First Circuit Vacates Denial Of Class Certification In Opinion Concerning Pfizer’s Off-Label Marketing Of Neurontin


In Harden Manufacturing Co. v. Pfizer, Inc., 712 F.3d 60 (1st Cir. 2013), one of three cases addressing Pfizer’s off-label marketing of the anticonvulsant drug, Neurontin, the First Circuit vacated the district court’s denial of certification as to a putative class of third-party payors and remanded for further proceedings. The court relied on its holdings pertaining to RICO causation in the lead case, Kaiser Foundation Health Plan, Inc. v. Pfizer, Inc., 712 F.3d 21 (1st Cir. 2013), to conclude the district court’s decision about the Harden plaintiffs’ second motion for class certification required further analysis, specifically as it related to proof of causation and damages.

This trio of cases concerned Pfizer’s off-label marketing of Neurontin and plaintiffs’ efforts to recover for the Neurontin prescriptions they had thereby been fraudulently induced to pay. In Kaiser, Plaintiffs’ primary evidence of causation and injury was provided by the expert testimony of Dr. Meredith Rosenthal, a Ph.D. in health economics from Harvard and Professor at the Harvard School of Public Health. Dr. Rosenthal compared Pfizer’s promotional spending to patterns in prescriptions using aggregate data and statistical approaches. Based on regression analysis, Dr. Rosenthal found a causal connection between Pfizer’s fraudulent marketing and the number of Neurontin prescriptions written for off-label indications. Rejecting Pfizer’s arguments to the contrary, the court concluded that Dr. Rosenthal’s use of aggregate evidence was sufficient to show causation for RICO claims based on fraudulent marketing.

Relying on that holding, the court concluded in Harden that the district court’s denial of class certification should be vacated. The court noted that the district court based its denial on the determination that Dr. Rosenthal’s report could not provide proof of causation or damages and on the conclusion that “a class action would be ‘unmanageable’ due to the requirement of a ‘granular doctor-by-doctor analysis’” to establish whether Pfizer’s fraudulent marketing caused an increase in off-label Neurontin prescriptions. Harden, 712 F.3d at 70. Because it had concluded in Kaiser, generally, that the use of aggregate evidence and statistical regression analysis was acceptable in fraudulent-marketing RICO claims and, specifically, that Dr. Rosenthal’s testimony could provide such evidence in this matter, the First Circuit vacated the district court’s denial of class certification and remanded for further proceedings.


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