Thursday, March 05, 2009

Wyeth v. Levine and the End of Deregulation

A little more than a year ago, back in February 2008, a majority of the Supreme Court stated, in Riegel v. Medtronic, Inc.:


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.
128 S. Ct. 999, 1008 (2008). That opinion was joined by seven Justices – Justice Scalia (who wrote it), along with the Chief Justice and Justices Kennedy, Souter, Thomas, Breyer, and Alito.

Yesterday in Wyeth v. Levine, a majority of the Supreme Court stated:

State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information. Failure-to-warn actions, in particular, lend force to the FDCA’s premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times.

2009 WL 529172, at *12 (slip opinion here). That opinion was joined by five justices – Justice Stevens (who wrote it), along with Justices Kennedy, Souter, Ginsburg, and Breyer.

So what happened? How did the Court go from holding that tort litigation involving FDA-regulated products was “less deserving” of protection (in Riegel) to viewing it as the greatest thing since sliced bread (another FDA regulated product, by the way) in Levine?

Well, there’s one obvious thing. Justice Scalia, who wrote Riegel, dissented in Levine – conversely, Justice Stevens, who wrote Levine, did not concur in that part of Riegel. So, as is always the case, different justices see things differently.

But that still doesn’t explain Justices Kennedy, Souter and Breyer – fully a third of the Court – who joined both opinions.

So the question remains – what happened?

Well, an election happened, but: (1) we’re not so crass as to think that any member of the Court, beyond being aware of election returns, changes his or her mind for that reason, and (2) the briefing in Levine was all completed under the prior Bush administration, so it’s not like there was some abrupt change in the government’s position during the course of the case.

But beyond the election something else much more profound happened – large parts of the nation’s economy have come crashing down about our heads. Millions of people (including quite a few in the legal profession) have lost their jobs. The various stock markets have lost over half their value. Home values have fallen almost as far. We could go on, but don’t think we have to.

From President Obama on down, a lot of people have directed a lot of the blame for our current economic straits against the deregulation of the financial markets – a policy that was one of the hallmarks of the Bush Administration. The examples are legion, but here are a few. Thus deregulation doesn’t have a lot of friends anymore. And after Levine it’s painfully obvious that deregulation doesn’t have a lot of friends on the Court – at least with respect to FDA-regulated products.

So we think that the majority’s unwillingness to countenance what it saw as deregulation by way of preemption in Levine has a lot to do with the difference in both result and tone in contrast to Riegel – despite a significant overlap in the justices joining both opinions.

It all goes back to the facts.

We said a while ago that we thought that the facts in Levine were relatively favorable for the preemption defense. But facts turn out to be funny things – sometimes they appear and disappear as needed. Reading the Levine majority and dissenting opinions side by side, it’s sometimes hard to believe that they’re both discussing the same case. Indeed, the majority in Levine did something that’s quite unusual. Before making any other argument at all, Justice Stevens took great pains to address “two factual propositions decided during the trial court proceedings.” Levine, 2009 WL 529172, at *5. Then he proceeded to make (at least for purposes of the majority opinion – and that’s all that really counts at this point) most of the facts we liked disappear.

In particular, the majority held that through the miracles of post-verdict review, the plaintiff’s trial attacks on the FDA and its approval of the IV-push indication disappeared. Id. It no longer mattered that the plaintiff had expressly argued that the drug should never be used for that indication (id.: plaintiff “offered evidence that the IV-push method should be contraindicated and that [the drug] should never be administered intravenously”), since the Vermont Supreme Court later declared that the verdict “established only” that the “warning was insufficient.” There were thus “any number of ways” – all unstated – for Wyeth to change its warnings. Id. In this way, Levine was no longer the “failure to contraindicate” case that we always considered it to be. Id. Allowing that kind of a claim couldn't support a majority, so the plaintiff's claim became something else.

But we digress. The mere fact that the majority felt the need to address its “factual propositions” first, and in such detail, demonstrates how factually intensive the preemption analysis in Levine actually is. We think even our opponents would have to agree with that.

Now, let’s compare it to Riegel. The earlier case found preemption only after a very lengthy discussion of how the FDA had its mitts all over the device at issue. Riegel, 128 S. Ct. at 1004-05 (the seven paragraphs beginning with “[p]remarket approval is a ‘rigorous’ process”). Only after thus establishing that premarket approval “is in no sense an exemption from federal safety review – it is federal safety review,” id. at 1007 (emphasis original), did the Court proceed with the rest of its preemption analysis.

Thus the day after Riegel was decided we posted that preemption would produce a “a high regulation, low litigation” approach to medical device safety:

We fully expect [our clients] to continue doing the right thing, even with the threat of litigation substantially reduced. If they don’t. . .then the high regulation, low litigation model that Riegel is giving a chance to function isn’t going to work.

In this sense, Riegel presents a challenge to all of us who believe that free market capitalism – properly regulated – is the best economic system ever put into practice.

And this is not just a challenge for industry. Ditto the regulators. Riegel confers added responsibility on the FDA. The Agency has stated over and over again that it – not courts and lawyers – has primary responsibility for ensuring that the products it regulates are safe and effective. The FDA, like industry, now has to put up or shut up. . . . In short, it will have to exercise effective authority over PMA medical devices. . . . If the Agency doesn’t do this, the high regulation, low litigation model isn’t going to work.


That’s what we said over a year ago about Riegel. The FDA’s exercise of close review over medical devices is what supported the broad finding of preemption.

Fast forward.

Whatever else Levine does or doesn’t stand for, nobody can deny that the FDA failed – miserably – to convince a majority of the Court that the same high regulation, low litigation model that Riegel represented had been/could be followed with respect to the drug in question.

Again, it goes back to the facts. In Levine, first, there are the “facts” concerning Phenergan. We put quotation marks around the word facts because we don’t agree particularly with the majority’s view of them. But we’ll stop after this one time. That’s because the “true” facts – whatever they might be – don’t matter any more. The only facts that matter for interpreting and applying Levine are those the majority found to exist. So what did the majority find to be the facts about the FDA’s review of Phenergan, IV-push, and gangrene?
  • The drug was approved in 1955, with supplemental New Drug Applications (“sNDA’s”) approved in 1973 and 1976. Id. at *3.
  • After a third sNDA in 1981, during a 17-year period, the manufacturer and the FDA “intermittently corresponded about [the] label.” Id.
  • During 1987-88 “the FDA suggested different warnings about” the relevant risk, and the defendant “submitted [to the FDA] incorporating the proposed changes.” Id.
  • The FDA then didn’t respond to the defendant’s proposed changes. Eight years later, in 1996, “it requested from [defendant] the labeling then in use and, without addressing [defendant’s] 1988 submission, instructed it to “[r]etain verbiage in current label” regarding intra-arterial injection. Id.
  • Two years after that, in 1998, after some back and forth not relevant to the case, “the FDA approved [defendant’s] 1981 application in 1998, instructing that [the drug’s] final printed label “must be identical” to the approved package insert. Id.
  • There was “‘no evidence in this record that either the FDA or the manufacturer gave more than passing attention to the issue of”’ IV-push.” Id. at *9 (quoting Vermont Supreme Court decision).
  • “[T]he FDA had not made an affirmative decision to preserve the IV-push method.” Id.
  • The label changes that the defendant proposed in 1988 “did not differ in any material respect from the FDA-approved warning.” Rather, “the FDA viewed the change as non-substantive.” Id. at *9 n.5 (the second quote being from the government’s amicus brief).
  • “[T]he FDA did not consider and reject a stronger warning against IV-push injection of Phenergan.” Id. at *13 n.14.
It’s clear from this discussion, just of the facts that the majority deemed relevant, that the question of “what in blazes went on for 17 years?” was high in their minds. It's not hard to see from this rendition how the majority found the FDA’s “identical” labeling instruction nothing more than pro forma, devoid of significant, risk-specific content.

More generally, the majority also called into question the FDA’s overall ability to carry out the sort of high regulation, low litigation model represented by the pro-preemption alternative (Riegel) to the current litigation dominated system. Just as the majority had a low opinion of the quality of the FDA’s superintendence of this aspect of Phenergan, it had a low opinion of the FDA’s overall competence to oversee warnings about drug risks:
  • Prior to 2007 (that is, at the time of the events in question), the FDA had no power to order manufacturers to revise previously approved labeling. Levine, 2009 WL 529172, at
    *9.
  • “The FDA has limited resources to monitor the 11,000 drugs on the market.” Id. at *12 (long footnote citing several studies critical of the FDA omitted).
  • “[M]anufacturers have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge.” Id.
  • “[T]he FDA long maintained that state law offers an additional, and important, layer of consumer protection that complements FDA regulation.” Id.
Again, whether we agree or disagree is irrelevant. The Levine majority set out to trash the FDA and did so. After Levine, it behooves the defense to demonstrate that, in any particular case, the FDA did not in fact exhibit these general shortcomings. Rather, we’re going to have to prove, in as much detail as possible, that the FDA gave serious consideration and review to not only the particular drug, but to the particular risk as well. Given how the majority chose to frame the question (probably to keep itself together) this drug-specific and case-specific door has not been shut on implied conflict preemption. But nobody on this side of the “v.” should kid him/herself. After Levine we’ll need strong ("clear") evidence for preemption to work. Not a lot of cases are going to have it.

Finally, the majority’s overall low opinion of the FDA was mirrored by its evaluation of the power of the agency’s legal arguments. Historically, the Supreme Court has agreed with the government most of the time about tort preemption. The Solicitor General supported implied preemption only in Geier v. American Honda Motor Co., 529 U.S. 861 (2000), and that’s what the Court found. The Solicitor General supported implied preemption only in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), and that’s what the Court found. The Solicitor General supported express preemption in Riegel, and that’s what the Court found. The Solicitor General opposed preemption in Altria Group, Inc. v. Good, 129 S. Ct. 538 (2008); Sprietsma v. Mercury Marine, 537 U.S. 51 (2002); and Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), and in each case, that’s what the Court found. The only recent variance was Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005), in which the Solicitor General supported a significantly broader scope of express preemption than the Court found.

Not this time. This time, the government’s position received “no weight.” Levine, 2009 WL 529172, at *13. The majority wasn’t buying what the FDA (represented by the DoJ/Solicitor General) was selling:
  • “[T]he Court has performed its own conflict determination, relying on the substance of state and federal law and not on agency proclamations of pre-emption.” Id. at *11. The Court does “not defer[] to an agency's conclusion that state law is pre-empted.” Id.
  • The FDA’s preemption preamble is “an agency’s mere assertion that state law is an obstacle to achieving its statutory objectives.” Id.
  • The FDA did not “offer[] States or other interested parties notice or opportunity for comment” about “a sweeping position on the FDCA’s pre-emptive effect” and therefore the preamble is “inherently suspect in light of this procedural failure.” Id.
  • The preamble is “at odds with what evidence we have of Congress’ purposes.” Id. at *13.
  • The preamble “reverses the FDA’s own longstanding position without providing a reasoned explanation. . .of how state law has interfered with the FDA’s regulation of drug labeling during decades of coexistence.” Id.
  • “Not once prior to [plaintiff’s] injury did the FDA suggest that state tort law stood as an obstacle to its statutory mission.” Id.
  • “[T]he ‘complex and extensive’ regulatory history and background relevant to this case, undercut the FDA’s recent pronouncements of pre-emption.” Id. at *13.
  • “[T]he Government’s explanation of federal drug regulation departs markedly from the FDA’s understanding at all times relevant to this case.” Id. at *13 n.13.
We’ll state again the we don’t agree with much/most of what the majority found in this regard, particularly about the history of the FDA’s statements about preemption (see, e.g., here), but the Court has spoken, so the law is now what it is. Given that the FDA is under new management, from our perspective, this aspect of Levine may turn out to be the opinion’s least worrisome aspect.

Further, the majority took some care to frame the preemption argument that it shot down as: “Once the FDA has approved a drug’s label, a state-law verdict may not deem the label inadequate, regardless of whether there is any evidence that the FDA has considered the stronger warning at issue.” Levine, 2009 WL 529172, at *10 (emphasis added); see also id. (characterizing main defense argument as “the agency must be presumed to have performed a precise balancing of risks and benefits and to have established a specific labeling standard that leaves no room for different state-law judgments”). This manner of restating the defense argument further demonstrates that the majority in Levine wasn’t willing to rule out preemption in other, more limited, circumstances.

What are those circumstances? And what does all this tell us about the future of implied preemption after Levine?

We keep going back to the comparison to Riegel. What Levine thus tells us is we have to have good, case-specific facts to have a chance with preemption. After Levine the maximalist argument (assuming it was ever anything more than a strawman) is gone. There won’t be preemption if the FDA didn’t (or can be made to appear not to) pay significant attention to the particular risk of the particular drug. Thus, the more FDA involvement the better. Here’s a list of all the things that we’ve plucked out of the majority opinion in Levine that Justice Stevens suggested might make a difference in the ultimate preemption result:
  • Levine wasn’t about the failure to contraindicate an FDA-approved drug use (in other words, the plaintiff wasn’t saying “no” where the FDA had said “yes”). 2009 WL 529172, at *5.
  • The defendant offered no evidence that its accumulated adverse experience reports couldn’t be reanalyzed to fit within the “new analyses of previously submitted data” provision of the post-2008 changes being effected regulation – 21 C.F.R. §314.70(c)(6)(iii). Levine, 2009 WL 529172, at *7-8.
  • There was no “clear evidence that the FDA would not have approved a change to [the drug’s] label.” Id. at *9.
  • The defendant did not “attempt[] to give the kind of warning required by the Vermont jury but was prohibited from doing so by the FDA.” Id.
  • “[Defendant] does not argue that it supplied the FDA with an evaluation or analysis concerning the specific dangers posed by the IV-push method.” Id.
  • Unlike Geier, in Levine there wasn’t “a formal rulemaking” followed by an agency “plan” that “revealed the factors the agency had weighed and the balance it had struck.” 2009 WL 529172, at *12.
  • “[W]e have no occasion in this case to consider the pre-emptive effect of a specific agency regulation bearing the force of law.” Id.
  • The record “belie[s]” the contention that “the FDA determined that no additional warning. . .was needed, thereby setting a ceiling on [the] label.” Id. at *13 n.14.
And at the end of the opinion, the kicker: “[W]e recognize that some state-law claims might well frustrate the achievement of congressional objectives, this is not such a case.” Id. at *13.

So where does preemption still have a decent chance? Well formal, drug-specific rulemaking would be nice, but that’s not going to happen very often, if ever.

So effectively we’re left with the majority’s other distinctions. Has the FDA considered and rejected a stronger warning about the risk in question? Turned down or required significant modification of a CBE because the basis for the change wasn’t there? Said yes where the plaintiff says no? Any/all of those would be very good facts – after all, there wasn’t a majority against preemption of failure to contraindicate, so Levine became something else.

As we said in our prior post about what might happen if we lost Levine, one result will likely be an increase in requests for agency action. Increased agency action, after all, is required in any high, regulation, low litigation model – and that’s the only thing preemption can be after Levine. Did the FDA affirmatively conduct its own investigation and arrive at its own warning – a warning contrary to what the plaintiff demands? Affirmative, contrary FDA action is the best scenario left for preemption in litigation involving prescription drugs.

Other preemption friendly facts: Is the plaintiff trying to prohibit something that the FDA required, or vice versa? That’s another situation (essentially the “failure to contraindicate”) that the Levine majority explicitly distinguished. Did the defendant supply the FDA with risk specific information, either an “analysis” of its own or something that prompted the FDA to analyze the data itself? If that’s the case, and the manufacturer then did what the FDA told it to do, then there’s a good argument that Levine should not apply – provided, of course, that the FDA’s effort involved the same risk the plaintiff is suing over. Other “clear evidence” of more than “passing attention” by the FDA might also work (we can't possibly predict all the permutations) – but we have to note that the demand is for “clear” evidence, not just any evidence.

All of these points go back to one core principle. There must be effective FDA oversight for preemption to apply. That’s what won for our side in Riegel and that’s what the majority found was not present in Levine. The Court has made clear that it is not going to apply preemption in a regulatory vacuum. De facto deregulation is no longer a viable use of preemption – certainly not in the FDA arena.

We think that looking at FDA-related preemption this way – as a function of effective agency oversight – reconciles the otherwise jarring disconnect between the Court’s statements in Levine and Riegel that we highlighted at the outset of this post. The PMA process effectively ensures detailed FDA oversight, and combined with Congress’ language, justifies broad preemption. There’s no such language for drugs, so preemption has to depend entirely on whether, in a particular case, there has in fact been detailed oversight of the sort the Court was willing to find on a more generalized basis in Riegel. The majority refused to find such oversight in Levine. From here on out, it becomes our job to demonstrate differently.

3 comments:

Anonymous said...

Another thing: Vioxx happened. Here again, the FDA dropped the ball on a massive scale.

Sheila said...

Anonymous Said

What about Prempro and the number of women who have been permanently maimed, breast cancer, lung cancer from radiation. Those cases hopefully will now go forward.

blackjames1 said...

Can the high regulation, low litigation model work when drug companies fund clinical trials? Statistics show that drugs in clinical trials funded by drug companies have a 90% chance of receiving a favorable opinion, whereas drugs in clinical trials not funded by drug companies have a 50% chance of receiving a favorable opinion. Is this discrepancy indicative of a conflict of interest? Should drug companies applying for approval of drugs through the FDA fund the clinical trials which will determine whether said drugs will be approved? Then be shielded from litigation because FDA researchers, paid by the drug companies, approve labels which omit certain warnings?