Preview Newsletter
Comprehensive List of Carlino Coverage Below
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2nd J&J Pelvic Mesh Trial Kicks Off In Philly
Jan 25, 2016 | Law360
By Matt Fair
A second trial over alleged injuries caused by a Johnson & Johnson unit’s pelvic mesh got underway in Philadelphia on Monday, as a jury heard arguments that a New Jersey woman was left with significant, irreparable pain due to scarring from a defective implant. -
Carlino v. Ethicon Transvaginal Mesh Trial Gets Started in Philadelphia
Jan 26, 2016 | Mesh Device News
By Jane Akre
he plaintiffs are Sharon and Charles Carlino of New Jersey and they are finally having their day in a Philadelphia, Pennsylvania court over her transvaginal mesh implant made by Johnson & Johnson. The case is A. Carlino v. Ethicon, Philadelphia Court of Common Pleas, Case No. 1306-03470 before Judge Kenneth J. Powell Jr. -
Pelvic Mesh Counsel Sanctioned for ‘Poisoning’ Questions
Feb 3, 2016 | Legal Intelligencer
By Max Mitchell
The trial judge overseeing the ongoing pelvic mesh trial in Philadelphia had harsh words for a defense attorney during a sanctions hearing, after the attorney was accused of asking a key witness “poisoning” questions in an alleged attempt to sway the witness’ testimony -
Jury Ready To Decide 2nd Philly Pelvic Mesh Case
Feb 9, 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 | Legal Intelligencer
By Max Mitchell
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. -
Toms River Woman Awarded $13.5 Million in Vaginal Mesh Case Against Johnson & Johnson
Feb 22, 2016 | New Brunswick Today
By Dave Schatz
On February 10, a Philadelphia jury found that Johnson & Johnson (J&J) manufactured a defective TVT pelvic mesh device, and awarded a Toms River woman $13.5 million. -
Jury docks Johnson & Johnson $14m in pelvic mesh lawsuit
Feb 12, 2016 | Mass Device
By Brad Perriello
A jury in Philadelphia this week reportedly docked Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon $13.5 million in the 2nd case involving its pelvic mesh products to go to trial in a mass tort in The City of Brotherly Love. -
Philly Pelvic Mesh Verdicts Spell Trouble For J&J
Feb 11, 2016 | Law360
By Dan Packel
After two consecutive jury verdicts exceeding $12 million in the first pelvic mesh cases tried in Philadelphia, Johnson & Johnson may think seriously about settling roughly 150 cases remaining in the jurisdiction’s mass tort program and focusing on the much larger federal multidistrict litigation, experts say. -
J&J Ordered to Pay $13.5 Million Over Mesh Implant
Feb 10, 2016 | Bloomberg (terminal only)
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. -
Just In: Carlino Pelvic Mesh Found Defective Awards $13.5 Million Against J&J
Feb 10, 2016 | Mesh Device News
By Jane Akre
Late this morning, a Philadelphia jury found Johnson & Johnson (J&J) made a defective pelvic mesh – the TVT- and awarded Sharon Carlino $13.5 million. The jury found the warnings to her doctor were defective and he said he would never have implanted the transvaginal polypropylene tape he used to treat her incontinence if he had known of its risks. -
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
Feb 10, 2016 | The 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.
Openings
During Trial
Closings
Verdict
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2nd J&J Pelvic Mesh Trial Kicks Off In Philly
Jan 25, 2016 | Law360
By Matt Fair
A second trial over alleged injuries caused by a Johnson & Johnson unit’s pelvic mesh got underway in Philadelphia on Monday, as a jury heard arguments that a New Jersey woman was left with significant, irreparable pain due to scarring from a defective implant.
Kline & Specter PC attorney Shanin Specter told the jury that the Ethicon Inc. mesh left Sharon Carlino living with constant pain and discomfort, and that the condition interferes with her ability to have sex with her husband.
“These problems have now gotten progressively worse,” Specter said. “They interfere with her daily life and with her very personal relationship with her husband, and unfortunately the mesh cannot be safely removed.”
Carlino’s is one of nearly 180 cases pending in a mass tort program — and the second to go before a jury — 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 the 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 award included $5.5 million in compensation plus another $7 million worth of punitive damages.
While Carlino is also pursuing claims of defective design and inadequate warnings, her case centers around Ethicon’s so-called TVT, or transvaginal tape, product.
Specter said Monday that Carlino received her TVT implant in 2005 to treat her stress urinary incontinence, which sees small amounts of urine involuntarily escape the body when sneezing or coughing.
After complaining of a sharp feeling in her vagina two years later, however, her doctor discovered that the mesh had become exposed, requiring surgery to remove a portion of the implant. Three years after that, Specter said, 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.
“When there is this vaginal scarring, the vagina simply can’t expand as it should,” Specter said. “This causes patients like Mrs. Carlino pain, including pain during intercourse. The defendants knew that this plastic mesh could erode through the wall of the vagina, requiring surgery to remove the eroded portion of the mesh, and that surgery to deal with erosions will cause further scarring, which in turn leads to more pain and permanent pain.”
Laura Smith of Friday Eldredge & Clark LLP, representing Ethicon, told the jury Monday that medical records in the case suggested Carlino had not complained to any of her doctors about the alleged pain and discomfort she began experiencing in 2012.
“Not one time did she ever complain of any of the problems Mr. Specter just told you she was claiming in this case,” Smith said.
Smith said that risks associated with any mesh implant for treating incontinence were well-known by the medical community.
“It is undisputed that this risk was well-known to Mrs. Carlino’s doctors and was warned about from the time of her surgery by Ethicon to all doctors,” Smith said.
Smith added that numerous independent medical organizations had praised the company’s mesh implants, calling them the “gold standard for treating women with incontinence.”
The case was argued for Carlino by Shanin Specter of Kline & Specter PC.
The case was argued for Ethicon by Laura Smith of Friday Eldredge & Clark LLP.
The case is Carlino et al. v. Ethicon Inc. et al., case number 130603470, in the Court of Common Pleas of Philadelphia County, Pennsylvania. -
Carlino v. Ethicon Transvaginal Mesh Trial Gets Started in Philadelphia
Jan 26, 2016 | Mesh Device News
By Jane Akre
he plaintiffs are Sharon and Charles Carlino of New Jersey and they are finally having their day in a Philadelphia, Pennsylvania court over her transvaginal mesh implant made by Johnson & Johnson. The case is A. Carlino v. Ethicon, Philadelphia Court of Common Pleas, Case No. 1306-03470 before Judge Kenneth J. Powell Jr.
This is the first trial of the TVT (transvaginal tape) since Lewis v. Ethicon which was dismissed by Judge Goodwin in WV federal court following a directed verdict motion by J&J. Unlike Lewis, this time a Failure to Warn the doctor will be allowed.
The case pits the couple against giant healthcare company J&J and its Ethicon division, maker of the transvaginal mesh implanted in Ms. Carlino. This is the second pelvic mesh trial in the Philadelphia court and one of 40,000 mesh cases filed against Ethicon, which is facing more defective product lawsuits filed in state and federal court than another other mesh maker.
In this court alone there are 180 cases pending for trial.
Mesh News Desk will not be in the courtroom, however, The Legal Intelligencer filed a story Monday, Jan. 25. See it here.
BACKGROUND
On August 18, 2005 Ms. Carlino was implanted with a Gynecare TVT to correct incontinence, by Dr. Andrew Blechman. By November 26, 2007 she had corrective surgery to revise and/or remove the J&J product. By December 2010, she had another revision surgery. All three surgeries were performed by Dr. Blechman.
TVT (transvaginal tape) is a polypropylene knitted mesh placed to support the urethra and bladder.
Secant Medical of Perkasie, PA is also a defendant in this case in that they manufactured and sold the mesh components to J&J.
As a result she has sustained injuries including, “mesh erosion, mesh exposure, mesh contraction, infection, inflammation, scar tissue, organ perforation, dyspareunia, blood loss, pelvic floor damage, pelvic pain and recurrent urinary incontinence,” which have led to corrective surgeries, mental and physical pain and financial losses, says her Complaint (Carlino complaint).
OPENING STATEMENTS
The Legal Intelligencer reports the TVT was the “worldwide gold standard” used in treating stress-related incontinence, according for the attorney representing Ethicon Laura Hensley Smith during opening statements Monday.
When the TVT was the first sling created by J&J to address incontinence, “It was revolutionary,” said Smith.
Shanin Specter said the TVT was defective in its design and was developed by Dr. Ulf Ulmsten who had a financial incentive to develop test results to J&J.
Eventually Dr. Ulmsten would sell his patented device to the company for millions, according to testimony in previous trials. TVT (transvaginal tape) was first sold in Europe in 1997 and in the U.S. in 1998.
Ms. Carlino first felt something sharp in her vagina and her doctor found part of the mesh had eroded. She had a second removal surgery after feel a sharp pain again. Her pain did not subside. Specter said the remaining pelvic mesh could not be removed safely.
The issue of small pelvic mesh pore size and and non-laser cut edges will also be brought into this trial as it has in other litigation. Small pores, under 3 mm, encourage bridging fibrosis and scar plate formation which shrinks the mesh. The TVT has sharp exposed edges not smoother edges which results when the polypropylene mesh material is cut with a laser.
Specter added that Ms. Carlino’s doctor was not informed of the defective and dangerous nature of the mesh. Dr. Blechman is an obstetrician-gynecologist. Ethicon attorney Smith said he was well trained in implanting the pelvic mesh and that she received the standard of care. Her problems are not related to the mes, the attorney said.
The mesh had to be removed because Ms. Carlino’s vaginal wall had thinned, she argued, reports The Legal Intelligencer.
The Carlinos are represented by Shanin Specter, Thomas Kline, Lee Balefsky and Michelle Tiger of Kline Specter O.C. of Philadelphia and Rich Freese of Freese & Goss, Dallas. Laura Hensley Smith is with Eldredge & Clark of Little Rock, Arkansas.
Plaintiffs’ attorney allege defective manufacture and design of the TVT and a failure to warn her physician or the plaintiff, “the defendants intentionally, recklessly, and maliciously misrepresented the safety, risks and benefits of the pelvic mesh products and or the mesh components understating the risks and exaggerating the benefits in order to advance their own financial interests, with wanton and willful disregard for the rights and health of the plaintiff.” Also alleged is negligence (a duty to care), common law fraud, negligent representation, negligent infliction of emotional distress, breach of express/ implied warranty (was safe to use by consumers), violation of consumer protection law, violating PA state consumer protection statutes, gross negligence, loss of consortium. Asking for punitive damages as well as compensatory damages. The Carlino case was filed June 26, 2013.
Judge Powell has limited each side to six days of testimony.
Kline Specter is the same law firm that just secured a $12.5 million jury award in the Patricia Hammons pelvic mesh case against Ethicon held in the Philadelphia court last month.
It took jurors less than one day to add the punitive portion of $7 million to the $5 million in compensatory damages.
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Pelvic Mesh Counsel Sanctioned for ‘Poisoning’ Questions
Feb 3, 2016 | Legal Intelligencer
By Max Mitchell
The trial judge overseeing the ongoing pelvic mesh trial in Philadelphia had harsh words for a defense attorney during a sanctions hearing, after the attorney was accused of asking a key witness “poisoning” questions in an alleged attempt to sway the witness’ testimony.
The defense attorney’s conduct eventually led the judge to issue a sanctions order Tuesday barring the defense from introducing any portions of its videotaped cross-examination of the witness.
According to court records, the defense attorney, Laura H. Smith, had asked the treating doctor in the case during a videotaped cross-examination about whether he was aware that the U.S. Food and Drug Administration approved the pelvic mesh device at issue. However, Philadelphia Judge Kenneth Powell, who is presiding over the case, Carlino v. Ethicon, had previously barred attorneys from making any mentions of the FDA.
A sanctions hearing was convened Tuesday after the plaintiff’s counsel objected to Smith’s line of questioning as a way of getting the treating doctor to change his testimony on whether he would have still prescribed the pelvic mesh device knowing what he knows now about the product.
According to a transcript of the hearing, Powell began the proceedings with some harsh words for Smith.
“Poisoning a witness is one of the most vile things you can do as an attorney, as an attorney who is competent and has questioned other witnesses in this case, and I know you can do cross-examination without violating orders, and that’s Ms. Smith, [she] took it upon herself to step outside the bounds of my order and to ask questions about the FDA,” Powell said, according to a transcript of the hearing.
“What you did was so far out of bounds that it’s astounding to me. Having seen you try this case or a piece of this case or the most of this case, I can’t believe that you did this,” Powell said later in the hearing.
In her defense, Smith, who practices out of Arkansas with the firm Friday, Eldrege & Clark, said she believed Powell’s order only related to conduct during trial and not to questions asked during depositions outside the court. She further said her mention of the FDA merely put some prior questioning by plaintiff’s attorney, Shanin Specter of Kline & Specter, in context.
“There were many statements made by counsel and some questions that I and I’m sure Mr. Specter would never have done in court, but it’s different in a deposition because it can be redacted before submitting,” Smith said, according to the transcript. “As to the issue of trying to poison, I think all good lawyers try to sway a witness to their side.”
Following the hearing, Powell issued an order barring the defense from introducing any portion of the cross-examination and recross-examination of the doctor “as a sanction for questioning during that deposition that violated this court’s order.”
A fuller version of this article will be posted later when the article is completed
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Jury Ready To Decide 2nd Philly Pelvic Mesh Case
Feb 9, 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 Carlino'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 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.
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 Carlino 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, Carlino'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 Carlino 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 Carlino'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 Carlino 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 Carlino'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. Carlino of what Ethicon warned Dr. Blechman, she would never had the surgery,” Gage said.
Carlino’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 | Legal Intelligencer
By Max Mitchell
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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Toms River Woman Awarded $13.5 Million in Vaginal Mesh Case Against Johnson & Johnson
Feb 22, 2016 | New Brunswick Today
By Dave Schatz
On February 10, a Philadelphia jury found that Johnson & Johnson (J&J) manufactured a defective TVT pelvic mesh device, and awarded a Toms River woman $13.5 million.
The award includes $10 million in punitive damages that J&J must pay.
The plaintiff, Sharon Carlino, now 58, had the TVT device implanted during a hysterectomy in 2005 at Jersey Shore University Medical Center, according to a report on Mesh Medical Device Newsdesk.
“The jury found the warnings to her doctor were defective and [Dr. Andrew Blechman] said he would never have implanted the transvaginal polypropylene tape he used to treat her incontinence if he had known of its risks,” reads the report.
But by 2007 she experienced feeling something “sharp” in her vagina because the mesh had eroded.
“After a partial removal surgery, in 2010 she felt the mesh eroding again and had a second removal surgery. By 2012 she felt pain and experienced dyspareunia or painful sex,” reads the report, adding that Carlino had a third surgery to remove the mesh.
Carlino’s complaint said she developed permanent injury, corrective surgery and experienced mental and physical pain and suffering. The complaint also cites her substantial financial and monetary losses as a result of a myriad of medical services and expenses related to having the plastic-like device implanted.
But, “at the same time [J&J marketed] their products as safe, effective reliable medical devices that are minimally invasive. Knowing the mesh had problems, J&J nonetheless sold it through ‘carefully planned, multifaceted marketing campaigns and strategies,’” says the report.
“They [Ethicon] rolled out the defense they’ve been using in mid-urethral sling case, after mid-urethral sling cases and this verdict shows those defenses don’t hold any water,” Attorney Adam Slater, who is said to have helped the team of Specter and Richard Freese, told Mesh Medical Device NewsDesk.
“The truth comes out in the courtroom...This trial shows is that these damages are meaningful to jurors. The defendant manufacturers have completely failed to convince any jury that the injuries caused by this mesh are mild and or acceptable.”
J&J recently paid $120 million, in its first large, multi-case mesh settlement, to stop as many as 3,000 lawsuits from going to trial.
And in December, an Indiana woman who had a similar J&J mesh product implanted was awarded $12.5 million by a Philadelphia jury.
"The longer J&J waits to settle, the numbers are not in their favor. They don't seem to understand that," Jane Akre, the founder of Mesh Medical Device News Desk, told New Brunswick Today in an email.
"There will be more deaths, suicides, more information coming forward about the additives to the mesh which may be causing autoimmune reactions in some women."
Akre said that women are still being harmed by the J&J mesh products.
"Just in case the public has the wrong impression- mesh is still being used, doctors are telling women 'it's different mesh' or that's been taken off the market. That's not true," said Akre.
"Women are still being injured. Docs are still being schooled in how to implant mesh. And these are not minor injuries such as 'cant have sex'... I regularly talk to women sobbing on the phone, they cannot leave their beds, they are on Oxycontin or morphine, they can't work, husbands leave, they lose their homes."
"The situation really hasn't improved much except J&J and others have quietly removed some of the worst offenders from the market (and are exporting them elsewhere)," Akre said.
"If you look at Risperdal and DePuy hips, the stance is always to fight them one-by-one in court, until the day they settle," said Akre. "So someone is watching and counting the risk versus benefit. Consider the recent restructuring of their medical device division, the benefit may not be exceeding the risk...and the risk is growing."
Attorneys who won the case wrote, “Cited in the latest case was a published study that noted a high incidence – 15.6 percent -- of mesh erosion in women. The two cases are the first of scores slated to be tried in Philadelphia.”
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Jury docks Johnson & Johnson $14m in pelvic mesh lawsuit
Feb 12, 2016 | Mass Device
By Brad Perriello
A jury in Philadelphia this week reportedly docked Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon $13.5 million in the 2nd case involving its pelvic mesh products to go to trial in a mass tort in The City of Brotherly Love.
The jury in the Philadelphia Court of Common Pleas awarded plaintiff Sharon Carlino $3.5 million in compensatory damages and $10 million in punitive damages, finding that the Ethicon transvaginal polypropylene tape implanted during a 2005 hysterectomy was defective and that the company failed to adequately warn of its risks, The Legal Intelligencer reported. Carlino eventually needed 3 revision surgeries to remove the eroded mesh.
In December 2015, a jury in the same court added $7 million in punitive damages to the $5.5 million in compensatory damages it leveled against Ethicon in the 1st of the mass tort cases to go to trial in Philly.
Carlino’s attorney, Shanin Specter, said the family is thankful for the verdict.
“We hope Johnson & Johnson undertakes a bottom-up review of their conduct in vaginal mesh,” Specter said, according to the newspaper.
“We have strong grounds for appeal,” Ethicon spokeswoman Samantha Lucas said in prepared remarks, the paper reported. “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.”
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Philly Pelvic Mesh Verdicts Spell Trouble For J&J
Feb 11, 2016 | Law360
By Dan Packel
After two consecutive jury verdicts exceeding $12 million in the first pelvic mesh cases tried in Philadelphia, Johnson & Johnson may think seriously about settling roughly 150 cases remaining in the jurisdiction’s mass tort program and focusing on the much larger federal multidistrict litigation, experts say.
On Wednesday, a jury hit J&J unit Ethicon Inc. with a $13.5 million verdict, which included $10 million in punitive damages, over a transvaginal tape product. This followed a $12.5 million jury verdict in December, including $7 million in punitives, over the company’s Prolift implant.
“Seeing two cases in a row producing a verdict in excess of $10 million, including substantial compensatory and punitive damages, is a trend that’s worrying for Ethicon,” Kennerly Loutey LLC attorney Max Kennerly told Law360.
J&J and Ethicon are defendants in the majority of the 177 cases currently listed in the Philadelphia County Court of Common Pleas pelvic mesh mass tort. These are included in the approximately 44,400 pelvic mesh suits the company faces nationwide, a figure that comes from the company’s most recent U.S. Securities and Exchange Commission filing. These cases are concentrated in the seven MDLs pending in West Virginia federal court, which together house more than 70,000 cases.
The implants are used widely to treat conditions including stress urinary incontinence and pelvic floor prolapse. But the plaintiffs have contended that the mesh pores are too small, leading to excessive scar tissue growth, and that the mesh is difficult to remove if it does not work properly.
Sharon Carlino, the recipient of Wednesday’s $13.5 million award, alleged that the transvaginal tape left her with near constant pain and discomfort and an inability to have sex.
Kennerly noted that she was able to land a sizable jury verdict even without a exceptional case.
“She didn’t have extraordinary injuries or a constellation of surgeries afterward,” he said. “It was a pretty standard implant problem, then partial excision, then continuing problems. I wouldn’t be surprised if there were thousands of cases virtually identical to hers out there.”
Even without shocking circumstances, the women bringing these cases can be very sympathetic plaintiffs, according to Duane Morris LLP partner Alan Klein.
“They had surgery in a sensitive area. They trusted their doctors to implant this device, and it didn’t work,” he said. “It’s not like a soft tissue injury. It’s an injury that is objectively discernable.”
While pelvic mesh defendants have had success elsewhere — in Missouri, a state jury found Boston Scientific and C.R. Bard not liable in a woman's $28 million suit over the companies' Solyx and Align devices — the plaintiffs have been able to prevail in Philadelphia thanks to Shanin Specter of Kline & Specter PC, the firm founded by the “best plaintiffs lawyers in the city” in Klein’s estimation.
“Soon, Shanin Specter is going to be able to do this in his sleep,” Kennerly said. “It’s going to become a trial in a box. And anyone else who tries these will have a nice, packaged, clean argument — openings, cross-examinations and closings that work really well.”
These realities suggest that J&J would be well-served by settling the suits that remain in Philadelphia and turning its attention to the MDL. The company has not been averse to avoiding some trials, including a Philadelphia case that had been scheduled for Feb. 22.
"From time to time, we have appropriately agreed to resolve some cases. However, we will not discuss the terms nor discuss our ongoing litigation strategy,” J&J spokesman Ernie Knewitz said in a statement.
But other factors militate against a swift resolution in Philadelphia. Kline & Specter also represents plaintiffs in the Philadelphia mass tort and will still be eager to litigate or pursue generous settlements in that forum. So will other lawyers, who, Kennerly says, would be “emboldened” by any sign of capitulation.
“Even if [a settlement is] confidential, no one is going to assume they’re closing it for $5,000 a case,” he said.
The next case on the schedule in Philadelphia is for November, after Kline & Specter withdrew as counsel for a case pegged for April.
To turn the course of the litigation in its favor, J&J is likely looking for one of two developments in its appeals of both Philadelphia verdicts, according to Cozen O'Connor PC partner James Heller. The first would be a defense verdict that gives it more leverage in any negotiations. The second would be a decision — ideally from an appellate court — that some of the evidence presented by the plaintiffs was inadmissible.
In any case, Heller said he would be surprised if there was not another trial in the mass tort.
“Two cases is not enough to throw up a white flag,” he said.
Heller added that the jury in the Carlino case seemed especially sympathetic to arguments that there was evidence of the transvaginal tape having failed in the past. The admission of this evidence depended on a court ruling that these prior occurrences were comparable to Carlino’s experience, but J&J will likely argue on appeal that this evidence shouldn't have been let in, he noted.
“They are going to argue on appeal that these prior issues or injuries aren’t substantially similar,” he said.
Any settlement decisions by the company will also depend on its internal valuation of the two cases already tried — whether it viewed them as matters that could be defended easily or whether it expected losses.
But a decision to soldier on in pursuit of a landscape-altering victory would have its risks.
“The more and more cases that you get where there’s plaintiffs’ verdicts of $12 million and $13 million or some large dollar amount, the harder it is to settle it cheap, either as a group or individually,” Heller said.
The cases are Carlino et al. v. Ethicon Inc. et al., case number 130603470, and Hammons v. Ethicon Inc. et al., case number 130503913, in the Court of Common Pleas of the State of Pennsylvania, County of Philadelphia. -
J&J Ordered to Pay $13.5 Million Over Mesh Implant
Feb 10, 2016 | Bloomberg (terminal only)
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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Just In: Carlino Pelvic Mesh Found Defective Awards $13.5 Million Against J&J
Feb 10, 2016 | Mesh Device News
By Jane Akre
Late this morning, a Philadelphia jury found Johnson & Johnson (J&J) made a defective pelvic mesh – the TVT- and awarded Sharon Carlino $13.5 million. The jury found the warnings to her doctor were defective and he said he would never have implanted the transvaginal polypropylene tape he used to treat her incontinence if he had known of its risks.
The case is A. Carlino v. Ethicon, Philadelphia Court of Common Pleas, Case No. 1306-03470 before Judge Kenneth J. Powell Jr.
After listening to the evidence in the two-week trial, the jury awarded Ms. Carlino $3.25 million in compensatory damages for her pain and suffering, $250,000 to Mr. Carlino for loss of consortium and $10 million in punitive damages.
This was the first trial of the TVT, made by the J&J division of Ethicon to go to a jury. A previous trial of the TVT in 2013, Lewis v. Ethicon, was dismissed by Judge Goodwin in a West Virginia federal court following a directed verdict motion by J&J.
According to The Legal Intelligencer, Ethicon attorney Laura Hensley Smith, told jurors J&J was proud of its TVT- the first mesh “sling” to treat stress-related incontinence. It was “revolutionary” and “the gold standard,” terms most mesh manufacturers use to describe their polypropylene implants used to treat prolapse and incontinence. The TVT was approved for sale by the Food and Drug Administration in 1998 in the U.S.
Shanin Specter of Kline & Specter representing Ms. Carlino told jurors the company blindly accepted data from the doctor who developed the TVT. “It was never properly analyzed and verified by anyone.”
Ms. Carlino has the TVT placed during a hysterectomy. She was implanted August 18, 2005, at Jersey Shore University Medical Center by Dr. Andrew Blechman. By 2007 she felt something “sharp” in her vagina where mesh had eroded. After a partial removal surgery, in 2010 she felt the mesh eroding again and had a second removal surgery. By 2012 she felt pain and experienced dyspareunia or painful sex. She had a third surgery, also by Dr. Blechman to revise and remove the mesh.
She has undergone permanent injury, corrective surgery and has experienced mental and physical pain and suffering, financial and economic loss including medical services and expenses, says her complaint. At the same time defendants market their products as safe, effective reliable medical devices that are minimally invasive. Knowing the mesh had problems, J&J nonetheless sold it through “carefully planned, multifaceted marketing campaigns and strategies.”
Attorney Adam Slater who helped the team of Specter and Richard Freese tells Mesh News Desk this is a very important verdict.
“They (Ethicon) rolled out the defense they’ve been using in mid-urethral sling case, after mid-urethral sling cases and this verdict shows those defenses don’t hold any water. The idea that the TVT is the Gold Standard and the professional societies think its the best treatment for women, juries don’t care when they see the truth through the internal documents and deposition testimony. The truth comes out in the courtroom. The other thing this trial shows is that these damages are meaningful to jurors. The defendant manufacturers have completely failed to convince any jury that the injuries caused by this mesh are mild and or acceptable.”
Slater adds that Specter and Freese put in a tremendous effort for their client.
SETTLEMENT OFFERED
Just last month, J&J made its first settlement offer to 2,000 to 3,000 pelvic mesh sufferers offering $120 million to end their product liability cases. See the story here.
After a disappoint fourth quarter 2015 report on its medical device division, the company said it planned to restructure by eliminating 3,000 jobs. Part of the problem is the enormous cost of litigation in fighting the 42,000 pelvic mesh cases filed against the company.
J&J says it has spent $141 million in total litigation costs in 2015, down from $1.2 billion in defense costs in 2014.
In December in the same Court of Common Please in Philadelphia, a jury there found for plaintiff Patricia Hammons, 65 and awarded her $12.5 million – $5.5 million in compensatory damages and $7 million in punitive damages. The jury found the Prolift mesh, used to treat prolapse, was defectively designed and the company failed to warn doctors about its inherent dangers that were well understood. See the story here.
J&J is facing nearly 31,000 cases consolidated in federal court in Charleston, WV in multidistrict litigation, the largest number of any of the six other manufacturers. Thousands of other cases have been filed against the company in state courts and globally.
While J&J quietly removed four of its pelvic meshes from the market in mid 2012, the TVT and its cousin the TVT-O (obturator) remain on the market and are still called the “Gold Standard” by many doctors. However, many doctors who sit at the head of medical societies such as AUGS are preceptors or consultants for device manufacturers.
FDA REACTS
The U.S. Food and Drug Administration has been slow to react to the thousands of injury reports coming into the agency. After first notifying the public that mesh complications are “rare ” in 2008, the FDA reversed itself by mid 2011 saying mesh complications are “not rare” especially for the larger meshes used to treat a prolapsing uterus and to reinforce a pelvic floor. The agency ordered three year post-approval monitoring of the POP (pelvic organ prolapse) mesh. Just last month, the FDA finally adapted a recommendation of its expert panel in 2011, and reclassified POP mesh as “high risk” or class III which will require clinical trials before it is marketed.
Mesh makers have 30 months to prove the safety and efficacy of their product to the FDA or POP mesh cannot be sold. The reclassification did not extend to mesh used to treat stress urinary incontinence or SUI mesh. It remains “moderate risk” or class II, despite the fact that it is more commonly used than POP mesh and may represent twice the number of cases filed in this product liability litigation. #
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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
Feb 10, 2016 | The 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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