More Thoughts On Bartlett by Dechert LLP on 5/7/2012 Our initial post about Bartlett v. Mutual Pharmaceutical Co., ___ F.3d ___, 2012 WL 1522004 (1st Cir. May 2, 2012), was more or less a crie de coeur over what we saw as an essentially absurd result: that while a simple...more
ALEC Leads the Legal War Against Consumers by Lawyers.com on 5/7/2012 Meet ALEC — the nickname for the American Legislation Exchange Council — that has recently come to light as a cozy meeting place where Big Business is accused of “ghostwriting” its wish list of laws that state legislators...more
An Agency "Warning Letter" Does Not a Lawsuit Make: Sometimes a "Warning Letter" Is Really Just a Warning by Sedgwick LLP on 5/2/2012 Unfortunately, the number of consumer class action complaints brought against consumer product manufacturers under state consumer protection and/or false advertising law statutes continues to rise. This increase can be traced...more
FDA Sends Warning Letters to DMAA Bodybuilding & Dietary Supplement Manufacturers by Schmidt & Clark, LLP on 5/2/2012 May 1, 2012 - The U.S. Food & Drug Administration (FDA) has issued stern warning letters to 10 manufacturers and distributors of dietary supplements containing dimethylamylamine (DMAA) for marketing products whose safety has...more
If At First You Don't Succeed.... by Dechert LLP on 4/24/2012 Sometimes good ideas don’t prevail the first time – or even the first few times – they make their appearance. With that in mind we bring to your attention Windle v. Synthes USA Products, Inc., 2012 U.S. Dist. Lexis 52397...more
Should Brake-Override Systems in Cars be Mandatory? by Howard Ankin on 4/19/2012 Are brake-override systems necessary? Should they be mandatory for all new vehicles? Federal regulators seem to think so. In fact, the National Highway Traffic Safety Administration just recently proposed that all automobile...more
Female Crash Test Dummies Now Regularly Being Used by Howard Ankin on 4/17/2012 It may surprise you to learn that it wasn’t until 2003 that the National Highway Traffic Safety Administration (NHTSA) began to sometimes use female crash test dummies when simulating crashes to determine the safety of...more
FDA Announces Propecia, Proscar to Receive New Sexual Dysfunction & Side Effects Warning Label by Schmidt & Clark, LLP on 4/13/2012 Two of pharmaceutical giant Merck’s best-selling drugs, Propecia and Proscar, will be required to carry warnings linking them to severe persistent sexual side effects, the U.S. Food & Drug Administration (FDA) announced...more
China Solicits Comments on Draft Rules for Writing Periodic Safety Update Reports by McDermott Will & Emery on 4/11/2012 China’s State Food and Drug Administration recently issued draft guidance on drafting and preparing Periodic Safety Update Reports for drugs and is seeking comments from the public until 16 April 2012. China’s State Food...more
Birth Control Blood Clot Risk Prompts FDA to Issue Drospirenone Label Change by Schmidt & Clark, LLP on 4/11/2012 April 10, 2012 - The U.S. Food & Drug Administration (FDA) issued a press release today stating that it had completed a review of epidemiological studies regarding the risk of blood clots in women taking birth control pills...more
FDA Ordered to Step Up Efforts Against Antibiotic Use in Animals by Patrick Malone & Associates P.C. | DC Injury... on 4/5/2012 A couple of months ago, we wrote about the overuse of antibiotics, and how the FDA had curbed use of some of them in livestock. The concern was that inappropriate use of antibiotics can encourage development of drug-resistant...more
How much should automakers be fined for not complying with recall rules? by Howard Ankin on 4/5/2012 In late March, the United States Senate approved legislation that would increase the fines levied against U.S. automakers who failed to comply with automobile recall regulations. Currently, automakers are fined a maximum of...more
N.J. Determines to What Extent the Product Liability Act's Presumption of Adequacy Applies to Toll the Statute of Limitations by Sedgwick LLP on 4/3/2012 Statutes of limitations have traditionally served a critical function in the judicial system. Not only do they compel a person to file an action within reasonable time so that the opposing party has fair opportunity to...more
"Fraud-on-the-FDA" Failure to Warn Claims Are Preempted by Federal Law by Sedgwick LLP on 4/3/2012 The extent to which federal law preempts state law claims is an issue that has been in the forefront of drug and medical device litigation throughout the past few years. In the context of medical device litigation, the U.S....more
Food Products Coverage: The Communicable Disease Exclusion Lacks Bite by Morgan Lewis on 4/3/2012 State and federal courts reject efforts to categorize salmonella as a "communicable disease." While the quality of the United States' food supply continues to be exceptionally reliable, problems do occasionally arise....more