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Jury Ready To Decide 2nd Philly Pelvic Mesh Case
Feb 10, 2016 | Law360
By Dan Packel
A Philadelphia jury will begin deliberating Wednesday whether a Johnson & Johnson unit could be held liable for a New Jersey woman's pain and inability to have sexual intercourse, in the second case to be tried in the jurisdiction's mass tort program for pelvic mesh implants. -
Attorney Slams Pelvic Mesh Maker As 'Beyond Reckless' in Closing
Feb 10, 2016 | Max Mitchell
By The Legal Intelligencer
The attorney representing the plaintiff in the ongoing pelvic-mesh trial in Philadelphia hammered the device makers during his closing argument for their alleged failure to tell doctors and patients about the erosion rates of the device and the risk of permanent harm.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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Jury Ready To Decide 2nd Philly Pelvic Mesh Case
Feb 10, 2016 | Law360
By Dan Packel
A Philadelphia jury will begin deliberating Wednesday whether a Johnson & Johnson unit could be held liable for a New Jersey woman's pain and inability to have sexual intercourse, in the second case to be tried in the jurisdiction's mass tort program for pelvic mesh implants.
Kline & Specter PC attorney Shanin Specter told the jury in closing arguments Tuesday that transvaginal tape manufactured by Ethicon Inc. was not reasonably safe, and that plaintiff Sharon Carolino's physician would never have implanted the product had he been aware of its risks.
“The evidence shows that this woman has been courageous. She's trusted Ethicon and Johnson & Johnson,” Specter said. “She trusted her doctor for apparently good reason, but he didn't know what he should have known. They've thrown everything at the wall to try to beat her down.”
Over the last two weeks, the eight women and four men on the jury have heard a number of doctors speak to the risks of Ethicon's so-called TVT product, which Carolino 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.
According to Specter, the evidence showed that the product had four key flaws. He said Tuesday 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. Even after follow-up surgeries, like one Carolino had to remove some of the mesh, “the pain remains or comes back or starts anew,” he explained.
Specter, nodding to current product liability law in Pennsylvania, noted to the jury that there was at least one reasonable alternative strategy to correct the ailment that did not use TVT — the “Burch procedure,” which he said used sutures manufactured by J&J.
Butler Snow LLP attorney William Gage responded by questioning the evidence behind Specter's alternatives, Carolino's medical history, and her doctor's testimony about his familiarity with the product's risks.
“It's like we didn't come to the same trial,” Gage told the jurors.
Gage highlighted that while Carolino said she had pain on the right side of her vagina, this was the side where the TVT had been removed.
“It's been taken out almost six years ago,” Gage said.
He also said that Carolino's medical records did not show she had experience pain from sex for several years after undergoing the procedure, suggesting this changed as the litigation advanced.
“The closer to trial, the worse the complaints got,” Gage said.
He also said that Carolino waited too long before filing her lawsuit in June 2013, pointing out what he called 26 reasons that the suit was barred by the statue of limitations.
And he suggested that Carolino's real complaint should have been with her implanting physician, Dr. Andrew Blechman, saying that Blechman testified that he knew of the risks of the product as early as 2005.
“If Dr. Blechman had only warned Mrs. Carolino of what Ethicon warned Dr. Blechman, she would never had the surgery,” Gage said.
Carolino’s is one of nearly 180 cases pending in a mass tort program in the Philadelphia County Court of Common Pleas.
An initial case, tried in December, resulted in $12.5 million in total damages against Johnson & Johnson, with a jury agreeing that a different Ethicon 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.
Carolino 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 Carolino et al. v. Ethicon Inc. et al., case number 130603470, in the Court of Common Pleas of the State of Pennsylvania, County of Philadelphia. -
Attorney Slams Pelvic Mesh Maker As 'Beyond Reckless' in Closing
Feb 10, 2016 | Max Mitchell
By The Legal Intelligencer
The attorney representing the plaintiff in the ongoing pelvic-mesh trial in Philadelphia hammered the device makers during his closing argument for their alleged failure to tell doctors and patients about the erosion rates of the device and the risk of permanent harm.
During closing arguments Tuesday, Kline & Specter attorney Shanin Specter told the jury in Carlino v. Ethicon that the company's conduct was "beyond reckless."
According to Specter, leaders at Ethicon had been aware that the pelvic mesh device had high failure rates, but they did not put the information in the medical literature, and they placed concerns about sales over patient safety.
"It is conclusive evidence of reckless disregard. Reckless, reckless, reckless. You know these things, and you don't act. You don't fix the product. You don't decline to sell it. You don't tell doctors about the risk, and you don't tell patients about the risks," Specter told the jury of eight women and four men. "It's the epitome of recklessness. It's why they built this courthouse, and this courtroom, and why you got a court summons. You've got to straighten it out. It's as simple as that."
The closings came after more than two weeks of trial in Philadelphia Court of Common Pleas Judge Kenneth Powell's courtroom focusing on the claims of plaintiff Sharon Carlino, who had an Ethicon-manufactured pelvic mesh device implanted in her in 2005 to combat her urinary incontinence. Carlino has alleged that the device failed because it was negligently designed, and that its failure led her to suffer permanent pain during sex.
Specter told the jury the mesh was defective because its pores were too small, it had a tendency to degrade, it was overly friable because it was cut by a machine and not a laser, and the mesh can erode through the patient's tissue.
According to Specter, the small pores of the mesh often caused a reaction where, instead of growing regular tissue around the mesh, hardened scar tissue developed, which caused the mesh to bunch. Specter said heads of Ethicon, which is a Johnson & Johnson subsidiary, had known of the bunching problem when the product was launched, and they had also received numerous reports of the mesh breaking apart in patients' bodies, but they did not change the labeling materials to warn doctors.
"What do they care about? They care about marketing. They care about sales. They weren't caring about safety," Specter said.
Specter contended that safer alternatives to the mesh had been used at the time—including mesh with thinner pores and a procedure, known as the Burch procedure—that involved placing two sutures to address the incontinence.
Specter said the jury had been told the Burch procedure had "stood the test of time."
"They were insistent on fixing something that wasn't broken. Why? To make money," Specter said. "Let's come up with a solution that is worse than the current situation."
However, counsel for Ethicon, Butler Snow attorney William Gage, argued many of the facts of Carlino's case did not add up.
Gage focused on Carlino's medical records to attack the claim that the mesh caused the claimed injuries. Gage noted that Carlino's complaints were primarily on the right side; however, he said the mesh had been removed from her right side in 2010, and only remained on Carlino's left side. Gage further noted that she had prior medical reports of pain and muscle spasms in her right leg and back, and that a doctor had diagnosed her with vaginal atrophy and pelvic floor muscle spasms.
"If the mesh is causing her pain on the right side, why isn't it causing pain on the left side where all the mesh remains?" Gage asked. "How can it be a substantial factor if it's nowhere near the place where it needs to be?"
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