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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. -
Just In: Carlino Pelvic Mesh Found Defective Awards $13.5 Million Against J&J
Feb 10, 2016 | Mesh Medical Device News Desk
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. -
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.
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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.
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, he said “the pain remains or comes back or starts anew."
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. -
Just In: Carlino Pelvic Mesh Found Defective Awards $13.5 Million Against J&J
Feb 10, 2016 | Mesh Medical Device News Desk
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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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 unanimously 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 is also the second multimillion-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 & Goss representing Carlino. Ethicon was represented by William Gage of Butler Snow and Laura H. Smith of Friday, Eldredge & Clark.
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," said Samantha Lucas, an Ethicon spokeswoman, 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.
Although Carlino's case was the second pelvic mesh trial in Philadelphia, litigation over the device has been active throughout the country.
As of January, more than 74,000 cases were pending in seven multidistrict litigations in the Southern District of West Virginia, according to court records. The largest MDL, which is against Ethicon, has 29,296 cases pending. More than 11,700 cases from the MDLs have been resolved, according to court records.
In May, a Delaware jury awarded $100 million, including $75 million in punitive damages, to a woman who experienced complications from a transvaginal mesh implant that Boston Scientific Corp. made. A Texas jury also awarded $1.2 million against J&J in a pelvic mesh case last year, although that verdict was recently tossed.
Earlier this month, a jury in a Missouri state court also handed up a defense verdict for Boston Scientific.
Bloomberg Business also reported late last month that Johnson & Johnson has proposed paying $120 million to settle 2,000 to 3,000 pelvic mesh suits.
According to court records, there are 179 cases pending in the Philadelphia pelvic mesh program.
During closing arguments Tuesday, Specter had hammered the device makers as "beyond reckless" for their alleged failure to tell doctors and patients about the erosion rates of the device and the risk of permanent harm.
"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."
According to Specter, 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.
However, Gage countered that many of the facts of Carlino's case did not add up.
In his closing arguments, 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?"
Gage also noted that Carlino did not begin making complaints of pain during sex until 2015, after she met with an attorney.
"When you look at these records, the closer we got to trial, the worse the plaintiff's complaints get," Gage said.
The Carlino case was tried before Philadelphia Court of Common Pleas Judge Kenneth Powell.
The next pelvic mesh case set for trial is expected to begin in early April.
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