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Rotondo v. Amylin Pharms.

Court of Appeal of California, Second Appellate District, Division Seven

November 6, 2018, Opinion Filed

B275314

Opinion

Plaintiffs in this consolidated proceeding allege state-law claims asserting that pharmaceutical manufacturers failed to warn consumers that a class of diabetes medication commonly known as "incretin-based drugs" increases the [*2]  risk of pancreatic cancer. The manufacturers filed a motion for summary judgment arguing that plaintiffs' claims were preempted under Wyeth v Levine (2009) 555 U.S. 555, 129 S. Ct. 1187, 173 L. Ed. 2d 51 (Wyeth) because the undisputed evidence showed the Food and Drug Administration would not have permitted a warning for pancreatic cancer. The trial court agreed and granted judgment in the manufacturers' favor.

We reverse, concluding that the trial court erroneously interpreted Buckman Co. v. Plaintiffs' Legal Committee (2001) 531 U.S. 341, 121 S. Ct. 1012, 148 L. Ed. 2d 854 (Buckman) to preclude the consideration of scientific evidence that the Food and Drug Administration had not previously evaluated.

FACTUAL BACKGROUND

A. Summary of the Plaintiffs' Claims

Plaintiffs in this consolidated proceeding are individuals, or the heirs of individuals, who developed pancreatic cancer after being prescribed one of four brand-named diabetes medications, collectively referred to as "incretin-based drugs," that are designed to stimulate insulin secretion in pancreatic cells by increasing the level of incretin hormone. Defendants are pharmaceutical manufacturers that developed and sold the four medications at issue under the brand names "Byetta" (defendant Amylin Pharmaceuticals), "Victoza" (defendant Eli Lilly and Company), "Januvia" and "Janumet" (defendant Merck [*3]  Sharp & Dohme Corporation).1

Plaintiffs' claims allege that defendants failed to warn consumers that incretin-based drugs increase the risk of developing pancreatic cancer. Although the Food and Drug Administration (FDA or the Administration) did not require defendants to include a pancreatic cancer warning on their product labels when the drugs were approved for market, plaintiffs contend the defendants should have amended the labels to add a warning based on subsequent research showing a causal relationship between incretin-based drugs and pancreatic cancer.

Plaintiffs filed more than 300 individual cases in Superior Court alleging failure-to-warn claims. The cases were consolidated, and the matter was assigned to Los Angeles County Superior Court Judge William Highberger. Numerous cases raising similar failure-to-warn claims involving incretin-based drugs have been filed in other state and federal jurisdictions throughout the country. In August 2013, a federal multi-district litigation was established, In re Incretin-Mimetic Cases (MDL # 2452), for all such claims pending in federal court. The case was assigned to Judge Anthony Battaglia in the United States District Court for the [*4]  Southern District of California.2 To minimize redundancy and inconsistent rulings, Judge Highberger and Judge Battaglia coordinated various aspects of discovery in the state and federal proceedings.

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2018 Cal. App. Unpub. LEXIS 7515 *; 2018 WL 5800780

AIDA ROTONDO, et al., Plaintiffs and Appellants, v. AMYLIN PHARMACEUTICALS, INC., et al., Defendants and Respondents.

Notice: NOT TO BE PUBLISHED IN OFFICIAL REPORTS. CALIFORNIA RULES OF COURT, RULE 8.1115(a), PROHIBITS COURTS AND PARTIES FROM CITING OR RELYING ON OPINIONS NOT CERTIFIED FOR PUBLICATION OR ORDERED PUBLISHED, EXCEPT AS SPECIFIED BY RULE 8.1115(b). THIS OPINION HAS NOT BEEN CERTIFIED FOR PUBLICATION OR ORDERED PUBLISHED FOR THE PURPOSES OF RULE 8.1115.

Subsequent History: Request denied by Rotondo v. Amylin Pharmaceuticals, Inc., 2019 Cal. LEXIS 664 (Cal., Jan. 30, 2019)

Prior History:  [*1] APPEAL from a judgment of the Superior Court of Los Angeles County, No. JCCP4574, William F. Highberger, Judge.

Disposition: Reversed.

CORE TERMS

pancreatic, cancer, plaintiffs', warning, manufacturer, state-law, drugs, incretin-based, preemption, label, clear evidence, preempted, defendants', regulation, failure-to-warn, summary judgment, asserting, summary judgment motion, intentionally, diabetes, studies, cases, causal relationship, federal proceeding, medical device, tort law, fraud-on-the-FDA, clarified, parties, fail to warn