We got your attention with that title on this blog, didn’t we?
So let’s cut to the chase: There are no loopholes in Riegel.
(Neutral observers sometimes ask why we aren’t more even-handed in our blog posts. We can’t be even-handed because we and our law firms defend pharmaceutical and medical device companies in product liability cases. If we were to type any pro-plaintiff words on this blog, those words might — unfairly, given the disclaimer over there to your right — come back to haunt us (or our colleagues, or our clients). So we simply cannot articulate plaintiffs’ arguments in this space. If we ever have a pro-plaintiff thought — and we don’t, ever! — we put it in the back of our minds, but we do not type it. We know that our stridency offends some folks who come to this space hoping for even-handed analyses of public policy issues, but that simply is not the game we play.)
Where were we, before we so rudely interrupted ourselves?
Oh, yeah: Loopholes in Riegel v. Medtronic:
1. Manufacturing defect claims: Suppose a medical device company agreed to use a specific manufacturing process and then did not follow that process. A plaintiff might assert that Riegel does not apply to preempt a claim that a manufacturing defect caused a resulting injury.
We’re not abandoning all hope there. The FDA has ample enforcement power to punish companies that violate manufacturing requirements, which leaves open an argument in favor of preemption. But we suspect that plaintiffs who can legitimately plead manufacturing defects will think that Riegel poses no obstacle.
2. Devices that the FDA approved through something other than the premarket approval process.
Riegel involved a PMA-approved device. Plaintiffs will surely assert that Riegel‘s preemption analysis does not apply to devices that went through anything other than the pure PMA process.
You’ll be startled to read that we beg to differ.
The New York Times relied on a plaintiff’s lawyer to assert that Riegel might not preempt claims brought against manufacturers of devices that were approved through PMA Supplements.
No loophole there: The balloon catheter involved in Riegel had itself been approved by a PMA Supplement, so the Supreme Court has already implicitly held that approval by a PMA Supplement suffices to preempt state law. If that weren’t enough (and it should be plenty), the pre-Riegel law on PMA Supplement preemption was already pretty darn good. Here’s our earlier collection of those cases.
How about a device being used in a clinical trial under an Investigational Device Exemption?
You’ll be startled to learn that we don’t think there’s a loophole there.
Product development protocols?
A device originally approved through the PMA process, but then down-classified to a Class II device?
There surely aren’t many of those cases out there, but here’s the good news:
Indeed, despite Medtronic v. Lohr, 518 U.S. 470 (1996), we’ll still make preemption arguments in certain circumstances for devices that were cleared for marketing under premarket notification (the “510(k)”) process), although Lohr plainly limits the availability of the preemption argument for those devices generally.
3. Parallel state law claims.
Riegel tells us that PMA approval “does 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.” Riegel v. Medtronic, slip op. at 17, 552 U.S. __, __ (2008).
We don’t see much of a loophole there, either.
First, as we’ve posted previously, a plaintiff must plead and prove that the defendant in fact violated an existing regulation. If a plaintiff simply makes up some crazy stuff and finds an expert to say that the defendant therefore violated some non-existent regulation, courts shouldn’t hesitate to throw out those claims.
Second, for a State to have “provid[ed] a damages remedy for claims premised on a violation of FDA regulations,” a State must have provided a damages remedy. That means that the State must have enacted a law that unequivocally says that a plaintiff can recover damages under State law if the plaintiff can prove violation of a federal regulation causing an injury. As we’ve posted previously, mere allegations of negligence per se should not suffice; plaintiffs must identify a law that creates the right of action they’re searching for.
Not only that — courts should require real proof of causation in those situations. A plaintiff allegedly injured by, for example, a physician’s over-inflation of a balloon catheter, has not pled causation if he pleads only that the manufacturer violated, say, the time periods for reporting adverse events unrelated to over-inflation. Plaintiffs must have not only a state law route for recovery, but also non-speculative proof that compliance with a real regulation would have avoided the injury.
Even if a plaintiff pleads and proves all that, we’re pretty sure that the plaintiff still doesn’t win. We don’t yet know why, but we’re confident it’ll come to us if a client in that situation ever retains us.
We have in mind two other possible categories of loopholes in Riegel, but this post is already pretty long, and it’s a nice Sunday afternoon, and blogging ain’t quite as relaxing as a walk in the park.
So we’re off for a walk in the park, and perhaps we’ll post next week about (1) adverse events that the company has not yet reported to the FDA and (2) claims for relief other than for personal injury, such as consumer fraud, economic injury, and nuisance lawsuits.
For those of you who just can’t wait, however, we’ll cut to the chase: We think we win those cases, too.
(Hey, we warned you at the top of this post that we’re defense lawyers. Public Citizen’s website will probably satisfy those searching for the other side of these arguments.)
Off to the park.