It really doesn’t sound like a question we need to be asking because it should be a matter of common sense. Shouldn’t any medical device that is permanently implanted in the human body be put through a high degree of scrutiny for safety and efficacy so we don’t have to test it […]
Author: Cal Warriner
Testosterone is the new big drug on the market. Marketed to men with low T, a vague illness with even vaguer symptoms, there has been a recent explosion in its use. In line with this explosion are also the vast amounts of ways one can take testosterone, either as a […]
A major move toward public safety may be one step closer with the U.S. Food and Drug Administration announcing this week that it will put a proposal out for public comment that would reclassify pelvic organ prolapse (POP) mesh from moderate to high risk. If approved, that move would require […]
There appears to be no shortage of advertising for testosterone products for men to relieve low sex drive and fatigue. But these products remain without any warning on the product labels despite a recent study that showed the risk of heart attack is doubled in men taking Low-T supplement products. The […]
This news is not surprising to anyone who pays attention to medical device recalls. There has been a substantial jump in medical device recalls – up 97 percent over the last decade! This news comes from the division within the U.S. Food and Drug Administration (FDA) that regulates medical devices. […]
Shareholders have sued the maker of a surgical robot claiming the company has “grossly underreported” injuries and deaths attributed to the da Vinci. The 67-page shareholder derivative complaint was filed by the city of Birmingham and Alabama’s Relief and Retirement System naming Intuitive Surgical of Sunnyvale, California, the maker of […]
Johnson and Johnson (J&J) and its subsidiary Janssen Pharmaceuticals have been dealing with multiple lawsuits stemming from its drug Risperdal. Shortly after dodging a $1.2 billion judgment in Arkansas, J&J has returned its focus to the multidistrict litigation (MDL) currently pending in Pennsylvania. The company is now trying to shield […]
Congratulations, Brenda! We’ve reprinted the article below. Reprinted with permission of Trial (March 2014) Copyright American Association for Justice, formerly Association of Trial Lawyers of America (ATLA®) Gender equity in the law March 2014, Volume 50, No. 3 Sidebar: Brenda Fulmer: Working hard and staying true Courtney L. Davenport When […]
Doctors and physicians are given a great deal of discretion when it comes to prescribing drugs for uses other than those indicated by the FDA. This is known as “off-label” use. The FDA, realizing the danger of off-label promotion in its 2009 guidance, has set forth rules to restrict the […]
While it is not official, Bloomberg is reporting that Coloplast A/S, one of the smaller manufacturers of transvaginal meshes, is said to be willing to settle a number of lawsuits for $16 million. Three different individuals tipped the news outlet, but none were reportedly authorized to speak. The Danish company […]
