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Pa. Panel Backs Woman's $13.5M J&J Mesh Injury Award
Apr 11, 2019 | Law 360
By Adam Lidgett
A Pennsylvania state appellate court on Thursday backed a $13.5 million award in favor of a New Jersey woman who claimed she was injured by an allegedly defective mesh product manufactured by Johnson & Johnson subsidiary Ethicon Inc. -
Pa. court upholds jury’s $13.5M award against Johnson & Johnson subsidiary over ‘defective’ mesh implant
Apr 11, 2019 | Penn Live
By Matt Miller
A state appeals court panel on Thursday upheld a jury’s $13.5 million verdict against a Johnson & Johnson subsidiary over a malfunctioning mesh implant that will leave a woman in pain for the rest of her life. -
Justices Take Up Jurisdictional Fight in Pelvic Mesh Litigation
Apr 11, 2019 | The Legal Intelligencer
By Zack Needles
In a case with potentially wide-reaching ramifications, the Pennsylvania Supreme Court is now set to determine how the U.S. Supreme Court’s high-profile decision in Bristol-Myers Squibb v. Superior Court of California impacts the pelvic mesh litigation centralized in Philadelphia. -
Texas Doctor Can't Duck Claims Over Hernia Repair
Apr 11, 2019 | the bmj
By Michelle Casady
A Texas appellate court has decided a doctor can't escape a patient's claims that an additional procedure the physician performed while surgically repairing a hernia caused hemorrhaging, rejecting the doctor's argument the patient hadn't connected his actions to the alleged injuries.
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Pa. Panel Backs Woman's $13.5M J&J Mesh Injury Award
Apr 11, 2019 | Law 360
By Adam Lidgett
A Pennsylvania state appellate court on Thursday backed a $13.5 million award in favor of a New Jersey woman who claimed she was injured by an allegedly defective mesh product manufactured by Johnson & Johnson subsidiary Ethicon Inc.
A Superior Court panel affirmed the award won by New Jersey resident Sharon Carlino on claims that inherent defects in Ethicon’s transvaginal tape, or TVT, left her in constant pain and interfered with her ability to have sex with her husband.
Thursday’s decision said there was evidence showing that even though Ethicon was aware the TVT could give rise to various medical issues, like permanent vaginal pain, the product’s risks were downplayed in its instructions for use and the company misinformed doctors about how many adverse results have come about.
“The instructions for use in use at the time of Ms. Carlino’s initial surgery in 2005 listed transitory local irritation and transitory foreign body response among its potential adverse reactions,” the decision said. “Ethicon’s IFU provided no warning about the risks of foreign body reaction, fibrotic bridging, mesh shrinkage, vaginal scarring, vaginal perforation, nerve damage, chronic pain, dyspareunia or complications requiring mesh removal.”
A jury handed down a verdict at issue in February 2016 as it agreed that TVT, which Carlino received to treat urinary stress incontinence, was not reasonably safe and that Carlino's physician would never have implanted the product had he been aware of its risks.
Stress urinary incontinence and uterine fibroids had been giving Carlino back pain, and in 2005 she underwent a procedure to alleviate it, during which the TVT was implanted, according to court documents. She would eventually have to go through more than one corrective surgery.
Ethicon raised a number of arguments challenging the award, including that Pennsylvania courts should not have been allowed to retain jurisdiction over the case and that the claims were untimely.
The Superior Court rejected those arguments, however, saying for one thing that “the trial court properly exercised jurisdiction over Ethicon.”
For another, the court said that the statute of limitations in the case would be two years. Carlino didn’t know her injuries were from the TVT until 2013, the court said, and she filed her suit less than two years after that.
“Sharon Carlino is gratified by the Superior Court’s affirmance of her verdict,” Shanin Specter, one of Carlino’s attorneys, said in a statement. “This brave woman has been horribly injured by Johnson & Johnson’s vaginal mesh product that, unfortunately, they’re still making and selling for permanent implantation. We hope J&J will get the message and take this product off the market for the health and safety of America’s women.”
An Ethicon spokesperson called the decision “disappointing.”
“Ethicon doesn’t believe this case or other out-of-state cases belong in Pennsylvania and is looking forward to the opportunity to present our arguments to the Pennsylvania Supreme Court,” Ethicon spokesperson Mindy Tinsley said in a statement.
Carlino is represented by Shanin Specter, Charles "Chip" Becker, Michael A. Trunk, Lee Barry Balefsky, Kila Briget Baldwin and Ruxandra Maniu Laidacker of Kline & Specter PC.
Ethicon is represented by D. Alicia Hickok, Kenneth Alonzo Murphy, Melissa A. Graff and William Carr of Drinker Biddle & Reath LLP and Stephen Brody of O’Melveny & Myers LLP.
The case is Sharon Carlino v. Ethicon Inc. et al., case numbers 1129 EDA 2016 and 1294 EDA 2016, in the Pennsylvania Superior Court.
https://www.law360.com/articles/1149227/pa-panel-backs-woman-s-13-5m-j-j-mesh-injury-award
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Apr 11, 2019 | Penn Live
By Matt Miller
A state appeals court panel on Thursday upheld a jury’s $13.5 million verdict against a Johnson & Johnson subsidiary over a malfunctioning mesh implant that will leave a woman in pain for the rest of her life.
In the Superior Court ruling, Judge Victor P. Stabile rejected claims by Johnson & Johnson and its subsidiary Ethicon that the award to Sharon and Charles Carlino is unjustified and that the firms didn’t receive a fair shake during the civil trial in a Philadelphia court.
At issue were the Carlinos’ claims that a “TVT” mesh device that was implanted in Sharon Carlino to deal with stress urinary incontinence malfunctioned with catastrophic health results. The couple claimed the design of the TVT was defective.
Stabile found the evidence presented at trial showed Ethicon continued to promote TVT as a treatment for stress urinary incontinence even though it “knew that the TVT could cause permanent vaginal and muscular pain and sexual dysfunction.”
He wrote that evidence showed Ethicon also “knowingly understated the risks of the TVT…and consistently misled physicians that the TVT produced few adverse results.”
As Stabile noted, Sharon Carlino had the TVT implanted in August 2005. Two years later, she had to undergo another corrective surgery because the mesh had migrated, causing her pain. That was just the first of a series of corrective surgeries. The New Jersey couple filed their suit in 2013.
In appealing the $13.5 million award, Ethicon argued that a Philly judge should have dismissed the case on statute of limitations grounds. It claimed the cases shouldn’t have been tried in Pennsylvania because the Carlinos don’t live in this state.
Ethicon contended as well that it was improperly barred from introducing as evidence clearances for the TVT received from the U.S. Food and Drug Administration. Also, the company claimed the Philly judge should have instructed the jury that the Carlinos were obligated “to show a safer alternative design to the TVT.”
None of those arguments were accepted by Stabile in his 53-page opinion on the case.
“The TVT has a high rate of failure,” he wrote. “Ethicon’s medical director…admitted that the rate of the TVT’s long-term success as a treatment for incontinence was around 66 to 68 percent. Ethicon, however, officially reported the success rate as over 90 percent.”
“Taken as a whole…this evidence permitted the jury to find Ethicon acted with wanton and willful disregard of Ms. Carlino’s rights and that this conduct caused her injuries,” Stabile concluded.
The Carlino case is one of thousands of lawsuits filed in courts across the country alleging problems with the TVT implants.
Earlier this week, the state Supreme Court agreed to hear an appeal in another Ethicon/Johnson & Johnson case, that one involving a lawsuit over the firm’s pelvic mesh product. The issue Pennsylvania’s highest court will address is whether Pennsylvania courts have jurisdiction to hear suits filed against New Jersey-based Ethicon by plaintiffs who do not live in the Keystone State.
https://www.pennlive.com/news/2019/04/pa-court-upholds-jurys-135m-award-against-johnson-johnson-subsidiary-over-defective-mesh-implant.html
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Justices Take Up Jurisdictional Fight in Pelvic Mesh Litigation
Apr 11, 2019 | The Legal Intelligencer
By Zack Needles
In a case with potentially wide-reaching ramifications, the Pennsylvania Supreme Court is now set to determine how the U.S. Supreme Court’s high-profile decision in Bristol-Myers Squibb v. Superior Court of California impacts the pelvic mesh litigation centralized in Philadelphia.
In a one-page order issued April 10 in Hammons v. Ethicon, the justices granted defendant pelvic mesh maker Ethicon’s appeal to consider a single issue: “Whether the due process clause of the Fourteenth Amendment to the United States Constitution and 42 Pa.C.S. Section 5322(c) precludes Pennsylvania from asserting personal jurisdiction over two New Jersey companies in a case brought by an Indiana resident asserting claims under the Indiana Product Liability Act.”
A unanimous three-judge Superior Court panel ruled last June to affirm a $12.85 million award handed up by a Philadelphia jury in late 2015. The award was the first verdict to come out of the pelvic mesh mass tort program in Philadelphia, where nearly 100 similar cases are pending.
The case also presented the Superior Court with its first opportunity to address the U.S. Supreme Court’s 2017 decision in Bristol-Myers Squibb, which made clear that out-of-state plaintiffs can’t sue companies where the defendants aren’t considered to be “at home,” or haven’t conducted business directly linked to the claimed injury. The ruling was hailed by the defense bar as “game-changing” and led to an immediate wave of venue challenges across the country.
Ethicon, which is a subsidiary of Johnson & Johnson, had contended that plaintiff Patricia Hammons’ claims were not sufficiently connected to activities that happened in Pennsylvania to establish specific jurisdiction under Bristol-Myers, and so, since Hammons is an Indiana resident and Ethicon’s principal place of business is New Jersey, Philadelphia did not have jurisdiction to handle the case.
However, Superior Court Judge Victor Stabile, who wrote the court’s 82-page precedential decision, said, “The connection between Ethicon and Pennsylvania is considerably stronger than the connection between Bristol-Myers and California.”
Specifically, Stabile noted that Ethicon had worked with an Allentown doctor, as well as Bucks County, Pennsylvania-based Secant Medical, to develop the pelvic mesh that was at issue in Hammons’ case.
“Emails between Ethicon and Secant officials demonstrate that Ethicon repeatedly communicated its requirements for mesh design and development, manufacturing, quality control, testing, and certification to Secant—all issues central to this litigation. The emails also show that Ethicon employees visited Secant’s plant in Pennsylvania on multiple occasions to observe the mesh production process,” Stabile said. “This evidence establishes an affiliation between Pennsylvania and Hammons’ cause of action against Ethicon for defective design of the Prolift device.”
Hammons’ case stemmed from having a Prolift mesh device implanted in 2009 to address a prolapsed bladder. Hammons contended that the density of the mesh caused scar tissue to build up and contract, which eventually led to erosion of Hammons’ bladder and “excruciating” pain. After the device failed, she had to have numerous surgeries, but contended that she will not be able to completely remove portions of the mesh that eventually adhered to the bladder.
In December 2015, the jury hit Ethicon with a $7 million punitive damages verdict after it initially awarded the plaintiff $5.5 million in compensatory damages. The judge later awarded delay damages.
The company raised 10 issues on appeal, arguing, among other things, that Hammons’ claims were not brought quickly enough, that the judge should not have allowed punitive damages and that the plaintiff failed to provide sufficient evidence to support her claims.
Stabile, however, denied those arguments.
Reached for comment about the April 10 allocatur grant, Hammons’ attorney, Shanin Specter of Kline & Specter, said in an emailed statement, “I think it’s wise for the Pennsylvania Supreme Court to provide guidance to other courts in the wake of the U.S. Supreme Court’s recent decision in [Bristol-Myers Squibb]. I’m confident that our Supreme Court will affirm the Superior Court given Ethicon’s relevant contacts in Pennsylvania.”
A spokeswoman for Ethicon said in an emailed statement that the company “doesn’t believe these out-of-state cases belong in Pennsylvania and is looking forward to the opportunity to present our arguments to the Pennsylvania Supreme Court.”
The April 10 allocatur grant in Hammons came about a week after a three-judge Superior Court panel, relying on Hammons, determined that ties between Ethicon and Secant were sufficient under Bristol-Myers Squibb to establish jurisdiction in the Keystone State.
https://www.law.com/thelegalintelligencer/2019/04/11/justices-take-up-jurisdictional-fight-in-pelvic-mesh-litigation/
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Texas Doctor Can't Duck Claims Over Hernia Repair
Apr 11, 2019 | the bmj
By Michelle Casady
A Texas appellate court has decided a doctor can't escape a patient's claims that an additional procedure the physician performed while surgically repairing a hernia caused hemorrhaging, rejecting the doctor's argument the patient hadn't connected his actions to the alleged injuries.
In an opinion issued Wednesday, the Twelfth Court of Appeals of Texas said the expert report Ansel Strahan submitted in support of his claims had adequately alleged that Dr. Darry Meyer's decision to perform a hernia repair on Strahan's right side, at the same time he was performing surgery to fix that problem on the left side, caused Strahan to hemorrhage.
Strahan alleged in his lawsuit that Meyer didn't have consent to fix the right-side hernia, and the extra procedure caused his injuries. There was a clause in the surgical consent form that allowed the doctor to perform additional procedures, but the expert report Strahan provided from Dr. David Befeler argued that should have been reserved for “life-threatening conditions” uncovered during surgery.
Befeler noted in his report that Strahan had a preexisting condition — essential thrombocythemia — which meant he had a high risk of bleeding from surgical procedures.
Meyer had argued Befeler's report doesn't address whether the right-side repair caused the hemorrhaging, or whether Strahan may have suffered hemorrhaging if the right-side repair hadn't been done.
Befeler's opinion was that prolonging the surgery and making “unnecessary incisions” caused the hemorrhaging and that Meyer should have performed two separate surgeries, allowing Strahan time to heal in between, according to the opinion.
The appellate panel wrote at this stage of the case, Befeler's reports gave the trial court enough basis to allow the lawsuit to proceed.
“At this stage we do not require a claimant to marshal all his proof or present evidence in the report as if he were actually litigating the merits,” the panel wrote. “Dr. Befeler’s reports, when read together, constitute an objective, good faith effort to comply with [Texas Civil Practice and Remedies Code] Chapter 74’s requirement to provide a fair summary of his opinion with respect to the causal relationship between Dr. Meyer’s alleged breach and Strahan’s injury.”
According to the opinion, Strahan, then 78, went to see Dr. Meyer on July 23, 2015, complaining of stomach pain. It was determined he needed surgery that day to repair a hernia. The surgical consent form contained a clause that allowed the doctor to perform another procedure if he realized one was needed after starting the planned surgery.
In this case, Meyer noticed Strahan had a hernia on his right side as well, and decided to repair that at the same time. The next day, after Strahan was discharged, he returned to Meyer complaining of pain and stomach swelling.
A CT scan showed he was hemorrhaging, according to the opinion, and an additional surgery was performed to fix that issue, but Strahan alleges it caused him “serious and permanent injuries.”
Aaron Arenas of The Lewis Law Firm, who represents Strahan, told Law360 he didn't think there was any merit to this appeal.
“I'm glad that the court of appeals followed the Texas Supreme Court precedent" on what qualifies as a sufficient expert report, he said.
Counsel for Meyer did not immediately return a message seeking comment Thursday.
Chief Justice James T. Worthen and Justices Brian Hoyle and Greg Neeley sat on the panel for the Twelfth Court of Appeals.
Strahan is represented by Aaron J. Arenas and Craig Lewis of The Lewis Law firm.
Meyer is represented by D. Jeffrey Rambin of Fairchild Price Haley & Smith LLP.
The case is Darry G. Meyer D.O. et al. v. Ansel Strahan, case number 12-18-00352-CV, in the Twelfth Court of Appeals of Texas.
https://www.law360.com/articles/1149020/texas-doctor-can-t-duck-claims-over-hernia-repair
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