July 23, 2019 Articles

Searching for “Clear Evidence” in the Wake of Albrecht

The ruling failed to provide the degree of clarity that many in the industry had hoped for.

By Elie Biel

Last month, the U.S. Supreme Court decided Merck Sharp & Dohme Corp. v. Doris Albrecht, 139 S. Ct. 1668 (2019), a case that presented a rare opportunity for the Court to weigh in on the Third Circuit’s controversial decision in In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017), as well as clarify and build upon its decade-old decision in Wyeth v. Levine, 555 U.S. 555 (2008), the landmark case that established that a drug manufacturer could be immunized from liability under a state-based failure-to-warn theory if “clear evidence” existed that the Food and Drug Administration (FDA) would not have approved the plaintiff’s preferred product warning label. Unfortunately, while the Court unanimously vacated the Third Circuit’s decision, the ruling failed to provide the degree of clarity that many in the industry had hoped for. 

By way of background, the subject litigation concerns Fosamax, a drug widely used to treat osteoporosis in postmenopausal women. Osteoporosis is a condition in which a patient develops weak or brittle bones due to a progressive loss of bone cells. Fosamax combats the effects of osteoporosis by slowing a patient’s rate of bone cell loss, allowing the body time to replace lost bone cells, thereby decreasing the risk of osteoporotic fractures. Like all medications, however, Fosamax is not without risk. One potential risk—and the one at issue in the underlying litigation—is that a long-term Fosamax user may develop an atypical femoral fracture.

When the FDA first approved Fosamax in 1995, its warning label did not warn of the risk of an atypical femoral fracture. Over time, however, evidence began to accumulate that long-term Fosamax users were experiencing atypical femoral fractures. As a result, in 2008, Merck applied to the FDA for preapproval to add language to the Adverse Reactions and Precautions sections of the Fosamax label; namely, by referencing the risk of a “low-energy femoral shaft fracture” in the Adverse Reactions section and discussing the risk of “stress fractures” in the Precautions section. The FDA approved Merck’s proposed adverse reactions language but rejected the proposed precautions language, asserting that Merck’s justification for the proposed precautions language was “inadequate.” Thereafter, Merck changed Fosamax’s Adverse Reactions section. It made no change to the Precautions section.

The plaintiffs (individuals who took Fosamax and suffered atypical femoral fractures between 1999 and 2010) brought state-based failure-to-warn claims against Merck, asserting that the company had failed to warn about the risk of atypical femoral fractures. Relying on Wyeth, Merck moved for summary judgment on the plaintiff’s failure-to-warn claims, arguing that such claims were preempted because “clear evidence” demonstrated that the FDA would not—and did not—approve of the proposed label change. The district court agreed, but the Third Circuit did not, holding that (1) Wyeth’s reference to “‘clear evidence’ referr[ed] solely to the applicable standard of proof,” which Merck failed to satisfy, and (2) the issue of whether the FDA would have rejected the label change was a fact question for the jury. Merck then appealed the decision to the Supreme Court, which unanimously vacated the Third Circuit’s decision.

In doing so, the Court rejected the Third Circuit’s attempt to characterize or define Wyeth’s “clear evidence” language in terms of evidentiary standards, holding instead that the simple question for a judge is “whether the relevant federal and state laws irreconcilably conflict.” Albrecht, 139 S. Ct. at 1679 (internal quotes and formatting omitted). See also id. at 1685 (“Standards of proof, such as preponderance of the evidence and clear and convincing evidence, have no place in the resolution of this question of law.”) (Alito, J., concurring). The Court further rejected the Third Circuit’s contention that a lay jury, as the trier of fact, was best situated to determine whether the FDA would (or did) reject a proposed label change. Per the Court, such a determination amounted to a legal question, as “judges, rather than lay juries,” were best “equipped to evaluate the nature and scope of [the] agency’s determination.” Id. at 1680. The matter was thereafter remanded for further proceedings.

While Albrecht certainly left a great deal to be desired—many observers had hoped that this case, in contrast to Wyeth, would provide the perfect illustration for applying conflict preemption in a failure-to-warn case—there are certainly positive takeaways. As an initial matter, by vacating the Third Circuit’s decision, the Supreme Court eradicated a key authority used by plaintiffs to survive dismissal. That, by itself, is worth celebrating. In addition, this decision should also dispel any further attempts by plaintiffs (or jurists) to punt the issue to a jury. Indeed, for those defendants who may have lost dispositive motions because of a court’s reluctance to decide a legal question—see, e.g., In re Zofran (Ondansetron) Prods. Liab. Litig., 368 F. Supp. 3d 94, 99 (D. Mass. 2019); Rinder v. Merck Sharp & Dohme Corp., 2019 IL App (1st) 171969, ¶ 66 (Jan. 23, 2019)—now may be a good time to evaluate the merits of filing for reconsideration or an appeal.

But beyond the above, the decision disappoints. Particularly unfortunate is that Albrecht failed to elucidate the true meaning of “clear evidence” in the context of the preemption analysis. The decision did at least clarify that “clear evidence” should not be considered akin to an evidentiary standard like “preponderance of the evidence” or “clear and convincing evidence.” Albrecht, 139 S. Ct. at 1679. But it would have been much more helpful if the Court had taken this opportunity to affirmatively define an otherwise undefined term. See Seufert v. Merck Sharp & Dohme Corp., 187 F. Supp. 3d 1163, 1170 (S.D. Cal. 2016) (Wyeth’s “clear evidence standard remains undefined”); In re Depakote, 87 F. Supp. 3d 916, 922 (S.D. Ill. 2015) (Wyeth “does not define ‘clear evidence’”); Dobbs v. Wyeth Pharm., 797 F. Supp. 2d 1264, 1270 (W.D. Okla. 2011) (Wyeth “does not define ‘clear evidence,’ nor does it suggest the level of proof required to constitute such evidence.”). Instead, the Court’s guidance essentially amounted to characterizing “clear evidence” in “I know it when I see it” terms, which is akin to no guidance at all.

Accordingly, as was the case before Albrecht, “lower courts are left to determine what satisfies this ‘clear evidence’ standard in each case.” Schilf v. Eli Lilly & Co., No. CIV 07-4015, 2010 WL 3909909, at *4 (D.S.D. Sept. 30, 2010). Such a determination often involves evaluating several factors—among them, “the regulatory history of the drug or drug class at issue, temporal gaps between FDA action and accrual of a plaintiff’s claims, citizen petition submissions and rejections, available scientific data, and whether the FDA has reviewed the particular harm at issue and the consistency of any resulting conclusions.” Seufert, 187 F. Supp. 3d at 1170. And, more often than not, the analysis is guided by what has previously fallen short of the “clear evidence” standard. Mason v. SmithKline Beecham Corp., 596 F.3d 387, 393 (7th Cir. 2010). Notwithstanding, the following recent decisions may serve to illustrate circumstances where the “clear evidence” standard has been met: Dolin v. GlaxoSmithKline LLC, 901 F.3d 803, 814 (7th Cir. 2018) (preemption found where the FDA effectively told the company (GSK) to remove a specific warning from its label and then repeatedly rejected subsequent requests from GSK to reconsider that decision); Cerveny v. Aventis, Inc., 855 F.3d 1091, 1105 (10th Cir. 2017) (“[T]he rejection of a citizen petition may constitute clear evidence that the FDA would have rejected a manufacturer-initiated change to a drug label.”); Rheinfrank v. Abbott Laboratories, Inc., 119 F. Supp. 3d 749, 766 (S.D. Ohio 2015) (FDA’s decision—years after plaintiff’s alleged injury—to not incorporate the requested warning constitutes clear evidence it would not have approved a change to the drug’s label). Though hardly an exclusive list, these cases and the analyses presented therein merit the review and consideration of anyone considering preemption as valid defense to a state-based failure-to-warn claim.

Two additional points bear mentioning. First, the Albrecht decision underscores the continuing difficulty faced by defendants in asserting preemption as a means of defeating state-based failure-to-warn claims. Indeed, the Court pointedly noted that preemption occurs only if “federal law prohibit[s] the drug manufacturer from adding a warning” and that under the FDA’s Changes Being Effected (CBE) regulation, a drug manufacturer may, without prior FDA approval, unilaterally change a label “‘to reflect newly acquired information’ if the changes ‘add or strengthen a . . . warning’ for which there is ‘evidence of a causal association[.]’” Albrecht, 139 S. Ct. at 1678–79. The implication being that preemption may sometimes be available only if a drug manufacturer tries to make a label change pursuant to the CBE regulation but is then thwarted from doing so by the FDA. See id. at 1679 (“[T]he CBE regulation permits changes, so a drug manufacturer will not ordinarily be able to show that there is an actual conflict between state and federal law such that it was impossible to comply with both.”). Counsel advising manufacturing defendants regarding warning labels would be wise to take note.

Second, though the issue was neither before the Court nor decided, the opinion appears to suggest that only formal FDA actions, or similar agency actions carrying the force of law, matter to a preemption analysis—i.e., informal communications between the FDA and a drug manufacturer regarding a proposed label change may not be of significant value. Id. at 1679. Should that indeed be the case, it would be quite notable in part because of its potentially chilling impact on Albrecht on remand. See Albrecht, 139 S. Ct. 1668, 1685–86 (Alito, J., concurring) (describing how up until October 2010, FDA was regularly in contact with Merck personnel and effectively told the company to “hold off” on modifying Fosamax’s Precautions section). And it would also be quite notable because it would contradict some existing lower court views. See, e.g., Rheinfrank v. Abbott Labs., Inc., 680 F. App’x 369, 386 (6th Cir. 2017) (email from FDA making clear that proposed warning should not be incorporated into labeling satisfied “clear evidence” standard); Willis v. Abbott Labs., No. 1:15-CV-00057-JHM, 2017 WL 5988215, at *9 (W.D. Ky. Dec. 1, 2017) (emails and phone calls with FDA provided “clear evidence” the FDA would not have approved the change). But see Schilf, 2010 WL 3909909, at *4 (holding that “an email from the FDA indicating that Lilly should not change the Cymbalta label until it is finally approved by the FDA is not ‘clear evidence’”).

It may very well be the case that this issue—the “question of disapproval ‘method’”—will mark the next chapter of this ongoing saga.

Elie Biel is a drug and device litigator in the Minneapolis, Minnesota, office of Faegre Baker Daniels LLP.


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