Is the GRAS Food Safety process a Racket?

A 1958 law offers food companies who want to market new ingredients in their products a way to bypass extensive and costly FDA safety testing. The law provides the option for companies to demonstrate that the ingredient in question has been deemed “Generally Regarded As Safe” (GRAS) by a consensus panel of scientists and experts.





Premature Removals as Underhanded Defendant Tactics

No one can reasonably deny that law often resembles a game of chess, in which the filing of a claim is the opening salvo. However, there is a disturbing new trend that would have Bobby Fischer throwing up his hands in disgust, namely, premature removals of cases from state to federal courts. Some background is



JPML Maintains Narrow Focus of Mirena MDL

The orders from the March JPML panel hearing have been posted, and the JPML issued an order denying a motion by a plaintiff to centralize her case in the Mirena IUD device litigation MDL proceeding in the SDNY.  In its order, the JPML indicated that centralization into the pending MDL was denied because the potential


SCOTUS Denies Cert in Generic Preemption Case

Federal preemption of claims against generic drug manufacturers has prevented (or severely limited) the ability of users of generic drugs from bringing products liability claims premised upon the failure to warn.  Certain state courts have indicated that some state tort law claims may not necessarily be barred by federal preemption, but these “baby steps” potentially



Hepatitis C Drugs Combined with Antiarrhythmic Drug can Cause Serious Slowing of Heart Rate

Patients treating hepatitis C with Harvoni (ledipasvir/sofosbuvir) or Sovaldi (sofosbuvir) in conjunction with another direct acting antiviral such as the investigational drug daclatasvir or Olysio (simeprevir) and also treating arrhythmia with amiodarone are at serious risk of developing symptomatic bradycardia. This dangerous combination has already resulted in one patient death due to cardiac arrest and