The Food and Drug Administration approved Warner-Lambert's drug Neurontin in 1993 for the treatment of epilepsy. From June 1995 to April 2000, however, Warner-Lambert also engaged in a campaign to promote Neurontin for a variety of "off-label" uses such as pain relief and the treatment of psychiatric conditions such as bipolar disorder and anxiety. Following a six-year investigation of these activities, the United States Department of Justice prosecuted Warner-Lambert for (1) introducing into interstate commerce a misbranded drug that did not have adequate directions on the label for the intended uses of the drug and (2) introducing an unapproved new drug into interstate commerce. Warner-Lambert pled guilty and consented to criminal and civil fines of some $430. Warner-Lambert was acquired by Pfizer, Inc. in 2000.
That was not the end of the "off-label" controversy surrounding Neurontin for in New York one plaintiff sought to commence a statewide class action suit on behalf of all individuals who purchased Neurontin for "off-label" uses. Last Thursday however, the Third Department affirmed a dismissal of the class action suit finding that the plaintiff failed to state a cause of action in Baron v Pfizer, Inc., 2007 NY Slip Op 05813.
The plaintiff's action sounded in fraud, violation of General Business Law § 349, and unjust enrichment based upon the fact that she was prescribed and used Neurontin for neck pain. The plaintiff sought a refund of the purchase price of Neurontin on the ground that she would not have purchased the drug absent defendant's deceptive practices. In finding that the complaint was insufficient, the Court found that the plaintiff failed to allege any actual harm or a pecuniary injury. For instance, the Court noted that the plaintiff failed to allege that the Neurontin was ineffective to treat her neck pain, that the product otherwise adversely affected her health, or that the price of the drug was inflated as a result of the defendant's deceptive practices. The Court also stated that the plaintiff's claim that Neurontin was potentially dangerous was only speculative, and was belied by the fact that the "off-label" use of a drug is a widespread and accepted medical practice. Furthermore, the plaintiff failed to allege that her physician's decision to prescribe the drug was influenced by defendant. The plaintiff also had abandoned her common-law fraud claim during the appeal.
It is unclear how this decision will affect other suits in other jurisdictions.
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