Updated June 28, 2018 in light of the Supreme Court’s grant of certiorari. See more at the bottom of this post.

I’ve written many times before about the Supreme Court’s opinion Wyeth v. Levine, 555 U.S. 555 (2009), such as when the opinion came out in 2009 and when opioid manufacturers tried to use it and related preemption case law to stop the cases filed against them. Levine is by and large a good case: the Supreme Court held that, when a drug manufacturer fails to warn patients about the real harms of their drugs and injured patients bring lawsuits, the drug manufacturer can’t blame the FDA for the problem (for having approved the drugs) and demand the court throw out the patients’ cases.

The underlying logic of Levine was quite simple: the Food, Drug, and Cosmetic Act (“FDCA”) says that drug manufacturers, not the FDA, are responsible for the “Prescribing Information” and “Medication Guide” provided with each medication, and the FDCA does not say that injured patients can’t bring state tort lawsuits.

The Supreme Court, however, appeared to leave open the potential that some lawsuits could be “preempted” — as in, kicked out of court, even if the patient could prove the drug company was negligent — if the drug company could show “clear evidence that the FDA would not have approved a change to [the drug’s] label.” Levine at 571. Years later, the Supreme Court stated the rule a little bit more clearly: a drug company can “show, by ‘clear evidence,’ that the FDA would have rescinded any change in the label and thereby demonstrate that it would in fact have been impossible to do under federal law what state law required.” Pliva, Inc. v. Mensing, 564 U.S. 604, 624 fn 8.

The Supreme Court didn’t give much guidance on what it meant by “clear evidence.” The most natural interpretation is that courts should require the drug manufacturer to prove the FDA would have rescinded a change by “clear and convincing” evidence (which is higher than “preponderance”), which is what “clear evidence” meant in other Supreme Court cases, like Microsoft Corp. v. i4i Ltd. Partnership, 131 S. Ct. 2238, 2243 (2011). In practice, however, few District Courts or Circuit Courts ever needed to reach this question, because the evidence provided by the drug manufacturer to support preemption wasn’t enough under any standard. See, e.g., In re Incretin-Based Therapies Prod. Liab. Litig., 2017 WL 6030735, at *3 (9th Cir. Dec. 6, 2017)(holding there was no need to interpret “clear evidence” because “Uncertainty about whether the FDA considered the ‘new safety information’ and whether it would have altered the FDA’s conclusion establishes that a disputed issue of material fact should have prevented entry of summary judgment on the defendants’ preemption claim.”); see also Mason v. Smithkline Beecham Corp., 596 F.3d 387, 395 (7th Cir. 2010); Koho v. Forest Labs., Inc., 17 F. Supp. 3d 1109, 1117 (W.D. Wash. 2014); Dorsett v. Sandoz, 699 F. Supp. 2d 1142, 1157 (C.D. Cal. 2010).

In the Fosamax case, 852 F.3d 268 (3d Cir. 2017)(cert pending as Merck v. Albrecht, No. 17-290), in which people who used osteoporosis drug Fosamax suffered serious thigh bone fractures (the drug label warns about them now, although it didn’t then), the case had complicated enough facts that the Third Circuit reached the issue of “What is ‘clear evidence’? And who should determine whether clear evidence exists?” Id. at 282. The Third Circuit answered, “at the summary judgment stage, the court cannot decide for itself whether the FDA would have rejected a change, but must instead ask whether a reasonable jury could find that the FDA would have approved the change.” Id.

The Third Circuit provided a thorough explanation for how it reached its ruling, but, in truth, a thorough explanation wasn’t needed. Defendant drug companies typically raise preemption as a matter of summary judgment (the whole point for them is to try to avoid having a jury hear the case), but summary judgment — when a court decides there’s no “genuine dispute of material fact,” and so a jury trial won’t be held on that issue — is the exception, not the norm. The standards for applying summary judgment are well-settled, and in 2014 the Supreme Court reiterated:

Summary judgment is appropriate only if the movant shows that there is no genuine issue as to any material fact and the movant is entitled to judgment as a matter of law. Fed. Rule Civ. Proc. 56(a). In making that determination, a court must view the evidence in the light most favorable to the opposing party. …

The witnesses on both sides come to this case with their own perceptions, recollections, and even potential biases. It is in part for that reason that genuine disputes are generally resolved by juries in our adversarial system. By weighing the evidence and reaching factual inferences contrary to Tolan’s competent evidence, the court below neglected to adhere to the fundamental principle that at the summary judgment stage, reasonable inferences should be drawn in favor of the nonmoving party.


Tolan v. Cotton, 134 S. Ct. 1861, 1866, 1868 (2014)(quotations omitted). The drug companies try to avoid this well-settled law by claiming that what the FDA “would have” done if presented with the labeling change is solely a question of law, not of fact, but that doesn’t work, either. Whether or not the FDA would have rescinded a labeling change under the FDCA is a mixed question of law and fact, and those questions also go to the jury. As the Supreme Court held earlier this year,

We here arrive at the so-called “mixed question” of law and fact at the heart of this case. Pullman-Standard v. Swint, 456 U. S. 273, 289, n. 19 (1982) (A mixed question asks whether “the historical facts . . . satisfy the statutory standard, or to put it another way, whether the rule of law as applied to the established facts is or is not violated”). …

For all their differences, both parties rightly point us to the same query: What is the nature of the mixed question here and which kind of court (bankruptcy or appellate) is better suited to resolve it? See Miller v. Fenton, 474 U. S. 104, 114 (1985) (When an “issue falls somewhere between a pristine legal standard and a simple historical fact,” the standard of review often reflects which “judicial actor is better positioned” to make the decision). …

[In a mixed question] [t]he court takes a raft of case-specific historical facts, considers them as a whole, [and] balances them one against another…

U.S. Bank National Association v. Village at Lakeridge (U.S., March 5, 2018). Such “mixed” questions of law and fact go to the fact-finder, which is the jury. In the Oracle v. Google litigation, the Federal Circuit just applied the same analysis to a jury finding:

The Supreme Court has recently explained how we are to determine what the standard of review should be in connection with any mixed question of law and fact. Id. Specifically, the Court made clear that an appellate court is to break mixed questions into their component parts and to review each under the appropriate standard of review. Id. at *5-7. …

Where applying the law to the historical facts “involves developing auxiliary legal principles of use in other cases—appellate courts should typically review a decision de novo.” Id. (citing Salve Regina College v. Russell, 499 U.S. 225, 231-33 (1991)). But where the mixed question requires immersion in case-specific factual issues that are so narrow as to “utterly resist generalization,” the mixed question review is to be deferential. Id.

Even one of the very few cases to find preemption of a branded drug injury lawsuit — a case that was settled before the appeal was finished, so we don’t know if it would have been affirmed — held “application of the clear evidence standard is necessarily fact specific.” Dobbs v. Wyeth Pharms., 797 F. Supp.2d 1264, 1270 (W.D. Okla. 2011). If the “clear evidence” standard of Levine is “fact specific,” which no one denies, then it is the type of question that goes to the jury.

In other words, Fosamax wasn’t any sort of departure from the ordinary. Rather, it was a straight-forwarded application of well-settled law about impossibility preemption, summary judgment, and mixed questions of fact and law. Merck’s preemption defense was hardly a “matter of law;” it turned on their own internal notes about phone call they claim they had with the FDA, which is exactly the sort of credibility issue that must be decided by a jury. In re Fosamax, 852 F.3d at 276. Such is likely why the Third Circuit panel’s order was unanimous and why the Third Circuit denied en banc review.

Unsurprisingly, the drug company (Merck) disagreed, and so sought certiorari from the Supreme Court. Justice Alito recused himself (properly, because he owns Merck stock) and thereafter the Supreme Court requested the Solicitor General of the United States to file a brief expressing their views on the case.

Which brings us to yesterday, when the Solicitor General filed their brief.

I have no doubt that my frenemies over at Drug and Device Law Blog (they represent drug manufacturers–I call them “frenemies” in jest because our blogs have had a good rapport for years) would go ballistic over the description I just gave of Fosamax, which they considered “pure hogwash,” “based on crazy reasoning,” and myriad other colorful phrases, raising some other lawyers’ eyebrows. They were quite happy to see yesterday that the Solicitor General’s office has recommend the Supreme Court grant certiorari in the Fosamax case and reverse it.

In my humble opinion, however, the Solicitor General’s brief is not the silver bullet the drug companies have been looking for. In many ways, it supports the arguments plaintiff-patients usually make more than the arguments made by defendant drug companies.

First, the Solicitor General’s brief concedes that this case presents none of the usual reasons for granting certiorari. Supreme Court Rule 10 isn’t binding on the Court, but it’s a good guide, and it lists the three primary circumstances in which certiorari is granted:

(a) a United States court of appeals has entered a decision in conflict with the decision of another United States court of appeals on the same important matter; has decided an important federal question in a way that conflicts with a decision by a state court of last resort; or has so far departed from the accepted and usual course of judicial proceedings, or sanctioned such a departure by a lower court, as to call for an exercise of this Court’s supervisory power;

(b) a state court of last resort has decided an important federal question in a way that conflicts with the decision of another state court of last resort or of a United States court of appeals;

(c) a state court or a United States court of appeals has decided an important question of federal law that has not been, but should be, settled by this Court, or has decided an important federal question in a way that conflicts with relevant decisions of this Court.

The Solicitor General’s brief admits right up front that they don’t have any of these: “[n]o circuit conflict yet e​xists, however, and further percolation in the courts of appeals could potentially refine the issue for review.” They even admit that they have no argument for how a decision in Fosamax could make any difference in other cases: “It is also unclear whether the decision below will influence other courts addressing similar preemption defenses.”

The Solicitor General’s brief tries to squeeze in an argument, in the very last sentence, that “the Court’s consideration of the proper method for resolving the preemption issue in this case may inform the proper analytical framework for resolving FDA preemption issues in light of Wyeth more generally.” Problem for them is that the new “analytical framework” they present, on pages 18-19, has never been adopted by any court in the country, as revealed by the absence of any citations in support.

The Solicitor General is thus asking the Supreme Court to take up a case where there’s no conflict and no reason to believe it will make any difference in future cases, all so the Supreme Court can obliterate nine years of precedent interpreting Levine and make up an entirely new rule for cases with different facts that aren’t in front of the Court.

I suspect the drug companies begged the Solicitor General’s office to file this brief — I spotted some language that is almost verbatim to language I’ve seen in drug company briefs — but the brief admits every way that it can that this just isn’t the type of circumstance that warrants certiorari.

Second, the Solicitor General’s brief makes a concession that could be devastating to the preemption arguments made by drug companies in most drug injury lawsuits:

This case does not present circumstances in which there is no actual FDA labeling decision to interpret—for instance, because the manufacturer did not submit a labeling supplement. In such circumstances, Wyeth’s use of the phrase “clear evidence” could arguably be read to suggest that determining what FDA would have done with respect to such a supplement presents a question of fact for the jury to decide.

Fact is, Fosamax is unique because there is arguably an “actual FDA labeling decision to interpret.” In the vast majority of drug injury lawsuits, the manufacturer “did not submit a labeling supplement” at all, or did not submit a labeling supplement with either the language proposed by the plaintiff or with the scientific evidence identified by the plaintiff. Nexium and Prilosec? No warning for stomach or esophageal cancer proposed. Mirena? No warning for intracranial hypertension proposed. Januvia and Victoza? No warning for pancreatic cancer proposed. Onglyza? No warning for heart failure proposed (that is, in the time period when the plaintiffs took it — it has one now).

Drug manufacturers try to use their own negligence to their advantage, claiming that, even if they didn’t submit a labeling change, they can establish preemption based on some hand-waving arguments about regulatory standards, but the Solicitor General’s brief knocks that down, too: “Wyeth therefore may be understood as consistent with the view that, to establish impossibility preemption, a name-brand drug manufacturer cannot rely on speculation or merely plausible interpretations of ambiguous features of FDA’s regulatory framework and practices.”

The fact that the United States has adopted those two positions is bound to make its way into plaintiffs’ briefs from now on. If the Supreme Court adopts them, too, then it will make most branded drug preemption arguments even more frivolous than they already are.

Third, the Solicitor General’s brief includes a paragraph and footnote that justifies everything plaintiffs’ lawyers have been saying since Levine was originally decided:

FDA’s May 2009 decision rejecting petitioner’s proposal to modify Fosamax’s Warnings and Precautions section to address atypical femoral fractures was based on the agency’s determination that the data was then insufficient to justify such a warning. That conclusion flows directly from the terms of the agency’s May 2009 Complete Response Letter, the relevant regulatory context, and the agency’s subsequent actions. Given FDA’s determination, respondents’ claim that petitioner should have updated its Warnings and Precautions labeling at that time is preempted.10

Footnote 10: The question presented is based on the premise that petitioner provided FDA with “the relevant scientific data,” Pet. i, and respondents’ brief in opposition does not appear to contend otherwise.

In virtually every drug case, the drug manufacturers withheld scientific data from the FDA (see, e.g., In re Actos, 2014 WL 4364832 (W.D. La. 2014)(“not only did Takeda not supply the FDA with requested information that was evidence of a risk of bladder cancer with Actos use, Takeda withheld that information even when requested to provide additional information”)), and so the drug manufacturers always try to avoid discovery into their scientific data by claiming that it’s irrelevant whether or not the FDA actually had and reviewed “the relevant scientific data.” The Solicitor General’s brief blows that argument up entirely.

Under the Solicitor General’s view, a drug manufacturer not only has to show the FDA rejected the same warning proposed by the plaintiff, but must also show that, along with the proposed warning, the drug manufacturer provided all of “the relevant scientific data.” But the drug companies never do that in the circumstances that lead to litigation; if they had done so, the drug would have had an adequate warning and there would be no case.


It’s usually folly to predict what the Supreme Court will do, but I’ll do it anyway: with Justice Alito recused, I don’t see how certiorari would be granted. Justice Roberts has been scrupulous about avoiding plurality decisions, and, way back when Levine was originally decided, Justice Thomas wrote a concurrence in support of the plaintiffs, and so he would be unlikely to up-end Levine in favor of the drug companies, and that would still likely produce a 4-4 opinion. There’s no clear path to victory for the drug companies here and, as the Solicitor General’s brief shows, there’s no good reason why the drug companies should be victorious.

Update, June 28, 2018. It was indeed folly: today, the Supreme Court granted certiorari. Justice Alito was recused from the decision to grant certiorari, and, when deciding to grant certiorari, the full court was aware that Justice Kennedy would retire. The Roberts Court has shown a strong inclination against granting certiorari where the merits decision would fail to produce a majority. Thus, the grant of certiorari in Fosamax indicates that there is already a potential majority opinion which does not involve Justice Alito and in which the views of Justice Kennedy’s replacement are irrelevant. What could such a majority look like?

The answer is simple: Justice Thomas’s concurrence in Levine, in which “implied pre-emption doctrines that wander far from the statutory text are inconsistent with the Constitution” and “[t]he federal statute and regulations neither prohibited the stronger warning label required by the state judgment, nor insulated Wyeth from the risk of state-law liability.” Notably, when Justice Thomas authored the opinion in Pliva v. Mensing, 131 S. Ct. 2567 (2011), which found preemption of failure-to-warn lawsuits against generic manufacturers, he specifically did not join Part III-B-2 of the opinion, which argued that, in addition to the FDCA’s text and the enabling regulations, there was also “conflict pre-emption.” Fosamax thus might be the end of Levine’s “clear evidence” entirely: taking Justice Thomas’s concurrence in Levine and his implicit re-affirmation of those views by not joining Part III-B-2 of Mensing, and adding the dissent in Mensing by Justices Ginsburg, Breyer, Kagan, and Sotomayor, produces five votes to find no preemption at all of lawsuits involving branded prescription drugs.

Fosamax further presents a test for Justice Gorsuch’s commitment to federalism and textualism: his opinion in Cook v. Rockwell Intern. Corp., 790 F.3d 1088 (10th Cir. 2015), discussed here, a nuclear waste case, adhered strictly to the text of the Price-Anderson Act, rejecting implied preemption and sending the case back to the jury for fact-finding relating to preemption, just as the Third Circuit found in Fosamax. Moreover, earlier this year, Justice Gorsuch joined Justice Thomas’s dissent from the denial of certiorari in Garco Construction v. Speer, which argued that Seminole Rock and Auer. In that dissent, Justice Thomas argued Seminole Rock and Auer were “constitutionally suspect” and that courts should not give “controlling weight” to an agency’s interpretation of its own regulations. If Justice Gorsuch and Justice Thomas are consistent and apply that same analysis in Fosamax, it would be yet another argument in favor of scrapping Levine’s “clear evidence” test entirely and replacing it with a bright-line rule that failure-to-warn lawsuits against the manufacturers of branded drug lawsuits cannot be preempted under any circumstance.

Put simply, unless multiple Justices reverse course and adopt positions contrary to their prior opinions, in Fosamax there simply is no path to victory for drug companies.