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In today's notoriously litigious atmosphere, a spark of governmental investigation can quickly ignite into product liability litigation. The events surrounding the recent $430 million Neurontin global agreement provide a notable example.
The Investigation
In 1996, former medical liaison for Warner-Lambert (the “company”), Dr. David Franklin, filed a qui tam action alleging that the company was marketing the drug Neurontin for uses not approved by the U.S. Food and Drug Administration (“FDA”). Dr. Franklin alleged that the company had knowingly engaged in conduct that caused violations of federal Medicaid statutes and regulations. He alleged that although the company knew that it was unlawful to promote a drug for off-label uses without first proving to the FDA that the drug was safe and effective for the intended use, the company chose to forego seeking FDA approval and engaged in a deceptive marketing scheme that included providing kickbacks to physicians for promoting and writing Neurontin prescriptions.
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