Dean Atyia

Morrison & Foerster LLP

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Latest Posts › Food and Drug Administration (FDA)

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FDA’s Denial of Citizen’s Petition “Clear” Enough for Preemption of Failure-to-Warn Claims

The Tenth Circuit recently upheld a Utah district court’s finding that a branded drug manufacturer could not be held liable for failing to warn consumers about alleged birth defect risks when the FDA had previously rejected a...more

7/11/2017 / Citizen Petitions , Failure To Warn , Food and Drug Administration (FDA) , Manufacturers , Pharmaceutical Industry , Preemption

Still Waiting—FDA Delays Rulemaking

The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the...more

6/16/2016 / Failure To Warn , Food and Drug Administration (FDA) , Generic Drugs , Health and Safety , Labeling , Pharmaceutical Industry , PLIVA v Mensing , Prescription Drugs , SCOTUS , Warning Labels

Liability for Brand Drug Manufacturers All But Clear

Earlier this month, a federal district court in Illinois denied GlaxoSmithKline’s (GSK) renewed summary judgment motion based on federal preemption of failure-to-warn claims in an opinion setting tough standards for brand...more

2/26/2016 / Burden of Proof , Evidence , Failure To Warn , FDA Approval , Food and Drug Administration (FDA) , GlaxoSmithKline , Pharmaceutical Industry , Preemption , Prescription Drugs , Warning Labels

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