526 P.3d 395
Haw.2023Background:
- Plavix (clopidogrel) is a prodrug whose activation involves multiple CYP450 enzymes; CYP2C19 2/3 loss-of-function alleles can reduce metabolism and are more common in Asian populations.
- Bristol-Myers Squibb and Sanofi developed and marketed Plavix beginning in 1998; internal studies showed variability of response and a 1998 meta-analysis was not disclosed to the FDA until 2005.
- Scientific debate evolved from implicating CYP3A4 to recognizing CYP2C19’s role; a 2008 Mega study linked CYP2C19 loss-of-function alleles to worse outcomes, prompting FDA label revisions in 2009 and a boxed warning in 2010 (language partially removed in 2016).
- The State sued under Hawai‘i’s UDAP (HRS §480-2) alleging (1) deceptive omission of poor-responder information from Plavix labeling and (2) that the companies suppressed research to protect sales.
- The circuit court found both deceptive and unfair acts and imposed an $834 million penalty; on appeal the Hawai‘i Supreme Court vacated the deceptive-acts finding and the penalty, affirmed the unfair-acts finding, and remanded for a new trial on deceptive acts and for penalty recalculation.
Issues:
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether omission of CYP2C19 poor-responder information violated UDAP as a deceptive act (materiality and likelihood to mislead) | The boxed-warning information is plainly material; omission likely misled consumers and denied informed consent | Defendants lacked sufficient knowledge pre-2008; evidence shows doctors and Hawai‘i practice were not changed by the warning | Materiality determination at summary judgment vacated; deceptive-acts holding vacated and remanded for new trial (materiality remains an unresolved element) |
| Whether defendants engaged in unfair acts by suppressing or avoiding research to protect profits | Companies intentionally avoided or rejected studies and delayed disclosure to preserve sales; conduct offended public policy and was unethical | Research decisions reflected legitimate scientific/design limits, not profit-motivated suppression | Unfair-acts finding affirmed on independent grounds (offends public policy; unethical/unscrupulous conduct); substantial-injury sub-finding vacated insofar as it relied on the materiality error |
| Procedural defenses: UDAP safe-harbor, statute of limitations, federal preemption | Defendants contend FDA approval bars state claims (safe harbor); the State’s claims are time-barred; federal law preempts conflicting state duties | State: its claims concern conduct beyond mere FDA-approved labeling; not time-barred; no impossible dual compliance shown | Safe-harbor inapplicable; State not bound by HRS §480-24(a) limitations period under Hawai‘i law; federal preemption rejected (no "clear evidence" FDA would have forbidden earlier label change; CBE mechanism available) |
| Penalty amount and method ($834M, per-prescription calculation) | Penalty justified by combined deceptive + unfair findings and per-prescription measure tied to consumer injury | Penalty improperly relies on vacated materiality/deceptive holding and per-prescription method is inappropriate for unfair-research-suppression theory | Penalty vacated; remanded for recalculation after resolution of deceptive-acts claim at retrial |
Key Cases Cited
- Courbat v. Dahana Ranch, [citation="111 Hawai'i 254, 141 P.3d 427"] (Haw. 2006) (defines UDAP deceptive-act elements and materiality test)
- Wyeth v. Levine, 555 U.S. 555 (U.S. 2009) (FDA labeling rules, CBE procedure, and "clear evidence" preemption standard)
- F.T.C. v. Sperry & Hutchinson Co., 405 U.S. 233 (U.S. 1972) (articulates Sperry factors for unfairness)
- Hungate v. Law Office of David B. Rosen, [citation="139 Hawai'i 394, 391 P.3d 1"] (Haw. 2017) (Hawai‘i UDAP unfair-acts framework)
- Anderson v. Liberty Lobby, 477 U.S. 242 (U.S. 1986) (summary-judgment standard precluding judge factfinding at that stage)
- TransWorld Airlines v. American Coupon Exch., 913 F.2d 676 (9th Cir. 1990) (caution on disposing complex factual disputes at summary judgment)
- Umberger v. Dep’t of Land & Nat. Res., [citation="140 Hawai'i 500, 403 P.3d 277"] (Haw. 2017) (de novo review of summary-judgment rulings)
- Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019) (clarifies manufacturer burden to show FDA would have rejected label change for preemption)