Brand-name drugmaker can be sued for harm caused by generic drug

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Brand-name drugmaker can be sued for harm caused by generic drug

INICIO/Noticias Farmacéuticas | Posted 18/01/2013 0 Post your comment

On 4 January 2013 the Alabama Supreme Court ruled that Pfizer can be sued for failing to warn about a drug’s risks by a patient who claimed he was injured by a generic version of its gastric reflux medicine Reglan (metoclopramide).

The move comes after the patient, Mr Danny Weeks, failed to get a result after suing generics manufacturers, Actavis and Teva Pharmaceutical Industries, when he developed the serious movement disorder tardive dyskinesia after taking generic version of the stomach drug Reglan (metoclopramide).

The US Supreme Court ruled in 2011 that generics makers cannot be sued under state law for not changing their labels to warn of possible side effects. Federal law pre-empts state lawsuits because the generic drugs are approved by FDA and federal law requires generic drugs to have the same labels as their brand-name equivalents [1].

But if patients who use generic drugs cannot sue generics manufacturers can they then sue the brand-name drugmaker responsible for the drug’s labelling?

In its decision, the Alabama Supreme Court ruled that ‘an omission or defect in the labelling for the brand-name drug would inevitably be repeated in the generic labelling, foreseeably causing harm to a patient who ingested the generic product.’

The decision applies only to Alabama, USA, and Pfizer points out that more then 70 similar cases have taken the opposite view. Brand-name manufacturers also argue that they cannot be held liable for injuries caused by products that they have not manufactured. Nevertheless, the decision is likely to be closely read by lawyers with similar cases pending around the country whose clients have been barred from suing generics companies because of the US Supreme Court ruling.

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Reference

1. GaBI Online - Generics and Biosimilars Initiative. Generics manufacturers do not have to change drug safety labels in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jan 18]. Available from: www.gabionline.net/Generics/News/Generics-manufacturers-do-not-have-to-change-drug-safety-labels-in-the-US

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Source: The New York Times