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Ethicon Media Monitoring 01/09/2017
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Pa. Judge Won't Ax $13.7M Pelvic Mesh Award
Jan 6, 2017 | Law 360
By Matt Fair
A Pennsylvania state judge has rejected a Johnson & Johnson unit’s bid to strike down a $13.7 million verdict won by a woman who claimed that she suffered irreversible injuries from a pelvic mesh implant. -
Judge upholds $14m pelvic mesh win over J&J’s Ethicon
Jan 6, 2017 | Mass Device
By Fink Densford
A Pennsylvania state judge this week upheld a $13.7 million judgement in favor of plaintiffs in a pelvic mesh case against Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon. -
Polypropylene Resin Not Meant for Human Implants
Jan 6, 2017 | Mesh Medical Device Newsdesk
The polypropylene resin material that makes mesh used for hernia repair and transvaginal mesh, is not supposed to be used in the human body. But that’s exactly what’s happened for more than one million patients. -
Lawsuits Link Hernia Mesh Coatings and Inflammation
Jan 6, 2017 | Daily Hornet
By Elizabeth Bradley
At least 15 lawsuits blame hernia mesh coatings for causing inflammation, allergic reactions, infections, and other complications that require revision surgery.
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Pa. Judge Won't Ax $13.7M Pelvic Mesh Award
Jan 6, 2017 | Law 360
By Matt Fair
Law360, Philadelphia (January 6, 2017, 1:20 PM EST) -- A Pennsylvania state judge has rejected a Johnson & Johnson unit’s bid to strike down a $13.7 million verdict won by a woman who claimed that she suffered irreversible injuries from a pelvic mesh implant.
Judge Kenneth Powell rejected arguments raised as part of post-trial motions in the case that he should have remitted the verdict, which included $10 million in punitive damages, based on what Ethicon Inc. said was a lack of evidence about past or future medical costs that plaintiff Sharon Carlino could face as a result of her injuries.
The judge criticized the company for casting Carlino’s testimony in the case as simply that of intermittent pelvic pain and “an unqualified amount of emotional harm.”
“To characterize her testimony in this way is to minimize her real damages to an unreasonable degree,” he said in an opinion on Tuesday.. “This is not merely ‘intermittent’ pain — it is chronic pain, pain that will be with her for the rest of her life, with no real prospect of resolution.”
Carlino filed suit in June 2013 claiming that inherent defects in Ethicon’s so-called TVT, or transvaginal tape, had left her living with constant pain and discomfort and had interfered with her ability to have sex with her husband.
A jury handed down a verdict in February agreeing that TVT was not reasonably safe and that Carlino’s physician would never have implanted the product had he been aware of its risks.
Kline & Specter PC attorney Shanin Specter told the jury during the two-week trial that Carlino was implanted with the product in 2005 to treat her urinary stress incontinence.
After complaining of a sharp feeling in her vagina two years after she received the implant, Specter said that her doctor discovered that the mesh had become exposed, requiring surgery to remove a portion of the implant. Three years after that, she required another procedure after another patch of exposed mesh began causing her discomfort.
In 2012, Specter said, she began feeling pulling sensations and more pain due to scarring from the mesh implant and from the prior surgeries she had undergone to correct previous complications.
Ethicon filed post-trial motions challenging the outcome on multiple fronts in the weeks after Carlino won her verdict.
In addition to rejecting arguments about the sufficiency of Carlino’s testimony regarding pain and suffering, Judge Powell also rejected arguments that Carlino’s lawsuit was barred by a two-year statute of limitations given that she first began experiencing problems with the mesh in 2007.
Instead, the judge agreed that Carlino had no reason to suspect the product was defective until seeing advertisement warning about potential problems.
“The discovery rule tolled the running of the statute of limitations until the spring of 2013 when Ms. Carlino saw a television commercial that described transvaginal mesh products as defective,” the opinion said. “This was the first time Ms. Carlino learned that there was an issue with the TVT itself.”
Judge Powell added that Ethicon push for an earlier start to the two-year window was too focused on symptoms that Carlino suffered.
“[Defendants] focus overmuch on the initial appearance of negative symptoms related to the TVT, rather than making a case that Ms. Carlino should have understood the fuller implications of the nature and extent of her injury when her negative symptoms first arose,” the opinion said. “Notably, the [defendants] have made no assertion that they themselves made every effort to alert people in Ms. Carlino’s position when they first became aware that there might a systematic issue with their product.”
Ethicon spokesman Kristen Wallace told Law360 that the judge's decision did not come as much of a surprise, and said that it intended to press forward with an appeal to the Pennsylvania Superior Court.
“The denial of post-trial motions is not unexpected and we have already begun the appeal process," she said. "We filed an appeal in this case because we believe the evidence showed Ethicon's TVT midurethral sling was properly designed and labeled, that Ethicon acted appropriately and responsibly in the research, development and marketing of the product, and TVT 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.”
J&J is represented by Nils Snell, Christy Jones and William Gage of Butler Snow LLP, Julie Callsen of Tucker Ellis LLP, and Laura Smith of Friday Eldredge & Clark.
Carlino is represented Shanin Specter and other attorneys from Kline & Specter PC.
The case is Sharon Carlino et al. v. Ethicon Inc. et al., case number 130603470, in the Court of Common Pleas of Philadelphia County, Pennsylvania.
— Additional reporting by Dan Packel. Editing by Ben Guilfoy.https://www.law360.com/articles/878191/pa-judge-won-t-ax-13-7m-pelvic-mesh-award
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Judge upholds $14m pelvic mesh win over J&J’s Ethicon
Jan 6, 2017 | Mass Device
By Fink Densford
A Pennsylvania state judge this week upheld a $13.7 million judgement in favor of plaintiffs in a pelvic mesh case against Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon.
The plaintiff in the case claims she suffered severe and irreversible injuries after being implanted with Ethicon’s pelvic mesh implant.
Philadelphia Court of Common Pleas Judge Kenneth Powell Jr. issued an opinion this week in response to an appeal from Ethicon stating that the award should be allowed to stand, according to The Legal Intelligencer.
Ethicon asked the court to grant a new trial or reduce the verdict award, supplying reasons why the jury’s verdict should be reversed. But Judge Powell disagreed with Ethicon’s argument, saying “the evidence of defendant-appellant’s wanton and willful disregard for plaintiff adequately supported the jury’s award of punitive damages,” according to the report.
Judge Powell also defended the plaintiff’s compensatory damages, saying that the plaintiff’s pain “is not merely ‘intermittent’ pain – it is chronic pain, pain that will be with her for the rest of her life, with no real prospect of resolution,” according to The Legal Intelligencer.
A jury in Philadelphia last February awarded plaintiff Sharon Carlino $3.5 million in compensatory damages and $10 million in punitive damages, finding that the Ethicon transvaginal polypropylene tape implanted during a 2005 hysterectomy was defective and that the company failed to adequately warn of its risks, The Legal Intelligencer reported. Carlino eventually needed 3 revision surgeries to remove the eroded mesh.
In December 2015, a jury in the same court added $7 million in punitive damages to the $5.5 million in compensatory damages it leveled against Ethicon in the 1st of the mass tort cases to go to trial in Philly.
Carlino’s attorney, Shanin Specter, said the family is thankful for the verdict.
http://www.massdevice.com/judge-upholds-14m-pelvic-mesh-win-jjs-ethicon/
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Polypropylene Resin Not Meant for Human Implants
Jan 6, 2017 | Mesh Medical Device Newsdesk
The polypropylene resin material that makes mesh used for hernia repair and transvaginal mesh, is not supposed to be used in the human body. But that’s exactly what’s happened for more than one million patients.
Evidence revealed in transvaginal mesh trials show its basic material, a raw polypropylene resin, also known as PP, is accompanied by a warning not to use it to make implanted medical devices.
But that’s exactly what has happened.
And the PP mesh resides in as many as one million women around the globe, implanted to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI). The same PP resin is used in to make hernia mesh in about one million procedures in the U.S. every year.
Polypropylene resin is crafted into mesh used by all of the manufacturers currently facing defective product litigation – Boston Scientific, Johnson & Johnson, American Medical Systems, C.R. Bard, among others.
The warning is contained in the Material Safety Data Sheet or MSDS that accompanies the resin.
The MSDS is required by the Occupational Safety and Health Administration or OSHA. The MSDS gives detailed information about a chemical, its properties, safety and environmental hazards. It’s designed to alert workers who come in contact with the chemical during its processing so they can avoid any hazards it may impose.
It says – “MEDICAL APPLICATION CAUTION: Do not use this Phillips Sumika Polypropylene Company material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.”
It couldn’t be clearer.
What’s disturbing is that polypropylene mesh, naturally will come into contact with both bodily fluids and tissues for the rest of that patient’s life.
We could already surmise that in the case of Boston Scientific (BSC), counterfeit polypropylene resin, smuggled in from China with no oversight, might not be suitable for implantation.
That’s because any resin product from China, where there are no regulations, might be tainted with toxins incompatible with the human body, such as selenium, which has already been found in the BSC resin.
Polypropylene is a byproduct of the petroleum industry. The plastic resin is spun into fibers used to weave hernia and pelvic mesh. PP is also used for indoor-outdoor carpets, car parts and Tic-Tac box tops. It’s a cheap and plentiful plastic.
Phillips Sumika Polypropylene Co. formed in 1992 from a merger between Chevron Phillips and Sumika Polymers America, a Japanese company, creating the petrochemical, plastics producer. It closed its Texas plant and moved to Saudi Arabia in 2011.
“Phillips Sumika Polypropylene Company makes no representation, promise, express warranty or implied warranty concerning the suitability of this material for use in implantation in the human body or in contact with internal body fluids or tissues.”
It could be argued that the MSDS warning provides some degree of legal immunity to Phillips Sumika if any harm comes from products made from the raw resin.
But Judge Joseph Goodwin, overseeing pelvic mesh litigation in his Charleston, West Virginia federal court, says the MSDS represents “a genuine issue of material fact,” and it has been shown to jurors.
Jurors who have seen the MSDS, as well as other evidence in the 19 mesh trials, have decided for manufacturers only six times, raising the question, what did manufacturers know and when did they know it. ###
http://www.meshmedicaldevicenewsdesk.com/mesh-polypropylene-resin-not-meant-human-implants/
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Lawsuits Link Hernia Mesh Coatings and Inflammation
Jan 6, 2017 | Daily Hornet
By Elizabeth Bradley
At least 15 lawsuits blame hernia mesh coatings for causing inflammation, allergic reactions, infections, and other complications that require revision surgery.
Hernias occur when internal tissues bulge out of the body through a weak muscle, usually in the groin. Around 1 million Americans have hernia surgery every year.
In most surgeries, mesh patches are used to plug the hernia and prevent it from returning — but they do not always work.
It is very common for the body to reject synthetic mesh implants. Even low-level inflammation can cause pain, excessive scar-tissue growth, adhesions, or hernia recurrence.
About a decade ago, manufacturers started selling hernia mesh implants with coatings they claimed were anti-inflammatory.
Instead, more than 15 lawsuits claim the coatings can actually trigger allergic reactions, inflammation, infections, and other major complications that require revision surgery.
In May 2016, Johnson & Johnson recalled Ethicon Physiomesh in Europe and Australia after a massive study linked it to higher rates of hernias returning and needing another surgery.
Physiomesh was withdrawn without a recall in the U.S., which is why the FDA did not issue warnings, but that did not stop lawsuits.
One lawsuit was filed last week by a woman from Florida. She needed another surgery when her hernia returned less than four months after Physiomesh was implanted in her body.
Physiomesh is a patch woven from plastic-like fibers that is laminated between two layers of Monocryl (polyglecaprone).
Her lawyers say the coating is promoted to prevent or minimize inflammation and adhesions, but instead it “prevented adequate incorporation of the mesh into the body and caused or contributed to an intense inflammatory and chronic foreign body response.”
Those same allegations have been raised in at least 14 lawsuits involving another type of hernia mesh — Atrium C-QUR — which is coated in fish oil (Omega-3 fatty acid).
The fish oil coating is advertised as an “anti-adhesion barrier” to prevent scar-tissue sticking organs together during the healing process, a common problem after hernia surgery.
Last year, researchers published a case report of a 61 year-old woman who had an inflammatory reaction to fish oil-coated hernia mesh. Very few studies have investigated the safety of hernia mesh coated in active agents, the researchers warned.
The FDA approved C-QUR in 2006 without clinical trials because it was “equivalent” to other hernia mesh implants on the market, although it was — and still is — the only one coated in fish oil.
Likewise, Ethicon Physiomesh was approved through the same process in 2010. Its “equivalent” product was Ethicon Proceed Surgical Mesh, which does not have a Monocryl coating.
https://dailyhornet.com/2017/lawsuits-link-hernia-mesh-coatings-and-inflammation/
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