Rebutting the implied-preemption defense: in products suits, drug companies are seeking immunity under theories of implied preemption. Their arguments are flawed.

For more than a century, patients who have been injured by drugs and medical devices have sued manufacturers tot breach of common law duties. (1) In the early 1990s, medical device manufacturers began to argue that the law regulating their products immunized them from liability by expressly preempting state law damages claims. They premised this argument on a provision of the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act (FDCA), enacted to preempt certain state and local regulation of medical devices. The argument has met with mixed success. (2)

The FDCA contains no express preemption provision regarding prescription drugs, and, until recently, drug companies have not typically raised a preemption defense in products cases. Now, however, drug manufacturers are arguing, with increasing frequency, that federal law preempts state law suits.

Thus far, drug manufacturers have used this argument only with respect to failure-to-warn claims. Yet their theory, if adopted, would support broad immunity from products liability suits. This implied-preemption argument has several flaws, however, and the companies' attempts to evade responsibility for injuries caused by their products should fail.

Damages suits for drug-related injuries are generally based on theories of negligence or strict liability, for product defects or inadequate warnings. Relying on the FDA's marketing approval for new drugs, which includes scrutiny of clinical trials, manufacturing processes, and labeling, a company arguing that state law claims are preempted will focus on implied conflict preemption. The argument may be either that complying with both federal regulations and state laws is impossible, or that complying with the state laws would frustrate the purposes of the federal regulation.

A defendant arguing "impossibility" would not claim that it was physically impossible to provide the warning that the plaintiff alleges state law required. Instead, it would claim that FDA regulations prohibited the company from providing the warning and that, if the drug company had provided it anyway, the FDA would have considered the product misbranded and taken enforcement action against it.

In making these arguments, the company may claim either that the common law duties on which a claim is based establish a conflict or that a plaintiff verdict would impose duties that would conflict with federal law. In the latter case, for example, the defendant might suggest that a verdict finding that the company failed to warn of a known risk associated with its product is equivalent to a state law requirement that it add such a warning to the product's label.

However, a plaintiff verdict requires only that the defendant pay damages, not that it alter its product or label. (3) Indeed, a core principle of strict products liability is that although some potentially dangerous products will cause harm on occasion, it benefits society as a whole to keep them on the market and to compensate injured parties through the tort system. (4) Nonetheless, to fashion a preemption defense, defendants tend to overstate the regulatory effect of a plaintiff verdict. (5)

Presumption against preemption

In these cases, a presumption against preemption applies and may be overcome only by "clear and manifest" congressional intent to the contrary. (6) When Congress was considering the legislation that it ultimately enacted as the FDCA of 1938, it made clear its intention with regard to the effect on state-law damages claims: Congress specifically rejected a proposal to include a private right of action for damages caused by faulty or unsafe products that are regulated under the FDCA because such a right of action already existed under state common law. (7)

The notion that when Congress declined to provide a federal private right of action because state law already provided one, it approved a regulatory scheme that impliedly preempted those state remedies, is illogical. (8) Thus, it is not surprising that, since the FDCA's enactment 65 years ago, only one reported decision has held th at the act preempts common-law damages claims in pharmaceutical cases. (9)

Furthermore, where an allegedly pre-emptive federal regulation does not provide a damages remedy, the U.S. Supreme Court assumes that Congress intended preemption only in the most compelling circumstances. (10) Whether or not a drug company explicitly argues that all of a plaintiff's claims are preempted, the reasoning in rawer of preemption would open the door to sweeping preemption of personal injury claims related to prescription drugs. Therefore, the presumption against preemption requires that when the answer to the question of whether a state law claim is preempted is ambiguous, the court resolve the ambiguity in the plaintiff's favor.

High Court view

The Supreme Court's most recent look at implied preemption in a personal injury case is its 2002 ruling in Sprietsma v. Mercury Marine. That case involved the Coast Guard's 1990 decision not to issue a regulation addressing propeller guards on motor boats, but in stead to study the issue further.

The Court considered whether this decision impliedly preempted a state law claim that a boat was unreasonably dangerous because it lacked a guard. Finding no preemption, the Court explained that "it is quite wrong" to view a decision declining to impose a requirement as the "functional equivalent" of a prohibition against state regulation of the subject matter. Rather, a decision not to take regulatory action leaves the applicable law "exactly the same" as it was before the agency considered the matter."

In the context of prescription drugs, the FDA's decision whether express or implicit--not to require a particular warning will almost always mirror the situation presented in Sprietsma. That is, the defendant will premise its preemption argument on a requirement not imposed. The FDA rarely, if ever, prohibits a drug company from adding a warning.

In many failure-to-warn cases, the FDA will not have expressly discussed the warning at all. And in most cases in which the agency has considered but decided not to require a warning, it will not have prohibited the warning.

In these circumstances, as the Department of Justice explained in its brief to the Supreme Court, "the mere fact that the agency has made a considered decision to forgo federal regulation does not, in and of itself, give rise to an inference that all state law on the subject-including state tort law--is meant to be preempted." (12)

Often, a drug manufacturer adds a warning to a label based on reports of adverse events after the drug is on the market. In fact, "many serious ADRs [adverse drug reactions] are discovered only after a drug has been on the market for years. Only half of newly discovered, serious ADRs are detected and documented in the Physicians "Desk Reference within seven years after drug approval." (13) Moreover, in some instances, premarketing trials indicate an association between a drug and an adverse reaction, but the drug company does not warn about the possible reaction until after the FDA receives post-marketing adverse event reports. (14)

Put simply, the FDA's decision not to require a particular warning, whether an explicit decision or not, "does not convey an 'authoritative' message of a federal policy against" such a warning. (15) Therefore, a jury verdict finding a drug manufacturer liable for failure to warn would not conflict with any federal requirement.

OTC drug preemption

The FDCA's preemption provisions for over-the-counter (OTC) drugs further weaken the argument for implied conflict preemption. The FDCA provides that any state OTC drug requirements that are "different from or in addition to" federal requirements are preempted. (16) This provision essentially codifies conflict-preemption principles. The FDCA also provides that the OTC preemption provision shall have "no effect on product liability law." (17)

This OTC provision indicates that Congress sees no conflict between the continued viability of state-law damages actions and the FDA's regulation of OTC drugs. Yet federal regulation of over-the-counter drugs is similar to that of prescription drugs: The FDA reviews marketing applications for OTC drugs to evaluate the results of clinical trials, the manufacturing process, and proposed labeling. (18) and the same statutory provisions address misbranding of both over-the-counter and prescription drugs. (19) Given that Congress has expressly acknowledged that state-law damages actions can coexist with federal regulation of OTC drugs, surely such actions can also coexist with federal regulation of prescription drugs.

In arguing based on the OTC provisions, plaintiff attorneys must be careful not to overstate the Supreme Court's conclusion that when Congress expressly addresses the preemptive reach of a statute, it "implies" that it does not intend to preempt matters outside that reach. (20) Although an express preemption provision establishes a presumption of no implied preemption, that presumption can be rebutted.

Thus, in Geier v. American Honda Motor Co., the Supreme Court downplayed the significance of an express preemption provision and a savings clause that expressly preserved liability under common law to find that the plaintiff's personal injury claim conflicted with federal law by frustrating the purpose of a federal regulation. (21) However, one will almost always be able to distinguish the facts of Geier, a "no air bag" case, from those of a personal injury suit against a drug company.

In Geier, the Court relied on the U.S. Department of Transportation's "own contemporaneous explanation" of the regulation's objectives, which included giving automobile manufacturers flexibility in their choice of passive restraint systems. (22) Holding an automobile manufacturer liable for choosing a passive restraint system other than an air bag system would frustrate this goal of flexibility, the Court held. (23)

In contrast, to date, the preemption arguments presented in drug cases are not grounded in any prior FDA statements about FDCA implementation or labeling and misbranding regulations. To the contrary, outside of litigation, the FDA's formal statements have not supported preemption. (24)

Furthermore, the government agrees that "Geier does not suggest that common law suits will be preempted whenever the federal agency has focused its attention upon the particular aspect of motor vehicle performance that forms the basis of the plaintiff's claim." (25) In other words, even the FDA's premarket scrutiny of a drug's label does not preempt claims based on the inadequacy of warnings.

The FDA's position

Unfortunately, since the arrival of the agency's current chief counsel--a lawyer who represented the pharmaceutical company Pfizer in his private law practice--the FDA has filed several amicus briefs in the lower courts to support drug companies' preemption arguments. An amicus brief filed by the FDA warrants concern because courts generally give agency views significant weight in preemption cases. (26)

When addressing an FDA brief supporting preemption, plaintiff attorneys must remember--and point out to the court--that a statement in an amicus brief falls far short of final agency action necessary to evaluate potential conflict between state law claims and federal action. As the government stated in Sprietsma, "as a general matter, state law is not preempted by a mere expression of an opinion or statement of policy by a federal agency, untethered to any agency action that has legal effect in its own right." (27)

Moreover, as the US. Supreme Court made clear in United States v. Mead Corp., the lack of formality (such as notice-and-comment procedures) and the inconsistency between some of the arguments in the recent government amicus briefs in drug cases and those in cases such as Sprietsma undermine any call for deference to the government's position in the pharmaceutical cases. (28)

In two recent cases, Motus v. Pfizer. (29) and Dowhal v. Smith-Kline Beecham, (30) the FDA's amicus briefs argued that labeling claims were preempted because the agency would have brought enforcement actions against the companies if they had given the warnings that the plaintiffs say were required by state law.

To be sure, federal agency action having the force of law may preempt conflicting state requirements, just as a federal statute may preempt them. (31) Nonetheless, the threat of an enforcement action in an amicus brief is insufficient to create a conflict.

In addition, no conflict would exist even if a company added a warning and the FDA then took enforcement action. Under the FDCA, the determination that a drug is misbranded is not the FDA's to make. Instead, if the agency wants to pursue enforcement action for alleged misbranding, it must sue the manufacturer in federal district court, and the manufacturer is entitled to a jury trial. (32)

Filing an enforcement action does not guarantee that the FDA will eventually prevail, so no conflict would exist until the agency had won the action. As the Supreme Court has explained, "The existence of a hypothetical or potential conflict is insufficient to warrant the preemption of the state [law]." (33)

Causation v. association

In Motus, the FDA argued that it would be "misleading" to warn of a possible risk without proof of a causal relationship between the drug and that risk. Therefore, the agency wrote, to warn of the risk would render the product misbranded. This argument is contrary to both the agency's regulations and its practice. The key to debunking this reasoning is the difference between "causation" and "association."

FDA regulations state that "the labeling shall be revised to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved." (34) An association between a drug and an adverse effect may be shown by statistical evidence or reports of specific incidents experienced by users.

Association does not necessarily indicate a causal relationship. (35) Accordingly, the FDA often approves or requires labels to warn consumers about associations where no causal connection has been established.

For example, the original labeling for the cholesterol drug Lotronex stated, in part, "Acute ischemic colitis was infrequently reported in patients receiving Lotronex in three-month clinical trials.... A causal association between treatment with Lotronex and acute colitis has not been established, nor have risk factors been identified.

Similarly, the labeling of the arthritis drug Bextra states, under "adverse reactions": "The following reactions have been identified during postmarketing use of Bextra.... Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure." (37)

Thus, a decision by the FDA not to require a warning of a causal relationship between the drug and a possible risk does not conflict with a finding that the drug manufacturer failed to warn about an association between the drug and the risk.

Medical device cases

Because no appellate court has held a drug-related products liability claim to be impliedly preempted, defendants' arguments will invariably rely on cases finding express statutory preemption of medical device claims. (38) There is no comparable statutory preemption provision applicable to prescription drugs.

Moreover, the courts do not agree on whether FDA approval of a device expressly preempts inadequate warning and strict liability' claims. (39) Consequently, to the extent that they are relevant, the express-preemption cases can be used by either side. (40)

The company might also try to fashion an analogy to Buckman Co. v. Plaintiffs' Legal Committee, a medical device case that held that a "fraud on the FDA" claim was impliedly preempted. The claim was premised on the theory that the FDA would not have approved the product if the manufacturer had provided the agency with additional information. (41) Fraud-on-the-agency claims are preempted because they require a court or jury to predict what the FDA would have done with different information. (42)

In contrast, an inadequate warning claim does not challenge the FDA's decision to allow marketing of the drug or its decision that the drug should be labeled for certain indications. Instead, it challenges a company's decision not to include--either initially or later--a warning about the association between the product and the risk. (43) Therefore, consideration of such a claim would not require the court or jury to interfere with the FDA's decision-making process. (44)

Drug companies see preemption as a potential "get-out-of-jail-free card" in lawsuits for injuries that their products caused. The value to a defendant of a summary judgment victory based on preemption can be enormous, especially because one victory tends to lead to another, as happened with the express-preemption theory in medical device cases. As long as the FDA is witting to support drug companies' requests for immunity from liability, plaintiff lawyers should expect this defense.

Notes

(1.) See, e.g., Halloran v. Parke-Davis & Co., 280 N.Y.S. 58 (App. Div. 1935); Thomas v. Winchester, 6 N.Y. 397 (1852).

(2.) Compare Medtronic v. Lohr, 518 U.S. 470 (1996) (no preemption); Goodlin v. Medtronic, 167 F.3d 1367 (11th Cir. 1999) (same); and Weiland v. Telectronics Pacing Sys., 721 N.E.2d 1149 (Ill. 1999) (same), with Brooks v. Howmedica, 273 F.3d 785 (8th Cir. 2001) (preemption); Kemp v. Medtronic, 231 E3d 216 (6th Cir. 2000) (same); and Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir. 1997) (same).

(3.) See, e.g., Goodyear Atomic Corp. v. Miller, 486 U.S. 174, 185-86 (1988) ("The effects of direct regulation ... are significantly more intrusive than the incidental regulatory effects of such an additional award provision.... Congress may reasonably determine that incidental regulatory pressure is acceptable, whereas direct regulatory authority is not."); Ferebee v Chevron Chem. Co., 736 F.2d 1529, 1541 (D.C. Cir. 1984); Minton v. Honda of Am. Mfg., 684 N.E.2d 648,661 (Ohio 1998).

(4.) See W. PAGE KEETON ET AL., PROSSER AND KEETON ON THE LAW OF TORTS 536-57, 692-93 (5th ed. 1984).

(5.) Goodyear Atomic Corp., 486 U.S. 174, 185-86; Silkwood v. Kerr-McGee Corp., 464 U.S. 238,256 (1984) (despite federal preemption of state regulatory authority, state law punitive damages awards are not preempted even though "regulatory in the sense that a nuclear plant will be threatened with damages liability if it does not conform to state standards....").

(6.) Hillsborough County v. Automated Med. Labs., 471 U.S. 707,715 (1985): see also Hawaiian Airlines, Inc. v. Norris, 512 U.S. 246, 252 (1994); Wisconsin Pub. Intervenor v. Mortier, .501 U.S. 597, 605, 611 (1991).

(7.) See; e.g;, Hearings Before the Subcomm. of the Comm. on Commerce on S. 1944, 73rd Cong., 2d Sess. 400, 403 (1933); Robert S. Adler & Richard A. Mann, Preemption and Medical Devices: The Courts Run Amok, 59 MO. L. REV. 895,924 & n. 130 (1995) ("Congress rejected a provision in a draft, of the original FD&C Act providing a federal cause of action for damages because 'a common law right of action already exists'") (quoting legislative history).

(8.) Medtronic, 518 U.S. 470, 487 (plurality) (rejecting similar argument with respect to scope of express preemption).

(9.) See Ehlis v. Shire Richwood, Inc., 233 F. Supp. 2d 1189, 1197 (D.N.D. 2002).

(10.) See English v. Gen. Elec. Co., 496 U.S. 72, 87-90 (1990); Silkwood, 464 U.S. 238,251; see also Sprietsma v. Mercury Marine, 123 S. Ct. 518,527 (2002) ("perfectly rational for Congress not to preempt common law claims" when preempting state positive law because common law claims "perform an important remedial role in compensating accident victims").

(11.) Sprietsma, 123 S. Ct. 518, 527; accord Freightliner Corp. v. Myrick, 514 U.S. 280, 289 (1995) (where agency had no standard either requiring or prohibiting antilock brakes, state common law as applied to antilock brakes is not preempted); Puerto Rico Dep't of Consumer Affairs v. Isla Petroleum Corp., 485 U.S. 495,501, 503 (1988) (absent explicit statement of intent, federal inaction has no preemptive effect).

(12.) Brief for United States at 18, Sprietsma, 123 S. Ct. 518.

(13.) Karen E. Lasser et al., Timing of New Black Box Warnings and Withdrawals for Prescription Medications, 287 JAMA 2215, 2218 (2002).

(14.) Id.

(15.) Sprietsma, 123 S. Ct. 518,528.

(16.) 21 U.S.C. [section] 379r(d)(1) 0999).

(17.) Id. [section] 379r(e).

(18.) See generally id. [section] 355.

(19.) See id. [section] 331 (a), (b), (k); see also id. [subsection] 352(a), (f), 355.

(20.) Freightliner Corp., 514 U.S. 281), 288-89; Cipollone v. Liggett Group, Inc., 505 U.S. 504, 517 (1992).

(21.) 529 U.S. 861 (2000).

(22.) Id. at 877-80.

(23.) Id. at 881.

(24.) See Prescription Drug Product Labeling; Medication Guide Requirements, 63 Fed. Reg. 66,378, 66,384 (Dec. 1, 1998) ("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."); 44 Fed. Reg. 37,437 (1979) ("it is not the intent of the FDA to influence the civil tort liability of the manufacturer."), quoted in Feldman v Lederle Labs., 592A.2d 1176, 1195 (1991).

(25.) Brief for United States at 19, Sprietsma, 123 S. Ct. 518.

(26.) See, e.g., Geier, 529 U.S. 861,883; Medtronic, 518 U.S. 470, 496-97,498-99 (majority); id. at 505-06 (Breyer, J., concurring); Hillsborough County, 471 U.S. 707, 716-17.

(27.) See Brief for United States at 23, Sprietsma, 123 S. Ct.518.

(28.) United States v. Mead Corp., 533 U.S. 218, 228 (2001) (degree of deference due to government depends on, among other things, consistency, formality, and thoroughness).

(29.) 127 F. Supp. 2d 1085 (C.D. Cal. 2000), appeal pending, Nos. 02-55372, 02-55498 (9th Cir.). Victor Motus committed suicide one week after he began taking the antidepressant Zoloft. The plaintiff's case is based on Pfizer's failure to warn about an association between Zoloft and suicide, and its failure to warn about an association between Zoloft and akathisia, a condition characterized by agitation, restlessness, and suicidal thoughts. The FDA did not participate at the district court but filed a brief in support of Pfizer with the Ninth Circuit. Oral argument was held on October 10, 2003.

(30.) 122 Cal. Rpm 2d 246 (Ct. App. 2002), petition for review granted, No. S109306 (Cal. Oct. 23, 2002). This case was brought under California's Proposition 65 and is not a personal injury case. Rather, the lawsuit seeks to force the manufacturers and retailers of over-the-counter nicotine-replacement products to warn about the risks of using nicotine when pregnant. The FDA filed amicus briefs in the California Court of Appeal and in the California Supreme Court.

(31.) Sprietsma, 123 S. Ct. 518,527; Fidelity Fed. Sav. & Loan Ass'n v. De La Cuesta, 458 U.S. 141, 153 (1982).

(32.) 21 U.S.C. [section] 332 (injunctions), [section] 333 (criminal penalties). [section] 334 (seizure) (2000).

(33.) Rice v. Norman Williams Co., 458 U.S. 654, 659 (1982).

(34.) 21 C.F.R. [section] 201.57(e) (2001) (emphasis added).

(35.) In many cases, a study to prove causation may be impractical. For example, the incidence of a suspected adverse effect may be so small that thousands of study subjects would be needed to show a statistically significant connection. The incidence of suicide in the population, for instance, is so small--1.7 people in 10,000, according to the Centers for Disease Control and Prevention--that even if a drug increased that risk tenfold, thousands of study subjects would be necessary to demonstrate a statistically significant increase that would substantiate a causal connection between the drug and suicide.

(36.) PHYSICIANS' DESK REFERENCE 1438 (55th ed. 2001).

(37.) Pfizer & Pharmacia, Labeling for Bextra 2, at www.bextra.com/consumer/pages/pi.pdf (last visited Sept. 25, 2003).

(38.) See 21 U.S.C. [section] 360k (a) (2000).

(39.) Compare Medtronic, 518 U.S. 4.70 (no preemption); Goodlin, 167 F.3d 1367 (same); and Weiland, 721 N.E.2d 1149 (same), with Brooks, 273 F.3d 785 (preemption); Kemp, 231 F.3d 216 (same); and Mitchell, 126 F.3d 902 (same).

(40.) In Ehlis, the one reported case in which a court found that a failure-to-warn claim against a drug manufacturer was impliedly preempted, the court relied on a prior Eighth Circuit decision holding that the FDCA expressly preempted personal injury claims against a medical device manufacturer where the device had gone through the FDA's premarket approval process. 233 F. Supp. 2d 1189, 1197 (discussing Brooks, 273 F.3d 785, 791). The court's brief analysis finds that the claims in Ehlis mirror the claims in Brooks, and thus preemption is warranted, not withstanding that Brooks was an express preemption case. The opinion in Ehlis explains that because the defendant would need FDA approval before making most changes to the product's label, it could not be held liable for warnings not given, whether or not the company had sought approval to add the warning at issue. Ehlis is currently on appeal to the Eighth Circuit (Nos. 02-3933, 03-1057).

(41.) 531 U.S. 341,343 (20(11).

(42.) Id. at 349-50.

(43.) See 21 C.F.R. [section] 314.70(c) (2) (i) (2001 ) (manufacturer may add warning without prior agency approval).

(44.) See Eve v. Sandoz Pharm. Corp., No. IP98-1429-C-Y/S, 2002 WL 181972 (S.D. Ind. Jan. 28, 2002) (Buckman does not support preemption of inadequate warning and other tort claims in suit against drug manufacturer); Caraker v. Sandoz Pharm. Corp., 172 F. Supp. 2d 1018 (N.D. Ill. 2001) (same).

ALLISON M. ZIEVE is a lawyer at Public Citizen Litigation Group, the litigating arm of the consumer advocacy organization Public Citizen, based in Washington, D. C.