The lawsuits accuse GSK of “off-label” marketing, that is, it is prescribed for ailments (pregnancy) that is not mentioned in the drug’s official FDA labeling. Zofran’s 1991 FDA approval was for “treatment of nausea and vomiting related to chemotherapy and surgery.” According to San Francisco attorney Rachel Abrams, speaking at a bar conference in the city regarding the lawsuits, “If they’re marketing and pushing a drug for a certain indication, and don’t have FDA approval for that indication, that’s a problem for GSK in and of itself.”
Health & Medicine
Indeed the social media age has brought a new wrinkle in the FDA’s regulatory agenda. Social media marketing schemes are often designed to appear casual and conversational, as if friends are discussing an issue over coffee. While certainly not illegal and for the most part, and a useful form of advertisement, FDA risk statements rarely fit within 144 character-limit social-media parameters.
The newest development in surgical technology is not an instrument or a special technique; it’s basically a “black box” device that records the actions taken by the surgical team during the procedure. Legislators in Wisconsin and New York have introduced bills that, if passed, give patients the rights to the video recordings of their surgeries.
Foodmaker Nestle scored a major victory late Monday night when the U.S. Food and Drug Administration (FDA) granted marketing approval for the company’s Maggi noodles within the U.S. The U.S. joins six other countries in allowing the sale of the two-minute instant snack noodles, which had been tested by the regulator for unsafe levels of
There are approximately 250 pending lawsuits against drug manufacturer Eli Lilly over its wonder-child, Cymbalta. Plaintiffs claim that the withdrawal symptoms experienced occur much more frequently than the Big Pharma giant warns. The first case went to trial this month and Big Pharma wins the first Cymbalta withdrawal suit. The drug, which brings Lilly about
Leading medical device manufacturer Medtronic has issued its second recall in as many weeks involving recently developed technology. Coming off of the European recall of its MiniMed 640 insulin pump last week, which is scheduled for a Pre-Market Approval (PMA) review in the U.S. later this year, the company has recalled nearly 7,000 EnVeo R
A Los Angeles jury took just 3.5 hours to deliver a $9.2M Zimmer Durom Cup hip implant award. The award is the first plaintiff’s victory in the hundreds of pending suits against the company for failure to warn and negligent design of a defective product. The trial lasted three weeks. Plaintiff, Gary K., developed complications
In the wake of a buying and selling frenzy, Irish drugmaker Allergan has been subpoenaed by the Department of Justice (DOJ) over antitrust concerns regarding the pricing of its generic drugs. Last week, the company announced a $40.5 billion selloff of its generics unit to the global generic market leader, Israeli-based Teva Pharmaceuticals. That deal
A hyperbolic attempt by Republicans to defund Planned Parenthood was blocked in the Senate on Tuesday after a series of sting videos showed the agency selling aborted fetal tissue to fake medical researchers causing outrage among the social conservative wing of the party. The anti-abortion group, the Center for Medical Progress, released four videos in
The New York Times paid tribute yesterday to a man whose death nearly went unnoticed in a national sense, but whose life needs to be celebrated. Dr. Donald L. Rasmussen died on July 23rd in Beckley, West Virginia at the age of 87. According to his stepdaughter, Julia Holliday, Dr. Rasmussen died from complications following