Boone v. Boehringer Ingelheim Pharm., Inc.

• Decision Date: 04 May 2020
• Docket Number: SC 20200
• Citation: 239 A.3d 1175,335 Conn. 547
• Court: Connecticut Supreme Court
• Parties: Geralynn BOONE, Executrix (Estate of Mary Boone) v. BOEHRINGER INGELHEIM PHARMACEUTICALS, INC., et al.

335 Conn. 547

239 A.3d 1175

Geralynn BOONE, Executrix (Estate of Mary Boone)

v.BOEHRINGER INGELHEIM PHARMACEUTICALS, INC., et al.

SC 20200

Supreme Court of Connecticut.

Argued December 19, 2019

Officially released May 4, 2020^*

Brenden P. Leydon, with whom were Neal L. Moskow and Kelly A. Koehler, pro hac vice, and, on the brief, Richard I. Nemeroff, pro hac vice, for the appellant (plaintiff).

Paul W. Schmidt, pro hac vice, with whom were Patrick M. Fahey, Gregory Halperin and Michael X. Imbroscio, pro hac vice, and, on the brief, Phyllis A. Jones, pro hac vice, for the appellees (defendants).

Robinson, C. J., and Palmer, McDonald, D'Auria, Mullins, Kahn and Vertefeuille, Js.

KAHN, J.

The plaintiff, Geralynn Boone, the executrix of the estate of Mary Boone (decedent), brought the present action against the defendants, Boehringer Ingelheim Pharmaceuticals, Inc., and Boehringer Ingelheim International, GmbH, alleging, inter alia, that an oral anticoagulant medication, Pradaxa, wrongfully caused the decedent's death. A jury returned a verdict in favor of the defendants, from which the plaintiff now appeals.¹ The plaintiff claims that the trial court improperly (1) precluded evidence and arguments related to spoliation, (2) prevented the plaintiff from using an excerpt from a particular deposition on rebuttal, (3) granted the defendants’ motion for summary judgment on a design defect claim relating to the absence of a reversal agent, and (4) issued a curative instruction to the jury after closing arguments. We disagree with each of these claims and, accordingly, affirm the judgment of the trial court.

The following facts and procedural history are relevant to the present appeal. After experiencing intermittent heart palpitations in 2003, the decedent was diagnosed with nonvalvular atrial fibrillation

. That condition may cause the formation of blood clots and, as a result, substantially increased the decedent's risk of suffering an ischemic stroke. In order to reduce that risk, Jeffrey Fierstein, a cardiologist, prescribed an anticoagulant named warfarin to the decedent. The use of warfarin requires dietary restrictions, frequent blood testing, and dose titration to keep the concentration of medication present in the bloodstream within an accepted therapeutic range. Like all anticoagulants, warfarin

increases the risk of uncontrolled bleeding.²

In October, 2010, the defendants received approval from the United States Food and Drug Administration (FDA) to begin selling dabigatran etexilate, an anticoagulant marketed under the brand name Pradaxa. Unlike warfarin

, Pradaxa requires no dietary restrictions and was approved for use without blood monitoring or dose titration. In November, 2010, Fierstein met with the decedent and recommended switching from warfarin to Pradaxa. Fierstein testified at trial that the decedent had been tolerating warfarin well and that he had recommended the switch ‘‘out of convenience.’’ The decedent agreed and, for some time, took Pradaxa without any significant side effects.

On March 5, 2014, the decedent suffered a severe gastrointestinal bleed

and was admitted to a hospital. The decedent underwent kidney dialysis to remove Pradaxa from her blood and was administered multiple blood transfusions. Although the bleeding stopped three days later, the decedent's kidneys began to fail. On March 25, 2014, the decedent died. The death certificate lists ‘‘[a]cute [k]idney [i]njury,’’ ‘‘chronic kidney [d]is-ease,’’ ‘‘[r]etroperitoneal [f]ibrosis,’’ and ‘‘occult neoplasia’’ as causes of death.³ The death certificate also lists ‘‘[d]abigatran [i]nduced [c]oagulopathy’’ and ‘‘gastrointestinal bleed

’’ as ‘‘significant’’ conditions contributing to the decedent's death. (Emphasis omitted.) No autopsy was performed.

The plaintiff subsequently commenced the present action, alleging, inter alia, that (1) the defendants negligently failed to give adequate warnings, directions, and instructions to guard against the risk of bleeding caused by Pradaxa, (2) the defendants negligently failed to test, study, and investigate the benefits of establishing a therapeutic range for Pradaxa, and (3) Pradaxa was defectively designed due to the absence of a reversal agent. On January 24, 2018, the trial court granted the defendants’ motion for summary judgment on the claim relating to the absence of a reversal agent, concluding, among other things, that it was preempted by federal law.⁴

The plaintiff filed a pretrial motion asking the trial court to instruct the jury that the defendants had improperly failed to maintain certain relevant materials for the purpose of discovery. Specifically, the plaintiff claimed that the defendants had lost or destroyed files of one of its former employees, Dr. Thorsten Lehr, while litigating previous federal actions relating to Pradaxa. The trial court, applying the test set forth in Beers v. Bayliner Marine Corp. , 236 Conn. 769, 777–79, 675 A.2d 829 (1996), concluded that a spoliation instruction was warranted and, over the defendants’ objection, provided such an instruction to the jury at the end of the trial. See footnote 6 of this opinion.

The jury returned a verdict, finding that, although the defendants had negligently failed to give adequate warnings, directions, and instructions to guard against the risk of bleeding caused by Pradaxa, the plaintiff had failed to prove that the defendants’ wrongful conduct caused the decedent's death. The trial court subsequently rendered judgment in favor of the defendants, from which the plaintiff appealed. Additional facts and procedural history will be set forth as necessary.

I

The plaintiff first claims that the trial court improperly precluded certain evidence and arguments related to the issue of spoliation.⁵ Specifically, the plaintiff posits that the absence of such information deprived the jury of the context necessary to decide whether to draw an adverse inference against the defendants, as permitted by the trial court's spoliation instruction. In response, the defendants argue that the trial court's limitations in this regard were proper.⁶ For the reasons that follow, we decline to conclude that the trial court abused its discretion by precluding evidence and arguments relating to the issue of spoliation in the present case.

The following additional facts and procedural history are relevant to our consideration of this claim. In 2012, certain federal litigation relating to Pradaxa was centralized in the Southern District of Illinois pursuant to 28 U.S.C. § 1407, and a federal district court judge, David R. Herndon, was appointed to preside. In re Pradaxa (Dabigatran Etexilate) Products Liability Litigation , 883 F. Supp. 2d 1355, 1355–56 (J.P.M.L. 2012). Various discovery disputes in that consolidated federal litigation led to motions seeking sanctions against the defendants. See In re Pradaxa (Dabigatran Etexilate) Products Liability Litigation , Docket No. 3:12-MD-02385 (DRH), 2013 WL 6486921, *1 (S.D. Ill. December 9, 2013).

As a result of those disputes, on September 18, 2013, Judge Herndon issued a mandatory injunction requiring the defendants to conduct ‘‘an immediate search for any yet undisclosed materials ....’’ (Internal quotation marks omitted.) Id., at *3–5. During a subsequent deposition, the plaintiffs in that proceeding discovered that Lehr was a potentially relevant source of additional information and, as a result, requested production of his custodial file. Id., at *9. Approximately one month after that deposition, the defendants informed Judge Herndon that Lehr had not been identified as a custodian and that, as a result, some of his documents and files had been destroyed. Id.

In reviewing a subsequent motion for sanctions, Judge Herndon found that Lehr ‘‘was a prominent scientist ... that played a vital role in researching Pradaxa,’’ that the defendants were familiar with his work, and that the evidence on record in that case would ‘‘lead a reasonable person to infer a motive for the defendant[s] to abstain from placing a litigation hold on [Lehr's] materials ....’’ Id., at *12. On the basis of these findings, the court concluded that the defendants had failed to maintain Lehr's files ‘‘in bad faith.’’⁷ Id., at *18. This conduct, together with certain other discovery violations, led Judge Herndon to impose immediate sanctions on the defendants, including a substantial monetary fine and an order compelling the attendance of various corporate employees at depositions in the United States. Id., at *20. In a separate ruling, Judge Herndon also specifically put the defendants on notice that additional sanctions, including an adverse inference instruction, would be considered at the close of discovery and would ‘‘apply to any actions pending before [that] court at [that] time ....’’ In re Pradaxa (Dabigatran Etexilate) Products Liability Litigation , United States District Court, Docket No. 3:12-MD-02385 (DRH), MDL No. 2385, CMO 50-1 (S.D. Ill. December 18, 2013), available at https://www.ilsd.uscourts.gov/Documents/mdl2385/cmo50-1.pdf (last visited May 1, 2020). The defendants challenged Judge Herndon's order by filing a petition for a writ of mandamus in the United States Court of Appeals for the Seventh Circuit. In re Petition of Boehringer Ingelheim Pharmaceuticals, Inc. , 745 F.3d 216, 216–17 (7th Cir. 2014). In that proceeding, the Seventh Circuit concluded that the order compelling the deposition of corporate employees in the United States was improper. Id., at 219–20. In reaching this conclusion, the Seventh Circuit expressly declined to revisit the factual findings underlying the District Court's finding of bad faith and its imposition of other sanctions. Id., at 218. Following Judge Herndon's decision, the consolidated federal litigation settled. See In re Pradaxa (Dabigatran Etexilate) Products Liability Litigation , United States District Court, Docket No. 3:12-MD-02385 (DRH) (S.D. Ill. May 1, 2015), available...