Issue link: https://beckershealthcare.uberflip.com/i/1439613
31 DEVICES & IMPLANTS DePuy, J&J whistleblower case tossed over misuse of confidential files By Alan Condon A lawsuit accusing Johnson & Johnson and DePuy Orthopaedics of defrauding the gov- ernment by advertising defective hip replace- ment devices has been scrapped aer it was discovered that the plaintiffs misused confidential records, accord- ing to an order unsealed Dec. 8. Two orthopedic surgeons from the U.K. — who were expert witnesses in multidistrict litigation over the hip implants — violated court orders by using information from those cases in their whistleblower suit, according to U.S. Magistrate Judge Page Kelley, who presided over the case. Repeated attempts to hold Drs. Antoni Nargol and Da- vid Langton to their obligations "have proven futile, making dismissal the most appropriate sanction," the judge stated in the order. e surgeons filed the case against DePuy Orthopae- dics and Johnson & Johnson in 2012, claiming that a hip replacement implant in the "Pinnacle" portfolio was illegally promoted and sold by the company over a five-year period. Several devices allegedly fell outside FDA-approved manufacturing specifications, causing false claims to be submitted to Medicare and Medicaid. Since 2011, the Pinnacle implants have been the sub- ject of more than 5,000 personal injury suits. Johnson & Johnson was ordered to pay more than $1.5 billion in settlements in 2019, but other cases are still pending. Drs. Nargol and Langton served as expert witnesses in the Pinnacle litigation as well as lawsuits over DePuy's ASR hip implants when they filed the whistleblower suit under the False Claims Act in 2012. e judge said the surgeons were "chastised repeatedly" for not complying with court orders and failed to show whether information related to the Pinnacle implants — which they had access to through the lawsuit — was public and not confidential. Johnson & Johnson did not immediately respond to Becker's request for comment. n Dr. Stephen Hoschsuler among Premia Spine's 3 new board advisers By Carly Behm P remia Spine added three board advisers, including renowned orthopedic surgeon Stephen Hochschuler, MD, the device- maker announced Dec. 8 in a news release. Dr. Hochschuler is founder and chair emeritus of Plano-based Texas Back Institute. He was a past president and founding member of the International Society for the Advancement of Spine Surgery. Dr. Hochschuler is joined by Nicholas Pachuda, DPM, and Peter Wehrly. Dr. Pachuda is a medical device, biotech and orthopedics innovator and adviser. He was worldwide president of external innovation at Johnson & Johnson's medical device group, and he co-founded the extremities division at Arthrex. Mr. Wehrly is CEO of Vivex Biologics and has leadership experience at Medtronic, DePuy Orthopaedics and Covidien. All three will be involved in input supporting the commercial launch of Premia Spine's Tops System for degenerative spondylolisthesis and lumbar spinal stenosis. n Elon Musk's Neuralink implants could help patients with spinal cord injuries in 2022 By Carly Behm E lon Musk aims to use Neuralink implants in human patients in 2022, he told The Wall Street Journal in a Dec. 6 interview. Neuralink devices are awaiting FDA approval, Mr. Musk said in the interview. He added that the device is working well and can be safely used and removed in monkeys. In humans, Neuralink is expected to be first used in patients with spinal cord injuries, he said. "I think we have a chance with Neuralink to restore full-body func- tionality to someone who has a spinal cord injury," Mr. Musk said in the interview. Neuralink is Mr. Musk's surgical robot company and was founded in 2016. Brain chips have been tested in animals including a monkey and a pig. n