The FDA's Amicus Briefs on Preemption
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As everyone who litigates drug and medical device cases knows, the FDA has filed a number of briefs as amicus curiae over the past few years. It strikes us that it would be a good idea to collect them all in one place. Not only is this collection a resource in its own right, but a review of these briefs will show that, (1) by and large, the FDA has been much more consistent than the plaintiffs’ bar gives the Agency credit for, and (2) the advent of the FDA’s pro-preemption advocacy, far from being a figment of the change in political administrations that took place in January, 2001, actually began a year earlier, while the Democrats still ran the Agency.
What happened was not so much that the FDA changed its position, but that the type of lawsuits being filed plaintiffs have been infringing more and more on the FDA’s prerogative to approve prescription medical products and to control their labeling.
The first FDA amicus brief in this series argued in favor of preemption of what had become known as “fraud-on-the-FDA” claims. Under a fraud on the FDA theory, courts applying state law supposedly had the power to ignore in-force FDA decisions if those decisions were deemed “fraudulently” obtained by the defendants. Obviously, such claims posed a direct threat to, and inherent conflict with, the Agency actions challenged as fraudulent. When the question of preemption of fraud on the FDA claims reached the Supreme court in early 2000, the Court asked the Agency for its views. The Department of Justice (the FDA’s lawyers) filed an amicus brief urging that the Court take the case and find fraud on the FDA claims preempted on the basis of that conflict (the Agency argued against express preemption). See Brief For United States As Amicus Curiae, Buckman Co. v. Plaintiffs’ Legal Committee, No. 98-1768 (U.S. filed June 7, 2000).
The Supreme Court agreed with the FDA and accepted the appeal. The FDA/DOJ filed a second amicus brief in the Buckman case on the merits, and once again it argued that fraud on the FDA claims were preempted as inherently conflicting with federal agency decisions. See Brief For United States As Amicus Curiae Supporting Petitioner, Buckman Co. v. Plaintiffs’ Legal Committee, No. 98-1768 (U.S. filed Sept. 13, 2000). The Supreme Court unanimously agreed. Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).
Also in 2000 the FDA elected to file a brief supporting preemption of common-law tort claims in a case where the plaintiffs had moved for injunctive relief under state law to force a manufacturer to make changes in FDA-approved labeling and to issue “Dear Doctor” letters. Finding these claims were a direct challenge to the FDA’s control over labeling content and over issuance of such letters to physicians, the FDA argued that these claims could not stand in the face of the Agency’s approval of the existing warnings and the FDA’s power to order notices to the public, and that the FDA had primary jurisdiction over such matters. See Statement Of Interest Of The United States, Bernhardt v. Pfizer, Inc., 00 Civ. 4042 (LLM) (S.D.N.Y. filed Nov. 13, 2000). The court agreed that the FDA had primary jurisdiction and did not reach preemption. Bernhardt v. Pfizer, Inc., 2000 WL 1738645 (S.D.N.Y. Nov. 22, 2000).
After the change in administrations, a similar situation arose in 2002, where plaintiffs obtained an injunction under state law against a manufacturer’s continuation of FDA-approved advertising. In re Paxil Litigation, 2002 WL 1940708 (C.D. Cal. Aug. 16, 2002). Once again the Agency found the claim a direct threat to its superintendence of what regulated manufacturers told the public about regulated products and argued in favor of preemption. See Brief Of The United States, In re Paxil Litigation, No. CV 01-07937 MRP (C.D. Cal. filed Sept. 5, 2002). The district court, while not finding preemption, reconsidered its order and withdrew the objection. In re Paxil Litigation, 2002 WL 31375497 (C.D. Cal. Oct. 18, 2002).
At approximately the same time the FDA also intervened in litigation in California seeking to enforce a state proposition that mandated birth defect warnings under certain circumstances, even with respect to FDA-approved product labeling. The litigation sought to force manufacturers of smoking cessation devices to include such warnings. The Agency, however, had nixed these warnings because it considered the risk of birth defects from use of these products to be much less of a risk to the developing fetus than the risks posed by cigarette smoke if pregnant women, deterred by the state-law warnings from using the devices, continued to smoke. When this litigation reached an appellate stage in 2002, the FDA filed an amicus brief taking the position that, once the Agency had ruled that no warning was appropriate, state law could not hold the manufacturer liable for following the FDA’s direction in preference to the state proposition. See Amicus Curiae Brief of the United States of America in Support of Defendants/Respondents, Dowhal v. SmithKline Beecham Consumer Health Care LP, No. A094460 (Cal. App. filed March 25, 2002).
The intermediate appellate court disagreed with the FDA and held that the state proposition had been exempted by preemption by a federal statute. Dowhal v. SmithKline Beecham Consumer Healthcare, 100 Cal. App. 4th 8, 122 Cal. Rptr. 2d 246 (2002). On further appeal to the California Supreme Court, the FDA submitted a second amicus brief in the same case making the same arguments. See Amicus Curiae Brief Of The United States Of America, Dowhal v. SmithKline Beecham Consumer Healthcare, LP, No. A094460 (Cal. filed July 18, 2003). Siding with the FDA, the California Supreme Court reversed and held that the litigation was preempted - not even by statute could Congress approve state law prevailing in a direct conflict with supreme federal law. Dowhal v. SmithKline Beecham Consumer Healthcare, 32 Cal. 4th 910, 12 Cal. Rptr. 3d 262, 88 P.3d 1 (2004).
The next FDA intervention in state-law tort litigation occurred in state court in Tennessee. In medical device litigation, the plaintiffs contended that the product in question was approved by the Agency through one method of review, and the defendant contended that a different method of review had been used. The FDA filed a brief, siding with the defendant, stating how the product was approved, and arguing that plaintiff’s contrary contentions misapplied the FDCA and were therefore preempted. See Statement Of Interest Of The United States Of America, Murphee v. Pacesetter, Civ. No. ct-005429-00-3 (Tenn. Cir. 30th Dist. Dec. 12, 2003). The litigation did not produce any opinion resolving the issue.
Shortly after the turn of the millennium, plaintiffs started filing suits alleging that selective serotonin uptake inhibitors (“SSRIs”), cheap viagra approved to treat clinical depression, caused suicide. Since depression - the condition being treated - also caused suicide, these claims were problematic from a scientific standpoint. The FDA reviewed this issue several times and until recently refused to permit suicidality warnings on SSRIs as to any category of user (and as of this moment still requires only pediatric warnings). Ignoring the FDA’s resolution of this issue, plaintiffs alleged in state-law SSRI litigation that the warnings the FDA had prohibited were mandated by state tort law. Beginning in 2002, the FDA filed several amicus briefs arguing that its decisions not to require suicide/suicidality warnings preempted claims asserting a state-law duty to provide those same warnings. See Brief For Amicus Curiae The United States Of America, Motus v. Pfizer, Inc., Nos. 02-55372, 02-55498 (9th Cir. filed Sept. 3, 2002); Amicus Brief For The United States, Kallas v. Pfizer, Inc., No. 2:04CV0998 PGC (D. Utah. filed Sept. 15, 2005); Brief for Amicus Curiae United States of America, Colacicco v. Apotex Corp., C.A. No. 05-5500-MMB (E.D. Pa. filed May 10, 2006); Brief of United States as Amicus Curiae in Support of Defendants-Appellees, Colacicco v. Apotex Corp., No. 06-3107 (3d Cir. filed Dec. 4, 2006). The court in Motus avoided the preemption issue. Motus v. Pfizer Inc., 358 F.3d 659 (9th Cir. 2004). The Kallas litigation settled before there was any decision. The district court in Colacicco agreed with the FDA and found the SSRI claim preempted, Colacicco v. Apotex, Inc., 432 F. Supp.2d 514 (E.D. Pa. 2006) - a ruling that is currently on appeal.
In a recent case that did not involve a purported drug risk previously passed upon by the Agency, the FDA has taken the position that, unless it would have found the scientific basis insufficient, there is no preemption prior to the FDA actually taking a regulatory position. See Letter Brief of the United States as Amicus Curiae, Perry v. Novartis Pharmaceuticals, C.A. No. 05-5350 (E.D. Pa. filed Sept. 21, 2006). The FDA distinguished the SSRI cases as involving state-law challenges to actual FDA decisions, and the court ultimately ruled the same way. Perry v. Novartis Pharmaceuticals, ___ F. Supp.2d ___, 2006 WL 2979388 (E.D. Pa. Oct. 16, 2006).
In the only instance where the FDA has reversed a specific prior legal position in an amicus filing has to do with express preemption under the Medical Device Amendments (“MDA”) and pre-market approved devices - the most rigorously reviewed type of medical device. Acknowledging that it was reversing a 1998 position against preemption, the FDA determined in 2004 that the its pre-market approval process produced “device specific” requirements that preempted most product liability claims against this category of product. See Letter Brief of United States as Amicus Curiae, Horn v. Thoratec, No. 02-4597 (3d Cir. filed May 14, 2004). The court, which had invited the FDA’s participation, agreed with the Agency and affirmed preemption, notwithstanding the regulatory reversal of position. Horn v. Thoratec Corp., 376 F.3d 163 (3d Cir. 2004).
We’ve provided links to all of these amicus briefs. We believe that they demonstrate how the Agency’s trend in favor of preemption began before the change of administration, and thus cannot be waved away as political. Rather, the FDA’s advocacy of preemption is almost entirely a reflection on the types of claims being brought against regulated manufacturers. We also believe that, with the exception of Horn, the FDA has been quite consistent in its positions. The Agency’s position is, and has been that tort claims which either ignore FDA decisions, or threaten to undermine the Agency’s authority over the approval or labeling of regulated products, are preempted. That’s the position that the Agency has taken in these amicus briefs, and it’s also the position that it has taken in its 2006 Final Rule. See 71 Fed. Reg. 3922, 3933-36, 3967-69 (FDA Jan. 24, 2006).
As everyone who litigates drug and medical device cases knows, the FDA has filed a number of briefs as amicus curiae over the past few years. It strikes us that it would be a good idea to collect them all in one place. Not only is this collection a resource in its own right, but a review of these briefs will show that, (1) by and large, the FDA has been much more consistent than the plaintiffs’ bar gives the Agency credit for, and (2) the advent of the FDA’s pro-preemption advocacy, far from being a figment of the change in political administrations that took place in January, 2001, actually began a year earlier, while the Democrats still ran the Agency.
What happened was not so much that the FDA changed its position, but that the type of lawsuits being filed plaintiffs have been infringing more and more on the FDA’s prerogative to approve prescription medical products and to control their labeling.
The first FDA amicus brief in this series argued in favor of preemption of what had become known as “fraud-on-the-FDA” claims. Under a fraud on the FDA theory, courts applying state law supposedly had the power to ignore in-force FDA decisions if those decisions were deemed “fraudulently” obtained by the defendants. Obviously, such claims posed a direct threat to, and inherent conflict with, the Agency actions challenged as fraudulent. When the question of preemption of fraud on the FDA claims reached the Supreme court in early 2000, the Court asked the Agency for its views. The Department of Justice (the FDA’s lawyers) filed an amicus brief urging that the Court take the case and find fraud on the FDA claims preempted on the basis of that conflict (the Agency argued against express preemption). See Brief For United States As Amicus Curiae, Buckman Co. v. Plaintiffs’ Legal Committee, No. 98-1768 (U.S. filed June 7, 2000).
The Supreme Court agreed with the FDA and accepted the appeal. The FDA/DOJ filed a second amicus brief in the Buckman case on the merits, and once again it argued that fraud on the FDA claims were preempted as inherently conflicting with federal agency decisions. See Brief For United States As Amicus Curiae Supporting Petitioner, Buckman Co. v. Plaintiffs’ Legal Committee, No. 98-1768 (U.S. filed Sept. 13, 2000). The Supreme Court unanimously agreed. Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).
Also in 2000 the FDA elected to file a brief supporting preemption of common-law tort claims in a case where the plaintiffs had moved for injunctive relief under state law to force a manufacturer to make changes in FDA-approved labeling and to issue “Dear Doctor” letters. Finding these claims were a direct challenge to the FDA’s control over labeling content and over issuance of such letters to physicians, the FDA argued that these claims could not stand in the face of the Agency’s approval of the existing warnings and the FDA’s power to order notices to the public, and that the FDA had primary jurisdiction over such matters. See Statement Of Interest Of The United States, Bernhardt v. Pfizer, Inc., 00 Civ. 4042 (LLM) (S.D.N.Y. filed Nov. 13, 2000). The court agreed that the FDA had primary jurisdiction and did not reach preemption. Bernhardt v. Pfizer, Inc., 2000 WL 1738645 (S.D.N.Y. Nov. 22, 2000).
After the change in administrations, a similar situation arose in 2002, where plaintiffs obtained an injunction under state law against a manufacturer’s continuation of FDA-approved advertising. In re Paxil Litigation, 2002 WL 1940708 (C.D. Cal. Aug. 16, 2002). Once again the Agency found the claim a direct threat to its superintendence of what regulated manufacturers told the public about regulated products and argued in favor of preemption. See Brief Of The United States, In re Paxil Litigation, No. CV 01-07937 MRP (C.D. Cal. filed Sept. 5, 2002). The district court, while not finding preemption, reconsidered its order and withdrew the objection. In re Paxil Litigation, 2002 WL 31375497 (C.D. Cal. Oct. 18, 2002).
At approximately the same time the FDA also intervened in litigation in California seeking to enforce a state proposition that mandated birth defect warnings under certain circumstances, even with respect to FDA-approved product labeling. The litigation sought to force manufacturers of smoking cessation devices to include such warnings. The Agency, however, had nixed these warnings because it considered the risk of birth defects from use of these products to be much less of a risk to the developing fetus than the risks posed by cigarette smoke if pregnant women, deterred by the state-law warnings from using the devices, continued to smoke. When this litigation reached an appellate stage in 2002, the FDA filed an amicus brief taking the position that, once the Agency had ruled that no warning was appropriate, state law could not hold the manufacturer liable for following the FDA’s direction in preference to the state proposition. See Amicus Curiae Brief of the United States of America in Support of Defendants/Respondents, Dowhal v. SmithKline Beecham Consumer Health Care LP, No. A094460 (Cal. App. filed March 25, 2002).
The intermediate appellate court disagreed with the FDA and held that the state proposition had been exempted by preemption by a federal statute. Dowhal v. SmithKline Beecham Consumer Healthcare, 100 Cal. App. 4th 8, 122 Cal. Rptr. 2d 246 (2002). On further appeal to the California Supreme Court, the FDA submitted a second amicus brief in the same case making the same arguments. See Amicus Curiae Brief Of The United States Of America, Dowhal v. SmithKline Beecham Consumer Healthcare, LP, No. A094460 (Cal. filed July 18, 2003). Siding with the FDA, the California Supreme Court reversed and held that the litigation was preempted - not even by statute could Congress approve state law prevailing in a direct conflict with supreme federal law. Dowhal v. SmithKline Beecham Consumer Healthcare, 32 Cal. 4th 910, 12 Cal. Rptr. 3d 262, 88 P.3d 1 (2004).
The next FDA intervention in state-law tort litigation occurred in state court in Tennessee. In medical device litigation, the plaintiffs contended that the product in question was approved by the Agency through one method of review, and the defendant contended that a different method of review had been used. The FDA filed a brief, siding with the defendant, stating how the product was approved, and arguing that plaintiff’s contrary contentions misapplied the FDCA and were therefore preempted. See Statement Of Interest Of The United States Of America, Murphee v. Pacesetter, Civ. No. ct-005429-00-3 (Tenn. Cir. 30th Dist. Dec. 12, 2003). The litigation did not produce any opinion resolving the issue.
Shortly after the turn of the millennium, plaintiffs started filing suits alleging that selective serotonin uptake inhibitors (“SSRIs”), cheap viagra approved to treat clinical depression, caused suicide. Since depression - the condition being treated - also caused suicide, these claims were problematic from a scientific standpoint. The FDA reviewed this issue several times and until recently refused to permit suicidality warnings on SSRIs as to any category of user (and as of this moment still requires only pediatric warnings). Ignoring the FDA’s resolution of this issue, plaintiffs alleged in state-law SSRI litigation that the warnings the FDA had prohibited were mandated by state tort law. Beginning in 2002, the FDA filed several amicus briefs arguing that its decisions not to require suicide/suicidality warnings preempted claims asserting a state-law duty to provide those same warnings. See Brief For Amicus Curiae The United States Of America, Motus v. Pfizer, Inc., Nos. 02-55372, 02-55498 (9th Cir. filed Sept. 3, 2002); Amicus Brief For The United States, Kallas v. Pfizer, Inc., No. 2:04CV0998 PGC (D. Utah. filed Sept. 15, 2005); Brief for Amicus Curiae United States of America, Colacicco v. Apotex Corp., C.A. No. 05-5500-MMB (E.D. Pa. filed May 10, 2006); Brief of United States as Amicus Curiae in Support of Defendants-Appellees, Colacicco v. Apotex Corp., No. 06-3107 (3d Cir. filed Dec. 4, 2006). The court in Motus avoided the preemption issue. Motus v. Pfizer Inc., 358 F.3d 659 (9th Cir. 2004). The Kallas litigation settled before there was any decision. The district court in Colacicco agreed with the FDA and found the SSRI claim preempted, Colacicco v. Apotex, Inc., 432 F. Supp.2d 514 (E.D. Pa. 2006) - a ruling that is currently on appeal.
In a recent case that did not involve a purported drug risk previously passed upon by the Agency, the FDA has taken the position that, unless it would have found the scientific basis insufficient, there is no preemption prior to the FDA actually taking a regulatory position. See Letter Brief of the United States as Amicus Curiae, Perry v. Novartis Pharmaceuticals, C.A. No. 05-5350 (E.D. Pa. filed Sept. 21, 2006). The FDA distinguished the SSRI cases as involving state-law challenges to actual FDA decisions, and the court ultimately ruled the same way. Perry v. Novartis Pharmaceuticals, ___ F. Supp.2d ___, 2006 WL 2979388 (E.D. Pa. Oct. 16, 2006).
In the only instance where the FDA has reversed a specific prior legal position in an amicus filing has to do with express preemption under the Medical Device Amendments (“MDA”) and pre-market approved devices - the most rigorously reviewed type of medical device. Acknowledging that it was reversing a 1998 position against preemption, the FDA determined in 2004 that the its pre-market approval process produced “device specific” requirements that preempted most product liability claims against this category of product. See Letter Brief of United States as Amicus Curiae, Horn v. Thoratec, No. 02-4597 (3d Cir. filed May 14, 2004). The court, which had invited the FDA’s participation, agreed with the Agency and affirmed preemption, notwithstanding the regulatory reversal of position. Horn v. Thoratec Corp., 376 F.3d 163 (3d Cir. 2004).
We’ve provided links to all of these amicus briefs. We believe that they demonstrate how the Agency’s trend in favor of preemption began before the change of administration, and thus cannot be waved away as political. Rather, the FDA’s advocacy of preemption is almost entirely a reflection on the types of claims being brought against regulated manufacturers. We also believe that, with the exception of Horn, the FDA has been quite consistent in its positions. The Agency’s position is, and has been that tort claims which either ignore FDA decisions, or threaten to undermine the Agency’s authority over the approval or labeling of regulated products, are preempted. That’s the position that the Agency has taken in these amicus briefs, and it’s also the position that it has taken in its 2006 Final Rule. See 71 Fed. Reg. 3922, 3933-36, 3967-69 (FDA Jan. 24, 2006).