Drugs and Devices

Statprobe argued that plaintiffs' fraud allegation amounted to a claim of fraud-on-the-FDA, cast as a state law claim, and that any such claim was impliedly preempted by federal law in accordance with the U.S. Supreme Court's holding in Buckman Company v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001). In Buckman, plaintiff users of a medical device sued a consulting company whose role in the device's regulatory progress to market was much like Statprobe's in the present case. Plaintiffs there alleged that the consulting company made fraudulent representations to the FDA in the course of obtaining approval of the device and that but for those misrepresentations the injuries they suffered would not have occurred. The Supreme Court held that the Buckman plaintiffs' claims conflicted with, and were therefore impliedly preempted by, federal law because the subject matter of the alleged fraudulent statements made by the consulting company to the FDA were dictated by federal law provisions. In this context, the Buckman Court found that 'the relationship between a federal agency and the entity it regulates is inherently federal in character because the relationship originates from, is governed by, and terminates according to federal law.'

Also of importance to the Buckman Court were certain public policy considerations: For instance, if device companies were forced to comply not only with the FDA's detailed regulatory regime but also with regulations of the several states, it would discourage innovation and delay the marketing of products valuable to those in medical need. In addition, any required disclosures made to the FDA, although considered appropriate by federal regulators, might be found wanting under state law and could be used against device developers in state forums.