Preview Newsletter
Ethicon Media Monitoring 5/29/2017
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J&J's Ethicon hit with $2.16 million verdict in vaginal-mesh case
May 26, 2017 | Reuters
By Nate Raymond
A state court jury in Philadelphia on Friday ordered Johnson & Johnson to pay $2.16 million to a Pennsylvania woman who claimed she suffered injuries due to pelvic mesh devices manufactured by the company's Ethicon unit. -
J&J Hit With $2.16M Verdict In 4th Philly Mesh Case
May 26, 2017 | Law 360
By Dan Packel
Johnson & Johnson continued a string of losses in Philadelphia’s pelvic mesh mass tort program Friday, but the $2.16 million award in favor of a Pennsylvania woman was the lowest figure yet in the four cases tried to verdict and the first to not include punitive damages. -
Woman Awarded $2.1M in Fourth Pelvic Mesh Trial
May 26, 2017 | The Legal Intelligencer
By P.J. D'Annunzio
A Philadelphia jury has awarded $2.1 million to a woman claiming she experienced ongoing pain resulting from the deterioration of a pelvic mesh implant. -
Inside the Beltz Pelvic Mesh Trial
May 27, 2017 | Mesh Medical Device Newsdesk
The $2.16 million verdict for Sharon Beltz brought to an end the fourth consecutive trial for mesh-injured Plaintiffs in this court. -
Beltz Pelvic Mesh Case Yields $2.16 Mill Verdict for Plaintiff!
May 26, 2017 | Mesh Medical Device Newsdesk
The case of Sharon Beltz v. Ethicon began with jury selection May 8. The case concluded Friday afternoon after a 12-day trial with a $2.16 million dollar jury verdict for Ms. Beltz. -
Ethicon Seeks High Court Review In $3M Pelvic Mesh Suit
May 26, 2017 | Law 360
By Melissa Daniels
Johnson & Johnson subsidiary Ethicon Inc. has asked the U.S. Supreme Court to review a Fourth Circuit decision upholding a $3.27 million jury verdict in a bellwether trial over the company's allegedly harmful pelvic mesh, saying the appellate court misunderstood precedent in allowing the exclusion of certain product review evidence. -
Bard Ends 97 More Suits In Pelvic Mesh MDL
May 29, 2017 | Law 360
By Brian Amaral
A West Virginia federal judge on Friday dismissed dozens of pelvic mesh cases against C.R. Bard Inc. after the New Jersey company reached settlements. -
Pelvic mesh Senate inquiry will hold regulators to account
May 29, 2017 | Newcastle Herald
MORE than 1750 Australian women have responded to a call for submissions to a Senate inquiry into how pelvic mesh devices came to be cleared for use in Australia, and the experiences of women who were implanted with them. -
Wollongong women break their silence: ‘I don’t know where to go for help’
May 28, 2017 | Newcastle Herald
By Lisa Wachsmuth
A dozen Wollongong women have detailed the horrific side effects of pelvic mesh implant surgery in a nationwide survey – and that’s just the tip of the iceberg according to researchers. -
Lake Macquarie woman joins more than 1700 others for Senate inquiry on pelvic mesh
May 29, 2017 | Newcastle Herald
By Joanne McCarthy
JUDY* was implanted with a pelvic mesh device in Sydney in 2003 as two gynaecologists, including Newcastle’s Alan Hewson, wrote a paper warning doctors that the device she received “cannot be recommended”. -
Multiple-Plaintiff Trial Involving J&J Set to Start
May 26, 2017 | Nasdaq
... Johnson & Johnson has been slapped with thousands of lawsuits over its defective hernia mesh product, Physiometh, a product of its subsidiary Ethicon.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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J&J's Ethicon hit with $2.16 million verdict in vaginal-mesh case
May 26, 2017 | Reuters
By Nate Raymond
A state court jury in Philadelphia on Friday ordered Johnson & Johnson to pay $2.16 million to a Pennsylvania woman who claimed she suffered injuries due to pelvic mesh devices manufactured by the company's Ethicon unit.
The case in the Philadelphia Court of Common Pleas was the latest to go to trial out of around 54,800 lawsuits pending against J&J in state and federal courts over vaginal-mesh devices produced by Ethicon.
To read the full story on WestlawNext Practitioner Insights, click here: bit.ly/2s4YSxJ
https://www.reuters.com/article/johnsonjohnson-lawsuit-idUSL1N1IS1KF
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J&J Hit With $2.16M Verdict In 4th Philly Mesh Case
May 26, 2017 | Law 360
By Dan Packel
Law360, Philadelphia (May 26, 2017, 2:36 PM EDT) -- Johnson & Johnson continued a string of losses in Philadelphia’s pelvic mesh mass tort program Friday, but the $2.16 million award in favor of a Pennsylvania woman was the lowest figure yet in the four cases tried to verdict and the first to not include punitive damages.
A 12-member jury ruled that the risks of J&J subsidiary Ethicon Inc.’s Prolift mesh product outweighed its benefits and that the implant was responsible for plaintiff Sharon Beltz’s pain during sexual intercourse and chronic vaginal pain.
“It’s consistent with the previous verdicts, which there now are four, in which our firm has played a significant role as trial counsel,” said Thomas Kline of Kline & Specter PC.
But the jury found the mesh performed as expected and was properly designed, and concluded that Ethicon properly warned Beltz’s implanting surgeon about the risks of the product.
Kline noted that the first jury question, in which the jury found that Prolift did not fail to perform as safely as an ordinary consumer would expect, and the second question, in which the jury found the risks outweighed the benefits of the product, both came out of the Pennsylvania Supreme Court’s recent jurisprudence in the closely watched Tincher v. Omega Flex case. That case established two ways to assess product liability under state law.
“This case was a good test of the Tincher alternative standard,” he said. “It showed the plaintiff could win on one or another.”
He attributed the losses on the failure to warn claims and consumer expectations claims to a conclusion by the jury that Beltz’s doctor, who he said was closely tied to J&J, was an “insider” who knew what risks she was taking.
“But the cost-benefit analysis was a different story, especially because of our evidence that they had a better mesh and there was no additional cost to use the better mesh,” he said, adding that he had produced a “devastating email” that showed they didn’t want to use it because it would lower the price of the product.
The jury of eight women and four men was on its second day of deliberations when they returned the unanimous verdict just before noon on Friday, concluding a trial that lasted three full weeks.
Beltz, who filed her lawsuit in 2013, had the Prolift implanted in 2006, one year after it was released, to treat pelvic organ prolapse and stress urinary incontinence following four pregnancies. Ethicon stopped selling the mesh in 2012.
The suit was part of a string of more than 180 cases consolidated as part of a mass tort program in Philadelphia County’s Court of Common Pleas. The first went to trial in December 2015.
The first two trials, which were both argued by Kline’s partner Shanin Specter, resulted in a pair of awards against Ethicon totaling some $26 million.
Last month, in a case argued by Benjamin Anderson of Cleveland-based Anderson Law Offices, a jury awarded $20 million to a New Jersey woman. That verdict included $17.5 million in punitive damages.
But in spite of Kline’s plea for the jury to send a harsh message to J&J, which he said was valued at more than $70 billion, the jury declined to issue a punitive award.
Kristen Wallace, a spokeswoman for Ethicon, highlighted the fact that the jury did not award punitive damages and its findings that the product performed as expected and Beltz’s doctor was properly warned.
“We empathize with women suffering from pelvic organ prolapse, which can be a serious and debilitating condition,” she said in an email. “There are various treatment choices for this condition, including surgical treatment with implantable mesh, which is backed by years of clinical research and can be the preferred option for some women seeking to improve their quality of life.”
Wallace added that the company was studying the verdict on the risk utility claim and evaluating its legal options.
A fifth pelvic mesh trial is currently underway, and Kline noted that he did not see a global settlement on the horizon. He said the fact this case didn’t lead to punitives was an anomaly, arguing that eight out of 10 jury verdicts would likely trigger that additional sanction.
“The longer this goes on, the more it drives the price up, because juries consistently have proven these cases are not only seven-figure cases but multimillion dollar cases,” he said.
The case was presented for Beltz by Tom Kline of Kline & Specter LLP.
The case was presented for J&J by Kat Gallagher of Beck Redden LLP.
The case is Beltz v. Ethicon Women’s Health and Urology et al., case number 130603835, in the Philadelphia County Court of Common Pleas.
--Editing by Kelly Duncan.https://www.law360.com/lifesciences/articles/928912/j-j-hit-with-2-16m-verdict-in-4th-philly-mesh-case
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Woman Awarded $2.1M in Fourth Pelvic Mesh Trial
May 26, 2017 | The Legal Intelligencer
By P.J. D'Annunzio
A Philadelphia jury has awarded $2.1 million to a woman claiming she experienced ongoing pain resulting from the deterioration of a pelvic mesh implant.
The $2.1 million verdict in Beltz v. Ethicon came in the fourth pelvic mesh trial against Johnson & Johnson subsidiary Ethicon in the Philadelphia Court of Common Pleas. The jury handed up its verdict May 26 after 12 days of trial and nine hours of deliberation.
The verdict came just under a month after a jury handed up a $20 million verdict—including $17.5 million in punitive damages—in the third trial.
According to plaintiff Sharon Beltz's attorney, Thomas R. Kline of Kline & Specter, the 12-member jury found the Prolift mesh product was defective under the Tincher risk-utility test, answering "yes" to the question of whether the risk outweighed the cost or burden of making it safer.
"This is now our fourth consecutive Philadelphia jury verdict award [of] multimillion dollars against Johnson and Johnson for their dangerously defective transvaginal mesh products which injured tens of thousands of women, this being the second straight jury verdict relating to its dangerous Prolift product, which was withdrawn from the market in 2012," Kline said in an email. "We are pleased that Sharon Beltz, a woman from Pen Argyl, Pennsylvania, will be compensated, and expect many additional jury verdicts to follow."
Johnson & Johnson did not respond to a request for comment.
According to Beltz's pretrial memorandum, the mesh could not be removed.
"Mrs. Beltz's problems are thus permanent. She may elect to undergo further pain injections, resection of the mesh, or start taking pain medications regularly, but these options at best will only mitigate her symptoms. She has to live the remainder of her life with constant pelvic pain, a sensation her bladder is pulling, urinary incontinence and retention, lower flank pain, urinary tract infections, and severe pain with sex that lingers days after she has intercourse," court papers said.
"She will be at risk for exposure of the mesh in her vagina and erosion of the mesh into her bladder, urethra, or other organs for the remainder of her life."
Ethicon countered with several defenses, including statute of limitations arguments, claims that her suit was barred by the mesh's warranty, and that she couldn't prove causation. Additionally, Ethicon said punitive damages were not warranted.
Ethicon argued that the mesh "has been proven to be safe and effective in patients with SUI, is the standard of care, and is a suitable first-line surgical option as recognized in the pertinent professional society incontinence treatment guidelines, analyses, systematic reviews and position statements as well as Cochrane Reviews," according to its pretrial memorandum.
http://www.thelegalintelligencer.com/id=1202787649921/Woman-Awarded-21M-in-Fourth-Pelvic-Mesh-Trial
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Inside the Beltz Pelvic Mesh Trial
May 27, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, May 27, 2017 ~ The $2.16 million verdict for Sharon Beltz brought to an end the fourth consecutive trial for mesh-injured Plaintiffs in this court.
The jury verdict came down Friday May 26th after a 12-day trial in the Philadelphia Court of Common Pleas.
Beltz was awarded a compensatory amount with no punitive damages that had been present in the last three trials, and which totaled $34.5 million.
A Failure to Warn?
Ethicon argued the Instructions for Use (IFU) that accompanied the Prolift were adequate in informing the implanting physician, Dr. Heather van Raalte.
The instructions urge surgeons to seek additional training since “The IFU does not convey the impression that it presents all available information concerning the Prolift.”
The condition of (dyspareunia , painful sex) is not in the IFU but its implied, said Ethicon.
In this case, Dr. Vincent Lucente, preceptor and consultant to Ethicon, trained the Beltz implanting physician, Dr. van Raalte. (Dr. Lucente also trained Dr. Becky Simpson, the surgeon who implanted Joan Budke, who ultimately died from an infection originating with her mesh implant it was revealed during her trial in November 2014.)
A second consent form signed by the Plaintiff in 2006 shows she understood the dangers ahead, argued Ethicon. It said:
“The benefits and purpose of the operation and/or procedure have been explained to me in language I understand by Dr. Heather van Raalte as well as the risks, alternatives and complications pertaining to the above procedure/surgery which include but is not limited to: infections, deep vein thrombosis, blood clots to the lungs, wound healing problems, complications from extensive blood loss, including shock and possible death. Other risks include but are not limited to: bleeding, injury to surrounding structures (bowel, bladder, ureters), failure, recurrence, voiding dysfunction, nerve injury, mesh erosion, possible coversion [sic] to laparotomy.”It included chronic inflammation.
Ms Beltz testified her doctor warned her only about general risks of surgery and not risks particular to mesh or the Prolift device. Dr. van Raalte testified there were no long-term studies available on the Prolift to inform her patient, according to court records.
Mrs. Beltz also said she received no information on how the Prolift would be inserted with cannulas and trocars and puncture wounds to the vagina.
Dr. van Raalte was a consultant to Ethicon and received more than $100,000 for her services.
A motion by the Plaintiffs for Ethicon to produce its corporate designees including consultants Dr. Lucente, Dr. Kavaler, and Miles Murphy was quashed after Ethicon argued that it was a Plaintiff effort to harass.
On April 25, 2017 Ms. Beltz dropped her claims related to the TVT-O and would not make any claim that her current urinary and or incontinence issues were related to the Prolift.
Mr. Beltz also decided to voluntarily dismiss his claim for loss of consortium.
What remained were design defect of the Prolift +M, a failure to adequately warn of the risks of Prolift, and negligent and/or fraudulent misrepresentations as to the attributes of Prolift, in addition to punitive damages.
The Plaintiff had already withdrawn the designated testimony of expert urogynecologist, Dr. Rosenzweig which related to defects in the TVT-O. Also withdrawn was the expert testimony of Dr. Uwe Klinge, a biomaterial researchers related to the TVT-O.
Sharon Beltz underlying and ongoing urinary issues were no longer an issue in this case.
That did not stop the Defense on May 9, 2017, when its counsel announced it planned to introduce evidence of safety and efficacy of the TVT-O as defense of the Prolift.
Any evidence submitted about the safety of the TVT-O is no longer relevant to this case argued the Plaintiffs, and a waste of time for the jurors and the Court.
MISBRANDED AND ADULTERATED
Peggy Pence, PhD, in her expert report concluded that Ethicon marketed a misbranded and adulterated Prolift device because it did not have an adequate pre-market clearance through the 510(k) when it was launched in March 2005.
In 2004, in preparation for launching the Prolift mesh kits, Ethicon initiated two non-randomized non-controlled studies to evaluate a pre-cut surgical mesh made of the same non-absorbable polypropylene Gynemesh PS. Studies were also conducted at eight sites in France and three sites in the U.S. In the U.S. the failure rate was 12% and 20% had dyspareunia in the French study.
There were adverse events in 25.6% of the patients in the French study, and 65.9% of patients in the U.S. experienced adverse events, reports Pence.
In February 2005, Sean O’Bryan, Senior Project Manager, Regulatory Affairs at Ethicon issued a notification that Gynecare Prolift Pelvic Floor Repair System was considered a line extension of the Gynecare Gynemesh PS which had received a 510(k) clearance in January 2002.
So with no 510(k) clearance, Ethicon launched Prolift for marketing in March 2005.
The FDA had no notice of the existence of Prolift even though this mesh would be a novel device – pre-cut and boxed for an anterior implant, a posterior implant and a total implant complete with Gynecare Gynemesh PS, and with guide needles, fasteners and a fastener delivery device system.
According to regulatory expert Dr. Pence, the misbranding went to labeling issues and failures to follow-up on adverse event reports or interpret the data on serious injuries. Ethicon withheld known adverse complications from physicians because of a failure to seek a 510(k) clearance, and withheld information from the FDA during the 510(k) review that would have led to it not being approved.
They were exempt from premarket clearance, said Ethicon, because they were custom devices.
Dr. Pence said they were neither a custom device and were not exempt from compliance with the 510(k) premarket notification requirements. Nor were the instruments.
“Ethicon marketed a product that violated safety and ethical standards,” she concluded.
Ethicon motioned to omit the expert reports of Drs. Klinge, Rosenzweig, Margolis and Pence because they will offer “improper and inadmissible testimony concerning the purported knowledge, intent and motives of Ethicon of the Food and Drug Administration.”
LEARN MORE:
Beltz Peggy Pence Expert Report on Prolift
Beltz Motion Quashed for Def to Produce five corporate designees
Beltz Motion to take TVT O out of the case
http://www.meshmedicaldevicenewsdesk.com/inside-beltz-pelvic-mesh-trial/
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Beltz Pelvic Mesh Case Yields $2.16 Mill Verdict for Plaintiff!
May 26, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, May 26, 2017~ The case of Sharon Beltz v. Ethicon began with jury selection May 8.
The case concluded Friday afternoon after a 12-day trial with a $2.16 million dollar jury verdict for Ms. Beltz.
This becomes the fourth consecutive win for mesh-injured plaintiffs in the Philadelphia Court of Common Pleas.
Although the lowest of the four recent jury verdicts for the plaintiff, the jury did establish that the risks of Prolift +M outweighed the benefit and it was responsible for her injuries.
The jury found the Prolift +M, a large polypropylene mesh used to shore up pelvic organs, was defective in its design.
There were no punitive damages awarded in the Beltz case.
On September 20, 2006, Sharon Beltz was implanted with the Ethicon Prolift +M System to treat pelvic organ prolapse. Her surgeon was Dr. Heather Van Raatle, MD at St. Luke’s Hospital in Bethlehem, PA.
On that same day, Beltz was implanted with the Gynecare (Ethicon) TVT -O (tension-free tape obturator) System to treat incontinence.
According to Beltz’s pretrial memorandum, the mesh could not be removed and her injuries are permanent.
“She may elect to undergo further pain injections, resection of the mesh, or start taking pain medications regularly, but these options at best will only mitigate her symptoms. She has to live the remainder of her life with constant pelvic pain, a sensation her bladder is pulling, urinary incontinence and retention, lower flank pain, urinary tract infections, and severe pain with sex that lingers days after she has intercourse,” court papers said.
“She will be at risk for exposure of the mesh in her vagina and erosion of the mesh into her bladder, urethra, or other organs for the remainder of her life.”
Ethicon, a division of Johnson & Johnson, claims that the Beltz care had an expired statute of limitation and did not prove causation and that the TVT-O is the standard of care for incontinence as recognized by professional medical societies.
Beltz et al vs Ethicon Women’s Health and Urology, Case ID: 130603835, was the fourth win for plaintiffs injured by the healthcare giant’s pelvic mesh products.
The losses are substantial for a company that claims it is based on “sustainability.”
The TVT remains on the market while J&J quietly took Prolift +M off the market along with three other meshes in mid 2012.
A SERIES OF LOSSES FOR J&J
The last three trials in the Philadelphia Court of Common Pleas, resulted in wins for the Plaintiff including – $12.5 million (Hammons), $13.5 million (Carlino) and on April 28th $20 million for Ms. Engleman.
These verdicts include more than $35 million in punitive damages, intended to send a message to the company and to discourage its behavior.
Read the MND story of the Engleman trial here. MDN on Carlino here. Read the MND story on Hammons case here.
There are nearly 200 pelvic mesh product liability cases filed in this Philadelphia state court waiting for trial, most naming the Ethicon medical device division of Johnson & Johnson, which is also facing nearly 40,000 product liability cases amassed in multidistrict litigation in Charleston, WV and thousands of cases filed in New Jersey and elsewhere around the country and globally.
J&J has more defective product cases filed against it than another other mesh maker.
Like the other plaintiffs, Beltz says she has suffered permanent catastrophic injury, undergone corrective surgery, “has experienced, and will continue to experience, significant mental and physical pain and suffering, financial or economic loss, including, but not limited to, obligations for medical services and expenses.”
See the Beltz Complaint.
Ms. Beltz is represented by Kline & Specter, a Philadelphia law firm that remains in litigation over transvaginal mesh. It is the same team that has overseen a series of plaintiff wins in the same Philadelphia court.
The team is assisted by Aylstock Kreis of Pensacola.
J&J has reportedly stopped preparing cases for trial and instead is in a settlement mode.
Plaintiffs report to MND that the value of cases runs from a few hundred dollars up to about $250,000, before legal fees and expenses are subtracted. Most women say this amount will not even pay for their substantial medical bills.
Meanwhile in the West Virginia court before Judge Joseph Goodwin, J&J product liability cases are being gathered into “waves” so they can be litigated or settled en masse.
Rather than “sustainability” the business model echoed at the recent J&J shareholder’s meeting, this business model more closely resembles game of chicken with an enormous risk.
Read more on the Beltz case here and here.
The last three trials resulted in wins for the Plaintiff including – $12.5 million (Hammons), $13.5 million (Carlino) and on April 28th $20 million for Ms. Engleman.Read the MND story of the Engleman trial here.
MDN on Carlino here.
Mesh News Desk will report on the verdict when it comes in! Stay tuned. ###
http://www.meshmedicaldevicenewsdesk.com/beltz-case-jj-jury/
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Ethicon Seeks High Court Review In $3M Pelvic Mesh Suit
May 26, 2017 | Law 360
By Melissa Daniels
Law360, Los Angeles (May 26, 2017, 9:29 PM EDT) -- Johnson & Johnson subsidiary Ethicon Inc. has asked the U.S. Supreme Court to review a Fourth Circuit decision upholding a $3.27 million jury verdict in a bellwether trial over the company's allegedly harmful pelvic mesh, saying the appellate court misunderstood precedent in allowing the exclusion of certain product review evidence.
The suit, brought by plaintiff Jo Huskey, is one of the tens of thousands of cases involving J&J’s surgical mesh products and was the first bellwether case to go to trial in a massive multidistrict litigation against Ethicon.
The district court had prevented Ethicon from using the Food and Drug Administration’s 510(k) medical device clearance process as evidence during the trial, Ethicon says. In a petition for a writ of certiorari filed May 23, Ethicon said the Fourth Circuit’s affirmation was based on a misunderstanding of 1996’s decision in Medtronic Inc. v. Lohr as holding that the 510(k) review has little to do with safety.
The result of the misconstruing the Lohr decision is that the Fourth Circuit’s ruling now threatens companies’ ability to use FDA regulatory processes as evidence in defending the safety of their products, the petition said.
“Under the lower court's understanding of Lohr and the 510(k) process, for a device manufacturer subject to suit for marketing an allegedly unsafe device, it is literally impossible to present a complete defense — the manufacturer cannot even begin to offer jurors the wholly truthful account of how the device actually got to market,” the petition said. “Indeed, lay jurors unaware that the device was cleared by FDA may well infer that FDA thought the device was unsafe.”
The court should grant certiorari to correct the misunderstanding of the Lohr case and clarify that the 510(k) process includes safety and efficacy review, the petition said, citing the issue's importance to other pelvic mesh and medical device cases.
“The Fourth Circuit's decision will likely affect an extraordinary number of cases — fully 60,000 currently pending in the pelvic mesh MDLs,” the petition said. “And given that the vast majority of medical devices reach the market through [the 510(k) process] this recurring issue will likely affect an untold number of future product-liability cases as well.”
Huskey’s case is part of an MDL that contains 28,000 cases, according to Ethicon. The company's pelvic mesh is also at the center of a mass tort program in Philadelphia that on Friday saw a fourth jury verdict when a 12-member panel awarded $2.16 million to a Pennsylvania woman.
A response to the high court petition is due on June 23, court records show. Huskey's attorney Edward Wallace of Wexler Wallace LLP told Law360 on Friday that his team is proud to continue to fight on her behalf.
“Ethicon continues to distort the facts and the law with a last-shot bid to get before the United States Supreme Court,” Wallace said. “As I said after the verdict and after the well-reasoned decision by the Court of Appeals, Jo Huskey has taken every punch thrown by Ethicon and continues her march to see this through.”
Huskey filed her suit in West Virginia federal court in 2012. She claimed the polypropylene mesh in her TVT-O sling eroded, causing her severe, ongoing pain as the mesh could not be entirely removed through surgery. Her husband, Allen, sued for loss of consortium.
A jury delivered its compensatory damages verdict in September 2014, which was solidified in August 2015 when U.S. District Judge Joseph Goodwin refused to toss the decision as a matter of law or grant a new trial.
The verdict was upheld by a Fourth Circuit panel in January with a ruling that, citing the plaintiff’s expert testimony, said a reasonable juror could conclude that Ethicon’s use of a heavyweight quantity of polypropylene mesh in the TVT-O constituted a design defect that caused Huskey’s pain.
Ethicon urged the court to rehear the decision, citing its potential to effectively bar all FDA evidence in most product liability cases involving other Class II medical devices. But the court denied the petition in February.
Representatives for Ethicon didn’t immediately respond to requests for comment on Friday.
Ethicon is represented by Charles C. Lifland, Walter Dellinger, Jonathan D. Hacker and Stephen D. Brody and Jason Zarrow of O’Melveny & Myers LLP, David B. Thomas and Philip J. Combs of Thomas Combs & Spann PLLC and Christy D. Jones and Luther T. Munford of Butler Snow LLP.
Jo Huskey and Allen Huskey were represented at the Fourth Circuit by Edward A. Wallace and Mark R. Miller of Wexler Wallace LLP, Fidelma L. Fitzpatrick of Motley Rice LLC and Jeffrey M. Kuntz and Adam S. Davis of Wagstaff & Cartmell LLP.
The case is Ethicon Inc. et al. v. Jo Huskey et al., case number 16-1399, in the Supreme Court of the United States. The circuit court case is Huskey et al. v. Ethicon Inc. et al., case number 15-2118, in the U.S. Court of Appeals for the Fourth Circuit.
--Additional reporting by Steven Trader and John Kennedy. Editing by Jill Coffey.https://www.law360.com/articles/929012/ethicon-seeks-high-court-review-in-3m-pelvic-mesh-suit
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Bard Ends 97 More Suits In Pelvic Mesh MDL
May 29, 2017 | Law 360
By Brian Amaral
Law360, Boston (May 26, 2017, 2:39 PM EDT) -- A West Virginia federal judge on Friday dismissed dozens of pelvic mesh cases against C.R. Bard Inc. after the New Jersey company reached settlements.
U.S. District Court Judge Joseph R. Goodwin said 97 suits “have been compromised and settled.” Thousands of cases against the mesh maker for allegedly selling defective mesh products were consolidated in West Virginia, just a smaller part of tens of thousands of cases against companies like Johnson & Johnson and Boston Scientific.
Bard faced the first jury trial in the MDLs over the use of transvaginal surgical mesh to treat pelvic organ prolapse and stress urinary incontinence. It was hit with a $2 million verdict in August 2013 in a case by Donna Cisson, who alleged that its Avaulta Plus Posterior BioSynthetic Support System caused serious internal injuries.
The U.S. Food and Drug Administration recently reclassified pelvic mesh devices like those at issue in the suits as high-risk devices that must undergo the agency's most stringent safety evaluation before being put on the market.
Several cases against Johnson & Johnson have recently gone to trial in Pennsylvania. A Pennsylvania jury began deliberations Thursday in a state case there.
Kline & Specter PC attorney Tom Kline told a jury in closing arguments Wednesday that J&J subsidiary Ethicon Inc. ignored the risks of its Prolift mesh product in its rush to get it on the market, and that plaintiff Sharon Beltz bore the costs of the company’s recklessness.
Beltz had the product implanted in 2006, one year after it was released. Ethicon stopped selling the mesh in 2012.
“It was on the market for seven years, and she is one of the casualties. It ended in 2012, other than the people who stockpiled this monstrous product,” Kline said. “But for Sharon Beltz, then 34, there was and is no turning back.”
Ethicon attorney Kat Gallagher of Beck Redden LLP said the plaintiff’s case was marked by “drama and antics” from her lawyer, saying that the company had provided adequate warnings and that Prolift was not defective.
She noted that Beltz was facing serious complications from pelvic organ prolapse and stress urinary incontinence following four pregnancies.
“This was not a minor quality-of-life issue. This was a big problem for her and she wanted to have something done,” she said. “She decides after weighing her risks and benefits that she wants to go forward.”
Also this week, the fifth trial over pelvic mesh began in Pennsylvania.
Representatives for the parties didn’t immediately respond to requests for comment Friday.
Bard is represented by Lori G. Cohen of Greenberg Traurig LLP and Michael K. Brown of Reed Smith LLP.
The women are represented by The Potts Law Firm, among others.
The case is In Re: C.R. Bard Inc. Pelvic Repair Systems Product Liability Litigation, case number 2:10-md-02187, in U.S. District Court for the Southern District of West Virginia.
—Additional reporting by Emily Field, Dan Packel and Matt Fair. Editing by Orlando Lorenzo.https://www.law360.com/articles/928829/bard-ends-97-more-suits-in-pelvic-mesh-mdl
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Pelvic mesh Senate inquiry will hold regulators to account
May 29, 2017 | Newcastle Herald
MORE than 1750 Australian women have responded to a call for submissions to a Senate inquiry into how pelvic mesh devices came to be cleared for use in Australia, and the experiences of women who were implanted with them.
A Lake Macquarie woman, Judy, was one of them.
Her experiences demonstrate why a Senate inquiry – and possibly more – is needed.
Judy, then aged 36, was implanted with a device for incontinence in 2003. Her doctor told her the mesh was new and had a high success rate. It was only on Sunday, and after 14 years of severe complications, that Judy learnt doctors were warned about serious complications linked to the mesh she received at almost exactly the time she was being implanted.
We now know the device, the Intravaginal Sling or IVS, was invented by Australian Dr Peter Petros, and developed and marketed in America by Tyco where it was incorrectly cleared for use in prolapse as well as incontinence cases, despite the 2003 Australian warning that it could not be recommended even for incontinence.
The IVS device became the “predicate” case which other pelvic mesh manufacturers in America cited to have their own pelvic mesh devices cleared for use. It is only recently, after what has become known as the “Mesh decade”, and after tens of thousands of women around the world have taken legal action, that regulators are being held to account for what is a global catastrophe.
The Senate inquiry is expected to reveal the failure of science. Manufacturers withdrew devices, and some were cancelled, after evidence relied on to market the devices was found to be deficient, and in some cases seriously so.
It is expected to reveal the failure of regulators, medical colleges, the medical fraternity in general and individual doctors in what should be the most basic and fundamental of responsibilities – the care of patients.
Too many have been keen to point out that tens of thousands of women have been implanted with pelvic mesh devices as a way of minimising the problem. But as Australia’s medical device regulator conceded in a working paper in 2013, it is probably only aware of 10-20 per cent of the adverse cases and so has no real way of establishing the size of the problem.
And that is just not good enough.
http://www.theherald.com.au/story/4691394/pelvic-mesh-exposes-a-system-thats-failed/
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Wollongong women break their silence: ‘I don’t know where to go for help’
May 28, 2017 | Newcastle Herald
By Lisa Wachsmuth
A dozen Wollongong women have detailed the horrific side effects of pelvic mesh implant surgery in a nationwide survey – and that’s just the tip of the iceberg according to researchers.
The Health Issues Centre (HIC) is calling on more women in the region – and beyond – to respond to the survey into the procedure which treats incontinence and prolapse complications after childbirth.
Danny Vadasz, CEO of the health consumer advocacy group, said the risky intervention could end up ‘’eclipsing’’ the Thalidomide disaster of the 1950’s and ‘60s where a remedy for morning sickness led to a wide variety of birth defects.
Since the HIC launched the social media survey seven weeks ago, more than 1800 women have come forward with more than half citing problems such as chronic incontinence, abdominal pain, painful intercourse and even marital breakdown.
One Wollongong woman who responded claimed: ‘’The pain is ongoing. My surgeon has been dismissive. I don’t know where to go to seek further help and support. Please help!’’
Another local respondent said she’d been on antibiotics constantly since having the implant in 2006.
In another response, a woman said she feared for her future: ‘’What should have been a simple procedure left me broken. Traumatised, in pain and dreams shattered. Since then my life is hell. I am near suicidal due to pain and bladder dysfunction. My entire family is traumatised.’’
Mr Vadasz said while the alarm had been sounded about risks associated with the procedure as early as 2002, it had stayed under the radar until a group of affected women approached Senator Derryn Hinch and a senate inquiry was established earlier this year.
‘’The survey, and the comments from the women, will form the basis of our submission to the inquiry into the extent – and impact – of these implants in Australia,’’ Mr Vadasz said.
‘’We’ve heard from 1800 women so far and that’s just the tip of the iceberg. These women have suffered both physical and psychological pain from the procedure.
‘’While medical professionals and the Therapeutic Goods Administration claim it has revolutionised surgical options for women with urinary incontinence and pelvic organ prolapse, they can’t write off the pain inflicted on these other women as collateral damage.’’
Mr Vadasz said there was no central record of pelvic mesh implants performed in Australia, although it was estimated 100,000 women had them since the procedures first began in the late 1990s.
He encouraged women who’d had an implant to complete the HIC survey at www.facebook.com/pg/UnderstandingPelvicMesh
http://www.theherald.com.au/story/4691147/i-dont-know-where-to-go-for-help/?cs=2452
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Lake Macquarie woman joins more than 1700 others for Senate inquiry on pelvic mesh
May 29, 2017 | Newcastle Herald
By Joanne McCarthy
JUDY* was implanted with a pelvic mesh device in Sydney in 2003 as two gynaecologists, including Newcastle’s Alan Hewson, wrote a paper warning doctors that the device she received “cannot be recommended”.
The Lake Macquarie woman cried when told.
“I was told it was a new device that was safe and would help me, and for all this time these doctors have said it was just me. That I was the one with the problem. Now I find out doctors knew. You have no idea how that feels after everything that’s happened,” Judy said.
“I was definitely a guinea pig.”
Judy was implanted with a Tyco Intravaginal Sling (IVS) pelvic mesh device in October 2003. The device was invented by Australian gynaecologist Peter Petros and developed and marketed in America by Tyco.
In 2003 Dr Hewson and Dr Chris Maher wrote a paper, “Intravaginal Sling Distress”, noting there was “little data on the efficacy and safety” of IVS techniques and mesh. The paper reported on “disconcerting” complications in women implanted with IVS mesh including serious infections and pain syndromes.
“All necessitated removal of the mesh due to symptoms debilitating to the patients’, and partners’, quality of life,” Dr Hewson and Dr Maher said, and “the incidence of these complications is unknown”.
Judy is one of more than 1750 Australian women who have made submissions to a Senate inquiry looking at how transvaginal mesh devices – where mesh is implanted in women via the vagina rather than abdomen – came to be cleared in Australia, and how an adverse events reporting system failed to act on the level of complications for more than a decade.
Judy, who was 36 when she had the surgery because of incontinence problems after a difficult birth, said her doctor told her the success rate with mesh was “really high”. But “when I woke after the surgery I knew straight away there were problems”.
What followed was a long list of complications including discharges, extreme pain, extreme infections including pelvic bone infections requiring hospitalisation, painful intercourse, mesh erosion and repeated surgery to remove the mesh, which left her with further complications including a vaginal wall that “caved in”.
Making contact with other pelvic mesh victims on the Australian Pelvic Mesh Support Group Facebook page was both positive and negative. It was a comfort to find she wasn’t alone, but sickening to discover the extent of the problem.
“These devices were put into us and they didn’t even know if it was safe. How does this happen?” she said.
(Judy asked that her surname not be published.)
http://www.theherald.com.au/story/4691250/mesh-victims-anguish-at-missed-warnings/
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Multiple-Plaintiff Trial Involving J&J Set to Start
May 26, 2017 | Nasdaq
A multiple-plaintiff trial over the cancer risks associated with Johnson & Johnson 's ( JNJ ) talc powder is scheduled to begin June 5. The trial, which will be held in Missouri state court, will be broadcasted by the Courtroom View Network.
This is the first multiple-plaintiff trial in Missouri, and it involves claims brought on behalf of three women who died from ovarian cancer after using Johnson & Johnson's talc powder for decades on their genitals. One woman was a Missouri resident; the other two women lived in Texas and Virginia.
Previous trials have resulted in verdicts totaling nearly $200 million. All of the plaintiffs allege that Johnson & Johnson knew for years that its talc powder could cause ovarian cancer. The company maintains that the conclusions are based on outdated and flawed science. Johnson & Johnson has stated that talc powder is no more dangerous than alcohol or red meat.
One of the three plaintiffs may be removed from the lawsuit, depending on the U.S. Court of Appeals for the Eighth Circuit's ruling on an emergency motion by Johnson & Johnson . The motion seeks to remove Michael Blaes, one of the plaintiffs, from the suit.
Blaes sued Johnson & Johnson initally in federal court over his wife's death, but he moved to have the case dismissed after two years of discovery and filed suit in a new court. The company opposed the dismissal. Johnson & Johnson claims the plaintiff is engaging in "blatant forum shopping" and claims the trial must not move forward while that appeal is still pending.
Johnson & Johnson has been facing increased pressure as the company attempts to mitigate the damage of mounting lawsuits related to defective products.
Johnson & Johnson has been slapped with thousands of lawsuits over its defective hernia mesh product, Physiometh, a product of its subsidiary Ethicon.
The company on Wednesday also settled a lawsuit brought by 42 states and the District of Columbia over its misrepresentation of its production process for several over-the-counter drugs, including Benadryl, Tylenol and Motrin.
Johnson & Johnson has agreed to pay $33 million to settle.
Between 2009 and 2011, the company recalled millions of packages voluntarily after one of its subsidiaries released batches of drugs that did not meet federal standards and were believed to be contaminated.
"Johnson & Johnson's disregard for proper manufacturing practices of children's medications was unacceptable," said Lisa Madigan, Illinois attorney general.
Shares of Johnson & Johnson were lower in afternoon trading Thursday but ended the day up 0.68% at $127.53.
http://www.nasdaq.com/article/multiple-plaintiff-trial-involving-jj-set-to-start-cm795649
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