The issue centered on “causation.” The Supreme Courts’ RICO causation analysis is controlled by the high Court’s decisions in Holmes v. The jury awarded the health insurer $47.3 million in damages, and, per RICO, the judge tripled the damages, for a total jury verdict of $142 million. Pfizer was found to have misrepresented Neurontin’s effectiveness for off-label uses directly to doctors, sponsored misleading informational supplements 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. filed a RICO lawsuit against Pfizer for “engaging in a pattern of racketeering activity consisting of multiple acts of fraud” based on the company’s marketing of Neurontin for multiple off-label uses. However, instead of filing a health care fraud suit, Kaiser and Co. David Franklin, filed a False Claims Act qui tam action in 2001 in which he claimed that Parke-Davis had engaged in a fraudulent scheme to promote the off-label use of Neurontin.Īlmost immediately following the Warner-Lambert settlement, Kaiser and other health insurance plans brought suit, claiming Pfizer’s promotional efforts led them to cover the costs for the off-label treatment of Neurontin, even though the drug’s effectiveness in those off-label uses was often no better than a placebo. Furthermore, a former medical liaison at Warner-Lambert, Dr. Warner-Lambert (which had been acquired by Pfizer) ultimately paid the Government $430 million in civil and criminal penalties. Warner-Lambert entered into a Plea Agreement with the Government in 2004, which specifically stated that the company’s criminal conduct caused $150 million in losses and that, as a result of a prior Food, Drug & Cosmetic (FDCA) conviction, Warner-Lambert’s off-label violations constituted felonies. More than a third of the prescriptions were for higher than approved daily doses or for off-label treatments. In Pfizer’s case, during one year, only 10 percent of Neurontin prescriptions were for on-label uses. The FDA approved Neurontin in 1993 for anti-seizure use by epilepsy patients. The Government charged that the drug’s manufacturer, Warner-Lambert, illegally marketed Neurontin for several off-label uses, including treatment of bipolar disorder, migraines, and Lou Gehrig’s disease.Īs we have written before, while doctors may prescribe and patients may take drugs for unapproved or off-label uses, and private and government payors frequently reimburse such uses, pharmaceutical companies are prohibited from promoting such uses directly to healthcare providers. Furthermore, the decision means that two related cases brought against the company by insurer Aetna Inc. and Harden Manufacturing Corp can also go forward.īackground on Off-Label Promotion Charges Regarding Neurontin: This case is one of only a handful of off-label promotion cases involving the RICO Act, a law traditionally used to combat organized crime. The high court’s denial means that Pfizer has to pay Kaiser $142 million in damages for violating the Racketeer Influenced and Corrupt Organizations (RICO) Act and a further $65.4 million in restitution for violating the California Unfair Competition Law (UCL). The US Supreme Court recently rejected an appeal from Pfizer, letting stand a First Circuit ruling that the drug company improperly marketed the epilepsy drug Neurontin to Kaiser Foundation Health Plan.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |