A troubling trend in preemption rulings.

Other cases may receive more headlines, but for trial lawyers, the Supreme Court's most important decisions this year will focus on preemption. And the Court is already displaying a troubling trend on this issue.

On February 20, the Court handed down three decisions that address the question of when federal law trumps state law. All three found that the state law claims involved were preempted. (1) Still pending is Wyeth v. Levine, which considers whether a patient who was injured by off-label use of a drug can recover from the manufacturer, even though the FDA approved the label. (2)

[ILLUSTRATION OMITTED]

One would expect that a conservative Court, committed to protecting states' rights, would narrow the scope of federal preemption. After all, a good way to empower state governments is to restrict the federal government's reach. Restricting preemption gives state governments more autonomy.

But there is every indication that the Roberts Court, although unquestionably conservative, will interpret preemption doctrines broadly when businesses challenge state and local laws. The recent decisions--especially Riegel v. Medtronic, Inc.--suggest a Court very willing to let federal law trump state law when business interests are at stake.

The Rehnquist era

A tendency to find in favor of businesses pushing the preemption argument began with the Rehnquist Court. For example, in the 2000 case Geier v. American Honda Motor Co., (3) the Court found that federal law preempted a state products liability lawsuit over an unsafe vehicle, despite a statutory provision that expressly provided that "compliance with" a federal safety standard did "not exempt any person from any liability under the common law." (4) In Lorillard Tobacco Co. v. Reilly, the Court found that federal law preempted a state law regulating the location of cigarette advertisements (the regulation was part of the state's campaign to reduce underage smoking). (5) In Crosby v. National Foreign Trade Council, the Court invalidated a Massachusetts law that prohibited the state from purchasing goods and services from companies that did business with Burma because of that country's human rights record. (6)

In American Insurance Association v. Garamendi, the Court found preemption of a California law requiring that insurance companies doing business in that state disclose their Holocaust-era insurance policies. (7) California adopted this law because insurance companies had refused to provide such information and many of the companies were doing business in the state. The Court invalidated the California statute--despite the absence of any federal law expressing an intent to preempt state law--based on the dormant foreign affairs power of the president.

At the very least, these decisions and others like them are inconsistent with the Court's oft-stated presumption against preemption. In 1985, the Court declared that in all preemption cases, and particularly in those in which Congress has legislated in a field that the states have traditionally occupied, "we start with the assumption that the historic police powers of the states were not to be superseded by the federal act unless that was the clear and manifest purpose of Congress." (8)

Yet the recent cases clearly put the presumption in favor of preemption. Each involved a situation where the text of the federal law was silent about preemption in that specific context, and where there was no conflict between federal and state law. Yet each time, the Court found preemption, and often the justices most committed to using federalism to limit federal power were in the majority.

In Lorillard, the decision to preempt state regulation of cigarette advertising was 5-4, the majority being then-Chief Justice William Rehnquist and Justices Anthony Kennedy, Sandra Day O'Connor, Antonin Scalia, and Clarence Thomas. These are the same five justices who were in the majority in the 5-4 decisions limiting the scope of Congress's commerce power, (9) reviving the Tenth Amendment, (10) and expanding the scope of sovereign immunity. (11)

The recent preemption cases seem to be a continuation of the Rehnquist-era trend. In Preston v. Ferret, the Court held that when parties agree to arbitrate all questions arising under a contract, the Federal Arbitration Act (FAA) supersedes state laws lodging primary jurisdiction in another forum, whether judicial or administrative. (12) The case involved a dispute between a performer and his attorney. The Court held that a provision in the contract requiring arbitration preempted the authority of the California labor commissioner to determine that the contract was invalid and unenforceable under California's Talent Agencies Act.

In Rowe v. New Hampshire Motor Transport Association, the Court found that a state law regulating the shipment of tobacco products was preempted by the Federal Aviation Administration Authorization Act of 1994, which forbids states to "enact or enforce a law ... related to a price, route, or service of any motor carrier." (13)

The Riegel ruling

For plaintiff lawyers, the most important of the three rulings is Riegel v. Medtronic, Inc. (14) It is a powerful, troubling example of the Court's willingness to find preemption and help businesses at the expense of injured people. Riegel will make it more difficult to bring suits for injuries caused by FDA-approved medical devices.

The issue in Riegel was whether FDA approval of a medical device precluded a tort suit for money damages. When Charles Riegel underwent an angioplasty, his surgeon used a balloon catheter manufactured by Medtronic. The doctor used this device even though it was contraindicated for Riegel's condition. And although the label warned that the catheter should not be inflated beyond its rated burst pressure of 8 atmospheres, Riegel's doctor inflated it to a pressure of 10 atmospheres. The catheter ruptured; Riegel developed a heart block, was placed on life support, and underwent emergency coronary bypass surgery.

Riegel and his wife sued in federal district court, alleging that Medtronic's catheter was designed, labeled, and manufactured in a manner that violated New York common law, and that these defects caused Riegel to suffer severe and permanent injuries. The complaint raised a number of common law claims.

The key question was whether FDA approval of the device preempted the state claims. To answer it, the justices looked to the Medical Device Amendments of 1976 (MDA), a statute that classifies medical devices?

The MDA defines Class III devices, which are the most stringently regulated, as those "purported or represented to be for a use in supporting or sustaining human life, or for a use which is of substantial importance in preventing impairment of human health," or those that present "potential unreasonable risk of illness or injury." (16) Balloon catheters, like the one that was used in Riegel's angioplasty, are Class III medical devices. Under the statute, the FDA must follow a rigorous process for evaluating these products and deciding whether to approve them.

The MDA contains a preemption provision; the issue in Riegel was its scope. Specifically, the act states:

   Except as provided in subsection (b) of this
   section, no state or political subdivision of a
   state may establish or continue in effect with
   respect to a device intended for human use
   any requirement (1) which is different
   from, or in addition to, any requirement applicable
   under this chapter to the device,
   and (2) which relates to the safety or effectiveness
   of the device or to any other matter
   included in a requirement applicable to the
   device under this chapter. (17)

By its own terms, this provision is entirely about keeping states from imposing requirements on medical devices that are different from the requirements that the FDA has established. The obvious concern here is that individual states could impose conflicting requirements, making the national marketing of medical devices difficult--even impossible.

Tellingly, the preemption provision never mentions civil liability. If Congress had wanted to preclude civil suits under state law, it could have done so and expressed this intention in the section on preemption.

According to the courts' long-standing presumption against preemption, state laws should retain their autonomy unless it is clear that Congress intended to preempt. In the Riegel case, that would mean a finding of no preemption. But the Court, in an 8-1 decision, found that FDA approval of a medical device did preempt state common law liability. Scalia wrote for the Court:

   [A]bsent other indication, reference
   to a state's "requirements"
   includes its common law duties....
   [C]ommon law liability is
   "premised on the existence of a
   legal duty" and a tort judgment
   therefore establishes that the defendant
   has violated a state law
   obligation. And while the common
   law remedy is limited to
   damages, a liability award "'can
   be, indeed is designed to be, a potent
   method of governing conduct
   and controlling policy.'" (18)

The Court explained that tort liability could impose requirements on manufacturers greater than those approved by the FDA and that such requirements would be preempted by the federal statute. The majority concluded that FDA approval preempts all state common law claims, whether based on strict liability, negligence, breach of warranty, or any other basis.

But plaintiffs can still bring state law claims for failing to meet the FDA's standard. As Scalia explained,

   State requirements are preempted under
   the MDA only to the extent that they are
   "different from, or in addition to" the requirements
   imposed by federal law. Thus,
   [section] 360k does not prevent a state from providing
   a damages remedy for claims premised
   on a violation of FDA regulations; the state
   duties in such a case "parallel," rather than
   add to, federal requirements. (19)

This wording is crucial because it identifies how lawyers might still be able to sue for injuries from medical devices: by arguing that the manufacturer failed to comply with FDA standards.

The problem with this analysis is that it is not what the statute says. By its terms, the MDA precludes conflicting state regulations but says nothing about damages liability. As Justice Ruth Bader Ginsburg argued in her dissenting opinion, it is "'difficult to believe that Congress would, without comment, re move all means of judicial recourse'" for consumers injured by FDA-approved medical devices. (20) She noted that "the MDA's failure to create any federal compensatory remedy for such consumers further suggests that Congress did not intend broadly to preempt state common law suits grounded on allegations independent of FDA requirements." (21)

Although alone in dissent, Ginsburg clearly has the better argument. Congress could have preempted damages suits, but nothing in the statute or its legislative history even hints at such a purpose. If the presumption against preemption means anything, there should not be preemption here.

Looking forward

Why, then, was the decision 8-1, and why is this a likely precursor to other preemption cases? Preemption cases create the opportunity for an unusual coalition of the more liberal justices, like Justice Stephen Breyer, who favor more expansive national power, and the conservative justices, like Scalia and Chief Justice John Roberts, who are strongly pro-business. That is exactly what happened in Riegel, and that is what will probably happen in future cases.

Some commentators have said the Roberts Court may be the most pro-business Court since the mid-1930s. (22) Its attitude toward preemption, especially in Riegel, provides strong evidence for this conclusion. In Wyeth v. Levine, we will see further indication of how far the Court is willing to go in preempting state tort law claims to protect business interests.

Notes

(1.) Preston v. Ferrer, 128S. Ct. 978 (2008);Rowe v. N.H. Motor Transport Assn., 128 S. Ct. 989 (2008); Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008).

(2.) 2006 WL 3041078 (Vt. Oct. 27, 2006), cert. granted, 128 S. Ct. 1118 (2008).

(3.) 529 U.S. 861 (2000).

(4.) 15 U.S.C. [section]1397(k) (repealed 1994).

(5.) 533 U.S. 525 (2001).

(6.) 530 U.S. 363 (2000).

(7.) 539 U.S. 396 (2003).

(8.) Hillsborough Co. v. Automated Med. Labs., Inc., 471 U.S. 707,715 (1985).

(9.) See e.g. United States v. Morrison, 529 U.S. 598 (2000); United States v. Lopez, 514 U.S. 549 (1995).

(10.) See e.g. Printz v. United States, 521 U.S. 898 (1997); New York v. United States, 505 U.S. 144 (1992).

(11.) See e.g. Alden v. Me., 527 U.S. 706 (1999) (holding that state governments have sovereign immunity and that they cannot be sued in state court on federal claims); Seminole Tribe of Fla. v, Fla., 517 U.S. 44 (1996) (limiting the power of Congress to authorize lawsuits against state governments).

(12.) 128 S. Ct. 978.

(13.) 49 U.S.C. [section]14501 (c) (1) (2006).

(14.) 128 S. Ct. 999.

(15.) Pub L. No. 94-295, 90 Stat. 539 (1976) (codified as amended in scattered sections of 21 u.s.c.).

(16.) 21 u.s.c. [section]360c(a) (1) (C)(ii) (2006).

(17.) Id. at [section]360k(a).

(18.) 128 S. Ct. 999, 1008 (citations omitted).

(19.) Id. at 1011 (citation omitted).

(20.) Id. at 1016 (Ginsburg, J., dissenting) (quoting Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 251 (1984)).

(21.) Id.

(22.) Jeffrey Rosen, Supreme Court, Inc., N.Y. Times Mag. (Mar. 16, 2008).

ERWIN CHEMERINSKY is the Alston & Bird Professor of Law and Political Science at Duke University. He can be reached at [e-mail].