The FDA today asked the public to submit comments on how devices that contain certain materials should be labeled. The materials are ones to which patients have long-term exposure — contact time exceeding 30 days — and that have presented “high-profile safety concerns,” according to the agency. They include female sterilization devices, metal-on-metal hips and […]
metal-on-metal hips
Zimmer Biomet wants federal court to throw out $3.55M hip implant judgment
Zimmer Biomet (NYSE:ZBH) wants either a judgment or a new trial after a federal jury’s $3.55 million award in a metal-on-metal hip implant case. The jury awarded the money to Lori Nicholson and her husband Willis in November for injuries sustained as a result of the M2A Magnum. In a brief filed Feb. 12, Zimmer Biomet claimed […]
Report: Johnson & Johnson to settle metal-on-metal hip cases for $1B
Most of the remaining metal-on-metal hip cases facing Johnson & Johnson (NYSE:JNJ) subsidiary DePuy could reportedly be settled for about $1 billion. The deal, which includes a prior $400 million settlement, covers about 95% of the 6,000 cases involving Pinnacle hip implants that had to be removed, Bloomberg reported, citing two “people with knowledge of […]
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 […]
FDA chimes in on off-label use, preemption in Smith & Nephew hip suit
The FDA last week chimed in on a lawsuit brought against Smith & Nephew (NYSE:SNN) by a patient whose surgeon used the company’s hip implants off label, arguing that federal law preempts most tort claims even when medical devices are used outside of their indications. Plaintiff Walter Shuker was implanted with components from Smith & Nephew’s […]
Plaintiff wins new trial in DePuy ASR XL hip suit
The plaintiff in a product liability lawsuit brought against Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes won a new trial after an Illinois state court found that a joint replacement researcher’s testimony was unfairly excluded from her original trial. Carol Strum lost her first trial in April 2013 after a Chicago jury rejected her claims that the company, […]
Failure to thrive: Lessons learned from medtech innovations that missed the mark
Some of the medical device industry’s most heralded disruptors wound up being its biggest failures. Here’s what we can learn from their mistakes. Fink Densford, Associate Editor No one in medtech sets out to fail. No one invests in building a device believing that, despite years of research and development, it won’t make the cut. […]
Stryker Q4 earnings take hit from recalled hip implants
Stryker’s profits decreased 2.3% year-over-year in the fourth quarter, to $510 million, amid charges related to its recalled Rejuvenate or ABG II modular metal-on-metal neck hip stems, as well as expenses related to restructuring and acquisition costs. Earnings per share were $1.34, down 2.9% year-over-year, the company reported Tuesday evening. Excluding the charges, Stryker’s profits would […]
