Preview Newsletter
Ethicon Media Monitoring 8/23/2017
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J&J Unit Seeks To Boot Pelvic Mesh Cases From Philly Court
Aug 22, 2017 | Law 360
By Matt Fair
A Johnson & Johnson unit argued on Monday that the company's lack of tangible links to Pennsylvania prevented the Philadelphia County Court of Common Pleas from hearing nearly a hundred cases from out-of-state residents over injuries allegedly caused by faulty pelvic mesh implants. -
Pa. Ties Disputed in Pelvic Mesh Jurisdiction Fight
Aug 23, 2017 | The Legal Intelligencer (In Delaware Law Weekly)
By Max Mitchell
A fight over whether 90 pelvic mesh cases pending in Philadelphia state court against a Johnson & Johnson subsidiary should be transferred to other jurisdictions in the wake of the U.S. Supreme Court's game-changing decision in Bristol-Myers Squibb v. Superior Court of California is focusing on the defendant's contacts with a third-party mesh supplier that is based in Pennsylvania. -
The pelvic mesh device scandal reveals where medicine has lost its way
Aug 23, 2017 | Newcastle Hearld
THE traditional relationship between doctor and patient is understood to rely on trust – if your life is in the hands of the doctor in front of you, you’d like to think you can trust that he or she will have your best interests as a priority. -
A mesh implant 'robbed' this mum-of-three of five years of her life
Aug 22, 2017 | Wales Online
By Mark Smith
Six years ago Carolyn Churchill was an active woman who worked as a chef and spent hours each week walking her dogs. -
Alabama Man Files Physiomesh Hernia Patch Lawsuit
Aug 22, 2017 | Daily Hornet
A lawsuit has been filed by a man from Alabama who claims the Ethicon Physiomesh hernia patch caused him to develop severe complications that required another surgery after his hernia repair. -
A Guide to Polypropylene or PP
Aug 23, 2017 | Mesh Medical Device Newsdesk
What the heck is polypropylene? Its the polymer plastic that makes up many medical devices, including permanently implanted ones.
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J&J Unit Seeks To Boot Pelvic Mesh Cases From Philly Court
Aug 22, 2017 | Law 360
By Matt Fair
Law360, Philadelphia (August 22, 2017, 4:00 PM EDT) -- A Johnson & Johnson unit argued on Monday that the company's lack of tangible links to Pennsylvania prevented the Philadelphia County Court of Common Pleas from hearing nearly a hundred cases from out-of-state residents over injuries allegedly caused by faulty pelvic mesh implants.
Ethicon Inc. argued that the U.S. Supreme Court’s recent decision in Bristol-Myers Squibb v. Superior Court of California had limited the circumstances under which a state court is able to assert specific jurisdiction over nonresident companies, and that there was no evidence of any clear link between its conduct, the alleged injuries, and the state.
“The BMS court reinforced prior precedents as well as case law from Pennsylvania and elsewhere demanding a direct and proximate connection between contacts, forum and claims,” the company argued. “There, as here, no adequate link between the state and the nonresidents’ claim is to be found.”
The company’s arguments come after Judge Arnold New in Philadelphia County agreed earlier this month to reconsider his two-year-old ruling allowing nonresident claims against Ethicon over allegedly defective pelvic mesh products, part of a mass tort program pending in the court, to move forward.
Ethicon managed to convince the judge to rethink the jurisdictional issue in the wake of not only the BMS ruling, which was handed down in June, but also a second ruling, BNSF Railway Co. v. Tyrell, that limited the extent to which state courts can exercise general jurisdiction over nonresident companies.
Ethicon noted in its brief that both it and J&J were incorporated and had their principal place of business in New Jersey, and that neither had registered to do business as a foreign corporation in Pennsylvania. It argued that the the nonresident plaintiffs had received their mesh implants and other relevant treatment outside of the state.
The nonresident plaintiffs, meanwhile, have argued that Pennsylvania did play a key role in the manufacture of the implants at issue thanks to Ethicon’s contract with the Pennsylvania-based Secant Medical Inc. — which was initially named as a defendant in the suit but later dismissed — to knit plastic filaments into rolls of mesh used in the devices.
Ethicon, however, wrote off this contact in its filing on Monday.
“Secant’s involvement ceases as soon as it sends the rolls to Ethicon,” the company argued. “Ethicon manufactures the mesh devices outside of Pennsylvania. … Ethicon, not Secant, conducts all testing and trials on the products; is responsible for all regulatory submissions; and develops and prepares packaging inserts, labels and marketing materials.”
Shanin Specter, an attorney with Kline & Specter PC representing the plaintiffs, told Law360 on Tuesday that the recent Supreme Court decisions merely affirmed existing law on jurisdiction that the Philadelphia County judge had relied on in reaching its initial conclusion to allow the cases against Ethicon to move forward.
"The U.S. Supreme Court cases prior to BMS — now restated word for word in BMS — was briefed to Judge New when this issue was first decided, so the law is no better for Ethicon than before," he said. "So while it's understandable that the court wants the benefit of additional input, we are confident that Pennsylvania continues to have jurisdiction over Ethicon."
He added that additional evidence accrued as individual cases have been litigated in the past two years had also helped to reinforce the fact that Ethicon did have vital links to Pennsylvania in relation to its line of mesh products.
"The basis for jurisdiction against Ethicon in Pennsylvania is even stronger now than when Judge New first denied Ethicon's objections to jurisdiction because of additional evidence of Ethicon's already substantial and specific conduct within the commonwealth in relation to the development and marketing of its transvaginal mesh," he said.
Ethicon is represented by Kenneth Murphy and Melissa Merk of Drinker Biddle & Reath LLPand Julie Callsen of Tucker Ellis LLP.
The plaintiffs are represented by Lee Balefsky of Kline & Specter PC, Clayton Clark of Clark Love & Hutson GP and Joseph Blum of Shook Hardy & Bacon LLP.
The case is In Re: Pelvic Mesh Litigation, case number 140200829, in the Court of Common Pleas of Philadelphia, Pennsylvania.
--Editing by Alanna Weissman.https://www.law360.com/articles/956423/j-j-unit-seeks-to-boot-pelvic-mesh-cases-from-philly-court
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Pa. Ties Disputed in Pelvic Mesh Jurisdiction Fight
Aug 23, 2017 | The Legal Intelligencer (In Delaware Law Weekly)
By Max Mitchell
A fight over whether 90 pelvic mesh cases pending in Philadelphia state court against a Johnson & Johnson subsidiary should be transferred to other jurisdictions in the wake of the U.S. Supreme Court's game-changing decision in Bristol-Myers Squibb v. Superior Court of California is focusing on the defendant's contacts with a third-party mesh supplier that is based in Pennsylvania.
J&J subsidiary Ethicon, which is facing about 120 cases in Philadelphia Court of Common Pleas' pelvic mesh mass tort program, on Monday outlined its arguments for why 90 of those cases—all of which are being brought by non-Pennsylvania residents—should be taken out of the venue. The brief comes less than a month after Philadelphia Judge Arnold New granted the defendant's request to re-open the jurisdiction issue in light of Bristol-Myers Squibb.
A key part of Ethicon's argument is that it had a limited contractual relationship with the Bucks County-based company Secant, which manufactured and then supplied to the defendant the Prolene filaments Ethicon used to create the allegedly problematic pelvic mesh products.
The defendant likened its relationship with Secant to drugmaker Bristol-Myers Squibb's relationship to the company that distributed Plavix—the drug at issue in Bristol-Myers Squibb.
In that ruling, the justices made clear that out-of-state plaintiffs can't sue companies where the defendants aren't considered to be "at home," or haven't conducted business directly linked to the claimed injury. The plaintiffs had noted Bristol-Myers Squibb's relationship with McKesson Corp., a California Plavix distributor, as a reason for the cases to remain in California. However, the justices said that relationship was not adequate to establish jurisdiction in the Golden State.
According to the brief Drinker Biddle & Reath attorney Kenneth Murphy filed on behalf of Ethicon, "Secant is far less relevant to plaintiffs' claims than McKesson was to the non-resident plaintiffs' claims in Bristol-Myers Squibb."
"Plaintiffs have not shown and cannot show Secant was anything other than an independent biomaterials supplier," Ethicon said. "The record reflects only what any contracting party would seek and expect: the delivery of what it has agreed to pay for and the means to assure the other side's compliance. Merely contracting to have mesh knitted from filament by an independent company does not confer jurisdiction."
However, Kline & Specter attorney Shanin Specter, a lead attorney representing the plaintiffs in Philadelphia's pelvic mesh mass tort program, challenged Ethicon's argument, saying "this is not a close call."
Specter, who has tried several pelvic mesh cases to multimillion-dollar verdicts against Ethicon in Philadelphia, noted that his firm challenged Ethicon's arguments in a brief filed to the Pennsylvania Superior Court last week in the case Hammons v. Ethicon, which came to a $12.5 million verdict in late 2015.
In that brief, the plaintiff contended that the underlying due process considerations did not change after the Bristol-Myers Squibb decision, and the trial court weighed those same issues when it first decided Philadelphia had jurisdiction over the cases. The plaintiff specifically contended that Ethicon had worked closely with Secant officials, often meeting with them at their Pennsylvania facilities, and that the company also worked with Pennsylvania gynecologist Dr. Vincent Lucente to develop the mesh.
"Ethicon designed, tested and manufactured the mesh's physical properties in Pennsylvania. Yes, it did so through contracts with Secant and Dr. Lucente. But what matters is the activity itself," the plaintiff said in the brief. "Through those contracts, Ethicon chose Pennsylvania as the location where Ethicon directed the design, manufacturing, testing and overall production process for Prolift mesh. Ethicon chose Pennsylvania as the place where it funded extensive clinical studies and paid for the services of a prominent Pennsylvania consultant."
In an emailed statement, Kristen Wallace, a spokeswoman for Ethicon, said, "Ethicon will vigorously defend itself in lawsuits concerning the use of our pelvic mesh products."
http://www.delawarelawweekly.com/id=1202796166459/Pa-Ties-Disputed-in-Pelvic-Mesh-Jurisdiction-Fight?mcode=1202615337490&curindex=0&slreturn=20170723022009
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The pelvic mesh device scandal reveals where medicine has lost its way
Aug 23, 2017 | Newcastle Hearld
THE traditional relationship between doctor and patient is understood to rely on trust – if your life is in the hands of the doctor in front of you, you’d like to think you can trust that he or she will have your best interests as a priority.
It’s a breach of this trust that women implanted with some pelvic mesh devices feel.
They believed some doctors who said mesh would fix their incontinence and prolapse problems after childbirth. They believed those doctors operated within a system that would weed out risks to patient safety early. What we’re discovering now is how vulnerable too many women were when it came to pelvic mesh devices – all of which remain classified as medium to high risk, even those described by some doctors as being “the gold standard”.
For the past three years the Newcastle Herald has explored how too many women came to suffer devastating, permanent and life-altering injuries after they received mesh implants for what were, in the main, relatively minor incontinence and prolapse issues where alternative remedies were often available.
A Senate inquiry, established in February after a campaign by the Australian Pelvic Mesh Support Group, backed by the Herald, has already heard evidence from doctors that could be classified as concerning.
Two doctors who supported pelvic mesh did not disclose they were also giving evidence on behalf of Johnson & Johnson in a landmark class action case brought by hundreds of Australian women.
A third doctor repeatedly told a Senate hearing in Melbourne that manufacturers had withdrawn their devices from the Australian market from 2014 because of commercial reasons, and not because evidence to back their safety and efficacy was deficient. It was a Therapeutic Goods Administration senior executive who set the record straight.
Australian Medical Association national president Dr Michael Gannon’s acknowledgement on Tuesday that the AMA promoted and exclusively distributed a pelvic mesh device that helped spark the global mesh scandal was sobering, but he deserves credit for speaking frankly.
The decision more than 15 years ago to promote the device was not the AMA’s proudest hour, he said, before conceding the consequences are a tragedy.
http://www.theherald.com.au/story/4873140/the-trust-issue-and-picking-up-the-pieces/
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A mesh implant 'robbed' this mum-of-three of five years of her life
Aug 22, 2017 | Wales Online
By Mark Smith
Carolyn Churchill, 57, wants TVT implants banned
Six years ago Carolyn Churchill was an active woman who worked as a chef and spent hours each week walking her dogs.
But that all changed when a plastic mesh was implanted into her in a bid to combat her stress incontinence, a condition which affects as many as 10% of women.
The 57-year-old said the implant left her in agonising pain, stopped her walking properly and ruined a 14-year relationship with her partner.
She is one of potentially hundreds of women across the UK who have suffered at the hands of the plastic mesh.
Mum-of-three Carolyn, who finally had the mesh removed last year after six years of “torture”, said she is calling on the NHS to ban them.
“I feel absolutely traumatised by it all,” she said.
“I was left in horrendous pain. I was unable to walk properly, I couldn’t lie on my side for five years and I couldn’t bend as all the movement from my waist down was restricted.
“I’ve given birth to three children naturally and I would rather go through that 10 times over than go through the pain of the mesh again.”
After seeing her GP about her stress incontinence she was referred to the Royal Glamorgan Hospital in Llantrisant to see a specialist.
The Nantgarw resident was then given some physiotherapy and told a transvaginal mesh (TVT) mesh implant would resolve the problem.
“I was told that if it does fail it would be no problem to sort it out,” she added.
“But they didn’t tell me anything about the possible complications.
“The operation took just 20 minutes. I really had no idea what I was getting myself into.”
As the epidural wore off after the surgery, she immediately felt something was wrong.
“I was in absolute agony.
“I felt like I was being ripped to pieces,” she added. “But they wouldn’t listen to me and made me feel like some sort of baby, and that it was normal.
“If I could have walked to A&E that night, I would’ve begged them to take it out.”
Carolyn, who also has three grandchildren, said, despite her concerns, she was discharged by the hospital.
Three months after the initial surgery, she was forced to leave her job as chef at the Farmer’s Arms in Church Village because the pain was too unbearable.
She said she then spent the next five years trying, and failing, to get the doctors to take out the mesh.
“Within eight weeks the mesh had eroded through the wall of vagina,” she added.
“It effectively ended my relationship. I couldn’t deal with all the pain and worry of the mesh and be with someone.
“I just needed to be on my own.
“It changed my life and left me depressed.”
As a last resort she went to her MP Owen Smith about the delays in getting the mesh taken out.
And in May 2016 she finally had it removed through a major surgical procedure which involved a lengthy recovery period.
“I felt instant relief,” she added.
“Instead they carried out surgery which used my own tissue, which is what they suggested in the first place.
“I want them banned and I want someone to take responsibility for denying us the treatment we deserved. They just wanted to save time and money.”
Carolyn, who still has not made a full recovery, said she still struggles walking long distances.
Dozens of “mesh victims” travelled to Parliament in July for a special meeting organised by Mr Smith.
As a consequence, an all-party mesh group will be set up to investigate the implants further.
But at present the mesh devices are still being used.
In response, Rachel Fielding, head of midwifery, gynaecology and sexual health for Cwm Taf University Health Board, said: “We can’t comment on individual cases, however we are aware of this national issue and would encourage any woman who has concerns about this procedure to contact their local health professional.”
http://www.walesonline.co.uk/news/health/mesh-implant-robbed-mum-three-13505627
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Alabama Man Files Physiomesh Hernia Patch Lawsuit
Aug 22, 2017 | Daily Hornet
A lawsuit has been filed by a man from Alabama who claims the Ethicon Physiomesh hernia patch caused him to develop severe complications that required another surgery after his hernia repair.
The lawsuit was filed by Bill Tedford, a man from Alabama who had surgery to repair a hernia in December 2013. He developed complications and reactions to the Ethicon Physiomesh hernia patch implant that required him to undergo additional medical procedures.
The most serious reactions left him with permanent scarring and other injuries. He accuses Ethicon Inc. of selling a defective medical device and failing to warn about the risk of complications.
Lawyers say the multi-layered design of Physiomesh was advertised to prevent or minimize the risk of inflammation and adhesions (scar-tissues growing together abnormally) and facilitate the incorporation of the mesh into his body — but it did not.
According to the complaint:
Instead, the multi-layer coating prevented adequate incorporation of the mesh into the body and caused or contributed to an intense inflammatory and chronic foreign body response.”
His adverse tissue reaction resulted in migration and damage to surrounding tissue in the form of sclerotic, granulomatous, and/or fibrotic tissue, and improper healing, the lawsuit states.
The case will be centralized into a federal Multi-District Litigation (MDL No. 2782), where it will be overseen by U.S. District Judge Richard W. Story along with around 85 other Physiomesh lawsuits nationwide.
The lawsuit was filed on August 15, 2017 in the U.S. District Court for the Northern District of Alabama (Southern Division) — In RE: Bill Tedford v. Johnson & Johnson and Ethicon, Inc. — Case No. 2:17-cv-01370-AKK.
Source: Over 80 Lawsuits Already Pending in Consolidated Physiomesh Litigation
https://dailyhornet.com/2017/alabama-man-files-physiomesh-hernia-patch-lawsuit/
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A Guide to Polypropylene or PP
Aug 23, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, August 22, 2017 ~ What the heck is polypropylene? Its the polymer plastic that makes up many medical devices, including permanently implanted ones.
Polypropylene is also known as PP.
If you want to know more, use the Search Bar onMesh Medical Device News Desk and put in polypropylene.
Or you can use this handy guide created by a polymer scientist, Paul Martin.All you ever wanted to know about polypropylene
Polypropylene, also known as PP, is a plastic derived from the petroleum industry.
No doubt you stay up nights wondering about it, so Omnexus has written an Advanced Guide for A to Z Information on PP and its many applications including for a permanent implant in your body that can never be removed.
The author, Paul Martin, reached out to the MNDeditor to thanks us all for our contributions to his knowledge about PP (here), some of which can be found here.
He is asking for any more information people may have about the polymer. Perhaps about its biocompatibility or lack of? Just a suggestion.
Read more about PP and foreign body response and synthetic PP mesh implant complications here.
###https://www.meshmedicaldevicenewsdesk.com/guide-polypropylene-pp/
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