Before becoming LegalReader's Editor-in-Chief, Jay W. Belle Isle worked as a freelance copywriter with clients on four continents. Jay has a degree in Business Administration from Cleary University and a Juris Doctor from Thomas M. Cooley Law School. Jay has also worked as a contracts administrator for a DOD contractor specializing in vehicle armor.
A Louisiana man died from complications brought on by taking the anti-coagulant drug, Pradaxa. The new-gen drug has no known antidote that will counteract it’s blood thinning effects. In the event of a medical emergency, such as internal bleeding, patients must first endure multiple blood transfusions in order to remove Pradaxa from their systems.
Pfizer is grumpy because the FDA wants to add additional cautionary information for pregnant women to the Zoloft label. Despite internal memos stating that the Big Pharma giant’s own scientists have been warning management for years that there are increased risks for birth defects, Pfizer is resistant to the label change, stating that there isn’t enough data to support it.
The FDA is adding another warning to the label of popular type-2 diabetes drug, Invokana. The drug, part of a new class, is already under scrutiny for increasing the risk of ketoacidosis and kidney failure. Now, armed with several studies, the FDA has reason to believe that Ivokana may cause low bone density and fractures.
Johnson & Johnson and its subsidiary, Ethicon, won the first case involving the company’s Gynecare Prosima pelvic mesh to go to trial. The plaintiff, Carol Cavness, had asked for $9.5M in damages for past and future medical expenses, pain & suffering and an unspecified amount in punitive damages. The jury decided in favor of J&J with a 10-2 vote.
There is a new FDA committee on its way. The agency announced last week that it is forming the first-ever FDA Patient Advisory Committee on Medical Devices. The FDA hopes to get real patient input in the development, approval and monitoring processes it uses for medical devices.
XenoPort is developing a new psoriasis drug but has hit some snags. During patient trials, one-third of the study participants dropped out due to severe gastrointestinal side effects involving diarrhea.
Alabama is in trouble. The state has until October 1st to solve a $200M overspending crisis or face a government shutdown. Their answer? A 40% tax on all gross receipts involving pornography. The plan is to milk the residents for every penny the state can get from indulgence in porn. The whack-it tax is sure to get a rise of of Gov. Robert Bentley’s constituency as he promised not to hike up taxes.
News is surfacing that may indicate an additional warning needs to be added to Xarelto’s label. Cases of liver damage in patients taking the drug have been reported. The current warning does not mention liver damage but that information is available through non-manufacturer sites.
William L. filed suit against 3M and Arizant Healthcare, Inc. claiming that their Bair Hugger caused him to develop an infection requiring additional surgeries and leaving him with permanent injuries. A patient warmer, the Bair Hugger blows hot air right onto the patient’s exposed skin during surgery.
The risk of pain is serious enough that the FDA added a new “Warning and Precaution” to the labels of all drugs in this class. These include sitagliptin, saxagliptin, linagliptin, and alogliptin. The FDA issues warning about type 2 diabetes drugs and joint pain, stating that the pain may be severe and disabling.