Horn v. Thoratec: FDA's Bold New Position on the Pre-emptive Effect of Product Approvals

By and large, the FDA has confined its participation to cases where it had specifically considered ' and rejected ' the plaintiffs' claims that a product's labeling or advertising should have included different language from that which was used. See Daniel E. Troy, FDA Involvement in Product Liability Lawsuits, Update: Food & Drug. L., Reg. & Educ. (Food & Drug Law Inst., Wash., D.C.), Jan./Feb. 2003, at 1. In 2004, however, the FDA submitted a brief in a state products liability action that signals the agency's willingness to be much more aggressive in protecting its jurisdiction from lay judge and jury determinations concerning a product's risk-benefit balance that conflict with the FDA's own determination of where that balance lies. See Br. of Amicus Curiae U.S. Dep't of Justice, Horn v. Thoratec Corp., 376 F.3d 163 (3d Cir. 2004) (No. 02-4597) (“FDA Br.”).

Background

The medical device at issue in Horn was a HeartMate heart pump. After extensive review and numerous communications with the manufacturer, the FDA approved the pump in 1994 pursuant to the Pre-Market Approval (“PMA”) process set forth in 21 U.S.C. '360e(c). See Horn v. Thoratec Corp., 376 F. 3d 163, 164-65, 169-70 (3d Cir. 2004). The plaintiff brought design defect and failure to warn claims against the device manufacturer following her husband's death a few days after the HeartMate implanted into him became disconnected from his heart. Id. at 165. The district court granted summary judgment in favor of the device manufacturer, finding that such claims were pre-empted by the Medical Device Amendments' (“MDA's”) express pre-emption provision set forth in 21 U.S.C. '360k(a). Id. That provision prohibits states from establishing or maintaining any safety or effectiveness requirement for a medical device that is “different from, or in addition to, any requirement applicable” under the FDCA. 21 U.S.C. '360k(a)(1). The plaintiff appealed the ruling to the U.S. Court of Appeals for the Third Circuit. Horn, 376 F.3d at 165.

Before reaching a decision, the Third Circuit requested the FDA's views on whether the plaintiff's claims were pre-empted by the MDA's express pre-emption clause. FDA Br. at 1. The court acknowledged that “FDA's pre-emption determinations are significant and should inform our interpretation of '360k(a)” and cited the Supreme Court's statement that the agency was “'uniquely qualified to determine whether a particular form of state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress, and, therefore, whether it should be pre-empted.'” Horn, 376 F.3d at 171 (quoting Medtronic v. Lohr, 518 U.S. 470, 495-96 (1996)).

FDA's Position on Pre-emption

In a 31-page submission, the FDA argued that the state common law claims were pre-empted and that it believed “that this view is compelled in order to achieve Congress' important public health protection purposes, carried out through FDA's implementation of the FDCA.” FDA Br. at 1-2. The FDA asserted that the Supreme Court's decision in Medtronic, Inc. v. Lohr, which found that the MDA's express pre-emption provision did not pre-empt state tort law claims brought against medical devices cleared pursuant to Section 510(k) of the FDCA, provided the analytical starting point but did not control the outcome of cases involving PMA-approved devices. Id. at 14-19 (discussing Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)).

Distinguishing the PMA approval process from the Section 510(k) clearance procedure, whereby devices may be cleared for marketing if they are found to be “substantially equivalent” to a predicate device, the FDA observed that “[p]reparation of a PMA and FDA's process of reviewing a PMA constitute a massive undertaking. … [the review] is thorough and scientifically rigorous, generally taking an average of 1200 hours of review time by the agency.” Br. at 8. The agency further observed that any revisions made after the FDA approves a PMA for a medical device, are considered with “the same type of rigorous scientific process utilized for review of original PMAs.” Id. at 10. The FDA then stated that the Section 510(k) procedure, “which typically requires an average of only twenty hours to complete” and “which only determines whether two products are substantially equivalent,” was “entirely different from a PMA” approval. … ” Id. at 12, 20.

The FDA argued that, unlike the Section 510(k) substantial equivalence requirements at issue in Lohr, the PMA process did impose sufficiently specific requirements as to pre-empt contrary or supplemental state law requirements imposed via state tort actions. Id. at 14-17.

Although the FDA focused its analysis on the MDA's express pre-emption provision, it strongly suggested that the plaintiff's claims were also precluded on conflict pre-emption grounds. That type of pre-emption exists either “when compliance with both state and federal law is impossible, or when the state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Capital Cities Cable, Inc. v. Crisp, 467 U.S. 691, 699 (1984). The agency made an extensive argument indicating its belief that recognition of state design defect and failure to warn claims would, indeed, “stand[ ] as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress” (id.) by thwarting “Congress's important public health protection purposes.” FDA Br. at 2, 25-26.

Notably, the agency acknowledged that its view represented a change from its previous position that the PMA process only represented the “FDA's endorsement of a minimum standard” and that therefore “PMA approval should not displace state common law that may provide additional protection to consumers.” See id. at 29. The FDA explained that its prior opinion did not appropriately consider either “the highly detailed and prescriptive nature of the PMA approval process” or the state-of- the-art risk management principles currently employed by FDA, which properly recognize that minimizing risk through additional warnings or market withdrawal may actually discourage or prevent appropriate product use. Id. at 28-29. In light of the FDA's comprehensive review and risk-benefit balancing analysis it conducts with respect to each PMA-approved device, the FDA concluded that it now believes that “a PMA approval sets a ceiling as well as a floor.” Id. at 29.

Third Circuit's Decision

The Third Circuit agreed with the FDA and the lower court that the MDA's express pre-emption provision pre-empted plaintiffs' claims. Horn, 376 F.3d at 180. In reaching this conclusion, the court followed in the FDA's footsteps both by distinguishing the case from Lohr and by finding that the Section 510(k) process at issue in Lohr was not at all comparable to the “far more thorough and rigorous PMA approval process” that the HeartMate had undergone. Id. at 167, 169-70, 174-76.

The court also appeared to adopt the FDA's view that the plaintiff's claims would be precluded by principles of conflict pre-emption. While the court did not decide this question, it nonetheless stated that any finding in the plaintiff's favor “would 'stand as an obstacle to the accomplishment and execution of' the objective of the safety and effectiveness of the [medical device] specifically and would conflict with the federal requirements imposed by the PMA” ' an almost verbatim recitation of the purposes and objectives form of conflict pre-emption. Id. at 166, 179 (quoting Geier v. American Honda Motor Co., 529 U.S. 861, 873 (2000)).

Implications

The FDA's brief in Horn appears to represent a significant shift from the agency's previous reticence in taking aggressive positions on pre-emption. In the recent past, the agency generally had focused on cases where a plaintiff sought to impose a requirement on a product that would have been in direct conflict with a specific prior decision by the agency and that often would have rendered it impossible for the product's manufacturer to comply with both federal standards and a state court judgment in the plaintiff's favor. For example, in Motus v. Pfizer Inc., the agency had examined and “repeatedly found that there was no causal relation between taking [the drug at issue] and an increased risk of suicide.” See Br. of Amicus Curiae U.S. Dep't of Justice at 2-3, Motus v. Pfizer Inc., 358 F.3d 659 (9th Cir. 2004) (No. 02-55372). It thus argued that the drug would be misbranded under the FDCA if its labeling included the plaintiff's proposed warning suggesting such a relationship. Id. at 17-22. In a similar case, the FDA had specifically considered and refused to adopt the plaintiff's proposed warnings on a nicotine replacement therapy product and therefore argued that a ruling in the plaintiff's favor would make it impossible for the defendants to comply with both federal and state law. Br. of Amicus Curiae U.S. Dep't of Justice at 12, 16-19, Dowhal v. Smithkline Beecham Consumer Healthcare, 32 Cal. 4th 910 (Cal. 2004) (No. S109306). Furthermore, in litigation over Paxil, the FDA had, on five separate occasions, reviewed challenged advertisements stating that Paxil was not habit forming and refused to find them misleading. Br. of Amicus Curiae United States of Am. at 4, In re Paxil Litig., No. CV 01-07937 (C.D. Cal. Aug. 16, 2002). The FDA thus argued that the plaintiff's request that advertisements containing this statement be halted “directly impinges on FDA's role as the protector of the public interest in this field by ordering specific changes to ads that FDA has deemed acceptable.” Id. at 5.

In contrast to these cases, the FDA in Horn espoused a much broader form of conflict pre-emption that does not hinge on the agency's isolated consideration and rejection of the precise argument raised by a state court plaintiff. Instead, the FDA relied on the searching and comprehensive ' indeed, prescriptive ' nature of the PMA approval process and argued that its risk-benefit balancing determinations concerning a product and its labeling ' decisions calculated to protect and promote the overall public health ' should constitute the final, authoritative word regarding the product. As the FDA made clear, allowing state lay judges and juries to redetermine a product's risks and benefits or revise a product's FDA-approved labeling based on the experience of a single individual or group of individuals would thwart Congress' goal of protecting the overall public health and therefore should be precluded. FDA Br. at 2, 25-26, 28-29.

Significantly, although Horn involved a medical device, the agency's reasoning would appear to apply equally to cases involving prescription drugs approved pursuant to a New Drug Application (“NDA”). Even though the statutory provisions governing prescription drugs do not contain an express pre-emption provision analogous to the provision governing medical devices, the agency's arguments in favor of pre-emption went beyond express pre-emption to encompass “objects and purposes” conflict pre-emption, as discussed above. Like PMA-approved medical devices, NDA-approved drugs and their proposed labeling undergo searching scrutiny by the FDA in a lengthy back-and-forth process with the manufacturer before they are permitted on the market. Just as the agency does for PMA-approved medical devices, the FDA performs systemic risk-benefit assessments for each NDA drug to determine whether it should be marketed, comprehensively regulates the mix of information accompanying a drug to optimize use and continuously monitors the drug to ensure that ongoing experience does not materially alter the drug's risk-benefit calculus. Therefore, there is no logical reason why the FDA's position that “a PMA approval sets a ceiling as well as a floor” (FDA Br. at 29) would not apply equally to NDA approvals, thereby counseling in favor of pre-empting design defect or failure to warn lawsuits brought against NDA-approved drugs.

Only time will tell the extent to which the FDA will continue to invoke broad principles of conflict pre-emption in vigorous defense of its jurisdiction and the extent to which courts will adopt the FDA's position, as the Third Circuit in Horn did. To date, courts have been divided on the extent to which conflict pre-emption precludes common law claims against drug manufacturers whose products are in compliance with FDA regulations. Compare Ehlis v. Shire Richwood, Inc., 233 F. Supp. 2d 1189, 1198 (D.N.D. 2002) (finding that failure to warn action was pre-empted and observing that the “FDA dictates the contents of the label for [defendants' drug product] and defendants were prohibited from changing it without prior approval from the FDA”), aff'd, 367 F.3d 1013 (8th Cir. 2004) with Merrell Dow Pharms., Inc. v. Oxendine, 649 A.2d 825, 829 (D.C. 1994) (rejecting pre-emption argument and observing that “the FDA action with respect to [defendant's drug product] was not intended to resolve the issue of safety for all purposes, and its finding of safety does not irreconcilably conflict with the jury's finding of liability with respect to Merrell Dow.”). One can only hope that Horn is the bellwether case that it appears to be and that courts will accord increasing deference to the FDA's centralized, expert risk-benefit decisions concerning the safety and efficacy of drugs and medical devices and refuse to allow state judges and juries lacking the FDA's expertise and experience to second-guess these decisions to the detriment of the overall public health.

By and large, the FDA has confined its participation to cases where it had specifically considered ' and rejected ' the plaintiffs' claims that a product's labeling or advertising should have included different language from that which was used. See Daniel E. Troy, FDA Involvement in Product Liability Lawsuits, Update: Food & Drug. L., Reg. & Educ. (Food & Drug Law Inst., Wash., D.C.), Jan./Feb. 2003, at 1. In 2004, however, the FDA submitted a brief in a state products liability action that signals the agency's willingness to be much more aggressive in protecting its jurisdiction from lay judge and jury determinations concerning a product's risk-benefit balance that conflict with the FDA's own determination of where that balance lies. See Br. of Amicus Curiae U.S. Dep't of Justice, Horn v. Thoratec Corp., 376 F.3d 163 (3d Cir. 2004) (No. 02-4597) (“FDA Br.”).

Background

The medical device at issue in Horn was a HeartMate heart pump. After extensive review and numerous communications with the manufacturer, the FDA approved the pump in 1994 pursuant to the Pre-Market Approval (“PMA”) process set forth in 21 U.S.C. '360e(c). See Horn v. Thoratec Corp., 376 F. 3d 163, 164-65, 169-70 (3d Cir. 2004). The plaintiff brought design defect and failure to warn claims against the device manufacturer following her husband's death a few days after the HeartMate implanted into him became disconnected from his heart. Id. at 165. The district court granted summary judgment in favor of the device manufacturer, finding that such claims were pre-empted by the Medical Device Amendments' (“MDA's”) express pre-emption provision set forth in 21 U.S.C. '360k(a). Id. That provision prohibits states from establishing or maintaining any safety or effectiveness requirement for a medical device that is “different from, or in addition to, any requirement applicable” under the FDCA. 21 U.S.C. '360k(a)(1). The plaintiff appealed the ruling to the U.S. Court of Appeals for the Third Circuit. Horn, 376 F.3d at 165.

Before reaching a decision, the Third Circuit requested the FDA's views on whether the plaintiff's claims were pre-empted by the MDA's express pre-emption clause. FDA Br. at 1. The court acknowledged that “FDA's pre-emption determinations are significant and should inform our interpretation of '360k(a)” and cited the Supreme Court's statement that the agency was “'uniquely qualified to determine whether a particular form of state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress, and, therefore, whether it should be pre-empted.'” Horn , 376 F.3d at 171 (quoting Medtronic v. Lohr , 518 U.S. 470, 495-96 (1996)).

FDA's Position on Pre-emption

In a 31-page submission, the FDA argued that the state common law claims were pre-empted and that it believed “that this view is compelled in order to achieve Congress' important public health protection purposes, carried out through FDA's implementation of the FDCA.” FDA Br. at 1-2. The FDA asserted that the Supreme Court's decision in Medtronic, Inc. v. Lohr, which found that the MDA's express pre-emption provision did not pre-empt state tort law claims brought against medical devices cleared pursuant to Section 510(k) of the FDCA, provided the analytical starting point but did not control the outcome of cases involving PMA-approved devices. Id. at 14-19 (discussing Medtronic, Inc. v. Lohr , 518 U.S. 470 (1996)).

Distinguishing the PMA approval process from the Section 510(k) clearance procedure, whereby devices may be cleared for marketing if they are found to be “substantially equivalent” to a predicate device, the FDA observed that “[p]reparation of a PMA and FDA's process of reviewing a PMA constitute a massive undertaking. … [the review] is thorough and scientifically rigorous, generally taking an average of 1200 hours of review time by the agency.” Br. at 8. The agency further observed that any revisions made after the FDA approves a PMA for a medical device, are considered with “the same type of rigorous scientific process utilized for review of original PMAs.” Id. at 10. The FDA then stated that the Section 510(k) procedure, “which typically requires an average of only twenty hours to complete” and “which only determines whether two products are substantially equivalent,” was “entirely different from a PMA” approval. … ” Id. at 12, 20.

The FDA argued that, unlike the Section 510(k) substantial equivalence requirements at issue in Lohr, the PMA process did impose sufficiently specific requirements as to pre-empt contrary or supplemental state law requirements imposed via state tort actions. Id. at 14-17.

Although the FDA focused its analysis on the MDA's express pre-emption provision, it strongly suggested that the plaintiff's claims were also precluded on conflict pre-emption grounds. That type of pre-emption exists either “when compliance with both state and federal law is impossible, or when the state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Capital Cities Cable, Inc. v. Crisp , 467 U.S. 691, 699 (1984). The agency made an extensive argument indicating its belief that recognition of state design defect and failure to warn claims would, indeed, “stand[ ] as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress” (id.) by thwarting “Congress's important public health protection purposes.” FDA Br. at 2, 25-26.

Notably, the agency acknowledged that its view represented a change from its previous position that the PMA process only represented the “FDA's endorsement of a minimum standard” and that therefore “PMA approval should not displace state common law that may provide additional protection to consumers.” See id. at 29. The FDA explained that its prior opinion did not appropriately consider either “the highly detailed and prescriptive nature of the PMA approval process” or the state-of- the-art risk management principles currently employed by FDA, which properly recognize that minimizing risk through additional warnings or market withdrawal may actually discourage or prevent appropriate product use. Id. at 28-29. In light of the FDA's comprehensive review and risk-benefit balancing analysis it conducts with respect to each PMA-approved device, the FDA concluded that it now believes that “a PMA approval sets a ceiling as well as a floor.” Id. at 29.

Third Circuit's Decision

The Third Circuit agreed with the FDA and the lower court that the MDA's express pre-emption provision pre-empted plaintiffs' claims. Horn, 376 F.3d at 180. In reaching this conclusion, the court followed in the FDA's footsteps both by distinguishing the case from Lohr and by finding that the Section 510(k) process at issue in Lohr was not at all comparable to the “far more thorough and rigorous PMA approval process” that the HeartMate had undergone. Id. at 167, 169-70, 174-76.

The court also appeared to adopt the FDA's view that the plaintiff's claims would be precluded by principles of conflict pre-emption. While the court did not decide this question, it nonetheless stated that any finding in the plaintiff's favor “would 'stand as an obstacle to the accomplishment and execution of' the objective of the safety and effectiveness of the [medical device] specifically and would conflict with the federal requirements imposed by the PMA” ' an almost verbatim recitation of the purposes and objectives form of conflict pre-emption. Id. at 166, 179 (quoting Geier v. American Honda Motor Co., 529 U.S. 861, 873 (2000)).

Implications

The FDA's brief in Horn appears to represent a significant shift from the agency's previous reticence in taking aggressive positions on pre-emption. In the recent past, the agency generally had focused on cases where a plaintiff sought to impose a requirement on a product that would have been in direct conflict with a specific prior decision by the agency and that often would have rendered it impossible for the product's manufacturer to comply with both federal standards and a state court judgment in the plaintiff's favor. For example, in Motus v. Pfizer Inc., the agency had examined and “repeatedly found that there was no causal relation between taking [the drug at issue] and an increased risk of suicide.” See Br. of Amicus Curiae U.S. Dep't of Justice at 2-3, Motus v. Pfizer Inc., 358 F.3d 659 (9th Cir. 2004) (No. 02-55372). It thus argued that the drug would be misbranded under the FDCA if its labeling included the plaintiff's proposed warning suggesting such a relationship. Id. at 17-22. In a similar case, the FDA had specifically considered and refused to adopt the plaintiff's proposed warnings on a nicotine replacement therapy product and therefore argued that a ruling in the plaintiff's favor would make it impossible for the defendants to comply with both federal and state law. Br. of Amicus Curiae U.S. Dep't of Justice at 12, 16-19, Dowhal v. Smithkline Beecham Consumer Healthcare , 32 Cal. 4th 910 (Cal. 2004) (No. S109306). Furthermore, in litigation over Paxil, the FDA had, on five separate occasions, reviewed challenged advertisements stating that Paxil was not habit forming and refused to find them misleading. Br. of Amicus Curiae United States of Am. at 4, In re Paxil Litig., No. CV 01-07937 (C.D. Cal. Aug. 16, 2002). The FDA thus argued that the plaintiff's request that advertisements containing this statement be halted “directly impinges on FDA's role as the protector of the public interest in this field by ordering specific changes to ads that FDA has deemed acceptable.” Id. at 5.

In contrast to these cases, the FDA in Horn espoused a much broader form of conflict pre-emption that does not hinge on the agency's isolated consideration and rejection of the precise argument raised by a state court plaintiff. Instead, the FDA relied on the searching and comprehensive ' indeed, prescriptive ' nature of the PMA approval process and argued that its risk-benefit balancing determinations concerning a product and its labeling ' decisions calculated to protect and promote the overall public health ' should constitute the final, authoritative word regarding the product. As the FDA made clear, allowing state lay judges and juries to redetermine a product's risks and benefits or revise a product's FDA-approved labeling based on the experience of a single individual or group of individuals would thwart Congress' goal of protecting the overall public health and therefore should be precluded. FDA Br. at 2, 25-26, 28-29.

Significantly, although Horn involved a medical device, the agency's reasoning would appear to apply equally to cases involving prescription drugs approved pursuant to a New Drug Application (“NDA”). Even though the statutory provisions governing prescription drugs do not contain an express pre-emption provision analogous to the provision governing medical devices, the agency's arguments in favor of pre-emption went beyond express pre-emption to encompass “objects and purposes” conflict pre-emption, as discussed above. Like PMA-approved medical devices, NDA-approved drugs and their proposed labeling undergo searching scrutiny by the FDA in a lengthy back-and-forth process with the manufacturer before they are permitted on the market. Just as the agency does for PMA-approved medical devices, the FDA performs systemic risk-benefit assessments for each NDA drug to determine whether it should be marketed, comprehensively regulates the mix of information accompanying a drug to optimize use and continuously monitors the drug to ensure that ongoing experience does not materially alter the drug's risk-benefit calculus. Therefore, there is no logical reason why the FDA's position that “a PMA approval sets a ceiling as well as a floor” (FDA Br. at 29) would not apply equally to NDA approvals, thereby counseling in favor of pre-empting design defect or failure to warn lawsuits brought against NDA-approved drugs.

Only time will tell the extent to which the FDA will continue to invoke broad principles of conflict pre-emption in vigorous defense of its jurisdiction and the extent to which courts will adopt the FDA's position, as the Third Circuit in Horn did. To date, courts have been divided on the extent to which conflict pre-emption precludes common law claims against drug manufacturers whose products are in compliance with FDA regulations. Compare Ehlis v. Shire Richwood, Inc., 233 F. Supp. 2d 1189, 1198 (D.N.D. 2002) (finding that failure to warn action was pre-empted and observing that the “FDA dictates the contents of the label for [defendants' drug product] and defendants were prohibited from changing it without prior approval from the FDA”), aff'd , 367 F.3d 1013 (8th Cir. 2004) with Merrell Dow Pharms., Inc. v. Oxendine , 649 A.2d 825, 829 (D.C. 1994) (rejecting pre-emption argument and observing that “the FDA action with respect to [defendant's drug product] was not intended to resolve the issue of safety for all purposes, and its finding of safety does not irreconcilably conflict with the jury's finding of liability with respect to Merrell Dow.”). One can only hope that Horn is the bellwether case that it appears to be and that courts will accord increasing deference to the FDA's centralized, expert risk-benefit decisions concerning the safety and efficacy of drugs and medical devices and refuse to allow state judges and juries lacking the FDA's expertise and experience to second-guess these decisions to the detriment of the overall public health.