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Ethicon Media Monitoring 12/7/2016
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NJ Justices Won't Review $11M J&J Pelvic Mesh Bellwether
Dec 7, 2016 | Law 360
By Jeannie O'Sullivan
The New Jersey Supreme Court has refused to second-guess an $11 million jury award against Johnson & Johnson unit Ethicon Inc. in a bellwether case involving a woman who experienced adverse effects from the device maker's pelvic mesh product. -
Linda Gross $11.1 Mill Jury Verdict Survives Final J&J Challenge
Dec 6, 2016 | Mesh Medical Device Newsdesk
It was February 2013 when South Dakota nurse, Linda Gross was awarded $11.3 by an Atlantic City New Jersey jury after a seven-week trial.
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NJ Justices Won't Review $11M J&J Pelvic Mesh Bellwether
Dec 7, 2016 | Law 360
By Jeannie O'Sullivan
The New Jersey Supreme Court has refused to second-guess an $11 million jury award against Johnson & Johnson unit Ethicon Inc. in a bellwether case involving a woman who experienced adverse effects from the device maker's pelvic mesh product.
In a Monday order made public Tuesday, the justices denied Ethicon and J&J's certification petition for review of an Appellate Division’s affirmation of a verdict that found jurors heard sufficient evidence showing Linda Gross’ doctor might have offered different guidance had he possessed more information about the Ethicon product’s risks.
An attorney for Gross said Tuesday that his client and the other plaintiffs in the mass tort are owed a "debt of gratitude" for fighting the legal battle, which has spanned more than a decade.
"This case now establishes certain key legal rulings are binding, including the propriety of punitive damages, which strengthens every case in this litigation," Adam M. Slater of Mazie Slater Katz & Freeman LLC told Law360. "We will now look at motions that can be filed to cement the benefits of the decision for thousands of deserving women, including collateral estoppel on the failure-to-warn verdict."
Representatives for the pharmaceutical parties did not immediately respond to requests for comment Tuesday.
The guidance that Gross never received might have led her to pursue a different course of treatment and avoid the injuries for which she sued the pharmaceutical entities, a three-judge appellate panel had ruled in the bellwether case in March.
Gross and her husband had sued in 2008, saying Ethicon failed to fully disclose risks associated with its Gynecare Prolift mesh product, which Gross used to repair a pelvic floor collapse. Gross' case was the bellwether in New Jersey’s multidistrict litigation over Ethicon's vaginal mesh products, which the company agreed to stop selling in June 2012 despite saying it did not believe them harmful.
The trial featured testimony from an array of Ethicon employees, who were questioned about the design, testing and marketing of Prolift, which Gross was implanted with in 2006. Gross had 18 subsequent surgeries to remove the mesh, she said, after the product caused severe nerve pain that ended her nursing career and prevented her from enjoying time with her family and from having a normal sex life. In February 2013, the jury awarded Gross $3.35 million in compensatory damages and $7.76 million in punitive damages for injuries caused by the product.
During oral arguments in February 2016 before the Appellate Division, Ethicon challenged New Jersey Superior Court Judge Carol E. Higbee’s determination that sufficient evidence existed to support a finding that the company was responsible for Gross’ injuries after she used the product, according to the panel decision. The company previously asked the judge to issue a judgment notwithstanding the verdict or to order a new trial, on the grounds that the jury award was not supported by adequate evidence. The judge declined to do either.
The panel agreed with the move in March, noting the doctor’s testimony that he would have counseled against the procedure or spent at least 45 minutes discussing its drawbacks had he known the product “should not be implanted in sexually active people.”
Gross was represented in the Appellate Division by Adam M. Slater and David A. Mazie of Mazie Slater Katz & Freeman LLC.
J&J and Ethicon were represented in the Appellate Division by Christy Jones and William M. Gage of Butler Snow O'Mara Stevens & Cannada PLLC and Kelly Crawford-Riker, Maha M. Kabbash and Mary Ellen Scalera of Riker Danzig Scherer Hyland & Perretti LLP.
The case is Gross v. Gynecare Inc. et al., case number 077827, in Supreme Court of the State of New Jersey.
--Additional reporting by Adam Sege. Editing by Edrienne Su.https://www.law360.com/trials/articles/869546/nj-justices-won-t-review-11m-j-j-pelvic-mesh-bellwether
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Linda Gross $11.1 Mill Jury Verdict Survives Final J&J Challenge
Dec 6, 2016 | Mesh Medical Device Newsdesk
It was February 2013 when South Dakota nurse, Linda Gross was awarded $11.3 by an Atlantic City New Jersey jury after a seven-week trial.
Ms. Gross alleged the Prolift Pelvic Floor Repair System, she received to treat pelvic organ prolapse, caused her permanent damage and the jury agreed.
J&J, maker of the Prolift and its subsidiary, Ethicon immediately appealed.
In March of this year a state appeals court upheld the jury award. J&J took the issue to the highest court in New Jersey. It’s been three years, but on Monday, the New Jersey Supreme Court declined to second-guess the case of Gross v. Gynecare.
“I’m happiest for Linda and Jeff who have sacrificed so much and are heroes as far as I am concerned. This decision will help the thousands of women who are still fighting this fight with us in the Courts,” said Ms. Gross attorney Adam Slater to MND this evening.
Theoretically, J&J can file another motion for the high court to rehear and reconsider the denial.
The state Supreme Court will generally only consider a Petition for Certification if there are conflicted rulings in the lower court.
In an appeal filed after trial, J&J argued that the lower court failed to apply the learned intermediary doctrine to the fraud or deceit claim. The learned intermediary is the doctor who is supposed to inform a patient about all risks and benefits of a medical device. He doctor then has the burden to warn the patient about risks, not manufacturer J&J.
The company also argued the trial court mistakenly allowed the jury to consider punitive damages.
The jury found Prolift was not defectively designed and that the defendants did not provide adequate warning to the implanting surgeon, Dr. Kevin Benson.
MONETARY AMOUNTS
What the court awarded Ms. Gross was:
Past pain and future pain of suffering, disability loss of enjoyment of life $1.1 million.
For her past wages $180,000.
For her future wages $500,000.
For the reasonable value of past medical services $385,000.
For the reasonable cost of future medical treatment and household services $1 million.
Compensation to Jeff Gross $185,000 for loss of the companionship of his wife.
After additional proceedings, the jury awarded $7.76 million in punitive damages.
BACKGROUND
The Prolift Pelvic Floor system was an innovative new transvaginal mesh that for the first time would be sold pre-cut in a kit with hook like trocars of metal implanting devices.
Made by Ethicon, the medical device division of Johnson & Johnson, Prolift would use the Gynemesh soft prolene (PS) used for hernia repair.
During the trial jurors saw that the marketing team always worked closely with Research & Development and Regulatory Affairs with a targeted March 2005 launch date. The date was important. Ethicon wanted to take advantage of the market and beat out the upcoming competition and charge a “premium price” for the Prolift, according to internal company records.
But as late as January 2005 the launch team was hearing from its French scientists who developed the TVM procedure (how to use new tools to place the mesh). Evidence at trial showed the team suggested a different type of mesh be used to replace the Gynemesh because early indications on cadaver and animal testing showed a 21 percent and higher complication rate with Gynemesh placed in the pelvis.
Gynemesh was called the “worst of a bad lot” of meshes and some inside the company thought it caused too many complications.
Ms. Gross who had worked as a hospice nurse, is now unable to sit any more than 20 minutes. She has to self-catheterize in order to urinate and has chronic pain in her legs and pelvis. She has undergone more than 20 mesh removal operations and hundreds of doctors consults since the Prolift was implanted in July 2006.
In mid 2012, Ethicon decided to remove Prolift and three other transvaginal meshes from the market in a phased stages over 18 months.
Only one other jury trial award has been paid, that in the case of Ms. C. Scott v C.R. Bard. Her $5.5 million judgment was paid after Bard exhausted the appeals process.
http://www.meshmedicaldevicenewsdesk.com/linda-gross-11-1-m-jury-verdict-survives-final-jj-challenge/
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