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.”

Ethicon seeks data on Neuwave liver ablations


Ethicon’s Neuwave is a target ablation tool for small to large lesions, as well as a resection tool. (Image from Ethicon)

Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said it has launched a global registry to collect and analyze real-world data on patients with soft tissue liver lesions ablated with the company’s Neuwave microwave ablation system.

The multicenter, observational registry will follow approximately 1,500 patients worldwide for five years from the date of their first liver ablation procedure with the Neuwave system, a minimally invasive microwave ablation technology that uses heat transmitted through image-guided needle-like probes to destroy soft tissue lesions.

The company will collect data from up to 30 centers throughout the world on the technical aspects of the procedure, including ablation time under varying liver tissue and lesion conditions. Efficacy and other outcome data will also be documented and assessed at various time points over the course of the study, according to the company, which announced the registry at the Society of Interventional Radiology (SIR 2019) meeting in Austin, Texas.

Neuwave is a minimally invasive system designed to enable physicians to tailor ablations for lesions of varying shapes and sizes with consistency and control, according to Ethicon. Most patients leave the hospital the same day with only a bandage at the probe insertion site, according to a 2014 study published in the Journal of Vascular Interventional Radiology.

“The goal of the registry is to systematically and comprehensively develop ablation parameter guidance for the microwave ablation of liver lesions with the Neuwave system,” said University of Wisconsin School of Medicine and Public Health interventional radiologist Dr. Paul Laeseke in a prepared statement.

“Microwave ablation is an important treatment option that is increasingly being utilized throughout the world, and this data may provide new insights into factors that are critical for successful outcomes across a range of patients, clinical settings and health care providers,” added Laeske, who consulted on the registry’s design. “The registry will be an important contribution to our understanding of microwave ablation and support its further adoption.”

The registry will also include data from consenting patients enrolled in other Ethicon-sponsored studies on microwave liver ablation with the Neuwave system in Korea and China and a multicenter study that is evaluating the device using Neuwave’s ablation confirmation software, which is designed to help physicians identify ablation targets, assess appropriate probe placement and confirm the technical success of each procedure.

“Microwave is the fastest growing ablation modality, and as this treatment grows, Ethicon is committed to working with clinicians throughout the world to generate robust clinical evidence for the innovative Neuwave microwave ablation system,” said Piet Hinoul, global head and leader of Ethicon’s medical and clinical franchise. “This will help inform treatment decisions and improvements in procedural efficiency and patient outcomes.”

Neuwave is cleared for the ablation of soft tissue in percutaneous, open surgical and in conjunction with laparoscopic surgical settings, including the partial or complete ablation of non-resectable liver tumors. It is not cleared for the treatment of any specific disease or condition and is not indicated for use in cardiac procedures.

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Philly jury hits J&J’s Ethicon with $41m judgment in pelvic mesh case

gavel, legal

Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon has been hit with a $41 million verdict in a pelvic mesh product liability suit in Philadelphia, according to a report from the Mesh News Desk.

A jury in Philadelphia found that Ethicon’s Gynemesh, Prolift and TVT-O meshes were defective, and that the company was negligent in manufacturing the devices, according to the report.

The plaintiff, Suzanne Emmett, was implanted with a Prolift pelvic mesh to treat pelvic organ prolapse, a TVT-O mesh as a treatment for incontinence and a Gynemesh implant, according to the Mesh News Desk report.

The verdict includes $25 million in punitive damages, $15 million in compensation and $1 million to Emmett’s husband, according to the report.

The company has not yet commented officially on the case, and has not stated if it plans to appeal the decision.

Last November, a state judge in Pennsylvania ordered a new trial in a suit alleging a that a woman was injured by Ethicon’s TVT-Secur pelvic mesh implant.

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J&J’s Ethicon touts surgical staplers study

J&J Johnson & Johnson Ethicon Echelon Flex GST system

Ethicon’s Echelon Flex GST system [Image courtesy of Ethicon]

Johnson & Johnson’ Ethicon business is promoting the results of a head-to-head study between an Ethicon surgical stapler and a Medtronic stapler system.

Ethicon’s Echelon Flex GST system had a 20% staple-line air leak rate when tested out on pig lungs under modeled physiologic breathing conditions, versus a 44% rate for Medtronic’s Endo Gia with Tri-Staple technology.

Ethicon funded the research, which is being announced this week at the 2019 Society of Thoracic Surgeons annual meeting in San Diego.

Get the full story on our sister site Medical Design & Outsourcing.

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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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Auris Health, Ethicon’s NeuWave ink robot-assisted bronchoscope ablation dev deal

Auris Health, previously known as Auris Surgical Robotics, said today it inked a cooperative development and commercialization deal with Johnson & Johnson (NYSE:JNJ) division Ethicon’s NeuWave Medical subsidiary looking to develop systems for the robotically-assisted bronchoscopic ablation of lung lesions.

Through the agreement, both companies will help develop an integrated system for robotic control, navigation and application of bronchoscope-delivered microwave ablation. The bronchoscope in development will be equipped with a small camera and accessory channel to allow tools to enter the lungs through the mouth, Auris said.

“For those treating people with suspicious nodules in the lung, the holy grail is to one day be able to detect and treat the disease in a single procedure. When this option becomes a reality, we may see many patients seek early screening and minimally invasive treatment,” Dr. Kazuhiro Yasufuku of the University of Toronto said in a prepared release.

The development deal also covers tech optimization and procedure development, Redwood City, Calif.-based Auris said.

“From the beginning, our vision has been to create a platform capable of enabling advanced diagnosis and therapy for a spectrum of disease, using the least-invasive approach. We are honored to have Ethicon as a partner. Through this collaboration, we believe we are taking a significant first step together toward making the goal of diagnosing and treating lung cancer, all through the body’s natural openings, an eventual reality,” Auris co-founder & CEO, and former founder of Intuitive Surgical (NSDQ:ISRG), Dr. Frederic Moll said in a press release.

In March, Auris Health said it won FDA clearance for its Monarch robotic endoscopy platform.

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Johnson & Johnson break ground on Chinese factory


Johnson & JohnsonJohnson & Johnson‘s (NYSE:JNJ) Ethicon subsidiary has broken ground on a new factory in China’s Jiangsu province, according to a report from China Daily.

The new $180 million factory will produce devices including triclosan-coated sutures, endoscopic staplers and linear cutters, according to the report.

The groundbreaking marks Johnson & Johnson’s first foray into producing minimally invasive and open surgical solutions in China, and is the 1st facility of its kind outside of the US, China Daily reports.

The planned 60,521 square-foot facility will open in 2 phases, with the 1st operations beginning in the fourth quarter of 2018 and the second in the third quarter of 2020, according to the report.

Johnson & Johnson will also look to localize its procurement process for the facility and “support local partners to upgrade their technological and management standards,” China Daily reports.

Yesterday, Johnson & Johnson said it launched the Health Partner platform designed to improve preparations and recovery from knee, hip and weight loss surgeries through personal motivation.