Last month, the Southern District of California issued an important decision for manufacturers relying on a preemption defense to failure to warn claims.  The heart of the claims asserted in In re Incretin-Based Therapies Products Liability Litigation was that Defendants – including pharmaceutical companies Amylin Pharmaceuticals, Eli Lily, Merck, and Novo Nordisk – failed to warn that four prescription drugs used to treat type 2 diabetes cause or create an increased risk of pancreatic cancer.  Specifically, Plaintiffs, individuals with type 2 diabetes who were prescribed the drugs are issue, claimed that Defendants should have referenced pancreatic cancer in their product labeling.  In response, the  manufacturers moved for summary judgment, urging that Plaintiffs’ failure to warn claims were conflict preempted because it would have been impossible to reference pancreatic cancer in the drug labeling and simultaneously comply with FDA labeling regulations.

By way of introduction, the Court’s decision sets forth the Food and Drug Administration’s (“FDA”) authority delegated by Congress to regulate drug manufacturers and their products.  With later amendments, the FDA’s power became broader to protect the public health, and to assure the safety, effectiveness, and reliability of drugs.  With that, the FDA oversees the introduction of new drugs, regulates drug labeling, and monitors post-marketing reporting compliance.  Even though the FDA has broad powers, a drug manufacturer still remains responsible for maintaining the adequacy of product labeling.  State tort law is therefore “viewed as a complimentary form of drug regulation, providing additional protections, and recourse for injured consumers.”  However, when state tort law imposes a duty “impossible” to meet in light of FDA regulations, federal law preempts state tort law.

The Court began with the seminal impossibility preemption case – Wyeth v. Levine, 555 U.S. 555, 565 (2009).  Although the Supreme Court rejected the drug company’s preemption defense there, the court held that “absent clear evidence that the FDA would not have approved a change to Phenergan’s label” the court would “not conclude that it was impossible for Wyeth to comply with both federal and state requirements.”  While the Supreme Court set forth the conflict preemption standard, the question of what would constitute “clear evidence” for a successful preemption defense remained.

The Court went through a very thorough analysis of prior cases addressing this precise issue.  On one side (for plaintiffs), there is Wyeth v. Levine, 555 U.S. 555, 565 (2009) and Gaeta v. Perrigo, 630 F.3d 1225 (9th Cir. 2011), which both found the clear evidence standard not satisfied.  And, on the other side (for manufacturers), there is Dobbs v. Wyeth Pharm., 797 F. Supp. 2d 1264, 1267 (W.D. Okla. 2011), which, while characterized as an outlier, identifies the type of record needed to meet the clear evidence standard.

In Dobbs, plaintiff’s husband committed suicide after taking a drug for depression.  At that time, the label and package insert included an FDA-approved statement regarding suicidality in adult patients with depression, but plaintiffs argued that it was inadequate to warn her husband of the risk.  The record there, however, showed the FDA’s extensive consideration of the enhanced warning, along with evidence that the FDA consistently concluded that there was insufficient evidence warranting the additional warning.  In fact, there, the FDA had rejected citizen petitions specifically requesting the enhanced warnings.  On that record, the court found that plaintiff’s claims were preempted.

The Court continued with a helpful catalogue of prior cases where the clear evidence standard had been satisfied: Rheinfrank v. Abbott Laboratories, Inc., No. 1:13-cv-114, 2015 WL 4743056 (S.D. Ohio, Aug. 10, 2015) (finding clear evidence that the FDA would have rejected a label change where the FDA considered the safety issue and failed to issue a labeling change); Reckis v. Johnson & Johnson, 471 Mass. 272 (2015) (finding clear evidence that the FDA would have rejected the specific warning – although not the general warning – where the FDA had rejected a citizen’s petition); In re Fosamax Products Liability Litigation, 951 F. Supp. 2d 695 (D.N.J. 2013) (finding clear evidence satisfied where the FDA would not have approved a change to the label prior to plaintiff’s injury given the FDA’s rejection of the prior approval supplement with an enhanced warning only one month after plaintiff’s injury).

The Court further noted prior decisions where courts have concluded that citizen petition rejections did not constitute clear evidence that the FDA would have rejected the proposed warning due to a temporal gap:  Mason v. SmithKlinne Beecham Corp., 596 F.3d 387 (7th Cir. 2010) (focusing on the temporal gap between the citizen petition rejections and the decedent’s suicide, as well as the FDA’s evolving opinion regarding pediatric suicidality, concluding it was not unlikely that the FDA would have prevented the manufacturer from warning about suicide risks in young adults); Dorsett v. Sandoz, 699 F. Supp. 2d 1142 (C.D. Cal. 2010) (finding clear evidence did not exist since the FDA’s rejection of citizen petitions in the 1990’s did not establish what the FDA would have done in response to a label change request in 2004); Koho v. Forest Labs., Inc., 17 F. Supp. 3d 1109, 1118 (W.D. Wash. 2014) (finding clear evidence not satisfied where the FDA’s rejection of citizen petitions occurred five years prior to the decedent’s suicide and where the warnings sought and rejected were not the same).

Moving to the facts and arguments in the case, Defendants argued that it would be impossible to comply with federal labeling requirements and state tort law, given the FDA’s opinions regarding the causal association between the drugs at issue and pancreatic cancer.  Specifically, Defendants referred to seven situations where the FDA had previously held a position regarding pancreatic safety, emphasizing that these prove the FDA’s conclusion that current data did not support a pancreatic cancer reference.  These included: issuance of the FDA’s assessment of pancreatic safety in the New England Journal of Medicine; FDA’s rejection of a citizen petition; FDA’s conclusion that a causal association between incretin mimetics and pancreatic cancer is indeterminate; and lastly, the FDA’s subsequent approval of other incretin-based therapies without any reference to pancreatic cancer in the product labeling.

After analyzing the record, the Court concluded that the FDA would have rejected a pancreatic cancer label change.  Notably, in finding that clear evidence existed, the Court rejected Plaintiffs’ claim that Defendants could not establish preemption absent express rejection of the proposed label change.  In doing so, the Court focused on the language in Levine, where the Supreme Court stated that a manufacturer must demonstrate by clear evidence that the FDA would have rejected the label change, not that the FDA did reject the change.  Furthermore, despite Plaintiffs’ argument that the FDA did not reach a final conclusion and that the FDA’s pancreatic cancer safety signal remains open, the Court found that such ongoing review did not undermine its conclusion that clear evidence existed under the facts presented.

Lastly, Plaintiffs claimed that Defendants could not establish conflict preemption because they failed to give the FDA the data supportive of a causal connection.  Plaintiffs argued that this data constitutes new safety information, triggering Defendants obligation to provide the data to the FDA.  Relying on the Supreme Court’s decision in Buckman v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), the Court concluded that Plaintiffs’ misreporting and underreporting claims were preempted.  There, the Supreme Court found that fraud-on-the-FDA claims were preempted because they conflict with the FDA’s responsibility to police fraud.  Although the Court found that Buckman did not govern whether Plaintiffs’ failure to warn claims were conflict preempted, it found the case was implicated by Plaintiffs’ defense to the clear evidence standard.  The Court further noted that it was unclear whether the FDA considered the information and if it did not, whether the data would have altered the FDA’s conclusion.

Although this case illustrates that the clear evidence standard is, in fact, not so clear, it nevertheless provides a helpful rubric for manufacturers relying on a conflict preemption defense in a failure to warn case based on clear evidence that the FDA would have rejected the proposed warnings.