Payoff for Patients

FORUM COLUMN

One of the paradoxes of constitutional law in recent years has been the willingness of conservatives to find state and local law to be pre-empted by federal law. The Rehnquist and Roberts Courts are unquestionably conservative and one would expect a conservative court to want to narrow the reach of federal pre-emption. One way to empower state and local governments is to limit the circumstances in which they are pre-empted by federal law. But in a series of cases spanning many years, the Supreme Court repeatedly has found pre-emption when there have been business challenges to state and local regulations.

In a book published last year, "Empowering Government: Federalism for the 21st Century," I argue for limiting the circumstances of pre-emption so as to leave more governing authority to state and local governments. Interestingly, this is exactly the position take by Justice Clarence Thomas in an opinion in the Supreme Court's most recent preemption decision, Wyeth v. Levine, 2009 DJDAR 3199.

Wyeth is one of the most important pre-emption cases in recent years. The issue is whether the approval of a prescription drug pre-empts state tort liability against pharmaceutical companies on a failure to warn theory. The court, in a 6-3 decision, found that there is not pre-emption and that, in fact, state tort liability is complementary to and advances the goals of federal regulation. The case is thus very important in preserving the ability of patients injured by prescription drugs to sue pharmaceutical companies. More generally, it is one of the most important cases in many years to strongly reaffirm the presumption against pre-emption.

The case arose from tragic facts. Diana Levine is a professional musician in Vermont. In April 2000, Levine was suffering from a severe migraine and went to the emergency room for treatment. She was given Demerol to alleviate the pain and Phenergen for lessen her nausea. The physician's assistant administered these drugs through an "IV-push" method, whereby the drug was injected directly into her vein.

This is a dangerous and inappropriate way to administer this drug because of its corrosive effects. When administered in this manner, it can enter an artery and will cause gangrene. This is exactly what happened to Levine, and her arm had to be amputated. The proper method for administering Phenergen is through an IV-drip, where the drug is introduced into a saline solution in a hanging intravenous bag and slowly descends through a catheter inserted in a patient's vein. In fact, the evidence at trial showed that the use of this method eliminated the dangers from Phenergen, whereas even experienced clinicians could have devastating results when Phenergen is administered through an IV-push.

After settling claims against the health center and the clinician, Levine sued Wyeth, relying on common-law negligence and strict-liability theories. Phenergan's labeling warned of the danger of gangrene and amputation following inadvertent intra-arterial injection. But Levine alleged that the labeling was defective because it failed to instruct clinicians to use the IV-drip method of intravenous administration instead of the higher-risk IV-push method.

Wyeth argued that Levine's claims were pre-empted by federal law. It maintained that there could not be tort liability on a failure to warn theory since its warning label had been approved by the FDA. The trial court rejected this defense and the jury found in favor of Levine. In answering questions on a special verdict form, the jury found that Wyeth was negligent, that Phenergan was a defective product as a result of inadequate warnings and instructions, and that Phenergen was the cause of Levine's injury. The jury awarded total damages of $7.4 million which the court reduced to account for Levine's earlier settlement with the health center and clinician. The Vermont Supreme Court affirmed and rejected Wyeth's pre-emption claims.

There are two basic ways of finding pre-emption: express pre-emption and implied pre-emption. If a federal statute explicitly says that federal law wholly occupies a field, then there is express pre-emption. For example, last term, in Riegel v. Medtronic, 128 S.Ct. 999 (2008), the Supreme Court found that Food and Drug Administration approval of a medical device pre-empted state tort liability. The court said that the federal law expressly pre-empted states from imposing "requirements" inconsistent with federal law and tort liability would have that effect. Unlike Riegel, in Wyeth v. Levine there was no express pre-emption provision or claim.

The other way of finding pre-emption is implied pre-emption. Even if federal law is silent about pre-emption, it can be found if it is impossible to simultaneously comply with both federal and state law, or if state or local law impedes the achievement of a federal objective, or if Congress has evidenced a clear intent to have federal law wholly occupy a field.

In Wyeth v. Levine, the drug company raised the first two kinds of pre-emption: that it was impossible for it to comply with both federal and state law and that state liability would interfere with the achievement of a federal objective. The court emphatically rejected both of these arguments.

Wyeth maintained that the FDA's approval of its drug label made it impossible for it to provide additional warnings. The Supreme Court rejected this argument and explained that nothing in federal law precludes drug companies from providing more information to doctors and patients about the dangers of prescription drugs. In general, the court noted that drug companies are to change warning labels only with preapproval of the FDA. But the court said that federal law allows companies to provide more warnings of the dangers of drugs before receiving such approval. The court said that federal regulations specifically provide that if a "manufacturer is changing a label to 'add or strengthen a contraindication, warning, precaution, or adverse reaction' or to 'add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product,' it may make the labeling change upon filing its supplemental application with the FDA; it need not wait for FDA approval."

More importantly, the Supreme Court said that there had been repeated incidents of Phenergen causing exactly the type of harms that Levine suffered and it could have asked for FDA approval of a change in its warning label and acted to protect patients from the danger. The court said that "absent clear evidence that the FDA would not have approved a change to Phenergan's label, we will not conclude that it was impossible for Wyeth to comply with both federal and state requirements."

Justice John Paul Stevens concluded his analysis of conflicts pre-emption by declaring: "Impossibility pre-emption is a demanding defense. On the record before us, Wyeth has failed to demonstrate that it was impossible for it to comply with both federal and state requirements. The [federal] regulation permitted Wyeth to unilaterally strengthen its warning, and the mere fact that the FDA approved Phenergan's label does not establish that it would have prohibited such a change."

Wyeth's second argument for pre-emption was that allowing state tort liability would impair the achievement of a congressional objective. The Supreme Court long has held that state and local laws are pre-empted if they interfere with the achievement of a federal objective. Wyeth maintained that it was Congress's purpose to have an expert federal agency, the FDA, entirely responsible for determining the content of warning labels. In other words, Wyeth's argument is that the FDA was to determine both the floor and the ceiling of a drug company's duty to warn physicians and patients.

The Supreme Court emphatically rejected this contention and declared: "We find no merit in this argument, which relies on an untenable interpretation of congressional intent and an overbroad view of an agency's power to pre-empt state law. ... The most glaring problem with this argument is that all evidence of Congress' purposes is to the contrary." Stevens explained that "[i]f Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express pre-emption provision at some point during the FDCA's 70-year history."

In fact, the court said that the FDA, until very recently, always had thought of state tort liability as providing an important, additional "layer of consumer protection that complements FDA regulation." Thus, the court found that Levine's claim furthered and did not interfere with Congress's purposes in regulating prescription drugs.

At the very least, Wyeth v. Levine means that those injured by prescription drugs may sue under a failure to warn theory. Moreover, if the court follows its approach, pre-emption will be more difficult to find. The court stressed the presumption against pre-emption and rejected claims of pre-emption based on both conflicts with federal law and impairment of congressional objectives.

Erwin Chemerinsky is dean and distinguished professor of law at UC Irvine School of Law.

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