Should Drugmakers Pay Punitive Damages? Novartis Says No

Should a drugmaker not have to pay punitive damages for product liability because such penalties encroach on the ability of the FDA to enforce its authority? This is the question that Novartis hopes the US Supreme Court will answer in its upcoming session, although whether the justices will agree to review the issue is unclear. A decision may be known next week. In arguing for a review, Novartis cites a 2009 ruling by the Supreme Court that a Vermont woman named Diana Levine had the right to sue Wyeth, which is now owned by Pfizer (PFE), in state court after alleging damage caused by one if its drugs. The drugmaker unsuccessfully cited preemption, which is the notion that FDA approval of a drug supersedes state law claims challenging safety, efficacy or labeling (more here). The ruling marked a watershed in the pharmaceutical industry, but Novartis maintains the decision does not apply to punitive damages, because the Levine case only involved compensatory damages. And Novartis is raising the issue following a 2010 case in which a North Carolina jury awarded a family $12.6 million for alleged misconduct in punitive damages, although that was later reduced to $867,00 under state law caps. In that case, the jury decided that Novartis failed to adequately warn about the risks of its Zometa and Aredia bone-strengthening medications taken by Rita Fussman, who died four years ago of breast cancer. And a federal court judge later upheld punitive damages after reviewing evidence that...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs