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 online…
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 gynecomastia associated with Risperdal. The jury awarded $2.5 million to Austin Pledger. Meanwhile, J&J’s “latest SEC filing says there are 4,200 Risperdal claims on dockets across the country.” All in all, author Stephen Brill argues, the Risperdal scandal raises concerns about regulation of drug manufacturers. Indeed, the company’s misconduct “would have gone unchecked” if not for the work of plaintiffs lawyers who “trudged through millions of documents.” The FDA “didn’t do that work.” Meanwhile, the “recent push from the bench, emanating from the Supreme Court, to expand the First Amendment rights of corporations could upend the core principle that a regulatory agency like the FDA can stop drug companies from spending whatever it takes to put their spin on what their products can be used for.”
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 (IVC) filters even after the company became aware that its filters were failing and causing death and other serious injuries at significantly high rates. The investigation alone revealed 27 deaths and more than 300 injuries related to the Bard Recovery model IVC filter. The people and injuries featured in this story are real. Their lives were affected in real ways, the same as many others might have been as well. If you are one of those people, please contact our office immediately to see how we might be able to help – (800) 269-3050.
Medical Device to Stop Blood Clots Associated With 27 Fatalities
Did Manufacturer of Medical Device Linked to 27 Deaths Ignore Safety Concerns?
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 risks of developing bladder cancer after using Actos. The filing further alleges that the defendants were specifically aware of these dangers prior to seeking approval to market Actos from the FDA in 1999. Finally, the court documents allege that Takeda continued to conceal this knowledge and willfully put the lives of the plaintiffs, as well as the general population, at risk by way of warnings on the product that were vague and inadequate.
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. from 2000-2011, FDA regulators are concerned that sufficient imaging and ion testing, to observe the metal’s effects on surrounding tissue, is not being performed.
Due to the higher rate of failure in metal on metal implants, as compared to other versions, regulators know that increased monitoring is necessary to observe the unique problems presented by these metal devices.