The U.S. Food and Drug Administration (FDA) wants to remind the public what a good job it’s been doing in monitoring drugs both before and after they are marketed. In a report issued over the weekend, April 21, “Advances in FDA’s Safety Program for Marketed Drugs,” the agency pats itself […]
Author: Cal Warriner
We now have a better idea of how one synthetic mesh medical device maker, American Medical Systems, Inc., plans to defend itself against the 318 lawsuits that have been consolidated in the Southern District of West Virginia before The Honorable Joseph R. Goodwin. In a Position Statement, issued and filed […]
The “antipsychotic” class of drugs is distributed liberally in nursing homes. Antipsychotics including Risperdal, Seroquel, Zyprexa, and Abilify, are frequently given to the elderly who are suffering from dementia so they are easier to control. It’s a handy tool in a nursing home that is understaffed and needs to find […]
The Mentor ObTape Sling is a transobturator vaginal sling, which was manufacturer by Mentor Corporation and was implanted in thousands of women to treat Stress Urinary Incontinence (SUI). Mentor’s ObTape replaced Mentor’s Uratape product. Uratape performed so poorly that Mentor quit selling it after an embarrassingly short time on the […]
We hear from them every day – consumers who trust and believe their doctor only to find out things like what Consumer Reports (CR) investigates in its May issue. Surprisingly, the majority of medical devices never have to pass through any sort of safety and efficacy standard with the Food […]
Johnson & Johnson (J&J) rarely responds to negative news, which it’s been experiencing a lot of lately, usually relying on the news cycles to wash away unfavorable reports. But in an unusual move, a J&J spokesman recently did defend the company from the latest blow – that the health care […]
If I sell you a product and make a profit from selling that product; do I owe a duty to you for the reasonable safety of that product? Most reasonable people would agree that a company should not be permitted to simply ignore the safety of products it profits from […]
The Mass Tort Unit at Searcy Denney recently filed an individual lawsuit against Davol, Inc., a division of C.R. Bard. in Broward County on behalf of a Margate, Florida resident. This South Florida woman underwent a hernia repair surgery in November of 2005 and was implanted with a Composix Kugel […]
A recently unsealed complaint filed by whistleblower Helen Ge reveals that over four years, Takeda Pharmaceuticals failed to report to the FDA congestive heart failure cases in patients taking Actos. Takeda manufactures the Type II diabetes drug Actos. Actos is the third in a long line of failed Type II […]
Published today in the Journal of Neurosurgery is a shocking report detailing the death of an elderly gentleman who had begun taking Pradaxa (Dabigatran) just one month earlier. Three University of Utah doctors (Garber, Sivakumar and Schmidt) report that the man died from catastrophic, irreversible brain hemorrhage after suffering a […]
