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Ethicon Media Monitoring 8/9/2018
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Judge Slashes $15M From Pelvic Mesh Verdict Against J&J
Aug 8, 2018 | Law 360
By Bonnie Eslinger
An Indiana federal judge Wednesday conditionally reduced a $35 million verdict against a Johnson & Johnson unit awarded to a woman who was found to have been harmed by a pelvic mesh device — saying if she didn’t accept a $15 million reduction she’d face a new trial on punitive damages. -
NJ Woman's Mesh Case Doesn't Belong In Pa., Ethicon Says
Aug 8, 2018 | Law 360
By Matt Fair
Pennsylvania courts should not have been allowed to retain jurisdiction over a case involving injuries that a New Jersey woman suffered after having an implant of an allegedly defective mesh product manufactured by Johnson & Johnsonsubsidiary Ethicon Inc., a state appeals court heard during oral arguments on Wednesday.
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Judge Slashes $15M From Pelvic Mesh Verdict Against J&J
Aug 8, 2018 | Law 360
By Bonnie Eslinger
An Indiana federal judge Wednesday conditionally reduced a $35 million verdict against a Johnson & Johnson unit awarded to a woman who was found to have been harmed by a pelvic mesh device — saying if she didn’t accept a $15 million reduction she’d face a new trial on punitive damages.
The product liability case brought by plaintiff Barbara Kaiser alleged that she was substantially injured by the product, designed and manufactured by Johnson & Johnson and its subsidiary Ethicon Inc. A jury agreed, awarding Kaiser $10 million in compensatory damages and $25 million in punitive damages in March.
U.S. District Judge Philip P. Simon’s ruling on Wednesday responded to a motion from Johnson & Johnson contesting the verdict and seeking the court’s judgment over that of the jury on Kaiser’s failure-to-warn and design-defect claims. In the alternative, the pharmaceutical giant asked for a new trial, or a reduction to the jury’s damages award.
The judge began his 45-page ruling by denying the company's motion for a judgment as matter of law as well as the motion for a new trial, saying there was "sufficient evidence for a reasonable jury to find in favor of Mrs. Kaiser.”
Similarly, the judge said, the jury’s compensatory damages award “was neither monstrously excessive nor the product of passion or prejudice.” As a result, he rejected Johnson & Johnson’s request for reduction of that $10 million award.
“The jury’s punitive damage award, however, is another story,” the judge continued. “I find the punitive damages award excessive and unreasonable under controlling law.”
A much more “reasonable” punitive damages award, Judge Simon said, is $10 million, a $15 million reduction from what the jury handed Kaiser.
For his review of the punitive damages award, the court turned to the three-part analysis set forth by the U.S. Supreme Court in its 2003 State Farm Mutual Automobile Insurance Co. v. Campbell ruling. The high court in that case instructs a court to look at (1) the degree of reprehensibility of the defendant's misconduct; (2) the disparity between the actual or potential harm suffered by the plaintiff and the punitive damages award; and (3) the difference between the punitive damages awarded by the jury and the civil penalties authorized or imposed in comparable cases.
Judge Simon said there was evidence showing that the Johnson & Johnson unit, “was well aware of known risks associated” with its vaginal mesh implant, “and either recklessly or intentionally concealed those risks for years.” And Kaiser suffered physical pain and suffering from the product, called Prolift, the judge said.
But the jury erred in considering evidence of Johnson & Johnson’s $70 billion net worth when it calculated the punitive damages to be awarded, which should have been held up against just the companies’ profits in Indiana, Judge Simon said.
“The punitive damages in this case were only to address them as to Indiana,” the judge said, adding that the U.S. Supreme Court held in its 2007 Philip Morris USA v. Williams ruling that states may not impose their policy preferences on ‘neighboring states’ that might have different perspectives.
Johnson & Johnson’s profitability from Prolift was a little over $150,000 in Indiana, Judge Simon wrote in his Wednesday ruling.
“Here, while the jury heard evidence and the parties stipulated to defendants’ net worth being $70 billion, the award of $25 million represents over 166 times the amount of relevant profits earned by defendants which from the perspective of the defendant is clearly excessive,” the judge stated. A remittitur is warranted, he agreed.
Calling the calculation for reducing the damages award an “inexact science,” the judge said the $10 million compensatory award is larger than many other Prolift vaginal mesh verdicts and decided to reduce jury’s punitive damage award to a 1:1 ratio, or $10 million.
“Mrs. Kaiser now faces a choice: she can either accept a reduced punitive damage award (and thus be awarded $20 million dollars in total compared to the original $35 million awarded by the jury) or I will order a new trial on the issue of punitive damages,” the judge states in his ruling.
Kaiser’s claims stems from a 2009 procedure in which the Prolift device was implanted in her vagina to treat her pelvic organ prolapse, a disorder in which one or more of the pelvic organs drop from their normal position. Two years later, she learned from a doctor that her complaints of low pelvic pain could be tied to the implant, according to her 2012 complaint.
Kaiser claimed she subsequently experienced various issues including vaginal pain, pelvic pain, pain during intercourse, bladder spasms and bowel issues.
“All of these problems associated with the mesh necessitated a second surgical procedure to have the mesh removed from Mrs. Kaiser’s vagina, or at least as much of it as could be removed,” Judge Simon noted in his Wednesday ruling. “There was evidence that once the mesh is implanted it becomes very difficult, if not impossible, to have it all removed; it grows into the tissue, hardens and causes substantial pain.”
In her complaint, Kaiser alleged that contrary to the company’s marketing to the medical community and patients, the Prolift device has high failure, injury and complication rates and has caused severe injuries to a “significant” number of women.
She also cited a 2011 safety alert from the U.S. Food and Drug Administration warning health care providers and patients that serious complications associated with surgical mesh for treating pelvic organ prolapse are not rare and it was not clear that treating transvaginal pelvic organ prolapse with mesh was more effective than traditional repairs that didn’t use mesh.
The company failed to use adequate testing and research to evaluate the risks and benefits of the Prolift device, according to the complaint.
Representatives for the parties were not immediately reachable Wednesday to comment on Judge Simon’s decision.
Kaiser is represented by Thomas O. Plouff of Costello McMahon Burke & Murphy Ltd., and Jeffrey M. Kuntz and Thomas P. Cartmell of Wagstaff & Cartmell LLP, and Edward A. Wallace and Timothy E. Jackson of Wexler Wallace LLP.
Johnson & Johnson is represented by Jennifer L. Steinmetz of Tucker Ellis LLP, Mary Nold Larimore of Ice Miller LLP, and Amy M. Pepke and Amy M. Pepke of Butler Snow LLP.
The case is Kaiser et al v. Johnson & Johnson et al., case number 2:17-cv-00114, in the U.S. District Court for the Northern District of Indiana.https://www.law360.com/productliability/articles/1071604/judge-slashes-15m-from-pelvic-mesh-verdict-against-j-j
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NJ Woman's Mesh Case Doesn't Belong In Pa., Ethicon Says
Aug 8, 2018 | Law 360
By Matt Fair
Pennsylvania courts should not have been allowed to retain jurisdiction over a case involving injuries that a New Jersey woman suffered after having an implant of an allegedly defective mesh product manufactured by Johnson & Johnsonsubsidiary Ethicon Inc., a state appeals court heard during oral arguments on Wednesday.
The appeal is just one in a string of attacks that Ethicon is pursuing over whether non-Pennsylvania residents should be allowed to pursue claims over alleged mesh injuries as part of a mass tort program established in the Philadelphia County Court of Common Pleas.
Members of the three-judge Superior Court panel hearing Wednesday's case questioned whether Ethicon's arguments could stand, in the face of a recent decision finding that the company's reliance on Pennsylvania-based Secant Medical Inc. in connection with the manufacture of the mesh allowed for jurisdiction over out-of-state plaintiffs.
"The record in this case is replete with evidence of Ethicon's contact with Secant," Judge Victor Stabile said.
Ethicon is asking the Superior Court to throw out a $13.7 million 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.
A jury handed down a verdict 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.
Since the verdict, Ethicon has launched a renewed attack in pelvic mesh cases in Philadelphia over the impact of a recent U.S. Supreme Court decision — Bristol-Myers Squibb Co. v. Superior Court of California — limiting the ability of state courts to hear claims from out-of-state plaintiffs.
In the Bristol-Meyers Squibb case, the justices ruled that the company did not have sufficient business contacts in California to confer courts there with jurisdiction over some 600 lawsuits brought by out-of-state plaintiffs over injuries allegedly caused by the blood thinner Plavix.
But Judge Arnold New, the supervising judge of the pelvic mesh mass tort in Philadelphia, ultimately ruled last December that Ethicon’s relationship with Secant allowed nonresident plaintiffs to bring suit in Pennsylvania.
The Superior Court upheld that conclusion in June as it affirmed a nearly $13 million verdict won by Indiana resident Patricia Hammonds in a separate mesh case.
But D. Alicia Hickok, an attorney with Drinker Biddle & Reath LLP representing Ethicon, said the jurisdictional question in Carlino's case is distinct from Hammonds' case because Hammonds' claims did not encompass manufacturing defects that would implicate Secant.
"The claims that are being asserted are different than the claims that were being asserted in Ms. Hammonds' case," Hickok said. "There was no mention of Secant anywhere in the trial record."
Kline & Specter PC attorney Charles "Chip" Becker, an attorney for Carlino, countered by saying that regardless of any granular differences between the claims, the jurisdictional appeal in Carlino's case springs from the same order that was affirmed in the Hammonds case.
"Let's just take a step back and look at where we are procedurally," he said. "In the Hammonds case, the court considered that very order — the order that is on appeal now — and concluded that Judge New had properly denied the motion to dismiss."
The court took the case under advisement.
Representatives for the parties didn't immediately respond to requests for comment on Wednesday.
Carlino is represented by Shanin Specter, Lee Balefsky, Charles "Chip" Becker, Kila Baldwin and Ruxandra Laidacker of Kline & Specter PC, and Adam Slater of Mazie Slater Katz & Freeman.
Ethicon is represented by D. Alicia Hickok and William Carr of Drinker Biddle & Reath LLP, Stephen Brody of O’Melveny & Myers LLP, and Julie Callsen of Tucker Ellis LLP.
The case is Sharon Carlino v. Ethicon Inc. et al., case numbers 1129 EDA 2016 and 1294 EDA 2016, before the Pennsylvania Superior Court.https://www.law360.com/articles/1071555/nj-woman-s-mesh-case-doesn-t-belong-in-pa-ethicon-says
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