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.

Johnson & Johnson Pelvic Mesh: Sell, Sell, Sell !!!! Profit over Safety.

Court told how Johnson & Johnson conducted 'tidal wave of promotion'

By Hannah Sinclair

Nine years ago Gai Thompson had a mesh implant that she said changed her life forever.

“The mesh destroys lives, it destroys you physically and emotionally,” Ms Thompson told reporters outside the court in Sydney.

Ms Thompson is one of the seven hundred women involved in one of the country's largest product liability class actions, taking on Johnson & Johnson and its subsidiary Ethicon.

“Today is their chance to be heard and seek justice for what was lost,” Shine Lawyers’ Rebecca Jancauskas said.

“This is about accountability and ensuring this never happens again.”

The mesh is used to treat common complications after childbirth, such as prolapse and incontinence.

Shine’s Barrister Tony Bannon SC told the court many of the women now live in excruciating pain due to inflammation and infection.

Some are unable to work or be intimate with partners, meaning their "enjoyment of life had been seriously compromised and dramatically altered for the worse."

The court heard Johnson & Johnson conducted an aggressive "tidal wave of promotion" towards surgeons, spruiking the procedure without conducting appropriate clinical trials.

Lawyers for the claimants say removing the implant is near impossible and "is a highly complex, life threatening surgery. Even if removed the pain and disability will continue."

The court heard patients weren't properly advised of the risks involved with the surgery, and that if they were they never would have gone ahead with it.

More than 100,000 women have started legal action against the pharmaceutical giant in the US, the UK and Canada.

Some of the products involved in the suit are still available to purchase.

“There’s too many women who are injured,” implant victim Joanne Maninon said.

“The pain, the complication, the autoimmune diseases. It’s lifelong. You don’t just have the mesh removed and then recover and go on with life. You’re damaged for life.”

Johnson & Johnson says the products were developed in consultation with specialist surgeons and the majority of women had a positive result.

A statement from Johnson & Johnson said: “We have sold over 100,000 mesh products in the Australian market.

“We have been notified of fewer than 200 total product events. 67 of these product events were assessed as reportable to the TGA and Medsafe, in line with their requirements.

“It is always a concern to us when a patient doesn’t get the outcome they had hoped for, or believes they have experienced an adverse event.

“However it is important to remember that the majority of women who have undergone this surgery have had a positive result, and it has improved their quality of life.”

Their lawyers will give evidence next week.

http://www.sbs.com.au/news/article/2017/07/04/court-told-how-johnson-johnson-conducted-tidal-wave-promotion

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."

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

$73M verdict: Observations on Martha Salazar v Boston Scientific Obtryx Surgical Mesh Trial

The $73M (compensatory and punitive) Martha Salazar (MS) v. Boston Scientific (BS) Obtryx verdict is in.  The Dallas jury (Texas 95th District) that was mixed racially, by age and gender executed the highest civilian peacetime service.  The were aware that even with an appeal it is likely that their unanimous verdict on punitive damages will stand.  The 10-day trial ended Monday, September 8, was conducted by Judge Ken Molberg with great decorum and attention to Texas state law.  Each side had excellent lawyers who vigorously defended their rights.  The jury was spared the convoluted and weak logic of FDA involvement in implanted medical device clearance for the U.S. market. Judge Molberg and the plaintiff attorneys had recently 'done that dance' at the Linda Batiste v Ethicon surgical mesh trial that ended with a $1.2M verdict(compensatory) in May 2014 and it was agreed by both parties that FDA 510(k) blessing was meaningless.
Instead, talk was about standard of care and standards of the industry.  Boston Scientific reasoning was akin to "everyone else is doing it" and "we have all been doing it this way forever, so it is OK".  In light of the excellent presentation of the plaintiff Martha Salazar on the stand, I believe the jury found BS reasoning not credible particularly when the MSDS (material safety data sheet) from the manufacturer of the resin in 2004 warned that the product was not to be medically implanted in a human body.  Martha Salazar's injuries began with the implantation of the surgical mesh at the time of a hysterectomy for another medical reason.  Her SUI(stress urinary incontinence) was not a recurrent, serious or main complaint, but an afterthought.  She was not given adequate warning of the irreversibility, severity, permanence or cascade of harm she may encounter with the implantation:  the doctor was not informed.  The jury learned from BS internal 'discovery' documents presented by Salazar's attorneys showing that BS knew of the potential for these injuries and suppressed the information so that it was not in the DFU (directions for use).
The jury verdict reflects an elevated communal decision to send a strong and irrefutable message to businesses that would knowingly harm for profit.  Both compensatory and punitive verdict figures far exceed the estimates of the plaintiff expert life planner witness and her attorneys.

The next trial in Dallas is Figueroa v. Boston Scientific beginning October 6, 2014.

More references:
http://www.classaction.org/blog/boston-scientific-to-pay-73-million-what-next-for-tvm-suits