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Boston Scientific, Bard Beat $28M Pelvic Mesh Defect Suit
Feb 2, 2016 | Law360
By Brandon Lowrey
A Missouri state jury on Tuesday found Boston Scientific and C.R. Bard not liable in a woman's $28 million suit alleging the companies' pelvic mesh implants rendered her incontinent and suffering from pain and other ailments. -
Boston Scientific, CR Bard Mesh Not Defective Find Jurors in Kansas City Pelvic Mesh Trial
Feb 2, 2016 | Mesh Medical Device News Desk
By Jane Akre
In its second day of deliberations, jurors in the only pelvic mesh trial to name two defendant manufacturers in the same action, handed defendants Boston Scientific and CR Bard a victory in a Kansas City, Missouri product liability trial.
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Boston Scientific, Bard Beat $28M Pelvic Mesh Defect Suit
Feb 2, 2016 | Law360
By Brandon Lowrey
A Missouri state jury on Tuesday found Boston Scientific and C.R. Bard not liable in a woman's $28 million suit alleging the companies' pelvic mesh implants rendered her incontinent and suffering from pain and other ailments.
The two-month trial centered on Boston Scientific's Solyx device and Bard's Align device. Plaintiff Eve Sherrer claimed that the devices were defective and caused a litany of problems for her, including pain, difficulty walking and a "nonfunctional vagina."
The defendants argued that the implants are safe and effective, and that other issues, including doctor error, past surgeries and medical problems, caused Sherrer's problems.
Sherrer had sought $28 million in compensatory damages from Boston Scientific and Bard, including $10 million for past injuries and $18 million for future injury. She also sought punitive damages.
Sherrer's attorney Thomas Philip Cartmell of Wagstaff & Cartmell LLP told jurors duringclosing arguments Monday that mesh implanted into her pelvic region became scar-plated, causing it to shrink and contract and become rigid, creating a dangerous and painful condition.
"That's not supposed to happen," he said. "Nobody disagrees with that. They never brought an expert witness in here, neither Bard nor Boston, to say, 'Oh, this is normal. It won't hurt a lady,' ... They all admitted that that is a dangerous condition, and that is what came out of Ms. Sherrer's pelvis."
Sherrer's attorneys told jurors during the trial that the Marlex-brand mesh in both devices wasn't medical grade, and that the devices caused pain and were prone to failing and shifting inside the body. The mesh was not designed or intended for permanent implantation, they said.
That fact prompted the mesh manufacturer to refuse to extend its contract with Boston Scientific for use with medical devices, he said. But Boston Scientific cut a deal in which it would buy 10 years' worth of the Marlex mesh at once and would release the manufacturer from liability, Sherrer's attorneys told jurors.
The U.S. Food and Drug Administration had expressed concern over potential safety risks with the product in a so-called 522 order, which demanded that Boston Scientific must conduct a post-market surveillance study.
Cartmell told jurors during opening arguments at the beginning of December that medical device companies, in a race to profit, used mesh designed for abdominal applications for the vagina without testing, despite the fact that the tissue areas are vastly different.
The Marlex mesh destabilized and degraded inside the body because it wasn't intended for medical use, he said.
"This is polypropylene that is supposed to be used for carpet backing. It's supposed to be used for ropes and cords," Cartmell said. "It's not medical-grade polypropylene that they decided to use."
Bard, he said, set up intermediary companies to buy the Marlex resin directly from its manufacturer, Chevron Phillips Chemical, while intentionally keeping it a secret from Chevron Phillips that the materials would be used in medical implants.
Sherrer received her Solyx implant in October 2010. The implant was partially removed, and an Align device implanted in January 2011. Pieces of both devices were removed in April 2014, and she had an additional surgery in August.
The defendants argued that the implants are safe and still on the market today, and that the problems were caused by other factors.
Bard attorney Lori Cohen of Greenberg Traurig LLP said that the company fully complied with FDA standards, and that its device remains the "gold standard" treatment for stress urinary incontinence. The device worked and benefited the patient until a doctor needlessly removed the Align and caused more damage, she said.
She also added that Sherrer had other pelvic floor surgeries dating back to 1997. More surgeries mean more scarring and potential for problems, Cohen said.
Cohen also pointed to Sherrer's other past medical issues, including severe osteoarthritis and degenerative disc disease, among others, as alternative causes for her alleged injuries.
Cohen said Marlex mesh has been implanted into patients for more than five decades, with great success and benefits to patients. The raw materials are also not the same as end-product mesh, she said.
In addition, Bard warned Sherrer's doctor, who, in turn, warned Sherrer, about possible risks of the Align implant, Cohen said.
On Monday, Cohen contended that Sherrer failed to follow her doctors' recommendations, and that the plaintiff's allegation that the product degraded over time fails because the only problematic mesh was implanted 18 years ago and was not Bard's or Boston Scientific's.
Following the verdict on Tuesday, Cohen told Law360 that she and her client are pleased with the total defense verdict.
"This jury obviously over the course [of the trial] reviewed all of the extensive science, data and literature and came to the right conclusion based on all of that," she said.
Sherrer is represented by Ben Bertram, Scott Bertram and Blair Bertram Matyszczyk of Bertram & Graf LLC, Grant Lavalle Davis and Shawn Foster of Davis Bethune & Jones LLC, Thomas Philip Cartmell, Diane K. Watkins, Andrew N. Faes and Jeffrey M. Kuntz of Wagstaff & Cartmell LLP, and Valley Renshaw and Kaitlyn Jennifer Syring.
Boston Scientific is represented by Robert Thomas Adams, Hildy Sastre and Mike Kleffner ofShook Hardy & Bacon LLP.
Bard is represented by Lori Cohen, Cliff Merrell, Marcella Ducca, Wade Bowden, Sara Deskins Tucker and Sean Jessee of Greenberg Traurig LLP.
The case is Sherrer v. Boston Scientific et al., case number 1216-CV27879, in the 16th Judicial Circuit of Missouri. -
Boston Scientific, CR Bard Mesh Not Defective Find Jurors in Kansas City Pelvic Mesh Trial
Feb 2, 2016 | Mesh Medical Device News Desk
By Jane Akre
In its second day of deliberations, jurors in the only pelvic mesh trial to name two defendant manufacturers in the same action, handed defendants Boston Scientific and CR Bard a victory in a Kansas City, Missouri product liability trial.
Voting 10-12, jurors rejected the contention by plaintiff Eve Sherrer that the Bard Align and Boston Scientific Solyx were defective and that the companies failed to warn doctors about their dangers and that the meshes were the cause of injuries to plaintiff, Eve Sherrer. Sheerer had sought $28 million in her product liability lawsuit.
The verdict was reported by Missouri Lawyers Weekly reporter Jessica Shumaker via Twitter after Mesh News Desk lost access to the courtroom camera due to a reader’s unfavorable comment about defense attorney, Lori Cohen (Greenberg Traurig).
The plaintiffs in this case had to prove, by the preponderance of the evidence, that the Solyx (Boston Scientific) and Align (C.R. Bard) were both defective and caused physical damages to Ms. Sherrer. They also were charged with proving the alleged failure to warn her physicians about the risks caused her damages.
The jury also has the opportunity to award Ms. Sherrer punitive damages, which have typically run into the millions of dollars. Both companies insist their products are safe and effective and the “gold standard” for treating incontinence and pelvic organ prolapse.
The verdict is a sharp departure from jury decisions of the past.
*Update* Boston Scientific is facing in excess of $128 million in jury awards to 14 plaintiffs so far in litigation that began in 2014. In April of 2015, Boston Scientific offered its first settlement to 3,000 pelvic mesh-injured women of $119 million.
Boston Scientific was recently charged with racketeering allegations for allegedly smuggling counterfeit polypropylene resin into the U.S. from China and using it to make pelvic mesh products. See the story here.
CR. Bard is facing in excess of $7 million in jury awards to six plaintiffs. In October 2014, the company offered to settle 500 cases for $21 million. *
As of today, Bard is facing 12,955 cases and Boston Scientific 19,829 cases all filed in federal court in Charleston, WV where multidistrict litigation has been consolidated. Including all seven manufacturers there are 86,445 cases in that single court. That does not include cases filed in state courts and around the globe.
THE TRIALThe jury got down to its first full day of deliberations Tuesday after choosing a foreperson. Jurors wanted to see medical reports submitted at trial by Dr. Vladimir Iakovlov, a pathologist, but that request was denied on the basis they were for demonstrative purposes only.
Dr. Iakovlov had showed jurors in a November 2014 trial in Miami against Boston Scientific, that mesh hardens like a piece of plastic and incites inflammation causing scar tissue to encapsulate the mesh as it tries to distance itself from the invader. He authored a study in 2013 “Mesh is Not Inert,”here.
Eve Sherrer, 65, from Oklahoma, was implanted with both meshes by Dr. Peter Greenspan, an Ob-Gyn, to treat her condition of incontinence.
The 40-day trial was the longest in pelvic mesh litigation history and also unusual in that it pitted one plaintiff against two separate mesh manufacturers, C.R. Bard of Murray Hill, New Jersey, and Boston Scientific (BSX) of Marlborough, MA.
Both companies are among the largest manufacturers of pelvic mesh crafted of polypropylene used to treat stress urinary incontinence and pelvic organ prolapse in women. A similar mesh is used in the treatment of hernias. Pelvic organ mesh is implanted transvaginally or through incisions in the vagina, thought to introduce a bacterial colony from the clean/contaminated field that is difficult if impossible to treat. Infections, mesh erosion, nerve injury, mesh migration, chronic pain, are among the many symptoms women report in this litigation.
Judge Robert M. Scheiber heard the case in the 16th Judicial Circuit Court of Missouri, Jackson Co Courthouse beginning Wednesday, December 2. Jury selection began Monday, November 30.
BARD BOSTON SCIENTIFIC TRIALS TO DATE
Mesh News Desk has been following these product liability trials since 2013. The following represents our accounting of the actions so far that we’ve covered:
Boston Scientific Verdicts so far representing 14 plaintiffs in 8 trials, $128 million in losses, four verdicts for BSX.
October 2015 – Carlson v Boston Sci – Verdict for the company maker of Uphold pelvic mesh, Statesville, NC
http://meshmedicaldevicenewsdesk.com/jury-finds-for-boston-scientific-in-north-carolina-pelvic-mesh-trial
October 2015 – Barba v Boston Sci – $100 million to Deborah Barba and her husband. Implanted with Pinnacle Pelvic Floor repair kit and Advantage Fit.
Punitive damages were later reduced as well as compensatory damages to $10 million by Judge Mary Miller Johnston. Delaware, New Castle Co. http://meshmedicaldevicenewsdesk.com/boston-scientific-denied-new-trial-in-100-million-barba-case
May 2015 – Sanchez v Boston Scientific – Case settles before closing arguments. Pinnacle Pelvic Floor Repair Kit and the Advantage Transvaginal Mid-Urethral Sling System. Terms not disclosed. Los Angeles.
http://meshmedicaldevicenewsdesk.com/ms-sanchez-not-warned-about-her-mesh-implants-lawyers-sayApril 2015- Boston Scientific offers first settlements to 3,000 pelvic mesh injured women of $119 million.
http://meshmedicaldevicenewsdesk.com/new-boston-scientific-offers-small-settlement-to-3000-pelvic-mesh-injured-womenNovember 2014 – Tyree v Boston Scientific, four plaintiffs were awarded $18.5 million. All four were implanted with the Obtryx mesh, a mid-urethral sling. The award includes $4 million in punitive damages. Tyree v Boston Scientific, Charleston, WV
http://meshmedicaldevicenewsdesk.com/punitives-plus-14-5-million-in-boston-scientific-mesh-sling-trialNovember 2014 – Eghnayem v. Boston Scientific, Four plaintiffs awarded $26.7 million. All four were implanted with the Pinnacle Pelvic Mesh Repair Kit. Miami, FL. http://meshmedicaldevicenewsdesk.com/breaking-news-jury-decides-28-million-for-four-women-injured-by-boston-scientific-pelvic-mesh
September 2014 – Salazar v. Boston Scientific – $73,465,000. (Includes $50 million in punitive damages), Martha Salazar was implanted with the Obtryx mid-urethral sling. Dallas
http://meshmedicaldevicenewsdesk.com/salazar-v-boston-scientific-73-5-million-how-it-breaks-downAugust 2014 – Cardenas v. Boston Scientific, Jury delivers verdict for Boston Scientific. Obtryx mid urethral sling. Middlesex Co. MA
http://meshmedicaldevicenewsdesk.com/cardenas-v-boston-scientific-trial-continuesJuly 2014 – Albright v. Boston Scientific, Jury delivers verdict for Boston Scientific. Albright was implanted with the Pinnacle Pelvic Floor Repair Kit.
Middlesex Co. Massachusetts, headquarters of Boston Sci.
http://meshmedicaldevicenewsdesk.com/plaintiff-loses-first-boston-scientific-pelvic-mesh-trialCR Bard Verdicts so far, 6 plaintiffs, 3 settled, $7 million in losses and numerous settlements
February 2015 – Wise v CR Bard, Settlement offered to Wise, terms not disclosed, Implanted with Avaulta Plus Anterior and Posterior BioSynthetic Support System, Charleston WV
http://meshmedicaldevicenewsdesk.com/new-bard-avaulta-trial-to-begin-in-charleston-federal-courtOctober 2014 – Bard offers to settle 500 cases for $21 million
http://meshmedicaldevicenewsdesk.com/c-r-bard-may-settle-500-cases-for-21-millionOctober 2013- Rizzo v Bard, Case is dropped by the plaintiff and Bard wants $14,000 in court costs from her. Charleston WV
http://meshmedicaldevicenewsdesk.com/c-r-bard-wants-14k-from-linda-rizzo-over-dismissed-transvaginal-mesh-lawsuitSeptember 2013 – Vigil v CR Bard, case settled by Bard for undisclosed amount. Vigil had Avaulta Suburethral Plus. Atlantic City, NJ
http://meshmedicaldevicenewsdesk.com/c-r-bard-settles-second-transvaginal-mesh-case-for-undisclosed-amountAugust 2013 – Queen v CR Bard, case settled by Bard. She received the Avaulta Solo. Charleston, WV
July 2013 – Cisson v. CR Bard, $ 2 million for Cisson. Implanted with Avaulta Plus. Includes $175,000 in punitive damages. Charleston WV bellwether
http://meshmedicaldevicenewsdesk.com/cisson-2-million-compensatory-and-punitive-verdict-against-c-r-bard-upheld-by-appellate-courtJuly 2012- Scott v. CR Bard, $5.5 million for Scott,($3.6 million against company, remainder her physician), Implanted with Bard Avaulta Plus, Bakersfield California
http://meshmedicaldevicenewsdesk.com/c-r-bard-pays-precedent-setting-first-pelvic-mesh-scott-case-for-3-6-million
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