Category Archives: Medical Device

FDA Says Intuitive May Have Failed to Test Some Da Vinci Robots

The United Stated Food and Drug Administration said Thursday that the robotic surgical device manufacturer Intuitive Surgical Inc. may have failed to test some of its da Vinci robotic surgical system equipment in accordance with acceptable factory testing standards. According to the FDA, Intuitive has informed customers that 30 devices may not  reached compliance standards; the agency has called the action a “class 2 recall”  (“a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health…

Continue Reading....

Foreign Manufacturer of Surgical Masks Hit With FDA Warning Letter

The U.S. Food and Drug Administration (FDA) recently issued a warning letter to a manufacturer of surgical masks.  The manufacturer, located in Taiwan, was subject to inspection by the FDA that revealed numerous violations of the Federal Food, Drug, and Cosmetic Act (the act).  The FDA determined that the masks (medical devices) were adulterated and misbranded under the act. Violations included failure to conform with current good manufacturing practice requirements of the Quality System found at Title 21, Code of Federal Regulations (CFR), Part 820;…

Continue Reading....

Endo Settles Some Vaginal Mesh Lawsuits for $55 Million

An Endo Health Solutions (ENDP) Inc. agreed to pay $54.5 million to settle some lawsuits that allege that its vaginal-mesh implants eroded in some women and left them incontinent and in pain. Officials of American Medical Systems, Inc.,  (AMS) which manufactures vaginal-mesh devices, including Perigee, Apogee, and Elevate, said it was paying to resolve an undisclosed number of suits. Endo representatives earlier this years said that suits filed over the implants had risen to about 5,100.  Endo acquired AMS for $2.9 billion in 2011. Endo…

Continue Reading....

Intuitive Not Negligent in Training Doctor To Use da Vinci Robot

A jury in Washington State found Intuitive Surgical Inc. not negligent in the training of a doctor who performed surgery on a patient using its da Vinci robot surgical system.  The patient, Fred Taylor, later died. The jury in Port Orchard, Washington, reached their 10-2 verdict after a five-week trial.  It was the first of at least 26 lawsuits against Intuitive involving its da Vinci robotic system.  Taylor suffered multiple medical complications after surgery to remove his prostate gland in 2008 and died last…

Continue Reading....

Changing the Law on Federal Preemption of Medical Devices?

St. Jude Medical Inc. is at the center of a number of lawsuits about an allegedly defective implanted defibrillator.  The lawsuits allege that the Riata defibrillator had faulty leads which caused the devices to fail or deliver excess electricity.  The plaintiffs allege that 30 people died as a result. Plaintiffs see this lawsuit as a way to reach the Supreme Court and reverse its decision in Riegel v. Medtronic.  The governing precedent generally holds that state court product liability claims are preempted by federal…

Continue Reading....

DePuy Wins Second Hip Implant Trial

After a five-week trial, an Illinois jury made up of seven women and five men reached its verdict, just one day after it started deliberations, and it was in favor of the Johnson & Johnson subsidiary DePuy Inc. In Carol Strum v. DePuy Orthopaedics, plaintiff claimed that the ASR XL implant she received in 2008 had a defective designed that caused it to shed large amounts of debris from metal-on-meal ware and made it prone to premature failure. DePuy had argued over the course of…

Continue Reading....