When our clients discover that their metal-on-metal (MoM) hip has failed and never went through U.S. Food and Drug Administration (FDA) approval for safety and efficacy, they ask – how did that happen? Most Americans do not understand that medical devices are largely unregulated, even for those devices that are […]
Category: Defective Medical Devices
An MDL (multidistrict litigation) was established for the prosecution of individual personal injury lawsuits against Biomet in the fall of 2012. The Judicial Panel on Multidistrict Litigation (JPML) heard attorney arguments on September 20, 2012, at a hearing in New York City. The plaintiffs requested consolidation of the pending lawsuits […]
This study published in the December issue of Arthritis Care & Research is the first to look at the risk factors that could lead to a revision after a primary total hip replacement (THR). In the U.S. population, identified by Medicare claims from 29 states, patients who were younger, taller […]
January first marks a new chapter for medical device manufacturers, who will be required to pay an excise tax of 2.3 percent on total revenues. Medical devices range from small stents and CT scans to pacemakers, defibrillators, metal hips and synthetic surgical mesh. The $125-billion-a-year industry complains it will be […]
Johnson & Johnson (J&J) is fighting a patient lawsuit and seeking to have it dismissed on the grounds that the company did warn patients of the potential for metal erosion and the need for revision surgery. This California case was filed by plaintiff Loren Kransky in December 2010, just after […]
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 […]
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 […]
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, […]
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) […]
