Pfizer and GSK may feel impact of Wyeth vs. Levine ruling

The decision, in favour of a Vermont woman who sued against Pfizer acquisition target Wyeth on the basis that approved labelling did not explicitly warn against administration of Phenergan (promethazine) via IV-push, effectively rejected the pre-emption argument that US Food and Drug Administration (FDA) approved labelling protects against such liability.

On Monday, as a direct result of the latest ruling, the US Court of Appeals in Philadelphia began reconsidering its initial rejection of lawsuits against Pfizer and GlaxoSmithKline (GSK) connected to suicide warning labels on antidepressants made by the two firms.

The cases in question were brought by relatives of patients who are alleged to have committed suicide after taking Pfizer’s Zoloft (sertraline HCl) and GSK’s Paxil (paroxetine).

In 2007 the FDA proposed expanding the labels for all antidepressant products from warning about suicide risk in children, which was mandated in 2005, to advise patients and doctors about the likely risk in adults.

The two families are pursuing Pfizer and GSK on the basis that, in 2003 when the suicides occurred, the respective drug’s labelling failed to warn about the risk suicide in adult patients.

The US Courts initially rejected the suits on the grounds that the FDA had studied antidepressant-associated suicide risk for 20 years and concluded that warnings for adults "are without scientific basis and would therefore be false and misleading,​" according to media reports.

However, in light of the US Supreme Court ruling the cases, as well as a similar suit against Canadian generics firm Apotex which makes a non-branded version of Paxil, are being reassessed.

Both Pfizer and GSK argue that their cases differ from Wyeth vs. Levine because the FDA had substantially considered and rejected the idea of suicide warning labels for adults.

In a subsequent court filing Pfizer said that the "FDA [had] repeatedly determined that the scientific evidence did not support such an association​."

While reconsideration is ongoing, both Pfizer and GSK will gain solace from a report in the Philidelphia Business Today​ that suggests the US Supreme Court “left open the possibility that product-liability suits would be precluded when they centred on a proposed warning that the FDA had considered and rejected​.”