J&J Pelvic Mesh Inventor: Dr. Bernard Jacquetin email exposed in court document.

“I would not want my wife to undergo this procedure”: pelvic mesh inventor

Joanne McCarthy

4 Jul 2017, 12:04 p.m

LANDMARK CASE: Gai Thompson, lawyer Rebecca Jancauskas and Jo Manion outside the federal court on Tuesday. Picture: Joanne McCarthy

A FRENCH doctor who invented a Johnson & Johnson pelvic mesh device told another doctor in 2005 that "I would not want my wife to undergo this procedure", the federal court in Sydney was told today.

Dr Bernard Jacquetin made the comment in an email to another doctor in the same year his Johnson & Johnson Prolift device was cleared for use in Australia.

The comment, revealed in a Johnson & Johnson internal document on the first day of a landmark class action by more than 700 Australian women, drew gasps from some of the women sitting in the public gallery at the federal court.

Tony Bannon SC, for the women, told Justice Anna Katzmann that Dr Jacquetin, who was part of a Johnson & Johnson transvaginal mesh evaulation team, concluded his comment about not wanting to have his wife to have a mesh procedure by saying "and I don't think I'm alone in that".

Mr Bannon told the court the comments' message was "those of us who were in the know".

"Once one understands what is really involved with this you wouldn't want your wife, your sister, your mother to undergo this, except in extreme circumstances," Mr Bannon said.

The landmark case, which has attracted international media attention, is expected to take six months.

Mr Bannon told the court each of the 700 women had suffered continuous, frequent and often unbearable pain.

"Their enjoyment of life has been seriously compromised,” he said.

"Their lives have been dramatically altered for the worse.”

Up to 100,000 Johnson & Johnson pelvic mesh devices for incontinence or pelvic organ prolapse were implanted in Australian women.

The three lead complainants in the case were seeking substantial damages in the hundreds of thousands of dollars, Mr Bannon told the court.

The court heard evidence from another internal Johnson & Johnson document from May 2010 which described the kind of doctor the mesh devices were aimed at.

They were doctors who could "do" a Johnson & Johnson TVT mesh device in eight minutes.

Johnson & Johnson envisaged these doctor-clients as the kind who would see the devices helping enhance their reputations and revenues.

They were more likely "mid-career doctors" who saw their practices as businesses.

The court heard the internal Johnson & Johnson document pictured doctors who would use the product as the type who would also enjoy holidays in St Moritz and Lamborghinis.

The document quoted one of the imagined doctor-clients as saying "that makes four (mesh surgeries) before lunch, that works for me".

Mr Bannon told the court the document exhibited the internal approach of Johnson & Johnson to the mesh devices.

He said there was a valuable market to be gained out there by emphasising the speed of the mesh surgery.

The court will also hear of the lack of evidence supporting the safety and efficacy of pelvic mesh devices.

One of the women implanted with a pelvic mesh device, Jo Manion, left the courtroom after Mr Bannon read the internal Johnson & Johnson documents.

Ms Manion was visibly upset through some of the evidence.

The hearing continues.

http://www.theherald.com.au/story/4769832/i-would-not-want-my-wife-to-undergo-this-procedure-pelvic-mesh-inventor/?cs=305

Billion: That is $2.5 billion !!! Settlement is not justice for harmed patients!

DePuy to pay $2.5 billion for hips

Warsaw firm to settle thousands of implant lawsuits

Paul Wyche | The Journal Gazette  Published: May 31, 2014 3:00 a.m.

DePuy Orthopaedics, a unit of Johnson & Johnson, has waived its “walk-away rights,” which means the Warsaw company agrees to pay more than $2.5 billion to settle thousands of hip implant lawsuits, court documents show.

Officials at the medical device company have decided that enough plaintiffs exist to proceed with the settlement, according to paperwork filed last week with the U.S. District Court for the Northern District of Ohio in Toledo.

“While Settlement Program enrollment forms are still being processed, most (eligible) patients have opted into the program,” court documents stated.

“The company is, therefore, moving forward before the June 1 decision deadline provided for in the Agreement. The exact timing and amount of compensation will depend on a number of factors and circumstances specific to each claim,” the documents continued.

“However, eligible patients with allowed claims can expect payment now that there is certainty the program is moving forward,” the court papers said.

In November, the parent company agreed to pay plaintiffs who received the DePuy-made ASR hip implants.

The settlement gives money to patients based on several factors, including age, extent of injuries and whether they had to replace the defective implant. That agreement set the base rate at $250,000 per patient.

The DePuy ASR recall was announced in August 2010 after post-market data indicated that 12 percent to 13 percent of recipients required revision surgery within five years, according to Bernstein Liebhard, a New York law firm offering free legal evaluations to patients.

Attorneys with Bernstein Liebhard said that by the time the recall was announced, nearly 100,000 people worldwide had received the devices. Evidence revealed during DePuy ASR lawsuit trials indicated that the implant’s actual failure rate may be closer to 5 percent.

Other circumstances could entitle plaintiffs to a supplemental award if, for example, they required multiple revision surgeries, or if they experience “certain extraordinary injuries” in the future, attorneys said.

“DePuy remains committed to the well-being of ASR patients, as demonstrated by the worldwide voluntary recall and the global Broadspire program providing support for recall-related care,” said Mindy Tinsley, a DePuy spokeswoman, in an email Friday.

Broadspire is an independent, third-party claims processor available to patients not eligible for the U.S. Settlement Program, DePuy said.

pwyche@jg.net

$3B on failed hips offset by Celebrity Shill?

 To object to direct-to-consumer marketing of implanted medical devices:
Deborah A. Wolf, JD
Regulatory Counsel-Office of Compliance, CDRH
U.S. Food and Drug Administration
301.796.5732   deborah.wolf@fda.hhs.gov
10903 New Hampshire Avenue
Silver Spring, MD 20993





9/18/2013 Norman, OK
"Coach Barry Switzer talks about his personal touchdown in the game against hip pain and his innovative hip replacement surgery."     click on link to see flyer for invitation



J&J Said to Weigh $3 BillionSettlement of Its Hip Implant Cases

By Jef Feeley & David Voreacos - Aug 20, 2013 11:00 PM CT  Bloomberg

FiDA highlight added

Johnson & Johnson (JNJ), the world’s biggest seller of health-care products, has discussed paying more than $3 billion to settle lawsuits over its recalled hip implants, according to five people familiar with the matter.

J&J seeks to resolve as many as 11,500 lawsuits in the U.S. and has considered paying more than $300,000 per case, according to the people. Such a settlement would exceed $3 billion if most plaintiffs accept the terms, an amount 50 percent larger than that proposed in previous discussions.

Enlarge image

Michael Kelly, attorney for plaintiff Loren Kransky, holds up an ASR XL hip implant made by Johnson & Johnson during his opening statement to the jury at the trial of Kransky v. DePuy, at the California Superior Court in Los Angeles, on Jan. 25, 2013. Photographer: Patrick T. Fallon/Bloomberg

A $3 billion settlement would dwarf a 2001 accord Sulzer (SUN) AG reached with patients who claimed that company’s hip and knee implants were defective. Sulzer, a Winterthur, Switzerland-based pump maker, agreed to pay $1 billion to resolve those suits, then the largest settlement involving hip implants.

Any accord would be affected by the outcome of seven product-liability trials between September and January, according to the people, who aren’t authorized to make the negotiations public.

“It’s going to be a fascinating case to watch settle because of the level of complexity of the injuries and the amount of money that will be involved,” said Bruce Cranner, a medical device defense lawyer not involved in the case. “You don’t see a lot of mass-tort implant cases settle for a substantial amount of money.”

Replacement Surgeries

The company is pushing to resolve U.S. cases by early next year, according to the people. J&J’s DePuy unit recalled 93,000 implants in 2010, including 37,000 in the U.S., after more than 12 percent failed within five years. That rate is climbing, along with suits by patients blaming the chromium and cobalt devices for pain, metal debris and replacement surgeries.

J&J, based in New Brunswick, New Jersey, has spent about $993 million on medical costs and informing patients and surgeons about the ASR recall, Lorie Gawreluk, a spokeswoman for DePuy, said in an e-mail. J&J set aside an undisclosed amount for litigation, which it increased before June 30, she said.

“The company also continues to support ASR patients with a reimbursement program to address recall-related testing and treatment costs,” she said. “Reports about a possible resolution of the litigation are premature and speculative, including any estimates of resolution amounts.”

Steven Skikos, a plaintiffs’ lawyer leading efforts to prepare lawsuits against DePuy, said his group is preparing for jury trials, which include the first case in federal court.

‘Dangerous Guess’

“With the trials rapidly approaching, and our continuing efforts to obtain more information and data about the patients, it’s easy to speculate about settlement,” Skikos said in an e-mail. “However, any comment relating to settlement that does not come from the plaintiff’s leadership, the court, or from the company itself remains premature, uninformed and a dangerous guess.”

J&J lost an $8.3 million verdict in the first trial over the ASR device and won the second. In the first case, a California jury in March awarded damages to a retired Montana prison guard. The panel also ruled the device was defectively designed, that DePuy properly warned of the risks, and that the company didn’t owe punitive damages. DePuy is appealing.

A Chicago jury ruled six weeks later for DePuy in rejecting a defective design claim by an Illinois nurse.

Other Trials

Seven other trials of lawsuits by plaintiffs blaming the ASR hips for injuries will help lawyers for both sides frame questions over liability and damages. The first is scheduled to begin Sept. 9 in federal court in Cleveland. U.S. District Judge David Katz is overseeing that lawsuit by Ann McCracken, 58, a resident of Rochester, New York, who needed two replacement surgeries known as revisions after her ASR implant.

Katz is overseeing about 8,000 federal cases consolidated before him for the pre-trial collection of evidence. About 2,000 cases are pending in the California Judicial Council Coordinated Proceeding before Judge Richard Kramer in San Francisco.

Trials also are scheduled in state courts in San Francisco in October; in Hackensack, New Jersey, in October and January; in West Palm Beach, Florida, in November; in Chicago in December; and in Los Angeles in January.

“DePuy believes the evidence to be presented at trial will show the company acted appropriately and responsibly,” Gawreluk said. “The ASR hip system was properly designed, physicians were properly informed of the product’s risks, and DePuy’s actions concerning the product were appropriate.”

Broad Outline

Lawyers for hip recipients are still reviewing more than 50 million pages of J&J documents and conducting pre-trial interviews of company officials and experts to prepare for those cases, Skikos said.

While settlement talks continue, J&J and lawyers for hip claimants have agreed on the broad outline of a so-called “global settlement” covering all U.S. cases, the people said.

In January, five people familiar with the talks had said J&J officials were willing to pay about $2 billion to resolve the cases. Lawyers for plaintiffs rejected that amount as too little, the people said.

Any overall accord would compensate patients based on such factors as age, extent of injuries and whether they had one or more surgeries to replace defective implants, according to the people. Negotiators would likely rank those and other factors on a matrix or grid, the people said.

“J&J’s strategy will be to find a way to negotiate a grid to settle each of the claims based on five or six variables that could be plugged in and changed up or down to determine the value of any claim,” said Cranner, a lawyer with the New Orleans-based law firm of Frilot LLC. He is past chairman of the Medical Liability and Health Care Law Committee of DRI, an organization of lawyers who represent corporations and insurers.

Obstacles Remain

Several obstacles to a final settlement still must be overcome, the people said. One includes the number of years that J&J may potentially have to pay future claims. Another is whether the settlement would include reimbursing Medicare for claims paid. A third is the amount of compensation for extreme medical cases, which include dual hip surgeries or cases where infection prompted long hospital stays, the people added.

“There are a significant subset of clients who got very badly hurt by the device, and their injuries are much more than a simple revision,” said Matthew Davis, a lawyer at Walkup Melodia Kelly & Schoenberger in San Francisco whose firm represents 270 ASR clients.

“If those cases went to trial and there was a finding of liability, a jury would award them general damages in the seven figures,” said Davis, who isn’t involved in the negotiations.

Alloy Used

The J&J hips were made from a cobalt-and-chromium alloy used in two related models -- the ASR XL Acetabular System, and the ASR Hip Resurfacing System. In announcing its recall, J&J cited unpublished data from the U.K. showing that within five years, 13 percent of ASR XL hips failed and needed revisions, and 12 percent of the ASR Hip Resurfacing System failed.

At the first trial in Los Angeles, lawyers for plaintiff Loren Kransky argued DePuy failed to test the device adequately before selling it in the U.S. in 2005, buried surgeon complaints of mounting failures, and studied a redesign of the ASR before scrapping that effort in 2008.

Lawyers for patients claim that debris from the metal ball sliding against the metal cup causes tissue death around the joint and may increase the amount of metal ions in the bloodstream to harmful levels.

J&J set up a help line for patients that is “available in dozens of countries and has served tens of thousands of callers,” Gawreluk said. J&J runs a worldwide reimbursement program resulting in “thousands of payments to patients for testing and treatment of other out-of-pocket expenses.”

The McCracken DePuy case is McCracken v. DePuy, 11-dp-20485, U.S. District Court, Northern District of Ohio (Toledo). The consolidated federal case is In re DePuy Orthopedics Inc., ASR Hip Implant Products Liability Litigation, 10-MD-2197, U.S. District Court, Northern District of Ohio (Toledo).

To contact the reporters on this story: Jef Feeley in Wilmington, Delaware, at jfeeley@bloomberg.net; David Voreacos in Newark, New Jersey, at dvoreacos@bloomberg.net.

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

Failed Surgical Mesh producer C.R. Bard guilty.

BardLoses $250,000 Verdict in Vaginal-Mesh Implant Trial

By Jef Feeley & Phil Milford - Aug 15, 2013 2:51 PM CT

            C.R. Bard Inc. (BCR) should pay $250,000 to a woman who sued saying she suffered injuries from the company’s vaginal-mesh implant, a jury found.

The first federal-court trial of more than 5,000 claims over the devices now moves to the punitive-damages phase in Charleston, West Virginia.

Jurors deliberated about 12 hours over two days before finding Murray Hill, New Jersey-based Bard liable today for injuries that Donna Cisson blamed on its Avaulta line of devices.

Patients claim the implants cause organ damage and make sexual intercourse painful when they erode. Johnson & Johnson (JNJ), Endo Health Solutions Inc. (ENDP)-formerly American Medical Systems- and Boston Scientific Corp. (BSX) face similar claims that their implants, threaded in place through incisions, degrade and shrink over time.

Cisson’s first trial, in July, ended in a mistrial after a witness began testifying about the devices’ marketing and removal from the market. U.S. District Judge Joseph Goodwin ruled earlier that plaintiffs couldn’t mention that Bard had withdrawn the products.

Scott Lowry, a Bard spokesman, wasn’t immediately available at his New Jersey office to comment on the verdict.

The Bard consolidated cases are In re C.R. Bard Inc. Pelvic Repair System Products Liability Litigation, 10-md-02187, and Cisson’s case is Cisson v. C.R. Bard Inc., 11-cv-00195, U.S. District Court, Southern District of West Virginia (Charleston).

To contact the reporters on this story: Jef Feeley in federal court in Charleston, West Virginia, at jfeeley@bloomberg.net; Phil Milford in Wilmington, Delaware, at pmilford@bloomberg.net.

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

Failed Hip Implant: $8.3 million award to plaintiff

J.&J. Loses First Case Over Faulty HipImplant

By BARRY MEIER

Published: March 8, 2013

                                   

A jury in Los Angeles on Friday ordered Johnson & Johnson to pay more than $8.3 million in damages to a Montana man in the first of more than 10,000 lawsuits pending against the medical products maker in connection with a now-recalled artificial hip.

The 12-member panel, however, declined to issue punitive damages, saying the company’s DePuy orthopedics unit, which made and marketed the all-metal device, did not act with fraud or malice. The implant, known as the Articular Surface Replacement, or A.S.R., was recalled in mid-2010.

In a statement, the company described the verdict as “mixed” and said that it planned to appeal the damage award. It disputed the finding by the jury that the A.S.R. was defectively designed.

It was impossible to say what the verdict, which came in a Los Angeles state court, would mean for other A.S.R.-related cases. A trial on a second lawsuit is scheduled to begin Monday in Chicago, with other cases expected to proceed later this year.

In its decision, the panel ordered Johnson & Johnson to pay the case’s plaintiff, a retired Montana prison guard, Loren Kransky, $338,000 to cover his medical expenses. It also ordered him to be paid $8 million to cover his pain and emotional suffering.

Some lawyers and industry analysts have estimated that the suits ultimately would cost Johnson & Johnson billions of dollars to resolve.

Thousands of the individual cases have been consolidated into a large proceeding in a Federal District Court in Ohio and a resolution of that action could provide a framework for settling the bulk of the cases and determining awards to patients.

The A.S.R. belonged to a class of once widely used hip replacements whose cup and ball components were both made of metal.

It was first sold by DePuy in 2003 outside the United States for use in an alternative hip replacement procedure called resurfacing. Two years later, DePuy started selling another version of the A.S.R. for use in the United States in standard hip replacements that used the same cup component as the resurfacing device.

However, the A.S.R.’s design caused the cup and ball to strike against each other as a patient moved, resulting in the shedding of metallic debris. That debris inflamed and damaged tissue and bone, causing pain and, in some cases, permanent injuries to patients.

Today, all-metal hips like the A.S.R. are rarely used by surgeons because most models suffered from similar problems. But data from orthopedic registries suggests that the A.S.R. was far worse than many competing products.

An internal Johnson & Johnson document introduced at the Los Angeles trial estimated that close to 40 percent of patients who received an A.S.R. will need to undergo a second operation within five years of the first to have the implant removed and replaced. In a recent filing with the Securities and Exchange Commission, Johnson & Johnson said that there are 10,750 A.S.R. lawsuits.

Traditional artificial hips, which are made of metal and plastic, are expected to last 15 years or more before needing to be replaced, and the normal replacement rate for early unexpected failures is about 5 percent after five years.

The lawsuit heard in Los Angeles was not originally scheduled to be the first over the A.S.R. but it was moved up because Mr. Kransky was found to have terminal cancer. Before the start of the Los Angeles trial, which began in late January, Mr. Kransky’s lawyers had not expected him to live through it.

Internal Johnson & Johnson documents that became public during the trial indicated that company executives were told by surgeons, who were also paid consultants to the device maker, that the design of A.S.R. was flawed. In addition, some surgeons also urged the device maker to slow sales of the implant or stop them completely, records show.

In the case, evidence was also presented that showed that Johnson & Johnson considered redesigning the A.S.R. to reduce its problems, but then abandoned the project because the implant’s sales did not justify the costs of the redesign. One of the DePuy executives involved in that decision was Andrew Ekdahl, who now heads Johnson & Johnson’s orthopedics division.

Johnson & Johnson executives like Mr. Ekdahl have said throughout the A.S.R. episode that they acted responsibly and moved to recall the device in 2010 when data from an orthopedic registry in Britain showed that its failure rate was higher than normal.

Before reaching its verdict Friday, the jury that heard Mr. Kransky’s case deliberated for more than five days. Mr. Kransky’s lawyers, citing what they described as the unethical behavior of DePuy executives in failing to warn doctors and patients of the device’s defects, asked jurors to punish Johnson & Johnson by awarding their client $36 million to $144 million. Jurors declined to do so.

Nonetheless, lawyers representing Mr. Kransky hailed the verdict.

“This is a victory for Mr. Kransky and thousands of other badly damaged A.S.R. patients who have yet to get their day in court,” Brian Panish, one of Mr. Kransky’s lawyers, said in a statement. “Jurors across the country will return similar verdicts until J.&J. takes full responsibility.”

A DePuy spokeswoman, Lorie Gawreluk, said in the company’s statement that it planned to appeal Friday’s verdict, contending that the A.S.R.’s design was not defective.