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Ethicon Media Monitoring 5/22/2019
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More pelvic mesh cases are heading to Pa. federal court in wake of series of big verdicts
May 21, 2019 | The Legal Intelligencer
By Max Mitchell
Philadelphia juries have hammered Johnson & Johnson subsidiary Ethicon with more than $345 million in verdicts over its pelvic mesh products, and now another wave of litigation is coming to Pennsylvania. -
J&J tells 7th circuit missing FDA evidence dooms $20M Verdict
May 21, 2019 | Law360
By Celeste Bott
A Seventh Circuit panel on Tuesday pushed back against Johnson & Johnson's argument the court should throw out a $20 million verdict because the company was wrongly barred from presenting evidence from the U.S. Food and Drug Administration that its pelvic mesh was safe and effective. -
Philadelphia jury smacks Johnson & Johnson, Ethicon with $80M pelvic mesh verdict
May 21, 2019 | The Pennsylvania Record
By Nicholas Malfitano
Just weeks after a Philadelphia jury reached a $120 million verdict against Johnson & Johnson and its subsidiary, Ethicon, Inc. and in favor of a plaintiff who claimed she suffered at the hands of a defectively-designed pelvic mesh device, another jury in a similar action has handed down a verdict of $80 million.
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More pelvic mesh cases are heading to Pa. federal court in wake of series of big verdicts
May 21, 2019 | The Legal Intelligencer
By Max Mitchell
Philadelphia juries have hammered Johnson & Johnson subsidiary Ethicon with more than $345 million in verdicts over its pelvic mesh products, and now another wave of litigation is coming to Pennsylvania.
Late last month, the judge overseeing the multidistrict litigation in West Virginia federal court transferred dozens of cases back to their home districts across the country, with the largest batch of lawsuits—nearly 20—ending up in Pennsylvania federal court. Since the April 26 transfer, defendants have sought to toss some cases, and in others judges have begun entering scheduling orders, complete with 2020 trial dates.
Kline & Specter attorney Shanin Specter, a leading attorney in the pelvic mesh litigation whose firm tried each successful case in Philadelphia, said he expects the federal cluster of cases will move quickly to trial.
“The judges right now are scheduling conferences in the cases,” he said. “We expect, particularly given how quickly judges in this district move their dockets, that there will be some additional discovery done in a brief time, and there will be prompt trial listings.”
Mindy Tinsley, a spokeswoman for Ethicon, said in an emailed statement, “We look forward to defending these cases in federal court.”
U.S. District Judge Joseph Goodwin of the Southern District of West Virginia transferred a wave of nearly 50 cases out of the MDL last month. Of those cases, 18 cases were sent to Pennsylvania federal courts, with 16 going to the U.S. District Court for the Eastern District of Pennsylvania and two going to the Western District.
The pelvic mesh MDL, which once included more than 100,000 cases pending against six defendants, stood at about 15,000 cases as of mid-May. According to Goodwin’s order, plaintiffs in the majority of remaining cases have settled, but “thousands remain languishing” in the court.
“For convenience of the parties and in order to promote the final resolution of these cases, it appears to the court that the cases would be more expeditiously concluded in the jurisdiction from which they originally came to this court,” Goodwin said.
Along with sending nearly 20 cases to Pennsylvania in his first wave of transfers, Goodwin also sent cases to Connecticut, New York, Texas, California, Georgia and other states.
Although federal juries have awarded juries significant verdicts over the allegedly dangerous products, the largest verdict in the litigation so far was handed up by a Philadelphia state court jury late last month. The case, McFarland v. Ethicon, ended with a $120 million verdict, including $100 million in punitive damages. The judge who oversaw the trial denied Ethicon’s post-trial motions Monday.
The McFarland verdict was followed up less than a month later with an $80 million verdict for a Pennsylvania woman.
McFarland was also preceded by a $41 million verdict in January. All three cases were tried before a Philadelphia state court jury.
Ethicon has won two defense verdicts in the litigation, with the latest coming in mid-April. The first defense win, however, was later reversed by the trial court, after the judge who oversaw the case determined that the jury’s findings were inconsistent on the issue of whether the alleged design defect caused the injuries.
The judge ultimately determined that the case should proceed to a damages hearing, but that decision is currently on appeal to the Pennsylvania Superior Court.
A significant difference between state and federal trials is the jury pool. While the Philadelphia Court of Common Pleas pulls jurors from around the city, the Eastern District jury pool includes jurors from as far west as Lancaster County and as far north as Northampton County.
Specter said he did not expect the trials in federal courts to be substantially different than those that have taken place in state court because Philadelphia’s trial judges largely modeled their rulings off of Goodwin’s decisions.
“We’ve now had nine trials, our firm. Eight victories, seven of those involved the imposition of punitive damages. Even the ninth case, the jury found negligence,” Specter said. “There’s an overwhelming message that’s being transmitted by eight separate juries, really nine separate juries, that the company has acted very badly, and it’s disturbing that the mesh products for stress urinary incontinence are still on the market.”
However, before any of the federal trials get underway, one pelvic mesh case is scheduled to come before another Philadelphia jury in early June, and another wave of state court cases are set to be tried in state court in the fall.
https://www.law.com/thelegalintelligencer/2019/05/21/more-pelvic-mesh-cases-are-heading-to-pa-federal-court-in-wake-of-series-of-big-verdicts/
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J&J tells 7th circuit missing FDA evidence dooms $20M Verdict
May 21, 2019 | Law360
By Celeste Bott
A Seventh Circuit panel on Tuesday pushed back against Johnson & Johnson's argument the court should throw out a $20 million verdict because the company was wrongly barred from presenting evidence from the U.S. Food and Drug Administration that its pelvic mesh was safe and effective.
The panel raised concerns that reversing the lower court's decision to exclude evidence regarding FDA regulation of medical devices would be a departure from the findings of other federal appellate courts.
"We would be running upstream against other circuits reversing on that ground," U.S. Circuit Judge Diane S. Sykes said during oral argument. "Federal law did not prohibit your client from redesigning this implant to be safer and submitting a request for a safer design."
J&J subsidiary Ethicon Inc. told the court the jury heard "one-sided fiction" during the trial, in part because it wasn't allowed to present the FDA findings. A jury sided against the company on design defect and failure-to-warn claims over the company's Prolift pelvic mesh device.
"Excluding the FDA evidence in this case is equivalent to dropping a soldier in the middle of a battlefield with no weapon or even shoes," said Lisa Blatt of Williams & Connolly LLP, counsel for Ethicon.
Ethicon also said federal law requiring device designs to get FDA approval preempts Indiana's design defect tort law and should have blocked the case altogether. And Blatt said Tuesday that Indiana resident Barbara Kaiser failed to show evidence the mesh was unreasonably dangerous or that an alternative design would have prevented her injuries, nor did she show the risks of implanting pelvic mesh weren't understood by her surgeon.
Manufacturers such as Ethicon owe a duty to the doctors that are their customers and doctors in turn have duties to their patients, Blatt said, noting Kaiser could have brought a medical malpractice lawsuit against her surgeon.
"There's no dispute surgeons unquestionably knew these side effects could occur," Blatt said. "No one stopped [Kaiser] from suing her doctor."
But Mark Miller of Wexler Wallace LLP, Kaiser's attorney, pointed to testimony from the surgeon who implanted the mesh. Gregory Bales testified at trial that Prolift posed greater risks of harm than he and other surgeons expected at the time, including higher than expected risks of chronic pelvic pain and scarring.
"This is competent testimony from an experienced surgeon," Miller said.
When Bales did become aware of the "the nature, the intensity and severity" of the side effects, he stopped using Prolift, Miller said.
In Kaiser’s case, those side effects include chronic pain, painful bladder spasms and bowel movements and pain during sex that prevents her from having intercourse with her husband, according to court documents. The mesh implant "ruined her life," Miller said.
Judge Sykes asked Miller if the jury needed to have the FDA background to determine what a manufacturer could or couldn't do in this situation, but Miller said whether Ethicon followed the regulatory process has nothing to do with whether the device was unreasonably dangerous under Indiana law.
Kaiser was implanted with the Prolift device in January 2009 to treat her pelvic organ prolapse, according to court documents. Two years later, she learned from a doctor that her complaints of low pelvic pain could be tied to the implant, she said.
In her 2012 lawsuit, 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.
An Indiana jury awarded Kaiser and her husband awarded Kaiser and her husband in compensatory damages and $25 million in punitive damages, but the trial court judge slashed the latter award by $15 million, finding it to be excessive and unreasonable.
On appeal, Ethicon said any award of punitive damages was inappropriate in this case because it requires clear and convincing evidence of wrongdoing, which Kaiser could not show.
U.S. Circuit Judges Michael S. Kanne, Joel M. Flaum, Diane S. Sykes sat on the panel for the Seventh Circuit.
Ethicon is represented by Lisa S. Blatt and Katherine Moran Meeks of Williams & Connolly LLP, Stephen D. Brody, Jason Zarrow and David K. Roberts of O'Melveny & Myers LLP, R. Stanton Jones, Stephen K. Wirth, Samuel Callahan and William Perdue of Arnold & Porter Kaye Scholer LLP, Mary Nold Larimore of Ice Miller LLP, and Amy M. Pepke of Butler Snow LLP.
https://www.law360.com/trials/articles/1161803/j-j-tells-7th-circ-missing-fda-evidence-dooms-20m-verdict
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Philadelphia jury smacks Johnson & Johnson, Ethicon with $80M pelvic mesh verdict
May 21, 2019 | The Pennsylvania Record
By Nicholas Malfitano
Just weeks after a Philadelphia jury reached a $120 million verdict against Johnson & Johnson and its subsidiary, Ethicon, Inc. and in favor of a plaintiff who claimed she suffered at the hands of a defectively-designed pelvic mesh device, another jury in a similar action has handed down a verdict of $80 million.
The verdict, comprised of $30 million in compensatory damages and $50 million in punitive damages, is the eighth result delivered in favor of pelvic mesh plaintiffs in Philadelphia courts and it brings the total amount of damages awarded to them to well over $340 million.
Thomas Kline of Kline & Specter, a member of counsel for plaintiffs Patricia and George Mesigian, offered comment on the trial result.
“In this largest transvaginal compensatory jury verdict to date, this jury resoundingly found that Johnson & Johnson terribly injured another one of thousands of women implanted with its defective transvaginal mesh device, recognizing not only the severity of the injury but the abhorrence of the conduct,” Kline stated.
An Ethicon spokeswoman stated while the company “respects the legal process," in its view, the jury did not have the opportunity to hear all the evidence and will appeal the verdict.
“While Ethicon empathizes with women who experience medical complications, this verdict and the damages awarded are inconsistent with the science and Ethicon’s actions. We believe the evidence showed Ethicon’s PROLIFT device was properly designed and that Ethicon acted appropriately and responsibly in the research, development and marketing of the product,” Mindy Tinsley said.
“The jury was not permitted to hear critical evidence related to the FDA’s review and classification of these devices, which we believe significantly influenced the verdict and punitive award in this case. We respect the legal process, but we want to reiterate that jury verdicts are not medical, scientific or regulatory conclusions about a product and Ethicon will appeal this verdict.”
Mesigian, a 75 year-old Media resident, suffered organ prolapse more than a decade ago and had the pelvic mesh device implanted in 2008 to treat that condition – but her counsel said the device failed and left her with chronic inflammation, infections, and pain during sexual intercourse, even after subsequent surgeries attempted to remedy those after-effects.
Last month, the Food & Drug Administration ordered pelvic mesh product manufacturers to immediately cease sales of their products, as there was no “reasonable assurance” that they were safe.
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair pelvic organ prolapse. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.
“Patient safety is our highest priority, and women must have access to safe medical devices that provide relief from symptoms and better management of their medical conditions. The FDA has committed to taking forceful new actions to enhance device safety and encourage innovations that lead to safer medical devices, so that patients have access to safe and effective medical devices and the information they need to make informed decisions about their care.”
In a separate case resolved in April, a jury found in favor of Johnson & Johnson and Ethicon in a similar pelvic mesh trial.
More than 80 similar cases are currently being litigated in the Philadelphia County Court of Common Pleas’ Complex Litigation Center.
https://pennrecord.com/stories/512504166-philadelphia-jury-smacks-johnson-johnson-ethicon-with-80m-pelvic-mesh-verdict
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