In In re Neurontin Marketing, Sales Practices, and Products Liability Litigation, 618 F. Supp. 2d 96 (D. Mass. 2009), numerous plaintiffs sued the manufacturers of an anti-epilepsy drug in various courts alleging that plaintiffs or their decedents suffered various injuries including suicidal behavior or ideation (“suicidality”). The federal actions were consolidated in the United States District Court for the District of Massachusetts, where defendants moved to dismiss the fraud claims in twelve amended complaints, which generally alleged that defendants engaged in a fraudulent scheme to market the drug for off-label uses by misrepresenting to physicians the drug’s safety and effectiveness for such uses and failing to disclose details of the drug’s side effects including suicidality.
As a preliminary matter, the court emphasized the requirement of Fed. R. Civ. P. 9(b) that circumstances alleged to constitute fraud be pleaded with particularity. The court also held as a preliminary matter that a drug manufacturer has a duty affirmatively to disclose to physicians and patients material facts about the risks of a drug, especially when it is engaged in marketing the drug for non-FDA-approved uses, if it knows the plaintiff and/or his prescriber does not know or cannot reasonably discover the undisclosed facts.
The court observed that seven of the twelve amended complaints failed to allege any particular connection between the physician’s decision to prescribe the drug for an off-label use and defendants’ marketing and advertising campaign. The court rejected plaintiffs’ argument that defendants’ campaign was so pervasive that any prescribing physician was “most likely influenced” by it or by another physician who was in contact with defendants, analogizing that argument to the securities law theory of “fraud on the market” and holding that different concepts and policies underlie securities markets than the pharmaceutical industry. The court thus dismissed these seven amended complaints’ fraud claims for failing to allege that a physician relied on a specific statement or misrepresentation.
Turning to the amended complaints that alleged that defendants visited a physician’s office to promote the drug for off-label use, the court found that one amended complaint alleged an affirmative misrepresentation with particularity and accordingly was not subject to dismissal. Plaintiffs argued the remaining amended complaints did not need to allege an affirmative misrepresentation to make out fraud because defendants had a duty to disclose details of the drug’s side effects, including suicidality, where defendants knew that over 90 percent of the drug’s use would be off-label. Although defendants responded that plaintiffs’ argument rendered such fraudulent concealment claims duplicative of plaintiffs’ failure-to-warn claims, the court disagreed, finding that such claims, unlike failure to warn, required scienter in the form of an intent to deceive. The court accordingly declined to dismiss plaintiffs’ fraudulent concealment claims.