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Hammons Trial Media Report 12/02/2015
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Civil trial begins over safety of vaginal mesh device
Dec 2, 2015 | Philadelphia Inquirer
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 & Johnson unit'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.
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Civil trial begins over safety of vaginal mesh device
Dec 2, 2015 | Philadelphia Inquirer
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.
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