Report: J&J willing to pay more than $400m to settle Pinnacle hip cases

Johnson & Johnson

Johnson & Johnson (NYSE:JNJ) is willing to put more than $400 million on the table to settle consumer allegations that its Pinnacle line of metal-on-metal hips were defective and caused problems including metal poisoning, according to a new report from Bloomberg.

Officials at the New Brunswick, N.J.-based company agreed to payments of approximately $125,000 per case on average to resolve about a third of the Pinnacle hips suit pending against the company, according to the report, which references people familiar with the settlement.

So far, J&J has settled or is in the process of settling approximately 3,300 out of 10,000 lawsuits targeting its Pinnacle line of hip-replacement devices, Bloomberg reports.

The $125,000 average payout would mean the company would need to pay approximately $413 million to settle the 3,300 cases, according to the report.

The medical giant is looking to resolve all remaining pinnacle cases before another trial begins next month, Bloomberg said, though the company remains in talks with lawyers for residual hip recipients who have sued.

The settlements mark the first payout after seven years of litigation over the metal-on-metal hip implants which were removed from the market in 2013, according to the report.

J&J has not yet officially commented on the settlements.

The company is set to return to court next month in Dallas, facing allegations from five Pinnacle-hip recipients that it rushed its Pinnacle device to the market and misled doctors about the device’s safety, according to Bloomberg.

Johnson & Johnson is reportedly seeking to settle cases with separate groups as handled by individual lawyers rather than one global settlement, the same tactic it used to resolve vaginal mesh cases.

In August, the Texas Northern District Court entered an approximately $246.1 million final judgement against J&J subsidiary DePuy Orthopaedics after a jury found J&J liable for defects and fraud related to Pinnacle hips.

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FDA advisory panel to mull transvaginal mesh

FDAThe FDA plans to hold an advisory committee meeting in February 2019 to discuss the safety and efficacy of surgical transvaginal mesh as a treatment for pelvic organ prolapse.

According to a document from the U.S. regulatory watchdog, the committee will be tasked with assessing the benefits and risks of placing mesh transvaginally in the anterior vaginal compartment, as well as clarifying the appropriate patient group and physician training needed for those products.

The meeting will be open to the public, the FDA said, and the agency is requesting comments.

Earlier this year, reports surfaced that Johnson & Johnson (NYSE:JNJ) tried to stop health authorities in France from publishing a report that warned against the use of untested pelvic mesh devices.

Also this year, Ireland temporarily suspended all transvaginal mesh procedures for the treatment of stress urinary incontinence or pelvic organ prolapse at Health Service Executive funded hospitals.

The country said that the suspension will stay in place “until a set of conditions to mitigate the risks of injury are met.”

Ireland’s Minister for Health, Simon Harris, said that the Department Chief Medical Officer requested the suspension following a review by the Dept. of Health, HSE and the Health Products Regulatory Agency.

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J&J’s Cerenovus launches global thrombectomy registry

Cerenovus

Johnson & Johnson‘s (NYSE:JNJCerenovus said today that it launched a new registry aiming to collect and analyze stroke-inducing blood clots removed with the company’s Embotrap II revascularization device.

The Irvine, Calif.-based company touted the Excellent registry as the single largest global registry of its kind to date, looking to enroll up to 1,000 ischemic stroke patients across 50 locations in the U.S. and Europe. Investigators in the trial will collect and analyze clots removed to explore how different characteristics, including size, composition and density may affect outcomes, the company said.

In addition to the registry launch, Cerenovus said that it developed and recently won CE Mark approval in the European Union for its Geometric Clot Extractor revascularization system, a novel device intended to retrieve various thrombus types. The approval came based on a controlled study prior to the launch exploring its clinical utility and potential advantages over existing tech.

“This is a landmark registry study that will provide real-world data on the Embotrap II device while advancing the scientific community’s understanding of how variations in blood clots correlate with treatment and outcomes. We believe thoughtful and extensive research into the science of blood clots is the key to developing the most effective endovascular treatments and bringing its benefits to the greatest number of stroke patients. We are excited by both the clinical insights the Excellent Registry will provide and the possibilities for GCE in helping to bring the benefits of mechanical thrombectomy to difficult to treat stroke patients.We have a deep commitment to meaningful innovation through the development of evidence-based solutions that give patients the best chance for a high quality of life after stroke,” Cerenovus prez Daniella Cramp said in a press release.

In August, Cerenovus said that it won CE Mark approval in the European Union for its Bravo flow diverter designed to treat intracranial aneurysms.

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How Reggie Groves reinvented Medtronic’s atrial fibrillation biz

Reva Medical (ASX:RVA) CEO Reggie Groves got her start in the medical device industry at medtech titan Medtronic. In her upcoming keynote interview at DeviceTalks West, Groves will discuss how that experience has shaped her as a leader and an innovator. Here’s a preview:

When Reggie Groves joined Medtronic (NYSE:MDT) in 2002, she didn’t know very much about the medical device industry. That was by design, she told MassDevice – the company was looking for somebody outside of the medtech world to launch their CareLink Network. It was the world’s first remote monitoring system designed to link the data in patients’ implanted devices with physicians.

Reggie Groves“I knew that (Medtronic) was a big company that was well respected and that was about all I really knew about them,” she said. “I saw what they were doing in remote device check as the start of a complete transformation of the medical device industry – moving away from being the implant to being the data managers.”

After commercializing CareLink and then moving to the regulatory and quality side of the business, Groves stepped up to build Medtronic’s atrial fibrillation ablation business. At the time, according to Groves, Johnson & Johnson (NYSE:JNJ) held a sizable lead in the AF space, followed by St. Jude.

Medtronic’s AF unit “basically didn’t exist,” Groves said – the company had previously sold its electrophysiology business. It was Groves’ job to determine how the company could build an AF division that would stand out among fierce competition.

Catch Groves’ keynote interview at DeviceTalks West on Dec. 11 – register today!

She decided to rethink the way that the company’s sales force was selling its newest technologies to electrophysiologists.

“Most companies would have said, ‘We’ve got this great big sales force, here’s another product in their tool bag. Give it to them and let them sell it.’ And I said, ‘That’s the worst thing we could do because it’s a disruptive technology and we don’t want every customer to have it.’ If you’re the sales rep who’s also selling CRT devices and ICT devices, you’re going to bundle,” she said. “Something is going to be given away and the easiest thing to give away is the new novel thing. You’ll never make any money in AF, which is why Medtronic walked away from it the first time.”

Groves set up her own sales team and told them to only sell Medtronic’s AF technology to early adopters.

“When you walk in the door for the sales meeting, if you get the ‘Oh, it’s too expensive, oh it’s not flexible enough, oh it doesn’t do enough,’ – turn around and walk out the door. That’s not an early adopter. You need to find the customers who get the value proposition,” she explained.

At the time, competitive devices from St. Jude and J&J were designed to allow the very best doctors to perform an ablation anywhere in the heart. At Medtronic, Groves was positioning the company’s AF device as usable by any electrophysiologist who was looking to isolate the pulmonary vein.

Her plan was not without pushback, according to Groves.

“It wasn’t easy, even within Medtronic. I had lots of naysayers and it took the CEO stepping in, listening to the argument and making the call,” she said. “But I got really lucky that I believed in a different approach to launching a product compared to most big companies and Medtronic let me do it my way.”

Don’t miss out on the rest of Groves’ exciting story – see her at DeviceTalks West on Dec. 11-12.

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J&J’s Biosense Webster launches Heliostar multi-electrode ablation cath trial

J&J's Biosense Webster multi-electrode catheterJohnson & Johnson‘s (NYSE:JNJ) Biosense Webster said this week that it enrolled and treated the first patient in its Stellar U.S. investigational device exemption study.

The 640-patient trial is designed to assess the safety and efficacy of the Heliostar multi-electrode radiofrequency balloon ablation catheter as a treatment for drug refractory recurrent paroxysmal atrial fibrillation.

The Heliostar device features 10 electrodes and is designed to allow electrophysiologists to achieve pulmonary vein isolation with a single application of RF energy, according to Biosense Webster.

Cardiac electrophysiologists Drs. Rodney Horton and Andrea Natale treated the first patient in the Stellar study at the Texas Cardiac Arrhythmia Institute.

“This new balloon catheter is unique because it conforms to any pulmonary vein anatomy and allows me to control electrodes individually to deliver tailored energy when ablating around pulmonary veins,” Dr. Horton said in prepared remarks.

“The Heliostar catheter design has the potential to overcome the limitations of current balloon ablation catheters, result in fewer catheter exchanges and, most importantly, shorter procedure times. Heliostar is an exciting technology and we look forward to seeing the final study results,” Dr. Natale added.

“The Stellar study is an important step forward in expanding treatment options for atrial fibrillation patients in the United States,” Uri Yaron, worldwide president of Biosense Webster, said. “The burden of atrial fibrillation on quality of life, morbidity and mortality is significant and we are committed to developing innovative and life-enhancing technologies that fill important clinical needs, improve care and reduce this burden.”

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Medtech companies, industry groups shrug off ICIJ’s “Implant Files” report

Medtech companies and industry groups have shrugged off the recently released “Implant Files” report from the International Consortium of Investigative that was highly critical of the industry, seeing shares stay steady or rising only days after the report was posted.

The highly critical “Implant Files” report, which was released early this week, is a collaborative effort overseen by the ICIJ and includes work from 252 journalists from 59 media groups across 36 countries.

On its first day of trading this week after the release of the report, industry giant Medtronic (NYSE:MDT) saw its shares rise 1.6% to close at $92.06. Other major players, including Johnson & Johnson (NYSE:JNJ), Boston Scientific (NYSE:BSX) and Zimmer Biomet (NYSE:ZBH) saw shares drop less than 1% in response to the report.

Responses from medical device industry groups varied greatly, with some expressing sympathy to the issues presented in the report and reiterating their intentions to improve global health and wellness through the use of advanced technology.

“The medical device industry understands that just one adverse event is too many, particularly if it affects you or your loved ones. It is heartbreaking when our healthcare system, which is set up to heal people, results in patients being harmed. Everyone involved in care feels the pain when a patient is hurt, from the nurses and doctors on the front lines of care, to the women and men building medical technology. Our first and primary purpose is to help patients and we do that, every day for millions of people around the globe,” MassMEDIC president & former MassDevice publisher Brian Johnson wrote in a statement in response to the ICIJ report. “Patients can feel confident that the medical devices being used to treat them are safe and have been rigorously vetted by a robust and stringent regulatory system. Independent research has shown that the overall recall rate of medical devices, cleared through the FDA is remarkably low, less than 1%. However, nobody involved in this system believes in resting on their laurels. The medical device industry, the FDA and our healthcare system will continue to seek ways to improve the process of patient safety, while giving patients access to groundbreaking new treatments that will improve their lives.”

“While there is no medical procedure that can be performed without risk, Medical Alley companies always strive to innovate and produce the safest possible technologies that deliver better outcomes for patients. Medical Alley has a history of leadership, as the birthplace of the modern medical technology industry and as the co-creator of the Medical Device Innovation Consortium. Medical Alley looks forward to working with all health stakeholders to improve the products, the regulatory process and the press coverage of the medical technology industry and the patients whose lives depend on these products,” Minnesota’s Medical Alley Association representatives wrote in response to the report.

Other groups were more dismissive of the issues covered in the release and accused investigators of “cherry-picking” dramatic stories and “overlooking the overwhelmingly positive experiences” that the industry supports.

“The ICIJ’s coverage of this dynamic industry is cherry-picking a handful of adverse outcomes at the exclusion of the nearly 200,000 medical devices currently on the market improving patient care. This only serves to frighten the millions of patients who benefit from medical technology innovation every day, while inaccurately portraying the rigorous regulatory pathways that are in place to ensure patient safety,” Medical Device Manufacturer’s Association prez & CEO Mark Leahey said in press release responding to the ICIJ report.

“Every one of us will inevitably face a moment where we will hope for a miracle to make a child, sibling, parent, grandparent or loved one well again. Whether it’s a pacemaker that keeps a heart beating, an implant that allows a child to hear for the first time, or an artificial knee that allows a grandmother to play with her grandkids, medical devices are the foundation of modern medicine, providing physicians and nurses the tools they rely on to improve patient care. Yet, instead of a comprehensive look at both the challenges and the achievements of an industry that touches almost every human life, these stories counterfeit the life-changing and life-saving solutions delivered to billions of people worldwide,” AdvaMed wrote in response to the ICIJ report. “We should never discount any patient’s experience. But by magnifying the stories of only a few individuals, we overlook the overwhelmingly positive experiences of millions of others. We take seriously all reports of patient impact, and though the medical community can never completely eliminate risk, we always strive to improve our technologies and care delivery.”

The report is the second major examination of the medtech industry to release this year, after Netflix released a highly critical documentary, titled “The Bleeding Edge,” earlier this summer.

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J&J Vision inks $26m Singapore collaborative myopia research deal

Johnson & Johnson Vision

Johnson & Johnson‘s (NYSE:JNJ) Vision business said this week that it inked an approximately $26.4 million collaborative research deal with The Singapore National Eye Centre and the Singapore Eye Research Institute looking to improve treatments for myopia.

The public-private strategic partnership is the first of its kind in Asia, according J&J, and will promote exploration of how myopia develops, progresses and possible interventions.

“SNEC is honored to be working with collaborators coming together to address the growing burden of myopia,” Professor Wong said. “By leveraging the diverse strengths of our clinicians, clinician scientists and strategic partners to establish new disease frameworks and share this knowledge across world communities to help eradicate myopia,” SNEC medical director Wong Tien Yin said in a prepared statement.

“The incidence of myopia is increasing at an alarming rate around the world and if left unchecked, the human and financial toll could skyrocket in the coming decades, especially in Asia. We are delighted to be collaborating with SERI and SNEC to better understand the underpinnings of this condition and identify ways to halt this global public health threat. Together, we hope to bring important progress to individuals and families throughout the Asia Pacific region and ultimately, around the world,” J&J chief scientific officer Dr. Paul Stoffels said in a prepared release.

The groups will look to develop predictive tools to identify individuals at high risk of developing high myopia through the exploration of the underlying mechanisms of it.

“Documented increases in myopia, especially among young people, are a serious concern and if we can understand the underlying mechanisms that are contributing to its rapid rise, we can work to tackle the problem at its roots. SERI is strongly committed to collaborating with leading companies to address eye diseases, and we are excited to be embarking on this research collaboration to break new ground against the epidemic,” SERI executive director Aung Tin said in a press release.

Last month, Johnson & Johnson posted third quarter sales and earnings that topped the consensus forecast, prompting the healthcare giant to raise its outlook for the rest of the year.

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Pa. State Judge orders new trial in J&J pelvic mesh case

Ethicon TVT Secur

A state judge in Pennsylvania this week ordered a new trial in a suit alleging a that a woman was injured by Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon’s TVT-Secur pelvic mesh implant.

The jury had previously ruled that the TVT-Secur device was defective in design and that the company did not appropriately warn pelvic floor surgeons of the risks of using the device, but the same jury also found that neither the warnings or defect caused injuries to the plaintiff.

In a five-page opinion, Judge Michael Erdos ordered a new trial that will re-examine the entirety of the case.

“Upon further examination of the issue, the Court now believes that a new trial should not be limited to the issues of compensatory and punitive damages. Rather, the new trial must also involve re-litigation on the issue of Appellants’ liability for design defect.”

The re-hearing was due to an “inadequate verdict,” as experts from both sides of the trial agreed that the “defendant’s negligence” caused injuries to the plaintiff, and the jury ruled in opposition to the expert opinions, according to court documents.

“Here, both Appellee’s Expert, Dr. Bruce Rosenzweig, and Appellee’s (non-retained) treating physician, Dr. Andrew Hundley, testified that the TVT-Secure caused Appelee much harm, including sharp pain during sexual intercourse, burning, irritation and a feeling of rawness. Significantly, even Appellants’ expert, Dr. John Wagner, conceded that the mesh caused injury to Appellee, necessitating explant surgery,” court documents read.

Details on the new trial have not yet emerged.

In July, a Pennsylvania state court judge overturned part of a jury verdict that gave Ethicon its first win in five pelvic mesh trials in Philadelphia.

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Carrot raises $25m for tech-enabled smoking cessation program

Carrot logoDigital health company Carrot said today that it raised $25 million to commercialize its tech-enabled Pivot smoking cessation program.

The round was led by Johnson & Johnson‘s (NYSE:JNJ) strategic venture capital arm, JJDC. New York Life Ventures and existing investors Khosla Ventures, Marc Benioff, founder Dr. David Utley and R7 Partners also contributed to the financing round.

Get the full story at our sister site, Drug Delivery Business News.

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BARDA, J&J launch ‘reimagined’ emergency respiratory device challenge

The Dept. of Health and Human Services’ Biomedical Advanced Research and Development Authority and Johnson & Johnson‘s (NYSE:JNJ) Janssen R&D are launching a new crowdsourced tech development challenge looking to support innovative respiratory protection devices, according to a recently listed government posting.

The new contest, dubbed the QuickFire Challenge, will look to award up to $100,000 to developers of “reimagined, transformative respiratory protection” devices, according to the release.

Both J&J’s Janssen and BARDA will collaborate on the challenge, alongside J&J’s JLABS incubators, according to the release.

The aim of the challenge is to advance “reimagined” devices that would eliminate the issues associated with traditional respiratory devices, which are mainly designed for use in occupational settings and are often only available for adults.

“In an outbreak of a novel or newly emerging respiratory disease, respiratory protection may be the only countermeasure available to protect health care workers and the general public,” HHS wrote in the announcement.

BARDA said the challenge will directly benefit its mission of providing medical countermeasures to address health security threats, saying that respiratory protections are “often the first line of defense, and a radically improved approach to protect both health care workers and the general public, including children, would truly improve our ability to respond to public health emergencies.”

Neither J&J or Barda have released any further details on the project, which has a performance period ending on June 30, 2019.

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