Thursday, April 26, 2007

Preemption and FDA Archaelogy

One of the more insistent refrains that we hear from plaintiffs in prescription drug cases where implied preemption is at issue is that the FDA’s current position – foursquare in favor of preemption in six specified circumstances – should be ignored because the Agency’s pro-preemption position is “inconsistent” with the supposedly anti-preemption viewpoint that it is said to have previously taken.

We think that argument’s beside the point (but then, that's how we feel about most plaintiff legal arguments – that’s our job), primarily because administrative inconsistency by itself is hardly a disabling factor in this kind of case. “[T]hat the agency has from time to time changed its interpretation. . .does not. . .lead us to conclude that no deference should be accorded. . . . An initial agency interpretation is not instantly carved in stone.” Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 863-64 (1984). Administrative agencies “must be given ample latitude to “adapt their rules and policies to the demands of changing circumstances.” Motor Vehicle Manufacturers Ass’n v. State Farm Mutual Automobile Insurance Co., 463 U.S. 29, 42 (1983). “This Court has rejected the argument that an agency’s interpretation is not entitled to deference because it represents a sharp break with prior interpretations of the statute in question.” Rust v. Sullivan, 500 U.S. 173, 186 (1991) (citation and quotation marks omitted).

To date, courts have respected the FDA’s current preemption positions even when there has actually been an outright reversal of prior views. For example, the Supreme Court unanimously found preemption in Buckman Co. v. Plaintiffs’ Legal Committee, despite the FDA unquestionably having previously taken a contrary position. See 531 U.S. 341, 354 n.2 (2001) (noting 1994 “FDA amicus brief that “took the position that state-law tort suits alleging fraud in FDA applications for medical devices do not conflict with federal law”) (Stevens, J. concurring).

As to pre-market approved medical devices, the FDA’s current position in favor of broad tort preemption is a 180ยบ reversal of the Agency’s prior position, but because the current position is well-explained, it remains worthy of deference. Riegel v. Medtronic, Inc., 451 F.3d 104, 125 (2d Cir. 2006) (“It is certainly true that FDA previously took a different view, but. . .an agency may change its course so long as it can justify its change with a ‘reasoned analysis’”) (citation and quotation marks omitted); Horn v. Thoratec Corp., 376 F.3d 163, 179 (3d Cir. 2004) (“We cannot agree that the FDA’s position is entitled to no deference, or ‘near indifference’ simply because it represents a departure from its prior position”).

But beyond the “foolish consistency is the hobgoblin of small minds” argument, we wondered about the accuracy of the factual underpinning of the plaintiffs’ “inconsistency” argument. Some of the briefs we’ve seen attack the FDA’s position as some sort of Bush administration conspiracy. That’s just hooey. The FDA’s first three pro-preemption amicus briefs were filed in 2000 by the Clinton administration FDA and Justice Department. See our prior post on FDA amicus briefs for details, here.

So just how accurate is the other factual assumption that plaintiffs make – that the FDA once steadfastly opposed implied preemption of tort law by its regulations? This has been called the “era of good feelings” argument. Richard A. Epstein, “Why the FDA Must Preempt Tort Litigation: A Critique of Chevron Deference and a Response to Richard Nagareda,” 1 J. Tort Law Art. 5 at p. 4 (2006). This argument pre-supposes an administrative consensus before 2000 that conflict preemption was unnecessary because tort law and the FDA “administrative state” peacefully coexisted.

Well, now we’ve looked, and we can tell you – t’aint exactly so. If there’s a case to be made for FDA “inconsistency,” it’s during the pre-2000 period. We now have evidence.

That evidence is an FDA amicus brief filed in 1992 – squarely during the commissionership of Dr. David Kessler, the last FDA commissioner that plaintiffs don’t say bad things about – arguing in favor of implied preemption by reason of conflict in a state tort suit called Biffle in Texas. A copy of that brief is here.

The FDA’s Biffle brief concerned the propriety of state-law discovery rather than a state-law cause of action, but be that as it may, the point we’re making is the same. Once the FDA came around in 2000 to the pro-preemption position that it continues to hold to this day, the Agency has been more consistent in its views on preemption than it ever was before 2000 when plaintiffs allege that the FDA adhered to an anti-preemption party line. That being the case, how can courts justify dismissing the FDA’s current position as “inconsistent” with a prior position that wasn’t consistently held in the first place? In light of the FDA’s pro-preemption position in Biffle, the contention that the FDA was “consistently” anti-preemption prior to 2000 is exposed as the myth that it is.

So what went on in Biffle? It was yet another anti-depressant suicidality case, and that case apparently was the FDA’s first brush with how profoundly destructive that litigation has been of practically every FDA administrative policy with which it has come into contact. In addition to the usual discovery, plaintiffs demanded that the defendant produce the Adverse Drug Experience reports (“ADEs”) that it had received from doctors around the country – reports that the defendant was obligated to submit, in turn, to the FDA.

The dispute centered over the defendant’s insistence – in conformity with FDA regulations at the time – that the confidentiality of the doctors who filed the ADEs be respected. The defendant insisted on redacting the doctors’ identifying information, and the plaintiffs refused. The trial court gave the back of its hand to the FDA’s promise of confidentiality to the medical profession and ordered production of unredacted reports.

At this point the FDA became involved. To encourage physicians to prepare ADEs, the FDA had written reporter confidentiality into its regulations. “Regulations governing the disclosure of information. . .expressly prohibit FDA from revealing the information Plaintiffs seek here.” Biffle br. at 2 (citing 21 C.F.R. §430(e) (1992)). Unfortunately, the regulations covered only the FDA – allowing plaintiffs to argue that nothing prevented them from obtaining unredacted ADEs directly from manufacturers through discovery.

FDA said “no.” The regulations, although not precisely applicable, reflected an Agency policy of encouraging reporting by offering confidentiality to litigation-adverse physicians:


Underlying this regulatory scheme is FDA’s policy judgment, based on decades of experience, that maintaining the confidentiality of the reporters’ identities is necessary to ensure the viability of the system for reporting of adverse drug reactions.
Biffle br. at 4.

In the FDA’s view, once it had established a confidentiality policy, state-law discovery requirements that did not preserve reporter confidentiality were subject to implied conflict preemption. Biffle br. at 5-6. Moreover, the FDA argued in favor of “obstacle” preemption – demonstrating that the Agency has never adhered to the view that this form of preemption was in any way impaired by uncodified 1962 language that some plaintiffs have recently seized upon:


[T]he [state court] orders compel disclosure of the reporters’ identities while the regulations are premised on a policy to prevent such disclosure. This Court’s orders effectively stand as an obstacle to the accomplishment and execution of the full purposes and objectives of the federal regulations.
Biffle br. at 7 (emphasis added). And again, later on:


[T]he orders are pre-empted not because the regulations prohibit Defendants from disclosing the reporters’ identities, but because they are facially inconsistent with the policies underlying those regulations and thus impede the accomplishment of the federal objectives.
Biffle br. at 9-10 (emphasis added). Clearly, a claim that the 1962 language excluded “obstacle” preemption would have been news to the FDA – even though at the time of the Biffle brief, that language had already been moldering for thirty years.

Finally, in Biffle, the FDA made clear that it wasn’t arguing any form of field preemption (“not to suggest that federal regulation of pharmaceuticals. . .pre-empts all efforts by state courts or legislatures to regulate the industry”). Biffle br. at 7. It couldn’t, even if the Agency had wanted to, because the FDA’s confidentiality regulations did not “impede, or even address” substantive tort law. But with respect to reporter confidentiality, where the FDA had in fact spoken, “any state efforts inconsistent with firmly established federal policy and regulations must yield.” Id.

So what happened after the FDA filed its brief in Biffle? Two things: First, the Texas Supreme Court deferred to the FDA’s confidentiality policy and entered a mandamus order.


The FDA regulations clearly embody a vital public interest in confidential voluntary reporting that is eviscerated as equally by a manufacturer’s compelled disclosure as by the FDA’s disclosure. While [defendant] claims no privilege per se in maintaining reporter confidentiality, we do not doubt its protectable economic interest – in addition to the public interest, as asserted here by the FDA – in maintaining the free flow of information derived from adverse reaction reports. Consequently, we agree that the congressional objective of fostering post-approval reporting of possible adverse reactions for all FDA-approved drugs is severely compromised by the trial court's order of wholesale disclosure of reporters' identities.
Eli Lilly v. Marshall, 850 S.W.2d 155 (Tex. 1993) (Marshall was the judge who was subject to mandamus, the Biffles were the real parties in interest). It must be pointed out, however, that this ruling rested on voluntary deference, not preemption. Marshall held only that the defendant was “ordered to act in a manner inconsistent with the public interest concerns manifested by federal law, and without due consideration having been given to those concerns, that order is erroneous as a matter of law.” Id. at 160.

Second, because the Marshall court (and others) did not pay sufficient heed to the Agency’s preemption arguments, the FDA undertook formal rulemaking in 1994 to make federal preemption of contrary state law explicit. See 59 Fed. Reg. 3944 (FDA Jan. 27, 1994); 21 C.F.R. §20.63(f)(2). Sound familiar? The parallel to the current situation – where FDA also filed pro-preemption amicus briefs before resorting to the Federal Register – is unmistakable. Indeed, the Preemption Preamble cites the Agency’s post-Biffle/Marshall rulemaking as an example of how it “previously preempted State law requirements relating to drugs in rulemaking procedures.” 72 Fed. Reg. 3922, 3935 (FDA Jan. 24, 2006).

So there it is – further proof that the sudden harping upon FDA “consistency” in the preemption context is a bunch of malarkey. What’s undeniable is that, since early 2000, the FDA has more consistently supported implied preemption than it previously had ever consistently opposed implied preemption.

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