Why did this case make it to the Supreme Court?
Typically, a case like this wouldn’t get to the Supreme Court because there wasn’t a circuit split [a disagreement between one or more federal courts] that generally [implies] a Supreme Court review. However, the court has granted review in a series of preemption cases, and it seems to me that the Court might be attempting to articulate a clear preemption doctrine. What we have, at least in the implied preemption context, is a lot of ambiguity. The Riegel v. Medtronic case last year was an express preemption case. [In the Riegel decision, the Supreme Court ruled that Congress’s premarket approval process for medical devices such as Medtronic’s pacemakers, expressly barred injured patients from filing lawsuits against device makers.]
Is this going to prevent injured consumers from suing manufacturers? Will we see a bunch of trial lawyers out of a job?
I don’t see tort lawyers going out of business anytime soon. Would you see a change to different series of litigation? Absolutely. We’ve already seen some of that shift where a lot of what used to be typical product liability suits are being brought under state consumer protection statutes, consumer fraud statutes, and false advertising statutes. A lot of it may hinge on the election today, and there’s a lot of speculation that should the Democrats get control you will get congressional language eliminating preemption that could alter this playing field entirely.
What is the broader significance of the case?
For both manufacturers and injured plaintiffs this brings a lot of issues to the forefront. Think about the scope here: A manufacturer submitted products to federal agency as part of agency review process, product and warning label were approved by the agency. If the court comes down in favor of a very broad implied preemption doctrine that is going to ricochet throughout other industries. A broad preemption doctrine would limit the number of tort suits. However, we do have a manufacturer here who went fully through the approved FDA process, did everything they were told to do, and they can’t change their label without FDA approval.
Now, it becomes a bit of a policy question. Do you view the tort system as complementing a federal agency’s role in regulating consumer goods or not? That’s really where this case falls along policy lines. There have been congressional bills introduced that would do away with implied preemption. Congress can easily come out and amend the Food, Drug, and Cosmetic Act to say there is no preemption here. You could easily see a bit of a backlash on the Hill where they attempt to fix it on a legislative level.
So what do you think the Supreme Court will do?
I don’t have an opinion about how the court is going to come down on this. That’s the exciting thing about this case. Whatever the court does here very likely will apply in other contexts of agency regulation and that’s why everyone is following it so closely.