As the delta variant of the COVID-19 pandemic sweeps through largely unvaccinated swaths of populations around the world, certain Philips ventilators and other breathing apparatuses have been pulled from service for a failure to function properly. The severity of the failure has earned the recall a Class I status from the U.S. Food and Drug Administration which is reserved only for the direst of circumstances where continued use of ...
continue reading...Another Day, Another Story of the FDA Failing the American People
In a narrative that has become all too familiar when referring to one of the most openly corrupt institutions in the American government, reports have surfaced that the FDA knowingly allowed a faulty medical device to make its way into unwitting patients. This time the device in question is quite literally responsible for keeping patients’ blood circulating through their bodies.
The HeartWare Ventricular Assist Device, or HVAD ...
continue reading...Philips Device Recall Expands with Cancer Risk Warnings
As electronics manufacturer Philips struggles to cope with its second medical device recall of the year, the news regarding its first recall has just gotten significantly worse. Earlier this year, a variety of Philips ventilators, BiPAP, and CPAP machines were taken out of service and recalled over concerns that the sound-deadening foam used to insulate the machines and make them quieter could enter the breathing circuit and allow ...
continue reading...Florida Zantac Decision Likely to Have Major Impact
A U.S. District Court judge in Florida recently dismissed a number of claims against generic manufacturers of Zantac products, as well as various packagers, retailers, and distributors of the products. Ranitidine is the active ingredient in the heartburn medications and is at the center of a firestorm of controversy over concerns of contamination with a carcinogenic compound called N-nitrosodimethylamine, or NDMA.
Thousands of plaintiffs across ...
continue reading...St. Jude to Settle Defibrillator Allegations for $27 Million
“The government contends that St. Jude knowingly caused the submission of false claims and failed to inform the FDA with critical information about prior injuries and a death which, had the FDA been made aware, would have led to a recall.” These words from Acting United States Attorney Jonathan Lenzer merely scratch the surface of the horrors inflicted on unwitting patients by a company that continue reading...