United States District Court, D. Massachusetts
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,
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
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.
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. 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.
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.
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.
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,
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.
Negligent or Defective Design
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.
¶¶ 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