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Ethicon Media Monitoring 4/4/2019
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Pa. Superior Court Clears Way For Out-Of-State Mesh Cases
Apr 3, 2019 | Law 360
By Mike LaSusa
Plaintiffs from outside Pennsylvania can pursue claims in the Keystone State related to a Johnson & Johnson unit’s allegedly defective pelvic mesh products, a Superior Court panel ruled Wednesday. -
‘This is a massive medical scandal’- Surgeons accused of putting on pressure to lift vaginal mesh suspension
Apr 3, 2019 | Cambs Times
By Kath Sansom
Owen Smith, MP, told the BBC Victoria Derbyshire show that too many women were given the implant for relatively minor problems and at too young an age. -
Sweeping reforms in the wake of pelvic mesh scandal
Apr 4, 2019 | Newcastle Herald
By Joanne McCarthy
Australia's medical device regulator will announce sweeping reforms to improve public safety, including device cybersecurity risks, in the wake of a series of scandals and a damning Department of Health review of its device failure monitoring system. -
TGA overhauls medical implant rules and admits 'more can be done' to protect patients
Apr 4, 2019 | ABC News
By Sophie Scott and Brooke Wylie
Australians with medical implants like plates, stents and pelvic mesh could soon have their devices tracked with a barcode system under a new plan health authorities are calling the biggest shake-up in patient safety in 30 years. -
Bard Hernia Mesh MDL Moving Quickly
Apr 3, 2019 | National Law Review
By Martin P. Schrama and Stefanie Colella-Walsh
We have already written about the thousands of Bard hernia mesh cases pending in Rhode Island state court moving swiftly towards bellwether trials.
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Pa. Superior Court Clears Way For Out-Of-State Mesh Cases
Apr 3, 2019 | Law 360
By Mike LaSusa
Plaintiffs from outside Pennsylvania can pursue claims in the Keystone State related to a Johnson & Johnson unit’s allegedly defective pelvic mesh products, a Superior Court panel ruled Wednesday.
The three-judge panel shot down a bid by J&J subsidiary Ethicon Inc. aimed at upending a December 2017 ruling by the supervising judge of a pelvic mesh mass tort program in Philadelphia County. The judge in that case said the New Jersey-based company’s business links with Pennsylvania made the state an appropriate forum for out-of-state residents to pursue claims over the allegedly faulty implants.
The Superior Court judges on Wednesday said the “pertinent jurisdictional facts” in the case being appealed are the same as those addressed in a June decision by the appeals court that rejected substantially similar arguments in a case that resulted in a nearly $13 million verdict for Indiana resident Patricia Hammons.
In both the Hammons case and the instant case, the plaintiffs were out-of-state individuals implanted with a mesh device that was partially manufactured by a Pennsylvania company called Secant Medical Inc., the panel said.
“Ethicon’s direct oversight of the knitting of the mesh in Pennsylvania, coupled with its reliance on clinical studies performed by a Pennsylvania gynecologist, is sufficient to bring Ethicon within the jurisdiction of this commonwealth,” the judges said.
Ethicon’s fight to toss about 70 mesh cases from non-Pennsylvania residents is based on recent U.S. Supreme Court precedent narrowing the scope of jurisdiction for plaintiffs looking to pursue claims in venues outside either where they were injured or where a defendant is headquartered.
The company had previously looked to toss claims from out-of-state mesh plaintiffs in Philadelphia County, but Judge Arnold New, who oversees the pelvic mesh mass tort program, rejected that bid in March 2015.
Ethicon sought reconsideration after the U.S. Supreme Court handed down its ruling in Bristol-Myers Squibb Co. v. Superior Court of California in June 2017, which held that BMS did not have sufficient business contacts in California to confer courts there with jurisdiction over some 600 lawsuits brought by out-of-state plaintiffs over injuries allegedly caused by the blood thinner Plavix.
Judge New, however, ultimately ruled that Ethicon’s work with the Pennsylvania-based Secant as its chosen manufacturer of the implants was enough to give the state courts jurisdiction in mesh-related lawsuits. The Superior Court panel on Wednesday agreed.
Ethicon has asked the Pennsylvania Supreme Court to take up the cases, but its petition is still pending, according to court records.
Shanin Specter, a partner at Kline & Specter PC, which represents the plaintiffs, told Law360 in a statement Wednesday that J&J “has engaged in judge and court shopping in an effort to get some ruling somewhere exempting them from the Pennsylvania courts.”
“We are gratified by the Superior Court’s confirmation of their earlier ruling affirming the jurisdiction of the Pennsylvania courts,” Specter said. “J&J acted wrongfully here and must face justice here.”
Representatives for Ethicon and J&J did not respond to requests for comment Wednesday.
Judges Paula Francisco Ott, Alice Beck Dubow and President Judge Emeritus Correale F. Stevens sat on the Superior Court panel.
Ethicon is represented by Alicia Hickok, Kenneth Murphy, William Carr and Melissa Merk of Drinker Biddle & Reath LLP, Stephen Brody and David Roberts of O'Melveny & Myers LLP and Julie Callsen of Tucker Ellis LLP.
The plaintiffs are represented by Charles “Chip” Becker, Lee Balefsky and Ruxandra Laidacker of Kline & Specter PC.
The case is In re: Pelvic Mesh Litigation, case number 652 EDA 2018, before the Pennsylvania Superior Court.
https://www.law360.com/articles/1146237/pa-superior-court-clears-way-for-out-of-state-mesh-cases
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Apr 3, 2019 | Cambs Times
By Kath Sansom
Owen Smith, MP, told the BBC Victoria Derbyshire show that too many women were given the implant for relatively minor problems and at too young an age.
And he feared that writers of new guidelines into how to treat of incontinence and prolapse had been “got at.”
Speaking on the BBC show this week Mr Smith, who chairs the All Party Parliamentary Group into mesh, said: “NICE are burying their heads in the sand.
“I think they have been got at by the medical profession.
“I think the Royal Colleges and clinicians who have been putting mesh into women are absolutely determined to defend it, not least because there will be liabilities associated with it being proven to be mis sold.”
Owen added: “It is a massive scandal. These devices were over sold by the companies to the medical profession as a quick fix.
“They were implanted into thousands of women who didn’t need it. Many of them were far too young for such a radical surgery for relatively minor problems.
“We’ve got a wide scale global crisis.”
This week NICE issued new guidelines which said mesh could be used again following a suspension, once five other checks are put in place.
Owen said: “I am deeply disappointed that the updated guidelines appear to disregard mesh-injured women’s experiences by stating that there is no long-term evidence of adverse effects.
“Thousands of women have faced life-changing injuries following mesh surgery and they must not be ignored.”
Kath Sansom of Sling The Mesh vowed to keep fighting and said she is taking legal advice on the new guidelines.
She is also seeking to put pressure on the Government for a 20 year review of every single woman in the UK who has had a mesh implant.
“The NHS holds this data, it is just a case of trawling it,” she said.
“Women are appalled that these guidelines are no different from what was published in 2003.
“They are so weak, they clear the way for our daughters and grand daughters to be harmed.
“Our Sling The Mesh survey shows 1 in 20 women have attempted suicide and more than half have regular suicidal thoughts because of chronic pain, loss of sex life, constant infections and auto immune disease.
“These are unacceptable risks from what is sold as a simple fix. If a men’s operation was creating this level of harm it would have been stopped a long time ago.”
Margie Maguire turned to mesh surgery to treat prolapse after the birth of her daughter.
Following the surgery she had two miscarriages and suffered severe and hospitalising pain attacks.
She has since had most of the mesh removed and, while the pain has lessened, she remains reliant on a mobility scooter and a number of home adaptations, such as a stair lift.
Margie said she was “shocked, appalled and extremely disappointed” by NICE’s guidelines.
She said: “By definition, NICE is supposed to strive for ‘excellence’, but any organisation that is content to allow these surgeries to continue, despite the serious and life-changing side effects that they can cause, is anything but ‘excellent’.
“To think that more people may have mesh surgery and face the life-changing complications I have suffered is wrong.”
Linda Millband, lead lawyer for clinical negligence at Thompsons Solicitors, said: “We know, from those for whom we act, the devastating legacy that mesh has left on families and communities across the UK.
“This isn’t ‘clinical excellence’, this is passing the buck.”
Earlier this year, health and social care minister, Jackie Doyle-Price, acknowledged there had been a failure in the regulation of medical devices like mesh and encouraged women to sue their surgeons.
https://www.cambstimes.co.uk/news/nice-guidelines-slammed-by-owen-smith-and-sling-the-mesh-1-5976800
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Sweeping reforms in the wake of pelvic mesh scandal
Apr 4, 2019 | Newcastle Herald
By Joanne McCarthy
Australia's medical device regulator will announce sweeping reforms to improve public safety, including device cybersecurity risks, in the wake of a series of scandals and a damning Department of Health review of its device failure monitoring system.
The Therapeutic Goods Administration will release an Action Plan for Medical Devices today that includes toughening device assessments before approval and strengthening monitoring, after health consumer groups that will meet in Melbourne on Friday announced a campaign to make device regulatory failure a federal election issue.
The TGA will examine ways to better monitor device cybersecurity risks and provide "clearer guidance to industry on cybersecurity requirements for medical devices and the IT systems they connect with".
"With the fast-paced increase in the numbers of medical devices with software or digital components, the coverage of regulation in Australia will be broadened to ensure new and emerging technology such as 3D printed devices and software apps are safe and provide reliable information to consumers," the plan said.
The TGA will establish a specialist unit to evaluate emerging technology such as 3D printed devices and software apps because "poorly performing apps may pose a significant consumer risk".
The TGA announcement follows confirmation it has only initiated four device criminal prosecutions in the past decade, and no pelvic mesh device prosecutions, despite nearly 2000 women pursuing class actions against two multinational mesh manufacturers and a Senate inquiry hearing up to 15,000 women could have mesh injuries, some "catastrophic".
The action plan also follows publication of a federal Department of Health report in the European Medical Journal in January estimating only 0.5 per cent of medical device adverse events, including life-saving devices, are captured by the TGA's device monitoring scheme.
This is despite device manufacturers being the only mandatory reporters under the scheme, subject to prosecution for failing to report adverse events relating to their products.
The Action Plan for Medical Devices: The Safety of Australian Patients Comes First report acknowledges transparency about medical devices released onto the Australian market can be "significantly improved" and more information about individual devices is required so that patients can make informed decisions about their use.
The plan anticipates possible law changes and closer links with consumer groups after a Senate inquiry into the pelvic mesh scandal heard damning evidence about the TGA's failure to respond to rising concerns about the devices for more than a decade from women patients, some doctors and consumer groups.
"The TGA will ensure that all perspectives, but particularly those of consumers who use medical devices, are taken into account," the action plan said.
The action plan acknowledged the failure of its monitoring system to pick up emerging problems with pelvic mesh devices.
"Recent incidents involving medical devices such as transvaginal mesh (pelvic mesh devices implanted through the vagina) have highlighted the need to access more complete data on adverse events and rapidly share information about emerging safety issues to more promptly address threats to patient safety and to take quicker action," the TGA said in the report.
The TGA acknowledged "many incidents are not currently reported by private or public hospitals or by individual healthcare professionals".
The regulator will review the system that allows manufacturers to self-certify devices they deem low risk and whether more devices deemed medium risk should be subject to TGA audits before they are registered for use in Australia.
Under the current system many pelvic mesh devices were cleared for use in Australia as medium risk devices not subject to audits, and based on overseas assessments not subject to independent scrutiny in Australia.
"For higher risk devices the TGA will consult on whether the government should require greater levels and scrutiny of clinical evidence for certain groups of devices," the action plan said.
"These devices include spinal implants, devices that make diagnoses, diabetes management devices, medical devices used for IVF, and companion diagnostics (tests used to guide the choice of medicines for particular cancers or rare diseases)."
The TGA will introduce systems to "improve its ability to identify problem medical devices earlier and to take action quicker", allowing it to "confirm with other international regulators whether they have also had significant reports of adverse events with particular products".
"The TGA's IT systems and analysis capability for adverse events will be enhanced to improve our assessment and investigation processes.
"Together with health consumer organisations, we will also develop simpler ways for consumers to report adverse events (including using smartphone apps) and publicise how reporting of adverse events can improve the safety of products."
The action plan is being released as women left with permanent and serious pelvic mesh complications meet in Melbourne on Thursday for a screening of the film, The Bleeding Edge, about American regulatory failures that contributed to the mesh scandal, and a conference in Melbourne on Friday organised by consumer health groups from across Australia.
https://www.theherald.com.au/story/5994009/regulators-action-plan-after-medical-device-scandals/
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TGA overhauls medical implant rules and admits 'more can be done' to protect patients
Apr 4, 2019 | ABC News
By Sophie Scott and Brooke Wylie
Australians with medical implants like plates, stents and pelvic mesh could soon have their devices tracked with a barcode system under a new plan health authorities are calling the biggest shake-up in patient safety in 30 years.
Federal regulators acknowledged patient safety needed to be boosted after an investigation by the International Consortium of Investigative Journalists (ICIJ) and the ABC highlighted serious problems with a range of medical devices, including pelvic mesh and breast implants.
Deputy secretary of the federal Health Department Professor John Skerritt told the ABC the Therapeutic Goods Administration's (TGA) plan would ensure patient safety came first.
"One of the most important things is to increase the level of adverse event reporting," he said.
"A central part of this new action plan is to increase the number of reports from patients, but also Government is considering whether doctors in healthcare facilities should be required by law to report adverse events."
Under the proposed changes:A pilot register of devices, particularly pelvic mesh would be establishedPatients could register side effects and complaints about implants on a smart phone appDoctors and surgeons could be compelled to report complications from devicesA barcode system could be introduced so all medical implants can be tracked
Professor Skerrit said patients were rightly concerned there was much more information available about medicines than devices implanted into their bodies.
In unusually strong language, the department's plan noted "more can be done to strengthen and improve Australia's medical device regulatory system and patient safety".
And that transparency could also "be significantly improved".'At no time was the word mesh used': patient
One person who knows all too well how damaging medical implants can be is Victorian mother of five Deni Cameron.
The former weight lifter said she was "a shadow of her former self" after she experienced complications from mesh used in a hernia operation.
During a 10-minute consultation, doctors told her they would fix her hernia and she would be back to work in 10 days.
One year later, she has just gone back to work part time.
"He didn't say anything about mesh," Ms Cameron said.
"I probably didn't do enough research, I was looking to find the quick solution."
Hundreds of women have now come forward with horror stories of how they have been left in chronic pain through having pelvic mesh implanted.
Ms Cameron said what patients want more than anything is compulsory reporting of complications by doctors and surgeons, as well as a way of tracking individual devices.
"Mandatory reporting would give us the true figures of what's going on," she said.
"If each device had a unique number on it, you would know what's in your body."
Professor Skerrit said authorities needed a better understanding of devices and any complications.
"Recent incidents involving medical devices such as transvaginal mesh highlighted the need to access more complete data and rapidly share information about emerging safety issues to more promptly address threats to patient safety and to take quicker action," he said.
Sydney University health, law and ethics professor Cameron Stewart said there were some privacy concerns.
"We'd be passing on information about faulty implants in the same way that we'd be passing on information about problems with drugs, or problems with other types of treatments," he said.
"There are certainly privacy concerns when we're doing that, but they're ones that I think could be dealt with under existing frameworks."
Under the proposed changes, authorities would also scrutinise spinal implants, diabetes and IVF devices, as well as establishing a specialist unit to review health apps, including those currently on the market designed to help people track and measure their health.
"The regulatory framework, which was designed in the 1990s and early 2000s, didn't really envisage such things as software apps or 3D printing," Professor Skerritt said.
"These are tremendous developments in technology."Major changes 'in the hands of the Parliament'
In 2018, a Senate committee looking into mesh recommended mandatory reporting of adverse events by medical practitioners, a national registry for all high-risk implantable devices and implant cards for all patients.
The TGA action plan announced today incorporates some of the key recommendation from that Senate inquiry.
Some of the changes can be introduced relatively quickly, such as developing an app for patients to register complaints.
Two initiatives that have already received in-principle approval include a pilot registry of medical implant devices, particularly pelvic mesh, and a barcoding system to track each one.
But Professor Skerritt said new laws would need to be drawn up — or existing laws amended — to allow the major changes, such as mandatory reporting, to happen.
"I don't have a crystal ball. That's in the hands of the Parliament," he said.
"It is really up to the Government, and in many cases the whole Parliament, to decide whether the framework should be changed, and whether there should be additional safeguards added to the system.
"It's a lengthy process, but it could be a very important process for the safety of men and women who have surgery and require an implanted device."
The TGA said it would need additional funding for the changes to be implemented.
https://www.abc.net.au/news/2019-04-04/medical-implants-overhaul-planned-after-icij-investigation/10964256
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Bard Hernia Mesh MDL Moving Quickly
Apr 3, 2019 | National Law Review
By Martin P. Schrama and Stefanie Colella-Walsh
We have already written about the thousands of Bard hernia mesh cases pending in Rhode Island state court moving swiftly towards bellwether trials. Not to be outdone, the federal Multidistrict Litigation (MDL) cases in the United States District Court for the Southern District of Ohio, before Judge Edmund A. Sargus, are heating up as well.
The MDL encompasses claims against C.R. Bard and its corporate subsidiary, Davol, based upon allegations that Bard’s polypropylene hernia mesh was defective and caused injuries to patients. Even though the MDL was formed in August 2018, the Court has already put together an aggressive procedure and schedule for bellwether cases.
Again, a bellwether case is selected through a lengthy process in the courts to be tried as, essentially, a “test case” to help anticipate the outcome of future similar cases. It would not be feasible for the courts to address the thousands of cases filed across the country, so the cases are consolidated for pretrial purposes. Multiple cases are then selected as bellwether cases to potentially be tried, in hopes that an eventual global settlement may be reached between the parties. If settlement is not reached, then the cases may be remanded back to the plaintiff’s home state to be worked up for trial.
Right now in the Bard hernia mesh MDL, there are twelve cases in the bellwether pool to be worked up for trial – six cases were chosen by Plaintiffs and six cases were chosen by Defendants. As discovery in those cases proceeds, they will be whittled down to six cases. The Court will further reduce the amount of cases to three, with those cases to go to bellwether trials in May, July and September of 2020.
There are litigations around the country involving Bard hernia mesh product lines, including PerFix, 3DMax, Marlex, Kugel, Composix, Ventralex, Ventrio, Sepramesh and Ventralight. Litigation is proceeding simultaneously with hernia mesh cases across the country, concerning other manufacturers and their hernia mesh products. These include claims against manufacturers Johnson & Johnson and Ethicon over Physiomesh, Proceed, PHS and Prolene 3D product lines; claims against manufacturer Atrium over C-Qur and Proloop product lines; and claims against manufacturer Covidien over the Parietex product line. It is hoped that the aggressive trial dates in the state and federal Bard hernia mesh bellwether cases can help to lead to an expeditious resolution of the Bard hernia mesh litigation – and even contribute to propelling the other hernia mesh litigations forward.
https://www.natlawreview.com/article/bard-hernia-mesh-mdl-moving-quickly
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