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.
Bayer may have tampered with data from clinical trials and patient surveys pertaining to adverse effects caused by its Essure “permanent” birth control product. Patient surveys were altered, eliminating some valuable patient feedback. An advisory panel to the FDA met in late September to discuss Essure’s safety.
New York’s AG is investigating Martin Shkreli of Turing Pharmaceuticals for possible violation of antitrust laws. It seems Big Pharma’s bad boy has set up a distribution network for the anti-parasitic drug, Daraprim, that will all but eliminate the possibility of generic competition. Needless to say, AG Eric Schneiderman is not pleased.
Bayer’s Essure implantable birth control device is responsible for destroying thousands of women’s lives. They have had total hysterectomies in their early 20s, been diagnosed with fibromyalgia, lupus and even cancer. All for the sake of Bayer’s almighty bottom line. No more! Hey Bayer! #ImReal and I’m not going away!
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.