This article has been updated with a link to the FDA webcasts of the proceedings. An FDA panel will meet this week to discuss immunological responses to medical device implants made of metal, including artificial hips and the Essure permanent birth control device. The Immunology Devices Panel of the agency’s Center for Devices and Radiological […]
Have government scientists solved the artificial hips corrosion problem?
Argonne National Laboratory researchers tested metal alloys that ortho device companies have used in artificial hips for decades. Materials scientists at the U.S. Department of Energy’s Argonne National Laboratory usually test metal alloys for their ability to contain nuclear waste for millions of years. A couple of years ago, two of them decided […]
The grim stories behind seven of medtech’s worst failures
Medical devices save or restore thousands of patient lives every year, but the dark side to medtech innovation is increasingly drawing attention. For all the good the industry does, it’s worth remembering that the costs can be high – even fatal – when medical device companies don’t get things right. The examples range from women […]
FDA ramps up scrutiny of materials in medical devices
The FDA said today it has begun more closely scrutinizing the roles of certain materials associated with harm to patients who have breast implants, nitinol-containing devices, metal-on-metal hip implants and devices made from animal-derived substances. It’s the latest in a series of statements the agency has issued following increasingly harsh public criticism of its efforts […]
Is the medical device industry endangering people?
The highly critical “Implant Files” report overseen by the International Consortium of Investigative Journalists skewers the medtech industry as a whole and singles out particular companies and regulatory agencies for more intense scrutiny. The Implant Files is the second large-scale swipe at the medtech industry this year, following Netflix’s documentary, The Bleeding Edge. It includes six stories about […]
Stryker, plaintiffs to settle hip implant cases
A Massachusetts federal judge last week stayed the multi-district litigation brought over hip implants made by Stryker (NYSE:SYK) so that the company and lawyers representing thousands of plaintiffs can hash out a settlement. Judge Indira Talwani of the U.S. District Court for Massachusetts, who is overseeing one of the MDLs, stayed discovery through July 31, 2019, “so […]
Netflix’s ‘The Bleeding Edge’ blasts medtech & FDA
Netflix has unleashed a blistering indictment of the medical device industry, the FDA and doctors who accept money from medtech in its new documentary, ‘The Bleeding Edge,’ released today. The film depicts people who have suffered injuries and/or illnesses following placement of Bayer’s Essure sterilization device, Johnson & Johnson’s vaginal mesh, various manufacturers’ metal artificial […]
Wright Medical, plaintiffs extend deadline for $90m metal-on-metal hip settlement
Balky insurance companies delayed a final settlement between Wright Medical (NSDQ:WMGI) and the plaintiffs in product liability lawsuits brought over its metal-on-metal hip implants, according to a regulatory filing. Last October Wright agreed to an $89.8 million deal resolving any metal-on-metal hip claims not covered by a previous, $240 million settlement. But the new agreement was contingent on a $35 […]
Report: Justice Dept. closes tampering probe in Johnson & Johnson hip case
The U.S. Justice Dept. reportedly closed its probe into alleged witness tampering in a bellwether trial over the Pinnacle metal-on-metal hip implants made by Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics. In October a federal judge in Texas took the unusual step of asking federal prosecutors and the FBI to probe the possible witness tampering. Mark Lanier, lead attorney […]
Report: India eyes penalties for Johnson & Johnson over metal-on-metal hips
Johnson & Johnson (NYSE:JNJ) could reportedly be on the hook again for the metal-on-metal hip implants it pulled from the market in 2010, this time in India and for much less than it’s cost the company elsewhere. The world’s second-largest medical device maker has fielded numerous lawsuits about its ASR metal-on-metal hip replacement since it pulled the ASR XL […]
Johnson & Johnson lawyers deny tampering allegations in hip case
Lawyers for Johnson & Johnson(NYSE:JNJ) in a bellwether trial over metal-on-metal hip implants made by J&J subsidiary DePuy Orthopaedics yesterday denied witness tampering allegations leveled by the lead plaintiff’s attorney. Last week a federal judge in Texas took the unusual step of asking federal prosecutors and the FBI to probe the possible witness tampering. Mark Lanier, lead attorney […]
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