A Philadelphia jury has awarded $13.5 million to Sharon Carolino who claimed permanent damages from an Ethicon TVT midurethral sling mesh implant. This was the second verdict against Johnson & Johnson’s Ethicon unit in a pelvic mesh case. In December a jury awarded $12.5 million against J&J for injuries caused by another mesh product, the Ethicon ProLift pelvic organ prolapse repair kit.
St. Jude Medical sent a letter to doctors in November advising that several hundred of its Optisure dual-coil defibrillator leads may not work because of damaged insulation on the leads. The insulation on the leads may have been damaged during the manufacturing process. The Optisure lead recall was then announced by the FDA and classified as a Class 1 Advisory. A Class 1 recall means the FDA believes using one of the devices could result in serious health consequences.
A new lawsuit accuses transvaginal mesh manufacturer Boston Scientific of smuggling counterfeit pelvic mesh from China. Boston Scientific is charged with intentionally defrauding and endangering women by secretly importing defective polypropylene resin that wasn’t approved by the FDA.
Popular acid reflux drugs like Nexium, Prilosec, and Prevacid — classified as Proton Pump Inhibitors (PPIs) — may lead to an increased risk of chronic kidney disease, according to a recent study published in JAMA Internal Medicine.
The FDA has issued a final order reclassifying transvaginal mesh used to repair Pelvic Organ Prolapse (POP) from class II (moderate-risk) to class III (high-risk). The FDA will also require manufacturers of every surgical mesh used to treat POP to conduct a PreMarket Approval application demonstrating the safety and effectiveness of their mesh product for treating POP. Manufacturers have 30 months — two and one half years — to show that their products are safe and effective for POP. These new FDA orders do not apply to mesh sold for Stress Urinary Incontinence (SUI) or abdominal repair.
Senator Ed Markey of Massachusetts released a report sharply critical of schools across the country – including schools right here in Massachusetts – for failing to comply with federal laws meant to safeguard against the hazards presented by airborne asbestos in schools. The report, ‘Failing the Grade: Asbestos in America’s Schools’, reveals that most schools are not aware of all the asbestos in place in their buildings.
In a follow-up to its September report on 27 deaths associated with the C.R. Bard “Recovery” IVC blood clot filter, NBC News reports that Bard knew that its G2 Series IVC filters — intended to replace the company’s Recovery filter — also “had similar and potentially fatal flaws soon after it was put on the market.” NBC obtained internal Bard records showing that Bard was concerned about reported failures of the G2 Series filters just four months after they were approved by the FDA.
By Leah M. McMorris and Evan R. Hoffman Calls to poison control centers regarding e-cigarette and vaping liquids have risen dramatically over the past four years. In 2013, over 1,000 calls linked to liquid nicotine exposure were reported in the United States. In 2014,...
An Indiana woman was awarded $12.5 million dollars against Johnson & Johnson’s Ethicon unit in damages for the injuries she suffered from their ProLift transvaginal mesh implant. The Court of Common Pleas jury awarded $5.5 million dollars in compensatory damages and added $7 million dollars in punitive damages to punish Johnson & Johnson for recklessly marketing the device.
A study published in Environmental Health Perspectives found the presence of diacetyl, a buttery-tasting flavoring chemical linked to lung disease, in more than 75 percent of flavored electronic cigarette and refill liquids tested. Many of the tested flavors containing diacetyl were also found to contain two additional chemicals designated by the Flavor and Extract Manufacturers Association as respiratory hazards in the workplace. Diacetyl first became infamous in the early 2000s, when workers in microwave popcorn processing facilities were diagnosed with a serious obstructive lung disease known as bronchiolitis obliterans.
A federal jury in Georgia awarded $11 million to plaintiff Robyn Christiansen in the first Wright Conserve metal-on-metal hip implant bellwether trial. After a two-week trial and three days of deliberations, the jury ruled that the Conserve hip implant was defectively designed and unreasonably dangerous, and that manufacturer Wright Medical had mislead the plaintiff as to the product’s safety.
Boston Scientific has recalled the RotaWire Elite Guidewire and wireClip Torquer Guidewire components of its Rotablator Rotational Atherectomy System. The company received three reports of wires fracturing, one during preparation of the device, and two during actual surgeries. The fractures during surgery resulted in migration of the wire, puncturing the pericardium surrounding the heart. One patient died during surgery to remove the broken wire.
