Photo of Bexis

A long time ago – blogwise, anyway – we put together a post that described and linked to all the FDA’s amicus curiae briefs that the Agency had filed in favor of preemption in prescription drug and medical device product liability litigation. Several things have happened since then. One of those things was that we dug up another FDA pro-preemption brief from 1991. Another thing that happened was the government filing another amicus brief in support of preemption. A third thing that happened is technical to us – we changed our storage website, and we’re not so sure how well the old links continue to work. But the most important thing that’s happened since last year is that now we’ve got a much bigger audience. At least five times as many people visit this blog daily now as did last December.
Because we don’t know anywhere else – on the web or off – where a complete set of the FDA’s amicus briefs supporting preemption is publicly available, we’re repeating and updating our earlier post.
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 on the subject of preemption. We thought it would be a good idea (and a public service) 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, while the Democrats still ran the Agency.
What happened wasn’t so much that the FDA changed its position, but that the type of lawsuits being filed by plaintiffs have been infringing more and more directly on the FDA’s prerogative to approve prescription medical products and to control their labeling.
The very first brief that we know of in which the FDA advocated federal preclusion of state law came in 1991. The FDA filed its Statement of Interest the Food and Drug Administration, Biffle v. Eli Lilly & Co., No. 91-02496-A (Tex. Dist., filed Feb. 18, 1991). The FDA advocated in Biffle preemption of state-law discovery that would have revealed the identities of persons filing adverse experience reports with the Agency. Coincidentally, or not, Biffle was a suicidality case involving an anti-depressant. The trial court ignored the FDA’s position and the company sought mandamus. The Texas Supreme Court reversed, Eli Lilly v. Marshall, 850 S.W.2d 155 (Tex. 1993), and precluded the discovery, but the reversal was not based on preemption grounds.
The next FDA amicus brief to argue in favor of preemption – and the first to take a pro-preemption position on a matter of substantive law – involved what have 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 to have been “fraudulently” obtained by the defendants. Obviously, such claims posed a direct threat to, and inherent conflict with, the Agency actions that were being 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 in Buckman. The FDA/DOJ filed a second amicus brief in the Buckman case on the merits, which once again 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 that fraud on the FDA claims were impliedly preempted. 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 that claim was a direct threat to the FDA’s superintendence of what regulated manufacturers could tell 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 injunction. 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 litigation that sought 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 teratogenicity warnings. The Agency, however, had nixed precisely these warnings. The FDA 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 California appellate court disagreed with the FDA and held that the state proposition had been exempted from 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 mostly 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 – even an express savings clause could permit state law to prevail in a direct conflict situation involving 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., filed 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”), medication 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 these products as to any category of user (and to date still requires only pediatric warnings). Ignoring the FDA’s resolution of this issue, plaintiffs alleged in state-law litigation that 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) – and now (since this post was originally drafted), so has the Court of Appeals. Colacicco v. Apotex, Inc., 521 F.3d 253 (3d Cir. 2008). A certiorari petition is pending in the Supreme Court.
In a case that (unlike the SSRI litigation) 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 Corp., 456 F. Supp.2d 678 (E.D. Pa. 2006).
In the only instance where the FDA actually changed a specific prior legal position in an amicus filing having to do with preemption, the FDA argued that express preemption applied under the Medical Device Amendments (“MDA”) for pre-market approved (“PMA”) 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 FDA’s PMA 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 appellate 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).
Similarly, the FDA supported broad express preemption of product liability claims against a Class III PMA medical device in a brief filed in opposition to the certiorari petition in Riegel v. Medtronic. See Brief for the United States as Amicus Curiae, Riegel v. Medtronic, Inc., No. 06-179 (U.S., filed May 23, 2007). The Supreme Court accepted certiorari in Riegel notwithstanding the government’s recommendation. Riegel v. Medtronic, Inc., 127 S .Ct. 3000 (U.S. 2007) (mem.). And as we duly reported, Riegel was a big win for preemption in the medical device context. Riegel v. Medtronic, Inc., 128 S. Ct. 999 (U.S. 2008).
The FDA also filed a brief in support of preemption in the Warner Lambert v. Kent case. See Brief for the United States as Amicus Curiae Supporting Petitioners, Warner Lambert Co. v. Kent, No. 06-1498 (U.S., filed Nov. 2007). We discussed that brief here. There was never a decision in Kent. With Chief Justice Roberts recused, the Supreme Court split 4-4, the effect *as we explained, here) being an automatic affirmance with no precedential value. Warner Lambert Co. v. Kent, 128 S.Ct. 1168 (2008) (per curiam).
A couple more FDA amicus briefs on preemption topics are have been filed since the original date of this post, in Wyeth, Inc. v. Levine. First, as we’ve mentioned, the United States Supreme Court requested the government’s view on whether to accept the Levine certiorari petition. The Government did so in December, 2007. See Brief for the United States as Amicus Curiae, Wyeth v. Levine, No. 06-1246 (U.S., filed December 21, 2007). We reviewed that brief, here. After the Supreme Court accepted certiorari, the Solicitor General filed a brief on the merits, also supporting preemption. See Brief for the United States as Amicus Curiae Supporting Petitioner, Wyeth v. Levine, No. 06-1246 (U.S., filed June, 2007). Levine presents essentially the same question the FDA has already briefed in Motus, Kallas, and Colacicco.
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 more regulatorily invasive types of claims being brought against FDA-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).