2004, Compliance, FDA and Fraud - Health Care Compliance Brief

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2004

Compliance

FDA

Fraud

Pretty Potent Mix In A Prescription Painkiller Preemption Decision

Drug & Device Law

MAY 4, 2023

2015), finally gave appellate recognition to the preemption of design defect claims for FDA-approved branded prescription drugs. FDA approved the drug with its particular formulation and the manufacturer could not have changed the formulation on its own. As detailed here , the decision in Yates v. Ortho-McNeil-Janssen Pharms.,

FDA

FDA Fraud Compliance

Applying the Helpful but Problematic New Jersey Statute Creating a Rebuttable Compliance Presumption, the Third Circuit Affirms Dismissal of a Failure-to-Warn Claim

Drug & Device Law

MAY 5, 2022

2022), a short decision that came out the right way, but did so based on a problematic statute that creates a rebuttal presumption that warning labels approved by the FDA are adequate as a matter of state law. Stated differently, the rebuttal provision makes allegations and evidence of fraud on the FDA a prerequisite to state-law liability.

Compliance

Compliance FDA Fraud

Pretty Potent Mix In A Prescription Painkiller Preemption Decision

Applying the Helpful but Problematic New Jersey Statute Creating a Rebuttable Compliance Presumption, the Third Circuit Affirms Dismissal of a Failure-to-Warn Claim

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