Generic Drugs

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Opioid painkillers crisis and drug abuse concept

Generic pharmaceutical drugs are versions of brand-name counterparts with one major difference:  they typically cost a lot less. By FDA regulation, the two have the same active ingredients, dosage forms and strengths, and routes of administration.[1] And while federal law generally regulates pharmaceutical approval, states can regulate pharmaceutical distribution. Why is this significant? All states permit pharmacies to substitute generic drugs for the brand name equivalent, and some states require substitution in certain circumstances.[2] But a generic pharmaceutical company cannot change the brand company’s product label, so a person’s ability to sue a drug manufacturer is limited to the brand company who created the label.[3] Continue Reading Generically Speaking: Liability is Limited in Failure to Warn Claims

Policy Dictionary Definition

The consequences of the Supreme Court’s decision in Pliva v. Mensing continue to play out on multiple tracks.  Most recently, the FDA has reopened the comment period for its proposed rule that would allow generic drug manufacturers to unilaterally update their warnings labels.  The proposed rule would change the result in the Pliva decision which held that certain failure to warn claims against generic drug manufacturers are preempted, while those same claims against brand-name drugs are not.  In order to level the field and provide plaintiffs a way to sue generic drug manufacturers, the FDA proposed greater authority (and liability) for generic drug manufacturers over the content of their warning.  Interested parties have until April 27 to weigh in on the consequences of this rule and make suggestions for how the rule could be improved.
Continue Reading FDA Reopens Comment Period for Drug Labeling Rule

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Last week, the New Jersey Appellate Division added more uncertainty and unpredictability in generic pharmaceutical litigation when it allowed some failure to warn claims to proceed against generic providers of metoclopramide, a/k/a Reglan in the case of  In re: Reglan Litigation.   Most of plaintiffs’ claims were dismissed, but the Court allowed a claim based on an alleged failure to update the generic label to match brand-name labels.  The generic manufacturers argued that they had in fact matched the brand name labels, but the Court found issues of fact existed that needed to be sorted out by a jury.  The Court did not, however, identify what any of those issues of fact were. Continue Reading Generic Pharmaceutical Litigation Continues Amid Preemption Uncertainty