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David Mittleman
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Don't take the bait on drug labeling preemption

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An editorial in last Thursday’s Detroit Free Press by Sally C. Pipes had me scratching my head over the ramifications of an upcoming United States Supreme Court decision in Wyatt v Levine. Ms. Pipes, who is president and CEO of the Pacific Research Institute (which is partially funded by the pharmaceutical industry) in San Francisco was concerned that a lack of federal preemption would cripple drug companies from an onslaught of frivolous lawsuits (Wyatt, in case you were wondering, was so frivolous the plaintiff only had her forearm amputated). What really doesn’t make sense in Ms. Pipes’s argument is this:

"Michigan state law, which currently limits such lawsuits against pharmaceutical firms whose products have FDA approval, would be invalidated if the court rules against preemption."

That’s just wrong. In fact, it is the total opposite of what would happen if the court rules against preemption. If a body of state law is NOT preempted, states are free to regulate as they see fit. Michigan could still easily use FDA approval as a standard to bar lawsuits. It is only when federal preemption DOES apply that you have to figure out the ramifications of preemption on state law. First, if state law directly conflicts with federal law that says it preempts state law, then federal law trumps. Second, if state law were to frustrate the purpose of federal law, be in conflict with the state law such that you could not follow both at the same time, or overtook a field of state law, then federal law would trump again. So assuming that there is federal preemption (and nobody would love this more than big business) a state law that basically says "you can’t sue this company if they followed the federal rules for getting their drug approved" does nothing to frustrate the purpose of the federal law. Either way, Michigan can continue to use the FDA approval process (and the federal law concerning how a drug is approved for sale in the marketplace) as its standard for when you can sue a drug company when its drug just happens to make you lose your arm (let’s hope Ms. Levine was a lefty).

Here’s the dirty secret, though. Ms. Pipes and her followers at the PRI probably don’t care about consumer safety, what they care about is getting large pharmaceutical companies to walk away free and clear from liability. Fortunately, it doesn’t look like that will happen. The conservatives on the Court are usually pretty tough on plaintiffs, but even Samuel Alito had this to say: "how could the FDA conclude that [this] was safe and effective when on the benefits side you don’t have a life-saving drug, you have a drug that relieves nausea, and on the risk side you have the risk of gangrene?" Good question, maybe it’s because the FDA has been horribly underfunded to the point that key FDA career officials have warned against preemption because, frankly, the FDA stopped being an effective protector of consumer safety under the Bush Administration. Moreover, another Republican appointed justice, Anthony Kennedy, put in his two cents: "You argue that it’s impossible for Wyeth to comply with the State law and at the same time with federal label. As a textual matter, as a logical matter, I just – I just don’t understand that."

Congressman Henry Waxman has committed to changing the federal law that governs the FDA if the Supreme Court rules in favor of preemption. While that would be good news for this issue, should the Court make that mistake, it would signal a long winter for consumer safety down the road.

The reason big business is waiting to hear the outcome on this is because unlike the federal law governing medical devices that expressly says it preempts state law, the federal law that governs the drug approval process has no express preemption language (especially not with respect to your ability to sue in state court for distributing what is later discovered to be an unsafe drug). There are hundreds of other situations where federal law regulates some aspect of consumer activity, but is silent as to federal preemption. If the Supreme Court finds preemption in Wyeth it sets a dangerous precedent for future defendants to say, "wait, your state law claim has been preempted by some totally irrelevant federal law on getting my product/service approved/licensed!" What next, you can’t go after accountants that embezzled your retirement savings because he passed a licensing exam? You can’t sue the drunk driver because he got a federal Real ID driver’s license? You can’t get your money back from a crooked home developer because it was through a federal first time homeowner program? Maybe it’s time big business check themselves into rehab, so the rest of us can breathe easy for a change.