World Generic Markets Update

On 26th March 2012, Senator Patrick Leahy (D-Vt) announced that he was introducing legislation to the Senate with the aim of reversing a recent Supreme Court decision which the senator claimed threatens the safety of consumers taking generic drugs.  The senator explained that in a 5-4 decision in 2011, the Supreme Court had held that state law tort claims against generic manufacturers are pre-empted by federal laws, which requires generic drug manufacturers to use the same label as a branded drug, even when the generic manufacturer knows that the warning on the label is inadequate.  The litigation the senator was referring to was the case, Pliva vs. Gladys Mensing, together with Actavis Elizabeth vs. Gladys Mensing and Actavis vs. Julie Demahy.  The cases had centred on the drug metoclopramide, marketed by Alaven Pharmaceuticals under the brand name Reglan, but also produced by generic firms including Actavis, Pliva’s owner, Teva Pharmaceutical Industries, Ipca Laboratories, Northstar Healthcare, Vintage Pharmaceuticals and Watson Laboratories.

Metoclopramide is used to treat digestive tract problems, but, as the Supreme Court noted, evidence has accumulated to show that long-term use of the drug can cause tardive dyskinesia.  As a result, warning labels for the drug have been strengthened and clarified several times.  The two respondents in the case were prescribed Reglan in 2001 and 2002, but were issued with generic alternatives; after taking the drugs for several years, both developed tardive dyskinesia.  In separate legal actions, both sued the generic firms which manufactured the drugs they had taken, alleging that the condition had occurred as a result of taking the drug, and further alleging that generic manufacturers were liable under state tort law for failing to provide adequate warning labels.  In their defence, the generic firms argued that federal statutes and FDA regulations had pre-empted the state tort claims by requiring the same safety and efficacy labelling for generic metoclopramide as was mandated at the time for Reglan.  However, the lower courts had rejected this defence, leading to an appeals process which reached the Supreme Court.

Supreme Court finds in favour of generic firms

The Supreme Court found in favour of the generic firms, in a ruling which was not surprisingly welcomed by the generic drug industry.  However, the industry noted that its defence was that federal regulations had tied its hands, leaving it unable to alert consumers to issues which are not present in equivalent branded drug labelling.  At the time, Actavis’ CEO had commented that he believed a necessary next step would be for Congress to amend the law.

Senator Leahy noted that three years earlier the Supreme Court had held that a patient could sue a brand-name drug manufacturer for failing to warn because the brand-name manufacturer is permitted by law to update its warning.  The senator noted that in that case the plaintiff had been a resident of Vermont who had sustained life-threatening injuries resulting from the use of a drug manufactured by Wyeth.

Senator Leahy commented, “The Mensing decision creates a troubling inconsistency in the law with respect to prescription drugs.  If a consumer takes the brand-name version of a drug, she can sue the manufacturer for inadequate warnings.  If the pharmacy happens to give her the generic version, she will not be compensated for her injuries.  The result is a two-track system that penalises consumers of generic drugs – even though many consumers have no control over which drug they take, because state law and their health insurance plan require them to take generics if they are available.  I will introduce legislation to address this contradiction so that consumers are fully protected from harm and receive adequate warnings.”  Senator Leahy commented that he had been working to craft legislation that would permit generic manufacturers to improve the warning information for their products in the same way as brand manufacturers, thus providing adequate warnings to consumers.  This, of course, would also make generic manufacturers liable for deficiencies in their drug labelling, thus overturning the Supreme Court’s decision in the Mensing litigation.  At the time of writing, the legislation has yet to be introduced to the Senate.

Article source: Ian Platts, editor of World Generic Markets

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Filed under: Generics News

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