For the second time in a week we are considering a former professor at our law school, though this occasion swims in sorrow. Before he became a Justice on the Supreme Court, before he became a Judge on the DC Circuit, Antonin Scalia taught at the University of Chicago Law School. Many of the eulogies we are hearing this week highlight things about Scalia that remind us of how well he fit in with that remarkable faculty: the relentless intellectual jousting, where arguments but not the arguers were skewered. There must not have been much lounging in a faculty lounge with Scalia, Posner, Epstein, Easterbrook, Sunstein, Stone, et al. (We cannot overstate our disappointment at reading Epstein's complaint that when Barack Obama taught at the law school the future president displayed little enthusiasm for the robust intramural debates taking place all around him).
When the pundits discuss Scalia's legacy, they usually emphasize his decisions on guns or flag-burning, or his sharp dissents in cases involving the death penalty or gay rights. Not all of those opinions were to our liking. But defense drug and device law nerds will always have a soft spot in our hearts for Justice Scalia's opinion in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), where he held that most tort claims against PMA devices are expressly preempted by a federal statute. The decision is logical. The writing is clear. (It is not surprising that Scalia has co-authored books with Bryan Garner that urge lawyers to be more direct, concrete, and muscular in their writing.)
Let's honor Scalia in a way he would have liked - by saluting his logic and his prose in the Riegel decision. But let's first offer a prologue by way of considering Scalia's concurrence/dissent in the Cipollone (1992) case. That case was about preemption of tort claims against cigarette manufacturers. The court's opinion was authored by Justice Stevens and was a Brunswick stew. Some of it made sense and some of it was squirrelly. As with so many Stevens decisions, things that at first blush seem relatively sensible become muddy once you wrestle with the real-life consequences down the road. Stevens held some things preempted and some things not, but good luck figuring that out once you're down to actual cases. By contrast, Scalia's opinion in Cipollone is crisp and intelligible. One thing he was especially crisp on was the silliness of the presumption against preemption. As Scalia reasoned, the issue is what was the Congressional intent, as manifested by the plain words of the statute. There is no need to indulge in any presumption in making out that intent. Moreover, a presumption against application of a doctrine that can arise in the absence of any Congressional pronouncement whatsoever, such as conflict preemption, makes no sense.
Thus, there is not a word in the Court's Riegel opinion about the presumption against preemption. It is a bracing moment of lucidity. Instead, what we get is a rigorous reading of the statute. Scalia sets up the issue with unstinting directness: “We consider whether the preemption clause enacted in section 360k, bars common law claims challenging the safety and effectiveness of a medical device given premarket approval by the Food and Drug Administration.” The opinion then gets rolling into the background of the statute. The FDCA had “long required FDA approval for the introduction of new drugs,” but until 1976 “the introduction of new medical devices was left largely for the States to supervise as they saw fit.” After some high-profile device issues arose in the 1960s and 1970s, states became more proactive, to the point of threatening to create a crazy patchwork quilt of contrasting regulations. Congress “stepped in with passage of the Medical Device Amendments of 1976 (MDA).” Then we get to the MDA’s express pre-emption provision:
"Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a
device intended for human use any requirement –
(1) which is different from, or in addition to, any requirement applicable
under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other
matter included in a requirement applicable to the device under this chapter."
21 U.S.C. section 360k(a).
This preemption provision was at issue in the earlier SCOTUS case of Lohr (1996),where the Court declined to apply preemption in favor of a 510(k) cleared device. TheRiegel Court drew a distinction between the 510(k) process, which it characterized as an exemption from a requirement, and the “rigorous” PMA process, which constituted a real “requirement” under the preemption provision. In walking through this analysis, Scalia made some important observations:
- “The FDA may thus approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives.”
- “The premarket approval process includes review of the device’s proposed labeling.”
- “After premarket approval, the devices are subject to reporting requirements. The FDA has the power to withdraw premarket approval based on newly reported data or existing information and must withdraw approval if it determines that a device is unsafe or ineffective under the conditions in its labeling.”
- While §510(k) is “focused in equivalence, not safety,” "premarket approval is focused on safety, not equivalence."
Those first three points are fine. That last one is now turning out in some cases to be a wee bit problematic.
Under the MDA preemption provision, federal law displaces any state “requirement” that differs from the federal requirement and that relates to safety. That would clearly be true for a state regulation. But what about a state jury tort verdict? Cipollone and Lohr had both already made it clear that preemption applies to tort claims just as much as laws or regulations, but Scalia’s reasoning as to why that is so is perfectly compelling:
“[I]n the context of this legislation excluding common-law duties from the scope of pre-emption would make little sense. State tort law that requires a manufacturer’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.”
And there we have an eloquent expression as to why jury verdicts are a rotten way to regulate issues of medicine and science.
The dissent offered the usual objection to preemption, how awful it would be for Congress to “remove all means of judicial recourse” for consumers injured by FDA-approved devices. But Scalia’s rejoinder (not so different from his repeated, inelegant advice to Bush v. Gore doubters of “get over it”), is that “this is exactly what a pre-emption clause for medical devices does by its terms.” Just so.
Not everything in Riegel turns out to be so convenient for those of us on the right side of the v. In the briefing, the FDA had taken a position consistent with Scalia’s ruling. That's nice. But there was also an FDA regulation that the plaintiffs argued supported their interpretation against the scope of preemption. Scalia minimized the significance of the FDA’s stated legal position as being inconsistent with some earlier positions it had taken, and dismissed the regulation as being unhelpful in resolving the straightforward statutory interpretation issue. It is admirable how Scalia stood on principle, rather than gladly glom on to anything that supported his outcome. Nevertheless, as some of you may remember, an approach very like that permitted the majority in Levine (2009) to discount an FDA preamble favoring preemption, and we got an anti-preemption ruling (with Scalia joining in Alito's dissent) that continues to make life for our Pharma clients more difficult than it should be.
The Riegel opinion ends on a minor note. In retrospect, it grows ever more discordant. The plaintiffs argued to SCOTUS that their lawsuit raises “parallel claims.” But they “made no such contention in their briefs before the Second Circuit, nor did they raise this argument in their petition for certiorari.” Accordingly, the Court “decline[d] to address that argument in the first instance here.” Ever since, of course, opportunistic plaintiffs have made every claim against a PMA device a “parallel” one, often grounded on either (or both) federal and state rules so mushy as to be, in an often-used word of Scalia’s, applesauce. That last little, and perfectly proper, discussion at the end of Riegel of what the Court would not consider paved the way for botched parallel claim opinions such as the Seventh Circuit's Bausch.
The law, it turns out, is a tale full of cliffhangers. Some of the chapters, such as Riegel, are authored with brilliance and insight. Others - too many - are gobby gibberings.
Riegel gave rise to enormous optimism in this blog and elsewhere. Take a look at our Riegel topic listing. Not many of our topic headings have more entries, and perhaps none displays such ups and downs of exhilaration and disillusionment. For one brief moment, it looked like the Supreme Court had ushered in an era of high regulation/low litigation for our clients. Then we got Levine. Sigh. And then later we got Mensing (2011) and Bartlett (2013), which are promising, but that promise is a little - okay a lot - less lustrous without Scalia.
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We cannot help but mention that Justice Ginsburg’s statement in praise of her fallen fellow Justice was supremely touching. Scalia and Ginsburg were, in her words, “best buddies.” They attended operas together, rode on elephants together. By now you have probably seen the pictures. They also often wrote opposing opinions on the same case. Justice Ginsburg wrote a vigorous dissent in Riegel. But the disagreement on legal principles did not preempt humanity.