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Ethicon 2/25
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J&J Unit Looks To Dodge $13.5M Pelvic Mesh Verdict
Feb 24, 2016 | Law360
By Matt Fair
A Johnson & Johnson unit filed a post-trial motion on Monday aimed at upending a $13.5 million verdict a Philadelphia jury awarded earlier this month to a woman who claimed that she suffered irreparable injuries from a pelvic mesh implant she received to treat her urinary stress incontinence. -
First Bellwether Pelvic Mesh – Linda Gross Case Goes Before NJ Appeals Court
Feb 24, 2016 | Mesh Medical Device News Desk
By Jane Akre
Lawyers for Ethicon asked a New Jersey appeals court Tuesday to overturn the $11.1 million verdict in the case of Linda Gross who was the first bellwether trial over allegedly harmful pelvic mesh implants. -
J&J Must Pay $72 Million to Plaintiff’s Family Over its Toxic Talc
Feb 24, 2016 | Mesh Medical Device News Desk
By Jane Akre
Johnson & Johnson (J&J) is on the hook for $72 million to the family of a women who used the company’s talcum powder and developed ovarian cancer that killed her last year. -
Jury orders J&J to pay patient's family $72M in talcum powder-ovarian cancer case
Feb 25, 2016 | Bio Pharma Dive
By Sy Mukherjee
...J&J has faced several major suits over products such as vaginal mesh and Risperdal.
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J&J Unit Looks To Dodge $13.5M Pelvic Mesh Verdict
Feb 24, 2016 | Law360
By Matt Fair
A Johnson & Johnson unit filed a post-trial motion on Monday aimed at upending a $13.5 million verdict a Philadelphia jury awarded earlier this month to a woman who claimed that she suffered irreparable injuries from a pelvic mesh implant she received to treat her urinary stress incontinence.
The 109-page motion filed by Ethicon Inc. told Judge Kenneth Powell that $3.5 million in compensatory damages awarded to plaintiff Sharon Carlino and her husband were not supported by evidence of any past or future medical expenses, and should cancel out the $10 million in punitive damages in the case.
“Plaintiffs put on no evidence of past or future medical costs, meaning the entirety of the $3.5 million dollar compensatory awards was for noneconomic damages,” the motion said. “Where a compensatory award consists of primarily — or, as here, exclusively — of noneconomic damages, it is likely that the award already contains a punitive component.”
Carlino filed suit in June 2013 claiming that inherent defects in Ethicon’s so-called TVT, or transvaginal tape, had left her living with constant pain and discomfort and had interfered with her ability to have sex with her husband.
A jury handed down a verdict on Feb. 10 agreeing that TVT was not reasonably safe and that Carlino’s physician would never have implanted the product had he been aware of its risks.
Kline & Specter PC attorney Shanin Specter told the jury during the two-week trial that Carlino was implanted with the product in 2005 to treat her urinary stress incontinence.
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.
As part of their post-trial motion on Monday, Ethicon argued that a two-year statute of limitations barred Carlino’s claims because she first knew about problems with the products as a result of the corrective surgeries she underwent in 2007 and 2010.
“Plaintiffs were required to commence their claims within two years of her 2007 injury (and the 2010 injury, at the latest), yet they did not file suit until 2013,” the brief said. “The court should have granted defendants’ motion for compulsory nonsuit or their motion for directed verdict.”
At trial, the brief said, Carlino argued that they were not seeking damages stemming from the 2007 and 2010 injuries.
Judge Powell had rejected a motion for summary judgment on the statute of limitations issues in January, according to the brief.
Specter told Law360 on Wednesday that there had been no evidence of past or future medical expenses because there was no possibile treatment for Carlino's injuries, and argued that the compensatory damage award was reasonable.
"Mrs. Carlino has severe vaginal pain because of the mesh. There is no safe treatment for that, so of course there are no medical expenses," he said. "The fair range of damages to compensate for a sexually active woman who has severe vaginal pain certainly encompasses this award."
He similarly rejected arguments about the statute of limitations as he argued that Carlino didn't become aware that her injuries stemmed from a potential product defect until after her first two interventions.
"In order for the statute to begin to run the plaintiff must have an appreciation that they were injured due to the wrongful conduct of someone else," he said. "Mrs. Carlino was told by her gynecologist that the erosion she had was simply a risk of the original procedure."
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.
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.
J&J is represented by Nils Snell, Christy Jones and William Gage of Butler Snow LLP, Julie Callsen of Tucker Ellis LLP, and Laura Smith of Friday Eldredge & Clark.
Carlino is represented Shanin Specter and other attorneys from Kline & Specter PC.
The case is Sharon Carlino et al. v. Ethicon Inc. et al., case number 130603470, in the Court of Common Pleas of Philadelphia County, Pennsylvania. -
First Bellwether Pelvic Mesh – Linda Gross Case Goes Before NJ Appeals Court
Feb 24, 2016 | Mesh Medical Device News Desk
By Jane Akre
Lawyers for Ethicon asked a New Jersey appeals court Tuesday to overturn the $11.1 million verdict in the case of Linda Gross who was the first bellwether trial over allegedly harmful pelvic mesh implants.
A nurse from Watertown, South Dakota nurse, Ms. Gross was implanted with a Prolift mesh made by Ethicon, a subsidiary of Johnson & Johnson, to treat pelvic organ prolapse. In February 2013, she was awarded $11.1 million by a New Jersey jury which included $7.76 million in punitive damages. J&J immediately appealed.
Tuesday, Feb. 23, oral arguments were heard before judges Fisher, Espinosa and Rothstadt, as attorneys for Ethicon, the subsidiary, said the verdict should not be allowed to stand.
Here is the calendar.
The New Jersey Law Journal (here) reports attorney Charles Lifland (O’Melveny & Myers), arguing for Ethicon, said Ms. Gross had suffered and the company was “sympathetic” but that it was up to her physician, Dr. Kevin Benson, to inform his patient, not Ethicon.
Day 28, Linda Gross and Adam Slater
The case number is A-000011-14-T02 LINDA GROSS AND JEFFREY GROSS V. GYNECARE, ETHICON, INC., JOHNSON AND JOHNSON, JOHN DOES 1-20.
The panel was particularly interested with how Ethicon on its website and brochures minimized the possibility of complications, something both the doctor, who is the learned intermediary, and the patient rely on.
Lifland argued that the learned intermediary should have shielded the company from the punitive damages award. J&J/Ethicon cannot be expected to detail every possible complication, he argued. There was a good faith effort, he said.
Adam Slater, representing Ms. Gross said the company knew its problems from Day One.
“There was no learning curve, no ambiguity within the company.” Besides, South Dakota does not recognize the learned intermediary explanation especially when the doctor is also in the dark about possible complications.
Prolift partial explant from Gross v. Ethicon trial
Ms. Gross has undergone 20 surgeries to remove the Prolift and repair its damages. Prolift is no longer marketed in the U.S. by J&J.
New Jersey Superior Court appellate division could decide the latest Ethicon appeal in three to six months. ##
LEARN MORE:
Mesh News Desk, Feb. 28, 2013, Day 31: Linda Gross v. Ethicon It’s Over! $11.1 Million
http://meshmedicaldevicenewsdesk.com/day-31-linda-gross-v-ethicon-its-over-11-1-million
After a 31 day trial jurors awarded Gross both compensatory and punitive damages for a total of $11.1 million. They intended to deceive said attorney Adam Slater referring to J&J division, Ethicon. At that time, Ms. Gross had endured 18 surgeries and was unable to sit. NJ Law Journal writes: “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.”Mesh News Desk, Gross v. Johnson & Johnson, March 22, 2013, The Post-Trial Process
http://meshmedicaldevicenewsdesk.com/gross-v-johnson-johnson-the-post-trial-process
While the nine jurors did not find J&J’s Prolift mesh defective they did award Linda Gross $3.35 million in compensatory damages and $7.76 million in punitive damages. J&J appealed. Once the appeals court rules, the case could go before the New Jersey Supreme Court.Mesh News Desk, July 17, 2014, NJ Judge Upholds $11 million Linda Gross Award- Ethicon Announces Another Appeal
http://meshmedicaldevicenewsdesk.com/nj-judge-grants-11-million-linda-gross-award-ethicon-announces-another-appeal
Atlantic County Superior Court Judge Carol Higbee, who oversaw the Gross v. Ethicon trial in February 2013, denied motions by J&J for a new trial saying the evidence was very strong in support of plaintiff’s position. Dr. Benson had testified he would not have used the Prolift on Ms. Gross had he known about its risks. Ethicon had cited evidentiary errors made by Judge Higbee. Punitive damages could have been higher she said in declining to reduce them. -
J&J Must Pay $72 Million to Plaintiff’s Family Over its Toxic Talc
Feb 24, 2016 | Mesh Medical Device News Desk
By Jane Akre
Johnson & Johnson (J&J) is on the hook for $72 million to the family of a women who used the company’s talcum powder and developed ovarian cancer that killed her last year.
Of that $62 million is punitive damages intended to send a strong message to the company.
The trial in St. Louis Missouri was the first state court case over J&J’s baby powder with more than 1,200 other similar cases pending.
Jackie Fox, 62, of Birmingham Alabama was part of a claim in St. Louis Circuit Court that includes 60 people. The women allege J&J knew of the risks and link to ovarian cancer but failed to warn consumers.
Ms. Fox died in October 2015, two years after her diagnosis. Her son took over as the plaintiff, reports AP.
The talcum powder is sold as Johnson’s Baby Powder and Shower-to-Shower. Her son said the powder was a bathroom staple for years and just became second nature like brushing your teeth.
A J&J spokeswoman said to Bloomberg,
“We have no higher responsibility than the health and safety of consumers and we are disappointed with the outcome of the trial. We sympathize with the plaintiff’s family but firmly believe the safety of cosmetic talc is supported by decades of scientific evidence.”
It took jurors four hours to deliver their 10-2 decision against J&J on claims of failure to warn, negligence and conspiracy. The jury foreman says the company’s internal documents were “decisive” in their decision.
“It was really clear they were hiding something,” said Krista Smith of St. Louis. She added all they had to do was warn consumers in their label, but the company did not.
Jere Beasley (Beasley, Allen, Crow, Methvin, Portis & Miles) told The National Law Journal that plaintiffs had internal documents from 1997 that showed the company knew nine studies existed that showed the link of its talcum powder to cancer. A letter from a former consultant warned the findings could compare the talc industry to cigarettes which Beasley called a “devastating document.”
Shower-to-Shower was marketed to women for feminine hygiene. “Just a sprinkle a day keeps odor away,” was the slogan. The product was sold to Valeant Pharmaceuticals International in 2012.
The problem with talc is it can be contaminated with asbestos fibers. Talc is mined from the soil and can contain magnesium, silicon, oxygen and hydrogen, used to absorb moisture. There is more on talc reported by the Environmental Working Group’s Skin Deep here.
J&J, the largest US healthcare products company, has had problems over its other consumer products such as No More Tears baby shampoo. The Campaign for Safe Cosmetics has put the consumer push on the company to eliminate questionable ingredients from its products including formaldehyde and probably human carcinogens.
Johnson & Johnson’s Ethicon division is facing more product liability litigation over its pelvic meshes than any other manufacturer. J&J also made the power morcellator that’s been implicated in helping spread an aggressive uterine cancer.
Earlier this month, Ethicon, a division of J&J, lost a pelvic mesh action in Philadelphia where the plaintiff was awarded $13.5 million and the TVT made by Ethicon was found to be defective. Jurors awarded $10 million in punitive damages. Read about the Carlino case here.
In December, a different plaintiff in the same Philadelphia courtroom was awarded $12.5 million in damages against the company, which included $7 million punitive damages. Read more on the Hammond case here.
Just this week, the Mentor ObTape trial in Georgia resulted in a $4.4 million award for Teresa Stevens which included $4 million in punitive damages. Johnson & Johnson acquired Mentor Corp in 2009 and in doing so, acquired its Mentor ObTape litigation. See the story here. #
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Jury orders J&J to pay patient's family $72M in talcum powder-ovarian cancer case
Feb 25, 2016 | Bio Pharma Dive
By Sy Mukherjee
A St. Louis jury has ordered pharma giant Johnson & Johnson to pay the family of Jackie Fox, an ovarian cancer patient who died from the disease last year, $72 million in compensatory and punitive damages.Fox's lawyers contented (as part of a class-action suit which involves nearly 1,200 cases against J&J) that the company knew of an alleged link between talcum-based products such as Johnson's Baby Powder and an increased risk of ovarian cancer—and failed to warn consumers about the risk.The reward includes $10 million in compensatory damages and another $62 million in punitive damages. It is the first case in the class-action in which J&J has been ordered to pay a reward to plaintiffs.Dive Insight:As BioPharma Dive has previously reported, what complicates these cases is the fact that there is some conflicting evidence over the potential links between talcum-based products like the baby powder and Shower to Shower and an increased cancer risk.
Some studies have suggested that there is an appreciable link, particularly for Hispanic and African American women. But the FDA has stated that such links aren't yet supported by "conclusive evidence."
Johnson & Johnson, which still uses talc in some products, stuck by its contention that no definitive link exists.
"We have no higher responsibility than the health and safety of consumers and we are disappointed with the outcome of the trial," said J&J spokesperson Carol Goodrich in astatement to Bloomberg. "We sympathize with the plaintiff’s family but firmly believe the safety of cosmetic talc is supported by decades of scientific evidence."
Jurors, for their part, had a very different outlook. "It was really clear they were hiding something," said jury foreman Carol Goodrich, citing internal J&J documents reviewed by the jurors. "All they had to do was put a warning label on."
J&J has faced several major suits over products such as vaginal mesh and Risperdal.
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