The Supreme Court last Wednesday decided the first of an important series of cases having to do with whether FDA approval and regulation preempts lawsuits at the state level. The case was Riegel v. Medtronic, and it had to do with a balloon catheter that burst during an angioplasty. Though it’s a device case, not a drug case, it’s been widely watched as a sign of how the court is thinking about preemption. We called Mark Herrmann, partner at Jones Day and co-proprietor of the admirable Drug and Device Law blog for his take: “The fact that industry won is not a surprise,” Herrmann told us, “but the langauge that is in the decision is quite good for industry.”
He points in particular to one passage that discusses the need for a federal agency to balance safety and efficacy:
State tort law that requires a manufacturerâ€™s catheters to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme no less than state regulatory law to the same effect. Indeed, one would think that tort law, applied by juries under a negligence or strict-liability standard, is less deserving of preservation. A state statute, or a regulation adopted by a state agency, could at least be expected to apply cost-benefit analysis similar to that applied by the experts at the FDA: How many more lives will be saved by a device which, along with its greater effectiveness, brings a greater risk of harm? A jury, on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court.
“That fundamentally is the industryâ€™s position,” Herrmann says. “The Supreme Court does not say, ‘We guarantee that we will apply it to drugs.’ But if you read these things with my eyes, you are really pleased to see those words. What everybody is doing now is staring at this decision, asking what it does against Wyeth v. Levine, which is the drug case that asks a similar question and that will be argued in October.”
For the moment, the outlook looks good for Levine. And Herrmann, though he may be exhibiting a bit of professional bias, thinks that will be good for policy. “Overall,” he says, “drug policy should be made by neutral experts who are not inflamed by particular events. Thatâ€™s exactly why looking at Diane Levine with her amputated arm and saying, ‘Now Iâ€™m going to make drug policy’ is the wrong idea.
Looking for the Next Loophole
Even if Levine ends up supporting preemption for drugs, that won’t be the end of lawsuits against pharma.
“If youâ€™re being forward-looking,” Herrmann says, “the Supreme Court has some langauge about how you can still recover under state law as long as the state law actually parallels the FDA regulations. So the next big shoting match is going to be the plaintiffâ€™s bar coming in saying, ‘I want to sue you under state law saying that you violated the FDA regs.’ As sure as night follows day, in every lawsuit now thereâ€™s going to be an allegation that the manufacturer violated FDA regs, because that appears to be the only available loophole. The plaintiffsâ€™ bar will attempt to drive an 18-wheeler through it.”
You can read Drug and Device Law’s detailed comments on the decision here. And don’t miss the blog’s straight-talking posting about pharma’s responsibilities if preemption becomes the law of the land.