On January 29th, the FDA revised Penumbra’s Urgent Voluntary Recall of the Jet 7 Catheters with Distal Tip. The FDA has received over 200 reports of adverse reactions to their Medical Device Reporting system (MDRs) including death, serious injury and malfunctions. Serious injuries have been described as vessel damage, hemorrhage, […]
FDA
10 posts
The U.S. Food and Drug Administration is putting a stop to the use of a number of common ingredients in antibacterial soaps and washes because there is no evidence those products are safe for long-term use or more effective than plain soap. Read more here in the New York Times […]
In the 15th and final chapter of its series on Johnson & Johnson’s Risperdal (risperidone), the Huffington Post (10/2) “Highline” recounts how the jury in the Pledger case handed down its verdict Feb. 24, 2015, finding J&J was negligent by failing to provide an adequate warning about the risk of […]
In the past few weeks, more information has come to the public’s attention as C.R. Bard IVC filters were featured in a two-part NBC Nightly News segment. The year-long investigation raises more serious questions about why medical device manufacturer C.R. Bard continued to sell and market its inferior vena cava […]
By Cindy L. Nations UPDATE: March 24, 2014 : Ever since the 2011 Supreme Court ruling in Pliva, Inc. v. Mensing, the American Association for Justice has been working to close the generic drug accountability loophole which largely immunizes generic drug manufacturers from liability for injuries caused by their products. […]
Posted by Buck Daniel November 7, 2012 – A consolidated complaint was filed by 12 plaintiffs, who claim to have been diagnosed with bladder cancer as a result of using Actos, on August 14, 2012. Specifically, the court documents allege that the defendants, Takeda Pharmaceuticals, should have known about the […]
Posted by Buck Daniels July 5, 2012 – The Food and Drug Administration has suggested that metal on metal hip implants need closer, more consistent monitoring in order to cut down on high failure rates. Because the metal devices have been linked to almost 16,800 adverse events in the U.S. […]
June 6, 2012 – Johnson and Johnson has announced that its Ethicon unit will end sales of most of its vaginal mesh implants which are the subject of hundreds of lawsuits claiming the implants are defective and dangerous. It is expected that it will take several months for the products […]
June 1, 2012 – American Association for Justice Trial Magazine June 2012 Drugs & Devices: How Big Pharma Puts Patients at Risk “Bad Actos” by Howard L. Nations and John M. Restaino “The safety of Actos, an oral diabetes drug that increases the body’s sensitivity to insulin, has been increasingly […]
By Amber Stanford May 26, 2012 – The FDA has recently recognized a new study released in the issue May 17, 2012 of the New England Journal of Medicine that reports a small increase in cardiovascular deaths, and in the risk of death from any cause, in persons treated with a […]