By the end of the year, the U.S. Food and Drug Administration (FDA) had stated it would make sure that high-risk medical devices were approved through the most stringent premarket approval (PMA) review process to assure the safety of consumers. But it looks as though that will not happen. High-risk […]
Category: Blog
The U.S. Food and Drug Administration announced this week it has formed a collaboration with medical device manufacturers in order to speed up the development and approval of devices. The nonprofit group is called the Medical Device Innovation Consortium (MDIC) and is made up of industry, academics as well as […]
Boehringer Ingelheim, a German drug company and maker of the blood thinner Pradaxa, must pay the federal government $95 million in compensation for defrauding Medicare. The government charged that Boehringer Ingelheim promoted their drug “off label” meaning for uses they had not received regulatory approval by the U.S. Food and […]
With about 7,700 pharmacies in Florida, it remains a mystery as to how they compound drugs, even to state officials who should be monitoring them. Last week, Florida regulators issued an emergency order requiring those pharmacies to complete a survey about exactly how they compound drugs and how much material […]
University of Florida (UF) cheerleaders will no longer be allowed to perform aerial stunts or tumbles during football games. UF administrators say the decision was not made lightly but the timing is interesting. Three days before the announcement was made in November, a cheerleader for the Orlando Magic fell off […]
The manufacturers of defective medical devices have been the focus of a number of lawsuits filed by the Mass Tort Unit of Searcy Denney this week. A new lawsuit was filed in the United States District Court for the Middle District of Florida, Tampa Division, against Mentor Worldwide (a Delaware […]
The manufacturers of defective medical devices have been the focus of a number of lawsuits filed by the Mass Tort Unit of Searcy Denney this week. An individual lawsuit was filed on behalf of a Bartow, Florida woman who was implanted with a defective hernia mesh patch manufactured by Bard, […]
The government is releasing information about a growing number of injuries associated with those so-called energy drinks. Among them, 5-Hour Energy, a highly caffeinated energy shot that also contains vitamins and a substance called taurine. It’s marketed to “hardworking adults” who just need a little boost of energy. Since 2009, […]
If Johnson & Johnson is a family company, I’m not sure if it’s a family I want to belong to. The latest black eye for the once stellar and highly respected American company is the recall of 157,000 surgical staples used to treat hemorrhoids. The Wall Street Journal reports malfunctions […]
A new study reports on the likelihood of needing a second surgery after a hip replacement procedure for osteoarthritis, and the news is not good for men and younger seniors. Researchers from Brigham and Women’s Hospital in Boston analyzed data from 51,000 Medicare patients who received total hip replacements (THR) […]