Ethicon multi-layered hernia mesh lawsuits into a Multicounty Litigation (MCL).

Plaintiffs Advocate for Consolidated Hernia Mesh Litigation

On behalf of 62 plaintiffs who have filed cases in Bergen County, the application was filed advocating for an MCL designation for cases involving personal injuries allegedly caused by multi-layered hernia mesh products designed and manufactured by Ethicon, Inc. and its parent company Johnson & Johnson.

Plaintiffs’ attorneys noted in the letter that they expect many more multi-layered hernia mesh cases to be filed in the future. They added that consolidation will “conserve resources, reduce costs, eliminate delay, and reduce the likelihood of inconsistent results.” Comments either for or against the proposed MCL are due to Acting Administrative Director Grant by May 14th, 2018.

The MCL, if approved, would consolidate cases concerning a number of different polypropylene-based mesh prosthetics intended for the repair of hernias. These include the Proceed Surgical Mesh, Proceed Ventral Patch, Physiomesh Flexible Composite, Prolene 3D Polypropylene Patch, and Prolene Hernia System. Plaintiffs allege that the products were defectively designed and/or manufactured and were unsafe for their intended use.

All of these mesh products are composed of several layers of materials that the plaintiffs say substantially increase the risk of serious side effects and complications, including pain, mesh migration, mesh erosion, and mesh contraction.

Why Jury Trials/Verdicts Do Not Stop Medical Device Harm-for-Profit

Listen to this link: J&J defense lawyers attempt to void a $502 federal trial verdict by disassociating the 'parent' company from toxic metal-on-metal DePuy Pinnacle hips

This took place on December 7 at the New Orleans 5th District Federal Court of Appeals.

J&J Tramples on Basic Civil Rights to Jury Trial Verdict

J&J Faces High-Stakes Appeal to Toss Pinnacle Hips Judgment

By Jef Feeley

December 7, 2017, 10:16 AM CST  Bloomberg  FiDA highlight

• Challenge to $151 million judgment affects 10,000 other cases 
• Former Solicitor General Clement squares off against Ken Starr 

The stakes are high as Johnson & Johnson seeks an appeals-court ruling tossing out a $151 million judgment over its Pinnacle artificial hips in a case could foreshadow the outcome for thousands of lawsuits over the devices.

J&J and its DePuy unit, which makes the artificial hips, will have former Solicitor General Paul Clement arguing Thursday that the verdict should be reversed because there was insufficient evidence that the hips were defectively designed and deceptively marketed. The companies will also attack “highly inflammatory comments” at the trial by prominent plaintiffs’ lawyer Mark Lanier.

Kenneth Starr, the Clinton-era independent counsel, will defend the verdict in favor of five hip patients who won a $502 million verdict last year, only to see it slashed to $151 million by the trial judge. Starr will argue that there was enough evidence to support the verdict, including proof that J&J knew the metal-on-metal hips were flawed and would prematurely fail but concealed its knowledge to preserve billions in sales.

J&J, winner of only one of the four Pinnacle cases that have gone to trial since 2014, faces more than 10,000 patient suits blaming the company for selling faulty hips. The argument is scheduled for Thursday afternoon in the U.S. Circuit Court in New Orleans.

Juries in federal court in Dallas have ordered the company to pay a total of more than $1.7 billion in damages over the hips, but several of the awards were later cut by U.S. District Judge Ed Kinkeade, who is overseeing a consolidation of suits over the devices. One verdict was for more than $1 billion.

J&J Ordered to Pay $502 Million Over Pinnacle Hip Failures

J&J welcomes the court’s “review of the multiple legal issues presented by our appeal, many of which have implications for’’ the remaining Pinnacle cases, said John Beisner, a Washington-based lawyer for the company.

A central issue on appeal is whether Pinnacle’s hips were defectively designed and doomed to fail, forcing costly and painful follow-up surgeries. J&J argues that plaintiffs failed to meet a legal standard that the product was unreasonably dangerous, a safer alternative design existed, and the defect caused the injuries.

J&J also vigorously protests Kinkeade’s decision to let Lanier tell jurors at the trial about a litany of J&J’s bad acts that the company contends had nothing to do with the hips.

The judge allowed Lanier to “inflame the jury’s passions’’ by referring to almost $80 million in settlements J&J agreed to in 2011, amid claims that overseas officials bribed European doctors to implant the company’s hips and knees, the company says. Lanier should have also been barred from telling jurors that J&J paid kickbacks to “henchmen’’ of former Iraqi dictator Saddam Hussein under a United Nations program, the company argues.

The Dallas jury hit J&J with $360 million in punitive damages, which the judge reduced to $9.6 million under a Texas law limiting such awards.

Chamber Brief

The U.S. Chamber of Commerce filed a brief supporting J&J, which also argues on appeal that the plaintiffs failed to prove the company hid the risks from patients and that the trial court lacked jurisdiction.

The hip recipients say they proved a safer alternative design existed and the company’s warnings to patients were inadequate. They note that Lanier mentioned the J&J bribery scandal at the trial only after DePuy’s lawyers “opened the door’’ by hyping the company’s good works.

The plaintiffs are challenging Kinkeade’s decision to apply the punitive-damages cap, saying the measure unconstitutionally tramples on their equal-protection rights. The award was supported by the evidence, they say.

The case is Christopher v. DePuy Orthopedics, No. 16-11051, U.S. Fifth Circuit Court of Appeals (New Orleans).

— With assistance by Christie Smythe

https://www.bloomberg.com/news/articles/2017-12-07/j-j-faces-high-stakes-appeal-to-toss-pinnacle-hips-judgment

September 5, 2017: J&J Depuy Pinnacle hip fourth bellwether Dallas, Texas Federal jury trial begins

http://fortworth.legalexaminer.com/medical-devices-implants/depuy-pinnacle-hip-replacement-lawsuits-back-to-trial-in-texas/

New Jersey and New York residents are the plaintiffs 

http://www.txnd.uscourts.gov/mdl-2244-jury-trial-090517

3:11-cv-02460Kathleen Riedhammer | 3:12-cv-04647Claudia and Alan Heroth | 3:13-cv-00244Susan H. Cousin | 3:13-cv-04119Hazel Miura | 3:14-cv-01776Michael A and Audra L Stevens | 3:14-cv-02341Eugen Jr. and Yolanda Stevens | 3:14-cv-02750Denise Buonaiuto | 3:15-cv-03489Ramon and Carole Alicea | 3:16-cv-01245Uriel and Aviva Barzel | 3:16-cv-01526Karen Kirschner

AMS (American Medical Systems,now Endo and J&J (Johnson & Johnson/JNJ) HARM Women FOR PROFIT in AU

Australian Medical Association president confirms AMA WA(Western Australia)’s role in pelvic mesh scandal

• Joanne McCarthy  AUGUST 22 2017 - 12:11PM

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The Australian Medical Association acted as exclusive distributor of an Australian-invented pelvic mesh device for women that helped spark a global pelvic mesh scandal after it was sold and registered for use in America in 2001.

The AMA's marketing of the Intravaginal Sling (IVS) Tunneller device as an "Australian medical design breakthrough" to treat incontinence and prolapse, despite women's reports of complications in Western Australian public hospital trials from as early as 1989, was "a long way from our proudest hour", said current AMA president Dr Michael Gannon.

Australian Medical Association national president Dr Michael Gannon confirmed the AMA promoted and distributed a pelvic mesh device for women that helped spark a global pelvic mesh scandal. 

"It is unfortunately the case that many women have been injured by these kinds of operations. To call this a tragedy is not overstating it at all," he said, after confirming a wholly-owned subsidiary of the AMA's Western Australian branch promoted and exclusively distributed the IVS device.

It was a controversial decision that "I'm sure they now regret", and which some Perth gynaecologists continued to be unhappy about more than 15 years later, he said.

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"I can only answer that in good faith the AMA WA thought it was a good product. History will not judge that decision kindly. It already has not judged that decision kindly," Dr Gannon said.

His comments come only months after the Royal Australian and New Zealand College of Obstetricians and Gynaecologists conceded there was "very little robust information" of the long term safety of some prolapse mesh devices, despite estimates more than 30,000 Australian women received them.

The IVS Tunneller's sale to Tyco Health and registration in America in April, 2001 was used by pharmaceutical giants, including Johnson & Johnson, to register their own prolapse devices by arguing they were "substantially the same" as IVS and subsequent devices, without producing independent evidence of safety. They were then cleared for use in Australia.

More than 700 Australian women alleging serious and permanent injuries after pelvic mesh surgery for incontinence and prolapse are suing Johnson & Johnson in a Federal Court case in Sydney.

An Australian Medical Association document describing the IVS Tunneller device as an "Australian medical design breakthrough" to treat incontinence and prolapse in women.

Another 300 Australian women are registered for a second class action against American Medical Systems (AMS), which developed pelvic mesh devices including Perigee and Apogee. Apogee was cleared for use in America in 2004, after AMS argued it was "substantially the same" as the Australian-invented IVS Tunneller.

Dr Gannon, a Western Australian obstetrician and gynaecologist, said he was aware of "hundreds of operations" by Perth specialists trying to "remedy the damage" caused by mesh devices including the IVS.

Australian Pelvic Mesh Support Group members fought for a Senate inquiry into how pelvic mesh devices were cleared for use in Australia. 

"I have been personally involved in the care of women who have suffered greatly from bladder dysfunction, bowel dysfunction and sexual dysfunction because of some of these devices," he said.

It was a "regulatory failure that so many individual women were damaged".

"The TGA (Therapeutic Goods Administration) takes great care when it looks at new medicines entering the market, but I don't think they are resourced to take the same care with devices. We would like to see them use the same blowtorch on devices as applies to medicines," he said.

Perth woman Jeanette McKinnon, who said she "wanted to vomit" several weeks ago when a specialist confirmed she was implanted with at least two mesh devices at the Bentley public hospital in 2004 and 2005, allegedly without her knowledge or consent, was outraged when told of the AMA's involvement.

"I'm absolutely horrified. I'm so angry I'm shaking. That this has been allowed to go on, and the AMA's been involved. How dare they? We're human beings," Mrs McKinnon said.

The IVS Tunneller device was developed during experiments on 13 large dogs in 1987 by inventor Dr Peter Petros and other Royal Perth Hospital doctors.

A WA East Metropolitan Health Service spokesperson confirmed Royal Perth Hospital approved a research study in 1989 into the IVS device and procedure. It was granted standard clinical practice status by the hospital's ethics committee in 1993.

A Medical Journal of Australia report in July, 1994 acknowledged many doctors were critical of the procedure.

In February 2001, only two months before the IVS Tunneller was cleared for use in America as an incontinence and prolapse device, the Royal Australasian College of Surgeons found there was "no peer-reviewed, good quality evidence available to determine the safety and efficacy of the IVS procedure to treat women's incontinence". There was no assessment of its use to treat prolapse.

In a paper in 2003 called "Intravaginal Sling Distress", three Australian specialists, including Newcastle gynaecologist Alan Hewson and Brisbane gynaecologist Chris Maher, reported "disconcerting complications" in women after IVS surgery, including infections, pain syndromes and "symptoms debilitating to the patient's and partner's quality of life".

"Until further data on the safety and efficacy of the IVS procedures is available they cannot be recommended," they concluded.

A 2010 Melbourne Mercy Hospital for Women review of 10 years of pelvic mesh surgery found the IVS device had significantly higher rates of pain, mesh erosion and infection complication rates than eight other devices reviewed.

Dr Petros did not respond to Newcastle Herald questions.

In a paper in 2012 Dr Petros said his "early experimental studies" had been "wrongly" used as "an intellectual cornerstone to justify the use of mesh in prolapse surgery".

In the paper he distanced himself from the global mesh scandal, saying complications were related to "large sheet" mesh adopted by some companies, and not the small tapes advocated by him which preserved "vaginal elasticity".

In a submission to a Senate inquiry into pelvic mesh devices, which will hold its second public hearing in Perth on Friday, Dr Petros referenced his 1990 paper produced after trialling the Intravaginal Sling procedure on "13 female mongrel dogs", in association with Royal Perth Hospital and the University of Western Australia.

-  Newcastle Herald

http://www.watoday.com.au/wa-news/australian-medical-association-president-confirms-ama-was-role-in-pelvic-mesh-scandal-20170822-gy1hzj.html

J&J Accused of Criminal Behavior: Pelvic Surgical Mesh

Protest Targets J&J CEO on Day of Annual Shareholder Meeting

Women Allegedly Harmed by Pelvic Mesh Express Disappointment with J&J

ARTICLE | MAY 11, 2017 - 9:48PM | BY DAVE SCHATZ   FiDA highlight

MAM co-founder Lisa Mason is seen here during a rally on April 27 outside the State Theatre. Mesh Awareness Movement

NEW BRUNSWICK, NJ–Members of  the Mesh Awareness Movement (MAM) want Johnson & Johnson’s (J&J’s) shareholders “to know they are investing in criminal behavior,” according to a statement.

The group, a grassroots effort to bring awareness to the harmful effects of mesh on the human body, held a rally against J&J in New Brunswick on April 27, during its annual meeting of shareholders. 

MAM has a Facebook group that's grown from about 20 to 700 people in just a year-and-a-half, according to co-founder Tammy Jackson, who said others have contacted her but aren't keen on taking part in social media due to their attorneys' advice.

Jackson said a couple woman in the group were recently offered $189 by the pharma giant to settle their cases, but declined, while five others she knows personally accepted $4,000, and seven received $200,000, in the past six to seven months.

“It’s hard to get people so badly injured to travel across the country and stand all day,” said Jackson, a 50-year-old resident of Kentucky, and former nurse, adding she also brought chairs to the rally for some of the women.

Yet during the hour-plus meeting of shareholders inside the State Theatre, where audio was streamed live on the internet, the women held a protest outside the theatre and say they feel their voices were heard.

Their chants included:

• “No more mesh…”
• “Stop the harm, No more profits.”
• “You are not going to be able to hide from us.”
• “Profit over lives.”

Jackson has had 17 mesh removal and reconstruction surgeries over the past four years, she said.

“Trying to remove mesh out of your pelvic is like removing rebar out of concrete," said Jackson. "Your bladder is angry."

J&J says "we are nothing more than a 'cost of doing business.' We say, we are a hundred thousand severely and permanently injured people who could just as easily be your wife, mother or sister," continues MAM’s statement.

"It doesn’t matter to [J&J] that they’ll have to spend, for example, $2.5 Billion in Litigation, Verdicts, Penalties and fines because they’ve already made $25.1 Billion,” added the statement.

Jackson’s 10-year-old daughter was interviewed for a documentary about patient safety while in the Garden State with her mother and father for the rally.

She told the producers, “I would say quit making mesh and help my mommy,” according to Jackson, who said many MAM members were also interviewed for the film. 

“Where's the media?” wondered one MAM member during the rally. “They need to tape this -- we should flood the TV stations.”

One journalist, Jane Akre, operates the Mesh Medical Device News Desk (MMDND), and was present for J&J's annual meeting of shareholders on the morning of April 27. 

She thought the presentation to J&J's stock holders was "rehearsed" and highlighted "the health of J&J's stock," as Alex Gorsky, J&J's chief executive officer, repeated the words "sustainable" or "people come first." 

Yet across the street, she writes, via an "orderly, heart-felt display," some 30 women and their families rallied.

But their signs indicated they didn't feel like they came first: “The Johnson & Johnson Credo: ‘Research must be carried on, innovative programs developed and mistakes paid for.' Pay the mesh injured for your mistake!”

“Mr. Alex Gorsky” was targeted by another sign that continued, “The highest form of ignorance is when you reject that which you know nothing about.”

A sign urged Gorsky to “Talk to the mesh injured,” while the message on another read: “#SerialKiller CEO. It’s time for you to go!”

"Each [woman] represents at least 10,000 [pelvic] mesh implanted women who can’t make it to a mesh rally, because they are too sick or broke from fighting to regain their health! And that doesn’t even begin to include the one million hernia mesh implants a year!” wrote Akre.

"All use polypropylene! Some day in the not so distant future, we may come to recognize that this cheap plastic is not an ideal, bio-compatible material for an implant, I believe."

"The legal facts have shown that [J&J] knew these mesh devices were unsafe, but they quickly put them on the market anyway... bypassing proper FDA approval, failing to conduct thorough testing and withholding serious risks and warnings,” continues MAM’s statement.

"Little did I know that [during the shareholders meeting], a Philadelphia jury was delivering the third verdict for a plaintiff in another mesh trial – $20 million, which included $17.5 million in punitive damages!"

http://newbrunswicktoday.com/article/protest-targets-jj-ceo-day-annual-shareholder-meeting#.WRTstHiim44.facebook

Akre wondered whether J&J might now be considering a "multi-billion dollar global settlement" and whether "fighting mesh-injured women in court" is worth it. 

The pharma giant is facing $34.5 million in punitive damages, plus other amounts awarded by juries in three separate mesh trials in Philadelphia state court, according to reports.

Akre noted that after half a decade of writing reports for MMDND, media coverage of mesh issues is gaining  some traction.

"Internationally, the media is less afraid to report of Pharmaceutical Giants," she writes citing front page stories in Scotland, Australia, New Zealand and the UK, for instance.

Though Akre provided coverage of the April 27 MAM rally, she said very few reporters were there.

“It was a powerful day," said one woman who took part in the event.

"J&J had a line of buses on the other side of the street to block the view of the rally. [The company] rented those buses with money they earned from harming us,” she added, saying that she felt like J&J owned New Brunswick.

J&J did not respond to a request for comment. 

http://newbrunswicktoday.com/article/protest-targets-jj-ceo-day-annual-shareholder-meeting#.WRTstHiim44.facebook

Verdict $110M: Johnson & Johnson Baby Powder and Ovarian Cancer

Johnson & Johnson ordered to pay $110m in US talc cancer case  

5 May 2017  FiDA highlight

Pharmaceutical firm Johnson & Johnson (J&J) has been ordered by a US court to pay more than $110m (£85m) to a woman who says she developed ovarian cancer after using its talcum powder.

Lois Slemp, 62, from Virginia, Missouri said she developed the cancer after four decades of using talc products.

Prosecutors argued the company did not adequately warn about the cancer risks associated with the items.

Experts say links with ovarian cancer are unproven. J&J says it will appeal.

The verdict in a St Louis state court is the largest so far to arise out of about 2,400 lawsuits against J&J over its talc-based products, Reuters news agency reports.

Ms Slemp is currently undergoing chemotherapy after her ovarian cancer initially diagnosed in 2012 returned and spread to her liver.

She said the products she used included J&J's Baby Powder and Shower to Shower Powder.

"Once again we've shown that these companies ignored the scientific evidence and continue to deny their responsibilities to the women of America," said Ted Meadows, a lawyer for Ms Slemp.

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The verdict included $5.4m in compensatory damages and $105m in punitive damages against J&J.

The company said it planned to appeal. "We are preparing for additional trials this year and we continue to defend the safety of Johnson's Baby Powder," it said in a statement.

"We deeply sympathise with the women and families impacted by ovarian cancer."

J&J lost three jury verdicts last year in cases related to its talc-based products, but won its first trial in March, when a jury in Missouri sided with the company.

There have been concerns for years that using talcum powder, particularly on the genitals, may increase the risk of ovarian cancer.

But the evidence is not conclusive. The International Agency for Research on Cancer classifies talc used on the genitals as "possibly carcinogenic" because of the mixed evidence.

Why is there any debate?

The mineral talc in its natural form does contain asbestos and does cause cancer, however, asbestos-free talc has been used in baby powder and other cosmetics since the 1970s. But the studies on asbestos-free talc give contradictory results.

It has been linked to a cancer risk in some studies, but there are concerns that the research may be biased as they often rely on people remembering how much talc they used years ago. Other studies have argued there is no link at all and there is no link between talc in contraceptives such as diaphragms and condoms (which would be close to the ovaries) and cancer.

Also there does not seem to be a "dose-response" for talc, unlike with known carcinogens like tobacco where the more you smoke, the greater the risk of lung cancer.

What should women do?

The charity Ovacome says there is no definitive evidence and that the worst-case scenario is that using talc increases the risk of cancer by a third.

But it adds: "Ovarian cancer is a rare disease, and increasing a small risk by a third still gives a small risk. So even if talc does increase the risk slightly, very few women who use talc will ever get ovarian cancer."

International #MeshAwarenessDay #LiveLifeMeshFree May 1, 2017

Caz Chisholm recognised for campaign supporting women pelvic mesh victims

Joanne McCarthy

1 May 2017, 10:23 a.m.

A WOMAN who launched a campaign to support women victims of pelvic mesh and hold Australian health regulators to account has won two awards for consumer health advocacy.

Australian Pelvic Mesh Support Group founder Caz Chisholm received the Western Australian Health Consumers Council health consumers award and the Rosemary Caithness Award for outstanding service to health consumers after a campaign, supported by the Newcastle Herald, for a Senate inquiry into pelvic mesh.

Winner: Australian Pelvic Mesh Support Group founder Caz Chisholm with two health consumer awards received for her work since 2014 campaigning for victims of pelvic mesh.

Ms Chisholm’s group jumped from 39 members in early 2015 to more than 600 by Thursday when she received the awards, only days before International Mesh Awareness Day on Monday, May 1. The day was initiated by mesh support groups in countries including Australia, America, New Zealand, Great Britain and European countries including the Netherlands. In America alone more than 125,000 women have initiated legal action against mesh manufacturers after they were implanted with transvaginal mesh (surgery through the vagina rather than the abdomen) after post-childbirth complications.

An American woman on Friday was awarded $20 million compensation for complications after mesh surgery in 2007 using a Johnson & Johnson transvaginal mesh. In Australia 450 women have joined a class action against Johnson & Johnson, another 350 women have joined a class action against a second American device manufacturer, and more than 1000 women in total have complained of serious injuries after mesh surgery.

Ms Chisholm said she was “thrilled and honored to receive these awards as this represents the acknowledgement of all women suffering from the devastating effects of mesh”.

“What we seek first and foremost is recognition of our pain and suffering because most of us have been ignored by doctors, and when we do present with complications we are told they are caused by anything other than mesh,” Ms Chisholm said.

“Yet when women join the support group and they read about the same complications as others, they breathe a sign of relief and often cry because finally they have the recognition that they are not imagining their pain and they are not going crazy.

“They realise their pain is real and their pain is from mesh.”

Western Australian Health Consumers Council executive director Pip Brennan said Ms Chisholm’s double win of the two most prestigious consumer health awards recognised her tireless advocacy for mesh victims and outstanding work on giving them a voice.

“The use of mesh is now the subject of a federal Senate inquiry, which is taking submissions until May 31, and the inquiry’s title is ‘Number of women in Australia who have had transvaginal mesh implants and related matters’. This highlights that we simply don’t know how many women have had these implants, and how many of them have suffered complications,” Ms Brennan said.

“Caz Chisholm has spent significant time and energy raising awareness for women about the issue and providing essential peer support. She was also directly responsible for ensuring that the Senate inquiry was successfully advocated by Senator Derryn Hinch.”

In 2016 Australia’s peak health regulator for medical devices, the Therapeutic Goods Administration, quietly placed on its website a list of at least 30 known complications following pelvic mesh surgery, after TGA executives met with Ms Chisholm and other support group members.

The complications include punctures of vessels, nerves, structures or organs including the bladder, urethra or bowel; foreign body response including erosion of mesh into the vagina, bladder or bowel; chronic infections; acute or chronic pain; pain during intercourse; temporary or permanent inability to void via the lower urinary tract; bleeding; chronic pain in the groin, thigh, leg or abdomen; atypical vaginal discharge; exposed mesh may cause pain to the patient’s partner during intercourse and abscess.   

Johnson & Johnson shareholders: are you listening? Divest or be complicit!

Jury delivers $20 million verdict against Johnson & Johnson in local vaginal mesh case

POSTED:APR 28 2017 03:07PM EDT

UPDATED:APR 28 2017 03:09PM EDT  FiDA Highlight

PHILADELPHIA, PA (WTXF) - On Friday, April 28, a jury handed down a $20 million verdict against Johnson & Johnson for injuries suffered by a New Jersey woman after being implanted with a vaginal mesh device.

The verdict was the third consecutive eight-figure award against the corporate giant in a mesh case in a Philadelphia courtroom.

The award—$2.5 million in compensatory and $17.5 million in punitive damages—for Peggy Engleman, now 56, of Cinnaminson, followed a three-week trial in Common Pleas Court in which her attorneys claimed the TVT-Secur medical device was not only defective but that J&J and its Ethicon subsidiary had failed to warn of its risks, risks they had been well aware of while continuing to market the product.

Engleman was implanted with the device in 2007 to relieve stress urinary incontinence, a leakage caused by things such as exercise or coughing. But within a month the TVT-Secur failed and Engleman's stress urinary incontinence returned.

She began experiencing pain and discomfort when the polypropylene mesh started to erode inside her body. Despite three subsequent surgeries, doctors were unable to remove all the remaining mesh.

As a result, Engleman now suffers chronic vaginal pain and pelvic floor spasms. She also developed permanent urinary dysfunction.

“I'm happy I could be a voice for other women,” Engleman said after the verdict. “It's been a nightmare, and I feel justice was truly served today."

The vaginal mesh product in Engleman’s case, the TVT-Secur, was launched in September 2006 but, as her attorneys noted, J&J had already had numerous reports of high failure rates from countries all over the world.

"This jury sent a strong message today to Johnson & Johnson that they continue to hear in courtrooms across the country—our communities deserve better than these dangerous mesh devices and putting profits before safety will not be tolerated," said lead plaintiff’s counsel Benjamin Anderson.

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“The jury made the right decision,” added Thornburgh. “They looked at the evidence and heard the testimony and decided that the company had rushed the product to the market, did woefully inadequate studies and didn’t warn about the risks. So we feel they made the right decision and our client will finally get justice.”

Said Gomez: “The jury spoke and they sent a message that J&J and Ethicon need to take responsibility.”

The verdict was the third straight against a J&J vaginal mesh product in which the plastic-like device eroded inside a patient, leaving shards of mesh that doctors were unable to entirely remove.

The first two cases, in 2015 and 2016 respectively, produced verdicts of $12.5 million for an Indiana woman and $13.5 million for a Toms River, N.J., woman.

Johnson & Johnson toxic metal-on-metal hips: trial 'discovery' exposes secrets of scandal

Hip implant maker was alerted to safety fears, as surgeon told them: ‘It borders on unethical to market’

• Edward Malnick Claire Newell Lexi Finnigan  FiDA Highlight

11 APRIL 2017 • 10:00PM  The Telegraph

British patients were fitted with controversial hip implants despite the company behind them being warned by experts that the type of device was unsafe, secret documents reveal.

A senior engineer working for DePuy reported in 1995 that metal-on-metal constructions were “unpredictable” and parts prone to “catastrophic breakdown” five years before DePuy’s hips began to be implanted in Britons.

More than 20,000 patients were later fitted with the implants, which experts say can deposit toxic ions into the bloodstream as they wear. Thousands  were left in agony and had to have costly operations to have them replaced with safer alternatives.

Andrew Selous, a Conservative MP on the Commons health committee,  described the disclosure as “appalling”, saying: “If the company was aware of problems, they should have acted on the precautionary principle.”

A Daily Telegraph investigation today exposes a series of previously unseen memos, reports and emails, obtained from DePuy, that raised questions about the safety of metal-on-metal devices.

Dr Graham Isaac, a senior engineer based in DePuy’s Yorkshire factory, warned in a 1995 report that testing showed metal implants were “working well for a period of time” before wearing down, prompting the “release of a large volume” of debris.

In the same year, a surgeon advising DePuy told the firm that “we need to be cautious of the legal/litigation issues, lawyers etc ... perception of metal debris and metal ion release.” 

More than two decades later, the firm faces thousands of legal claims by patients who say they have suffered as a result of the metal-on-metal joint subsequently produced by DePuy wearing away in their bodies.

The Telegraph’s investigation also reveals how: 

• Senior company figures were told in 2003 that one surgeon had already collected “a lot of bad data about metal-on-metal debris” in patients who had received DePuy implants; 
•  A 2005 report warned that risks to patients of metal-on-metal were “as yet undetermined” but “the risk to DePuy may be major in terms of product liability or business impact”; 
• An internal email in September 2008 acknowledged there were “growing concerns over metal-on-metal hips”. Surgeons needed “a high stability non-metal option”; 
• Tony Nargol, a surgeon based in North Tees, repeatedly told DePuy from around 2008 about problems with its implants but was labelled an “outlier” and told his patients may simply have high volumes of metal in their blood because of a local “water supply problem”; 
• A report commissioned by the company in 2008 about the use of one of DePuy’s first metal-on-metal implants found that tiny particles released from the devices “have killed the bone” and soft tissues around the hip and “resulted in the tendons ripping away”. 

The papers, filed in a US court, include an email from John Irving, a US orthopaedic surgeon, in 2010, forwarded internally to the company’s president, insisting that “it borders on unethical to continue to market” the Pinnacle type of metal-on-metal hips “until the issues are elucidated”. 

The metal ions released have killed the bone and soft tissues around the hip replacement resulting in:

a. Fluid retention often under high pressure causing pain

b. Tendon rupture causing hip dislocation

c. Bone death resulting in fractures around the implant

Excerpt from Investigation into the Performance of the Ultima Metal-on Metal Hip Replacement, East Norfolk and Waveney Research Consortium, 2008

He accused the firm of a “head-in-the-sand response to this problem” and warned that “the products are harming patients” – three years before the implant was eventually discontinued.

DePuy’s Pinnacle implant was first used in the UK in 2002, with the ASR, another metal-on-metal device, released two years later. They were promoted as offering better mobility than devices that used a metal ball and plastic socket.

In his 1995 memo, Dr Isaac, now “distinguished engineering fellow” at the firm, examined data on metal-on-metal hips produced by rival companies. He wrote: “It is clear from the literature the survivorship of cobalt chromium [the materials used in metal implants], metal-on-metal prostheses in the past have been far from satisfactory.

Paul Peters MD: We need to be cautious of the legal/litigation issues and lawyers etc… perception of metal debris and metal-ion release.

Minutes from the first Alternate Bearing Project designing surgeon meeting, May 1995

“Manufacturing methods have improved. However, simulator testing of such components suggests their performance is as unpredictable as ever, working well for a period of time before suffering a sudden catastrophic breakdown of the bearing surface accompanied by a release of a large volume of wear debris.”

He quoted an expert warning that the combination of metal with metal was “likely to give rise to toxic levels of metal under clinical conditions”.

I do not feel DePuy is doing enough to understand the extent of Pinnacle MOM hip disease. I believe it borders on unethical to continue to market the product until the issues are elucidated. These products are harming patients. DePuy needs to contact physicians that have used the product and encourage them to contact their patients for an urgent follow-up. Many of our hips have asymptomatic osteolysis!

Excerpt of letter to DePuy head of US marketing, Paul Berman, from John F Irving MD

The document was part of papers read out in a Texas court, where patients are suing DePuy over the Pinnacle implant. They were passed to the Telegraph by their lawyers. 

Mark Lanier, a lawyer,  said: “These documents show that DePuy knew this hip would fail.”

DePuy’s lawyers have said in court that the company had “always warned about the potential for a tissue reaction in a metal-on-metal device”.

A spokesman said patient safety was its “first priority” and it “acted appropriately and responsibly in the design and testing” of the Pinnacle.

The implant was cleared for sale by national regulators and “is backed by a strong track record of clinical data showing reduced pain and restored mobility for patients suffering from chronic hip pain”.

The spokesman added that the plastic and ceramic alternatives also “wear and produce debris”, and “the body reacts to any foreign material”.

Boz Michalowska Howells, representing more than 300 UK claims, said  it “appeared to be commonly known in the 90s that metal-on-metal hips cause could adverse reactions and it should have rung alarm bells”. 

Metal implants put under scrutiny

• 2002
  
  
  Pinnacle hip implants, including metal-on-metal type, sold in UK by DePuy
  
  
  
  
  
• March 2004
  
  
  DePuy sells its ASR metal-on-metal implants in Britain
  
  
  
  
  
• 2008
  
  
  DePuy aware some metal-on-metal parts for Pinnacle Ultamet “were slightly outside our manufacturing specifications”. Internal investigation finds it would not cause “safety issues”
  
  
  
  
  
• August 2010
  
  
  DePuy recalls its ASR Hip System “after receiving new information from the UK National Joint Registry as part of the company’s ongoing surveillance of post-market data”
  
  
  
  
  
• June 2011
  
  
  US Food and Drug Administration report states that “production capabilities for the Pinnacle metal-on-metal liners and femoral heads at the Leeds facility should be reviewed”
  
  
  
  
  
• June 2012
  
  
  Medicines and Healthcare Products Regulatory Agency guidelines say larger metal-on-metal hip implants should be checked for “life”, not just five years, with tests for metal particles in patients’ blood
  
  
  
  
  
• March 2013
  
  
  DePuy announces “discontinuation” of Pinnacle Ultamet device “because of low clinician use”