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Ethicon Media Monitoring 10/12/2017
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J&J Unit Says Wrong Venue Merits Toss Of $12M Mesh Award
Oct 11, 2017 | Law 360
By Matt Fair
A $12.5 million pelvic mesh verdict against a Johnson & Johnson unit should be thrown out on grounds that Pennsylvania did not have jurisdiction to hear claims from the Indiana woman who brought the case, the subsidiary told a state appeals court Wednesday. -
British Parliament Members Face Mesh-Injured
Oct 11, 2017 | Mesh Medical Device Newsdesk
While the U.S. media is focused on crazed gunman and crazed media moguls, mesh campaigners in the United Kingdom have made some real headway in making public the issue of polypropylene mesh and the thousands it has injured. -
Doctors Claim Media Stories Are Causing Patients to Refuse Hernia Mesh Repairs
Oct 11, 2017 | The Ring of Fire Network
By KJ McElrath
According to a surgeon from Christchurch, New Zealand, patients are refusing to undergo what he considers to be the “best surgery treatment for hernias” because of media stories about patients who suffer from permanent injuries resulting from pelvic mesh. -
Oregon Woman Blames Physiomesh for Multiple Corrective Surgeries
Oct 11, 2017 | The Legal Examiner
By Eric T. Chaffin
On August 22, 2017, an Oregon woman filed a Physiomesh lawsuit against manufacturers Ethicon and parent company Johnson & Johnson (J&J). She claims that after being implanted with Ethicon’s hernia mesh, she suffered serious injuries.
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J&J Unit Says Wrong Venue Merits Toss Of $12M Mesh Award
Oct 11, 2017 | Law 360
By Matt Fair
Law360, Philadelphia (October 11, 2017, 7:31 PM EDT) -- A $12.5 million pelvic mesh verdict against a Johnson & Johnson unit should be thrown out on grounds that Pennsylvania did not have jurisdiction to hear claims from the Indiana woman who brought the case, the subsidiary told a state appeals court Wednesday.
D. Alicia Hickok, an attorney with Drinker Biddle & Reath LLP representing the New Jersey-based J&J unit Ethicon Inc., maintained during oral arguments that Patricia Hammons had no connection to Philadelphia sufficient to give a court there jurisdiction over claims that the company’s mesh left her suffering chronic pain from excessive scarring.
“Mrs. Hammons is and has been a resident of a small town in rural Indiana,” Hickok told the state’s Superior Court. “She wasn’t prescribed the mesh in Philadelphia, it wasn’t implanted here, and she wasn’t treated afterwards by any Philadelphia doctor.”
She said Hammons was improperly attempting to claim jurisdiction in the state by virtue of Ethicon’s contract with Pennsylvania-based Secant Medical Inc. to manufacture the mesh that was used in the implant she received in 2009 to correct sagging of her internal organs.
But she argued that the company’s work with Secant was just one link in a lengthy design and production chain for the product that involved contacts with multiple jurisdictions such as West Virginia, Georgia, Puerto Rico and Europe. The mesh was sold to doctors as part of a kit that included surgical tools and instructions for use.
Hammons filed suit against Ethicon in May 2013 as part of a mass tort program established in the Philadelphia Court of Common Pleas to consolidate claims over alleged mesh-related injuries. She argued that the company’s Prolift mesh became implanted in her bladder and left her unable to have sex as a result of ongoing pain.
A jury sided with Hammons in December 2015 following a three-week trial and awarded $5.5 million in compensatory damages and $7 million in punitive damages.
Questions over the Philadelphia County court’s ability to hear claims from out-of-state residents have flared up following a U.S. Supreme Court decision in June this year clarifying the standards for the assertion of specific jurisdiction over nonresident companies.
The Philadelphia County judge overseeing the pelvic mesh mass tort is reconsidering whether to allow out-of-state plaintiffs to move forward with their claims.
While Hickok argued that Ethicon’s contract with Secant was insufficient to establish jurisdiction in Pennsylvania, Hammons attorney Chip Becker of Kline & Specter PC counteredthat Ethicon had supervised and controlled the company’s work in Pennsylvania to manufacture the mesh.
“You could’ve put ‘Ethicon’ over the door of the factory and that would’ve been substantively correct,” he said.
The court took the case under advisement.
Ethicon is represented by D. Alicia Hickok, William Carr, Kenneth Murphy and Molly Flynn of Drinker Biddle & Reath LLP, Julie Callsen of Tucker Ellis LLP, Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum LLP, Stephen Brody of O’Melveny & Myers LLP and Susan Robinson.
Hammons is represented by Charles “Chip” Becker, Shanin Specter, Michelle Tiger, Lee Balefsky, Kila Fickes and Ruxandra Laidacker of Kline & Specter PC.
The case is Patricia Hammons v. Ethicon Inc. et al., case numbers 1522 EDA 2016 and 1526 EDA 2016, before the Pennsylvania Superior Court.
--Additional reporting by Dan Packel. Editing by Bruce Goldman.https://www.law360.com/trials/articles/972407/j-j-unit-says-wrong-venue-merits-toss-of-12m-mesh-award
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British Parliament Members Face Mesh-Injured
Oct 11, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, October 11, 2017 ~ While the U.S. media is focused on crazed gunman and crazed media moguls, mesh campaigners in the United Kingdom have made some real headway in making public the issue of polypropylene mesh and the thousands it has injured.
U.S. readers have a chance to make a difference and weigh in.
On Wednesday, October 18th, Parliament will debate the controversial vaginal mesh implants, their safety and risks of harm.
Thousands of women in Britain say it wrecked their lives. Some report they felt suicidal from the pain and denial from doctors.
Ministers are concerned there is little evidence to support those claims, reports the Daily Mail.
The scandal has been compared to thalidomide, the drug taken by pregnant women that led to birth defects in their children. An estimated 800 British women have sued mesh makers. They want to follow Scotland’s lead and ban mesh implants.
Kath Sansom of Sling the Mesh campaign tweeted: ‘Not enough words to thank you for securing a debate on behalf of so many women whose lives have been devastated by #mesh.’
Julie Gilsenan, 49, from Liverpool, also tweeted: “Emotional is not the word! Let our voices be heard…we will NOT suffer in silence #banmesh.”
The debate will be heard October 18, Wednesday.
Campaigners hope to dispel the belief that complication rate is only 1 to 3 percent after
a polypropylene mesh implant used to treat incontinence or pelvic organ prolapse.The same polypropylene is used to make mesh used to treat hernias.
Emma Hardy MP secured the debate.
She tweeted :” After meeting with women from my constituency regarding @MeshCampaign I’m delighted to have secured a debate on this issue.”
This comes on the heels of a three-year government report released in July (here) that concluded the use of mesh to treat incontinence and prolapse is a safe option for women.
According to Sling the Mesh campaigners, there have been 126,000 women fitting in England with polypropylene mesh implants in the last ten years.
Tom Joyce, a professor of orthopaedic enginnering at Newcastle University, tells Camb Times that is similar concerns existed over a car, it would have been taken off the market. Joyce says the country needs a medical devices registry so complications can be tracked and regulators can see sooner rather than later if a device is failing.
With no place to report failed medical devices in the UK there is no way to know how they are performing.
Joyce points to the U.S. MAUDE (Manufacturer and User Facility Device Experience) database as an example of one that is purported to track adverse events, as they are called. MND has reported on the many failures of MAUDE, such as failing to report complications and sending them to manufacturers rather than directly to the FDA. See MND story here and here.
HEAR YOUR VOICE
Even if you do not live in Britain, you can contribute by writing to Jackie Doyle Price, the UK health minister, who believes at this time, she says there is not enough evidence to suspend mesh.
Include your full name, town, county and country where you live. Include the type of mesh you were implanted with and what was the condition it was used to treat ie hernia, incontinence or prolapse.
Mesh campaigner, Kath Sansom is asking for this to make it very clear to Jackie that all mesh is a risk . Apparently she doesn’t understand the complexities of the situation.
Include year in, when you noticed problems and when you realized mesh was the cause.
Then under that say what mesh has done to your life. Try to keep it concise, but be honest.
Include before and after photos or any other images you think support your email.
Kath will package this all up to send to Ms Doyle Price.
WRITE TO : Please email slingthemesh@gmail.com.
LEARN MORE:
Mesh News Desk, December 2016, FDA Pelvic Mesh Data, Are Thousands of Deaths Not Being Reported?
https://www.meshmedicaldevicenewsdesk.com/fda-pelvic-mesh-data-thousands-deaths-not-reported/MND, July 2017, Is UK Mesh Report a Whitewash?
https://www.meshmedicaldevicenewsdesk.com/uk-mesh-report-whitewash/https://www.meshmedicaldevicenewsdesk.com/british-parliament-faces-mesh-injured/
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Doctors Claim Media Stories Are Causing Patients to Refuse Hernia Mesh Repairs
Oct 11, 2017 | The Ring of Fire Network
By KJ McElrath
According to a surgeon from Christchurch, New Zealand, patients are refusing to undergo what he considers to be the “best surgery treatment for hernias” because of media stories about patients who suffer from permanent injuries resulting from pelvic mesh. Dr. Steven Kelly says it was important for patients to understand the difference, and points out that only one percent of patients who undergo hernia mesh repair experience the type of complications that have resulted in lawsuits against the manufacturers.
Still, given that approximately 95,000 hernia mesh repairs were performed in the U.S. last year alone, that means nearly one thousand of those patients run the risk of permanent injuries and a lifetime of debilitating pain. It also bears mentioning that both hernia and vaginal meshes are made from the same synthetic material – which means that hernia meshes have been subject to the same problems, including erosion into neighboring tissues, organ perforation, shrinkage and inflammation due to autoimmune response.
Many surgical mesh devices are made from polypropylene plastic, primarily because of its low cost and ready availability. This petroleum-based product is found in thousands of everyday products, and is not biodegradable, nor absorbable into human tissues. Such non-absorbable synthetic mesh is intended to serve as a permanent repair for hernia or pelvic organ prolapse (POP).
Although some doctors say there is a difference between pelvic mesh and hernia mesh, the fact is that the former was developed from the latter. Forty years ago, gynecologists believed that (POP) was similar to hernia injuries. Those beliefs led to the development of the first surgical mesh intended to treat female incontinence, manufactured by Boston Scientific in the late 1990s.
Although that product was recalled three years later, approximately five dozen more vaginal meshes were approved over the next several years though the 510(k) Clearance process, with manufacturers citing Boston Scientific’s product as a “predicate” (meaning their products were “substantially similar” to the original). Between 1992 and 2010, nearly 170 pelvic mesh products were given a green light by the FDA – and no clinical studies or any proof of efficacy or safety were ever required.
Today, hernia mesh patients are suffering the same complications associated with pelvic mesh products. The common denominator is the material used: plastic polypropylene mesh.
It is true that there are “biologic” mesh devices currently in development that provide a safer alternative to polypropylene. There is also evidence that many surgeons who have implanted these devices were poorly trained and unqualified. Nonetheless, given the horrific nature of complications suffered by patients when hernia mesh repairs go wrong, their hesitance to undergo such surgery is understandable.
https://trofire.com/2017/10/11/doctors-claim-media-stories-causing-patients-refuse-hernia-mesh-repairs/
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Oregon Woman Blames Physiomesh for Multiple Corrective Surgeries
Oct 11, 2017 | The Legal Examiner
By Eric T. Chaffin
Eric T. Chaffin is an attorney with Chaffin Luhana LLP
On August 22, 2017, an Oregon woman filed a Physiomesh lawsuit against manufacturers Ethicon and parent company Johnson & Johnson (J&J). She claims that after being implanted with Ethicon’s hernia mesh, she suffered serious injuries.
The case was filed in The United States District Court for the District of Oregon, but was transferred to the Northern District of Georgia where all federally-filed Physiomesh lawsuits have been coordinated.After Implantation with Physiomesh, Plaintiff Goes Through Multiple Corrective Surgeries
According to the complaint, the plaintiff underwent surgery to implant Physiomesh on September 3, 2015. The surgery was an attempt to repair her recurrent incisional hernia, which is a bulge of tissues and/or muscles protruding through a weakened area in a previous abdominal incision. The procedure was performed at the OSV Providence St. Vincent Medical Center in Portland, Oregon.
The plaintiff states that after the surgery she started to experience severe pain and significant bleeding, among other symptoms. On September 4, 2015—a day after the original surgery—she underwent another procedure to reduce the swelling and stop the bleeding.
Then, on October 27, 2015, she was admitted to the medical center again. This time, doctors performed a CT-guided procedure to remove fluid from the abdominal area where a seroma (pocket of fluid) had formed after the hernia repair.
About a year later, on September 28, 2016, the plaintiff was back in the hospital again. Doctors found that the Physiomesh had adhered or “stuck to” multiple areas of her small bowel. She had to undergo another surgery that lasted two to three hours, during which doctors dissected and attempted to free up enough bowel so they could remove the Physiomesh. When they finished, the implanted a new mesh product to again repair the hernia.Plaintiff Suffers Lengthy Ordeal with Physiomesh
Unfortunately for the plaintiff, that wasn’t the end of her ordeal. On February 24, 2017, she was readmitted to the medical center because of the recurrent incisional hernia. She was also suffering other symptoms including pain, nausea, and a bulge in her abdominal area.
Doctors found that the Physiomesh implanted in the plaintiff seemed to have disintegrated and that some of her bowels were as bulging through the remaining mesh. Doctors removed the mesh from the surface of the underlying bowel.Plaintiff Blames Physiomesh Design for Hernia Repair Complications
The plaintiff blames Physiomesh for her difficulties. She states that the product’s unique 5-layer design—the only one of its kind on the market—prevents adequate incorporation of the mesh into the body, causes an intense inflammatory reaction, encourages damage to surrounding tissue, and delays proper healing.
She adds that when the Physiomesh is implanted, it prevents fluid to escape, which leads to the formation of seromas (pockets of fluid), like those she suffered. These pockets can also encourage the buildup of bacteria, leading to infections.
The plaintiff brings counts of defective design and manufacture, failure to warn, negligence, breach of warranties, and misrepresentation. She seeks both compensatory and punitive damages in excess of $75,000.
http://newyork.legalexaminer.com/medical-devices-implants/oregon-woman-blames-physiomesh-for-multiple-corrective-surgeries/
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