But even the usual fluctuations in pre-emption law do not account for the dramatic change wrought by a recent Supreme Court decision. In Buckman Co. v. Plaintiffs' Legal Comm., 121 S. Ct. 1012 (2001), the Supreme Court decided that a federal law — the Medical Device Amendments to the Food, Drug and Cosmetic Act — pre-empted a state law tort claim in a lawsuit stemming from injuries allegedly caused by a prescription medical device regulated by the Food and Drug Administration.
While Buckman's reasoning and holding are sound, it is hard to conceive of a case more different than the Supreme Court’s last decision on the very same issue, Medtronic Inc. v. Lohr, 518 U.S. 470 (1996). In both Lohr and Buckman, the plaintiffs asserted product-liability claims arising from allegedly defective prescription medical devices — a pacemaker in Lohr and orthopedic bone screws in Buckman — but that is where their similarities end.
In Lohr, the court could not agree on whether the express pre-emption clause of the Medical Device Amendments (21 U.S.C. section 306(k)) barred state-law tort claims for design defect and failure to warn. The court issued an 84-page, multi-opinion tome and split 4 (plurality) to 1 (concurring in part) to 4 (concurring and dissenting) in favor of the conclusion that the state-law tort claims were not pre-empted. But in a stunning shift, in Buckman, those same justices voted 9–0 that the state-law tort claim at issue was pre-empted by federal law — and the whole case barely spans nine pages.
Because Lohr involved interpretation of the express pre-emption clause in the federal Medical Device Amendments and Buckman involved implied pre-emption — pre-emption of state law claims by virtue of a conflicting federal regulatory scheme — the two cases can be reconciled. But nevertheless they reflect two remarkably different approaches to federal law pre-emption of state-law tort claims, even though both arose in virtually the same context.
According to Lohr, even though the Medical Device Amendments contained a broadly worded express pre-emption clause, the clause only had express pre-emptive effect in narrow circumstances, turning on whether the FDA had sufficiently scrutinized the questioned device when granting regulatory approval. Even though Lohr narrowly curtailed the utility of the express pre-emption defense, some courts still applied it when the evidence showed careful FDA review of the medical device in question and regulatory approval having a connection with the plaintiff’s state law tort claims. See Kemp v. Medtronic Inc., 231 F. 3d 216 (6th Cir. 2000).
Other federal courts, however, read Lohr's requirements quite restrictively and refused to allow the defense to impede any state law tort claim. See Goodlin v. Medtronic Inc., 167 F. 3d 1367 (11th Cir. 1999).
The issuance of the Buckman case, however, has completely altered this landscape. Buckman arose from claims that patients suffered injuries from orthopedic bone screws implanted into the "pedicles" of their spines. All the federal cases relating to this bone screw litigation were coordinated as a multidistrict litigation, and many of the plaintiffs asserted state-law fraud claims.
With respect to the Buckman Co., the plaintiffs’ theory was that it had made misrepresentations to the FDA when it filed applications and obtained approval for its client, a manufacturer, to market and sell its bone screws. The plaintiffs claimed that but for the Buckman Co.’s alleged misrepresentations, the FDA never would have approved the marketing and sale of bone screws, and without FDA approval, the bone screws would not have been implanted or caused the alleged injuries.
In response to this "fraud on the FDA" claim, the Buckman Co. noted that the plaintiffs’ causation theory was suspect, since the FDA continued to approve the marketing and sale of bone screws even after the allegations of fraud surfaced. The Buckman Co. also asserted a pre-emption defense. The judge ruled that the Lohr test for the express pre-emption clause of the Medical Device Amendments was satisfied.
After the 3rd Circuit concluded that the plaintiffs’ fraud-on-the-FDA claims were neither expressly nor impliedly pre-empted and reversed, the Supreme Court granted certiorari to resolve conflicting decisions about whether fraud-on-the-FDA claims were pre-empted under Lohr. See, e.g., Kemp (pre-empted); Goodlin (not pre-empted); Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir. 1997) (pre-empted).
Ultimately, the court declined to decide the case using the express pre-emption defense and, thus, passed on an opportunity to clarify the fractured Lohr decision. But the court’s focus on implied pre-emption may have been a good thing, since it enabled the court to decide Buckman with an unambiguous rationale and a 9–0 decision in favor of preemption.
As with any pre-emption analysis, the Buckman court first examined whether the allegedly pre-empted state law pertained to an activity traditionally carried out by the states. In Lohr, this examination began with the comment that by passing the Medical Device Amendments with its express preemption provision, Congress was legislating in a field — tort law — traditionally occupied by the states. As a result, the plurality opinion applied a "presumption against pre-emption," which required the court to accord the narrowest possible scope to the federal law’s express pre-emption clause.
In Buckman, however, the court characterized the state activity quite differently — with a dramatically different result. Instead of characterizing the fraud-on-the-FDA claim as simply another tort falling within the traditional area governed by state law, the court said that the claim actually was an attempt by the states to police fraud against a federal agency, and, thus, it was not an activity traditionally carried out by the states.
As a result, the court did not presume that pre-emption would not apply, but instead assumed that the Buckman Co.’s dealings with the FDA were solely a product of the federal scheme for medical devices and, thus, fell in an area that was uniquely federal in nature.
Next, the court took note of the comprehensive nature of the federal regulatory scheme for medical devices. The court observed that federal law already vested the FDA with the power to investigate whether representations made to it were true, accurate and complete, and also vested the FDA with the power to punish and deter fraud.
Moreover, to carry out its duties, the FDA must use its regulatory expertise to decide how best to ensure the safety of the public at large and the availability of medically important products for sick and injured patients. But the FDA’s delicate balancing of competing statutory objectives would be upset if liability resulting from state-law fraud claims forced manufacturers to comply with reporting requirements different from those the FDA imposes. As a result, the court concluded that state-law fraud-on-the-FDA claims had to give way to federal law.
At heart, the Buckman court acknowledged the difficulty medical device manufacturers face when they are subject to differing liability standards for producing products that are vitally important, yet almost always carry some risk of harm. As the FDA itself argued as an amicus curiae for Buckman Co., federal law has given the FDA the primary responsibility for medical devices, and this necessarily requires it to employ its regulatory expertise in carefully balancing competing statutory objectives. See Brief of the United States as Amicus Curiae Supporting Petitioner in Buckman Co., 98-1768, 2000 WL 1364441 (U.S. Sept. 13, 2000).
Accordingly, under Buckman, the FDA, with its experienced scientists and doctors, is left to decide whether a medical device manufacturer has submitted accurate and sufficient documentation of its product’s safety and efficacy, taking into account the good of the public as a whole and not just the concerns of a one-tort plaintiff seeking damages.
With this broad recognition of the important role the FDA plays in balancing competing health and safety concerns, it seems likely that Buckman will invigorate the implied pre-emption defense and lead defendants to argue for its application to claims other than those for fraud on the FDA. After all, the FDA’s decisions about the wording of a medical-device warning label or the safety of a given product design entail no less of a balancing act than its decision that a manufacturer did not commit fraud when it sought regulatory approval. In addition, the FDA’s regulatory scheme arguably is just as endangered when liability is imposed due to a failure-to-warn or design defect claim as it is when liability is imposed for a fraud-on-the-FDA claim. Whether the lower courts will recognize the applicability of Buckman's implied pre-emption analysis to other state-law tort claims, however, remains to be seen.