Bartlett – that is to say Mutual Pharmacy Co. v. Bartlett, No. 12-142 – is being argued in the United States Supreme Court today. All of the briefs, and lots of other useful information on Bartlett, can be found on the invaluable SCOTUSblog. In the early days of our blog (back during the days of the Riegel/Levine/Kent trilogy) we used to collect the briefs ourselves, but other than examine the government’s pro-preemption in Bartlett (which we’ve already done), anything we could do in that regard would be redundant, and not as good or as comprehensive as those guys.
So if you want to read up on what’s been filed in Bartlett, all the necessary information is there. To access our own commentary on various aspects of Bartlett (we’ve been following this case since 2009, when it was in the district court) you can go here.
We remain cautiously optimistic about the outcome of Bartlett. We suspect this was “cert. granted with intent to reverse.” Primarily, that’s due to the plaintiff’s claim being truly extreme. Their only theory of recovery, as interpreted by the First Circuit, is a “design defect” without any alternative design being offered. That’s a form of absolute liability (what the Third Restatement calls “categorical” liability, and roundly rejects) where, once a jury concludes that the product’s overall risks outweigh its benefits, then liability attaches simply for selling the drug. As the First Circuit explained it, liability exists for not removing the drug from the market.
But evaluation of the overall risks and benefits of a drug is at the core of what the FDA does. Ditto for determining what drugs should, and should not, be on the market. Even the First Circuit conceded that the theory second-guesses the FDA’s approval decisions, but didn't let that get in the way of the result it wanted. This conflict with core FDA values is why, unlike Mensing, the Department of Justice, representing the FDA as amicus curiae, has come down pretty strongly on the side of preemption in Bartlett. The DoJ argues that claims of this ilk should be preempted whether the drug in question is generic or branded.
So the claims in Bartlett are well beyond even the “failure to contraindicate” claim that the Supreme Court rewrote the facts in Levine to avoid having to reach. Reading tea leaves, we don’t think that the Supreme Court would have done that in Levine if there had been a majority against preemption of a claim asserting that pharmaceutical company can be liable for not contraindicating an FDA-approved use. A fortiori, we doubt there is a majority against preemption of a tort claim (assuming such a thing in fact exists under state law) asserting that a pharmaceutical company can be liable for not removing an FDA-approved drug from the market altogether.
To us, the conflict between an FDA “yes” to the marketing of a drug and a state common-law “no” to the marketing of the same drug seems glaringly obvious. That’s why we’re cautiously optimistic that the Court will see things the same way.
But we’ve said it before, and we’ll say it again, strange things happen when preemption meets product liability.