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…
From Harvard College Effective Altruism: The Risks of Biotechnology, with George Church Monday, Oct. 20, 5.30pm, Sever 102 Genetic manipulations can reintroduce extinct viruses or create viruses much deadlier than ever before. What are the dangers associated with biotechnology? Can a mistake in a lab lead to a global pandemic? Can this technology be used…
By Rachel Sachs For all those who have been following the ongoing fight between pharmaceutical companies and HHS over the 340B Program’s coverage of orphan drugs (I know you’re out there), last week PhRMA filed a new complaint challenging HRSA’s interpretive rule on the subject under the APA. For all those who are not (but…
