medical device product liability News

FDA Vows Overhaul of Medical Device Approval System

U.S. health officials said this week they plan to overhaul the nation’s decades-old system for approving most medical devices, which has long been criticized by experts for failing to catch problems with risky implants and medical instruments. The Food and …

FDA Cites Hospitals for Under-Reporting of Injuries from Medical Devices

The U.S. Food and Drug Administration is seeking to improve hospital reporting of injuries and deaths associated with medical devices after inspections at 17 hospitals revealed widespread under-reporting of such events. The FDA initiated the inspections following high-profile safety scandals …

Pelvic Mesh Maker Alleges Doctors, Lawyers, Litigation Funders Schemed to Inflate Damage Claims

American Medical Systems, a major defendant in litigation over controversial vaginal mesh devices, is accusing “a pyramid of businessmen, doctors and lawyers” of luring women into unwarranted surgeries to remove the implants and inflate their damages claims. The company, a …

Delaware Judge Slashes $100M Boston Scientific Mesh Verdict to $10M

A Delaware judge on Oct. 9 said Boston Scientific should only have to pay $10 million to a woman originally awarded $100 million by a jury who found she was injured by transvaginal mesh, a device that is the subject …

Boston Scientific Ordered to Pay $100M to Delaware Woman

A Delaware jury has ordered a medical device manufacturer to pay $100 million to a woman who, despite two surgeries, still has pieces of transvaginal mesh embedded inside her. The News Journal of Wilmington reports the 51-year-old Newark woman was …

ACE Expands Life Sciences Coverage through Wholesale Division

ACE Group has expanded its suite of products developed to address the needs of U.S.-based life sciences companies through its wholesale-focused business, ACE Westchester Professional Risk. The ACE Westchester Professional Risk Life Sciences policy addresses the exposures faced by life …

Technical and Medical Device Convergence Exposes New World of Risks

When the acclaimed television drama series Homeland climaxed with a devious plot by terrorists to kill America’s vice-president by hacking into his electronic pacemaker, critics mocked the ludicrousness of the idea deeming it as simply far-fetched fiction. However, the storyline …

J&J Reaches $4 Billion Settlement of Hip-Implant Suits: Sources

Johnson & Johnson will pay more than $4 billion to resolve thousands of lawsuits over its recalled hip implants in the largest settlement of U.S. legal claims for a medical device, three people familiar with the deal said. The accord …

Marketing, Not Medicine, Boosts Robotic Surgery, Misrepesents Safety

Porter Adventist Hospital in Denver announced last year that Warren Kortz, a general surgeon on the medical staff, was the first in the Rocky Mountain region to use a technique known as robotic surgery to remove gall bladders through one …

Supreme Court Shows Interest in Medical Device Liability Laws

The U.S. Supreme Court expressed interest in Medtronic Inc.’s appeal in a lawsuit by a man who was rendered a paraplegic after surgeons implanted a system that infuses pain medication into the spine. The justices today asked the Obama administration …