Dean Chemerinsky has undoubtedly forgotten more constitutional law than we know – and he doesn’t forget much. Thus it is with some trepidation that we find ourselves in the position of offering a rejoinder to his recent piece in the online ABA Journal on preemption and prescription drugs. But in this limited area, preemption and prescription medical products, we’ve done a great deal of thinking and writing about both prescription drugs and medical devices. So we’ve decided to take the plunge.
We don’t have much quarrel with Dean Chemerinsky’s initial observation that the existing regime for preemption and prescription drug product liability litigation, fashioned by the trilogy of Wyeth v. Levine, 555 U.S. 555 (2009), PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), in his words, “makes no sense”:
What emerges from these cases is a strange distinction: Those who take the brand name version and are injured may sue, but those who take the generic version are out of luck. All nine justices agree that this is a distinction that makes no sense, but the five justices in the majority say that it must be for Congress to bring rationality to the law in this area.
We do take issue with his proposed solution, which is that Congress should go ahead and amend the FDCA to expand liability – without addressing anything else:
[A]ccording to the FDA, nearly 80 percent of all prescriptions are filled with generic drugs. When there is a generic equivalent . . ., greater than 90 percent of the time a generic is prescribed. [Mensing and Bartlett] involved the Supreme Court interpreting federal statutes. Congress can remedy this by revising these statutes to make clear that makers of generic drugs can be sued − just like makers of brand name drugs − for claims based on failure to warn or design defects.
Unfortunately, Dean Chemerinsky’s article displays a knee-jerk reaction, common to academe, that more liability is always better. The FDA statistics, for example, are used in an exaggerated fashion, since after seventeen years − the duration of a patent − most risks of most drugs are pretty well known (that’s one of the reasons Hatch-Waxman was passed in the first place). Thus, even assuming that generic drugs represent 80% of all prescriptions, the chances are pretty good that they don’t represent anywhere near 80% of emergent, post-marketing risks that have typically driven product liability litigation involving these products (suits over drug risks that are already known and warned about are, of course, of little merit). Dean Chemerinsky, we repeat, is a really smart guy. He knows what he’s doing.
We’ve speculated before on where this pro-liability bias of law school faculty might come from – everything from self selection (the typical mindset of persons drawn to teaching, rather than practicing, law), to academic imperatives (it’s easier for one’s articles to become widely cited if they create new theories of liability rather than support the status quo), to quasi-Marxist economic determinism (more litigation means more jobs for law students and thus increased demand for law professors (and deans), particularly in today’s relatively depressed legal market for new lawyers). And we’ve seen this attitude manifested in ways that strike close to home, such as the unfortunate defense firm (which will remain anonymous) that in a recent Supreme Court preemption case found its name (it had endowed the professor’s chair) associated with an amicus curiae law professor who advocated extreme absolute liability theories to the Court (fortunately rejected by all but two justices). Yes, we noticed. And if we noticed, we don’t doubt that many of that firm’s potential clients – those that ask about support of civil justice reform in their RFPs – noticed, too.
In this instance, we think that Dean Chemerinsky’s advice that Congress simply create more tort liability is both simplistic and short sighted.
The problem, as we see it, is not so much what happened in Mensing and Bartlett as what happened in Levine (we’ve blogged extensively about all three cases, so we’re not going to clutter up this post with citations, which is also true of the Chemerinsky piece). We think that Levine erred by creating a uniquely difficult “clear evidence” standard limited to prescription drugs (found in no other implied preemption case), based largely upon an unwarranted expansion of a “presumption against preemption” to implied conflict preemption jurisprudence. If such a presumption has any place at all (and thankfully the Court may be on the verge of abolishing it, as we discussed here), it is as a tie-breaker in express preemption cases involving ambiguous language and legislative history, and it disappears (a bubble-bursting presumption) once a court has construed the relevant provision. In implied preemption, it has no place, as the scope of preemption should be measured – no more and no less – by the scope of the actual conflict. The Founders gave the constitution a Supremacy Clause, so in conflict cases we don’t need a presumption.
Conflict preemption has two prongs: (1) impossibility (the type recognized in the Mensing and Bartlett generic drug cases), and (2) so-called “purposes and objectives” preemption, which endeavors to judge preemptive effect by the adverse impact of a particular legal position (hereafter synonymous with a tort theory) on the relevant statutory and regulatory scheme. Another problem with Levine, as we see it, is Justice Thomas’ concurring opinion in which he, also uniquely, rejects prong 2 altogether. He’s the only justice on the Court to take that position.
The Court is closely divided on tort preemption issues, and Justice Thomas is found in the pro-preemption camp more often than not (how the defense lost him in Levine (and in an earlier non-decision called Kent, for that matter) is beyond the scope of this post). Both Mensing and Bartlett were 5-4 decisions, and therefore dependent upon Justice Thomas’ vote to make the majority. Thus, those two decisions were decided on the basis of the impossibility prong of implied preemption (which Justice Thomas likes just fine), rather than on the basis of the more nuanced “purposes and objectives” analysis.
We think that’s a mistake. Assuming, for now, our “if we were kings of the world” perspective, we think that an implied preemption analysis that evaluates the adverse impact of a particular tort theory on the FDA’s administration of the FDCA and its regulatory scheme is usually preferable to the bright line approach taken in the impossibility preemption cases − although we recognize that bright lines do have their advantages (such as ease of application). Unfortunately, most courts applying Levine have set the “clear evidence” bar so absurdly high that the “purposes and objectives” prong has been almost entirely read out of prescription drug preemption.
We think that’s a mistake, too. Not all tort theories – let alone all tort warning theories – are created equal in terms of their adverse impact on the FDA’s administration of the FDCA. The design defect/remove-from-the-market claim in Bartlett was particularly bad in this respect, since it posited that a state could impose absolute liability on an FDA-approved product simply because it was sold in the state. As the Court recognized in Bartlett, it’s absurd to talk about “alternative designs” for anything that’s a chemical molecule, as most drugs are, and that was approved by the FDA as such. If the control that Congress gave to the FDA over which drugs (and medical devices) may be marketed in this country means anything, it means that states (through their tort systems and otherwise) can’t say “no” to a product that has received a “yes” from the FDA. However, these arguments are essentially “purposes and objectives” in nature. They don’t argue that something’s impossible, rather they argue that something’s a really bad idea. Thankfully, design changes also happen to require prior FDA approval for all drugs, innovator or generic, and the Court was sufficiently repulsed by the remove-from-the-market rationale that it broadly rejected that theory as well (both in Bartlett).
With impossibility preemption, we get a different focus – on whether a defendant can simultaneously comply with both (1) an immediate state-law obligation to make whatever changes are necessary for its product to be “safe,” and (2) a federal obligation to obtain prior FDA approval before making certain changes. However, we don’t think (and it’s evident from relevant FDA guidances) that either Congress or the Agency has imposed requirements for prior regulatory approval with those requirements’ preemptive effect on civil litigation being a major factor considered (up until now, anyway; since Mensing the other side has been trying to change that). Indeed, we can think of a number of past occasions on which the FDA has rather ostentatiously declared that its regulations aren’t intended to have any effect on civil liability. We agree with that. The FDA’s regulatory actions should be taken in furtherance of the Agency’s congressional charge to foster the public health rather than to preserve/prevent some patients’ ability to later become plaintiffs by fiddling with preemption. There are a lot of other reasons, including administrative convenience, that this or that change could require prior FDA approval. Likewise, we’re sure that the FDA did not create its “changes being effected” (“CBE”) exception, the one allowing label changes without its prior approval, with preemption in mind either.
As we see it, there are quite a few warning claims involving innovator drugs – especially those where the FDA has given considerable internal consideration to the scope and language of a particular statement about a particular risk – that pose a greater threat to the FDA’s superintendence of the FDCA than some of the label changes (listed here) for which the FDA requires prior approval (and thus that would be preempted under current law). Indeed, the Bush-era FDA was first drawn into the preemption wars by one of these. The FDA had analyzed and reanalyzed the possible risk of suicide with respect to a certain class of drugs (SSRIs, see our discussion here) and determined repeatedly that the risk was not scientifically supported (as to adults, anyway). Yet plaintiffs kept suing, arguing that courts and juries could ignore the FDA’s determination of that question, and enough courts and juries did that the FDA was forced to act. In a situation like that, we think that a straightforward application of “purposes and objectives” preemption (without the artificial obstacle of the Levine “clear evidence” standard) should mandate preemption.
On the other hand, there are other warning claims – where the FDA has not actively considered the particular risk at issue, or where there’s genuinely “new” information, as to which the adverse impact of state tort litigation on FDA regulation is not as clear cut. And then there are claims, such as failure to include a warning change already approved by the FDA, where it could be argued that there’s no adverse impact at all. “Purposes and objectives” preemption allows such nuances to be considered. Impossibility preemption does not. Thus, we have the current state of affairs, where any claim concerning a warning change is preempted as to generic drugs (because FDA prior approval is required) and any warning change (almost) is not preempted as to innovator drugs (because of the CBE exception) even though the FDA may have paid a great deal of regulatory attention to a particular issue.
We mentioned failure to update claims. The preemption problem with this sort of claim comes from another aspect of the FDCA. Ever since the statute was enacted in its current form back in the 1930s, the FDCA has contained a flat prohibition on anybody but the federal government enforcing alleged statutory violations. For both drugs and devices (but not food) that prohibition is essentially absolute. Thus, the problem with failure to update claims is that they look a lot like private enforcement of what’s more of an FDCA violation than a traditional warning claim under state law. Private enforcement is thus preempted because it conflicts with this statutory provision. Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001). There’s been a lot of legalistic hemming and hawing over the no-private-right-of-action provision, and just as many attempts to put state-law fig leafs over what are really FDCA-based claims, but the fundamental question strikes us as relatively straight forward. In any given state, has the law actually recognized a non-statutory tort claim based on the same alleged conduct? For example, have you ever heard of pre-existing common-law claim, outside of the drug/device context, for failure to change a warning after some state agency required it? We haven’t either.
So if we were kings of the world, what would we prefer? Well, like Dean Chemerinsky, we’d like to see Congress amend the statute to fix the current nonsensical state of affairs. Only our amendment would not blindly increase liability. Rather, we’d prefer to see Congress end another statutory quirk and enact, for prescription drugs, the same preemption provision that that currently applies to medical devices – that states can’t impose any restrictions, including tort liability, on FDA-approved drugs (that is to say, drugs that the FDA has evaluated for safety and effectiveness by means of an new drug application (“NDA”)) that are “different from or in addition to” those imposed by the FDA.
We posted a long time ago that conceptually we support a “high regulation/low litigation model” for FDA regulated products. We think that the general outlines of express preemption for medical devices make much more sense than what has evolved under the implied preemption regime (since there’s currently no relevant FDCA express preemption clause) applicable to prescription drugs. We agree with Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), that the existence of “rigorous” FDA oversight of a product’s safety and effectiveness is a factor that should weigh heavily in favor of preemption. That’s how it is with medical devices (putting aside “parallel claims”) – the more extensive the FDA regulation (as with pre-market approved devices, the device equivalent of an NDA), the greater the scope of preemption. With prescription drugs, the scope of preemption is exactly the reverse. The less heavily regulated drugs – generics approved by the “abbreviated” NDA process – enjoy far more preemption protection than do the more heavily regulated innovator drugs as to which the Agency independently assesses safety and effectiveness. This seems backward to us, which is why we agree with Dean Chemerinsky’s initial proposition that the extant preemption regime for prescription drugs “makes no sense.”
So our proposal for Congressional action on FDCA preemption issues would be for Congress to create a level statutory playing field by equalizing express preemption for both prescription drugs and prescription medical devices by extending the current device-only preemption clause to cover drugs as well.
But we’d consider (if we were kings of the world) going even further. If it could be suitably cabined, we’d even be willing to consider changing the FDCA’s no private right of action clause. Here, we are informed – generally, not by every statutory jot and tittle – by the Vaccine Act (we’ve discussed this here and here). The Vaccine Act more or less junks the tort system altogether in favor of a private federal cause of action. We’d be willing to trade a private FDCA right of action based on violations of the FDCA for getting rid of the current crazy quilt of 50 different state-law tort systems. As long as there’s some reasonable mechanism for the FDA itself to opine (perhaps by advisory opinion at the behest of either party) that what a particular plaintiff is alleging actually did violate the FDCA, and is not some fantasy created by a hired-gun FDA “expert,” we have no philosophical objection to predicating all compensation for drug or device related injuries on a defendant’s compliance with its obligations under the FDCA; where, of course, non-compliance actually caused the injury to the plaintiff. That seems to us to be the apotheosis of the “high regulation/low litigation model” that we endorsed back in 2008.
So that’s our counterproposal to Dean Chemerinsky’s recommendation that Congress simply amend the FDCA to allow even more liability. Our proposal addresses the same nonsensical aspect of current preemption doctrine and not only fixes it, but gets rid of a second, equally nonsensical anomaly in current FDCA preemption jurisprudence – the existence of express preemption for medical devices, but not for prescription drugs approved by the FDA under essentially the same level of scrutiny.
As much as we admire Dean Chemerinsky, we think our proposal makes a lot more logical and legal sense. But we’re sure that both his and our proposals share one fundamental attribute – both of them have the same likelihood, which is to say zero percent, of being enacted into law by the current do-nothing Congress.