(Amended 09/14/22)

No. SCAP-21-0000363, Tuesday, December 13, 2022, 10 a.m.

STATE OF HAWAIʻI, EX REL. HOLLY T. SHIKADA, ATTORNEY GENERAL, Plaintiff-Appellee, vs. BRISTOL-MYERS SQUIBB COMPANY; SANOFI-AVENTIS U.S. LLC; SANOFI US SERVICES INC., formerly known as SANOFI-AVENTIS U.S. INC.; SANOFI-SYNTHELABO LLC, Defendants-Appellants; and SANOFI S.A., Defendant-Appellee.

The above-captioned case has been set for oral argument on the merits at:

Supreme Court Courtroom
Aliʻiōlani Hale, 2nd Floor
417 South King Street
Honolulu, HI 96813

The oral argument will also be livestreamed for public viewing via the Judiciary’s YouTube channel at YouTube.com/hawaiicourts.

Attorneys for Appellants Bristol-Myers Squibb Company, Sanofi-Aventis U.S. LLC, Sanofi US Services Inc., and Sanofi-Synthelabo LLC:

Paul Alston and Claire Wong Black of Dentons US LLP

Attorneys for Appellee State of Hawaiʻi, ex rel. Holly T. Shikada, Attorney General:

L. Richard Fried, Jr. and Patrick F. McTernan of Cronin, Fried, Sekiya, Kekina & Fairbanks; Kimberly T. Guidry, Solicitor General, and Nicholas M. McLean, Deputy Solicitor General

NOTE: Order granting Application for Transfer, filed 05/03/22.

NOTE: Order granting motion to continue oral argument from 10/18/22 at 10:00 a.m. to 12/13/22 at 10:00 a.m., filed 9/14/22.

COURT: Recktenwald, C.J., Nakayama, McKenna, Wilson, and Eddins, JJ.

[ Listen to the entire audio recording in mp3 format ]

Brief Description:

In 2014, Plaintiff-Appellee the State of Hawai‘i sued Defendants-Appellants Bristol-Myers Squibb and Sanofi (both pharmaceutical companies) for violating Hawai‘i’s Unfair or Deceptive Acts or Practices law (UDAP). The State claimed that Plavix was less effective for patients with certain liver-enzyme genotypes (poor responders). It alleged that Defendants-Appellants had knowingly omitted information about Plavix’s diminished efficacy for poor responders from the Plavix label and failed to adequately research variability of response to Plavix. The State alleged these omissions violated the UDAP’s prohibition of unfair and deceptive acts and practices. The Circuit Court of the First Circuit granted summary judgment for the State on one aspect of its deceptive-acts UDAP claim (materiality) and then, following a bench trial, held for the State on its UDAP claim. The court said Defendants’ acts were both deceptive and unfair under the UDAP and imposed a $834 million penalty.

Defendants-Appellants appealed to the ICA and the State petitioned for transfer to this court. We granted the State’s petition.

On appeal, Defendants-Appellants argue the Circuit Court erred in granting summary judgment for the State and concluding they violated the UDAP. They challenge the circuit court’s approach to promoting settlement and drafting its Findings of Fact and Conclusions of Law. They also argue that the State’s suit is time-barred, preempted, and barred by the UDAP’s safe harbor provision. (UDAP’s safe harbor provision, HRS § 481A-5(a)(1), exempts “[c]onduct in compliance with the orders or rules of, or a statute administered by, a federal, state, or local governmental agency” from the statute’s ambit.) Finally, Defendants-Appellants challenge the penalty imposed on them as unlawful and unconstitutional. The State maintains that the circuit court did not err in granting it summary judgment on the issue of materiality or in concluding that Defendants violated the UDAP. The State also maintains that its suit is timely and neither preempted nor barred by the UDAP’s safe harbor provision, and that the penalty imposed by the circuit court is lawful and constitutional.