The US Supreme Court’s rejection of an appeal from drug maker Pfizer, letting stand a First Circuit ruling that the drug company improperly marketed the epilepsy drug Neurontin to Kaiser Foundation Health Plan, could unleash a flood of cases
Pfizer must pay Kaiser $142 million in damages for violating the Racketeer Influenced and Corrupt Organizations (RICO) Act and an additional $65.4 million for violating the California Unfair Competition Law (UCL).
The Food and Drug Administration (FDA) approved Neurontin in 1993 as an anti-seizure medication. The government charged that Warner-Lambert (acquired by Pfizer) illegally marketed Neurontin for off-label uses, including treatment of bipolar disorder, migraines, and Lou Gehrig’s disease, Policy and Medicine (policymed.com) reports. Doctors may prescribe a drug for any use they deem appropriate, even unapproved or off-label uses, but drug makers are prohibited from promoting drugs to health care providers for any uses other than those approved by the FDA.
The 2010 trial found that Pfizer misrepresented Neurontin’s effectiveness for off-label uses; sponsored misleading informational materials and continuing medical education programs; suppressed negative information about Neurontin; and published articles in medical journals that reported positive information about Neurontin’s off-label effectiveness. The jury awarded the health insurer $47.3 million in damages, and, under RICO provisions, the judge tripled the damages, bringing the award to $142 million, according to Policy and Medicine.
Off-label promotion cases are not usually pursued under the RICO Act, which has traditionally been used in organized crime cases. The Supreme Court decision means that two related cases brought against the company by the insurer Aetna Inc. and by Harden Manufacturing Corp can also go forward, Policy and Medicine reports.