Several years ago, the medical device company DuPuy Synthes issued a recall of over 50,000 elbow-joint replacement devices. The device, referred to as a radial head prosthesis system, is a two-piece elbow joint replacement implant that received clearance from the Food and Drug Administration (FDA)…
An investigation into Johnson & Johnson’s talc-based baby powder products suggest the company may have targeted sales toward minority women. A recently revealed internal memo from the company discussed how Johnson & Johnson could increase profits by targeting African American and Hispanic women. This memo…
As hundreds of injuries and multiple deaths have been directly attributed to various e-Cigarette products, the Food and Drug Administration (FDA) and the Center for Disease Control (CDC) are scrambling to investigate and craft a response. The only commonality among the reported cases has been…
An increasing number of health studies and lawsuits have started to appear that raise concern about the use of electronic cigarettes – or e-cigarettes. While e-cigarettes, like the popular brand JUUL, were initially praised as a way to quit smoking or reduce some of the…
Gilead Sciences Inc. is under scrutiny from 41 individuals who have taken HIV/AIDS medication made by the massive pharmaceutical company. These individuals, living with HIV/AIDS, had taken a TDF-based drug and PrEP medication that is thought to cause long-term damage to the kidneys and bones.…
The Roundup Weed Killer cases are mounting against Monsanto, a unit under pharmaceutical behemoth Bayer AG. There have been several verdicts reached but the one announced late Monday afternoon is by far the largest – $2 billion for a married couple who both used Roundup…
According to a recent NPR report, which you can find here, soldiers who have used 3M earplugs reported hearing loss in both ears, as well as a persistent hearing defect known as tinnitus. Veterans described the hearing effects of these injuries as, “a chorus of…
After increasing incidents of necrotizing fasciitis of the perineum reported among Type II diabetic patients taking sodium-glucose cotransporter-2 (SGLT2) inhibitors, the FDA is requiring the risk to be added to the prescribing information. The infection, commonly called Fournier’s gangrene, is rare but potentially lethal. The…
Although the FDA has announced that it is reconsidering and overhauling its current expedited approval process for medical devices, the agency has not made any similar announcements regarding updates on its drug approval process. The agency’s lack of action is concerning because the recall of medical drugs…
The FDA has announced that it is overhauling its system for approving medical devices. Under the current system, a manufacturer can rely on the safety information from similar products already on the market, which has led to companies using information from devices that were tested…
