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Comprehensive Gross Appeal Coverage
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In mesh litigation, how a casual corporate decision ruined one woman’s life
Mar 30, 2016 | Reuters
By Alison Frankel
In 2005, as Johnson & Johnson was preparing to roll out Prolift, a new medical device designed to treat a urogynecological condition that affects millions of women, a French physician sent an urgent email to the J&J product director in the United States. Clinical evidence in Europe, the doctor’s email said, showed that Prolift mesh occasionally eroded through the walls of the vagina in women implanted with the device. Prolift also had a tendency to retract, according to the French physician, who said both of those complications could interfere with a patient’s ability to have sex. The doctor proposed adding cautionary language to the information J&J planned to provide to doctors in the U.S., warning them about potential complications of implanting Prolift in sexually active women, especially those who’d had hysterectomies. -
New Jersey appeals court upholds $11m pelvic mesh decision against J&J
Mar 30, 2016 | Mass Device
By Fink Densford
A New Jersey appeals court today upheld a $11.1 million jury award against Johnson & Johnson’s (NYSE:JNJ) Ethicon subsidiary in a case concerning injuries caused by the company’s Prolift vaginal mesh. -
Are Big Verdicts a Sign Johnson & Johnson Has 'Lost Its Way'?
Mar 30, 2016 | New Jersey Law Journal
By Charles Toutant and Max Mitchell
Plaintiffs lawyers haven been winning a steady stream of big products liability verdicts against Johnson & Johnson recently, and some have suggested the company's size makes it a bigger target for litigation—and also more willing to take cases to trial. -
NJ Court Affirms $11M Pelvic Mesh Verdict
Mar 29, 2016 | New Jersey Law Journal
By Michael Booth
A New Jersey state appeals court has upheld an $11.1 million damages verdict against Johnson & Johnson subsidiary Ethicon Inc. in the first bellwether trial over allegedly harmful pelvic mesh implants. -
NJ Appeals Panel Affirms $11M J&J Pelvic Mesh Judgment
Mar 29, 2016 | Law360
By Adam Sege
A state appeals court in New Jersey has upheld a $11.1 million jury award to a woman who claims a Johnson & Johnson unit's vaginal mesh product caused debilitating nerve pain, saying ample evidence presented at trial showed that better warnings of the product's risks might have prevented her injuries. -
Just In* – Linda Gross Prolift Case Survives Appeal by J&J
Mar 29, 2016 | Mesh Medical Device News Desk
By Jane Akre
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.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Comprehensive Gross Appeal Coverage
Full Text of Stories Below
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In mesh litigation, how a casual corporate decision ruined one woman’s life
Mar 30, 2016 | Reuters
By Alison Frankel
In 2005, as Johnson & Johnson was preparing to roll out Prolift, a new medical device designed to treat a urogynecological condition that affects millions of women, a French physician sent an urgent email to the J&J product director in the United States. Clinical evidence in Europe, the doctor’s email said, showed that Prolift mesh occasionally eroded through the walls of the vagina in women implanted with the device. Prolift also had a tendency to retract, according to the French physician, who said both of those complications could interfere with a patient’s ability to have sex. The doctor proposed adding cautionary language to the information J&J planned to provide to doctors in the U.S., warning them about potential complications of implanting Prolift in sexually active women, especially those who’d had hysterectomies.
The French doctor worked for J&J and had helped develop Prolift. His suggestion was reviewed by a number of corporate officials in the U.S. Ultimately, J&J didn’t add the cautionary disclosures he proposed – but not because the company engaged in some kind of sophisticated cost-benefit analysis and decided potential profits outweighed liability risk.
J&J’s decision, if you can call it that, seems to have been motivated by inertia. Prolift information packets had already been written, approved and delivered to the printer. According to sworn testimony from J&J witnesses, the company didn’t want to go to the trouble of revising and reprinting the materials it planned to send doctors. In principle, J&J officials didn’t object to adding a warning about Prolift complications. They just didn’t want to delay the device’s roll-out. They figured they could add the warning later, in a subsequent version of the information packet.
The company didn’t end up revising the Prolift warnings until 2008, which was way too late to help a South Dakota nurse named Linda Gross. Gross was 41 years old in 2006, when she was diagnosed with pelvic organ prolapse, a condition in which the muscles of the pelvic floor cannot support internal organs. (In Gross’s case, after a hysterectomy, her small intestine collapsed into her uterine cavity.) She and her doctor talked for about 15 or 20 minutes about her options, and Gross checked J&J’s website for patient information. They concurred that Prolift was the best treatment for her. Gross was implanted with Prolift in June 2006.
Her reaction to the mesh was “catastrophic,” to use her surgeon’s word. When Gross went totrial against J&J in New Jersey Superior Court in 2013, she and a bevy of doctors testified about the years of chronic pain, disabling medical complications and additional surgery Gross endured after her Prolift implant. Gross is under treatment for anxiety and depression. She can no longer have sexual intercourse with her husband.
Gross said she would not have chosen Prolift if she had known all of risks the product posed for sexually active women who had had hysterectomies. The doctor who implanted her mesh testified that he relied on J&J to provide him with a complete disclosure of the potential complications in the information packet the company sent to doctors. He said he recommended Prolift to Gross based on that information – and would not have recommended it if J&J had included the additional warning suggested by the French doctor.
Linda Gross’s fate, in other words, was sealed because J&J happened to have already sent doctors’ information packets to the printer when the French doctor sent his cautionary 2005 email.
The New Jersey Appellate Division made that point twice Tuesday in its opinion affirming an $11 million verdict – $3.35 million in compensatory damages and $7.76 million in punitive – for Gross. The three-judge panel said J&J cannot shift blame onto Gross’s doctor for failing to tell her about possible complications because the company, in a rush to get the product to market, sent doctors information packets that didn’t disclose all of the potential problems the company knew Prolift could cause. The three-judge panel also said Gross was entitled to punitive damages because of J&J’s failure to warn doctors and patients. The panel of judges paraphrased testimony from a J&J witness: “The document was already at the printers and the company wanted to get the product to market as soon as possible.”
The 68-page opinion from Judges Clarkson Fisher, Marianne Espinosa and Garry Rothstadtis a deeply depressing account of the extraordinary consequences of seemingly ordinary corporate decision-making. The appellate ruling does not suggest a cover-up or conspiracy at J&J, just a series of ill-considered choices, culminating in the 2005 decision to disregard a warning from Prolift’s developer about adverse clinical results because materials were already at the printer. The opinion portrays the French doctor’s cautionary email as a matter of corporate routine at J&J, like other reports in 2004 and 2005 of clinical problems with Prolift.
J&J stopped selling Prolift in 2012, though it still sells other mesh products to treat prolapsed and urinary incontinence. Unlike pelvic mesh manufacturers Boston Scientific and C.R. Bard, the company has not reached a billion-dollar settlement with thousands of mesh plaintiffs. (It did reportedly agree in January to a $120 million deal to resolve claims by as many as 3,000 women.) J&J and other mesh makers contend they followed Food and Drug Administration regulations and sold safe products that have helped hundreds of thousands of women.
Retrospect is easy, of course. From the perspective of 2016, with J&J accused of harming tens of thousands of mesh implant patients and facing hundreds of millions of dollars (if not more) in exposure to personal injury claims, it seems crazy that no one at the company stood up and said J&J should wait a few weeks and eat a few bucks in printers’ fees to put out more robust information about Prolift. But it also seems crazy that no one at GM called on the company to investigate ignition-switch defects even as the company reached confidential settlements with crash victims.
Even if they don’t stop to think of the consumers who will be affected by their decisions, people who work at big companies that make dangerous products by now ought to know enough to consider how their actions will look to judges and juries. Maybe then, they will remember the ripples of ordinary corporate business.
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New Jersey appeals court upholds $11m pelvic mesh decision against J&J
Mar 30, 2016 | Mass Device
By Fink Densford
A New Jersey appeals court today upheld a $11.1 million jury award against Johnson & Johnson’s (NYSE:JNJ) Ethicon subsidiary in a case concerning injuries caused by the company’s Prolift vaginal mesh.
The plaintiff in the case claimed the product caused debilitating nerve pain and said that better labeling and warnings could have prevented injuries. The plaintiff added that the product resulted in multiple complications which required intensive medical treatment and numerous operations, according to court documents.
In the initial case, the jury found for the plaintiff to the tune of $3.4 million in compensatory damages and an additional $7.8 million in punitive damages.
Johnson & Johnson argued that the trial judge “erroneously failed to apply the learned intermediary doctrine to the fraudulent misrepresentation or deceit claim,” and failed to recognize causation evidence as sufficient to prove a failure to warn, and said that punitive damages should not have been considered by the jury, according to court documents.
The appeals court held up the original finding and the award initially issued.
Earlier this month, Johnson & Johnson’s Ethicon subsidiary agreed to settle a bellwether lawsuit filed over its Prolift pelvic mesh product, the company said.
Ethicon spokesman Matthew Johnson confirmed with MassDevice.com that the company agreed to settle with plaintiffs Dianne Bellew and her husband, Dan Bellew.
“The parties have agreed to resolve the matter,” Johnson wrote.
The trial had entered its 5th day March 6 when jurors were informed of the settlement at about 11: 30 a.m., according to documents filed with the U.S. District Court for Southern West Virginia.
A judge in that court, Judge Joseph Goodwin, has been assigned to oversee more than 70,000 product liability lawsuits filed against a slate of pelvic mesh manufacturers including Ethicon, Bard, BSX and Coloplast.
A week earlier, J&J logged a loss and a win in some of the cases brought against Ethicon. In the loss, a California jury hit it with a $5.7 million verdict, finding it liable for design problems and failure to warn plaintiff Coleen Perry about the Abbrevo mesh.
But the U.S. Court of Appeals for the 4th Circuit upheld Ethicon’s year-old win in the 1st pelvic mesh bellwether to go to trial. Goodwin had issued a directed verdict Feb. 18, 2014, ordering the case dismissed and stricken from the record.
Last September Ethicon vowed to appeal a $3.3 million loss involving its TVT-O transvaginal sling.
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Are Big Verdicts a Sign Johnson & Johnson Has 'Lost Its Way'?
Mar 30, 2016 | New Jersey Law Journal
By Charles Toutant and Max Mitchell
Plaintiffs lawyers haven been winning a steady stream of big products liability verdicts against Johnson & Johnson recently, and some have suggested the company's size makes it a bigger target for litigation—and also more willing to take cases to trial.
All the litigation hasn't kept Wall Street from taking a liking to Johnson & Johnson—several brokerages upgraded their ratings on the company's stock in recent weeks, including Goldman Sachs, which changed its prognosis for Johnson & Johnson to "neutral," after rating it "sell" for 14 months. But the heavy burden of litigation facing the company may have some questioning the company's direction and management.
On March 17, a federal jury in Dallas ordered the company to pay $502 million to five plaintiffs who claimed the company's Pinnacle artificial hips failed prematurely. And on Feb. 22, a state jury in Missouri returned a $72 million verdict in the case of a woman whose death from ovarian cancer was linked to long-term use of Johnson & Johnson's talcum powder products. The company is expected to appeal both verdicts.
On another front, Johnson & Johnson's Janssen Pharmaceuticals has been hit with plaintiff verdicts in three of the four cases tried before Philadelphia juries in the past year concerning a tendency by antipsychotic drug Risperdal to cause male users to develop breasts. The company has seen verdicts of $500,000, $2.5 million and $1.75 million in those cases. Also in Philadelphia, the company was hit with verdicts of $12.5 million in January and $13.5 million in February over its pelvic mesh products. And in the fall, the company faces the first trial in multidistrict litigation in Philadelphia of 217 suits claiming that Tylenol causes liver damage.
In addition, on March 29, the New Jersey Appellate Division upheld an $11.1 million verdict against Johnson & Johnson subsidiary Ethicon Inc. in the first bellwether pelvic mesh trial in New Jersey state court.
Erik Gordon, who studies drug companies as an assistant professor at the University of Michigan's Ross School of Business, said he sees a departure from the vow by Johnson & Johnson's founders to put patients' interests ahead of those of stockholders.
"J&J seems to have changed from a company that lived its famous credo of putting patients first to a company that puts 'hit the sales numbers' first and cites the credo, with feeling, when it is in a public relations mess related to allegedly defective products," Gordon said.
The root cause of the verdicts lies in the conduct of Johnson & Johnson, said Shanin Specter of Kline & Specter in Philadelphia, who recently tried two pelvic mesh cases against the company to verdict for a total of $26 million in jury awards.
"Johnson & Johnson is being told by juries that they have acted negligently and recklessly more than any other company in the United States," Specter said. "Their internal documents demonstrate that they are a company that has lost its way, and they are putting sales over safety."
Specter added that the history of punitive damage awards against Johnson & Johnson is striking. In his pelvic mesh cases, $17 million of the $26 million awarded were for punitives. In the Pinnacle case in Texas, $360 million of the $502 million awarded were for punitives, and in the Missouri talcum powder case, $62 million of the $72 million were for punitives.
In addition, the $11.1 million verdict in the New Jersey pelvic mesh case included a $7.76 million punitive damages award, which the appeals court held was "more than adequately supported" by the evidence.
"Remember that punitive damages are a rare event in the United States, so to see J&J be assessed these damages over and over again is a regrettably meaningful statement about the culture of the company," Specter said. "You don't see this happen with the same frequency with other huge companies."
Still, other lawyers said that punitive damages are particularly vulnerable on appeal, and that the $502 million Texas verdict is likely to be overturned.
The heavy toll of plaintiffs' verdicts against Johnson & Johnson and other drug companies comes as the pharmaceutial industry is undergoing a shift in public perceptions, said Christopher Placitella of Cohen, Placitella & Roth in Red Bank, who represents plaintiffs in mass tort suits.
"It used to be big tobacco was an issue, and I think that some of that color has shifted to the pharmaceutical industry, as people are paying more and more for drugs, and having to shoulder that load," he said. "I think the public has a higher demand for competency and foresightedness."
But John Beisner of Skadden, Arps, Slate, Meagher & Flom in Washington, who represents Johnson & Johnson in the Pinnacle case and other products liability suits, said he sees the series of large verdicts against the company as a consequence of the current litigation environment, in which plaintiffs lawyers advertise heavily to find clients to join their lawsuits. Those lawyers look to inflate the number of plaintiffs in their cases without carefully vetting the merits of each client's claims, said Beisner.
Then, plaintiffs' counsel in those cases are "a lot more aggressive about crossing the line on many kinds of things," such as "trying to put in everything or make arguments to the jury that are not going to be sustained on appeal. Plaintiffs' counsel are going for the headlines," Beisner said.
"If you look at federal court statistics, recently upwards of 40 to 45 percent of all civil lawsuits in the federal court system are in these multidistrict litigation, mass tort proceedings. That is stunning. That tells you how big this mass tort, lawyer-driven industry has become," Beisner said.
Johnson & Johnson spokesman Ernie Knewitz said in a statement about the recent crop of litigation: "While each product and legal case is handled uniquely, it's important to distinguish that jury verdicts should not be confused with regulatory rulings or rigorous scientific findings."
Knewitz added, "We have no greater responsibility than to the patients and consumers who use our products. We have quality controls in place to ensure that our products are safe and effective for consumers when used as directed, and we actively engage in transparent discussions with health authorities from the time we begin developing our products and while they're on the market, to ensure they work as intended."
Attorneys for both plaintiffs and defendants most often pointed to the size of the company and its wide range of products to explain why Johnson & Johnson is now the target of so much litigation. But its size, and the deep pockets in particular, also allow the company to be more aggressive and take more cases to trial than similar smaller companies, attorneys said.
Unlike smaller drug companies that might hesitate about taking a case to trial, "J&J is never afraid of what their exposure could have been ... If you compare J&J to other manufacturers, whether it's pills or devices, they're in a stronger position because of their size, and just who they are, to be more aggressive in fighting off plaintiffs," said Kevin Hart, who represents plaintiffs in drug and medical device litigation at Stark & Stark in Lawrenceville.
The steady stream of verdicts against Johnson & Johnson could be a factor of the company having a more aggressive litigation posture, said Placitella.
"Part of that is the litigation position they're trying to assert. I think that's a big piece of it," Placitella said. "They're digging in harder, pushing themselves to the forefront of trial."
But Hart cautioned against drawing any big conclusions about Johnson & Johnson based on the current crop of verdicts against the company. He noted that trials are very fact-specific and six months from now Johnson & Johnson may no longer be the focus of so much litigation.
"It's a product-by-product thing, as opposed to saying J&J overall is getting hammered," Hart said.
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NJ Court Affirms $11M Pelvic Mesh Verdict
Mar 29, 2016 | New Jersey Law Journal
By Michael Booth
A New Jersey state appeals court has upheld an $11.1 million damages verdict against Johnson & Johnson subsidiary Ethicon Inc. in the first bellwether trial over allegedly harmful pelvic mesh implants.
The three-judge Appellate Division panel said March 29 that it saw no reason to overturn the award of $3.35 million in compensatory damages and $7.76 million in punitive damages awarded to the plaintiff and her husband, Linda and Jeffrey Gross.
The mesh implants were designed and manufactured by Ethicon.\
The lawsuit filed by Gross alleged that she sustained serious injuries as a result of having the implant and that she has undergone 20 surgeries in an effort to repair the damages. She testified that she would not have agreed to have the implant had she been adequately warned of the potential dangers that Ethicon allegedly knew about.
“The jury was presented with sufficient evidence by which it could reasonably conclude that the lack of adequate warning was a proximate cause of plaintiff’s injuries,” said Judges Clarkson Fisher Jr., Marianne Espinosa and Garry Rothstadt in an unpublished opinion.
“The evidence was sufficient to allow the jury to find an adequate warning would have prevented plaintiff’s injuries,” the judges said.
Ethicon knew of the potential dangers of the implants and failed to warn patients of those dangers in its marketing materials.
The judges rejected Ethicon's arguments that it should not be held liable since it was the responsibility of Gross' doctor to warn her of the potential dangers under the "learned intermediary doctrine."
"[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.
“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.
The Gross’s lawyer, Adam Slater, said the ruling is a “very strong decision that clarifies important points of the law on failure to warn.”
“This will have wide implications across the pharmaceutical landscape,” said Slater, of Roseland’s Mazie Slater Katz & Freeman, adding that the ruling will have an impact on pending mesh implant litigation both in New Jersey and nationally because of the court’s detailed factual findings.
A spokeswoman for Ethicon, Samantha Lucas, said the company is evaluating its options.\
“We disagree with the appellate court’s application of the law to the facts of this case,” she said in a statement. “We believe Ethicon acted appropriately and responsibly in the research, development and marketing of the [implant].\
“We empathize with all women suffering from pelvic organ prolapse, which can be a serious and debilitating condition, and we are always concerned when a patient experiences adverse medical events. We have always made patient safety a top priority and will continue to do so,” Lucas said in her statement.
Ethicon’s product, the Gynacare Prolift pelvic organ prolapse repair kit, is designed to support pelvic muscles that become weak or dysfunctional and cease supporting the organs. The dysfunction allegedly can cause connective tissue attachments to stretch or break and allow organs to become displaced.
The product 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.
On appeal, Ethicon’s lawyer, Charles Lifland, of the Los Angeles office of O’Melveny & Myers, argued that the claims of deceit should have been dismissed because of the learned intermediary doctrine.
The appeals court disagreed.
Gross is a resident of South Dakota, and both sides agreed that for the liability claims, South Dakota law would apply.\
The appeals court cited a 2012 decision by the U.S. District Court for the District of South Dakota, Northwestern Public Services v. Union Carbide. In that case, the court said a deceit claim “requires proof of intentional misrepresentation or concealment of a fact on which plaintiff relied and that caused an injury to plaintiff.”
“Plaintiff’s proofs were clearly sufficient to meet this standard,” the appeals court judges said.
The judges noted that Gross relied heavily on information contained in Ethicon’s Prolift online brochure.
“The record ,,, contains sufficient evidence from which the jury could have found defendants willfully deceived plaintiff by providing intentionally misleading information in the patient brochure and by suppressing facts they were bound to disclose, that they made the misrepresentations to induce plaintiff to use the Prolift system, that plaintiff relied on the information in the brochure, and that she suffered damages as a result of the deception,” the judges said.\
Both sides also agreed that New Jersey law would apply to the punitive damages claim.
Lifland argued that the punitive damages award was excessive. The appeals court again disagreed.
“Such damages are appropriate where the manufacturer knew of the dangers created by its product and failed to warn users of serious health hazards,” the judge said. “The evidence more than adequately supported the jury’s award of punitive damages.”
In July 2014, Atlantic County Superior Court Judge Carol Higbee, who presided over the trial, 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, marketed by Somerville-based Ethicon beginning in 2002.
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 found by a 7-2 vote 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 the 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.
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 noted that punitive damages claims are typically barred in pharmaceutical cases, but Gross’ injuries occurred before any FDA approval was obtained. She declined to reduce the punitive damages total, noting that it “could have been a $15 million award and still fit under the parameters.”
A New Jersey state appeals court has upheld an $11.1 million damages verdict against Johnson & Johnson subsidiary Ethicon Inc. in the first bellwether trial over allegedly harmful pelvic mesh implants.
The three-judge Appellate Division panel said March 29 that it saw no reason to overturn the award of $3.35 million in compensatory damages and $7.76 million in punitive damages awarded to the plaintiff and her husband, Linda and Jeffrey Gross.
The mesh implants were designed and manufactured by Ethicon.
The lawsuit filed by Gross alleged that she sustained serious injuries as a result of having the implant and that she has undergone 20 surgeries in an effort to repair the damages. She testified that she would not have agreed to have the implant had she been adequately warned of the potential dangers that Ethicon allegedly knew about.
“The jury was presented with sufficient evidence by which it could reasonably conclude that the lack of adequate warning was a proximate cause of plaintiff’s injuries,” said Judges Clarkson Fisher Jr., Marianne Espinosa and Garry Rothstadt in an unpublished opinion.
“The evidence was sufficient to allow the jury to find an adequate warning would have prevented plaintiff’s injuries,” the judges said.
The judges found that there was “substantial evidence” that Ethicon knew of the potential dangers of the implants and failed to warn patients of those dangers in its marketing materials.
The judges rejected Ethicon’s arguments that it should not be held liable since it was the responsibility of Gross’ doctor to warn her of the potential dangers under the “learned intermediary doctrine.”
“[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.
The Gross’s lawyer, Adam Slater, said the ruling is a “very strong decision that clarifies important points of the law on failure to warn.”
“This will have wide implications across the pharmaceutical landscape,” said Slater, of Roseland’s Mazie Slater Katz & Freeman, adding that the ruling will have an impact on pending mesh implant litigation both in New Jersey and nationally because of the court’s detailed factual findings.
A spokeswoman for Ethicon, Samantha Lucas, said the company is evaluating its options.
“We disagree with the appellate court’s application of the law to the facts of this case,” she said in a statement. “We believe Ethicon acted appropriately and responsibly in the research, development and marketing of the [implant].
“We empathize with all women suffering from pelvic organ prolapse, which can be a serious and debilitating condition, and we are always concerned when a patient experiences adverse medical events. We have always made patient safety a top priority and will continue to do so,” Lucas said in her statement.
Ethicon’s product, the Gynacare Prolift pelvic organ prolapse repair kit, is designed to support pelvic muscles that become weak or dysfunctional and cease supporting the organs. The dysfunction allegedly can cause connective tissue attachments to stretch or break and allow organs to become displaced.
The product 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.
On appeal, Ethicon’s lawyer, Charles Lifland, of the Los Angeles office of O’Melveny & Myers, argued that the claims of deceit should have been dismissed because of the learned intermediary doctrine.
The appeals court disagreed.
Gross is a resident of South Dakota, and both sides agreed that for the liability claims, South Dakota law would apply.
The appeals court cited a 2012 decision by the U.S. District Court for the District of South Dakota, Northwestern Public Services v. Union Carbide. In that case, the court said a deceit claim “requires proof of intentional misrepresentation or concealment of a fact on which plaintiff relied and that caused an injury to plaintiff.”
“Plaintiff’s proofs were clearly sufficient to meet this standard,” the appeals court judges said.
The judges noted that Gross relied heavily on information contained in Ethicon’s Prolift online brochure.
“The record ,,, contains sufficient evidence from which the jury could have found defendants willfully deceived plaintiff by providing intentionally misleading information in the patient brochure and by suppressing facts they were bound to disclose, that they made the misrepresentations to induce plaintiff to use the Prolift system, that plaintiff relied on the information in the brochure, and that she suffered damages as a result of the deception,” the judges said.
Both sides also agreed that New Jersey law would apply to the punitive damages claim.
Lifland argued that the punitive damages award was excessive. The appeals court again disagreed.
“Such damages are appropriate where the manufacturer knew of the dangers created by its product and failed to warn users of serious health hazards,” the judge said. “The evidence more than adequately supported the jury’s award of punitive damages.”
In July 2014, Atlantic County Superior Court Judge Carol Higbee, who presided over the trial, 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, marketed by Somerville-based Ethicon beginning in 2002.\
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 found by a 7-2 vote 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 the 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.
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 noted that punitive damages claims are typically barred in pharmaceutical cases, but Gross’ injuries occurred before any FDA approval was obtained. She 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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NJ Appeals Panel Affirms $11M J&J Pelvic Mesh Judgment
Mar 29, 2016 | Law360
By Adam Sege
A state appeals court in New Jersey has upheld a $11.1 million jury award to a woman who claims a Johnson & Johnson unit's vaginal mesh product caused debilitating nerve pain, saying ample evidence presented at trial showed that better warnings of the product's risks might have prevented her injuries.
The jury heard sufficient evidence showing Linda Gross’ doctor might have offered different guidance if he'd had more information about the product’s risks, which might have led Gross to pursue a different course of treatment and avoided the injuries for which she sued Johnson and Johnson and its subsidiary Ethicon Inc., a three-judge panel ruled in the bellwether case Tuesday.
“The evidence was sufficient to allow the jury to find an adequate warning would have prevented plaintiff's injuries,” the panel wrote.
Gross and her husband sued in 2008, saying Ethicon had 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 it agreed to stop selling in June 2012, despite saying it did not believe the products to be harmful.
During oral arguments in February, Ethicon had challenged the judge’s determination that sufficient evidence existed to support a finding that the company was responsible for Gross’ injuries after using the product, according to the panel’s opinion. The company had previously asked the judge to issue a judgment notwithstanding the verdict or order a new trial, saying the jury award was not supported by adequate evidence, but the judge declined to do either.
The panel agreed with the judge Tuesday, noting the doctor’s testimony that he would have counseled against the procedure or spent at least 45 minutes discussing its drawbacks if he had known it “should not be implanted in sexually active people.”
“The judge also relied on plaintiff's testimony that she would not have selected the Prolift option if she had known of the risks and recognized there was overwhelming evidence to show the company had information about Prolift that it chose not to provide to the physician,” the panel wrote.
The panel’s ruling follows the decision by New Jersey Superior Court Judge Carol E. Higbee not to second-guess the jury’s February 2013 award of $3.35 million in compensatory damages and $7.76 million in punitive damages for injuries caused by her use of the Gynecare Prolift mesh product to repair a pelvic floor collapse.
The trial featured testimony from an array of Ethicon employees who were questioned about the design, testing and marketing of Prolift, which Gross had implanted in 2006 to repair a pelvic organ prolapse. Gross had 18 subsequent surgeries to remove the mesh after she said the product caused severe nerve pain that ended her nursing career and prevented her from enjoying time with her family or from having a normal sex life.
In a statement, Ethicon said the company disagrees with the panel ruling and continues to believe it "acted appropriately and responsibly in the research, development and marketing" of Prolift.
"We empathize with all women suffering from pelvic organ prolapse, which can be a serious and debilitating condition, and we are always concerned when a patient experiences adverse medical events," the company said. "We have always made patient safety a top priority and will continue to do so."
Asked about the ruling, an attorney for Gross and her husband said he was "gratified" for the couple. Because the case is the first pelvic mesh case to go to trial in New Jersey, where Johnson & Johnson is headquartered, attorney Adam M. Slater also said the ruling will have a meaningful impact for more than 9,000 other women who claim injuries related to pelvic mesh use.
"I'm happy for all the other women out there who are waiting for trials, because the decision gives tremendous guidance to the courts that are going to hear these cases going forward,” he said.
Gross is represented by Adam M. Slater and David A. Mazie of Mazie Slater Katz & Freeman LLC.
Johnson & Johnson and Ethicon are represented by Christy Jones and William M. Gage ofButler Snow O'Mara Stevens & Cannada PLLC, and by Kelly Crawford-Riker, Maha M. Kabbash and Mary Ellen Scalera of Riker Danzig Scherer Hyland & Perretti LLP.
The case is Gross v. Gynecare Inc., case number Atl-L-6966-10, in the Superior Court of the State of New Jersey, County of Atlantic. -
Just In* – Linda Gross Prolift Case Survives Appeal by J&J
Mar 29, 2016 | Mesh Medical Device News Desk
By Jane Akre
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:
Christy Jones, Feb 2013
“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.
THE APPEAL
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.
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.
Adam Slater, Feb. 2013
“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.
WHAT’S NEXT?
Johnson & Johnson has 20 days to Petition the New Jersey Supreme Court to ask it to hear theGross 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
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