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

Filing 94

Judge William G. Young: ORDER entered. MEMORANDUM OF DECISION: For the foregoing reasons, this Court on October 18, 2016, GRANTED IN PART and DENIED IN PART the Defendants motion forsummary judgment, ECF No. #41 . Summary judgment is GRANTED as to the claims of negligent design and testing; it is DENIED as to the adequacy of Pradaxas label and proximate cause.(Paine, Matthew)

UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS
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Plaintiffs,
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v.
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BOEHRINGER INGELHEIM
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PHARMACEUTICALS, INC., BOEHRINGER )
INGELHEIM CORPORATION, BOEHRINGER )
INGELHEIM USA CORPORATION, AND
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BOEHRINGER INGELHEIM INTERNATIONAL )
GMBH,
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Defendants.
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___________________________________)
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,

YOUNG, D.J.

CIVIL ACTION
NO. 14-13234-WGY

January 23, 2017
MEMORANDUM OF DECISION

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.
1.

Compl. & Demand Jury Trial (“Compl.”), ECF No.

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

1

Discovery and other multi-district proceedings took about a
year. Some of the transferred cases settled. This one did not.
Judge Herndon commendably promptly sent it back to the District
of Massachusetts for trial. Cf. DeLaventura v. Columbia Acorn
Trust, 417 F. Supp. 2d 147 (D. Mass. 2006) (inveighing against
the practice of holding cases in the transferee court to induce
them to settle). Unfortunately, all parties agreed this case
was not ready for trial. Another year elapsed while the parties
prepared this particular case for trial. While multi-district
practice has obvious consolidated cost savings for a defendant,
one wonders whether doubling or trebling the time from complaint
[2]

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

to trial (with the attendant costs) confers equivalent benefits
on the Lius.
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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.
Defs.’ Mem. 10.

Compl. ¶ 42;

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
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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
[5]

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.
¶ 59.

Compl.

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 the Court granted the Defendants’ motion for summary
judgment on the issues of defective design and negligent design
and testing.2 

2

The Court’s resolution of the design defect claims on these
grounds obviates the need for a discussion of the preemption
issue, and the Court expresses no opinion thereon. The Supreme
Court, however, has held that some state failure-to-warn claims
are not preempted by federal law, noting that “[the
manufacturer] is charged with both crafting an adequate label
and with ensuring that its warnings remain adequate as long as
the drug is on the market.” Wyeth v. Levine, 555 U.S. 555, 571
(2009). The Supreme Court emphasized that the FDA’s “changes
being effected” regulation, 21 C.F.R. § 314.70(c)(6)(iii), which
permits manufacturers unilaterally to add or strengthen a
warning to improve drug safety, is applicable to “newly acquired
information,” including not only new data, but also “‘new
analyses of previously submitted data.’” Wyeth, 555 U.S. at 569
(quoting Supplemental Applications Proposing Labeling Changes
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C.

Adequacy of the Warning on Pradaxa’s Label

In failure to warn cases, “the plaintiff carries the
initial burden of producing sufficient evidence that the
defendant manufacturer failed to warn of a non-obvious risk
about which the manufacturer knew or should have known.”
Garside v. Osco Drug, Inc., 976 F.2d 77, 81 (1st Cir. 1992)
(applying Massachusetts law).

“A reasonable warning not only

conveys a fair indication of the nature of the dangers involved,
but also warns with the degree of intensity demanded by the
nature of the risk.”

MacDonald v. Ortho Pharmaceutical Corp.,

394 Mass. 131, 141 (1985).
This Court has noted that “it is a jury question whether
[a] warning . . .

[is], in fact, adequate in light of the risks

that the use of [the product] presents.”

Lowery v. AIRCO, Inc.,

725 F. Supp. 82, 85 n.2 (D. Mass. 1989) (citing MacDonald, 394
Mass. at 140); see also Fiorentino v. A. E. Staley Mfg. Co., 11
Mass. App. Ct. 428, 434 (1981).3

Indeed, in MacDonald, the

Supreme Judicial Court noted that generally, “judicial intrusion
into jury decision-making in negligence cases is exceedingly

for Approved Drugs, Biologics, and Medical Devices, 73 Fed. Reg.
49603, 49609 (Aug. 22, 2008)).
3

In Cottam v. CVS Pharmacy, 436 Mass. 316 (2006), the Supreme
Judicial Court grappled with the question of whether there is a
need for expert testimony so that a jury can determine the duty
to warn, implying that a warning’s adequacy is a question for
the jury. Id. at 326.
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rare.”

394 Mass. at 140.

The Defendants, however, refer to a

recent Massachusetts Appeals Court decision, Niedner v. OrthoMcNeil Pharm., Inc., 90 Mass. App. Ct. 306 (2016), evidencing
just such intrusion.

Notice Suppl. Authority Supp. Defs.’ Mot.

Summ. J. 1-2, ECF No. 56.

In Niedner, the court determined that

“plain, numerous[,] and comprehensive” warnings were adequate as
a matter of law when the information was “in terms
understandable to a lay person.”

90 Mass. App. Ct. at 312.

Here, the Lius argue that Pradaxa’s label did not
adequately warn of the risks associated with prescribing the
drug to patients over 80 years of age, such as Dr. Zhensheng
Liu.

Pls.’ Opp’n 8.

The Lius offer the affidavits of Dr.

Molofsky, Aff. Walter J. Molofsky, M.D. (“Dr. Molofsky’s Aff.”),
ECF No. 47, and Dr. Emily Liu, Aff. Emily Liu, M.D. (“Emily
Liu’s Aff.”), ECF No. 48, to support their claim.

Both Dr.

Molofsky and Dr. Emily Liu assert that the Defendants knew of an
increased risk of major bleeding for patients over age 80 taking
Pradaxa, the Defendants did not include this risk in the
product’s warning label, and Dr. Zhensheng Liu would not have
taken or been prescribed Pradaxa if the Defendants had included
the appropriate information in the warning.
¶¶ 11-39; Emily Liu’s Aff. ¶¶ 11-18.

Dr. Molofsky’s Aff.

Unlike in Niedner, where a

label describing the risk in “no less than four places” in
language “understandable to an average user,” was found to be
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adequate as matter of law, evaluating whether Pradaxa’s warning
is “plain, numerous[,] and comprehensive” requires a fact finder
to weigh the evidence.
12.

See Niedner, 90 Mass. App. Ct. at 311-

Therefore, the issues of whether the Defendants’ label is

adequate and how the warning applies to older patients’ use of
Pradaxa present questions of fact.

Nonetheless, the Defendants

argue that this Court ought grant summary judgment on the Lius’
failure to warn claims because of the learned intermediary
doctrine and lack of proximate cause.

The Defendants are nearly

successful; however, the Lius manage to evade summary judgment
on the narrow issue of whether Pradaxa’s label adequately warned
of the risks of taking the drug for patients over 80 years of
age.
1.

Learned Intermediary

In MacDonald, the Supreme Judicial Court recognized the
prescribing physician as a “learned intermediary,” observing
that “a patient’s involvement in decision making concerning use
of a prescription drug necessary to treat a malady is typically
minimal or nonexistent.”

394 Mass. at 137 (noting that healthy

and young consumers of oral contraceptives typically play an
active role in the decision to use the pill and the physician’s
role is rather passive).

The manufacturer of a prescription

drug has the duty to warn the physicians who in turn, “after
considering the history and needs of their patients and the
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qualities of the drug, are required to inform their patients of
those side effects they determine are necessary and relevant for
patients to know in making an informed decision.”

Cottam, 436

Mass. at 321.
The Lius contend that the “learned intermediary” doctrine
is not applicable here because Dr. Zhensheng Liu and Dr. Emily
Liu themselves had the required skills and education to judge
whether Pradaxa would be suitable for his condition.
Opp’n 15.

Pls.’

The Lius, however, do not provide any evidence to

imply their active role in the decision to use Pradaxa.

On the

contrary, Dr. Emily Liu admits to a lack of “experience with
Pradaxa” or in treating atrial fibrillation, as well as a
failure to ask Dr. Bilazarian any questions about Pradaxa or to
review the drug’s label.

Defs.’ Reply, Ex. D, Dep. Emily Liu

6:18-20, 9:14-23, 10:24-11:4, 12:21-13:3, 16:20-23, ECF No. 504.

She further states that Dr. Zhensheng Liu “rel[ied]

exclusively on his prescribing physicians to become familiar
with the risks and benefits of prescription medications.”
at 8:16-9:23.

Id.

Accordingly, the Lius have failed to provide

evidence that the “learned intermediary” doctrine does not apply
here.
2.

Proximate Cause

“‘[G]enerally, questions of causation, proximate and
intervening, present issues for the jury to decide.’”
[10]

Garside,

976 F.2d at 81 (quoting Solimene v. B. Grauel & Co., 399 Mass.
790, 794 (1987)).
Under Massachusetts law, therefore, the burden
shifting in a failure to warn case such as the
instant one works as follows: (1) the plaintiff
carries the initial burden of producing sufficient
evidence that the defendant manufacturer failed to
warn of a non-obvious risk about which the
manufacturer knew or should have known;
(2) assuming the plaintiff raises a triable issue
on this question, a rebuttable presumption arises
that the physician would have heeded an adequate
warning; (3) defendant must then come forward with
sufficient evidence to rebut that presumption; and
(4) once the presumption is rebutted, plaintiff
must produce sufficient evidence to create a
triable issue on the question of causation.
Id. (citations omitted).
The Lius argue that to prove proximate cause they need only
show that, had the warnings been adequate, Dr. Bilazarian would
have changed his prescribing decision.

Pls.’ Opp’n 13-14.

The

Lius further claim that it is presumed that Dr. Bilazarian would
have heeded an appropriate warning.

Id. at 13.

Indeed, in

Cottam, the Supreme Judicial Court held that “Massachusetts law
permits the jury to infer that a warning, if properly given,
would have been followed.”

436 Mass. at 327.

Here, the initial burden is on the Lius to prove causation
by showing that if the proper warning and information had been
provided, Dr. Bilazarian would not have prescribed Pradaxa to a
patient like Dr. Zhensheng.

See Garside, 976 F.2d at 81.

As

discussed above, the Lius produce the affidavits of Dr. Emily
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Liu and Dr. Molofsky which suggest inadequacies in the warnings
by the Defendants.

This raises the rebuttable presumption that,

had Dr. Bilazarian been adequately warned, he would have changed
his decision to prescribe Pradaxa.

See Knowlton v. Deseret

Med., Inc., 930 F.2d 116, 123 (1st Cir. 1991).
This presumption, in turn, shifts the burden of going
forward to the Defendants.

See id.

They carry their burden in

spades, turning to Dr. Bilazarian himself.

During Dr.

Bilazarian’s deposition, the Lius’ counsel made Dr. Bilazarian
aware of a clinical study that concluded: “Dabigatran [Pradaxa’s
chemical name] was associated with a higher incidence of major
bleeding, regardless of the anatomical site.

In addition,

dabigatran was associated with higher risk of gastrointestinal
bleeding, but a lower risk of intracranial hemorrhage than
warfarin.”

Defs.’ Mem., Ex. 2, Dep. Seth Bilazarian, M.D.

37:14-38:9, ECF No. 42-2.

The Lius’ counsel then asked: “So, if

at the time . . . you were aware of this clinical information,
would you have still put [Dr. Zhensheng Liu] on Pradaxa?”
at 38:12-16.

Dr. Bilazarian responded, “Yes.”

Id.

Id. at 38:19.

Counsel then persisted: “[W]ould you not have concluded that
warfarin posed a safer alternative as a blood thinner
anticoagulant for Dr. [Zhensheng] Liu than the Pradaxa that he
was put on by you?”

Id. at 39:16-20.

would not have concluded that.”

Id. at 39:24.

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Dr. Bilazarian stated, “I

Dr. Bilazarian’s responses extinguish the presumption,
W.G. Young, J.R. Pollets & C. Poreda, Massachusetts
Evidence 2d Ed. § 301.1 (3d ed. 2016), in so far as it
pertains to the risk of internal hemorrhaging -- the risk
that caused Dr. Zhensheng Liu’s death.

Absent the

presumption, there is no evidence here that the warnings
were inadequate to advise a physician of the risks of
internal hemorrhaging; further, Dr. Bilazarian, as a
learned intermediary, breaks the chain of proximate
causation as to these Defendants.
The Lius nevertheless escape summary judgment although
their case dangles by a most tenuous thread, viz. that
Pradaxa is especially risky for a patient of Dr. Zhensheng
Liu’s age, that the warning should have so indicated, and
if it had, Dr. Bilazarian would not have prescribed it.
Dr. Molofsky’s Aff. ¶¶ 11-12, 13-15, 16.

The questions put

to him at his deposition do not go this far and, since all
reasonable inferences must be drawn in favor of the nonmovant, the plaintiffs here, Reeves, 530 U.S. at 150, this
case ought proceed to trial.
III. CONCLUSION
For the foregoing reasons, this Court on October 18, 2016,
GRANTED IN PART and DENIED IN PART the Defendants’ motion for
summary judgment, ECF No. 41.

Summary judgment is GRANTED as to
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the claims of negligent design and testing; it is DENIED as to
the adequacy of Pradaxa’s label and proximate cause.
SO ORDERED.
/s/ William G. Young
WILLIAM G. YOUNG
DISTRICT JUDGE

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