By Ryan Abbott Actavis is back in the spotlight regarding its allegedly anticompetitive behavior. Last month, the U.S. District Court for the Southern District of New York issued an injunction against Actavis and its subsidiary, Forest Laboratories LLC based on the New York Attorney General’s “product hopping” suit. The suit concerns Actavis’ attempt to extend monopoly…
By Rachel Sachs Last week’s issue of the New Yorker featured a terrific article about fecal microbiota transplantation, or FMT. Much of the article focused on OpenBiome, a nonprofit stool bank spun off from MIT that screens donors, processes samples, and ships them to hospitals around the country. For those who are unfamiliar with FMT,…
By Joan H. Krause [Cross-posted at HealthLawProf Blog] Whether it be a social media campaign to convince a company to provide an experimental anti-viral drug to a young cancer patient suffering from a life-threatening infection or the debate over appropriate treatment for high-profile Ebola cases, access to potentially life-saving but unapproved medications remains a controversial…
By Emily Largent On Wednesday, the FDA published the “Pregnancy and Lactation Labeling Rule” (PLLR), which “requires changes to the content and format for information presented in prescription drug labeling . . . to assist health care providers in assessing benefit versus risk and in subsequent counseling of pregnant women and nursing mothers who need…
[Blogger’s Note: I am very pleased to share this post by my colleague at Seton Hall Law, Carl Coleman. This post was cross-posted at Health Reform Watch.] By Carl H. Coleman With well over 5,000 global deaths from Ebola already reported, drug developers are working fast to begin human clinical trials of promising experimental treatments. Earlier this month,…
By Zachary Shapiro In the field of pharmaceutical product-liability litigation, the Learned Intermediary Rule (LIR) is a defense doctrine for failure to warn claims, which has been adopted in 22 states, and applied in 48. The LIR means that if a pharmaceutical manufacturer that gives an adequate warning to a prescribing physician, the company has…
By Timo Minssen The current Ebola outbreak already attracted much attention on “Bill of Health” resulting in some excellent blogs on a horrible topic. While it is evident that the current health crisis requires both immediate responses and more sustainable changes in health care policy, research and regulation, medicines regulators are collaborating internationally to find innovative…
By Rachel Sachs The recent arrival of Ebola in the United States has captured the attention of both the public and the media for many reasons. One key reason is that Ebola is making many people realize for the first time that serious diseases which were formerly confined largely to developing countries have the potential to…
By Kate Greenwood [Cross-posted at Health Reform Watch] As I have blogged about before, last year, in Kaiser v. Pfizer, the First Circuit joined the handful of courts to have approved a causal chain of injury running from a pharmaceutical company’s fraudulent promotion, through the prescribing decisions of thousands of individual physicians, to the prescriptions for…
By Emily Largent California Proposition 46, the Medical Malpractice Lawsuits Cap and Drug Testing Doctors Initiative, is on the November 4, 2014 ballot. If approved by voters, the initiative would: increase the state’s cap on non-economic damages that can be assessed in medical negligence lawsuits; require hospitals to test certain physicians for drugs and alcohol; and…
