Stryker is finally acknowledging that their Rejuvenate and ABG II modular hip product line can cause serious problems in patients – even if they aren’t yet feeling symptoms of metal poisoning or tissue destruction. Since the Rejuvenate product recall on July 4th, Stryker has been telling patients that if you […]
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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 […]
U.S. News and World Report is revisiting a topic that needs to be revisited – the huge number of medical errors that harm and kill patients. The in-depth news report starts with a lesson presented to students at the University of Buffalo, New York, about an 88-year-old woman who was […]
The first hearing for the newly-created Pradaxa MDL has been scheduled for October 3, 2012, at 1:30 PM at the United States Courthouse in East St. Louis, Illinois. On August 8, 2012, the Judicial Panel on Multi-District Litigation (JPML) granted the plaintiffs’ request for establishment of an MDL and assigned […]
If a medical device such as a metal-on-metal (MoM) hip or synthetic vaginal mesh go bad in a patient, the current system has no way of identifying and tracking that medical device. There is no national registry in the U.S. as there is in Britain and Australia, so the recipient of the device gone […]
Consumers Union has posted an ad in the online news source, Politico, Monday, May 21, asking “Should medical device makers be allowed to sell new devices based on manufacturer-recalled products – without ever having to prove that the safety flaws were fixed?” Sounds like the answer should be a resounding […]
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 […]
March has been a busy month for new filings in the national litigation efforts involving bisphosphonate drug-induced femur fractures. Currently, there are coordinated state court proceedings pending in Atlantic City, New Jersey as well as Southern California involving the manufacturers of Fosamax, Boniva, and other osteoporosis drugs. There are also […]
It is old hat in the medical device and drug industry; do not ask for permission—simply deal with the fall out of asking for forgiveness. The US Attorney’s Office announced indictments against a number of Stryker executives for lying to the Food & Drug Administration. Apparently, Stryker was given permission […]
