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Ethicon 2/24
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J&J Subsidiary Seeks to Ax $13.5M Pelvic Mesh Verdict
Feb 24, 2016 | The Legal Intelligencer
By Max Mitchell
The Johnson & Johnson subsidiary that was recently hit with a $13.5 million verdict over one of its pelvic mesh products has asked the court to toss the verdict. -
Appeals Court Hears Arguments Over $11M Pelvic Mesh Verdict
Feb 24, 2016 | Michael Booth
By New Jersey Law Journal
A Johnson & Johnson subsidiary asked a New Jersey appeals court Feb. 23 to overturn an $11.1 million verdict awarded in the first bellwether trial over allegedly harmful pelvic mesh implants. -
Much-needed advances made in treatment for women with pelvic support issues
Feb 23, 2016 | PIX 11 News
By Kirstin Cole
Starting in their 30’s, usually after having children, a third of all women start to develop pelvic support issues. Once in menopause, it can really take a turn for the worse.
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J&J Subsidiary Seeks to Ax $13.5M Pelvic Mesh Verdict
Feb 24, 2016 | The Legal Intelligencer
By Max Mitchell
The Johnson & Johnson subsidiary that was recently hit with a $13.5 million verdict over one of its pelvic mesh products has asked the court to toss the verdict.
Ethicon, which was slammed earlier this month with the verdict, has filed post-trial motions with the Philadelphia Court of Common Pleas, outlining numerous arguments for why the jury's verdict should be reversed, including statute of limitation, federal pre-emption and evidentiary disputes.
The motion, filed Monday by Butler Snow Law Firm attorney Nils B. Snell, asked the court to either enter judgment notwithstanding the verdict, grant a new trial, or reduce the verdict award.
"This court should order a new trial—or, in the alternative—remit the compensatory and punitive damages award, because they are excessive and unsupported by the evidence in the case," Ethicon said in the motion.
An Ethicon spokeswoman said in a statement that evidence showed the device was properly designed, the company acted responsibly during the research, development and marketing, and the mesh did not cause the plaintiff's injuries.
"We have always made patient safety a top priority and will continue to do so," spokeswoman Samantha Lucas said.
Plaintiff Sharon Carlino's attorney, Shanin Specter of Kline & Specter, said the motion is "boilerplate."
"Judge [Kenneth] Powell tried the case conservatively, and I'm not concerned about appellate review," Specter said. "The verdict will grow at 6 percent per year, so we're happy to let the appellate process run its course."
Ethicon's post-trial motion came several days after Carlino filed a motion for delay damages. In the motion, Carlino asked the court to add $918,460 to the verdict, including $238,120 in compensatory and $680,340 in punitive damages.
On Feb. 10, a Philadelphia jury handed up the verdict, which broke down into $3.5 million in compensatory damages and $10 million in punitive damages.
Carlino had alleged Ethicon's mid-urethral sling device failed because it was negligently designed, and that its failure led her to suffer permanent pain during sex.
The device was implanted in her in 2005 to combat urinary incontinence; however, she claimed 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.
Along with making arguments that Carlino failed to prove that the device caused her injuries, Ethicon contended in its 105-page post-trial motion that the plaintiff failed to show that a safe alternative product was available.
"Supposed alternative designs theorized by plaintiff and their experts ... are not legally cognizable because they required but had not received clearance as of 2005, or even to this day," the motion said. "Any contrary result would unfairly and illogically subject defendants to liability for not taking an action that federal law prohibited them from taking."
Ethicon further contended that the case should have been tossed out because it was not timely filed within the two-year statute of limitations.
The motion noted that, although Carlino underwent surgeries to address complications that arose with the mesh in 2007 and 2010, she did not file her lawsuit until 2013.
Although Specter had told the jury that Carlino was seeking recovery of damages that arose only after the 2010 revision surgery, Ethicon contended the statute of limitations still should have begun to run when the 2007 revision procedure was performed.
"A cause of action accrues when the harm occurs, not when a plaintiff chooses to seek damages," the motion said. "If every plaintiff were permitted to define the statute of limitations by recovering only damages within the statutory period, the very idea of a period of limitations would be illusory."
Regarding causation, Ethicon argued Carlino had numerous health conditions that could have led to pain during sex, and she failed to rule out that these conditions, such as vaginal atrophy and pelvic floor hypertonicity disorder, were the cause of her injuries.
Carlino's urogynecologist expert "acknowledged that Mrs. Carlino has intermittent muscle spasms, which are synonymous with pelvic floor muscle disorder," the filing said. "Nowhere did [the expert] exclude the possibility that the spasms were the result of Mrs. Carlino's back and knee pain, which [another expert] identified as the cause of the spasms."
The motion also contended that Powell should not have issued a blanket ban on all U.S. Food and Drug Administration-related evidence. Ethicon said that decision barred evidence that the FDA cleared the device and the label, and that it underwent a rigorous approval process. The ruling further stopped the company from countering specific arguments from Carlino.
Ethicon also argued that numerous emails and company documents, including one in which an Ethicon official told a doctor that "it might be wise to be more elusive" about the rates of erosion, were irrelevant and should not have been allowed at trial. The motion specifically said the internal document telling a doctor to be "evasive" related to a different product.
"Defendants were plainly prejudiced by the court's admission of this improper evidence," the motion said, noting that Specter had cited the internal document during his closing arguments. "Introduction of this evidence—and, indeed, this argument at closing—were improper and warrant a new trial."
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Appeals Court Hears Arguments Over $11M Pelvic Mesh Verdict
Feb 24, 2016 | Michael Booth
By New Jersey Law Journal
A Johnson & Johnson subsidiary asked a New Jersey appeals court Feb. 23 to overturn an $11.1 million verdict awarded in the first bellwether trial over allegedly harmful pelvic mesh implants.
Charles Lifland, representing the subsidiary, Ethicon, acknowledged that the plaintiff sustained serious injuries as a result of having the implant and that the company was "sympathetic" to the plaintiff, but added that the verdict should not be allowed to stand.
Having the company held liable violated the learned intermediary doctrine, said Lifland, of the Los Angeles office of O'Melveny & Myers. In this case, it was the responsibility of the plaintiff's surgeon to adequately warn her of the risks of the implant.
"It's the physician's job to advise the patient properly," he said.
Appellate Division Judge Garry Rothstadt noted that the plaintiff, Linda Gross of Watertown, South Dakota, obtained much of her information about the pelvic mesh from an Ethicon website. The website did not list all of the possible complications that could occur with the implant.
"That website was not pushed out there," Lifland replied before returning to his original point that the "duty to warn goes to the doctor," who has been given more detailed information from the manufacturer.
"It is from the doctor that the patient is supposed to get the details," he said.
The jury in Atlantic County that heard the case awarded Gross $3.35 million in compensatory damages and $7.76 in punitive damages.
But the learned intermediary doctrine should have blocked the punitive damages award, Lifland said.
"There was a lack of sufficient evidence," he said.
Punitive damages cannot be awarded merely because a manufacturer fails to detail each and every possible complication, Lifland said.
"The warnings could have been stronger, but there was a good faith effort," Lifland said. "There wouldn't be any advances if there were punitive damages with every new product."
Gross' attorney, Adam Slater, urged the appeals court to let the verdict stand.
"The problems with the product were known from day one," said Slater, of Mazie Slater Katz & Freeman in Roseland. "There was no learning curve, no ambiguity within the company."
Presiding Appellate Division Judge Clarkson Fisher Jr. asked why the learned intermediary doctrine should not apply.
Because, Slater said, South Dakota has never recognized that doctrine.
"The learned intermediary doctrine is a very limited concept," he said. "You also have to adequately warn the doctor. The jury found the warnings were inadequate."
Slater said Gross has undergone 20 surgeries in an effort to repair the damage caused by the mesh implant.
"Her body has been decimated," he said.
Slater defended the punitive damages verdict, saying Ethicon officials were deeply aware of the dangers of the implant and did not give adequate warnings.
In July 2014, Atlantic County Superior Court Judge Carol Higbee denied motions by Ethicon for a new trial and judgment notwithstanding the verdict.
At trial, "there was strong evidence presented and multiple sources of evidence that in fact there were many problems with this product," Higbee said in court, according to a preliminary transcript.
The litigation, In re Pelvic Mesh/Gynecare Litigation, No. 291, encompasses thousands of suits claiming injuries from the Gynecare Prolift pelvic mesh product, created by Somerville-based Ethicon to treat organ prolapse and urinary incontinence, and marketed beginning in 2002.
It was designed for minimally invasive implantation through the vagina, and J&J has maintained that the products are safe.
But the plaintiffs claim they have a high failure rate, cause serious complications and necessitate corrective surgeries, despite their billing as safer than other surgical methods. The products allegedly erode into organs and vaginal walls, causing chronic pain, pain during sexual intercourse, scar tissue and other injuries.
Suits were first filed in 2008, shortly before the federal Food and Drug Administration first announced that complications were being reported.
Gross sued in November 2008, claiming she underwent multiple surgeries to correct injuries caused by a Gynecare Prolift mesh implant.
After five days of deliberation, the jury found in a 7-2 vote that Ethicon failed to warn Gross' doctor about possible side effects and made fraudulent misrepresentations to Gross.
The jury unanimously found no cause of action on Gross' defective-design claim and voted 7-2 that there was no cause of action on a fraudulent misrepresentation claim as to Gross' doctor.
The jury's compensatory damages award was made up of $1.1 million for pain and suffering, $1 million for future medical expenses, $500,000 for future lost wages, $385,000 for past medical expenses, $180,000 for past lost wages, and $185,000 for a per quod claim.
Days later, in the ensuing punitive damages trial, the panel delivered a 7-2 verdict awarding an additional $7.76 million.
The evidence "not only was sufficient, but it was extremely strong in support of the plaintiff's position," Higbee said, according to the transcript of the 2014 hearing.
She cited evidence that Ethicon was aware of the medical complications associated with Prolift.
That testimony "could have been believed, and apparently was believed by the jury...that the defendant knew about this problem, that they were told about this problem, that their own doctors were warning them about this problem, that their own studies were showing this problem...and therefore, that the defendant had a duty to warn about the problem," Higbee was quoted as saying in the transcript.
Higbee also relied heavily on testimony of the physician who performed the implanting procedure for Gross. He testified that he was not fully aware of the risks and probably wouldn't have recommended the product to Gross, a young patient at age 41, had he been informed, according to Higbee. The doctor was not named in the transcript.
Higbee also brushed aside Ethicon's claims that she made evidentiary errors and didn't properly charge the jury.
"The idea that I could have gone through the trial and not made one evidential mistake is not likely, but I don't see any myself at this point in time," Higbee said according to the transcript. "The Appellate Division is going to have to see it."
She noted that punitive damages claims are typically barred in pharmaceutical cases, but Gross' injuries occurred before any FDA approval was obtained.
Higbee also declined to reduce the punitive damages total, noting that it "could have been a $15 million award and still fit under the parameters."
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Much-needed advances made in treatment for women with pelvic support issues
Feb 23, 2016 | PIX 11 News
By Kirstin Cole
Starting in their 30’s, usually after having children, a third of all women start to develop pelvic support issues. Once in menopause, it can really take a turn for the worse. It’s not to be ignored, since currently women should expect to spend a third of their lives in menopause. Many women suffer in silence, never bringing the issues up to doctors. But now there is hope.
Celebrities from Whoopi Goldberg to Lisa Rinna are making money selling “absorbent underwear” or adult diapers. It’s a $1.4 billion business, on track to out sell baby diapers in just four years. Half of those buying are under 50 years old.
There’s also been a dramatic rise in surgeries to correct stress urinary incontinence and pelvic organ prolapse, but now a massive groundswell of lawsuits is shining a light on just how dangerous those surgeries are. Linda, we’re not using her last name, is currently suing the maker of her pelvic mesh used in a surgery to correct her problems.
“I no longer can have sexual intercourse,” she explains. “I’m angry.” Her attorney Adam Slater says like most other lawyers involved in these suits that there are tens of thousands of women who are currently suing a variety of pharmaceutical and surgical device companies. Most have the same complaints.
Slater shows me a kit like the one used inside Linda’s pelvis. He points out the “massive amount of polypropylene, what they make your garden hose out of” that’s used. It forms scars tissue, hardens, and becomes like “concrete” once inside a woman. It was never even initially FDA approved, instead it was allowed to be used since it was already being used in abdominal surgeries.
Attorneys point out a woman’s pelvis and vaginal area is a much more dynamic area than the abdominal wall. Some of the judgments have already come in at in excess of $10 million. “It’s a life-long daily catastrophe when it goes bad. It hardens and erodes, it causes pain and it moves, starts to extrude through a woman’s body. It leaves women with the inability to have sexual relations with any sort of pleasure.”
While the FDA has now ordered recalls and safety studies of these mesh products, which will take years, there are other ways women are taking back their lives back “south of the border.”
Dr. John Paciuc is using the “MonaLisa” laser on his patients to reclaim their sex lives. One of his patients, Margaret, developed debilitating symptoms after breast cancer treatment. It also left her unable to use traditional estrogen based medicines.
“I was really in pain and uncomfortable and something had to happen. Sex was off the table. It hurt too much. It was awful.” Dr. Paciuc used the Mona Lisa on Margaret. It uses the same laser as one already used to rejuvenate facial skin. It’s been shown to bring vaginal tissue back to its younger state. How? “By producing collagen and elastin, new blood vessels again. And then vaginal health is restored. This is going to be a huge game changer.”
Still other women are using an at home treatment called the VSculpt. Lorin, a mom of four who loves to run and play soccer, found herself having to line her shorts anytime she wanted to run. It was not how she wanted to live. “Did it bring you back to your pre baby years?” this reporter asked. “I would say very close!” Lorin enthusiastically answered.
Dr. Donnica Moore, the medical director for VSculpt explains it this way. “It’s toning the muscles of the pelvic floor. An overwhelming majority of women report improved symptoms in 30-60 days.”
Another woman who tested the Vsculpt said she was taken twenty years back in time. Belle Gayer went in to menopause at just 45, and didn’t want to give up on her sex life. But, “I didn’t feel safe going the chemical cream or pill route after.”
“It’s not just me. It’s not just one woman. When it makes you feel better physically and emotionally and helps your relationship, how can you beat it?”
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