Pennsylvania appeals court upholds $14m plaintiff win in Ethicon mesh case

J&J's EthiconA state appeals court in Pennsylvania yesterday upheld the plaintiff’s $13.7 million win in a product liability lawsuit brought over one of Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon‘s pelvic mesh products.

Plaintiff Sharon Carlino was awarded $13.5 million in damages in February 2016, after a Keystone State jury found that the Ethicon transvaginal polypropylene tape implanted during a 2005 hysterectomy was defective and that the company failed to adequately warn of its risks; Carlino needed three revision surgeries to remove the eroded mesh. That decision was upheld early the following year, with the court adding some $238,000 in delay damages.

Ethicon and Carlino cross-appealed, with the company pressing seven arguments seeking to overturn the decision and Carlino arguing that the delay damage award should have been calculated on both compensatory and punitive damages, not just the compensatory award.

Yesterday the Pennsylvania Superior Court ruled on the cross-appeals, backing the lower court’s decision on all fronts, including Ethicon’s challenge to the punitive damages award and the delay damages ruling.

“Taken as a whole, and viewed in the light most favorable to the verdict winner, this evidence permitted the jury to find Ethicon acted with wanton and willful disregard of Ms. Carlino’s rights and that this conduct caused her injuries. The evidence showed that Ethicon knew that the TVT could cause permanent vaginal and muscular pain and sexual dysfunction, because of its mesh weight, pore size, pore collapse, and particle loss. Despite this knowledge, Ethicon promoted the TVT for patients who sought to fix SUI, knowingly understated the risks of the TVT in its IFU, and consistently misled physicians that the TVT produced few adverse results,” the Superior Court found.

“The evidence demonstrates that Ethicon knowingly understated the risks of the TVT in all six versions of the [instructions for use] published between 2000 and 2015. The IFU’s adverse reactions section did not change during that time, and it failed to acknowledge new information Ethicon was obtaining from treaters and its own researchers on adverse effects associated with the TVT. In addition, Ethicon consistently and misleadingly informed physicians that the TVT produced few adverse results and was intentionally evasive about common complications,” according to the ruling.

In January a Philadelphia jury hit Ethicon with a $41 million decision in another pelvic mesh suit brought over its Gynemesh, Prolift and TVT-O meshes. That verdict includes $25 million in punitive damages, $15 million in compensatory damages and $1 million for loss of consortium.

Ethicon has said it intends to appeal the decision and that it stands by its pelvic mesh products.

J&J’s Ethicon touts economic study of magnetic Torax GERD device

Ethicon's Torax Linx GERD deviceJohnson & Johnson (NYSE:JNJ) subsidiary Ethicon touted a study showing that the Linx device it acquired two years ago was cheaper than laparoscopic Nissen fundoplication in treating gastrointestinal reflux disease.

Shoreview, Minn.-based Torax Medical makes the Linx device, an implant of interlinked titanium beads with magnetic cores designed to augment the esophageal sphincter to prevent reflux in GERD patients. Ethicon paid an unspecified amount for Torax in March 2017.

Presented last week at the annual meeting of the Society of American Gastrointestinal & Endoscopic Surgeons in Baltimore, the study was funded by Ethicon and Highmark Health’s Vital incubator. It compared total procedural cost and disease-related and overall medical claim costs 12 months before and 12 months after 180 Linx patients and 1,130  LNF patients at Highmark’s Allegheny Health Network in Pennsylvania. Laparoscopic Nissen fundoplication wraps a portion of the upper stomach around the lower esophagus to prevent reflux.

The mean per-member-per-month reimbursement claims for upper GI disease one year after Linx dropped 66% percent to $104 and 46% for LNF, according to the study. Overall PMPM claims fell 10.7% for Linx patients and 1.4% for LNF patients; reimbursement for proton pump inhibitors and GERD acid suppression drugs fell 95% after Linx and 90% after LNF.

The average Linx procedure was more expensive, costing $14,379 compared with $13,691 for LNF. The difference is offset by lower costs a year out, the researchers said.

“The higher initial cost of a Linx procedure compared to a Nissen fundoplication is perceived as a drawback by insurers, which made getting insurance approvals challenging,” lead researcher Dr. Blair Jobe, director of Allegheny’s  Esophageal & Lung Institute, said in prepared remarks. “This study suggests that perception may be short-sighted in that insurance plans can provide better care for their GERD patients at a similar cost to laparoscopic Nissen fundoplication when you factor in the greater reductions in medical costs after the procedure.”

“This study demonstrated that the Linx System was cost effective and should be more widely covered by insurers,” added Ethicon endomechanical president Tom O’Brien. “Ethicon will continue to help support studies that enable clinicians, patients, insurers and health systems to make the best possible decisions about which treatments work best for which patients and at what cost.”

Report: J&J plans €100m expansion in Ireland, to add 100 jobs

Johnson & Johnson VisionJohnson & Johnson (NYSE:JNJ) is reportedly planning to expand its vision business in Ireland with a €100 million project that’s slated to add 100 jobs to the local economy.

The plant in Limerick is expected to bring 100 permanent jobs on top of 200 temporary construction jobs, Silicon Republic reported.

“We believe that the new manufacturing roles being introduced in Limerick in 2019 will be foundational in helping us bring new, innovative contact lens products to our patients and customers around the world at an industry-leading pace,” J&J Vision Care plant leader John Lynch said.

J&J Vision employs roughly 1,000 people in Limerick, according to the website.

Last week Edwards Lifesciences (NYSE:EW) said it’s looking to open a new facility in Limerick that could bring in up to 600 new jobs for the region.

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Varian leads $54m Series C for HistoSonics

HistoSonicsHistoSonics said today that it closed a $54 million Series C round led by Varian Medical (NYSE:VAR) that included a contribution from Johnson & Johnson (NYSE:JNJ).

The Ann Arbor, Mich.-based company, which is developing an image-guided, robotically assisted platform using non-invasive and non-thermal technologies, said Lumira Ventures, Venture Investors, the State of Wisconsin Investment Board and existing backers also participated – including robot-assisted surgery pioneer Dr. Fred Moll.

HistoSonics said it plans to use the proceeds to complete “key regulatory and commercial milestones” and expand its development efforts.

“We are very excited to be adding this group of experienced investment partners who share in our vision and mission,” president & CEO Mike Blue said in prepared remarks. “[Robotically assisted sonic therapy] will offer transformative change for both patients and physicians and will help overcome many of the major limitations and side effects of today’s cancer therapies. It has also shown great promise to work synergistically with other therapies and platforms, such as drug and immunotherapy, a big focus of our preclinical work, as well as with other surgical robotic platforms. We are confident that RAST will provide an entirely new experience for patients and physicians, as well as a more cost-effective alternative that better aligns with value-based healthcare initiatives, and we are thrilled to have such a strong syndicate joining us on this journey.”

“We believe that the HistoSonics platform offers a unique solution and significant promise to treat patients with a number of different diseases across global markets and care settings,” added Varian strategy & business development VP Greg Sorensen, who is slated to join the HistoSonics board in connection with the Series C round.

“Venture Investors has been an investor in HistoSonics from the start and it is incredibly exciting to see the progress we have made over the past several years,” Venture Investors chairman & managing partner Jim Adox said. “The vision of the company from the very beginning has been to develop a true platform that will revolutionize how patients are treated across a broad spectrum of diseases, including some of the most significant cancers, and it is very gratifying to now see the tremendous advancement of the system as it nears market launch.”

HistoSonics said Lumira managing director Gerry Brunk and a representative from Johnson & Johnson Innovation are also slated to join its board.

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J&J’s Ethicon warns EMEA docs on Intraluminal stapler issues

Johnson & Johnson

Johnson & Johnson‘s (NYSE:JNJ) Ethicon subsidiary late last month released a notice it filed in the Europe, the Middle East and Africa region warning of issues with its Intraluminal Staplers related to malformed staples and uncut washers that can “compromise staple line integrity.”

The company said that it initiated a medical device field safety corrective action for 378 lots of Intraluminal Staplers distributed in the region and that after investigating the complaints it found uncut washers and malformed staples in the devices.

“If a problem with the staple line is not adequately addressed or is not recognized, there is a potential risk of postoperative anastomotic leak, gastrointestinal injury, hemorrhage or hemorrhagic shock,” the company wrote in its notice.

J&J’s Ethicon said that it has received reports of adverse events due to malformed staples, but that the occurrence of such events remains below 0.1%.

The company provided instructions for customers with the staplers, advising them to use a non-affected device if possible and requesting the return of identified products.

Ethicon said that in the case that an alternative device is not available, surgeons should adhere to a number of specific steps to avoid possible issues with the device.

In January, Ethicon released the results of a head-to-head study between an Ethicon surgical stapler and a Medtronic stapler system.

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Johnson & Johnson closes Auris Health buyout, sterilization biz sale

Johnson & Johnson

Johnson & Johnson (NYSE:JNJ) said yesterday that its Ethicon biz completed its $3.4 billion acquisition of robotic surgery dev Auris Health and the $2.8 billion divestiture of its Advanced Sterilization Products to Fortive (NTSE:FTV).

Redwood City, Calif.-based Auris Health, which was created by Intuitive Surgical (NSDQ:ISRG) founder and surgical robotics pioneer Dr. Fred Moll, developed and produces the robotic Monarch platform which has FDA clearance for diagnostic and therapeutic bronchoscopic procedures.

The Monarch system features a controller interface for navigating the integrated flexible robotic endoscope into the periphery of the lung and combines traditional endoscopic views with computer-assisted navigation based on 3D patient models, the company said.

J&J said that Auris’s platform will complement technologies it currently has in development with Verb Surgical for robotic general surgery and the orthopedic platform it obtained when it acquired Orthotaxy.

“We are focused on building a connected, data-driven digital ecosystem that pairs our market-leading surgical solutions with advanced technologies to improve the patient experience. The passionate team and differentiated innovation from Auris will help us amplify the power of digital surgery to address unmet clinical needs and lead a transformation in surgical care and lung cancer intervention,” J&J medical devices worldwide chair Ashley McEvoy said in a press release.

In a separate announcement, the company also said it sold its Advanced Sterilization Products biz to Fortive for a total of $2.8 billion, with $2.7 billion in cash from Fortive and $100 million in retained net receivables. J&J said that the ASP biz had a net revenue of approximately $800 million last year.

The ASP division includes capital, consumables and software for use in low-temperature terminal sterilization and high-level disinfection of reusable surgical instruments, the company said in a press release.

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Johnson & Johnson touts drug-releasing lens studies for itchy eyes

Johnson & JohnsonContact lenses imbued with an antihistamine drug reduced itchy eyes in a pair of older studies funded by the vision business at Johnson & Johnson(NYSE:JNJ), the company said today.

The Phase 3 studies, conducted in 2007, involved a total of 244 patients, divided into three cohorts. In the first patients wore a plain lens made of etafilcon a in one eye and the same lens treated with 0.019mg of the drug ketotifen in the other eye. In the second group, patients wore treated lenses in both eyes; the third group was the control, consisting of patients wearing placebo lenses in both eyes. There were about 40 subjects in each group.

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

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FDA warns J&J, Sientra over lack of post-approval silicone gel breast implant studies

FDA

The FDA today released warning letters it sent to Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Worldwide and Sientra (NSDQ:SIEN) over failures to conduct appropriate post-approval studies to analyze the long-term safety and risks associated with their silicone gel-filled breast implants.

The federal watchdog said that every manufacturer of approved silicone gel-filled breast implants is required to conduct post-approval studies of the devices to maintain appropriate data on the long-term safety and potential risks associated with the devices that premarket trials cannot foresee.

In its letter to J&J’s Mentor, the FDA noted a failure to enroll the appropriate amount of patients in the post-market study of its MemoryShape breast implant which won approval in 2013. The federal watchdog also said that Mentor had poor follow-up rates with patients and noted significant data inconsistencies in the report, including poor patient accounting and missing race and ethnicity data.

In its letter to Sientra, the federal watchdog knocked the company on its 61% follow-up rate, which falls below the target for the post-market study.

The agency said that both companies’ failure to address the raised concerns and comply with the post-approval study requirements violates its pre-market approval order. The FDA gave both companies 15 days to comply with the warnings.

“Post-approval requirements are critical to ensuring the safety and effectiveness of the medical products we regulate and we’ll continue to hold manufacturers accountable when they fail to fulfill these obligations. We’re issuing these warning letters based on the manufacturers’ low recruitment, poor data, and low follow-up rates in their required post-approval studies. We expect these manufacturers to meet the pre-specified study requirements in order to ensure the collection of long-term data that can be used to inform long-term patient safety. Post-approval studies, along with other surveillance tools such as adverse event reports, registries, and scientific literature, allow the FDA to help ensure the safety of medical devices and protect patients,” FDA Commissioner Dr. Scott Gottlieb said in a prepared statement.

Last month, the FDA said that it has received reports of 457 unique cancer cases related to breast implants since 2010, including nine patient deaths.

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Lessons learned from Lantheus CEO Mary Anne Heino

At MassMedic’s Women in Medtech event last month, Lantheus Medical Imaging CEO Mary Anne Heino spoke with MassDevice.com editor Sarah Faulkner about her career in life sciences, the power of mentorship and the necessity of courage.

When Mary Anne Heino first joined Lantheus Medical Imaging (NSDQ:LNTH) in 2013, she knew admittedly very little about the field of diagnostics.

“I was walking into a company where the average tenure was more than 25 years,” she said. “So these were people who knew what they were doing and had been doing it for so long…I was intent from day one to show that I was ready to learn and that I knew nothing and therefore was an open sponge for them to teach me.”

Six years later, Heino describes Lantheus as a “completely different company” – public, profitable and “one of the darlings of medtech.”

She came to Lantheus with 20 years of experience at Johnson & Johnson (NYSE:JNJ) and training as a nurse under her belt, so she certainly wasn’t new to the world of healthcare. But she believed that successfully transitioning to the C-suite at Lantheus would require showing her employees that she was willing and excited to learn from them.

“If people sincerely read that you want to learn and that you value them and what they can teach you, you get this incredibly different experience than if you come in trying to superimpose some kind of experience that you think is relevant on them,” Heino explained. “And I just left myself open to learning from them and to learning the entire field of diagnostics.”

Mentorship

The value of mentorship is clearly written out in Heino’s career – her first female mentor now sits on Lantheus’ board alongside a former J&J colleague whom Heino has known for two decades.

“I asked them to join my board and help me and they did. Because if you ask, you get more than you think,” she said.

“I met a lot of folks who were professional mentors and the commonality that you always find is that your mentor is right for you if they challenge you and don’t console you,” Heino added.

Offering advice to audience members seeking a mentor, the CEO noted that people need to keep in mind the commitment that they’re asking of a mentor.

“You’re asking for someone’s time and your asking for their commitment and their energy. We’re all incredibly busy; we all have very, very busy lives and so it is a request and it’s one that you should honor by bringing the type of conversation that has a goal that takes you forward in some direction for having had it and for having used somebody’s time,” she said.

But Heino also made sure to point out that, generally speaking, “people want to help and people want to feel like they have value and that’s what a great mentor can do for somebody.”

Leadership

Beyond the relationships with mentors that she formed throughout her career, Heino found another way to learn from those around her.

“I looked around me my entire career and saw people doing great things. Either thinking different ways or coming at situations different ways and I modeled what I liked and what worked and I also learned what didn’t work for me,” she said.

Early on, Heino learned that if she wanted something, she needed to ask for it. She found herself constantly looking for and asking for new ways to grow within J&J, Heino explained.

“I quickly got myself into a pattern of looking for things that were different from what I had been doing that would stretch me in a different way,” Heino said.

This technique served her well over the course of her career, as she stepped into the new opportunities presented by J&J and later at Lantheus.

“My true belief about leadership is that the most important component of it is courage, because courage makes everything else possible,” Heino said. “What has to sit right behind it is your own confidence in yourself.”

“The world desperately needs leaders,” she added. “Our industry desperately needs leaders. So it’s almost our charge and our obligation to step up and fill in the spots.”

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HydroCision names Tranchemontagne as CEO | Personnel Moves – March 12, 2019

HydroCision CEO Tranchemontagne

HydroCision said early this month that it tapped former Smith & Nephew (NYSE:SNN) exec Alain Tranchemontagne as its new chief executive officer.

Prior to joining Boston-based HydroCision, Tranchemontagne held a position as U.S. business commercial development senior VP at Smith & Nephew. Before joining Smith & Nephew, Tranchemontagne also held positions at Covidien in senior marketing roles in the patient care division.

We are delighted to have Alain spearhead the next growth chapter in HydroCision’s future. The board was impressed with Alain’s proven track record at major medical device companies, his leadership and market development experience, as well as his passion and energy to broaden the use of our patented, proprietary technology,” board chair John Schulte said in a press release.

“I’m incredibly honored to be joining HydroCision, and I look forward to working closely with the dedicated HydroCision employees and the Board to deliver on the enormous opportunity that lies ahead. I’m also eager to quickly accelerate HydroCision’s growth trajectory, particularly leveraging our unique and differentiated technology into new surgical applications,” Tranchemontagne said in a prepared statement.

 Senseonics taps Kaufman as chief medical officer

Senseonics (NYSE:SENS) said this month it named Dr. Francine Kaufman as its new chief medical officer, effective immediately.

Kaufman previously served as a director at the Comprehensive Childhood Diabetes Center and head of the Children’s Hospital of Los Angeles’ Center for Endocrinology, Diabetes and Metabolism, Germantown, Md.-based Senseonics said.

“We are pleased to have Fran join the executive leadership team at Senseonics. As chief medical officer, she will be instrumental in helping drive forward our innovation platform and the clinical value proposition of the Eversense system. Fran is one of the world’s leading endocrinologists and her deep understanding of the global medical, research, and clinical diabetes community coupled with her track record of applying novel technologies to advance diabetes care for patients make her ideally suited for the role. We are confident that with her leadership, we will further transform and elevate the Eversense platform and bolster our US commercialization efforts at this critical point,” prez & CEO Tim Goodnow said in a press release.

“I am very excited to join the Senseonics team, especially at this point where I feel I have an opportunity to help lay the foundation for the first long-term implantable continuous glucose monitoring system. I have spent my career exploring the treatment and management of diabetes to improve outcomes for patients. I believe in the clinical value the Eversense system provides and am eager to help patients and providers realize its benefits,” Kaufman said in a prepared statement.

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 Camber Spine Tech appoints Dickinson as sales & new biz dev VP

Camber Spine Technologies said last week that it appointed Ryan Dickinson as its new sales and new business dev VP.

Prior to joining King of Prussia, Penn.-based Camber Spine, Dickinson has held positions with Verticor Spine and Invictus Medical, which he helped found.

“After leaving corporate America in 2017 and moving to West Palm Beach I vowed never to return to it again. It only took a few interactions with the founders of Camber Spine to see that they had something truly special brewing. Once I saw the efficacy and revolutionary technology of their implants I was hooked. That coupled with the testimonials of my own doctors using their products, I wanted in, I needed to be a part of what they were doing.  There’s a sense of magic in their implants, a magic that is going to catapult them to limitless heights. I am very excited to join the Camber Spine team. I believe the potential for growth is tremendous given the smart and passionate people that I have already met in the company and a very strong brand portfolio including their two very exciting proprietary technology platforms Spira and Enza,” Dickinson said in a prepared statement.

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 Qure.ai taps former GE Health exec Singh as CCO

Qure.ai said last week that it named former GE Healthcare exec Chiranjiv Singh as its new chief commercial officer.

Prior to joining Qure.ai, Singh served in a number of marketing and sales roles with GE Healthcare including X-ray division chief marketing officer, the San Mateo, Calif.-based company said.

“Chiranjiv’s track record of delivering growth in diverse geographies combined with his recent experience of leveraging the power of artificial intelligence to deliver improved patient outcomes, is aligned to Qure.ai’s key objectives. Over the last 3 years, we have been on a mission to deploy our solutions in the emerging markets, including a strong focus on Tuberculosis, the leading infectious cause of mortality worldwide. Chiranjiv’s global experience will help us reach new markets and drive adoption globally,” co-founcer & CEO Prashant Warier said in a press release.

“I’m proud to join a team that has recently published its 5th peer reviewed journal publication in the last year, including the first AI publication in The Lancet. The data science teams from Qure.ai have also presented more than 20 scientific abstracts at leading Radiology conferences such as RSNA and ECR. While there are many companies building algorithms, the fact that we are one of the few AI healthcare companies that is backing up the technology with both academic and industry validations is proof of the quality of our solutions. I see a huge opportunity for market creation and growth by understanding clinical needs and embedding Qure.ai solutions into user workflows to deliver maximum impact. I’m excited to be part of this journey to deliver value to patients and our healthcare system,” Singh said in a prepared statement.

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 Aethlon Medical names Boswell as quality systems, regulatory affairs director

Aethlon Medical (NSDQ:AEMD) said last week that it appointed Lisa Boswell as its quality systems and regulatory affairs director.

Prior to joining San Diego-based Aethlon Medical, Boswell held positions in quality assurance and regulatory affairs at Zoll Data Systems as well as positions in quality control at GlobeImmune.

“Lisa’s leadership will be critical as we move the Hemopurifier through the next stages of development.  Given the recent designation of the Hemopurifier as a Breakthrough Device by the FDA, it is extremely important that robust Quality Systems and Manufacturing processes are in place to support ongoing development and planned clinical trials,” interim CEO Dr. Timothy Rodell said in a press release.

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