Supreme Court Rules For Generic Drugmakers

Med Page Today reports:

In a 5-4 ruling, the U.S. Supreme Court has decided that generic drugmakers have more protection from lawsuits than brand-name drugmakers when it comes to failing to warn patients about harmful side effects of their drugs.

The case -- Pliva, Inc. v. Mensing -- centers around Gladys Mensing, a Minnesota woman who was prescribed metoclopramide (Reglan) in 2001 to treat her diabetic gastroparesis. Her pharmacist filled her prescription with a generic version of the drug, which she took for four years, eventually developing tardive dyskinesia.

She sued Pliva and Actavis, the makers of the generic, arguing that, although there was growing evidence that long-term metoclopramide use carried a risk for these uncontrollable, repetitive body movements that was far greater than indicated on the drugs' label, no metoclopramide manufacturer took steps to change label warnings.

A federal law requires generic drugmakers' products to carry identical labels as their brand-name counterparts, but state tort law requires that manufacturers label their products in a way that renders then "reasonably safe."

Generic drugmakers argued that because of the federal law, they weren't in a position to add updated warnings to their drugs. The Supreme Court agreed in a ruling issued Thursday.

"If the Manufacturers had independently changed their labels to satisfy their state-law duty to attach a safer label to their generic metoclopramide, they would have violated the federal requirement that generic drug labels be the same as the corresponding brand-name drug labels," wrote Justice John Roberts in the majority opinion. "Thus, it was impossible for them to comply with both state and federal law."