The U.S. Food and Drug Administration’s requirement that pharmaceutical companies report dangerous side effects cause by medicines they manufacture is being flouted by a few bad actors. Such violations of the federal law are rare, fortunately, but the fact that some are failing to follow it can spell danger […]
More than 1,200 pending lawsuits against Johnson & Johnson involving the company’s iconic baby powder and other products received a big boost when a Missouri jury awarded the family of an ovarian cancer victim $72 million in damages. The case of Jackie Fox, of Birmingham, Ala., who died in October […]
A new report criticizing pharmaceutical companies for releasing incomplete data about the side effects of certain medications should raise a red flag for consumers. The report, issued February 10, 2016, describes information required to be provided to the agency by drug manufacturers as “poor” because it contains holes in key […]
A gross discrepancy in the number of fetal deaths attributed to the birth control device Essure has prompted the U.S. Food and Drug Administration to analyze the data and decide whether to change the way the product is marketed. The agency has reported five fetal deaths – along with the […]
Ethicon Women’s Health & Urology, maker of the Gynecare Prolift Pelvic Floor Repair System, is appealing an $11 million verdict awarded to a South Dakota women injured by the defective mesh implant. According to the company’s lawyers, the damages should be stricken because of the learned intermediary doctrine. “It’s the […]
Cyber attacks have broken free from their initial molds of carting off with consumer credit card numbers or stealing someone’s identity. The act of digitally digging into cyberspace has hit the U.S. Department of Health & Human Services and some of its 11 government agencies. Instead of hackers hounding out […]
In 2004, North Carolina resident Melanie Cole was implanted with Mentor’s OB Tape, which is a sling device that is used to treat urinary incontinence. Three weeks after the surgery, Ms. Cole visited her surgeon and complained that it was not working properly, and that her incontinence was worse. Ms. […]
The Uphold Vaginal Support System is a transvaginal mesh product used to treat pelvic organ prolapse (“POP”). Marta Carlson sued Boston Scientific Corporation (“Boston Scientific”), the maker of the Uphold Vaginal Support System, and asserted that the device caused her to suffer chronic vaginal pain, difficulty during intercourse and incontinence. […]
The nominee for the top job at the U.S. Food and Drug Administration is being held hostage by Congress until the agency agrees to revamp its approval process for opioid painkillers. Sen. Ed Markey, D-Mass., has led the delay in appointing Robert Califf to the position of commissioner until the […]
One of the foremost father figures in the history of medicine famously said, “There are in fact two things, science and opinion; the former begets knowledge, the latter ignorance.” Hippocrates, the ancient Greek physician revered for high ethical and moral standards that are the reason every doctor in America pledges […]
