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Liu v. Boehringer Ingelheim Pharmaceuticals Inc.

United States District Court, D. Massachusetts

January 23, 2017

LI LIU AND DR. EMILY LIU, AS CO-ADMINISTRATORS OF THE ESTATE OF DR. ZHENSHENG LIU AND PERSONAL REPRESENTATIVE OF THE HEIRS AT LAW OF DR. LIU, Plaintiffs,
v.
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC., BOEHRINGER INGELHEIM CORPORATION, BOEHRINGER INGELHEIM USA CORPORATION, AND BOEHRINGER INGELHEIM INTERNATIONAL GMBH, Defendants.

          MEMORANDUM OF DECISION

          WILLIAM G. YOUNG DISTRICT JUDGE

         I. INTRODUCTION

         This diversity action arises out of the alleged wrongful death of Dr. Zhensheng Liu, due to side effects from taking the prescription drug Pradaxa. Li Liu and Dr. Emily Liu (collectively, the “Lius”), in their capacities as administrators of the estate of Dr. Zhensheng Liu and personal representatives of the heirs-at-law of that estate, have brought claims against the drug's manufacturers and distributors -- Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim Corporation, Boehringer Ingelheim USA Corporation, and Boehringer Ingelheim International GMBH (collectively, the “Defendants”) -- for negligent failure to warn, negligent design defect, and negligent design and testing. The Defendants have moved for summary judgment, arguing that (1) the Lius' design claims are preempted, (2) the Lius fail to establish proximate cause, and (3) Pradaxa's label was adequate.

         A. Procedural History

         The Lius initially filed their complaint in this Court on August 5, 2014. Compl. & Demand Jury Trial (“Compl.”), ECF No. 1. On August 18, 2014, the United States Judicial Panel on Multi-District Litigation transferred this case to the Southern District of Illinois for consolidated proceedings before Judge David R. Herndon. Joint Local Rule 16.1 Scheduling Conference Statement 2, ECF No. 27. Judge Herndon remanded the case to this Court on September 11, 2015. Id.[1] The Defendants then filed the instant motion for summary judgment. Defs.' Mot. Summ. J. Basis Adequacy, Proximate Cause, & Preemption, ECF No. 41. The parties fully briefed the issues, Pls.' Mem. Law Opp'n Defs.' Mot. Summ. J. (“Pls.' Opp'n”), ECF No. 46; Mem. Law Supp. Defs.' Mot. Summ. J. Basis Adequacy, Proximate Cause, & Preemption (“Defs.' Mem.”), ECF No. 42; Reply Supp. Defs.' Mot. Summ. J. Basis Adequacy, Proximate Cause, & Preemption (Defs.' Reply”), ECF No. 50, and appeared before the Court for oral argument on October 13, 2016, Electronic Clerk's Notes, ECF No. 67. After taking the matter under advisement, id., the Court partially granted the Defendants' motion for summary judgment, Order, ECF No. 71, and here explains its reasons for doing so.

         B. Factual Background

         Pradaxa is a brand name anticoagulation medication that was approved by the Food and Drug Administration (“FDA”) in 2010. Compl. ¶ 15; Def. Boehringer Ingelheim Pharmaceuticals Inc.'s Answer Pls.' Compl. (“BIP Answer”) ¶ 15, ECF No. 17; Boehringer Ingelheim Corporation's Answer Pls.' Compl. (“BIC Answer”) ¶ 15, ECF No. 18; Def. Boehringer Ingelheim USA Corporation's Answer Pls.' Compl. (“BIC USA Answer”) ¶ 15, ECF No. 19. It “is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.” Compl. ¶ 14; BIP Answer ¶ 14; BIC Answer ¶ 14; BIC USA Answer ¶ 14. Pradaxa is labeled, designed, produced, marketed, distributed, and sold by the Defendants and their agents. Compl. ¶ 13; BIP Answer ¶ 13.

         Dr. Zhensheng Liu was over 80 years old and had been diagnosed with atrial fibrillation at all times relevant to this suit. See Compl. ¶ 41; Pls.' Opp'n 3; Defs.' Mem. 8. Around March 31, 2011, Dr. Seth Bilazarian (“Dr. Bilazarian”) prescribed Pradaxa to Dr. Zhensheng Liu, who began using the drug. Compl. ¶ 42; Pls.' Opp'n 3; Defs.' Mem. 10. Approximately a year and a half later, on November 25, 2012, Dr. Zhensheng Liu fell and sustained a head injury. Compl. ¶ 42; Defs.' Mem. 10. He was subsequently admitted to Massachusetts General Hospital, Compl. ¶ 42; Defs.' Mem. 10, where the Lius allege that he experienced continued bleeding, prompting failed attempts to remove Pradaxa from his system through fresh frozen plasma and hemodialysis, Compl. ¶ 43. Dr. Zhensheng Liu died from cranial bleeding on November 29, 2012. Id.; Defs.' Mem. 10.

         The Lius allege that neither Dr. Zhensheng Liu nor Dr. Bilazarian knew of the risks or dangers associated with Pradaxa and that, had either known, Dr. Zhensheng Liu would not have used the drug. Compl. ¶ 46. The Lius further allege that the Defendants knew or should have known of the dangers, and through their negligence, caused Dr. Zhensheng Liu's wrongful death. Compl. ¶¶ 45, 47, 50, 54, 62, 72, 78-80, 83-85.

         II. ANALYSIS

         A. Legal Standard

         Summary judgment is appropriate when there “‘is no genuine issue as to any material fact and . . . the moving party is entitled to judgment as a matter of law.'” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247 (1986) (quoting Fed.R.Civ.P. 56(c)). An issue is genuine if it could be “‘resolved in favor of either party' at trial.” Iverson v. City of Boston, 452 F.3d 94, 98 (1st Cir. 2006) (quoting Garside v. Osco Drug, Inc., 895 F.2d 46, 48 (1st Cir. 1990)). A fact is material if it could affect the outcome of the suit. Anderson, 477 U.S. at 248. In ruling on a motion for summary judgment, the Court “must draw all reasonable inferences in favor of the nonmoving party, ” Reeves v. Sanderson Plumbing Prods., Inc., 530 U.S. 133, 150 (2000), granting the motion “against a party who fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial, ” Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986). On an issue upon which a party bears the burden of proof, absent an admission of the point, summary judgment cannot enter in favor of that party on that issue even in the absence of contrary evidence, as the fact finder could disbelieve the proffered evidence. See Reeves, 530 U.S. at 142-43.

         B. Negligent or Defective Design

         The Lius argue that Pradaxa was defective in design because there were safer alternative designs, the product did not comply with its specifications or performance standards, and Pradaxa was not as safe as any other drugs in the same class. Compl. ¶ 59. They further assert that the Defendants negligently tested and designed the drug. Id. ΒΆΒΆ 67-80. The Lius, however, have produced no evidence supporting these claims. Accordingly, they have failed to establish the elements of their claims, and thus ...


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