In April 2009, Kira Gilbert was prescribed the Darvocet painkiller and died eight days later from pulmonary edema, or a build up of fluid in the lungs. Three months earlier, however, an FDA advisory panel decided the benefits did not outweigh the risks of the drug - which contains propoxyphene, an opiate narcotic. And only a few weeks later, the European Medicine Agency banned the drug.

Yet in July 2009, the FDA ignored its panel and, instead, required a boxed warning, a patient med guide and the manufacturer, Xanodyne Pharmaceuticals, to conduct new trials to assess cardiac risks. The FDA move followed a long-running debate in which consumer advocates urged a withdrawal and prompted fresh accusations that the agency unnecessarily dragged its feet.

Xanodyne, subsequently, ran the trials and last November, under FDA pressure, withdrew both Darvocet and Darvon, a related med (see this), after finding cardiotoxicity (look here). Now, Gilbert’s parents have filed the one of the first lawsuits against Xanodyne and Eli Lilly - which sold the meds to Xanodyne - for failing to conduct needed studies much earlier and concealing risks. And the litigation is reiterating harsh questions about the wisdom of issuing new safety warnings, while simultaneously allowing a medicine to remain on the market amid long-running concerns. The UK, for instance, had ordered a phased withdrawal in 2005.

“We had originally petitioned the FDA 32 years ago to ban” drugs containing propoxyphene, Sid Wolfe, director of Public Citizen’s health research group, tells Cincinnati.com, which wants an investigation into the FDA decisionmaking. The new trial “was a pitiful excuse and the harm in doing it is that it left (propoxyphene) on the market even longer” (you can read a chronology of the group’s efforts here).

In their lawsuit, for instance, the Gilberts cite FDA data indicating that about 10 million people in the US received prescriptions for Darvocet and other meds containing propoxyphene in 2009 alone. And Public Citizen estimates that anywhere from 1,000 to 2,000 people in the US may have died died from using meds containing propoxyphene since the UK ban was announced.

“I took the doctor’s word, and I took the information on that medicine that it was safe. It wasn’t,” Tammy Gilbert tells Cincinnati.com. “This has destroyed our life.”