Addressing the Conflict: FDA vs. Torts

FDA Defends Its Exclusive Role

In four recent cases, the FDA warned of the potential for conflict between scientific judgments made by it in the exercise of its authority to ensure the safety and efficacy of approved drugs and the positions being advanced by litigants under state law who allege that federally approved drugs and/or drug labels create unreasonable risks to patients. The FDA asked courts to acknowledge the constitutional supremacy of federal law and to preempt certain conflicting state law claims for relief to avoid interference with the objects and purposes of the Federal Food Drug and Cosmetic Act (FDCA).

In Bernhardt v. Pfizer, Nos. 00-Civ-4042 LMM and 00 Civ. 4379 LMM (S.D.N.Y. 2000), the U.S. Department of Justice (DOJ) was asked to submit its views on whether the FDA's labeling regulations pre-empted the plaintiffs' claims. With the agency's concurrence, DOJ argued that the FDA prescription drug labeling regulations preempted a court from ordering changes to approved labeling in failure-to-warn tort litigation. In support of its conclusion that Congress intended FDA's regulation of drug labeling to be 'exclusive,' DOJ noted in detail the agency's comprehensive program for the review and approval of prescription drug labeling and warnings. Given the pervasive regulatory regime, DOJ and the FDA argued that it would frustrate the FDA's ability to regulate prescription drug labeling if a court or jury could substitute its judgment for that of the FDA. Ultimately, the court in Bernhardt did not decide the pre-emption issue, but invoked the doctrine of primary jurisdiction to require the plaintiffs first to submit their request to the FDA in the form of a Citizen Petition. (Statement of Interest of the United States at 5-6, Bernhardt v. Pfizer, Inc., Nos. 00-Civ-4042 LMM, 00-Civ.-4379 LMM (S.D.N.Y. filed Nov. 13, 2000.)

In Dowhal v. SmithKline Beecham Consumer Healthcare LP, Case No. A094460 (Cal. Ct. App. Filed Mar. 25, 2002), appeal granted, No. S1090306 (Cal. Oct. 23, 2002), the FDA filed an amicus brief on appeal opposing the plaintiff's attempt to compel the inclusion of certain warnings in over-the-counter nicotine replacement products based on California's Safe Drinking Water and Toxic Enforcement Act (Proposition 65), which listed nicotine as a developmental and reproductive hazard. The agency already had rejected a Citizen Petition submitted by the plaintiff, finding that the request was not scientifically supportable and that the proposed warning language overstated the risks of using nicotine replacement products. (Amicus Curiae Brief of the United States of America in Supp. of Defs./Respondents SmithKline Beecham Consumer Healthcare LP, et al. at 13, 18-19, Case No. A094460 (Cal. Ct. App. filed Mar. 25, 2002), appeal granted, No. S1090306 (Cal. Oct. 23, 2002.)

After the trial court ruled that Proposition 65 was impliedly pre-empted by the FDCA, the FDA filed an amicus brief in the plaintiff's appeal to the California Court of Appeal supporting such pre-emption. The FDA argued that it would be impossible for manufacturers to include a warning consistent with Proposition 65 and to comply with the FDCA ' including the warning language at issue not approved (and specifically rejected) by the FDA could render a complying manufacturer's products misbranded. The FDA also advanced a second pre-emption argument ' that application of Proposition 65 would hinder the FDA's accomplishment of the full purposes and objectives of the FDCA by over-deterring pregnant and nursing women from using nicotine replacement products in place of far more dangerous cigarettes. Despite the FDA's submission, the Court of Appeal reversed the trial court, and the Supreme Court of California has granted review.

In Motus v. Pfizer Inc., Case Nos. 02-55372 and 02-55498 (9th Cir. appeal docketed Mar. 4, 2002), the FDA filed an amicus brief advocating pre-emption to address an ongoing issue with Selective Serotonin Reuptake Inhibitors (SSRIs), antidepressants that have been credited with providing millions with life-altering relief from major depression. They also have been the focal point of persistent litigation alleging that they may actually contribute to suicide or violent behavior. The FDA, after specifically considering the scientific evidence, including reviews by its independent Psychopharmacological Drug Advisory Committee and a 2002 internal review, rejected multiple claims that SSRIs can cause such behavior. In each case, the agency and its experts have concluded that there is no increased risk of suicide in patients taking SSRIs over the baseline risk among depressed patients, and that warnings connecting the risk of suicide to SSRIs (as opposed to the risk of suicide among depressed patients generally) are not scientifically justified.

In its brief, the FDA argued that the plaintiff's claim attributing a patient's suicide to a SSRI manufacturer's failure to warn of increased suicide risk was preempted under the FDCA. Amicus Brief of the United States in Support of the Defendant-Appellee and Cross-Appellant at 15, Motus v. Pfizer Inc., Nos. 02-55372 & 02-55498 (9th Cir. filed Sept. 3, 2002). The Agency noted that, had the manufacturer included the warning the plaintiffs claimed was lacking, the FDA would not have approved it. Id. at 17. Including the warning would therefore render the drug misbranded, and thus illegal, under the FDCA. The FDA also argued that including such scientifically unsubstantiated warnings would obstruct the FDCA's purposes and objectives because the warnings would inappropriately discourage use of the drug, resulting in patients foregoing treatment and potentially being at a higher risk for suicide or other negative behaviors associated with depression. The case is still pending before the U.S. Court of Appeals for the Ninth Circuit.

The FDA has intervened in another SSRI case, In re Paxil Litigation, Case No. CV-01-07937 MRP (CWx) (C.D.Cal. filed Sept. 4, 2002), where plaintiffs seek damages for alleged dependency and withdrawal symptoms caused by the SSRI and an injunction against the advertising claim that the drug is 'non-habit-forming.' After the trial court initially granted the requested injunction, the FDA filed a Statement of Interest noting that its safety review of the drug had not revealed evidence of tolerance, dependence or drug-seeking behavior, and that the agency had reviewed the advertisements and had not found them to be false or misleading. The court ultimately reversed its decision on the injunction, although it rejected the FDA's arguments that the lawsuit was preempted and that courts should defer to the FDA on such matters in the first instance, under the doctrine of primary jurisdiction. Memorandum of Decision re: Motion for Reconsideration of Order Granting Preliminary Injunction, In Re Paxil Litig., No. CV 01-07937 MRP, slip op. at 2-4 (C.D. Cal. Oct. 18, 2002). The case is still pending in the district court.

The Case for Preemption

Allowing lay judges and juries to engage in a post-hoc re-evaluation of the benefit/risk determinations made by the FDA directly conflicts with the FDA's mission. Thus, there is a strong case that many state-law-based design defect and failure-to-warn cases against FDA-approved prescription drugs should be preempted.

As the U.S. Supreme Court has noted, 'state law must yield to a congressional act in at least two circumstances. When Congress intends federal law to occupy the field, state law in that area is preempted. And even if Congress has not occupied the field, state law is naturally preempted to the extent of any conflict with a federal statute.' Crosby v. Nat'l Foreign Trade Council, 530 U.S. 363, 372 (2000). The Court in Crosby went on to say that it also 'will find pre-emption where it is impossible for a private party to comply with both state and federal law, and where 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.' Moreover, the 'phrase 'state law' ' include[s] common law as well as statutes and regulations' for pre-emption purposes. Cipollone v. Liggett Group Inc., 505 U.S. 504, 522 (1992).

Design defect claims, by their nature, necessarily entail a determination that, overall, a medication's inherent risks exceed its potential benefits. See, e.g., Restatement (Third) of Torts ' 6(c) (1998) ('A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.'). That, of course, strikes at the very core of the FDA's determination, based on extensive review of all relevant data, that a product should be permitted on the market. Similarly, failure-to-warn claims based on allegations of inadequate product labeling directly challenge the FDA's comprehensive regulatory authority over the precise content of that labeling and the agency's necessary determination that the labeling provides the directions and warnings needed for the drug's safe and effective use. By allowing juries to make these judgments independent of the FDA's evaluation, the tort system becomes the ultimate arbiter of which drugs are marketed and the labeling that those drugs should bear ' and, unlike the FDA, it does so without any scientific expertise and based solely on the limited and self-interested testimony of paid 'experts' in litigation.

Because Congress has mandated that the FDA make the ultimate risk/benefit assessment on whether a drug should be marketed and, if so, under what labeling, lawsuits that subvert the FDA's determinations should be preempted by federal law. Such pre-emption is called for where state and federal law impose conflicting obligations such that it would be 'impossible for a private party to comply with both state and federal law' in deciding how to label its product.

Likewise, where state law tort actions that second-guess the FDA's expert scientific judgments pose 'an obstacle to the accomplishment and execution of the full purposes and objectives of Congress,' they also fall within the ambit of the pre-emption doctrine. Crosby, 530 U.S. at 373.

Those who disagree with the FDA's scientific judgment on a drug's approval or labeling still would have an alternative remedy available ' they can go directly to the FDA and challenge those determinations through a Citizen Petition and, if appropriate, bring an Administrative Procedure Act proceeding against the agency if they are unhappy with the response.

Where Next?

The FDA's recent court activity shows that the agency has become increasingly aware of the collision between its actions and tort law and has become more proactive in arguing that its expert scientific conclusions should foreclose inconsistent judgments by state judges and juries. Should the pending cases uphold the FDA's scientific determinations against the plaintiffs' civil claims for relief, the FDA would at least be assured that it will not be forced to manage 50 independent labeling systems as juries modify FDA labeling on an ad hoc, state-by-state basis.

Manufacturers could find some satisfaction in the fact that they will not be held liable in civil tort actions for not warning of risks that the FDA has determined are not posed by their products. Health care practitioners and the public would benefit from the existence of a single nationwide, expert decision-maker on the potential side effects of prescription drugs, as well as from the increased innovation and savings potentially resulting from assurance that the FDA's scientific judgments would be respected. In short, the overall healthcare system would be well served by ensuring that there is only one, expert, independent voice regarding drug safety.

Bert W. Rein, William A. McGrath, and Karyn K. Ablin are members of the law firm Wiley Rein & Fielding LLP, in Washington, DC. Mr. Rein is a member of the Editorial Board of this publication.

Our legal system supports two regulators of the safety of prescription drugs ' the U.S. Food and Drug Administration and courts applying the tort liability regime. The FDA's mission, while narrowly circumscribed in its early years, grew dramatically over the last half of the twentieth century. Today, the FDA administers the most comprehensive drug regulatory system in the world. (See Jeffrey E. Shuren, The Modern Regulatory Administrative State: A Response to Changing Circumstances, 38 Harvard J. on Legis. 291, 299-315 (2001); Michael D. Green, Statutory Compliance and Tort Liability: Examining the Strongest Case, 30 U. Mich. J.L. Ref. 461, 464 (1997); Charles J. Walsh et al., Rationalizing the Regulation of Prescription Drugs and Medical Devices: Perspectives on Private Certification and Tort Reform, 48 Rutgers Law Rev. 883, 890-929 (1996) (detailing the 'pervasive' reach of FDA regulation as controlling 'nearly every aspect of the development and marketing of a prescription drug or medical device, from the earliest clinical testing to the contents of the final advertisements used to present the final product to health care providers.').

Yet despite the agency's pervasive oversight of drug safety and effectiveness, and its accumulated expertise, the state-law-based tort system routinely invites judges and juries to second-guess the agency's regulatory decisions in order to ensure compensation to plaintiffs who allege a drug-related injury. This second-guessing raises serious questions concerning the applicability of federal pre-emption principles to avoid inconsistencies between the two regulatory schemes. The tort system may actually have played a role in enhancing drug safety in the days when the FDA did not engage in a thorough review of prescription drugs for safety and efficacy both prior to their distribution and once on the market.

Today, however, tort lawsuits pose an increasing risk of conflicting with the greatly expanded regulatory scheme under which the FDA operates. Unbridled tort litigation also poses the risk of supplanting the FDA's rational, science-based regulation of drugs with judgments made by sympathy-driven lay juries. Indeed, as the FDA's chief counsel recently explained (See Daniel E. Troy, FDA Involvement in Product Liability Lawsuits, FDLI Update, Jan./Feb. 2003), the FDA itself has confronted these conflicts in a number of recent court submissions seeking pre-emption of actions brought under state law where the relief requested would conflict with the Agency's prior scientific determinations.

FDA Defends Its Exclusive Role

In four recent cases, the FDA warned of the potential for conflict between scientific judgments made by it in the exercise of its authority to ensure the safety and efficacy of approved drugs and the positions being advanced by litigants under state law who allege that federally approved drugs and/or drug labels create unreasonable risks to patients. The FDA asked courts to acknowledge the constitutional supremacy of federal law and to preempt certain conflicting state law claims for relief to avoid interference with the objects and purposes of the Federal Food Drug and Cosmetic Act (FDCA).

In Bernhardt v. Pfizer, Nos. 00-Civ-4042 LMM and 00 Civ. 4379 LMM (S.D.N.Y. 2000), the U.S. Department of Justice (DOJ) was asked to submit its views on whether the FDA's labeling regulations pre-empted the plaintiffs' claims. With the agency's concurrence, DOJ argued that the FDA prescription drug labeling regulations preempted a court from ordering changes to approved labeling in failure-to-warn tort litigation. In support of its conclusion that Congress intended FDA's regulation of drug labeling to be 'exclusive,' DOJ noted in detail the agency's comprehensive program for the review and approval of prescription drug labeling and warnings. Given the pervasive regulatory regime, DOJ and the FDA argued that it would frustrate the FDA's ability to regulate prescription drug labeling if a court or jury could substitute its judgment for that of the FDA. Ultimately, the court in Bernhardt did not decide the pre-emption issue, but invoked the doctrine of primary jurisdiction to require the plaintiffs first to submit their request to the FDA in the form of a Citizen Petition. (Statement of Interest of the United States at 5-6, Bernhardt v. Pfizer, Inc. , Nos. 00-Civ-4042 LMM, 00-Civ.-4379 LMM (S.D.N.Y. filed Nov. 13, 2000.)

In Dowhal v. SmithKline Beecham Consumer Healthcare LP, Case No. A094460 (Cal. Ct. App. Filed Mar. 25, 2002), appeal granted, No. S1090306 (Cal. Oct. 23, 2002), the FDA filed an amicus brief on appeal opposing the plaintiff's attempt to compel the inclusion of certain warnings in over-the-counter nicotine replacement products based on California's Safe Drinking Water and Toxic Enforcement Act (Proposition 65), which listed nicotine as a developmental and reproductive hazard. The agency already had rejected a Citizen Petition submitted by the plaintiff, finding that the request was not scientifically supportable and that the proposed warning language overstated the risks of using nicotine replacement products. (Amicus Curiae Brief of the United States of America in Supp. of Defs./Respondents SmithKline Beecham Consumer Healthcare LP, et al. at 13, 18-19, Case No. A094460 (Cal. Ct. App. filed Mar. 25, 2002), appeal granted, No. S1090306 (Cal. Oct. 23, 2002.)

After the trial court ruled that Proposition 65 was impliedly pre-empted by the FDCA, the FDA filed an amicus brief in the plaintiff's appeal to the California Court of Appeal supporting such pre-emption. The FDA argued that it would be impossible for manufacturers to include a warning consistent with Proposition 65 and to comply with the FDCA ' including the warning language at issue not approved (and specifically rejected) by the FDA could render a complying manufacturer's products misbranded. The FDA also advanced a second pre-emption argument ' that application of Proposition 65 would hinder the FDA's accomplishment of the full purposes and objectives of the FDCA by over-deterring pregnant and nursing women from using nicotine replacement products in place of far more dangerous cigarettes. Despite the FDA's submission, the Court of Appeal reversed the trial court, and the Supreme Court of California has granted review.

In Motus v. Pfizer Inc., Case Nos. 02-55372 and 02-55498 (9th Cir. appeal docketed Mar. 4, 2002), the FDA filed an amicus brief advocating pre-emption to address an ongoing issue with Selective Serotonin Reuptake Inhibitors (SSRIs), antidepressants that have been credited with providing millions with life-altering relief from major depression. They also have been the focal point of persistent litigation alleging that they may actually contribute to suicide or violent behavior. The FDA, after specifically considering the scientific evidence, including reviews by its independent Psychopharmacological Drug Advisory Committee and a 2002 internal review, rejected multiple claims that SSRIs can cause such behavior. In each case, the agency and its experts have concluded that there is no increased risk of suicide in patients taking SSRIs over the baseline risk among depressed patients, and that warnings connecting the risk of suicide to SSRIs (as opposed to the risk of suicide among depressed patients generally) are not scientifically justified.

In its brief, the FDA argued that the plaintiff's claim attributing a patient's suicide to a SSRI manufacturer's failure to warn of increased suicide risk was preempted under the FDCA. Amicus Brief of the United States in Support of the Defendant-Appellee and Cross-Appellant at 15, Motus v. Pfizer Inc. , Nos. 02-55372 & 02-55498 (9th Cir. filed Sept. 3, 2002). The Agency noted that, had the manufacturer included the warning the plaintiffs claimed was lacking, the FDA would not have approved it. Id. at 17. Including the warning would therefore render the drug misbranded, and thus illegal, under the FDCA. The FDA also argued that including such scientifically unsubstantiated warnings would obstruct the FDCA's purposes and objectives because the warnings would inappropriately discourage use of the drug, resulting in patients foregoing treatment and potentially being at a higher risk for suicide or other negative behaviors associated with depression. The case is still pending before the U.S. Court of Appeals for the Ninth Circuit.

The FDA has intervened in another SSRI case, In re Paxil Litigation, Case No. CV-01-07937 MRP (CWx) (C.D.Cal. filed Sept. 4, 2002), where plaintiffs seek damages for alleged dependency and withdrawal symptoms caused by the SSRI and an injunction against the advertising claim that the drug is 'non-habit-forming.' After the trial court initially granted the requested injunction, the FDA filed a Statement of Interest noting that its safety review of the drug had not revealed evidence of tolerance, dependence or drug-seeking behavior, and that the agency had reviewed the advertisements and had not found them to be false or misleading. The court ultimately reversed its decision on the injunction, although it rejected the FDA's arguments that the lawsuit was preempted and that courts should defer to the FDA on such matters in the first instance, under the doctrine of primary jurisdiction. Memorandum of Decision re: Motion for Reconsideration of Order Granting Preliminary Injunction, In Re Paxil Litig., No. CV 01-07937 MRP, slip op. at 2-4 (C.D. Cal. Oct. 18, 2002). The case is still pending in the district court.

The Case for Preemption

Allowing lay judges and juries to engage in a post-hoc re-evaluation of the benefit/risk determinations made by the FDA directly conflicts with the FDA's mission. Thus, there is a strong case that many state-law-based design defect and failure-to-warn cases against FDA-approved prescription drugs should be preempted.

As the U.S. Supreme Court has noted, 'state law must yield to a congressional act in at least two circumstances. When Congress intends federal law to occupy the field, state law in that area is preempted. And even if Congress has not occupied the field, state law is naturally preempted to the extent of any conflict with a federal statute.' Crosby v. Nat'l Foreign Trade Council , 530 U.S. 363, 372 (2000). The Court in Crosby went on to say that it also 'will find pre-emption where it is impossible for a private party to comply with both state and federal law, and where 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.' Moreover, the 'phrase 'state law' ' include[s] common law as well as statutes and regulations' for pre-emption purposes. Cipollone v. Liggett Group Inc., 505 U.S. 504, 522 (1992).

Design defect claims, by their nature, necessarily entail a determination that, overall, a medication's inherent risks exceed its potential benefits. See, e.g., Restatement (Third) of Torts ' 6(c) (1998) ('A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.'). That, of course, strikes at the very core of the FDA's determination, based on extensive review of all relevant data, that a product should be permitted on the market. Similarly, failure-to-warn claims based on allegations of inadequate product labeling directly challenge the FDA's comprehensive regulatory authority over the precise content of that labeling and the agency's necessary determination that the labeling provides the directions and warnings needed for the drug's safe and effective use. By allowing juries to make these judgments independent of the FDA's evaluation, the tort system becomes the ultimate arbiter of which drugs are marketed and the labeling that those drugs should bear ' and, unlike the FDA, it does so without any scientific expertise and based solely on the limited and self-interested testimony of paid 'experts' in litigation.

Because Congress has mandated that the FDA make the ultimate risk/benefit assessment on whether a drug should be marketed and, if so, under what labeling, lawsuits that subvert the FDA's determinations should be preempted by federal law. Such pre-emption is called for where state and federal law impose conflicting obligations such that it would be 'impossible for a private party to comply with both state and federal law' in deciding how to label its product.

Likewise, where state law tort actions that second-guess the FDA's expert scientific judgments pose 'an obstacle to the accomplishment and execution of the full purposes and objectives of Congress,' they also fall within the ambit of the pre-emption doctrine. Crosby, 530 U.S. at 373.

Those who disagree with the FDA's scientific judgment on a drug's approval or labeling still would have an alternative remedy available ' they can go directly to the FDA and challenge those determinations through a Citizen Petition and, if appropriate, bring an Administrative Procedure Act proceeding against the agency if they are unhappy with the response.

Where Next?

The FDA's recent court activity shows that the agency has become increasingly aware of the collision between its actions and tort law and has become more proactive in arguing that its expert scientific conclusions should foreclose inconsistent judgments by state judges and juries. Should the pending cases uphold the FDA's scientific determinations against the plaintiffs' civil claims for relief, the FDA would at least be assured that it will not be forced to manage 50 independent labeling systems as juries modify FDA labeling on an ad hoc, state-by-state basis.

Manufacturers could find some satisfaction in the fact that they will not be held liable in civil tort actions for not warning of risks that the FDA has determined are not posed by their products. Health care practitioners and the public would benefit from the existence of a single nationwide, expert decision-maker on the potential side effects of prescription drugs, as well as from the increased innovation and savings potentially resulting from assurance that the FDA's scientific judgments would be respected. In short, the overall healthcare system would be well served by ensuring that there is only one, expert, independent voice regarding drug safety.

Bert W. Rein, William A. McGrath, and Karyn K. Ablin are members of the law firm Wiley Rein & Fielding LLP, in Washington, DC. Mr. Rein is a member of the Editorial Board of this publication.