Julie Park on Labeling

Pleading And Preemption: Immunization Against Vaccine Products Liability Claims

In a recent win for vaccine manufacturers, a district court found that federal law preempted claims against Merck, arising out of alleged injuries from the Gardasil vaccine. Herlth v. Merck & Co., Inc., No. 3:21-cv-438 (JAM),...more

4/18/2022 / Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Labeling , Manufacturing Defects , Merck , Pharmaceutical Industry , Vaccinations

Trump’s Nominee for FDA Commissioner Likely Dooms Generic Drug Labeling Rule

President Trump recently announced his intent to nominate a new commissioner of the U.S. Food and Drug Administration (FDA), likely sealing the fate of FDA’s proposed generic drug labeling rule. The proposed rule would give...more

3/30/2017 / Abbreviated New Drug Application (ANDA) , Food and Drug Administration (FDA) , Generic Drugs , Labeling , Manufacturers , Nominations , Proposed Rules , Trump Administration

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

Federal Preemption Claims: Clear Evidence and an Unclear Standard

Last week, a federal court in Utah granted Aventis Inc.’s motion for summary judgment based on federal preemption of failure-to-warn claims. Cerveny v. Aventis, Inc., 2016 U.S. Dist. LEXIS 34182 (D. Utah Mar. 16, 2016). The...more

4/1/2016 / Birth Defects , Failure To Warn , Food and Drug Administration (FDA) , Labeling , Pharmaceutical Industry , Preemption , Prescription Drugs , Summary Judgment

Alabama Legislature Says No to Innovator Liability

On April 29, 2015, the Alabama Senate passed a bill, SB80, “to provide that a manufacturer is not liable . . . for damages resulting from a product it did not design, manufacture, sell, or lease.” Sponsored by Senator Cam...more

5/3/2015 / Generic Drugs , Innovation , Labeling , Pharmaceutical Industry

FDA Proposed Rule in Flux?

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more

2/20/2015 / Failure To Warn , Food and Drug Administration (FDA) , Generic Drugs , Labeling , Manufacturers , Pharmaceutical Industry , Preemption , Prescription Drugs

$4 billion price tag? FDA's proposed generic drug labelling rule

An economic consulting group recently published findings that a Food and Drug Administration (FDA) proposed rule will increase annual healthcare costs by $4 billion. The FDA's proposal, announced in November 2013, will allow...more

3/14/2014 / Food and Drug Administration (FDA) , Generic Drugs , Labeling , Pharmaceutical Industry , Prescription Drugs

$4 Billion Price Tag for Pleasing Plaintiffs' Bar? New Study Estimates Costs of FDA's Proposed Rule on Generic Drug Labeling

An economic consulting group recently published findings that a Food and Drug Administration (FDA) proposed rule will increase annual healthcare costs by $4 billion. The FDA's proposal, announced in November 2013, would allow...more

2/27/2014 / Food and Drug Administration (FDA) , Generic Drugs , Labeling , PLIVA v Mensing , Prescription Drugs , SCOTUS

Julie Park

Morrison & Foerster LLP

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