Photo of Bexis

When we started this blog, we thought we were writing primarily for lawyers who defend pharmaceutical and medical device companies for a living. That’s still our main audience, and we try pretty hard not to bore that gang.

Over time, however, we’ve received a fair number of visits from the press. And several reporters have now asked us about the difference between the preemption defense in the context of drugs and devices. Why, reporters ask, are we talking about Riegel v. Medtronic as being a “device” preemption case that’s in the Supreme Court, and Colacicco v. Apotex as a “drug” preemption case that’s in the Third Circuit? When the Supreme Court decides Riegel, won’t that resolve the whole enchilada, for both drug and device companies, at once?

In a word, no.

This post explains why.

Our regular readers, who know the difference between drug and device preemption in their sleep, should skip this post and come back in a couple of days. For everyone else, here’s the story.

When there’s federal law on a subject, it trumps state law on the same subject. Federal law is “supreme.”

Why? Because the “Supremacy Clause” of the United States Constitution says so: “This Constitution, and the Laws of the United States which shall be made in Pursuance thereof; and all Treaties made, or which shall be made, under the Authority of the United States, shall be the supreme Law of the Land . . . .” U.S. Const., Art. VI, cl. 2. The Supremacy Clause has been interpreted to mean that federal law trumps state law when (1) Congress expressly preempts state regulation; (2) Congress intends federal law to occupy the field; or (3) state law conflicts with federal law. Crosby v. National Foreign Trade Council, 530 U.S. 363, 372 (2000). For obvious reasons, the first category is generally known as “express” preemption; the second as “field” preemption; and the third as “conflict” preemption.

For medical devices, there’s a law that expressly says that the FDA’s regulation of medical devices displaces state law. Thus, for medical devices, the spat is about “express” preemption. The relevant statute, 21 U.S.C. § 360k(a), provides:

§ 360k. State and local requirements respecting devices

(a) General rule

Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement

(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

That language leaves an awful lot for lawyers to quibble about. What does “different from, or in addition to” mean? What are “requirements”? What is “other matter included in a requirement”? And so on. But state laws — such as jury verdicts — that impose requirements different from, or in addition to, those imposed by the FDA are void. Thus, a jury verdict cannot compel a device manufacturer to give a warning that federal law does not require (or prohibits). For medical devices, that’s the battle.

For drugs, the legal sandbox is different.

Unlike the law governing medical devices, there is no statute that expressly says that FDA regulations displace state law. Thus, in the drug field, there’s no issue about “express” preemption or quibbling about the meaning of words in a federal statute. The second type of preemption — “field” preemption — is a notoriously narrow doctrine, which applies to very few areas of law; pharmaceuticals is not one of them. So, for drugs, the battle ground is “conflict” preemption.

Conflict preemption occurs “where it is impossible for a private party to comply with both the state and federal law” or when “‘under the circumstances of [a] particular case, [the challenged state law] stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.’” Crosby v. National Foreign Trade Council, 530 U.S. 363, 372-73 (2000) (citation omitted); see also Geier v. American Honda Motor Co., 529 U.S. 861, 873 (2000).

Preemption is not limited to displacing state statutes. State-law tort obligations — such as liability imposed by juries in product liability cases — may be preempted when they are founded upon duties that conflict with federal law. See, e.g., Geier, 529 U.S. at 882 (state-law tort obligation to install automobile airbags preempted); Cipollone v. Liggett Group, Inc., 505 U.S. 504, 521 (1992) (state-law tort obligation to warn of health risks of cigarette smoking preempted). And it does not require a federal law (passed by Congress) to displace state law. Federal regulations, such as those enacted by the FDA, “have no less pre-emptive effect than federal statutes.” Fidelity Fed. Sav. & Loan Ass’n v. de la Cuesta, 458 U.S. 141, 153 (1982).

When drug companies raise the preemption defense, they are saying that FDA regulations compel the manufacturer to do certain things — give certain warnings, manufacture a drug a certain way, and so on — and juries cannot require the manufacturer to act differently. If juries required manufacturers to act in ways that federal law forbids, then it would be “impossible for [the manufacturer] to comply with both the state and federal law” — the definition of “conflict” preemption.

In short, for medical devices, the question is “express” preemption: Does the governing federal statute displace state law?

But, for drugs, the question is “conflict” preemption: Could a jury verdict require a drug manufacturer to do something that federal law forbids?

Frankly, the more we’re typing, the crazier this regulatory scheme seems. But don’t blame us. Congress passed these laws; we just live with ’em.

We hope this explanation helps.