Of mice and men ...

On March 4, 2009, the U.S. Supreme Court issued a 6-3 majority decision in Wyeth v. Levine, No. 06-1249 against the pharmaceutical giant. The Court held that the Food and Drug Administration's (FDA) prescription drug labeling judgments, and specifically, its approval of the label for Wyeth's Phenergan, do not preempt state law tort claims alleging inadequate warning. At issue was a lawsuit by Vermont guitarist Diana Levine, who lost an arm to gangrene after Wyeth’s antinausea drug Phenergan was INADVERTENLTY injected into one of her arteries during a push IV injection. Ms. Levine had gone to a clinic for treatment of a migraine headache. Ms. Levine argued that Phenergan’s labeling, though approved by the Food and Drug Administration, didn’t provide proper warnings of the risk of administering the drug through a push IV injection instead of using an IV-drip.

For those following the case over the past few months, it was evident that heads would turn regardless who the court ruled in favour of. But few were expecting the decision to go against Wyeth, especially since the courts had ruled in favour of pre-emption in a similar case involving a medical device (see Riegel vs Medtronic). Ultimately, what it came down to was the presence of explicit wording in the Medical Devices Act saying “no State ‘may establish or continue in effect with respect to a device . . . any requirement’ relating to safety or effectiveness that is different from, or in addition to, federal requirements …”. Nothing of that sort is present in the Food, Drugs, and Cosmetics Act. So why did Wyeth’s legal team even consider pre-emption to be a plausible defense? Apparently the FDA was in the mood for an ol fashioned power trip in a preamble to a 2006 regulation the agency issued on prescription drug labeling. This included statements that the agency can indeed pre-empt state law as they provided for not only a floor but also a ceiling to such labeling language, and so on. Wyeth seems to have relied a bit too heavily on this preamble. So this decision might look like a whack at the drug industry, but it's actually a case of a federal agency being told that its powers aren't as broad as it occasionally seems to think. You wouldn't necessarily guess it to see that way the justices lined up in this case, but the verdict looks like a real endorsement of federalism. And in the same way, you might not guess it, but the drug companies would probably like for the FDA to be that powerful, actually - that way, some of the responsibility could be offloaded, and there would be a single place to go for regulatory clarity.

Of equal importance and worth mentioning is that this unfortunate incident could easily have been avoided but for the EMT’s negligence in administering the drug in a way the manufacturer did not intend. This litigious society is going down the toilet. Obviously, Ms Levine should be compensated, but by those who made the mistake, not by those who provided the cure, that when administered properly would have helped her, not harmed. I cannot help but think the main reason they went after Wyeth is because Wyeth is seen as the party with the deepest pockets. This is not to say that Wyeth was completely devoid of fault. The bigger issue is clearly whether or not it is pharma’s responsibility to provide adequate warnings in conflict with FDA approval. As it stands, and regardless of what the FDA says, the burden of proof is not on the FDA to prove harm, but rather on the manufacturer to prove its product is safe. The FDA warning requirements provide a “basement not a ceiling” - e.g., the manufacturer has some responsibility to update its labels and warnings over time, when more evidence is obtained as to the safety or danger of its products.

Preemption has a place but not in this case and not with these facts. That Wyeth could have requested a label change to reflect its growing awareness of possible heightened risk from certain routes of administration is incontrovertible. That Wyeth claimed that it could not have done so flies in the face of reason and past experience. None of this suggests, however, that a good case cannot be made for preemption. This just wasn’t that case. The facts were not on Wyeth’s side. All this is simply to suggest that I don’t think this is the last we’ll hear of preemption or the last the Supreme Court will have to say on the doctrine.

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Preemption: What is it good for?

For more than a decade, drug manufacturers in the US have been inadvertently protected from product liability claims thanks to preemption - the precedence of federal law over that of state law.

So what happens when a patient takes a generic version of a drug that results in an adverse event (or death) due to inadequate warnings? Surely the consumer is protected by being able to sue the manufacturer, correct? Apparently not. Generic manufacturers have successfully argued that they were unable to provide sufficient warning as their labels are required to be the same as the labeling approved for the original innovators drug. Additionally, a generic drug manufacturer may not unilaterally strengthen a label without prior approval of the FDA. Therefore, it "would be impossible" for the manufacturers to abide by federal law requiring that the generic have the same label as the innovator and the state-law requirements for stronger warnings. Surely then the onus falls on the innovator companies for not originally having sufficient warnings, correct? The uninformed patient may be shocked to learn that most state courts have ruled that the name-brand manufacturers could not be held liable for injuries caused by another manufacturer's product.

This is the conundrum posed by preemption. Preemption prevents plaintiffs from pursuing their claims against defendants whom they allege caused their injuries, and yet the preemption doctrine is based on a choice of the superior method for regulation. The distinct lack of a legal remedy in such cases may explain the California Court of Appeal's decision in Conte v. Wyeth.

In Conte v. Wyeth, Elizabeth Conte alleged she developed an irreversible neurological condition after long-term use of generic versions of Wyeth’s Reglan. Although she only took the generic version of the drug, she argued that Wyeth negligently misrepresented the serious risks associated with long-term use of the brand-name version of the drug and should be held liable. Conte filed a lawsuit against Wyeth as well as generic manufacturers Purepac, Teva, and Pliva. After obtaining summary judgement in trial court, Wyeth & the generic manufacturers succesfully argued that Wyeth's product information had no causal relationship to Conte’s injuries and the Conte's claims against the generics were preempted under the Food, Drug and Cosmetic Act.
The California Court of Appeals, First Appellate District, reversed in part and reinstated Conte’s action against Wyeth. Ignoring decades of products liability precedent, the Court concluded Conte could proceed against Wyeth on her negligent misrepresentation claim on the basis of common law.

Preemption is a classic example of instances where enforcing an optimal regulatory strategy does not necessarily translate into protection of the public. In the search for a one size fits all approach to streamline a process, several caveats can be left which prevent legislation from meshing with the justice system. This year, in Levine v. Wyeth, the Supreme Court will address the issue of preemption of claims against name-brand manufacturers' in what could be a landmark victory for consumers. The judgement may very well impact consumer confidence in public agencies such as the FDA and further tarnish the image of drug manufacturers.

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