Gasp!: Surgeon/Designer Calls His Own Pelvic Mesh Device Garbage

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

Joanne McCarthy

4 Jul 2017, 12:04 p.m  FiDA highlight

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

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

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/

BREAKING NEWS! MDND reports $100M verdict

Jury Awards Plaintiff $100 Million in Boston Scientific Pelvic Mesh Trial

May 28th, 2015 | By Jane Akre (FiDA highlight)

$100 million in damages.

That is the amount a Delaware jury today awarded to mesh injured woman Deborah Barba. The amount includes $25 million in compensatory and $75 million in punitive damages, established to send a message to the company.

The 51-year-old from Newark, Delaware, sued manufacturer Boston Scientific for her permanent and serious injuries caused by the company’s Advantage Fit and Pinnacle transvaginal meshes.  She was implanted in 2009 and has suffered significant complications and endured two surgeries that did not fully remove the devices.

“While we are extremely pleased with this verdict and the relief we hope it will bring to the Barbas for Deborah’s unspeakable suffering, we also hope Boston Scientific and other mesh manufacturers take note of this verdict and resolve all pending cases swiftly. Deborah’s case will hopefully bring more awareness of mesh issues,s however, no woman and her loved ones should have to endure the stress of going to trial and baring their souls publicly to achieve justice,” said Barba’s attorney Fidelma Fitzpatrick of the Motley Rice law firm.

The jury found Boston Scientific was negligent in its design and manufacture of the Pinnacle and Advantage Fit devices and that the warnings were insufficient to unsuspecting doctors and their patients.

“I am thankful for the jury’s verdict and hope my story can help other women who are suffering from mesh complications to receive the resolution they deserve,” said Deborah Barba. “While difficult to share, I hope my case demonstrates to all mesh manufacturers the dangers of their products and the justice they owe victims.”

The case is Deborah Barba v. Boston Scientific Corporation, Superior Court of the State of Delaware in and for New Castle County, C.A. No. N11C-08-050 MMJ.

http://meshmedicaldevicenewsdesk.com/jury-awards-plaintiff-100-million-in-boston-scientific-pelvic-mesh-trial#comment-519041
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Boston Scientific Told to Pay $100 Million Over Mesh

Jeff Feeley, May 28, 2015  (FiDA highlight)

Boston Scientific Corp. must pay $100 million to a Delaware woman who blamed the company’s vaginal-mesh inserts for leaving her in constant pain and unable to have sex, in the first verdict after the company agreed to begin settling cases over the devices, and the biggest yet.

A state-court jury in Delaware found Thursday that Boston Scientific’s Pinnacle and Advantage Fit inserts, built to buttress sagging organs and treat incontinence in women, were defectively designed and company executives hid the flaws from Deborah Barba.

The 51-year-old former bank teller contends the inserts eroded once they were implanted, leaving her with a scarred vagina and a host of medical problems. The verdict is the largest so far against Boston Scientific over its vaginal-mesh inserts. It eclipsed a $73 million award last year to a Texas woman who blamed the company’s Obtryx sling for her injuries.

The jury also found Boston Scientific engaged in fraud by failing to alert doctors to the devices’ faulty design. It awarded $25 million in compensatory damages and hit the company with a $75 million punitive-damages award.

The vaginal-mesh verdict is also the first since Marlborough, Massachusetts-based Boston Scientific agreed last month to pay $119 million to resolve about 3,000 lawsuits over the devices in the first settlements of claims the inserts damaged women’s organs and made sexual intercourse painful.

Appeal Planned

Kelly Leadem, a Boston Scientific spokeswoman, said the company disputes the conclusion that the inserts were flawed and caused Barba’s injuries.

“We disagree with the jury’s finding and intend to appeal based on the strength of our evidence,” she said in an e-mail.

The verdict is surprising because it came in Delaware, the most corporate-friendly state in the nation, Erik Gordon, a professor at the University of Michigan’s business and law schools who teaches classes on how drugs and medical devices are developed and regulated, said by e-mail.

“Corporation-friendly Delaware juries rarely award punitive damages,” Gordon said. “A good portion of Delaware’s economy is driven by its business of domiciling most of the country’s largest corporations.”

Delaware, the corporate home to more than half of the U.S.’s publicly traded companies and 63 percent of Fortune 500 firms, had more than 1 million legal entities incorporated in the 900,000-resident state by 2012, officials said.

‘Loudly, Clearly’

“The jury spoke loudly and clearly that Boston Scientific’s defective devices injured Mrs. Barba and many other women and they should step and take responsibility for causing that harm,” said Fred Thompson, one of her lawyers.

The U.S. Food and Drug Administration ordered Boston Scientific, Johnson & Johnson and more than 30 other vaginal-implant makers in 2012 to study rates of organ damage and complications linked to the devices after the companies faced a wave of lawsuits over them.

Women such as Barba allege that inserts produced by Boston Scientific and other companies are made of substandard materials and shrink once they are implanted, causing organ damage and persistent pain. J&J moved in June 2012 to pull four lines of inserts off the market.

Many of the more than 70,000 mesh-insert cases have been consolidated before U.S. District Judge Joseph Goodwin in Charleston, West Virginia. Others have been filed in state courts in Delaware, New Jersey, Missouri, Texas and California.

Goodwin has been pushing manufacturers to consider settling the cases before they face billions in jury awards.

Settlement Talks

Boston Scientific, C.R. Bard Inc. and other makers of vaginal inserts had talks two years ago about creating a global settlement of cases over the devices, according to people familiar with the discussions. J&J, which refused to participate in 2013 settlement talks, has now begun to settle some cases.

While Boston Scientific and Bard couldn’t agree on an overarching settlement program, both companies have begun to settle some individual suits and some lawyers’ inventories of cases.

Boston Scientific agreed to pay the $119 million to resolve nearly 3,000 cases collected by a group of plaintiffs’ lawyers led by Houston litigator David Matthews in April. The settlement provided an average payout of about $40,000 per case.

The Delaware case is Barba v. Boston Scientific Corp., CA No. 11C-08-050-MMJ, Superior Court of Delaware (Wilmington).

http://www.bloomberg.com/news/articles/2015-05-28/boston-scientific-ordered-to-pay-100-million-over-vaginal-mesh