Bayer AG recently agreed to pay $1.6 billion to settle claims by women in the United States involving its now-withdrawn Essure birth-control device. The settlement will resolve about ninety-percent of the nearly 39,000 lawsuits, which have been consolidated into courts in California and Pennsylvania.
Posts tagged "defective medical device"
On March 24, 2020, the FDA issued a warning alerting patients, caregivers, and health professionals that the auto-injectors in the EpiPen 0.3mg and the EpiPen Jr. 0.15mg, and the authorized generic versions, may have injection problems that can cause serious injury or death due to delayed treatment.
Michael Brassloff was 71 years old when he underwent surgery to remove a benign tumor at Thomas Jefferson University Hospital. During the procedure, the two-millimeter tip of a carbon dioxide-cooled laser probe snapped off after it was inserted through a hole in Mr. Brassloff's skull. As a result, the pressurized carbon dioxide drilled directly into Mr. Brassloff's brain. The force was eight times more powerful than that of a nail gun.
On February 1, 2019, a jury ordered Johnson & Johnson to pay $41 million to a Pennsylvania couple after the woman was injured by vaginal mesh. The woman, Suzanne Emmett, was implanted with the mesh in early 2007. Not long after, Emmett began experiencing complications with the mesh, when it began eroding through her soft tissues. She experienced discomfort, bleeding, infections, painful sex, and other symptoms. Despite having nine surgeries, in an attempt to correct the problems, Emmett continues to suffer from scarring and other permanent problems to this day.
Spinal-cord stimulators may be far more dangerous than previously understood, according to recent research. As part of a joint investigation into the medical device industry that involved more than 250 journalists and more than 50 news organizations, Associated Press research revealed that over 80,000 injuries involving the implantable devices had been reported to the U.S. Food and Drug Administration since 2008-the third-highest number for any type of medical device.
Inspections at 17 hospitals revealed widespread under-reporting of injuries and deaths associated with medical devices. The U.S. Food and Drug Administration is seeking to improve the under-reporting following the high profile safety concerns involving power morcellators and contaminated duodenoscopes.
Carla Warner, widow of Willie Warner, has sued the makers of a diagnostic instrument and the machine designed to clean it after her husband contracted a fatal infection. Olympus America Inc. and Custom Ultrasonics Inc. have been sued over the safety and reliability of their medical scopes and machines. The suit filed in federal court in Pennsylvania alleges fraud, negligence, and breach of warranty and asks for compensatory and punitive damages.
The U.S. Food and Drug Administration (FDA) issued another warning in regards to artery clearing tools. The devices are part of a new system used to open constricted arteries to help blood flow via cutting plaque from artery walls. In September. the FDA reported an incident where a wire piece from the component broke off and punctured a blood vessel, resulting in the patient's death. Two similar fatalities have also been reported in relation to the defective product. Several additional incidents have prompted emergency surgeries to retrieve dislocated parts. In one surgery the debris was unable to be extracted. Marlborough based Boston Scientific, the product manufacturer, issued a recall on October 9th.
The Recovery filter, a medical product used to prevent blood clots, has come under fire recently for being responsible for at least 27 deaths over the course of 10 years. The filter, a device inserted in the largest vein of the body, is prone to fragmentation and detachment, resulting in severe injuries and even death.
The company that manufactured the medical devices tied to a deadly "superbug" outbreak in California is being investigated by the United States Justice Department. The Associated Press reports Olympus Corp. of the Americas (an arm of Japan's Olympus Corp.) is being investigated for possible violations of false claims and anti-kickback laws.