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Carlino
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J&J ORDERED TO PAY $13.5 MILLION OVER MESH IMPLANT
Feb 10, 2016 | Bloomberg Terminal
By Jef Feeley
Johnson & Johnson ordered by Pennsylvania jury to pay $13.25 million to woman who said one of co.’s vaginal-mesh implants eroded and injured her, according to plaintiff’s lawyer. -
J&J Hit With $13.5M Verdict In 2nd Philly Pelvic Mesh Trial
Feb 10, 2016 | Law360
By Matt Fair
A Philadelphia jury returned a $13.5 million verdict against a Johnson & Johnson unit on Wednesday in a case over allegations that the company’s faulty pelvic mesh implants left a woman with near constant pain and discomfort and an inability to have sex. -
Jury Awards $13.5M in Second Pelvic Mesh Trial
| Legal Intelligencer
By Max Mitchell
A Philadelphia jury has handed up a $13.5 million award to a woman claiming she was permanently injured from a pelvic mesh device that eroded inside her. -
$13.4M Verdict Returned In Pennsylvania State Court Ethicon Pelvic Mesh Case
Feb 10, 2016 | Lexis Legal News
By Tom Moylan
A Pennsylvania state court jury on Feb. 10 returned a $13.45 million verdict in an Ethicon Corp. pelvic mesh trial after about two hours of deliberation, according to the parties (Sharon Carolino, et al. v. Ethicon Women’s Health and Urology, et al., No. 130603470, Pa. Comm. Pls., Philadelphia Co.). -
Pa. Jury Awards Plaintiffs $13.5 Million At Conclusion of Ethicon Transvaginal TVT Device Trial
Feb 10, 2016 | HarrisMartin
A Pennsylvania jury has awarded plaintiffs $13.5 million in compensatory and punitive damages at the conclusion of a trial involving Ethicon Inc.’s Gynemesh TVT transvaginal mesh device, finding the defendants failed to adequately warn of the device’s risks.
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J&J ORDERED TO PAY $13.5 MILLION OVER MESH IMPLANT
Feb 10, 2016 | Bloomberg Terminal
By Jef Feeley
Johnson & Johnson ordered by Pennsylvania jury to pay $13.25 million to woman who said one of co.’s vaginal-mesh implants eroded and injured her, according to plaintiff’s lawyer.
* Jurors in state court in Philadelphia Wednesday held J&J and its Ethicon unit liable for Sharon Carolino’s injuries tied to mesh implant designed to treat incontinence, according to Adam Slater, lawyer who worked on Carolino’s case
* J&J and Ethicon ordered to pay Carolino and her husband $3.5 million in compensatory damages plus $10 million in punitive damages, Slater says
* Ethicon says it will start appeals process
* “We believe the evidence showed Ethicon’s TVT midurethral sling was properly designed and labeled, Ethicon acted appropriately and responsibly in the research, development and marketing of the product, and TVT was not the cause of the plaintiff’s continuing medical problems,” co. spokeswoman Samantha Lucas says in statement; says product has been deemed safe and effective by regulators and doctors
* NOTE: It was second case tried in Philadelphia over the devices
* CASE: Carolino v. Ethicon Inc., No. 130603470, Court of Common Pleas of Philadelphia County, Pennsylvania
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J&J Hit With $13.5M Verdict In 2nd Philly Pelvic Mesh Trial
Feb 10, 2016 | Law360
By Matt Fair
A Philadelphia jury returned a $13.5 million verdict against a Johnson & Johnson unit on Wednesday in a case over allegations that the company’s faulty pelvic mesh implants left a woman with near constant pain and discomfort and an inability to have sex.
The jury agreed that an Ethicon Inc. transvaginal tape product, known as TVT, was not reasonably safe, and that plaintiff Sharon Carlino’s physician would never have implanted the product had he been aware of its risks.
A Shanin Specter, an attorney with Kline & Specter PC representing Carlino and her husband, praised the verdict in an interview with Law360 and said he hoped it would prompt new efforts by the company to ensure product safety.
“The Carlinos are very gratified with the verdict, and I hope that Johnson & Johnson undertakes a bottom-up review of their conduct with regard to transvaginal mesh,” he said.
The verdict is the second damage award Ethicon has faced as a string of nearly 180 cases consolidated as part of a mass tort program in Philadelphia County’s Court of Common Pleas began to go to trial in December.
A jury in an initial case returned a $12.5 million verdict in December after agreeing that Ethicon’s Prolift pelvic mesh product was negligently designed and that a physician who implanted the product in plaintiff Patricia Hammons in 2009 received inadequate warnings about the risks.
The verdict returned on Wednesday included $10 million in punitive damages, $3.5 million in compensatory damages, and another $250,000 to Carlino’s husband for loss of consortium.
Specter claimed that the TVT product was defectively designed and that the company had offered inadequate warnings to her implanting physician.
The eight women and four men on the jury heard testimony from a number of doctors during the two-week trial regarding the alleged risks of the product, which Carlino was implanted with in 2005 to treat her stress urinary incontinence. The disorder causes small amounts of urine to involuntarily escape the body when sneezing or coughing.
After complaining of a sharp feeling in her vagina two years after she received the implant, Specter said that her doctor discovered that the mesh had become exposed, requiring surgery to remove a portion of the implant. Three years after that, she required another procedure after another patch of exposed mesh began causing her discomfort.
In 2012, Specter said, she began feeling pulling sensations and more pain due to scarring from the mesh implant and from the prior surgeries she had undergone to correct previous complications.
Specter said during closing arguments on Tuesday that he evidence showed that the product had four key flaws. He said that the pores in the mesh were too small, which prevented the tissue from properly growing through the mesh; instead, the implant generated rigid scar tissue, which caused the vagina to contract. He also said the mesh changes shape when implanted and tends to erode, fray or curl.
Additionally, according to Specter, when the tape is cut with a machine rather than a laser, pieces fall of the edges and become embedded in the vaginal tissue. Finally, he said, the mesh degrades when implanted.
“Altogether, these combine to lead to permanent pain,” he said on Tuesday. Even after follow-up surgeries, like one Carlino had to remove some of the mesh, “the pain remains or comes back or starts anew,” he explained.
Ethicon spokesman Samantha Lucas said the company planned to appeal.
“We have strong grounds for appeal,” she said in a statement provided to Law360. “We believe the evidence showed Ethicon’s TVT midurethral sling was properly designed and labeled, Ethicon acted appropriately and responsibly in the research, development and marketing of the product, and TVT was not the cause of the plaintiff’s continuing medical problems.”
She said the company stood by the product as a safe and effective treatment for stress urinary incontnence.
"Ethicon’s TVT device has been deemed safe and effective by regulators and physicians alike, and is considered by many, including most doctors who treat stress urinary incontinence, to be the gold standard for the treatment of this condition," Lucas said. "We have always made patient safety a top priority and will continue to do so.”
A third trial had been scheduled to start on Feb. 22, but court records indicate that the case was settled.
Specter declined to say whether any additional settlements had been reached or were in the works.
"That's up to Johnson & Johnson," he said.
Additional trials in the mass tort program are scheduled to start beginning in November, according to court records.
Carlino is represented Shanin Specter and other attorneys from Kline & Specter PC.
Ethicon is represented by attorneys from Butler Snow LLP, Friday Eldredge & Clark LLP, Drinker Biddle & Reath LLP and Thomas Combs & Spann PLLC.
The case is Carlino et al. v. Ethicon Inc. et al., case number 130603470, in the Court of Common Pleas of the State of Pennsylvania, County of Philadelphia.
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Jury Awards $13.5M in Second Pelvic Mesh Trial
| Legal Intelligencer
By Max Mitchell
A Philadelphia jury has handed up a $13.5 million award to a woman claiming she was permanently injured from a pelvic mesh device that eroded inside her.
The jury handed up the award in Carlino v. Ethicon late Wednesday morning, giving plaintiff Sharon Carlino $3.5 million in compensatory damages and $10 million in punitive damages. Johnson & Johnson subsidiary Ethicon was the defendant in the case.
The verdict is the second from the pelvic mesh mass tort program to hit trial in Philadelphia. It was also the second multi-million dollar plaintiff’s victory from the pelvic mesh cases. In December, a jury handed up a $12.5 million award to a woman making similar claims about an Ethicon-made pelvic mesh device.
The award in Carlino came after more than two weeks of trial, with Kline & Specter attorneys Shanin Specter and Kila Baldwin, and Rich Freese of Freese and Goss representing Carlino. Attorneys, including William Gage of Butler Snow Law Firm and Laura H. Smith of Friday, Eldredge & Clark, represented Ethicon.
In a statement to the press, Specter said the Carlino family was gratified by the verdict.
“We hope Johnson & Johnson undertakes a bottom up review of their conduct in vaginal mesh,” Specter said. A statement from Ethicon said the company plans to appeal the verdict.
“We have strong grounds for appeal,” Samantha Lucas, an Ethicon spokeswoman, said in the statement. “We believe the evidence showed Ethicon’s TVT midurethral sling was properly designed and labeled, Ethicon acted appropriately and responsibly in the research, development and marketing of the product, and TVT was not the cause of the plaintiff’s continuing medical problems.”
The statement went on to say the company empathized with women who suffer from urinary incontinence, and that physicians and regulators had deemed the type of mesh device implanted in Carlino to be safe and effective.
Carlino, however, had alleged that the device failed because it was negligently designed in several ways, and that its failure led her to suffer permanent pain during sex.
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$13.4M Verdict Returned In Pennsylvania State Court Ethicon Pelvic Mesh Case
Feb 10, 2016 | Lexis Legal News
By Tom Moylan
A Pennsylvania state court jury on Feb. 10 returned a $13.45 million verdict in an Ethicon Corp. pelvic mesh trial after about two hours of deliberation, according to the parties (Sharon Carolino, et al. v. Ethicon Women’s Health and Urology, et al., No. 130603470, Pa. Comm. Pls., Philadelphia Co.).
Shanin Specter of Kline & Specter in Philadelphia told Mealey Publications that a jury in the Philadelphia Common Pleas Court awarded $3.2 million in compensatory damages to plaintiff Sharon Carolino, $250,000 for loss of consortium to her husband Charles and $10 million in punitive damages.
Defendants Ethicon and Johnson & Johnson confirmed the verdict award.
TVT Device At Issue
In 2005, Sharon Carolino was implanted with a TVT pelvic mesh device made by Ethicon Women’s Health and Urology. The device was implanted to treat stress urinary incontinence.
Carolino experienced vaginal pain after her surgery, and a doctor found that part of the surgical mesh was exposed in her vagina. Carolino underwent two surgeries to remove mesh.
The plaintiff complained of dyspareunia, or painful sexual intercourse.
The trial began Jan. 22. Specter said the jury began and ended its deliberations Feb. 10.
Warnings, Design Claims
On Feb. 5, Judge Kenneth Powell denied Ethicon’s motion for a compulsory nonsuit based on the statute of limitations. He denied the defendants’ motions to dismiss the plaintiffs’ claims of failure to warn, design defect, loss of consortium and punitive damages.
In a Feb. 10 statement, Ethicon and Johnson & Johnson said they will file post-trial motions. They said they believe the evidence showed that the TVT device was property designed and labeled and that it was not the cause of Carolino’s medical problems.
Carolino is represented by Shanin Specter and Kila Baldwin of Kline & Specter in Philadelphia.
Ethicon is represented by Laura Hensley Smith of Friday, Eldredge & Clark in Little Rock, Ark.
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Pa. Jury Awards Plaintiffs $13.5 Million At Conclusion of Ethicon Transvaginal TVT Device Trial
Feb 10, 2016 | HarrisMartin
A Pennsylvania jury has awarded plaintiffs $13.5 million in compensatory and punitive damages at the conclusion of a trial involving Ethicon Inc.’s Gynemesh TVT transvaginal mesh device, finding the defendants failed to adequately warn of the device’s risks.
The Philadelphia Court of Common Pleas jury rendered the verdict on Feb. 10 in favor of Sharon Carlino, awarding her $3.5 million in compensatory damages for pain and suffering, $10 million to her husband Charles for loss of consortium, and $10 million in punitive damages, according to the court.
Judge Kenneth L. Powell Jr. presided over the two-week trial, during which Carlino’s surgeon, Dr. Andrew Blechman, testified that had he been adequately warned, he would not have implanted the device to treat Carlino’s stress-related urinary incontinence.
The Gynemesh TVT device is a sling-like implant consisting of polypropylene fibers that are knitted into a strip of porous, flexible fabric that is approximately 18 inches long and 1/2 inch wide. It is implanted through incisions in the vagina and under the bladder, where it provides support for the urethra and prevents bladder leakage. The Food and Drug Administration approved the Gynemesh TVT device in 1998 and it remains on the market.
Carlino was implanted with the device in 2005 during a hysterectomy. She alleged that by 2007, the mesh had eroded, causing her pain, and she underwent a partial removal surgery. Following that surgery, she continued to experience pain and underwent a third surgery in 2010 to revise and remove the mesh. Carlino alleged that the TVT device caused her to suffer infection, inflammation, scar tissue, organ perforation, dyspareunia, blood loss, pelvic floor damage, pelvic pain, and recurrent urinary incontinence.
Carlino and her husband sued Ethicon and its parent company, Johnson & Johnson, on June 26, 2013, accusing them of marketing the TVT device as safe and effective via “carefully planned, multifaceted marketing campaigns and strategies,” despite being aware of the device’s “high failure, injury and complication rates.”
“Defendants have consistently underreported and withheld information about the propensity of their pelvic mesh products and/or the mesh components manufactured by Secant Medical to fail and to cause injury and complications, and have misrepresented the efficacy and safety of their pelvic mesh products and/or the mesh components . . . through various means and media, actively and intentionally misleading the FDA, the medical community, patients, and the public at large,” the complaint said.
Plaintiffs asserted that “feasible and suitable alternative designs and products,” and “suitable alternative procedures and instruments for implantation and treatment of stress urinary incontinence, pelvic organ prolapse, and other similar conditions, have existed at all times relevant.”
The complaint also accused defendants of providing “incomplete, insufficient and misleading training and information to physicians, in order to increase the number of physicians utilizing the pelvic mesh products and/or the mesh components.”
Counsel for Carlino are Shanin Specter, Kila Baldwin and Michael Trunk of Kline & Specter in Philadelphia and Richard Freese of Freese & Goss in Dallas.
Ethicon is represented by Laura H. Smith of Friday, Eldredge & Clark in Little Rock, Ark.
Carlino, et ux. v. Ethicon Inc., et al., No. 1306-03470 (Pa. Comm. Pls. Ct., Phila. Cty.)
Document Is Available Call (800) 496-4319 or Search www.harrismartin.com Complaint Ref# DRU-1602-15
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