Mesh News Desk, March 29, 2016 ~ An appeal by Johnson & Johnson in the $11.1 million Linda Gross Prolift mesh case was decided in favor of Ms. Gross by a three judge appellate panel from New Jersey this morning.
Judges Fisher, Espinosa and Rothstadt of the Superior Court of New Jersey Appellate Division ( Doc. A-0011-14T2), decided to allow to stand the $3.35 million in compensatory damages and $7.76 in punitive damages decided by an Atlantic City, New Jersey in February 2013.
Linda Gross, a nurse from South Dakota had been implanted with the Prolift, the largest of the polypropylene pelvic meshes made by Ethicon, a division of Johnson & Johnson. Prolift has since been quietly removed from the market.
Upon the jury award, J&J immediately filed an appeal. “The punitive damage award is unsupported by the evidence presented at trial,” said a J&J spokesperson to Bloomberg News at the time of the verdict. “Ethicon acted appropriately in the research, development and marketing of the Prolift.”
Upon hearing the jury verdict, a lawyer for Ethicon, Christy Jones said:
“I understand that you have found that we could have done a better job and that we in fact fell short,” Jones said Feb. 26.
“My clients understand that. We hear you, I promise you….while I confess to you from the bottom of my heart that it hurts, and we’re disappointed in the verdict, we nonetheless appreciate what you have said and recognize and respect your verdict.”
Jurors found in favor of Linda Gross on her claim that J&J failed to provide adequate warning to the implanting surgeon, Dr. Kevin Benson, fraudulent misrepresentation to Ms. Gross, and loss of consortium, however the jury did not find the Prolift Pelvic Floor Repair System was defectively designed.
J&J filed a motion for a new trial. On July 15, 2014, that was denied.
See the appellate decision here.
J&J argued trial judge Carol Higbee made an error when she failed to apply the learned intermediary doctrine to the fraudulent misrepresentation or deceit claim. The learned intermediary is the doctor, in this case Dr. Benson, who is the only person required to receive warnings about the product from the company. Ethicon argued it should not be held liable because it is the doctors’ responsibility to inform his patient.
“[T]he learned intermediary doctrine does not eliminate a factfinder’s need to consider whether the patient’s decision would have been different if the warning had been sufficiently thorough,” the judges said.
“The learned intermediary doctrine imposes a duty on a manufacturer to warn physicians of the risks involved with its product, thereby placing the physician in the role of intermediary between the manufacturer and the patient,” the judges said.
Linda Gross has said she would not have agreed to the surgery had she been properly informed by her doctor. She has endured 20 surgeries both for removal and repair. The lack of a full informed consent was the proximate cause of her injuries, the judges decided. Ethicon understood the potential dangers of its pelvic mesh implants and failed to pass those along to the doctors.
J&J also argued that the causation evidence was insufficient to prove a failure to warn. Judge Carol Higbee also erred when she made erroneous evidence rulings and allowed the jury to consider punitive damages, said J&J in its appeal.
“This decision is very good primer on learned intermediary,” says trial attorney Adam Slater to Mesh News Desk.
“Only if there is adequate warning given to Linda Gross can she have true informed consent.
“If the warning was not adequate, if she didn’t have true informed consent, the learned intermediary drops out of the case.
This is critical.”
Slater says the Bottom Line – A decision to have a pelvic mesh device permanently implanted in your body is that person’s decision.
“They put the power back in the hands of women not to the doctor to decide what happens to a woman’s body.”
Slater adds the defense has been winning a lot of arguments in court against that principle, based on the learned intermediary doctrine and this ruling will change the landscape for all pelvic mesh litigation.
Johnson & Johnson has 20 days to Petition the New Jersey Supreme Court to ask it to hear the Gross v. Ethicon case. Generally that is only granted if there are conflicting lower court rulings that must be sorted out by the high court of a state.
In this case, Slater says the respected New Jersey Appellate panel took care to carefully detail the case. A decision on whether the New Jersey Supreme Court will or will not hear it could be made by summer.
If the Gross cases is rejected by the NJ Supreme Court, J&J will have to pay $11.1 million. That would make it only the second time a plaintiff has received a jury award after the defendant company ran out of appeal options. That case was the $5.5 million pelvic mesh trial of Christine Scott in her case against C.R. Bard. #
SUPERIOR COURT OF NEW JERSEY APPELLATE DIVISION, March 29, 2016
Bloomberg News, J&J Owes $7.76 Million in Punitives in Vaginal Mesh Case, February 28, 2013
Mesh News Desk, Feb 24, 2016, First Bellwether Pelvic Mesh- Linda Gross Case Goes before NJ Appeals Court
Mesh News Desk, Feb. 28, 2013, Day 31: Linda Gross v. Ethicon It’s Over! $11.1 Million
Mesh News Desk, July 17, 2014, NJ Judge Upholds $11 million Linda Gross Award- Ethicon Announces Another Appeal
Mazie Slater, Testimony of Ethicon Witnesses that Resulted in Verdicts
Adam Slater, Mazie Slater, portion of closing argument in Gross trial, Feb. 2013, Atlantic City, NJ