As for the issues, the Supreme Court hasn't taken a case yet. But the general question will be whether FDA so heavily regulates
the warning, manufacture, and design of drugs that private plaintiffs simply don't have the right to sue because it would
be second-guessing decisions made by an expert federal agency—and whether it is wrong to let lay juries examining claims in
the presence of an injured plaintiff second-guess decisions that were made by government experts.
FDA has stated that it believes that it preempts state laws and state precedent on issues like this. What's the legal standing
for the claim of preemption?
Well, from the drug companies' perspective, it comes from the Constitution. The Supremacy Clause of the United States Constitution
says, basically, that federal law is supreme, therefore, state law must give way to it.
Sounds like a pretty strong claim. Why is it under such siege at the moment?
In January 2006, FDA issued new labeling regulations and, as part of the preamble to those regulations, said some words that
work in favor of industry in terms of preemption. And since those words have been written by FDA, preemption is getting raised
in a whole lot more lawsuits, making that area of law very, very hectic. There are probably a dozen decisions pro and a dozen
decisions con on preemption that have come down since FDA issued its so-called Preemption Preamble.
When the courts have found against FDA, what tend to be the grounds?
It hurts for me to say it, since I'm a defense lawyer, but some courts say that FDA's requirements are minimum requirements
and that drug companies could do more. So if FDA says you have to give a warning about X, some judges have held that it would
be possible to give a warning of X plus Y; therefore, state suits shouldn't be preempted, because what FDA says is just the
minimum. In the Preemption Preamble, FDA says that what it is doing is setting both a minimum and a maximum and that there
are dangers of overwarning. It gives some strength to the drug industry's argument that failure-to-warn claims, for example,
ought to be preempted.
The Preemption Preamble obviously is not something that was passed by Congress. What kind of legal weight does it carry?
That, too, is being fought in the courts. Some are saying that the Preemption Preamble expresses the agency's view that its
regulations are preemptive, which is sort of the strongest form of the industry's point of view. A less-strong version of
the industry's point of view is that the Preemption Preamble simply makes clear that it interferes with what FDA is doing
to have jury verdicts that impose different requirements on companies. So it is FDA speaking to a factual rather than a legal
point. It's saying, It makes our job much harder if state juries interfere with what we're doing.
If preemption stands, what happens in a situation like Vioxx, where there are a lot of cases. Is Merck protected from lawsuits
because the drug was approved?
Well, there are two different preemption issues. There is sort of the soft-form preemption that is up in Warner-Lambert v. Kent; and then there's strong-form preemption that is percolating through the courts. If the Supreme Court comes down on industry's
side in Warner-Lambert v. Kent, then Merck would not be able to be sued in Michigan, Merck would not be able to be sued for failure-to-warn in Texas, and
Merck would not be exposed to punitive damages in the six other states that have statutes that say you can't get punitive
damages unless the company defrauded FDA. With the stronger form of preemption, it could be that either failure-to-warn claims
are displaced or all claims are displaced; or, if the Supreme Court goes against industry, no claims are displaced. The stakes
are high in Warner-Lambert, because the stakes get higher when the broader form of preemption—the Preemption Preamble sort of preemption—goes up to the