Recent safety communications published by the US Food and Drug Administration indicate that type 2 diabetes drug, Invokana (canagliflozin), can cause increased risk for foot and leg amputations. This announcement was made after data from two clinical studies showed that such amputations were necessary in nearly twice as many patients taking Invokana as compared to […]
Olympus issued a recall of its TJF-Q180V duodenoscope model in January 2016, after reports linked the device to multiple outbreaks of Carbapenem-resistant enterobacteriaceae (CRE), a form of antibiotic resistant infection that is difficult to treat, and often fatal. Further investigation into the incidents revealed that at least 35 people died after suffering infections linked to […]
In early March, the Center for Disease Control and Prevention (CDC) released a report that indicated an increase in the mortality and the morbidity of individuals diagnosed with Mesothelioma. Mesothelioma is an aggressive and rare form of cancer that has been linked to asbestos exposure. The disease affects the lining of the lungs, or the […]
The medical device liability attorneys at The Law Offices of Peter Angelos provide important health-risk information related to heater-cooler devices. Nearly sixty percent of hospitals in the United States use heater-cooler systems to maintain internal body temperature and consistent blood circulation during invasive surgical procedures—approximately 250,000 procedures each year. However, recent reports suggest that the […]
Zimmer Biomet has issued a Class I recall for its Comprehensive Reverse Shoulder as the devices have exhibited higher rates of fracturing than previously stated. In December 2016, Zimmer Biomet issued an Urgent Medical Device Recall Notice to customers who may have undergone surgery in which a Comprehensive Reverse Shoulder was implanted. This recall has […]
On February 2, 2017, the Food and Drug Administration (FDA) issued a warning regarding reports of rare but serious allergic reactions on the skin of individuals who have used over-the-counter (OTC) products containing chlorhexidine gluconate. The FDA has requested that manufacturers, which produce antiseptic containing the ingredient, issue a warning detailing the risk on the […]
Last month, a Texas jury awarded more than $1 billion in damages to plaintiffs who claimed they suffered injuries after receiving DePuy Pinnacle metal-on-metal hip implants. Metal-on-metal hip implants, such as the DePuy Pinnacle implants, are surgical devices used during hip replacement surgery that have been claimed to be more durable and provide a greater […]
Over the past two years, Takata has remained at the center of the largest automobile vehicle recall ever recorded in the United States. This is because the airbags that the manufacturer produces, which are standard in over 45 different models of cars made between 2000 and 2008, were found to be defective and potentially dangerous […]
UPDATE: On January 17, 2017, the United States Food and Drug Administration updated safety information regarding the Pentax ED-3490TK video duodenoscope. Within this update, the FDA warned consumers that the device had the capacity to crack—making the transfer of fluids and bacteria to the device possible. Similar to other duodenoscope devices, the Pentax device can […]
In November, 2015, the U.S. District Court for the Eastern District of Louisiana announced that the first of the Xarelto® bellwether trials, stemming from the Xarelto® multidistrict litigation, would begin in February, 2017. Since that announcement, there have been many updates in the ongoing legal battle against Xarelto® manufacturer Bayer AG and distributer Janssen Pharmaceuticals. […]