No Way Around It: The Need for Federal "Permission and Assistance" Can Preempt a State Tort Duty

Note: Butler Snow represents companies that have been parties to cases referenced in this article. The information in this article derives solely from an analysis of the publicly reported decisions.

In the simplest case for federal preemption, federal law prohibits conduct that a state tort duty would require, such as a change in the design of an approved medical device to cure an alleged defect. Because federal law is supreme, it preempts that duty.¹

In 2011, the U.S. Supreme Court extended this principle and held that, even absent a federal prohibition, federal law would preempt a state tort duty if federal “permission or assistance” were required before the defendant could comply with the state duty. In PLIVA, Inc. v. Mensing,² the plaintiff challenged the accuracy of the label on a generic drug. Under federal law, the manufacturer could not change the label without the permission of the Food and Drug Administration (FDA). In an opinion by Justice Clarence Thomas, the Court not only found preemption but also rejected a claim that the manufacturer had a duty to ask for the change.

The test, the Court said, was whether the defendant could “independently do under federal law what state law requires of it,”³ and:

[W]hen a party cannot satisfy its state duties without the federal government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, the party cannot independently satisfy those state duties for preemption purposes.⁴

The Court dismissed contentions about what the FDA might do if a change had been requested as mere “conjectures.”⁵

Since Mensing, parties have debated the reach of this doctrine. While the answers have not been uniform, in general they have been as follows:

• Is it limited to generic drug cases? No.
• Is it limited to FDA cases? No.
• Can it be avoided by arguing that the defendant should have simply stopped selling the drug or device? No.
• Can it be avoided by arguing the defendant had a duty to act differently when the defendant first sought permission to market the drug or device? No.

Here are some of the leading decisions on both sides:

As would be expected, defendants have successfully invoked “special assistance and permission” preemption in cases (like Mensing) that challenge the composition or labeling of a generic drug.

In Metz v. Wyeth LLC,⁶ the United States District Court for the Middle District of Florida held that any claim that a generic drug manufacturer “should have redesigned metoclopramide to alleviate the risks associated with its long-term use” as well as any claim that it “should have pulled the generic version … from the market,” were preempted.⁷

In Strayhorn v. Wyeth Pharms., Inc.,⁸ the United States District Court for the Western District of Tennessee decisively stated, “Mensing means what it says: all failure-to-warn claims against generic drug manufacturers are preempted if generic manufacturers cannot independently alter their warning labels.”⁹

But the courts have not stopped there. They have also applied the doctrine to brand-name drugs in rejecting design defect claims, i.e. claims that the manufacturer should have changed the formulation or dosage of the drug or made some other “major change” to the drug’s design.¹⁰ Such a change requires FDA permission, even though it is not necessarily required to change brand-name labeling.

For example, in Yates v. Ortho-McNeil Pharm., Inc.,¹¹ the Sixth Circuit determined that a plaintiff’s design defect claim was preempted when the plaintiff’s state law claim would have required the defendant (a brand-name manufacturer) to change the product’s design.¹² The Sixth Circuit held that the plaintiff’s claim was “clearly preempted” because “[q]uite simply, federal law prohibited defendants from decreasing the dosage of estrogen post-approval.” In other words, any such design change would require the FDA’s permission.¹³

In Barcal v. EMD Serono, Inc.,¹⁴ the United States District Court for the Northern District of Alabama found that the plaintiff’s design defect claims were preempted because once the FDA approved the formulation of the prescription fertility drug at issue, the manufacturer could not change the drug’s composition without the FDA’s prior approval (i.e., the FDA’s special permission and assistance).¹⁵

In Robinson on Behalf of T.R. v. Eli Lilly & Co.,¹⁶ the plaintiff’s design defect claim was that “the chemical makeup of Prozac … created the risk suffered by T.R.” In other words, the plaintiff claimed the formula of Prozac itself was defective.¹⁷ The United States District Court for the Eastern District of Kentucky found that the plaintiff’s design defect claims were preempted because “Eli Lilly could not have independently made such fundamental changes to Prozac’s formula.”¹⁸

At issue in Gustavsen v. Alcon Laboratories, Inc.¹⁹ was whether the defendants could be required by state law to design the dropper tips of the containers dispensing their respective prescription eye drops in such a way as to dispense smaller drops (i.e., to dispense less solution).²⁰ The United States District Court for the District of Massachusetts determined that because changes to the size or shape of the dropper tip would be “major changes” under the applicable FDA regulations,²¹ such changes would require preapproval by the FDA. In other words, once the original container or container closure system was approved by the FDA, additional changes to the container closure system could not be made without the FDA’s special permission and assistance.²² See also Mutual Pharmaceutical Co., Inc. v. Bartlett: (“[o]nce a drug—whether generic or brand-name—is approved, the manufacturer is prohibited from making any major changes to the ‘qualitative or quantitative formulation of the drug product’”).²³

Courts have applied this conflict preemption principle in cases that have nothing to do with the FDA or with drugs or devices, which reinforces the view that it is not confined to generic drug cases.

In Horsemen’s Benevolent & Protective Ass’n-Ohio Div. Inc. v. DeWine,²⁴ the Sixth Circuit Court of Appeals examined whether an Ohio statute allowing racetracks to “secure authorization to simulcast races [for purposes of off-track wagering] even if they have not obtained consent from the horsemen’s group” was preempted by a federal statute requiring written consent of the horsemen’s group to off-track wagering.²⁵ Applying Mensing, the Sixth Circuit found that the state and federal laws “directly conflict[ed]” and, as a result, the Ohio statute was preempted.²⁶

In Sikkelee v. Precision Airmotive Corp.,²⁷ the Third Circuit Court of Appeals vacated a summary judgment ruling based on “field preemption” but remanded the case so that the district court could consider the application of “traditional conflict preemption principles.”²⁸ Field preemption applies when “federal law leaves no room for state...