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Hammons December 23
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Ethicon hit with $12.5 mln verdict in Philadelphia mesh trial
Dec 23, 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. -
UPDATED: Philadelphia jury awards woman $12.5 million in damages from Johnson & Johnson in vaginal mesh implant case
Dec 23, 2015 | Philadelphia Inquirer
By Chris Mondics
A Philadelphia jury awarded $12.5 million Tuesday to a woman who alleged that a vaginal mesh implant made by Johnson & Johnson caused her to have extreme pain during sex and required multiple corrective surgeries. -
UPDATED: $7M in Punitives Awarded in Pelvic Mesh Case
Dec 23, 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. -
Pharmalot, Pharmalittle: Turing layoffs, questions on Shkreli replacement
Dec 23, 2015 | STAT News
By Ed Silverman
A Pennsylvania jury awarded $12.5 million in damages to a woman who claims a Johnson & Johnson vaginal mesh implant caused extreme pain during sex and required multiple corrective surgeries, The Philadelphia Inquirer says.
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Ethicon hit with $12.5 mln verdict in Philadelphia mesh trial
Dec 23, 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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Dec 23, 2015 | Philadelphia Inquirer
By Chris Mondics
A Philadelphia jury awarded $12.5 million Tuesday to a woman who alleged 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, 65, a Wal-Mart shelf stocker from Indiana, claimed in her lawsuit, she could no longer have sex and suffered from other health problems.
The Common Pleas Court jury awarded $5.5 million in compensatory damages for her ongoing health problems and inability to have sex. The jury also awarded $7 million in damages to punish the health-care-products giant for having marketed an unsafe product.
Hammons is "gratified" by the jury's verdict, said her lawyer, Shanin Specter of the Center City law firm Kline & Specter.
"Every American depends on Johnson & Johnson to put safety ahead of selling," Specter said. "They aren't doing that, and they need to engage in some honest soul-searching."
A spokesman for Ethicon, the J&J subsidiary that made the product, said the company would appeal.
"We believe the evidence showed Ethicon's ... pelvic organ prolapse repair kit was properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the product, and the [mesh] 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," the spokesman said in a statement.
The 21/2 week trial pitted experts for Hammons against those of J&J, and focused on the testimony of J&J managers, physicians, and others who worked on development of the implant, known as Prolift.
In a pivotal moment in the trial, Hammons' lawyers elicited damaging testimony from a product engineer for Ethicon on the lack of a backup plan if the implant failed. Although removal of the implants is a hugely complex surgical procedure, Scott Ciarrocca said the company had never given any thought to how to remove the mesh if it caused problems. 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 was not included on the product warning label.
During the portion of the trial devoted to determining whether the company should be subject to punitive damages - hurt financially for acting recklessly in selling Prolift - a company official testified the company had $108 million in Prolift sales from the time the product was launched in 2005 until it took it off the market in 2012, following complaints from women who had the implants.
Pelvic mesh implants came into wide use a decade ago for treatment of a condition when the bladder and other organs, weakened by childbirth, sag over time into the vagina, causing urinary incontinence, pain during intercourse, and other maladies.
Hammons had implant surgery in 2009, when she was 58. Although she 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 her bladder and that the movement likely caused the perforation of her bladder.
About 180 women who alleged that failed pelvic mesh implants have caused them ongoing health problems and interfered with their ability to have sex have filed suit against J&J in Philadelphia courts. The company faces tens of thousands of additional lawsuits in courts around the country.
During his arguments in the punitive damage phase of the trial, Specter argued that J&J acted recklessly by placing the product on the market before it fully understood how it would work, and then by delaying its withdrawal even as evidence mounted that it was severely injuring some of the women who had the implant.
J&J's lawyer, Tarek Ismael, acknowledged that J&J made mistakes in the development of Prolift. But he said that the company never intended to do harm and that J&J employees were devoted to improving public health.
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UPDATED: $7M in Punitives Awarded in Pelvic Mesh Case
Dec 23, 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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Pharmalot, Pharmalittle: Turing layoffs, questions on Shkreli replacement
Dec 23, 2015 | STAT News
By Ed Silverman
Rise and shine. The middle of the week is upon us. However, this will be an abbreviated work week, as you know, given the upcoming holiday. In fact, we are about to check out for the next several days to enjoy some time with our short people and catch up on life. We hope you get to do the same. We will miss you, of course, but will return soon enough. Meanwhile, here are some tidbits. Hope you all have a wonderful holiday break and see you soon …
Turing Pharmaceuticals is laying off an unspecified number of employees and searching for a permanent chief executive, just days after Martin Shkreli resigned following his arrest for securities fraud. He was replaced on an interim basis by Ron Tilles, although Fortune writes there are questions about his work record. Shkreli caused an uproar for raising the price of a decades-old, life-saving medicine by 5,000 percent and thwarting generics.
Another spat is breaking out over drug prices as Catalyst Pharmaceuticals hopes to win regulatory approval to sell a treatment for an autoimmune disorder with a cost ranging from $37,500 to $100,000, NPR reports. But an existing version has been provided at virtually no cost by another drug maker, and doctors are concerned that patients will suffer because Catalyst is hoping to win market exclusivity under the Orphan Drug Act.
Celgene settled patent litigation that will allow Natco Pharma, an Indian generic drug maker, to market the best-selling Revlimid multiple myeloma treatment. The deal permits Natco and its US partner, Arrow International, to make and market a limited quantity starting in March 2022 and increase supplies through 2025. Cowen analyst Eric Schmidt believes the deal will thwart other potential generic entrants.
GlaxoSmithKline has temporarily stopped production of Ventolin HFA inhalers at a North Carolina plant while it looks into customer complaints, InPharma Technologist writes. The move comes after the drug maker recalled nearly 130,000 inhalers because some “canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life,” according to a regulatory notice.
A new deal was reached as part of the UK’s Pharmaceutical Price Regulation Scheme in which drug makers will provide nearly $800 million next year to help the National Health Service pay for medicines, PharmaFile writes.
The Food and Drug Administration approved an AstraZeneca drug called Zurampic to treat a condition associated with gout in combination with another type of medicine, Reuters writes.
A Pennsylvania jury awarded $12.5 million in damages to a woman who claims a Johnson & Johnson vaginal mesh implant caused extreme pain during sex and required multiple corrective surgeries, The Philadelphia Inquirer says.
In another sign that diabetes competition will be fierce next year, Sanofi asked the FDA to review its one-day diabetes injection in six months, instead of the usual 10 months, Reuters says.
A New York state judge ruled that Pfizer does not owe New York University any royalties for the Xalkori lung cancer drug, writes Reuters, noting NYU sought 2.5 percent royalties under a 1991 licensing deal.
Results of the first trial for a PCSK9 inhibitor — Amgen’s Repatha — should be available in 2016, a year earlier than planned, MedPage Today says.
Orchid Pharma’s UK subsidiary reached an agreement with Line Trust International to access a loan worth up to $800 million, The Economic Times tells us.
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