In re Incretin-Based Therapies Prods. Liab. Litig.

Decision Date09 November 2015
Docket NumberCase No.: 13md2452 AJB (MDD)
Citation142 F.Supp.3d 1108
Parties In re: Incretin-Based Therapies Products Liability Litigation As to all related and member cases
CourtU.S. District Court — Southern District of California
Hon. Anthony J. Battaglia
, United States District Judge

Through the enactment of the Federal Food, Drug, and Cosmetics Act, 21 U.S.C. § 301 et seq.,

Congress delegated authority to the Food and Drug Administration ("FDA") to regulate pharmaceutical manufacturers and their products. With subsequent amendments, Congress enlarged this authority, charging the FDA with the power to protect the public health, and to assure the safety, effectiveness, and reliability of drugs. In discharging its regulatory duties, the FDA oversees the introduction of new drugs into the market, regulates the content of drug labeling, and ensures manufacturers comply with postmarketing requirements. Despite the FDA's broad regulatory duties, a drug manufacturer remains primarily responsible for maintaining the adequacy of product 1 labeling. State tort law is therefore generally viewed as a complimentary form of drug regulation, providing additional protections and recourse for injured consumers. Yet, when state tort law imposes a duty impossible to meet in light of FDA regulations, federal law will preempt state law. Impossibility preemption is a form of conflict preemption and is a demanding defense—requiring a drug manufacturer to establish by clear evidence that the FDA would reject a proposed labeling change.

Despite the high burden imposed on a preemption proponent, the unprecedented facts of this case cross the clear evidence threshold, making Defendants' preemption defense not only viable, but also dispositive of Plaintiffs' failure-to-warn claims. The record establishes the FDA has specifically considered pancreatic cancer

risk, commented publicly on the adequacy of drug labeling, and maintained its position that scientific evidence of a causal association between incretin mimetics and pancreatic cancer is indeterminate. Because an indeterminate causal association falls below the federal regulatory standards required for labeling changes, clear evidence exists that the FDA would have rejected a reference to pancreatic cancer in product labeling. For the reasons set forth below, the Court GRANTS Defendants' motion for summary judgment and DENIES Plaintiffs' cross-motion for summary judgment on the affirmative defense of conflict preemption.


This multidistrict litigation involves claims that Defendants failed to warn that four prescription drugs used to treat type 2 diabetes

cause or create an increased risk of pancreatic cancer. Plaintiffs are individuals with type 2 diabetes who were prescribed and consumed one or more of the prescription drugs marketed respectively as Januvia, Janumet, Byetta, and Victoza.1 Defendants are the pharmaceutical companies that manufacture and market the drugs, including Amylin Pharmaceuticals, LLC ("Amylin"), Eli Lilly and Company ("Lilly"), Merck Sharp & Dohme Corp. ("Merck"), and Novo Nordisk Inc. ("Novo") (referred to collectively as "Defendants").

Byetta obtained FDA approval in April 2005. (Doc. Nos. 202–1 ¶ 38; 1163–2 Ex. F.) The FDA approved Januvia

in October 2006 and Janumet in March 2007. (Doc. Nos. 202–1 ¶¶ 34, 36; 1163–2 Exs. G, H.) Victoza obtained FDA approval in January 2010. (Doc. Nos. 1163–1 at 8; 1163–2 Ex. I.) Byetta and Victoza are glucagon-like peptide–1 (GLP–1) receptor agonists, and Januvia and Janumet are dipeptidyl peptidase–4 (DPP–4) inhibitors. (Id. ¶ 33.) Although GLP–1 receptor agonists and DPP–4 inhibitors are different classes of drugs, for the purposes of this litigation the parties treat them the same. (See generally Doc. Nos. 206, 1163, 1166.) The FDA has also reviewed both classes of therapeutic agents as a whole, recognizing all four drugs under the broader terms of incretin mimetics or incretin-based therapies. (See Doc. Nos. 202 ¶ 33; 1163–3 at 3; 1166–10 at 2.)

Plaintiffs allege Defendants should have referenced pancreatic cancer

in their product labeling.2 Defendants assert Plaintiffs' failure-to-warn claims are conflict preempted because it would be impossible to reference pancreatic cancer in the drug labeling and comply with FDA labeling regulations. Defendants initially moved for summary judgment premised on conflict preemption in April 2014. (Doc. No. 410.) The Court denied the motion without prejudice and granted Plaintiffs' request for additional discovery pursuant to Federal Rule of Civil Procedure 56(d). (Doc. No. 472.) In June 2015, following discovery focused on conflict preemption, Defendants renewed their motion for summary judgment, (Doc. No. 1163), and Plaintiffs filed a cross-motion for summary judgment, (Doc. No. 1166). The Court heard oral argument on the motions on September 11, 2015. (See Doc. No. 1445.)3


Federal Rule of Civil Procedure 56

governs motions for summary judgment. Summary judgment permits a court to enter judgment on factually unsupported claims, see Celotex Corp. v. Catrett, 477 U.S. 317, 327, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986), and may also be used in the area of affirmative defenses. Dam v. Gen'l. Elec. Co., 265 F.2d 612, 614 (9th Cir.1958). Granting summary judgment is proper if there is "no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(a). A fact is material when, under the governing substantive law, it could affect the outcome of the case. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). A dispute about a material fact is genuine "if the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Id. Where parties file cross-motions for summary judgment, a court must consider each party's evidence, regardless of which motion offers the evidence. Tulalip Tribes of Wash. v. Washington, 783 F.3d 1151, 1156 (9th Cir.2015) ; Las Vegas Sands, LLC v. Nehme, 632 F.3d 526, 532 (9th Cir.2011).


Under the Supremacy Clause, "Congress has the power to preempt state law." Crosby v. Nat'l Foreign Trade Council, 530 U.S. 363, 372, 120 S.Ct. 2288, 147 L.Ed.2d 352 (2000)

; see alsoOneok, Inc. v. Learjet, Inc., ––– U.S. ––––, 135 S.Ct. 1591, 1594–95, 191 L.Ed.2d 511 (2015)

. A preemption analysis begins with two governing principles. First, Congressional intent is the "ultimate touchstone." Wyeth v. Levine, 555 U.S. 555, 565, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009). Second, in a field the States have traditionally occupied, there is a presumption against preemption based on the notion that "Congress does not cavalierly pre-empt state-law causes of action." Medtronic, Inc. v. Lohr, 518 U.S. 470, 485, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996).

Preemption occurs in three forms: (1) express preemption; (2) field preemption; and (3) conflict preemption. Ting v. AT & T, 319 F.3d 1126, 1135 (9th Cir.2003)

. Express preemption exists "where Congress enacts an explicit statutory command that state law be displaced." Id. Field and conflict preemption are forms of implied preemption. Field preemption occurs when federal regulation is sufficiently comprehensive that it leaves no room for supplementary state regulation. Hillsborough Cnty., Fla. v. Automated Med. Labs., Inc., 471 U.S. 707, 712–13, 105 S.Ct. 2371, 85 L.Ed.2d 714 (1985). Conflict preemption occurs when: (1) "compliance with both federal and state regulations is a physical impossibility," or (2) "state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress." Id. (internal citation and quotation marks omitted).

Plaintiffs' claims are not expressly preempted by federal statute, and prescription drug regulation is a field in which the States have traditionally occupied. See Ri e gel v. Medtronic, Inc., 552 U.S. 312, 327, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008)

(noting Congress could have expressly preempted claims regarding pharmaceutical drugs, but chose not to); Lefaivre v. K.M. Pharm., Inc., 636 F.3d 935, 941 (8th Cir.2011) (citing Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 166–67, 109 S.Ct. 971, 103 L.Ed.2d 118 (1989) ( "[T]he FDA [has] long maintained that state law offers an additional, and important, layer of consumer protection that complements FDA regulation.")). Defendants do not assert Plaintiffs' claims create an obstacle to the full purposes and objectives of Congress, and thus obstacle preemption is not at issue. As such, the Court's inquiry will focus on whether concurrent compliance with federal regulations and state tort law is impossible.

As an initial matter, at oral argument Plaintiffs challenged whether conflict preemption presents an issue of law or an issue of fact, and whether resolution by summary judgment is appropriate. (See, e.g., Doc. No. 1445 at 64–65, 127:3–22.) Following oral argument, the state court requested additional briefing specific to this issue. (See Doc. No. 1502 at 1.) At the agreement of the parties in this case, that briefing was submitted as supplemental authority in these proceedings. (Id. ) Upon consideration of the arguments presented in the supplemental briefing, relevant authority, and the pending cross-motions for summary judgment, the Court is satisfied that preemption presents purely a question of law appropriate for resolution by summary judgment. See Dobbs v. Wyeth Pharm., 797 F.Supp.2d 1264, 1267 (W.D.Okla.2011)

("Where, as here, the moving party asserts entitlement to judgment because a claim is preempted by federal law, the motion presents only a legal question for the court; if the court concludes that a state law claim is preempted, summary judgment is proper as to that claim."); see also Bank of Am. v. City & Cnty. of San Francisco, 309 F.3d...

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