Preview Newsletter
Hammons Trial -- December 2015
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Civil trial begins over safety of vaginal mesh device
Dec 2, 2015 | Philadelphia Inqjuirer
By Chris Mondics
Jury selection began Tuesday in the civil trial of a lawsuit brought by a woman in Philadelphia Common Pleas Court against Johnson & Johnson, claiming that a vaginal mesh device made by the company failed after she had it surgically implanted, causing extreme pain and requiring multiple corrective surgeries. -
Pelvic Mesh Trial Opens in Philadelphia
Dec 2, 2015 | Legal Intelligencer
By Max Mitchell
Plaintiff’s counsel in Philadelphia’s first pelvic mesh trial focused his opening statements on the product’s design and injuries it allegedly caused. -
Pelvic Mesh Caused Irreversible Conditions, Pa. Jury Hears
Dec 2, 2015 | Law360
By Dan Packel
Counsel for an Indiana woman with pelvic organ prolapse told a Philadelphia jury Wednesday that a Johnson & Johnsonunit's mesh rendered her unable to have sexual intercourse and caused bladder dysfunction, in the first pelvic mesh case to go to trial in the jurisdiction. -
Ethicon Pelvic Mesh Trial Underway in Philadelphia Exposes Document Destruction by J&J
Dec 22, 2015 | Mesh News Desk
By Jane Akre
Opening arguments got underway for Philadelphia’s first pelvic mesh trial last week. -
First Phila. pelvic-mesh trial goes to jury
Dec 21, 2015 | Philadelphia Inquirer
By Chris Mondics
What is the value of a lawsuit against the maker of a surgical implant that causes some women such excruciating pain during sexual intercourse they are forced into celibacy? -
Jurors Begin Deliberating Philadelphia Prolift Pelvic Mesh Case
Dec 16, 2015 | Mesh News Desk
By Jane Akre
The two-week trial of Hammons v. Ethicon case went to the jury Friday in the first pelvic mesh tried in Pennsylvania. The Indiana woman, Patricia Hammons, filed a product liability case against Ethicon, a subdivision of Johnson & Johnson over a Prolift pelvic mesh she received to treat incontinence in 2009. (Case No. 130503913). The case is being heard in the Court of Common Pleas, believed to be favorable to plaintiffs. -
Jurors Prepare To Mull First Philly Pelvic Mesh Case
Dec 17, 2015 | Law360
By Dan Packel
Philadelphia jurors will begin deliberating Friday in the first pelvic mesh case to be tried in the jurisdiction, after hearing the attorney for an Indiana woman contend the negligence among scientists at a Johnson & Johnson unit is the root cause of her inability to have sex. -
Philadelphia jury awards woman $12.5 million in damages from Johnson & Johnson in vaginal mesh implant case
Dec 22, 2015 | Philadelphia Inquirer
By Chris Mondics
A Philadelphia jury on Tuesday awarded $12.5 in damages to a woman who alleged in a lawsuit that a vaginal mesh implant made by Johnson & Johnson caused her to have extreme pain during sex and required multiple corrective surgeries. -
(UPDATE) $7M in Punitives Awarded in Pelvic Mesh Case
Dec 22, 2015 | Legal Intelligencer
By Max Mitchell
A Philadelphia jury has hit Johnson & Johnson with a $7 million punitive damages verdict over conduct in the design and marketing of its pelvic mesh implant device -
Ethicon hit with $12.5 mln verdict in Philadelphia mesh trial
Dec 22, 2015 | Reuters Westlaw
By Jessica Dye
Johnson & Johnson subsidiary Ethicon Inc has been hit with a $12.5 million verdict in a lawsuit from a woman who said she was injured by transvaginal mesh, a device that is the subject of tens of thousands of lawsuits in state and federal courts. -
BREAKING: J&J Tagged With $7M Punitives In Pa. Pelvic Mesh Case
Dec 22, 2015 | Law360
By Dan Packel
Jurors on Tuesday hit a Johnson & Johnson unit with $7 million in punitive damages, on top of $5.5 million in compensatory damages, in the first case over the company’s Prolift pelvic mesh product to be tried in Philadelphia’s mass tort program. -
Johnson & Johnson lose 1st Philly mesh case
Dec 21, 2015 | Mass Device
By Fink Densford
A jury in Philadelphia ruled today that Johnson & Johnson (NYSE:JNJ) must pay $5.5 million in the 1st in a series of pelvic mesh lawsuits. -
$5.5 Million Compensatory Verdict Returned In 1st Pelvic Mesh Trial In Pennsylvania
Dec 22, 2015 | LexisNexis News
By Tom Moylan
A Pennsylvania state court jury on Dec. 21 returned a $5.5 million verdict in the first pelvic mesh case from the state’s complex litigation docket to go to trial, according to one of the plaintiff’s attorneys (Patricia L. Hammons v. Ethicon Inc., No. 130503913, Pa. Comm. Pls., Philadelphia Co.). -
Johnson & Johnson Hit With $12.5 Million Judgment in Mesh Case
Dec 23, 2015 | Outpatient Surgery Magazine
By Tim Berger
An Indiana woman who sued Johnson & Johnson, claiming that a vaginal mesh implant made by the company caused extreme pain during sex and required numerous corrective surgeries, has been awarded $12.5 million. -
Philadelphia Prolift Mesh Case Yields $12.5 Million Verdict for Plaintiff
Dec 22, 2015 | Mesh Device News
By Jane Akre
After negotiating for less than 24 hours, the 12 jurors in the case of a woman implanted with a Prolift pelvic mesh made by Johnson & Johnson (J&J), added to her $5.5 million compensatory award with $7 million in punitive damages bringing her total jury award to $12.5 million. -
Philadelphia Jury Adds $7 Million in Punitive Damages to $5 Million Compensatory Verdict At Conclusion of Prolift Mesh Trial
Dec 22, 2015 | HarrisMartin
A Pennsylvania jury has awarded a Prolift pelvic mesh plaintiff $7 million in punitive damages in the second phase of a Prolift transvaginal mesh device trial, sources tell HarrisMartin Publishing. -
Witnesses in Philadelphia Mesh Trial Tell Tale of Prolift Mesh Marketing
Dec 10, 2015 | Mesh Device News
By Jane Akre
While Mesh News Desk (MND) is not in the courtroom in Philadelphia for the Hammons v. Ethicon pelvic mesh trial (Case No. 130503913, Court of Common Pleas), reports are that two of the witnesses who have appeared on the stand in Philadelphia have appeared for plaintiffs during previous Prolift pelvic mesh trials. -
Ethicon Official In Pa. Mesh Trial Defends Product's Safety
Dec 7, 2015 | Law360
By Matt Fair
A top engineer with a Johnson & Johnson subsidiary told a Philadelphia jury on Monday that safety concerns over a pelvic mesh implant blamed for untreatable injuries in an Indiana woman had been rigorously vetted before the product went to market in 2005. -
Ethicon Safety Commitment Questioned In Pa. Mesh Trial
Dec 4, 2015 | Law360
By Matt Fair
The research and development head for a Johnson & Johnson subsidiary faced questioning Friday before a Pennsylvania jury, over whether the company had adequately warned surgeons about the risk of complications in patients implanted with a pelvic mesh product blamed for injuring an Indiana woman.
Openings
Closings
Verdict
During Trial
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Civil trial begins over safety of vaginal mesh device
Dec 2, 2015 | Philadelphia Inqjuirer
By Chris Mondics
Jury selection began Tuesday in the civil trial of a lawsuit brought by a woman in Philadelphia Common Pleas Court against Johnson & Johnson, claiming that a vaginal mesh device made by the company failed after she had it surgically implanted, causing extreme pain and requiring multiple corrective surgeries.
Thousands of lawsuits have been filed against J&J - one of the world's biggest makers of health-care products - and other pelvic mesh manufacturers contending that the devices were poorly tested and that the companies failed to disclose information showing the risks.
J&J withdrew some of its surgical mesh products from the market in 2012, including the Prolift product at issue in this suit, after an avalanche of complaints. At that time, the company said it properly warned all physicians and patients about possible risks. The Food and Drug Administration had warned in 2008 about the safety and effectiveness of the broad group of mesh products on the market.
The lawsuit, filed in July 2013 by Patricia Hammons of Indiana, is being tried before Judge Mark Bernstein. Opening arguments could begin as early as Wednesday.
Nationwide, there have been 16 verdicts in recent years against pelvic mesh manufacturers, including J&J, totaling $247 million. In May, a jury in Delaware awarded a woman $100 million in compensation for injuries caused by a pelvic mesh implant made by Boston Scientific. Overall, the exposure to mesh manufacturers could be in the billions of dollars, analysts say.
Philadelphia courts often are the venue of choice for plaintiffs lawyers pursuing mass torts cases, like the vaginal mesh lawsuits, because they have long experience with complicated civil claims, and Philadelphia juries are deemed sympathetic to plaintiffs. J&J and its subsidiary Ethicon, which marketed the vaginal mesh product, have facilities throughout the region, thus giving courts here jurisdiction.
"Contrary to J&J defendants' representations and marketing to the medical community and to the patients themselves, their pelvic mesh products ... have a high failure, injury, and complications rate, fail to perform as intended, require frequent and often debilitating re-operations, and have caused severe and irreversible injuries," according to Hammons' lawsuit.
Pelvic mesh implants came into wide use a decade ago for treatment of a condition where the bladder and other organs, weakened by childbirth, over time sag into the vagina, causing urinary incontinence, pain during intercourse, and other maladies.
Hammons had the pelvic mesh implant surgery in 2009, when she was 58.
After the surgery, Hammons complained of painful intercourse. Although Hammons underwent corrective surgery, the pain persisted, as did other problems, including incontinence. In subsequent surgeries to remove the mesh, her physician noted that the mesh was "bunched up" along the undersurface of the bladder and that the movement likely caused perforation to Hammons' bladder.
The multiple surgeries, moreover, caused Hammons to have a greatly shortened vaginal cavity, making it highly unlikely that she would ever be able to enjoy intercourse again, according to her complaint.
Hammons' Philadelphia lawyer, Shanin Specter, alleges that J&J rushed its vaginal mesh products to market, fearing competition from other makers, and in the process ignored evidence that the device might harm patients, particularly by shrinking over time.
In court papers in the case, J&J said both doctors and patients were adequately warned of the medical risks.
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Pelvic Mesh Trial Opens in Philadelphia
Dec 2, 2015 | Legal Intelligencer
By Max Mitchell
Plaintiff’s counsel in Philadelphia’s first pelvic mesh trial focused his opening statements on the product’s design and injuries it allegedly caused.
Shanin Specter, who represents plaintiff Patricia Louise Hammons in her suit against Johnson & Johnson subsidiary Ethicon, told the jury Wednesday the device that was implanted in Hammons to support her prolapsed bladder contained too much mesh. According to Specter, if unspooled, the mesh in the Gynecare Prolift device that Ethicon designed could stretch across two-and-a-half football fields.
“That is a lot of mesh,” Specter said.
Specter then told the jury that the density of the mesh caused scar tissue to build up and contract, which eventually led to erosion of Hammons’ bladder and “excruciating” pain during sex.
Opening statements in Hammons v. Ethicon were held in Judge Mark I. Bernstein’s court Wednesday. It is the first out of the Philadelphia Court of Common Pleas’ pelvic mesh mass tort to hit trial, and, according to court records, four additional mesh cases have been set for trial.
According to the court’s website, there are more than 180 cases in the pelvic mesh mass tort.
Hammons, an Indiana resident who worked as a stocker for Wal-Mart, has alleged the product was negligently designed, and Ethicon and J&J failed to properly warn health professionals about the risks of the Prolift device.
According to Specter, the device, which was approved for use by the U.S. Food and Drug Administration in 2005, was implanted into Hammons in 2009 to address a prolapsed bladder. After the device failed, she had to have numerous surgeries, but will not be able to completely remove portions of the mesh that eventually adhered to the bladder, Specter said.
Ethicon’s attorney, Susan M. Robinson of Thomas Combs & Spann, focused her opening statement on the history of the mesh device and its development. According to Robinson, development of the device was led by doctors, not Ethicon, and the risks of using pelvic mesh were well known throughout the medical community.
“Long before Prolift came to the market, doctors were operating with mesh in the vaginal area, using products that, year, after year, after year, had been studied,” Robinson said.
Opening statements are expected to continue this afternoon.
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Pelvic Mesh Caused Irreversible Conditions, Pa. Jury Hears
Dec 2, 2015 | Law360
By Dan Packel
Counsel for an Indiana woman with pelvic organ prolapse told a Philadelphia jury Wednesday that a Johnson & Johnsonunit's mesh rendered her unable to have sexual intercourse and caused bladder dysfunction, in the first pelvic mesh case to go to trial in the jurisdiction.
Patricia Hammons is accusing J&J and its Ethicon Inc. unit of overlooking negative side effects associated with its Prolift pelvic mesh product and hiding the risks from her implanting surgeon.
Her attorney Shanin Specter of Kline & Specter PC said that the implant's use was avoidable and that Ethicon ignored its internal guidelines in putting Prolift on the market.
“Ethicon rushed to get the product to the market even when complications were occurring to women in its initial premarket testing,” Specter said. “They violated their own internal written standard and kept moving forward anyway.”
He brandished the Prolift packaging — approximately the size of a packet of copy paper — and unfurled the implant before the jurors before detailing the effects of Hammons’ 2009 surgery. An Indian physician implanted the product between her bladder and her vagina in an effort to correct the sagging of her internal organs.
“She basically cannot have sexual relations,” Specter said, adding that “shards” of the product were now embedded in her bladder wall, could not be removed and caused urinary dysfunction.
“They are regrettably untreatable,” he said of these conditions.
Specter constructed an elegant story about the flaws of Prolift’s design, noting that it incorporated far too much mesh with far too few holes, making it harder for healthy tissue to grow around it when implanted. Instead, the construction of the mesh prompted the growth of scar tissue, which contracts over time, pulling the mesh with it, and ultimately causes the vagina to shrink.
He noted that jurors would hear a number of Ethicon and J&J employees testifying in depositions about the flaws of the product and Ethicon’s eagerness to get it to the market to beat the competition.
And he highlighted several other strategies for the treatment of pelvic organ prolapse, including the use of better mesh, which was on the market when the Prolift product was implanted in Hammons.
A lawyer for Ethicon defended the use of Prolift in Hammons’ surgery.
“It was the best product to be used at the time, and it worked,” Susan Robinson of Thomas Combs & Spann PLLC told the jury.
Robinson said that Hammons’ complaints were likely traceable to several other surgeries aimed at treating her condition, including a vaginal hysterectomy.
The defense attorney also told the jurors that pelvic implants made of polypropylene — the material in Prolift — had been evaluated and observed for years since gynecologists began using mesh designed for abdominal hernias in surgeries.
Robinson also defended the deposition testimony of Dr. Michael Heit — who performed two surgeries on Hammons that included removing some of the mesh.
Specter had suggested that Heit reversed his earlier belief that the mesh was flawed because of his financial relationship with Ethicon. Robinson responded that his change in position stemmed from evidence revealed in a follow-up exam.
And Robinson emphasized that the doctor who performed the original implant was certainly aware of the risks.
“A physician who’s been through medical training would be hard pressed to not know about the potential problems,” Robinson said.
The trial is expected to last for two weeks.
Hammons’ case is one of over 180 pending in a mass tort in the Philadelphia County Court of Common Pleas. Four others have been listed for trial. According to plaintiffs counsel in May, there are some 26,000 claims pending against Ethicon in a multidistrict litigation in West Virginia and nearly 8,000 in the consolidated litigation in New Jersey.
The plaintiffs are represented by Shanin Specter, Lee Balefsky, Kila Baldwin and Michelle Tiger of Kline & Specter PC.
The defendants are represented by Susan Robinson of Thomas Combs & Spann PLLC, Matthew Moriarty of Tucker Evans LLP, Molly Flynn of Drinker Biddle Reath LLP, and Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum LLP.
The case is Hammons v. Ethicon Inc. et al., case number 130503913, in the Court of Common Pleas of the State of Pennsylvania, County of Philadelphia. -
Ethicon Pelvic Mesh Trial Underway in Philadelphia Exposes Document Destruction by J&J
Dec 22, 2015 | Mesh News Desk
By Jane Akre
Mesh News Desk, December 8, 2015 ~ OPENING ARGUMENTS
Opening arguments got underway for Philadelphia’s first pelvic mesh trial last week.
Patricia Hammons, 64, filed her product liability action against Johnson & Johnson and its subsidiary Ethicon over her Prolift pelvic mesh implant, used to treat a condition known as bladder prolapse. Initially filed in multidistrict litigation in Charleston, WV, it was remanded to court in Philadelphia two years ago.
Patricia L. Hammons v Secant Medical, Ethicon, in the Philadelphia Court of Common Pleas, Case No. 2:13-cv-04086. Secant is the maker of a component of the polypropylene mesh implant.
Shanin Specter, Kline Specter
Attorney Shanin Specter (Kline & Specter,Philadelphia) said the Prolift pelvic mesh implant has too much mesh which causes scar tissue, mesh contraction and erosion. The amount of mesh could stretch across two-and-a half football fields, he said. Hammons suffers mesh erosion into her bladder and “excruciating” pain during sex or dyspareunia. The mesh was found to have folded under her bladder and repeated surgeries have caused a shortened vagina.
This case was filed in the Philadelphia Court of Common Pleas and is being heard before Judge Mark I. Bernstein. Attorney Adam Slater of Mazie Slater is also trying the case. Slater won the first Prolift case ever tried in Atlantic City in 2013. Linda Gross was awarded $11.1 million. That case is still under appeal.
THE PLAINTIFF
Hammons is from Indiana and works at Wal-Mart as a stocker. She alleges her product was negligently designed and that J&J failed to warn doctors about the risk of the Prolift. She was implanted in 2009 after which she had numerous surgeries to fix her prolapse after the Prolift reportedly failed. The mesh has reportedly adhered to her bladder and cannot be removed after numerous attempts.
Specter showed the jury the blue and white mesh that comes in a box pre-cut along with its stainless steel hooks or trocars used for implantation. He also criticized the mesh for having pores too small that cause excess scarification or scar growth. Scar tissue tends to contract and can take with it nerves, causing chronic pain. Ethicon had no idea how to remove the mesh if it caused complications, Specter told jurors.
This is the first of 181 cases filed in that venue, according to The Legal Intelligencer (here). Ethicon is facing additional cases filed in state courts around the country including New Jersey, California and Missouri as well as 30,163 product liability cases filed in the consolidated multidistrict litigation court in Charleston, WV. See the case list here.
Susan M. Robinson, Thomas Combs & Spann
Talking to the jurors for Ethicon was attorney Susan M. Robinson of Thomas, Combs & Spann. She said Ethicon brought the mesh to market on the advice of doctors and there are risks associated with any of these pelvic mesh products. She insists the mesh is not defective and it worked properly.
The attorney blamed pain during sex on the plaintiff’s hysterectomy she underwent in 2009 and additional prolapsing of her small bowel and uterus. Prolift had nothing to do with the fact she later developed the bowel prolapse, she said.
This trial has been limited to two weeks by Judge Mark I. Bernstein.
DOCUMENT DESTRUCTION REVEALED
Those who follow coverage of the pelvic and hernia mesh issue remember that two years ago, the court determined Johnson & Johnson had destroyed thousands of pages of documents that were under a litigation hold in preparation for this product liability litigation. See the MND story here and here.
The outcome was inconclusive with WV Chief Magistrate Cheryl Eifert saying that spoliation (document destruction) had occurred but no adverse instructions would be given for every trial, in part, because no one could be identified as the perpetrator. See PTO#100 Doc #1069, Feb. 4, 2014.
It was deemed to be a setback for the plaintiffs’ attorneys who had to piece together portions of discovery. Part of what was lost were inner-office emails, personal computers of J&J executives as they were moved to new positions within the company, the potential conflict of interest payments to mesh inventor Drs. Ulmsten and Nilsson who retrofitted hernia mesh to fit a woman’s pelvis. See MND story on what else was lost December 8, 2014 here.
The issue was never raised again.
Until now.
Adam Slater, Mazie, Slater
James P. Mittenthal was the designated corporate representative to testify on the subject. In the Philadelphia courtroom, his 2014 deposition was played. Under questioning by attorney Adam Slater, Mittenthal admitted ten-thousand documents had been destroyed by the company. J&J did it’s best to preserve documents and the destruction was unintentional, he said.
His deposition was taken for Lewis v. Ethicon, but never appeared to jurors before the trial ended in a directed verdict for the defense. See Lewis V. Ethicon MND coverage here.
LEWIS CASE – DO NOT DESTROY DOCUMENTS
In the Lewis case, Slater showed Mittenthal a document entitled Johnson & Johnson law department document preservation notice not to destroy specified documents.
It said “Do not discard, destroy, or alter in any way any of the documents, electronic or paper, described below.” The notice was issued May 22, 2003 by the Johnson & Johnson law department to preserve papers and documents in connection with current or future litigation.
A company-wide hold notice for mesh documents was issued April 30, 2007. Mr. Mittenthal said actually since 2003 there had been a defined policy. The employee is provided with a checklist and, along with their manager, they go through it to make sure “the departing employee’s obligations are complied with prior to his or her leaving the company, and that includes records retention or obligations.”
The policy has now been revised to take into account technology, he said. “
For my last question,” said Slater, “… you don’t expect people to actually tell you they did that (destroy documents) in direct violation of a policy right?”
A: I ask at every interview if information was destroyed. I have spent several years now looking at this company and have understood the climate by which information is managed, the information, the systems in place, and the general attitude and demeanor of the employees. And I have no reason to believe that anyone has withheld information from me or been false with me.”
Q: “There’s no way for you to know, for you to know what happened, right?”
A: “There’s no way for me to be absolutely certain. I would agree with you.”
PROLIFT OFF THE MARKET
Prolift, and three other pelvic meshes made by Ethicon, were quietly removed from the market in mid-2012 shortly after the U.S. Food and Drug Administration required mesh manufacturers to begin conducting three-years of post- approval studies on mesh products.
Philly.com (here) reports there have been 16 mesh verdicts totaling $247 million and ultimately the exposure for J&J and the six other mesh makers could be in the billions. The news outlet also reports that Philadelphia juries are “deemed sympathetic to plaintiffs.”
The first Prolift trial was that of Linda Gross of South Dakota and conducted by attorney Slater in state court in New Jersey. The $11.1 million jury verdict is still on appeal. The trial of another woman implanted with a Prolift mesh, Joan Budke, was settled just before it went to the jury in January of this year. Mrs. Budke died of mesh-related infections. #
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First Phila. pelvic-mesh trial goes to jury
Dec 21, 2015 | Philadelphia Inquirer
By Chris Mondics
What is the value of a lawsuit against the maker of a surgical implant that causes some women such excruciating pain during sexual intercourse they are forced into celibacy?
That is probably the most important question underlying a 21/2-week trial before Philadelphia Common Pleas Court Judge Mark Bernstein. Testimony concluded and on Thursday the jury began deliberations.
The trial involved allegations by Patricia Hammons, 65, a Walmart shelf stocker from Indiana, who underwent surgery in 2009 to correct a sagging bladder, a consequence of childbirth and a common problem in middle-aged women. It causes urinary incontinence and interferes with sex.
Her surgeon implanted a pelvic mesh barrier made by Ethicon, a subsidiary of global health-care products giant Johnson & Johnson, to shore up Hammons' bladder. But a short time later, Hammons complained sex had become so painful she had to cease relations with her boyfriend. In her lawsuit, Hammons claimed J&J's pelvic mesh implant was inherently unsafe, having a tendency to bunch up inside the pelvis while piercing her bladder. And she said that J&J knew about its safety problems but concealed them from doctors and patients.
Her lawsuit, the first to be tried in Philadelphia, is one of as many as 100,000 nationwide against makers of pelvic mesh implants. The outcome of a handful of cases like hers will decide how this overall legal battle will end. To say the stakes are enormous would be something of an understatement. Nationwide, there have been 16 verdicts in recent years against pelvic mesh manufacturers, including J&J, totaling $247 million. That includes a verdict in May in which a Wilmington jury awarded $100 million to a woman who said a pelvic implant made by Boston Scientific caused pain during sex.
Judging from the Hammons trial, it isn't a slam dunk for either side. Over the course of the trial, Hammons' lawyers, Shanin Specter of Kline & Specter in Philadelphia and Adam Slater of Roseland, N.J., who was assisting in the trial, elicited testimony from J&J executives that the company rushed to get the pelvic mesh product to the market in the face of competition from other companies.
Though use of pelvic mesh already had been associated with pain during sex - the medical term is dyspareunia - by the time J&J began selling it in 2005, no mention of this risk was made on the product label.
During the trial, one expert for the plaintiffs testified that removing the mesh completely was exceedingly difficult, if not impossible, and that doing so typically was a surgical "train wreck." Yet, in one particularly troubling bit of testimony, J&J product engineer Scott Ciarrocca said no one at the company had given any thought to how to remove the mesh if it failed.
One fact bolstering Hammons' case: J&J itself seems to have lost confidence in its mesh device named "Prolift." In 2012, the company pulled the product from the market.
J&J focused its defense on studies purporting to show the product was far more effective than earlier therapies, and testimony that the mesh was a safe and effective way to deal with pelvic organ prolapse - the sagging of organs into the vagina.
But J&J's defense wasn't entirely high road. While it argued that studies show the treatment was safe and effective, it also suggested Hammons' smoking habit may have played a role in her malady.
J&J lawyers also suggested the real reason Hammons wasn't having sex was that her boyfriend was impotent. In his concluding argument, Specter treated that assertion with contempt. Of Hammons' boyfriend, he said to the jury, "He was ready."
If I were sitting on the jury, I would likely decide that J&J knew too little about potential adverse outcomes and had brought the product to market prematurely, as one of the plaintiff's experts emphatically testified. The product had obviously failed in some patients and the company knew too little about how it would work in the real world.
But, for all the science bandied about in trials like these, verdicts often come down to judgment calls. The truth is no one can say with absolute certainty what caused Hammons' dyspareunia. Was it the vaginal mesh? Was it a hysterectomy she had undergone after the implant? Was it the natural atrophying of vaginal tissue that sometimes attends the aging process?
Evaluating the science is not an exact science. But juries usually are able to cut through conflicting data and claims and see through to the bottom line. What makes Hammons' lawsuit especially important, apart from her own claim to be compensated for a wrong she says was done to her, is that this case and a handful of others will help to form a legal consensus about J&J's conduct.
And that will shape the extent of J&J's liability in the tens of thousands of cases that remain.
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Jurors Begin Deliberating Philadelphia Prolift Pelvic Mesh Case
Dec 16, 2015 | Mesh News Desk
By Jane Akre
The two-week trial of Hammons v. Ethicon case went to the jury Friday in the first pelvic mesh tried in Pennsylvania. The Indiana woman, Patricia Hammons, filed a product liability case against Ethicon, a subdivision of Johnson & Johnson over a Prolift pelvic mesh she received to treat incontinence in 2009. (Case No. 130503913). The case is being heard in the Court of Common Pleas, believed to be favorable to plaintiffs.
She contends her pelvic injuries are permanent and she has undergone numerous removal surgeries. The mesh has reportedly adhered to her bladder and cannot be removed. She has pain, infection and urinary and sexual dysfunction.
The jury in the fist Prolift case to go to trial in 2013, delivered a $11.1 million verdict to plaintiff Linda Gross. That case is still under appeal. Attorney Adam Slater who represented Ms. Gross also represents Ms. Hammons along with Shanin Specter of Kline & Specter.
The Legal Intelligencer (here) reports Judge Mark Bernstein adjourned court for the day by mid-afternoon Wednesday due to a fire alarm disruption and a protest by cabs and Uber drivers outside of City Hall. Closing arguments continued and wrapped-up Thursday.
The Prolift is one of the largest meshes ever made by J&J and its division Ethicon. It is delivered to doctors in a box with implanting devices called trocars. In mid-2012, the Prolift was removed from the market by J&J, allegedly for financial reasons. That relieved the company of having to conduct FDA-imposed three-year post-approval monitoring of the effects the mesh on implanted women.
The Hammons trial is the first among among Ethicon pelvic mesh cases to tell jurors about the issue of document destruction. Ethicon destroyed documents that were under a hold for litigation purposes.
Specter showed the box and its contents to the jurors. With a hook-shaped installation tools, they resemble a hooked arm. The company had no clue how to remove the device if it failed, jurors were told. While Ethicon says the mesh system works. Specter argued it turns a woman’s posterior organs inside out, shrinks and deforms the vagina in the process.
Still ahead in early 2016 are a series of defective pelvic mesh cases to be heard in this venue beginning January 11, 2016 with De la Cruz, v. Ethicon, January 26, 23016, Carlino v. Ethicon, February 22, McGee v. Ethicon and Navarro v. Ethicon to be heard March 21, 2006. See background story on Hammons trial here. #
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Jurors Prepare To Mull First Philly Pelvic Mesh Case
Dec 17, 2015 | Law360
By Dan Packel
Philadelphia jurors will begin deliberating Friday in the first pelvic mesh case to be tried in the jurisdiction, after hearing the attorney for an Indiana woman contend the negligence among scientists at a Johnson & Johnson unit is the root cause of her inability to have sex.
Closing arguments in plaintiff Patricia Hammons' case against J&J subsidiary Ethicon Inc. finally came to an end Thursday, after being disturbed the previous day because of an Uber protest in Center City Philadelphia at a fire alarm that emptied City Hall, home to the courtroom.
Attorney Shanin Specter of Kline & Specter PC resumed his entreaty to the seven women and five men on the jury, emphasizing the company repeatedly prioritized sales over patient health in its decisions on its Prolift mesh product.
“The unifying theme here is that every time there was a contest between marketing and safety, marketing won,” Specter said.
Hammons had filed suit in Philadelphia in May 2013, alleging that shards of the Prolift mesh, which was implanted between her bladder and vagina in 2009 in an effort to correct sagging of her internal organs, became implanted in her bladder.
Specter argued to the jurors that testimony in the trial, which began over two weeks ago, revealed that Ethicon's data on the product's safety was false and that the success rate of surgeries to implant the mesh was less than the 80 to 90 percent figure the company cited.
He pointed to the pronouncement from Indiana physician Mark Baker, who performed the initial surgery on Hammons, saying that if he knew in 2009 what he knows now about Prolift, he would not have used the product.
“Dr. Baker is an expert in this case,” Specter said. “He's telling us that it's an unsafe product.”
He also stressed the costs of Hammons' condition, known as dyspareunia, saying that as a result of her inability to have sex, “she doesn't feel like a woman.” He also noted that she must deal with the constant worry that her boyfriend might elect to leave her.
“That worry is part of her harm,” Specter said.
He also preemptively warned the jury against the statute of limitations defense that Ethicon raised.
Ethicon's attorney Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum LLP quickly flagged that issue near the start of his presentation, as he proceeded to march methodically through the nine-question verdict sheet.
He disputed Hammons' contention that she was unaware of the connection between the mesh and her troubles until she saw a new doctor in 2012, pointing to a letter that authorized the release of her medical records on implants to personal injury attorneys in August 2011. He suggested that letter showed Hammons failed to meet her burden of proof that she was ignorant of the connection before May 2011 — two years before her suit was filed.
Ismail also defended Ethicon's scientists, calling Specter's attacks on their conduct baseless.
“He hurled a lot of accusations at the men and women of Ethicon, questioning not only how they do their jobs, but also their basic human decency,” Ismail said. “Time after time, the things he said were not supported by evidence.”
Ismail also showed sympathy for the jurors, noting that the trial had been largely built upon video depositions — 25, by his count.
“That's either a record, or it's cruel and unusual punishment,” he said. “I don't know which.”
Hammons is represented by Shanin Specter, Lee Balefsky, Kila Baldwin and Michelle Tiger of Kline & Specter PC and Adam Slater of Mazie Slater Katz & Freeman LLC.
The defendants are represented by Susan Robinson of Thomas Combs & Spann PLLC, Matthew Moriarty of Tucker Ellis LLP, Molly Flynn of Drinker Biddle Reath LLP, and Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum LLP.
The case is Hammons v. Ethicon Inc. et al., case number 130503913, in the Court of Common Pleas of the State of Pennsylvania, County of Philadelphia. -
Dec 22, 2015 | Philadelphia Inquirer
By Chris Mondics
A Philadelphia jury on Tuesday awarded $12.5 in damages to a woman who alleged in a lawsuit that a vaginal mesh implant made by Johnson & Johnson caused her to have extreme pain during sex and required multiple corrective surgeries.
Even after the surgeries, Patricia Hammons, a 65-year-old Walmart shelf stocker from Indiana, claimed in her lawsuit that she could no longer have sex and suffered from other health problems.
The Philadelphia Common Pleas Court awarded Hammons $5.5 million in compensatory damages for her ongoing health problems and inability to have sex. The jury also awarded her $7 million in punitive damages, a sum intended to punish Johnson & Johnson for having marketed an unsafe product.
The two-and-half week trial pitted experts for Hammons against those of health care products giant J&J, and focused on the testimony of J&J experts who worked on development of the vaginal mesh implant, known as Prolift.
In a pivotal moment for the trial, Hammons lawyers elicited damaging testimony from a product engineer for Ethicon, the J&J subsidiary that made the device. Although removal of the implants is a hugely complex surgical procedure, the engineer Scott Ciarrocca said the company had never given any thought to how to remove the mesh if it failed. In earlier testimony, a plaintiff's expert described such procedures as exceedingly difficult and tantamount to a surgical "train wreck."
Moreover, while the company knew before its product launch in 2005 that vaginal mesh implants had been associated with pain during sex, that fact was not included on the product warning label.
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(UPDATE) $7M in Punitives Awarded in Pelvic Mesh Case
Dec 22, 2015 | Legal Intelligencer
By Max Mitchell
A Philadelphia jury has hit Johnson & Johnson with a $7 million punitive damages verdict over conduct in the design and marketing of its pelvic mesh implant device.
The punitive damages award in Hammons v. Ethicon on Tuesday morning came one day after the same jury awarded plaintiff Patricia Hammons $5.5 million in compensatory damages. Hammons had alleged the product was negligently designed, and J&J subsidiary Ethicon failed to properly warn health professionals about the risks of the Gynecare Prolift device.
Hammons' attorney, Shanin Specter of Kline & Specter, called the award "a great victory."
"The jury worked very hard on the case throughout," he said. "I hope this sends a message to Johnson & Johnson that they need to exercise care in the development and marketing of their products."
A spokesman for Ethicon said the company plans to appeal the verdict.
"We believe the evidence showed Ethicon's Prolift pelvic organ prolapse repair kit was properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the product, and Prolift was not the cause of the plaintiff's continuing medical problems. We have always made patient safety a top priority and will continue to do so," spokesman Matthew Johnson said in an emailed statement. "Studies demonstrated that Prolift was efficacious and had a low rate of post-operative complications when used with appropriate patient selection and proper surgical technique."
The Hammons case was the first out of Philadelphia's pelvic-mesh mass tort program to hit trial. Judge Mark I. Bernstein presided over the case.
According to Stanley Thompson, director of the Complex Litigation Center, there are 181 pending cases in the pelvic-mesh mass tort, with the last case being filed in October.
In 2009, the Prolift device had been implanted into Hammons, an Indiana resident who worked as a stocker for Wal-Mart, to address a prolapsed bladder.
Her counsel had argued, among other things, that the density of the mesh caused scar tissue to build up and contract, which eventually led to erosion of Hammons' bladder and "excruciating" pain during sex.
After the device failed, she had to have numerous surgeries, but will not be able to completely remove portions of the mesh that eventually adhered to the bladder, according to Specter.
During the compensatory phase, Ethicon's attorney, Susan M. Robinson of Thomas Combs & Spann, said development of the device was led by doctors, not Ethicon, and the risks of using pelvic mesh were well known throughout the medical community.
According to Robinson, despite the later complications, the mesh worked and properly supported Hammons' bladder.
Robinson also noted that, along with Hammons' bladder, her uterus was also prolapsed, and, after she underwent a hysterectomy in 2009, her small bowel also began to prolapse into her vaginal canal. She argued that this can also lead to pain during sex.
After the jury of seven women and five men awarded Hammons $5.5 million in compensatory damages Monday afternoon, the case went directly into the punitive damages phase. The jury had voted during its deliberations in the compensatory phase that the case should also include the consideration of punitive damages.
Specter kept his opening statement in the punitive phase to J&J's net worth, which is more than $69.7 billion.
J&J then called accountant Mark Schneider to testify about the finances of Ethicon and J&J. Among other things, Schneider said that Ethicon made only $4.2 million from selling the Prolift product between 2005 and 2012, when the device was taken off the market.
On cross-examination, Specter questioned the claimed amount of profits from the device, and told jurors that the company had at least $44.1 billion in liquid assets that could easily be converted to cash.
During his subsequent closing argument in the punitive phase, Specter told jurors the company needed to be sent a message that its conduct after learning of the safety risks of the product was wrong.
According to Specter, the company had been told the device had problems before and after it went to market, but the product was sold for another seven years. He said the company knew the mesh was causing pain during sex in about 20 percent of the women using the device.
"That same 20 percent number, they knew it from the beginning. ... It was all designed simply to sell as many of these things as they could," Specter said. "You have to be heard from."
In his closing argument during the punitive phase, Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum, who also represented Ethicon, told the jurors that, even less than 90 minutes after the initial verdict came down, top company officials had already heard their message.
He also noted that the headquarters for J&J is close to Philadelphia.
"It stings to be told by members of our community that we didn't meet their expectations," he said.
Ismail additionally noted that the Prolift product has been off the market since 2012, and said the company acted appropriately in the wake of learning of the risks of the product.
"That corrective action has already been taken," Ismail said. "That decision was made over three years ago."
Specter tried the case with Kline & Specter attorney Kila Baldwin and Mazie Slater Katz & Freeman attorney Adam M. Slater.
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Ethicon hit with $12.5 mln verdict in Philadelphia mesh trial
Dec 22, 2015 | Reuters Westlaw
By Jessica Dye
Johnson & Johnson subsidiary Ethicon Inc has been hit with a $12.5 million verdict in a lawsuit from a woman who said she was injured by transvaginal mesh, a device that is the subject of tens of thousands of lawsuits in state and federal courts.
Following a three-week trial, jurors in the Philadelphia County Court of Common Pleas awarded plaintiff Patricia Hammons $5.5 million in compensatory damages on Monday, and an additional $7 million in punitive damages on Tuesday.
To read the full story on WestlawNext Practitioner Insights, click here: bit.ly/1QK0FBW
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BREAKING: J&J Tagged With $7M Punitives In Pa. Pelvic Mesh Case
Dec 22, 2015 | Law360
By Dan Packel
Jurors on Tuesday hit a Johnson & Johnson unit with $7 million in punitive damages, on top of $5.5 million in compensatory damages, in the first case over the company’s Prolift pelvic mesh product to be tried in Philadelphia’s mass tort program.
After the jurors concluded their second set of deliberations, Johnson & Johnson and its Ethicon unit immediately said that they would appeal the verdict from the three-week trial of a case brought by Indiana woman Patricia Hammons.
“We believe the evidence showed Ethicon’s Prolift pelvic organ prolapse repair kit was properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the product, and Prolift was not the cause of the plaintiff’s continuing medical problems. We have always made patient safety a top priority and will continue to do so,” Matthew Johnson, Director of Communications of Ethicon, said in a statement.
Hammons’ May 2013 suit alleged that shards of the Prolift mesh, which was implanted between her bladder and vagina in 2009 in an effort to correct sagging of her internal organs, became implanted in her bladder. She accused Ethicon scientists and officials of overlooking negative side effects associated with Prolift and hiding the risks from her implanting surgeon.
Ultimately, ten of 12 jurors concluded that the company failed to warn her implanting surgeon of the risks of the product, and that its negligence in designing the implant resulted in her inability to have sex. They also found that the company should be subject to punitive damages.
After hearing arguments on Thursday afternoon about the appropriate size of these damages, the jurors deliberated for roughly two hours before settling on the $7 million figure on Friday.
The case is the first of 180 in Philadelphia’s mass tort program over pelvic mesh products.
“We have to take them one at a time,” Hammons’ attorney Shanin Specter said Thursday.
There are also approximately 8,000 pelvic mesh suits pending in New Jersey state court and 35,000 in federal court.
Hammons is represented by Shanin Specter, Lee Balefsky, Kila Baldwin and Michelle Tiger of Kline & Specter PC and Adam Slater of Mazie Slater Katz & Freeman LLC.
The defendants are represented by Susan Robinson of Thomas Combs & Spann PLLC, Matthew Moriarty of Tucker Ellis LLP, Molly Flynn of Drinker Biddle Reath LLP, and Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum LLP.
The case is Hammons v. Ethicon Inc. et al., case number 130503913, in the Court of Common Pleas of the State of Pennsylvania, County of Philadelphia.
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Johnson & Johnson lose 1st Philly mesh case
Dec 21, 2015 | Mass Device
By Fink Densford
A jury in Philadelphia ruled today that Johnson & Johnson (NYSE:JNJ) must pay $5.5 million in the 1st in a series of pelvic mesh lawsuits.
The jury found J&J liable, based on the negligence of its scientists in relation to its Prolift pelvic mesh implant, citing it as the root cause of defendant Patricia Hammons’ inability to have sex after it was implanted.
After 2 days of deliberation, the jury ruled in Hammons’ favor and granted their bid for punitive damages, which allows for additional arguments and evidence.
Hammons case is one of many challenging pelvic mesh makers, including J&J and Boston Scientific (NYSE:BSX).
The pelvic mesh makers will have to challenge more than 860 product liability lawsuits on a case-by-case basis, a Pennsylvania state judge ruled in 2014 in a growing mass tort action in Philadelphia.
Judge Arnold New, director of the Complex Litigation Center at the Philadelphia Court of Common Pleas, on Sept. 2 dismissed joint motions by J&J subsidiary Ethicon, Boston Scientific, C.R. Bard(NYSE:BCR) and Endo Health Solutions (NSDQ:ENDP) unit American Medical Systems Holdings to toss all of the lawsuits en masse, according to court documents.
The defendants had argued that Pennsylvania law bars the bulk of the claims lodge in a master complaint covering some 863 product liability lawsuits filed with the Philly court.
“The preliminary objections are overruled without prejudice to raise as a choice-of-law issue via summary judgment on a case-by-case basis,” New wrote, according to court documents.
Earlier in 2014 New dismissed a 5th defendant, Secant Medical, from the mass tort. Keystone State law shields Secant from the lawsuits because the company only made a component of the larger companies’ transvaginal mesh products, New wrote.
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$5.5 Million Compensatory Verdict Returned In 1st Pelvic Mesh Trial In Pennsylvania
Dec 22, 2015 | LexisNexis News
By Tom Moylan
PHILADELPHIA — (Mealey’s) A Pennsylvania state court jury on Dec. 21 returned a $5.5 million verdict in the first pelvic mesh case from the state’s complex litigation docket to go to trial, according to one of the plaintiff’s attorneys (Patricia L. Hammons v. Ethicon Inc., No. 130503913, Pa. Comm. Pls., Philadelphia Co.).
Plaintiff attorney Shanin Specter of Kline & Specter in Philadelphia told Mealey Publications that the jury in the Philadelphia County Common Pleas Court found that the Prolift pelvic mesh device made by the Ethicon Inc. division of Johnson & Johnson was defective, that the defendant failed to properly warn of the risk of the device and that the defendant was negligent and acted in reckless disregard for the safety of others. The jury also found that the defendant acted in a way to justify punitive damages.
Specter said the jury awarded $5.5 million in compensatory damages for past and future pain and suffering, loss of the pleasures of life, disfigurement and humiliation.
Punitive Damage Verdict To Come
Specter said the jury is to consider punitive damages on Dec. 22.
Hammons alleges that the mesh in the Prolift device contracted and cause dyspareunia, or pain during sex.
In addition to Specter, Hammons is represented by Lee Balefsky, Kila Baldwin and Michelle Tiger of Kline & Specter and Adam Slater of Mazie, Slater, Katz & Freeman in Roseland, N.J.
The defendants are represented by Susan Robinson of Thomas Combs & Spann in Charleston, W.Va., Matthew Moriarty of Tucker Ellis in Cleveland, Molly Flynn of Drinker Biddle Reath in Philadelphia and Tarek Ismail of Goldman, Ismail, Tomaselli, Brennan & Baum in Chicago.
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Johnson & Johnson Hit With $12.5 Million Judgment in Mesh Case
Dec 23, 2015 | Outpatient Surgery Magazine
By Tim Berger
An Indiana woman who sued Johnson & Johnson, claiming that a vaginal mesh implant made by the company caused extreme pain during sex and required numerous corrective surgeries, has been awarded $12.5 million.
A jury in Philadelphia ordered the company to pay Patricia Hammons, 65, $5.5 million in compensatory damages for ongoing health problems and inability to have sex, and tacked on an additional $7 million in punitive damages. A spokesperson says Johnson & Johnson will appeal.
The trial was one of what could end up being thousands aimed at manufacturers of pelvic mesh implants. According to the Philadelphia Inquirer, there had previously been 16 verdicts against pelvic mesh manufacturers, including J&J, totaling $247 million.
J&J began marketing its "Prolift" product in 2005, and pulled it in 2012. The company's defense may have been weakened by revelations that it knew in 2005 that pelvic mesh had been linked to dyspareunia (pain during sex), but did not include a warning on its product label.
Additionally, during Ms. Hammons's trial, a product engineer for Ethicon, the J&J subsidiary that made the mesh, said the company had never given any thought to how the mesh would be removed if it failed. The engineer said such procedures would be extremely difficult, calling the situation a surgical "train wreck."
"We believe the evidence showed Ethicon's Prolift pelvic organ prolapse repair kit was properly designed," says Matthew Johnson, director of communications for Ethicon. "Ethicon acted appropriately and responsibly in the research, development and marketing of the product, and Prolift was not the cause of the plaintiff's continuing medical problems. Studies demonstrated that Prolift was efficacious and had a low rate of post-operative complications when used with appropriate patient selection and proper surgical technique."
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Philadelphia Prolift Mesh Case Yields $12.5 Million Verdict for Plaintiff
Dec 22, 2015 | Mesh Device News
By Jane Akre
After negotiating for less than 24 hours, the 12 jurors in the case of a woman implanted with a Prolift pelvic mesh made by Johnson & Johnson (J&J), added to her $5.5 million compensatory award with $7 million in punitive damages bringing her total jury award to $12.5 million.
According to a report in Philly.com (here), the seven women and five male jurors made that award to Patricia Hammons, 65, a store stocker at Walmart from Indiana.
Punitive damages are intended to send a message to a company to stop its behavior.
Hammons claimed that her pelvic damages are permanent and the Prolift cannot be removed causing her chronic infection, pain, repeated surgeries and an inability engage in sex. The polypropylene implant is implanted to treat incontinence or pelvic organ prolapse.
During closing arguments, attorney for Ethicon, a subsidiary of J&J, Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum represented J&J told the jury, “It stings to be told by members of our community that we didn’t meet their expectations,” referring to Philadelphia’s proximity to J&J headquarters in New Brunswick, New Jersey.
In a turn of events, Ismail said the Prolift was taken off the market three years ago indicating the company acted appropriately after it learned of the risks.
“The corrective action has already been taken,” Ismail is quoted by The Legal Intelligencer.
Ironically when Prolift and three other meshes were removed from the market, Matthew Johnson a spokesman for J&J (no relation), cited financial reasons for the product removal.
Johnson told Pharmalot that “This is not a product recall. We continue to have confidence in the safety and efficacy of these products. Our decision to discontinue these products is based on their commercial viability in light of changing market dynamics, and is not related to safety or efficacy.”
During punitive phase deliberations, the financial worth and size of the company was presented.
Johnson & Johnson brings is about $70 billion a year, but Prolift reportedly made only $4.2 million in sales between 2005 and 2012, according to an accountant with J&J. The $5.5 compensatory award given to Ms. Hammons Monday exceeds company profits for the medical device, he said.
Judge Mark Bernstein presided over the case in the Philadelphia Court of Common where 181 other pelvic mesh cases are pending. Adam Slater of Mazie Slater and Shanin Specter of Kline& Specter led Ms. Hammon’s case.
A CASE OF FIRSTS
This was the first pelvic mesh case to be heard in this court. It is also the first time the Prolift Pelvic Floor Repair System has been found defectively designed and that J&J failed to warn doctors about the dangers it understood were inherent with the product.
This jury trial marks the first time in Johnson & Johnson pelvic mesh litigation that there has been any mention of document destruction by the company to jurors. J&J destroyed thousands of pages of documents that were on a litigation hold to help plaintiffs prepare for litigation, according to a conclusion by WV Magistrate Judge Cheryl Eifert. So far that fact was never allowed to be mentioned before a jury.
During the two-and-a half week trial, J&J research and development engineer Scott Ciarrocca said the company had not considered how to remove the mesh if there were any complications.
Prolift was marketed in June 2005 bypassing any notification to the U.S. Food and Drug Administration (FDA). It wasn’t until three years later when the company wanted to put Prolift M+ on the market that the FDA had any awareness of the Prolift mesh kit. There were no sanctions imposed for bypassing the FDA approval process.
This marks the second time Prolift mesh has been the subject of a product liability trial. In 2013, the case of Linda Gross led to $11.1 million in compensatory damages for Ms. Gross. The couple from South Dakota still have not seen their compensation since their case is still on appeal.
The Prolift trial of the late Joan Budke ended with a settlement last January after her 91-year-old husband took the stand weeping over his lost “bride.” Ms. Budke, 77, died of a systemic infection that originated at the site of the pelvic mesh implant.
Ethicon has failed to return repeated email requests for a comment by Mesh News Desk.
Product liability litigation over Johnson &Johnson/Ethicon pelvic mesh implants are scheduled in rapid succession during the first four months of 2016.
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Dec 22, 2015 | HarrisMartin
PHILADELPHIA — A Pennsylvania jury has awarded a Prolift pelvic mesh plaintiff $7 million in punitive damages in the second phase of a Prolift transvaginal mesh device trial, sources tell HarrisMartin Publishing.
The verdict was rendered on Dec. 22, one day after the jury awarded the plaintiff $5.5 million in compensatory damages following a two-week trial and one day of deliberation. Judge Mark I. Bernstein of the Philadelphia Court of Common Pleas presided over the trial.
The plaintiff alleged that the product was negligently designed and that Ethicon and its parent, Johnson & Johnson, negligently failed to warn consumers and doctors of the device’s risks.
Indiana resident Patricia Hammonds, 64, alleges she sustained numerous injuries after being implanted with Ethicon’s Gynecare Prolift Pelvic Floor Repair System in 2009, which had been prescribed to treat her pelvic organ prolapse and stress urinary incontinence.
After experiencing painful intercourse following the implantation, Hammonds underwent corrective surgery, but allegedly continued to experience pain and other complications, including incontinence. When her surgeon attempted to remove the mesh in subsequent surgeries, it was “bunched up” along the undersurface of Hammonds’ bladder, which likely caused perforation of the organ, according to Hammonds. Portions of the mesh allegedly adhered to Hammonds’ bladder and could not be removed.
In her complaint, Hammonds alleged that the Prolift device’s Prolene polypropylene filaments were unfit for use in the human body and, as such, the device was defective.
The Food and Drug Administration granted 510(k) clearance of the Prolift device in 2005. In a July 2011 safety communication, the FDA warned that “surgical placement of mesh through the vagina to repair pelvic organ prolapse may expose patients to greater risk than other surgical options.” The agency added that there is “no evidence of greater clinical benefit such as improved quality of life.”
Ethicon removed its Gynecare Prolift Pelvic Floor Repair System, Prolift MTM, TVT Secur, and Prosima vaginal mesh systems from the market in mid-2012, citing financial reasons.
Dr. Anne Weber (urogynecology) appeared as a plaintiff’s expert. Plaintiffs' counsel also called Ethicon engineer Scott Ciarocca as a witness.
Counsel for Hammonds are Shanin Specter of Kline & Specter in Philadelphia and Adam Slater of Mazie Slater in Roseland, N.J.
Ethicon is represented by Susan M. Robinson of Thomas Combs & Spann in Charleston, W. Va.
Hammons v. Ethicon Inc., No. 130503913 (Pa. Court of Comm. Pls.)
Associated Law Firms
Kline & Specter
Mazie Slater
Thomas Combs & Spann
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Witnesses in Philadelphia Mesh Trial Tell Tale of Prolift Mesh Marketing
Dec 10, 2015 | Mesh Device News
By Jane Akre
While Mesh News Desk (MND) is not in the courtroom in Philadelphia for the Hammons v. Ethicon pelvic mesh trial (Case No. 130503913, Court of Common Pleas), reports are that two of the witnesses who have appeared on the stand in Philadelphia have appeared for plaintiffs during previous Prolift pelvic mesh trials.
Their stories tell a tale of how the Ethicon Prolift mesh kit mesh made it to market, blowing through any stop signs of safety and efficacy.
Ms Hammons received a Prolift pelvic mesh implant in 2009 to treat prolapse. She contends mesh particles had become implanted in her bladder, she has pain, infection, urinary and sexual dysfunction.
Ethicon is a division of Johnson & Johnson, the company facing in excess of 30,000 pelvic mesh product liability lawsuits, more than any of the other six manufacturers.
WITNESS SCOTT CIAROCCA
Ethicon engineer, Scott Ciarocca was on the stand and questioned by Adam Slater (Mazie Slater) in the Hammons case as was Dr. Anne Weber.
Both also appeared in the Budke Prolift case in Missouri in January, 2015. See MND on the Budke trial here.
Scott Ciarocca still works as an engineer for Ethicon Inc of Sommerville, NJ, the medical device division of Johnson & Johnson. Ciarocca started in research and development with the company in 1997. By June 2002, with just a bachelor’s degree in electrical engineering, he would became the head of the unit that would bring the Prolift to market.
Prolift is no longer marketed in the U.S. as a medical device to shore up sagging pelvic organs. It is one of the largest meshes ever produced and came in a box sent to doctors who had been trained on its use by other doctors/ consultants known as ‘preceptors.’ The company launched Prolift in March 2005, despite warnings from doctors inside the company.
Ciarocca would rely on the medical expertise of the Worldwide Medical Director Dr. Charlotte Owens, plucked from obscurity from a Florida women’s clinic and just four years out of her residency. The gynecologist would be in charge of signing off on documents presented to her to launch the Prolift.
A french team of doctors worked for Ethicon as consultants help bring Prolift to market. Among them was Professor Bernard Jacquetin, who led the group and held the patent on Prolift. Eventually he would sell his invention to the company.
In the Budke trial, Slater asked Ciarocca if a six-month study would provide enough assurance the product was safe.
“We did have extensive experience with suture mesh and Gynemesh PS” answered Ciarocca in the Budke case, comparing suture thread and flat hernia mesh with the Prolift.
The group performed more than 200 transvaginal mesh (TVM) implants with no slippage. But mesh erosion wand retraction was a problem and the European clinical study failed the grade. The failure rate at six months was 12.6 percent but when the confidence interval was applied it went to 20.1 percent. At the same time, the clinical strategy recurrence rate needed to be under 20 percent.
Ciarocca said he was not familiar with what was going on with the TVM group in Paris, he didn’t know if the design evaluation was flawed. However, in the Budke case, Slater affirmed Ciarocca was the principal developer of Prolift and in a position to know.
Two months before the March 2015 launch of Prolift, a member of the French team, Dr. Axel Arnaud, wanted to add a warning to the Instructions for Use (IFU) about a vaginal placement of mesh and the potential for complications but Ciarocca’s said the IFU stock was already printed. They would have to wait until the next revision.
On March 4, 2005 Prolift received the product release authorization to sell the Prolift. No studies had been done on the marketed kit, just on the tools (trocars) but not on the pre-cut mesh that would be the Prolift.
Law 360 reports here Ciarrocca testified in the Hammons case, the company had concluded Prolift pelvic mesh was safe and effective before it was sold. Adding to his testimony in the Budke case he explained the 20.1 percent failure rate was only revealed after the device was on the market. Prior studies had shown lower rates, he told jurors.
During testimony in the Hammons trial, Ciarocca he told jurors that safety concerns over Prolift had been answered and the conclusion was it was safe and effective.
Anne Weber, MD on the stand
ANNE WEBER, MD
Anne Weber has appeared as an expert witness for the plaintiffs in at least three pelvic mesh trials concerning Ethicon. (See the Linda Gross trial here. See the Budke trial here.) During the Budke trial, defense told jurors she is no longer a licensed urogynecologist and has never implanted a Prolift. She has made hundreds of thousands of dollars as an expert.
Weber helped develop the sub-specialty of urogynecology and has authored numerous articles on the field. She testified during the Budke trial that the ACOG (American College of Obstetrics and Gynecology) bulletin she authored had described the the mesh placement practice as “experimental.” That was later edited to remove the word “experimental” after numerous preceptors (industry consultant/ doctors) complained to ACOG. Weber testified doctors were concerned that insurance would not pay for an ‘experimental’ procedure.
She told jurors in the Budke case that Ethicon doctors/ developers were unhappy about the long-term complications for the Prolift mesh and wanted to replace it. It failed to fulfill expectations, Dr. Weber said.
Lawyers for defense include Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum LLP. Adam Slater of Mazie Slater and Shain Specter of Kline & Specter. The trial is expected to take two weeks. #
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Ethicon Official In Pa. Mesh Trial Defends Product's Safety
Dec 7, 2015 | Law360
By Matt Fair
A top engineer with a Johnson & Johnson subsidiary told a Philadelphia jury on Monday that safety concerns over a pelvic mesh implant blamed for untreatable injuries in an Indiana woman had been rigorously vetted before the product went to market in 2005.
After facing questions from a plaintiff’s attorney on Friday, Ethicon Inc. research and development director Scott Ciarrocca testified that company officials and the product’s developers had properly concluded that the Prolift pelvic mesh implant was a safe and effective way of treating organ prolapse in women.
“We felt that the benefits outweighed the risks,” he said. “I think we had come up with a very good, safe and effective way for treating a very difficult condition.”
Ciarrocca’s testimony on Monday came after Adam Slater, an attorney with Mazie Slater Katz & Freeman LLC representing plaintiff Patricia Hammons, posed questions on Friday over emails and other documents suggesting that Prolift developers had raised concerns about potential complications from the makeup of the mesh.
Goldman Ismail Tomaselli Brennan & Baum LLP attorney Tarek Ismail, however, pointed to a 2004 message from one of the product’s lead developers stating that he’d seen positive results using the so-called Prolene mesh versus several other options.
Hammons had filed suit in Philadelphia in May 2013, alleging that shards of the Prolift mesh, which was implanted between her bladder and vagina in 2009 in an effort to correct sagging of her internal organs, had become implanted in her bladder.
Attorneys for Hammons contend that her injuries have caused untreatable urinary dysfunction and had all but prevented her from having sex.
Trial in the case got underway last Tuesday and is expected to last another week.
Ciarrocca testified that, no matter the material used in developing the product, there was always a risk associated with implanting material in the body.
“I just think it’s an expected thing associated with implanting a foreign body,” he said. “We knew that there was always the potential for that with any mesh-based repair. That was well understood by both the [development] team and the leadership team.”
Ismail also walked Ciarrocca and the jury through portions of a study concluding that patients had largely had positive results after receiving the mesh to treat organ prolapse. Among the findings was a low incidence of mesh exposure, or when a portion of the implant becomes visible in the vaginal canal.
“It describes them as having significant improvements,” Ciarrocca said.
Slater had used the study during testimony on Friday to question whether it had shown a failure rate in excess of the 20 percent ceiling the company had set for reevaluating the project prior to taking Prolift to market in March 2005.
Ciarrocca, however, said that the 20.1 percent rate extrapolated from the data was only available in 2006 after the company had already gone ahead with the project.
Prior data, he said, had shown lower rates allowing the company to proceed.
The case was presented for the plaintiffs by Adam Slater of Mazie Slater Katz & Freeman LLC.
The case was presented for the defendants by Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum LLP.
The case is Hammons v. Ethicon Inc. et al., case number 130503913, in the Court of Common Pleas of the State of Pennsylvania, County of Philadelphia. -
Ethicon Safety Commitment Questioned In Pa. Mesh Trial
Dec 4, 2015 | Law360
By Matt Fair
The research and development head for a Johnson & Johnson subsidiary faced questioning Friday before a Pennsylvania jury, over whether the company had adequately warned surgeons about the risk of complications in patients implanted with a pelvic mesh product blamed for injuring an Indiana woman.
Plaintiff Patricia Hammons' attorney, Adam Slater of Mazie Slater Katz & Freeman LLC, suggested that Ethicon Inc. R&D director Scott Ciarrocca and other key decision makers had ignored a request for a stronger warning in the Prolift pelvic mesh's instructions prior to the product's March 2005 market debut. The case is the first in Philadelphia County to be tried over injuries from the mesh.
While Slater pointed to an email from an Ethicon official in France who asked that the warning be included in instructions for use, or IFUs, for the product, he said that Ciarrocca and others had ultimately opted not to include the language because the document had already been printed.
“If you print an IFU and it’s missing an important warning, shouldn’t you throw that away so you can include the warning?” Slater asked.
The question was one of a string Slater raised Friday over whether Ethicon had taken proper steps to ensure patient safety as they worked to pursue what company documents pegged as a $300 million market opportunity for the product.
Hammons had filed suit in Philadelphia in May 2013, alleging that shards of the Prolift mesh, which was implanted between her bladder and vagina in 2009 in an effort to correct sagging of her internal organs, had become implanted in her bladder.
Attorneys for Hammons contend that her injuries have caused urinary dysfunction and all but prevented her from having sex.
Trial in the case got underway Tuesday and is expected to last about two weeks.
Ciarrocca said Friday that Ethicon put a premium on patient safety and suggested all important warnings would have been placed in the product instructions.
“We would certainly want to include warnings for all the things we thought were critical,” Ciarrocca said.
Slater also questioned whether the clinical study designed by Ethicon prior to the product's hitting the market had shown the mesh failing in an excessive number of patients.
Ciarrocca testified that the study’s parameters had set a 20 percent failure rate as the threshold for the company to reconsider whether to move forward with the project.
Slater, however, pointed to a 2006 statistical analysis of results from 87 patients that extrapolated a maximum failure rate of 20.1 percent.
“Based on the documents we have, the results of the study, the documents in your files say, ‘Don’t sell Prolift,’” Slater said.
But Ciarrocca countered that the 20.1 percent figure was the upper limit of a confidence interval that dipped as low as 7.3 percent. The actual failure rate for the 87-patient group stood at 12.6 percent, according to documents shown in court.
He added that a prior analysis of the first 40 patients in the study to receive the implant must have been lower than 20 percent, or else the product would not have been greenlighted by Ethicon.
Anything lower, Ciarrocca said, “would’ve been a stop.”
“We certainly would not want a dangerous product to slip through and get to the market,” Ciarrocca said. “If we thought a product was dangerous, we would not have sold it.”
Ciarrocca’s testimony is expected to continue Monday.
According to Slater, the jury heard testimony Thursday from an executive with the electronic discovery consultancy Epiq Systems Inc. that Ethicon had destroyed tens-of-thousands of documents in violation of litigation holds put in place as early as 2003.
Briefing from J&J in the case, however, characterized the documents as being “inadvertently lost” and noted that a significant portion of the lost material was recovered and produced from other sources in the company.
The Hammons case is one of over 180 pending in a mass tort in the Philadelphia County Court of Common Pleas. Four others have been listed for trial. According to plaintiffs counsel in May, there are some 26,000 claims pending against Ethicon in a federal multidistrict litigation program in West Virginia and nearly 8,000 in consolidated litigation in New Jersey.
The case was presented for the plaintiffs by Adam Slater of Mazie Slater Katz & Freeman LLC.
The defendants are represented by Susan Robinson of Thomas Combs & Spann PLLC, Matthew Moriarty of Tucker Ellis LLP, Molly Flynn of Drinker Biddle Reath LLP, and Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum LLP.
The case is Hammons v. Ethicon Inc. et al., case number 130503913, in the Court of Common Pleas of the State of Pennsylvania, County of Philadelphia.
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