The U.S. Food and Drug Administration is taking novel action, in the form of final rule statements, to assert federal preemption in the field of prescription drug labeling. 71 FR 3922 (Jan.24, 2006). While a preemption defense has been an uphill battle in prescription drug and medical device cases in Oregon since the Mears v. Marshall opinion in 1997, the FDA’s new final rule provides strong support for defendants attempting to establish preemption by meeting the two-part test set forth in Mears. 149 Or App 641, 944 P2d 984 (1997). The rule, effective June 30, 2006, is intended to make drug labels and inserts more readable for both doctors and consumers by requiring "highlights" and "table of contents" sections, and mandating the use of less technical information and language. The rule applies to all human prescription drugs (including biological products regulated as prescription drugs) that are either newly approved or have been approved in the past five years; manufacturers of drugs approved more than five years ago may elect to comply with the new drug labeling requirements by submitting new labeling for FDA approval.
Changes in prescription drug labeling requirements embodied in the FDA’s final rule were initially proposed in December 2000. 65 FR 81082. A comment period was offered, closing in June 2001. During the comment period, several manufacturers raised concerns that streamlined drug labels and inserts would make manufacturers more vulnerable to state product liability and labeling law claims. Manufacturers of older prescription drugs also raised concerns that new labeling requirements would make them subject to lawsuits unless they also submitted new labels for approval. The FDA takes the position that preemptions should prevent these problems, stating the "FDA believes that under existing preemption principles, FDA approval of labeling under the act, whether it be in the old or new format, preempts conflicting or contrary State law." 71 FR at 3934 (emphasis added).
In a strongly worded discussion of federalism, the FDA asserts in the final rule that it is "the expert Federal public health agency charged by Congress with ensuring that drugs are safe and effective, and that their labeling adequately informs users of the risks and benefits of the product and is truthful and not misleading." 71 FR at 3934. Based on this role, the FDA’s labeling review process must preempt state product liability or labeling laws. Id. The rule cites several potential risks posed by state law interference with federal labeling standards. For example, state laws could frustrate the FDA’s regulation of prescription drugs, and could impede the FDA’s determinations of the appropriate (not just minimum) amount of information presented in prescription drug labels and inserts. Id. State law requirements could induce manufacturers to include "speculative risks" in drug labeling that could impede a doctor’s ability to appreciate far more significant risks; "[o]verwarning, just like underwarning, can…have a negative effect on patient safety and public health." Id. at 3935. "Defensive labeling" by manufacturers, including warnings for scientifically unsustained concerns, could lead consumers to unnecessarily avoid beneficial drug treatments. Id. at 3935-36. Finally, the FDA notes that state product liability or labeling law actions require a judge or jury to substitute their lay opinions for the expert decisions reached through the FDA. Id.
The final rule lists the types of claims the FDA believes are preempted, including failure to warn claims based on (1) failing to place information in the "highlights" section, (2) failing to include specific information in the drug label or insert, (3) failing to include contraindications or warnings unsupported by sufficient scientific evidence, (4) failing to include proposed language that the FDA has not required, and (5) failing to include language that the FDA has not required, and (5) failing to include language prohibited by the FDA. 71 FR at 3935-36. The FDA specifies that federal preemption extends to health care practitioners as well as manufacturers. Id.
While the agency’s statements are not binding on courts, they may be accorded significant deference by the courts. See Medtronics, Inc. v. Lohr, 518 U.S. at 496. Therefore, the statements in the FDA’s final rule reinvigorate a preemption defense in prescription drug product liability or labeling cases, principally in "failure to warn" cases. Some courts have accepted preemption, see Ehlis v. Shire Richwood, Inc., 233 F Supp 2d 1189, 1198 (D ND 2002), aff’d on other grounds, 367 F.3d 1013 (8th Cir 2004). Other courts have rejected preemption, see Motus v. Pfizer, Inc., 127 F Supp 2d 1085 (C.D. Cal. 2000); In re Paxil Litigation, 2002 U.S. Dist.Lexis 16221 (CD Cal Aug. 16, 2002). The Ninth Circuit ruled in favor of preemptions in the context of the 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act. Papike v. Tambrands, Inc., 107 F.3d 737 (9th Cir.)(upholding summary judgment on a failure to warn claim where state law would require warnings in addition to or different from the FDA, based in part on specific preemption language), cert. denied 522 U.S. 862 (1997); c.f. Medtronics, Inc. v. Lohr, 518 U.S. 470 (1996), but see Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005).
The Mears ruling by the Oregon Court of Appeals also examined preemption in the context of the Medical Device Amendments, 149 Or App 641, 944 P2d 984 (1997); see also Brown v. Chas. H. Lilly Co., 161 Or App 402, 985 P2d 846 (1999) (FIFRA pesticide labeling case). The Medical Device Agreements (MDA) contain a specific preemption provision prohibiting states from establishing or retaining any requirements that are different from or in addition to the MDA as applied to the device. 21 U.S.C. §360(k). Mears involved a cosmetic collagen injection regulated under the MDA. 149 Or App at 643, 646. The trial court granted summary judgment based in part on federal preemption. The Court of Appeals originally upheld the ruling, but reversed on remand after the U.S. Supreme Court’s opinion in Medtronics, Inc. v. Lohr was issued. Following Medtronics, the Court of Appeals held that there is no state law preemption unless (a) the federal law imposes requirements on the manufacturing or labeling of a product, and (b) the state common-law requirement would impede the ability of federal regulators to implement and enforce the federal requirements. The court then concluded that none of the plaintiff’s claims was preempted as a matter of law. Applying the FDA’s preemption discussion in its new prescription drug labeling rule to the test set forth in Mears may now lead to federal preemption in at least some cases.
The changes to the federal regulations governing content and format for prescription drug labeling proposed in 2000 did not include a discussion of the FDA’s position regarding preemption. Organizations such as the National Conference of State Legislatures have raised procedural objections to the preemption statements contained in the final rule adopted over five years later. It is interesting to note that the FDA has a history of using its rulemaking process to assert preemption. Preemption was raised during adoption of tamper-resistant packaging requirements for over-the-counter drugs in 1982. 47 FR 50442, 50447 (Nov.5, 1982); see also 47 FR 54750 (Dec. 3, 1982). The FDA reasserted this position in subsequent years in regulations relating to aspirin labeling (51 FR 8180, Mar.7, 1986), and regulations relating to non-disclosure of adverse events (59 FR 3944, Jan. 27, 1994).
Helpful discussions on federal preemption can be found also in amicus briefs the agency has filed over the past 30 years. For example, the FDA filed a brief asserting preemption in a California case that alleged that a nicotine replacement therapy manufacturer had a duty under California state law to include specific warnings even though the FDA specifically rejected the proposed warnings as lacking scientific evidence. Downhaul v. SmithKline Beecham Consumer Healthcare, 2002 Cal. App. Lexis 4384 (Cal. Ct. App), reversed 2004 Cal. Lexis 3040 (Cal. April 15, 2004); see also Jones v. Roth Packing Co., 430 U.S. 519 (1977).
The final rule contains an extensive discussion of the FDA prescription drug labeling approval process, and the risks posed by state law interference with the process and result. 71 FR 3922, 3933-36, 3967-69. This discussion may be useful for Oregon practitioners making arguments based on preemption in drug and medical device cases.
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