Buckman Preemption & State Safe-Harbor Presumptions of Non-Liability for Approved Warnings

In an attempt to insulate drug and device manufacturers from the flood of tort liability in the latter half of the twentieth century, many states adopted “safe-harbor” statutes. These safe-harbor provisions created the presumption that a drug or device manufacturer was not liable for injuries in tort if the FDA approved the drug or device as “safe and effective” and the drug or device and labeling complied with the FDA’s approval. Yet, some states allowed plaintiffs to rebut that presumption if the manufacturer “withheld information from or misrepresented information” to the FDA.

In 2001, the United States Supreme Court ruled that state law “fraud-on-the-FDA” claims were preempted as the state law claims “inevitably conflicted with the [FDA’s] responsibility to police fraud consistently with the Administration’s judgment and objectives.” Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350 (2001).

At first, the Buckman decision seemed to indicate that such “withholding or misrepresentation” exceptions would also be preempted as the Sixth Circuit applied the Buckman analysis to reach that result. See Garcia v. Wyeth, 385 F.3d 961 (2004).However, a circuit split was soon created when the Second Circuit upheld such an exception as valid. Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2006).

The Second Circuit distinguished Buckman on three grounds. First, the Second Circuit concluded that the cornerstone of the Buckman decision—an absence of the presumption against preemption because states did not have an historical interest in policing fraud against federal agencies—did not apply because states had a traditional interest in protecting the health and safety of its citizenry through common law tort actions. Second, plaintiffs’ claims for recovery were founded in the common law duty of care rather than a new “fraud-on-the-FDA” claim. Finally, proof of “fraud-on-the-FDA” was not an element of the claim but an affirmative defense. Finding preemption where no element of the claim was at issue would stretch preemption far beyond its historical application.

An evenly-divided U.S. Supreme Court, with the Chief Justice abstaining, failed to reverse the Second Circuit in Warner-Lambert v. Kent, 128 S. Ct. 1168 (2008). In 2012, the Fifth Circuit sided with the Sixth Circuit. See Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372 (2012).

A recent district court opinion arising out of the Third Circuit continues that split as The Honorable Robert Kugler of the United States District Court for the District of New Jersey adopted the Second Circuit’s reasoning. As the Third Circuit has not had the opportunity to rule on this split, appellate review of Tigert v. Ranbaxy Pharmaceuticals, Inc., No. 12-00154 (Dec. 18, 2012) will hold important ramifications for what defenses are available to Defendants in three states where mass tort litigation is at home.