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.
6/1/2015 Olympus Corporation set aside $450M for an expected settlement regarding its marketing practices. It’s already on the hook for its duodenoscopes, which are very hard to clean and have caused a number of superbug outbreaks in the U.S. Olympus failed to timely warn hospitals in the U.S. and three people died. Now federal investigators
5/29/2015 Boston Scientific must pay $100M to a plaintiff injured by its transvaginal mesh as ordered by a Delaware Jury. This is one of over 25,000 suits against BS; the suits typically claim that the product was poorly designed and that BS failed to warn doctors and patients of the risks involved in using it.
5/28/2015 A young girl got a $15M jury verdict for birth defects she suffered because her mother took Depakote, an anti-epileptic drug, while pregnant. The St. Louis, MO jury was unanimous in the verdict, which came down after only a few days’ deliberation. The $15M is just for damages; the jury is now considering adding
5/28/2015 Last year a Johnson & Johnson medical device, the laparoscopic power morcellator, was removed from the market. This year the FBI investigates the cancer-spreading hysterectomy device. The power morcellator was a favorite of surgeons for doing minimally-invasive hysterectomies and removing uterine fibroids. The device worked by grinding up tissue that could then be removed
5/25/2015 A recent ruling from the Court of Appeals for the Second Circuit tells Actavis it cannot withdraw Namenda IR. The drug, a popular drug for treating Alzheimer’s disease, needs to be taken twice daily. Actavis, in a bold move to make more money, decided to remove Namenda IR from the market, prior to a
5/25/2015 On Friday, the U.S. Court of Appeals for the D.C. Circuit handed down a ruling that tobacco companies must tell the public that cigarettes are designed to be addictive. However, the tobacco industry doesn’t have to tell the truth about past actions. The opinion’s author, Judge David Tatel, wrote that the court decided that,
5/22/2015 In the same week that Idiotic RFG questioned Ruth Bader Ginsburg’s faith, the Notorious RBG’s shout-out to the U.S. Constitution was a fabulously shining moment during a gay wedding she officiated. The ceremony was Sunday, May 17. It is widely known that RBG has been a staunch supporter of same-sex equality during her over
5/21/2015 The FDA announced yesterday that it is warning healthcare professionals of potential problems with Zerbaxa (ceftolozane and tazobactam). Apparently, the Zerbaxa labels cause confusion over dosages. The risk stems from the vial label being approved with each individual active ingredients’ strength listed (e.g. 1 g/0.5 g). The product is not dosed like that, though,
5/21/2015 Earlier this month, the FDA posted an alert regarding Hospira’s LifeCare PCA3 and PCA5 infusion pumps. The computerized systems are used to continuously deliver anesthetic or therapeutic drugs and can be programmed remotely over a hospital’s Ethernet or wireless service. Both Hospira and the FDA learned of certain security vulnerabilities in Hospira’s PCA3 and
5/21/2015 Quite surprising to me, I found that SGLT2 drugs have negative history with FDA. Not surprising, especially after finding the history, is the warning FDA released earlier this week. It appears that canagliflozin, sold as Invokana, may have created problems in the clinical trials that should have prevented its release. Just as other