And perhaps to set the stage, just last month, the 6th Circuit Court of Appeals issued an opinion on this very issue.
The Buckman case arose out of a federal multidistrict litigation before Judge Louis C. Bechtle in the Eastern District of Pennsylvania. Due to the multidistrict litigation, Judge Bechtle handled pretrial matters for all federal cases nationwide that alleged product-liability claims pertaining to FDA-regulated medical devices known as "orthopedic bone screws."
The plaintiffs’ "fraud on the FDA" claim is a normal fraud claim — except that the plaintiffs do not allege that the defendants made misrepresentations directly to them. Instead, so the theory goes, the defendant bone-screw manufacturers and regulatory consultants allegedly made misrepresentations to the FDA, and these misrepresentations allegedly were repeated to the plaintiffs’ doctors, who then relied on them in deciding to use the bone screws in medical procedures.
The first significant problem with the plaintiffs’ "fraud on the FDA" claims is that, as Judge Bechtle noted, it is unlikely that any plaintiff will be able to prove that his or her doctor received the misrepresentations purportedly made to the FDA and relied on them in exercising his or her independent medical judgment to proceed with the bone-screw surgery; the causal chain between misrepresentation and harm invariably would be tenuous and speculative. In re Orthopedic Bone Screw Prods. Liab. Litig., 1997 WL 305257 (E.D. Pa. March 28, 1997).
The second significant problem with the "fraud on the FDA" theory is that the validity of the cause of action is undercut by the fact that the Medical Device Amendments to the Food, Drug and Cosmetic Act place the burden of regulatory enforcement on the FDA alone. 28 U.S.C. § 337(a). Because the act grants sole enforcement authority to the FDA, some courts have concluded that private litigants impliedly are barred from enforcing the act or FDA regulations through a private right of action, whether termed "fraud on the FDA" or some other cause of action.
The final problem with the theory is the related issue of whether state-law "fraud on the FDA" claims are pre-empted by federal law pursuant to the Supremacy Clause of the Constitution — and this pre-emption issue may well present the most formidable obstacle to the prosecution of such claims.
To begin with, state-law "fraud on the FDA" claims might be deemed expressly pre-empted. If a jury concludes a bone-screw manufacturer or regulatory consultant should have done something different from what is called for by an express FDA requirement for that medical device, then the state law constitutes a requirement that is "different from or in addition to" federal law and is pre-empted. Unfortunately, the leading case on this issue, Medtronic Inc. v. Lohr, 518 U.S. 470 (1996), was a plurality decision subject to differing interpretations about the reasoning on which five justices agreed.
In addition, state-law "fraud on the FDA" claims might be deemed to be impliedly pre-empted, if the claim conflicts with the federal FDA legislative scheme. After all, as the FDA itself has explained, it has used its authority under the Food, Drug and Cosmetic Act to detail extensive regulations about what information a drug or medical-device manufacturer must provide, as well as a comprehensive scheme for enforcing those disclosure obligations. See Brief for the United States as Amicus Curiae Supporting Petitioner in Buckman Co. v. Plaintiff’s Legal Committee, 2000 WL 1364441 (Sept. 13, 2000).
By imposing tort liability for alleged frauds on the FDA, states could reach conclusions that differ with the FDA’s own conclusions about what those regulations mean and whether they were satisfied — not to mention the real possibility that the states could differ on these issues among themselves.
Moreover, the compensatory and punitive damages payable to an individual available as a tort remedy are not part of the penalty scheme allowed under the Food, Drug and Cosmetic Act. Instead, under the federal scheme, the FDA is vested with the discretion to impose a wide range of penalties (or no penalty) for misrepresentations but cannot order the payment of any damages to individuals.
In a worst case scenario, the conflict between state-law "fraud on the FDA" claims and the federal regulatory scheme for drugs and medical devices could become so acute that the imposition of damages for fraud on the FDA in a civil case would actually harm the FDA’s regulatory efforts. For example, the FDA has explained that its regulatory decisions — including how to punish alleged misrepresentations — must be based on the public’s interests and the purposes of the Food, Drug and Cosmetic Act.
Thus, the FDA may conclude that minor misrepresentations were made but nevertheless allow a medical device to remain on the market due to the benefit it provides to many patients. By contrast, those same patients might be deprived of access to that beneficial medical product if a private litigant obtains a significant punitive-damage award for that same misrepresentation and drives the product off the market.
Despite all these issues, in Buckman Co., the 3rd Circuit concluded that "fraud on the FDA" claims were not necessarily invalid. In particular, the 3rd Circuit reviewed the Lohr decision and concluded that the Food, Drug and Cosmetic Act’s silence on private rights of action did not bar the "fraud on the FDA" cause of action, and federal law did not expressly or impliedly pre-empt the cause of action either. Perhaps because a split already had developed in the circuits on the pre-emption issue [Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir. 1997) (pre-empted); Goodlin v. Medtronic, 167 F.3d 1381 (11th Cir. 1999) (not pre-empted)], and because Buckman highlighted the importance of the issue — Buckman potentially controlled in the 2,300 in the multidistrict litigation — the Supreme Court granted certiorari.
As the parties — and numerous amici — were preparing and filing their briefs to the Supreme Court in Buckman, the 6th Circuit decided to weigh in on the pre-emption issue with Kemp v. Medtronic Inc., 2000 WL 1639629 (6th Cir. Nov. 1, 2000). In that case, the medical device was a pacemaker lead instead of a bone screw, but — in keeping with a trend Buckman helped foster — the plaintiff asserted a "fraud on the FDA" claim. The plaintiff alleged that the defendant manufacturer had obtained the FDA’s pre-market approval to market the device through intentional misrepresentations to the agency.
Like the 3rd Circuit in Buckman, the 6th Circuit discussed and applied Lohr. But contrary to the 3rd Circuit, the 6th Circuit concluded that the plaintiff’s state-law "fraud on the FDA" claim was pre-empted. The court opined that the FDA had set specific federal requirements in granting regulatory approval for the pacemaker leads; thus, allowing any state law to hold a defendant liable on a "fraud on the FDA" claim impermissibly threatened different or additional requirements for the device. Under the Supremacy Clause, federal law controlled and pre-empted the state-law claim.
With the Lohr case now four years old and still causing dissension among the circuits — as demonstrated by Buckman and Kemp — and with "fraud on the FDA" claims increasingly in vogue, the stage now is set for the Supreme Court to decide once and for all whether these claims are viable or pre-empted. If the Court does so in an opinion that reflects a greater consensus than Lohr, the lower courts and litigants should have an easy-to-use blueprint for determining whether other state-law claims also are pre-empted by Food, Drug and Cosmetic Act or other federal regulatory schemes.