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12 février, 2008 17:51

James M. Beck

Special to Law.com

11-13-2006

Over the last decade or more, the U.S. Food and Drug Administration has made a number of statements supportive of the pre-emptive effect of its regulatory decisions on private, state-law tort litigation. The first major FDA pronouncement on pre-emption came in an amicus curiae brief filed in the Buckman Co. v. Plaintiffs' Legal Committee case. No. 98-1768, 2000 WL 1364441 (U.S., filed Sep. 13, 2000, Brief for the United States as Amicus Curiae Supporting Petitioner). The FDA supported implied pre-emption of fraud-on-the-FDA claims because such claims interfered with agency enforcement discretion and potentially distorted the information that the FDA desired to receive.

Other FDA-inspired amicus curiae briefs followed. Principally, the FDA took the position that once it had made an affirmative decision that certain labeling statements were not in the public interest, tort claims asserting that the FDA had approved products without the same warnings were pre-empted by reason of their conflict with the prior FDA decision.

Several of these briefs were written in connection with suicide claims involving selective serotonin reuptake inhibitors ("SSRIs"), a class of anti-depressant drugs. Until recently, the FDA had found insufficient scientific evidence to support any association between suicide and these drugs, since the disease they treated, depression, was itself a known source of suicide. Having taken the position that the science did not support a suicide warning, the FDA repeatedly filed amicus curiae briefs to defend its position against contrary tort claims. See Colacicco v. Apotex Inc., C.A. No. 05-5500, 2006 WL 1724170 (E.D. Pa., filed May 10, 2006, Brief for Amicus Curiae the United States of America); Kallas v. Pfizer Inc., No. 2:04CV0998PGC (D. Utah, filed Sep. 15, 2005, Amicus Brief for the United States); Motus v. Pfizer Inc., 2002 WL 32303084 (9th Cir. filed Sep. 3, 2002, Amicus Curiae Brief of the United States).

For similar reasons, the FDA has intervened in litigation involving the asserted teratogenic risks of nicotine-patch smoking cessation devices. Because the agency considers the risks of fetal tobacco smoke exposure to outweigh any risk of birth defects, it has declined to require that these products carry teratogenicity warnings for fear of deterring pregnant women from stopping smoking. See Dowhal v. SmithKline Beecham Consumer Health Care LP, No, S109306, 2003 WL 23527781 (Cal., filed Jul. 18, 2003, Amicus Curiae Brief of the United States of America).

In the medical device field, the FDA has supported pre-emption where the device in question has been approved by the agency through the agency's most rigorous pre-market approval process. Horn v. Thoratec Corp., WL 1143720 (3d Cir., filed May 14, 2004, Letter Brief for the United States of America); Murphree v. Pacesetter Inc., Civ. No. CT-005429-00-3 (Tenn. Cir., filed Dec. 12, 2003, Statement of Interest of the United States of America).

The FDA has also supported pre-emption where a remedy being sought in private litigation would interfere with the agency's power to control drug labeling. Thus, the FDA has opposed private injunctive relief that would have altered FDA-approved labeling. In re Paxil Litigation, 2001 WL 34883537 (C.D. Cal., filed Sep. 4, 2002, Brief of the United States of America); Bernhardt v. Pfizer Inc., No. 00 Civ. 4042 (LMM) (S.D.N.Y., filed Nov. 13, 2000, Statement of Interest of the United States).

Concerned that the courts were not affording its views about pre-emption adequate respect, the FDA on Jan. 24, 2006, promulgated a Final Rule regarding labeling. 71 Fed. Reg. 3922. This rule, published in the Federal Register, is thus subject to mandatory judicial notice, and made many of the same points that the agency had argued in its amicus curiae briefs. Specifically, the pre-emption preamble to the Final Rule takes issue with two general propositions that common-law courts have used to deny pre-emption: (1) the notion of FDA regulations as "minimum standards"; and (2) that regulated entities may make safety-strengthening changes to labeling without prior FDA approval under 21 C.F.R. § 314.70(c). See 71 Fed. Reg. at 3934-35.

Also, the FDA declared that "at least" the following six specific types of common-law labeling claims are impliedly pre-empted:

• Claims asserting that a manufacturer "fail[ed] to put in Highlights or otherwise emphasize any information the substance of which appears anywhere in the labeling";

• Claims concerning direct-to-consumer advertising that assert that a manufacturer "fail[ed] to include in an advertisement any information the substance of which appears anywhere in the labeling" where the manufacturer "used Highlights consistently with" the agency's draft guidance on "brief summaries" in such advertising;

• Claims asserting that a manufacturer "fail[ed] to include contraindications or warnings that are not supported by evidence that meets the standards set forth in this rule" regarding scientific proof of risk;

• Claims asserting that a manufacturer "fail[ed] to include a statement in labeling or in advertising" that "had been proposed to FDA" and that the FDA had "not required … at the time" the plaintiff claims the warning should have been given (unless the FDA first determined that material information had been withheld);

• Claims asserting that a manufacturer was obligated to include information "the substance of which FDA has prohibited"; and

• Claims asserting a manufacturer was obligated not to "mak[e] statements that FDA approved for inclusion in the … label" (unless the FDA first determined that material information had been withheld). 71 Fed. Reg. at 3936.

In the past, however, the FDA espoused positions that were more skeptical about pre-emption, so that the agency's more recent pronouncements can be viewed as a change in its position on the pre-emption question.

For instance, in the initial notice for the same proposed labeling revisions that were the subject of the 2006 Final Rule, the agency stated that only "minimum graphical requirements for labeling" were at issue, and that "the proposed rule does not pre-empt state law." 65 Fed. Reg. 81082, 81103 (FDA Dec. 22, 2000). In connection with a prior rule concerning patient labeling, the FDA both denied pre-emptive intent and characterized its own regulations as "minimal":

"Federal pre-emption could unduly interfere with the goals and objectives of existing State programs … This final rule is intended to complement these State efforts, not replace or hinder them. FDA does not believe that the evolution of state tort law will cause the development of standards that would be at odds with the agency's regulations. FDA's regulations establish the minimal standards necessary, but were not intended to preclude the states from imposing additional labeling requirements. States may authorize additional labeling but they cannot reduce, alter, or eliminate FDA-required labeling." 63 Fed. Reg. 66378, 66384 (FDA Dec. 1, 1998).

Further, in 1997, the FDA filed an amicus curiae brief which minimized pre-emption in the medical device field, characterizing both its pre-market and investigational device approval processes as "general criteria [that] establish minimum standards that do not displace state law standards of care or common law duties respecting the medical device." Smiths Industries Medical Systems Inc. v. Kernats, 1997 WL 33561767, at *15 (U.S., filed Dec. 10, 1997, Brief for the United States as Amicus Curiae). In that amicus brief, the FDA wrote:

"[T]he FDA's grant of a PMA under the statutory criteria provides assurance, but not a guarantee, that the device is safe and effective for its specified use. Where the FDA has taken no further action, the States are entitled to exercise their historic police powers to provide their citizens with additional protection through positive enactments or through imposition of common law duties."

The Supreme Court denied certiorari in Kernats, 522 U.S. 1044; thus, it never passed on the merits of the position espoused by the FDA. Note that the FDA's Kernats brief relied in large part upon a later-withdrawn agency effort to adopt an interpretive rule concerning pre-emption, so its continuing force was questionable even before the FDA revised its position on medical device pre-emption. A few months after the Kernats brief was filed, the FDA withdrew the proposed rule after the agency was discovered to be giving preferential access to a pro-plaintiff group. See 63 Fed. Reg. 39789, 39789 (FDA Jul. 24, 1988) (admitting secret contacts with Public Citizen Litigation Group).

The larger point nevertheless remains: The FDA's pre-emption positions over the years have been less than wholly consistent.