Events FDA Fraud Regulatory Compliance 
Drug & Device Law
MAY 24, 2022
In both New Jersey and Florida, there is a strong presumption against punitive damages in drug and device cases where there’s been regulatory compliance. In response to the summary judgment motions, plaintiff abandoned 11 of those claims including various strict liability, fraud/misrepresentation, and warranty claims.
Drug & Device Law
DECEMBER 29, 2023
2023) ( Buckman preemption barred MDL asserting fraud on EPA), cert. Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. Monsanto Co. ,
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