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Wyeth v Levine: Good decision?

By Robert D. Sargent, Jr.
web posted March 23, 2009

Recently (decided March 4), we read about a case that came before the Supreme Court, Wyeth v Levine.  I cringed when I read how the majority (6-3) ruled that states could sue drug companies even when they had completely complied with FDA rules about warnings on labels. 

What happened was that, in Vermont, a Diana Levine was given the antinausea drug Phenergan with a method called "IV-push," where the drug is injected directly into a vein.  The patient developed gangrene and her arm was amputated.  The drug came with warnings that this method (as opposed to "IV-drip") had a risk of developing gangrene, but Levine not only properly sued the doctors and hospital for ignoring the warnings, but sued the company, Wyeth, for not having stronger warnings. The trial court decided that if the label had more adequate warnings, or bigger warnings, or whatever, the accident wouldn't have happened, so they awarded petitioner 6.7 million dollars.  The Vermont Supreme Court affirmed.

What's a company supposed to do?  They not only had the warning, complying with FDA regulations, but they had, in the words of the forward to the Case, "…the preamble to a 2006 FDA regulation declaring that state-law failure-to-warn claims threaten the FDA's statutorily prescribed role."   There's also the "pre-emption concept that says federal law trumps state law when they are in conflict.

Well, I was planning on just trying to forget about it, when my curiosity took over:  Just which one of the new so-called "conservative" Justices sided with the liberal majority: Roberts? Alito? Stevens, who wrote the opinion, was joined by Kennedy, Ginsberg, Souter, Breyer, and…Whoa!  You can imagine my surprise when it turned out to be Justice Thomas, the most principled conservative Justice sitting on the Court.  Where was he going with this?

First, in the dissent, written by Alito and joined by Roberts and Scalia, the first thing Alito writes is: "This case illustrates that tragic facts make bad law."  Right away, I'm suspicious.  Judges are supposed to "apply the law," not decide if laws are good or bad.  The people through their representatives are supposed to make that decision.  The next sentence reveals some more of Alito's opinions:  "The Court holds that a state tort jury, rather than the Food and Drug Administration (FDA) is ultimately responsible for regulating warning labels for prescription drugs."  He obviously doesn't like that as he later wrote "By their very nature, juries are ill-equipped to perform the FDA's cost-benefit-balancing function."  I have no problems with Alito's opinions, but if it's legal for a jury to make those decisions in Vermont, isn't it irrelevant?  Alito says no.  "The result cannot be reconciled with Geier v. American Honda Motor Co."  Let's look at Geier.

This is s similar case where (from the summary) the "Department of Transportation promulgated Federal Motor Vehicle Safety Standard (FMVSS) 208, which required auto manufacturers to equip some but not all of their 1987 vehicles with passive restraints. Petitioner Alexis Geier was injured in an accident while driving a 1987 Honda Accord that did not have such restraints. She and her parents, also petitioners, sought damages under District of Columbia tort law, claiming, inter alia, that respondents (hereinafter American Honda) were negligent in not equipping the Accord with a drivers side airbag." When it got to the U.S. Supreme Court, they held, "petitioners' 'no airbag' lawsuit conflicts with the objectives of FMVSS 208 and is therefore pre-empted by the Act." 

In this case the majority ruled that federal law pre-empted state, or District of Columbia law, and in Wyeth, the majority ruled that federal law did not pre-empt state law.  Of course, being the principled Constitutionalist that he is, Thomas was consistent in dissenting the Geier decision and in assenting the Wyeth decision.  The other conservative who ruled on both cases, Scalia, was consistent the other way. 

Thomas's principles were ruled by federalism in both cases, and Scalia's was ruled, I suspect, by stare decicis, or precedent.  The liberals, as usual, were all over the place, which takes us back to Thomas's separate concurring opinion in Wyeth.

It is important to read Thomas's words to understand his commitment to the Constitution.  In his separate opinion he writes, "I agree with the Court that the fact that the Food and Drug Administration (FDA) approved the label for petitioner Wyeth's drug Phenergan does not pre-empt the state-law judgment before the Court…I write separately…because I cannot join the majority's implicit endorsement of far-reaching implied (my emphasis) pre-emption doctrines.  In particular, I have become increasingly skeptical of this Court's "purposes and objectives' pre-emption jurisprudence.  Under this approach, the Court routinely invalidates state laws based on perceived (my emphasis) conflicts with broad federal policy objectives, legislative history, or generalized notions of congressional purposes that are not embodied within the text (my emphasis) of federal law.  Because implied pre-emption doctrines that wander far from the statutory text are inconsistent with the Constitution, I concur only in the judgment."

In other words, as Thomas wrote, "Pre-emption must turn on whether state law conflicts with the text (my emphasis) of the relevant federal statute or with the federal regulations authorized by that text," not based on the meaning of a federal regulatory agency (FDA).  (By the way, there is nothing stopping Congress from writing such rules into the text of the statute that would make this pre-emption jurisprudence a simple thing:  If state laws conflict with federal or Congressionally-written statutes, then state laws are pre-empted, until then, federalism rules.)

While readers of ESR don't like the outcome of the ruling, it was a correct ruling.  If you want a clear meaning of our Constitution, follow Thomas. ESR

Robert S. Sargent, Jr. is a senior writer for Enter Stage Right and can be reached at rssjr@citcom.net.

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