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The Warner-Lambert unit of Pfizer Inc., maker of the epilepsy medicine Neurontin, has been sued in approximately 1,200 lawsuits alleging that the company promoted Neurontin for off-label uses that had not been approved by the U.S. Food and Drug Administration. In the first of the cases to reach trial, a former employee of the company testified in federal court in Boston that Pfizer had trained him from the start to promote the epilepsy drug for thirteen other medical conditions in order to make higher profits from sales of the medication. The problem, testified the former medical liaison with Warner-Lambert, was that such marketing was illegal because Neurontin’s use for the additional ailments had not received approval from the FDA.
Back in 1997, Franklin filed a whistleblower lawsuit under the False Claims Act that exposed Warner-Lambert’s scheme to illegally market the drug for attention deficit disorder and other unapproved uses. When the case was resolved, Franklin received a share of the sizable settlement, in accordance with the Qui Tam provisions of the statute.
The lawsuit at trial in Boston was brought by the family of Susan Bulger, who hanged herself after taking the drug. The Bulger family charged that Pfizer marketed Neurontin for off-label uses and failed to warn that the medication could increase the risk of suicide. In December of 2008, the FDA required all manufacturers of epilepsy drugs, including Neurontin, to include a warning on the label of the known suicide-risk.
The Bulger trial, which began on July 27, was dismissed midway through the trial when an anonymous donor offered to establish a trust to provide for Ms. Bulger’s ten-year-old daughter.
For the full story, go to NewsDay.com and Bloomberg.com.