The Food and Drug Administration is once again the target of public ire over its seemingly glacial response to a U.S. consumer crisis. A recent story posted to Politico indicates that parents and their congressional representatives have begun raising serious questions about the amount of time that elapsed between the discovery of the first illness allegedly associated with infant formula contamination and the government’s response ...
FDA Under Fire Over Failure to React to Baby Formula Crisis
Posted March 22, 2022 in Product News and Recalls | Recall
Another Day, Another Story of the FDA Failing the American People
Posted August 31, 2021 in Drug and Medical Device Lawsuits | Product News and Recalls
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...FDA Tracking: What Good is a Database if the Data is Inaccurate?
Posted December 31, 2020 in Drug and Medical Device Lawsuits
A new report out of the Milwaukee Journal Sentinel calls attention to the fact that the FDA’s tracking of drug side effects; many of them dangerous, has been out of date, underreported, and inaccurate for upward of 60 years.
Created in 1960, the system was devised as a way of tracking adverse drug events once the products received their clearance and made it to market. Based ...
continue reading...Clinical Drug Trial Inspections Lacking Under Trump Administration
Posted October 31, 2020 in Drug and Medical Device Lawsuits | Product News and Recalls
In the first three years of the Trump administration, a grand total of 12 letters were sent by the FDA to drug makers warning them over violations found in their clinical drug trials. The agency’s warning letters are sent when the FDA notes violations of practice, procedure, or in some cases, law. In contrast, the first three years of the Obama presidency saw 99 such letters ...
When the FDA made the decision to give Johnson & Johnson’s diabetes drug Invokana a black box warning in 2017, one would like to believe that the decision was not made lightly. The boxed warning is the strongest warning the agency can issue for a drug on the US healthcare market and indicates that the product can pose grave risks to the consumer if used. There is ...
Medtronic Stapler Litigation Shows Ties to Secret FDA Database
Posted February 25, 2020 in Drug and Medical Device Lawsuits | Product News and Recalls
When news broke of an internal FDA database of medical device injuries so secret that few within the agency even knew of its existence, the discovery obviously led to the raising of a multitude of questions. Why was an agency tasked with keeping American families safe allowing the companies it was supposed to be regulating to hide reports of injuries caused by their devices? Why ...
