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27 Jun 2011, 5:47 am by Lisa Baird
As many of you no doubt have heard, the United States Supreme Court last week decided that FDA regulations applicable to generic drug manufacturers preempt state law "failure to warn" claims in PLIVA, Inc. v. [read post]
18 May 2010, 3:09 am by Adam Wagner
British Airways Plc v Unite the Union Queen’s Bench Division, 17 May 2010 – Read judgment Update (07/06/20) – this decision was reversed by the Court of Appeal on 20/05/10. [read post]
Declaring the NLRB’s rationale to be “nonsense,” on March 26, 2024, a unanimous three-judge panel for the United States Court of Appeals for the District of Columbia in Stern Produce Company Inc v. [read post]
27 Aug 2010, 2:41 pm by Bexis
We disagree.In Hoffman, the United States Court of Appeals for the Third Circuit applied Pennsylvania law and concluded that there was sufficient evidence for the jury to find that the manufacturer failed to adequately test its drug to discover potentially harmful side-effects. [read post]
6 Dec 2011, 3:59 am by Mark Zamora
(“”Sears”) (collectively “Defendants”) in the United States District Court for the Central District of California (styled Steve Chambers, Lynn Van Der Veer, David Brown, Bach-Tuyet Brown, Kevin O’Donnell, Joseph Cicchelli, Kurt Himler, Susan Milicia, Gary LeBlanc and James Cashman v. [read post]
18 Jul 2016, 9:30 am by azatty
Most everyone in the United States has at least a rudimentary knowledge of the Miranda warning, if not of the case itself. [read post]
15 Dec 2015, 6:26 am
United States, 703 F.3d 149 (2d Cir. 2012), precedent, that forum will be in the Second Circuit, probably in New York City.This First Amendment process doesn't change the off-label warning impossibility argument that we've discussed, because not only is prior FDA review still required, but also a prior (perhaps lengthy) litigation process before any change to labeling (or promotion) can legally occur.We’ll be watching for the next case. [read post]