Photo of Bexis

We started writing over the weekend about “Loopholes in Riegel,” and then went for a walk in the park. We said we might get back to you with the back half of that post.

This is not that post.

(This is also not a post for lay readers or dabblers in drug and device law; we’ll be playing real inside baseball here. Good stuff, but inside baseball.)

One of your humble scribes — Herrmann — participated (with Rob Weiner, of Arnold & Porter) in a webcast earlier today about Riegel v. Medtronic. When we started discussing possible loopholes in Riegel, Rob raised a point that we thought we’d share. Although the words that follow are Herrmann’s, the thought is largely Rob’s.

Riegel says that the Medical Device Amendments do “not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case ‘parallel,’ rather than add to, federal requirements.” Slip op. at 17.

We confidently predict that much ink will be spilt over the meaning of those words, with plaintiffs trying to expand that exception and defendants trying to shrink it.

Plaintiffs will say that they can pursue claims for any violation of the FDA’s regulations that causes an injury — for example, a company’s failure to report adverse events within the appropriate time periods.

That’s wrong, of course, and here’s one reason why:

In Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001), the Supreme Court made clear that only the FDA can enforce obligations owed by a manufacturer to the FDA. If a manufacturer violates a federal regulation or some other duty, then the FDA has ample enforcement power. Private plaintiffs cannot interfere in the relationship between a manufacturer and the Agency.

That’s Buckman.

If private plaintiffs can’t complain about violations of obligations owed by a manufacturer to the FDA, then what does Riegel‘s language about “parallel” state law claims mean?

It means that, if a manufacturer violates a duty owed to the public, rather than to the FDA, then, in appropriate circumstances, state law can authorize a private recovery. Thus, if a manufacturer didn’t produce its product according to the FDA-approved design, or didn’t use the FDA-approved label, maybe a private plaintiff could sue.

That’s a fairly limited playing field.

If a manufacturer doesn’t submit some adverse event reports on time, that arguably violates a duty owed to the Agency, but it doesn’t violate a duty owed to the public. If a manufacturer receives a Form 483 about some regulatory breach, that arguably violates a duty owed to the Agency, but it doesn’t violate a duty owed to the public. Under Buckman, private plaintiffs cannot pursue state law claims related to those sorts of alleged violations.

That interpretation (though it’s a little hard to express) is the best way to reconcile Buckman and Riegel, so it must be right.

And that reading makes clear that Riegel’s exception for parallel state law claims is not an exception that swallows the rule. To the contrary, the exception applies in only a limited number of situations.

Our next post will be of broader interest.

We promise.