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Ethicon 6/4
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Boston Scientific Wants To Ax $34M Pelvic Mesh Judgment
Jun 3, 2015 | Law 360
By Jess Davis
Boston Scientific Corp. on Monday asked a Texas appeals court to throw out a $34.5 million judgment holding the company liable for making defective pelvic mesh, arguing because doctors adopted mesh as the standard of care, it cannot be negligent to have manufactured it. -
4th Circ. Told To Uphold $2M Bard Mesh Bellwether Verdict
Jun 3, 2015 | Law360
By Emily Field
A plaintiff who won a $2 million jury verdict against C.R. Bard Inc. in a bellwether trial over alleged defects in its vaginal mesh implants has asked the Fourth Circuit to uphold the verdict, saying that the lower court correctly excluded Federal Drug Administration regulatory evidence. -
Royston woman left in agony after surgery backs calls for procedure to be suspended
Jun 4, 2015 | Royston Crown
By Rebecca Day
A Royston woman is helping to launch a campaign calling for the suspension of a surgical procedure used to treat incontinence after it caused her agony. -
Pensioner joins campaign to ban operation after being left in 'intense' pain
Jun 4, 2015 | Surrey News
By Henry Brodkin
Kathleen Parrish, 70, had a TVT mesh implant and says she was not warned about the dangers nor that the device could not be safely removed -
*New* Canadian Class Action Certified Against AMS Pelvic Mesh Maker
Jun 3, 2015 | Mesh Medical Device News Desk
By Jane Akre
News out of Canada is that a class action lawsuit against American Medical Systems (AMS) has been certified clearing the way for defective product litigation and/or settlements. -
June: A Powerful Month for Empowered Women
Jun 3, 2015 | Mesh Medical Device News Desk
By Jane Akre
It appears women are the recipients of many sketchy medical devices that bypass any safety checks we assume are being conducted by the Food and Drug Administration before entering the market.
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Boston Scientific Wants To Ax $34M Pelvic Mesh Judgment
Jun 3, 2015 | Law 360
By Jess Davis
Boston Scientific Corp. on Monday asked a Texas appeals court to throw out a $34.5 million judgment holding the company liable for making defective pelvic mesh, arguing because doctors adopted mesh as the standard of care, it cannot be negligent to have manufactured it.
The company is arguing it’s entitled to a take-nothing judgment that would wipe out thedamages awarded to plaintiff Martha Salazar after a September 2014 trial because synthetic transvaginal slings like its Obtryx-brand device were the standard treatment for stress urinary incontinence. Calling Salazar’s case an “indictment of the medical judgment of the majority of practitioners in the field” who use the pelvic mesh devices in treatment, the company says there is no basis or evidence to hold it liable for manufacturing a device doctors sought out.
“If it is not negligent for a physician to use an Obtryx sling, can it possibly be negligent for Boston Scientific to have made or sold it? The answer is obviously, ‘No,’” Boston Scientific said in the brief.
A Dallas jury in September awarded Salazar what was at the time the largest verdict in any pelvic mesh trial, including about $23 million in compensatory damages and $50 million in punitive damages. But a trial judge slashed the punitives award the following month to about $11 million.
Boston Scientific argues the damages should be cut entirely because there was no showing of an alternative design for a sling that would reduce the risks to patients without posing additional risks or impairing the device’s utility. The company said it made adequate warnings about possible complications from using the device and argued the evidence of Salazar’s injuries isn’t linkable to the use of the Obtryx sling.
And it said even if compensatory damages are upheld, the punitive damages award should not be, arguing the evidence doesn’t support the jury’s gross negligence finding. Boston Scientific said it didn’t “commit an act with conscious disregard of an extreme risk,” but was producing and selling a medical device that doctors chose as the standard of care for the treatment of incontinence, and that the Obtryx device didn’t pose any special risk different from synthetic mid-urethral slings in general.
Boston Scientific also argued a jury may have found differently if the trial judge allowed the company to present evidence it complied with applicable federal regulations governing the design and marketing of the Obtryx device. It said it was unfairly barred from the statutory presumption of nonliability that products complying with regulatory standards are entitled to in Texas.
Salazar and her husband filed a medical malpractice suit in December 2012 against the doctor and hospital who implanted the sling, later adding Boston Scientific to the suit and dropping the other defendants. They alleged the mesh used in the Obtryx was designed with material “biologically incompatible with human tissue” and that it caused an immune response that degrades pelvic tissue and can contribute to a severe adverse reaction to the mesh.
The suit alleged Boston Scientific used aggressive marketing campaigns and paid valuable benefits to health care providers to promote use of the Obtryx sling and alleged its brochures and websites offered exaggerated and misleading expectations about the safety and utility of the pelvic mesh products.
In what was the first loss for Boston Scientific in litigation over its pelvic mesh products, the jury found there was a safer alternative design available for the Obtryx device and that it was unreasonably dangerous as marketed, and found unanimously that Boston Scientific had acted with gross negligence.
Lawyers for the parties did not immediately respond to requests for comment Wednesday.
Maria Salazar is represented by Tim Goss, Sheila Bossier and Tamara Banno of Freese & Goss PLLC; David Matthews and Julie Rhoades of Matthews & Associates; Richard Capshaw of Capshaw & Associates; and Peter de la Cerda and Kevin L. Edwards of Edwards & de la Cerda PLLC.
Boston Scientific is represented by Maria Karos and Vance Wittie of Sedgwick LLP.
The case is Boston Scientific Corp. v. Salazar, case number 05-14-01617-CV, in the Texas Court of Appeals for the Fifth District. -
4th Circ. Told To Uphold $2M Bard Mesh Bellwether Verdict
Jun 3, 2015 | Law360
By Emily Field
A plaintiff who won a $2 million jury verdict against C.R. Bard Inc. in a bellwether trial over alleged defects in its vaginal mesh implants has asked the Fourth Circuit to uphold the verdict, saying that the lower court correctly excluded Federal Drug Administration regulatory evidence.
Donna Cisson, to whom a West Virginia federal jury awarded $1.75 million in punitive damages and $250,000 in compensatory damages in August 2013, told the Fourth Circuit on Monday Bard’s argument that the court wrongly excluded evidence relating to an FDA rule requiring device makers to notify the agency 90 days before marketing a medical device rests on a faulty premise. She also asked the appeals panel to rule as unconstitutional a Georgia state law that requires prevailing product liability plaintiffs to pay 75 percent of their punitive damages to the state.
According to Cisson, Bard contends that the district court’s exclusion was based on a misunderstanding of the FDA’s process and argues that the process is designed to ensure that a medical device is safe and effective before it can be marketed
However, Bard’s argument itself rests on a misunderstanding “if not a misrepresentation” of that process, Cisson said in a nearly 100-page brief.
“It is precisely because the FDA never determined the safety or effectiveness of the Avaulta Plus, or any aspect of that device, that any argument or evidence related to this administrative process was properly found to be irrelevant, unfairly prejudicial, confusing, misleading, and a waste of trial time as the district court repeatedly ruled,” Cisson said.
The FDA doesn’t determine whether a medical device is safe under that process, Cisson said.
Furthermore, Bard hasn’t met its burden of showing that the district court abused its discretion under the federal rules of evidence, Cisson said.
Bard’s argument that a material safety data sheet that had accompanied the polypropylene resin material used to manufacture the Avaulta Plus should have been excluded as hearsay is also legally and factually flawed, Cisson said.
The sheet — which states that the material shouldn’t be used in permanent medical implants — isn’t hearsay because it was “offered for the truth of the matter asserted” and because Bard demonstrated during the trial that it believed that the statements on the sheet were true.
“Bard unequivocally manifested its knowledge that the medical safety data sheet prohibited the material’s use for permanent human implantation, and Bard admittedly knew that its use of the material was in direct contravention of this express prohibition,” Cisson said.
In fact, Bard’s witnesses admitted that the company had concealed that it was using the material in a medical implant from the material’s maker, Chevron Phillips Chemical Company LP, because Bard “‘knew’ Phillips would not allow the material to be used for permanent human implantation,” Cisson said.
Cisson also asked the appeals panel to overturn U.S. District Judge Joseph R. Goodwin’srefusal to find unconstitutional the provision in Georgia’s Tort Reform Act of 1987 that requires her to pay 75 percent of the punitive damages award to the state treasury, saying that he failed to consider a federal decision in McBride v. GMC that found that provision unconstitutional.
“Once the Georgia legislature created in the plaintiffs a property right to a punitive damages award by codification of punitive damages at [the provision], the plaintiffs could not constitutionally be deprived of that right without due process of law or just compensation without violating the takings clause of the U.S. Constitution,” Cisson said.
The case was the first jury trial within the seven multidistrict litigations assigned to the judge concerning the use of transvaginal surgical mesh to treat pelvic organ prolapse and stress urinary incontinence.
Cisson claimed she experienced “significant mental and physical pain and suffering” after being implanted in May 2009 with the Avaulta Plus Posterior Biosynthetic Support System manufactured by Bard to treat pelvic organ prolapse.
Representatives for the parties didn’t immediately respond to requests for comment on Wednesday.
Cisson is represented by Anthony J. Majestro of Powell & Majestro PLLC, Allison Van Laningham of Turning Point Litigation and Henry G. Garrard III and Josh B. Wages ofBlasingame Burch Garrard & Ashley PC.
Bard is represented by Lori G. Cohen, Brigid F. Cech Samole, Elliot H. Scherker Jay, Andrew Yagoda and Sean Jessee of Greenberg Traurig LLP.
The case is Cisson v. C. R. Bard Inc., case number 15-1102 in the U.S. Court of Appeals for the Fourth Circuit. -
Royston woman left in agony after surgery backs calls for procedure to be suspended
Jun 4, 2015 | Royston Crown
By Rebecca Day
Kath Sansom has launched a campaign against a gynaecology operation in which a TVT sling is used.
A Royston woman is helping to launch a campaign calling for the suspension of a surgical procedure used to treat incontinence after it caused her agony.
Three years ago Ann Cook had the TVT mesh operation, in which a mesh tape made of the same plastic used in drinks bottles is put under the urethra to keep it in place.
After six weeks the mesh knits into the live tissue, making it tricky to remove.
The 60-year-old, who had been suffering stress incontinence, said: “It was described as such a simple operation, day surgery with little or no complications, so I went for it.”
But the mesh has caused extreme stomach cramps, pain down her legs and constant urinary tract infections.
She said: “It was horrible. I couldn’t stand up straight and was doubled over.
“I am a strong woman but this stopped me in my tracks.”
Ann is not alone – in the USA about 100,000 lawsuits have been filed by women who have suffered permanent disabilities as a result of the operation and 40 per cent of women suffer from erosion of mesh
Thankfully Ann had her sling mesh removed last year, and had an alternative operation to fix the incontinence problem.
Stress incontinence issues are often caused by natural childbirth, especially if women have had big babies.
The campaign will be launched tomorrow by Cambs Times journalist Kath Sansom who said having the operation herself made her feel like the ‘unwilling victim of a cruel experiment that has gone horribly wrong’.
The mum-of-two said: “My legs and pelvic area feel like they are full of cut glass. I have gone from a super fit 47-year-old to a physical wreck who can just about walk my dog round the park.”
The operation was banned in Scotland last year and Kath, along with 12 other mums, is calling on the procedure to be suspended in England and Wales, too.
In the meantime, she is calling on health experts to fully outline all of the risks to patients, as she too was led to believe it would be a simple and harmless operation.
She said: “I was not told that I may suffer horrible leg and pelvic pains or that I would feel like I was being cut by cheese wire inside my body. I was not told that this was a permanent device.
“I have bad days and good days but if I walk too far – about 15 minutes – sit for too long or try to do too much, the pain kicks in.”
Although many surgeons can put in the mesh, only two surgeons in the UK can take it out.
Kath has been lucky enough to arrange an operation with one of the surgeons later this year, but is concerned for the welfare of those who have not.
Her campaign is also calling on the government to introduce tighter legislation on the introduction of new medical devises.
The TVT mesh is one of many devices – including hip implants, cochlea implants and PIP breast implants – that campaigners say are too easily approved.
In January a team of undercover Oxford scientists took a piece of fruit netting used to package oranges to a regulatory body in Austria to prove how lax the system is, and were on the brink of getting approval for it.
To find out more about the Sling the Mesh campaign, visit Kath’s blog at slingthemesh.wordpress.com.
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Pensioner joins campaign to ban operation after being left in 'intense' pain
Jun 4, 2015 | Surrey News
By Henry Brodkin
Kathleen Parrish, 70, had a TVT mesh implant and says she was not warned about the dangers nor that the device could not be safely removed
Kathleen Parrish, of Tongham, is suffering constant pain after a mesh implant operation
A Tongham woman who has suffered years of debilitating pain since undergoing a controversial procedure for incontinence has joined a campaign to outlaw the operation.
Kathleen Parrish has added her voice to a chorus of furious patients who say they were not forewarned about the dangers of having a TVT mesh implant, nor that the device could not be safely removed.
The 70-year-old Carfax Road resident travelled to London's Chelsea and Westminster Hospital in 2003, hoping the operation would solve her condition.
Instead, 14 months after the procedure, she began experiencing intense groin, back and leg pains, which have now grown so bad she can hardly walk.
She is now calling for such operations to be banned and wants to see the creation of a national register of mesh implant failures.
“I trusted what the surgeon said,” she told the News & Mail. “I thought it was going to make everything better.
“I had no idea that once this TVT mesh was put in it couldn’t be removed. They should be telling women that.
“If a surgeon cannot take it out if there are problems then they shouldn’t be putting it in.”
The divorced pensioner’s operation started more than a decade-long effort to persuade doctors to believe just how much agony she was suffering.
The procedure was banned by a Scottish health board last year due to concerns over its safety, and the European Commission is expected to release the findings of an investigation into the treatment this month.
Campaign group Sling The Mesh says the operation is ruining women’s lives and poses an ‘unacceptable risk’ for patients.
Ms Parrish's efforts to get effective remedial treatment have not been helped by the loss of her surgical notes by Chelsea and Westminster Hospital, which told her they went up in flames in 2006 during the Iron Mountain warehouse fire, where they were being stored.
The former Royal Aircraft Establishment employee, who has two daughters, believes she has now found a London-based doctor with the skills to safely remove the mesh, but says she is in too much pain to make the trip up to town.
“It feels very sharp, like something sticking into me," she said.
“It's a job for me to put my legs on the ground.”
Frimley Park Hospital said it had no record of Ms Parrish making a complaint about her consultation with Dr Cockburn, but urged her to get in touch with any concerns.
Chelsea and Westminster Hospital declined to comment
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*New* Canadian Class Action Certified Against AMS Pelvic Mesh Maker
Jun 3, 2015 | Mesh Medical Device News Desk
By Jane Akre
News out of Canada is that a class action lawsuit against American Medical Systems (AMS) has been certified clearing the way for defective product litigation and/or settlements.
The action affects potentially thousands of women in Canada, says attorney Daniel Bach of Siskinds LLP law firm of Toronto.
The certification means Siskinds will represent everyone in the class unless a woman chooses to opt out and pursue her own litigation. The settlements from AMS so far offered to women in the states do not include Canadian women.
Bach explains a Canadian class action process has similarities to the U.S. multi-district litigation system but allows “common issues” about the safety of mesh products to be determined at once, for all women implanted with AMS mesh, at a “common issue trial.” Damages in a class action, if it is successful at trial or settles, are generally awarded based on the degree of injury of each class member.
The court will be looking to try issues common to every member of the class focused on the conduct of the defendant – Is the mesh dangerous? And did AMS breach its duty of care when it marketed and designed the mesh?
“If we were to win at trial on those questions, every woman who has AMS mesh would have to come forward and say ‘I have an Apogee,’ for example, ‘and this many surgeries.’ It’s like a truncated trial because the common issues are already determined and bind every member of the class, and AMS.”~ Daniel Bach
The competency of the doctor could be an issue that could be tried separately. Trials could be years away, says Bach.
The Canadian system of justice rarely sees monumental jury awards such as the $100 million in damages recently awarded Deborah Barba in her Delaware trial naming Boston Scientific.“Awards for punitive damages in Canadian courts tend to be lower,” says Bach. Another difference is that damages across the board for defective medical devices or even car accidents generally range lower because Canada offers its citizens universal healthcare. In that case, the government may seek reimbursement from a defective mesh maker. Bach adds that generally the money is in addition to the plaintiffs’ claim so it will not further harm her.
On February 10, 2010, Health Canada issued a Notice to Hospitals relaying reports of various intraoperative and postoperative complications associated with the use of surgical mesh to treat SUI and POP. A second notice followed May 13, 2014 from Health Canada advising that “although many women treated with these devices have had good outcomes, Health Canada continues to receive reports of complications, including some serious and life-altering events, associated with the use of these surgical devices.” Regardless of the device in question, the use of transvaginal surgical mesh has been associated with severe side-effects.
The class actions relate to allegations that the defendants failed to adequately warn patients and physicians that use of transvaginal mesh increases the risk of serious injuries and complications.
Siskinds represents women in Canada who have had a transvaginal mesh implant to treat SUI or POP. Siskinds is also litigating mesh class actions against Johnson & Johnson, Boston Scientific, Coloplast and Covidien. #
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June: A Powerful Month for Empowered Women
Jun 3, 2015 | Mesh Medical Device News Desk
By Jane Akre
Welcome to Mesh Medical Device News Desk – a resource for news and information on this dark chapter in women’s health. It appears women are the recipients of many sketchy medical devices that bypass any safety checks we assume are being conducted by the Food and Drug Administration before entering the market.
That is a faulty assumption. If you are to be implanted with a medical device in the U.S. first ask- Was it approved under the FDA’s antiquated safety loophole- the 510(k)? If so, know you are part of the great experiment that will test its efficacy and safety in patients, not in clinical trials prior to marketing.
That’s what’s happened to hundreds of thousands of unsuspecting women not only in the States but around the world. There have been so many complications reported, that even the FDA had to admit in 2012 that complications are “not rare” and that a mesh implant to treat prolapse and incontinence might not be a first-line treatment.
Still it is used. And most meshes remain on the market.
The dissatisfaction with this loophole in the patient safety net is enough to bring out women in protest this June 2, as lawyers from both sides converged for a status hearing on the 80,000 or so lawsuits consolidated in federal court in Charleston, WV. While there were no solutions announced, the women tell MND the sisterhood felt among the women present was amazing and made them feel as though their voices do matter. They do. Manufacturers do not like to see powerful women they’ve harmed up close I’ve observed in the courtroom when mesh-injured watch the proceedings.
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