Legal News

Drugmakers Breathe Easier After Ruling in Warning Case

By Dan Slater

In 2003, Lois Colacicco, a psychotherapist who counseled patients against suicide, began taking a generic version of Paxil, an antidepressant marketed by GlaxoSmithKline. Later that year, Colaccio killed herself. In the same year, Theodore DeAngelis committed suicide eight days after beginning to take Pfizer’s Zoloft, another antidepressant.

Yesterday, the Third Circuit Court of Appeals ruled that the drugmakers could not be blamed for the suicides of Colacicco and DeAngelis, whose families claimed that the drug’s warning labels were not strong enough. (Here’s the opinion, and here’s a story from the Philadelphia Inquirer.) While narrowly written, according to the report, the decision was a victory for drugmakers and Bush administration officials who want scientists at the FDA, not lay juries, deciding what drug labels should say.

“The drug companies get a free ride here,” lamented Sol Weiss, a Philadelphia lawyer who represented one of the plaintiffs. “They interpret data in a way that’s not scientifically valid. The FDA may not ever know that, and so the drug companies get away with it for six, seven or eight years. People get injured and die because of it. You should have the right at least to expose this stuff to sunshine.”

Rob Weiner, a partner at Arnold & Porter, disagrees. “Pharmaceutical companies are caught in this situation where they need to follow FDA’s instructions,” said Weiner, who wrote an amicus brief in the case for a drug-industry lobbying organization. “They also need to worry about state courts’ telling them to do something else.”

The issue could come to a head in October, when the Supreme Court is scheduled to hear Wyeth v. Levine, another dispute over the adequacy of a drug label.

Full post as published by Law Blog - WSJ.com on April 09, 2008 (boomark / email).