James Mack v. Amerisourcebergen Drug Corp.

Filing

UNPUBLISHED PER CURIAM OPINION filed. Originating case number: 1:08-cv-00688-RDB Copies to all parties and the district court/agency. [998575715].. [10-1019]

Appeal: 10-1019

Document: 52

Date Filed: 04/26/2011

Page: 1 of 8

UNPUBLISHED
UNITED STATES COURT OF APPEALS
FOR THE FOURTH CIRCUIT

No. 10-1019

JAMES MACK, Individually, and as Surviving Parent and
Personal Representative of the Estate of Crystal Ann Mack;
SYLVIA MACK, Surviving Parent of Crystal Ann Mack,
Plaintiffs – Appellants,
v.
AMERISOURCEBERGEN
DRUG
CORPORATION,
d/b/a
Amerisource
Bergen; JOHNSON & JOHNSON; CENTOCOR, INCORPORATED,
Defendants – Appellees,
and
LISA S. PICHNEY, MD; LISA S. PICHNEY, MD PA; ST. JOSEPH’S
MEDICAL CENTER, INCORPORATED; REBECCA EVE MANCOLL; GREATER
BALTIMORE MEDICAL CENTER,
Defendants.

Appeal from the United States District Court for the District of
Maryland, at Baltimore.
Richard D. Bennett, District Judge.
(1:08-cv-00688-RDB)

Argued:

January 26, 2011

Decided:

April 26, 2011

Before MOTZ, KING, and GREGORY, Circuit Judges.

Affirmed by unpublished per curiam opinion.
a separate concurring opinion.

Judge Gregory wrote

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ARGUED: Governor Jackson, III, LAW OFFICE OF GOVERNOR E.
JACKSON, III, LLC, Baltimore, Maryland; Donald Ray Huskey, LAW
OFFICE OF DONALD R. HUSKEY, Baltimore, Maryland, for Appellants.
John Winter, PATTERSON, BELKNAP, WEBB & TYLER, New York, New
York, for Appellees.
ON BRIEF: William H. Robinson, Jr.,
LECLAIR RYAN, PC, Alexandria, Virginia, for Appellees.

Unpublished opinions are not binding precedent in this circuit.

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PER CURIAM:
In this products liability action filed in state court but
removed

to

the

District

of

Maryland

pursuant

to

28

U.S.C.

§ 1441(a), removal being based on the diversity of citizenship
of the opposing parties, see 28 U.S.C. § 1332(a)(1), Plaintiffs
James and Sylvia Mack, as surviving parents of Crystal Ann Mack,
and Mr. Mack in his capacity as personal representative of his
daughter’s estate, appeal the district court’s award of summary
judgment

to

Defendants

AmerisourceBergen

Drug

Corporation

and

Johnson & Johnson, along with the latter’s subsidiary, Centocor,
Inc.

The

appeal

also

encompasses

the

court’s

interlocutory

rulings denying the Macks’ motion to remand and excluding from
consideration the expert testimony of one of their witnesses as
the result of an evidentiary assessment prompted by the Supreme
Court’s decision in Daubert v. Merrell Dow Pharm., Inc., 509
U.S. 579 (1993).
The Macks allege that their daughter’s death was caused by
Remicade, a drug manufactured by Centocor and distributed by
AmerisourceBergen.
in

Crystal’s

Remicade is typically prescribed, as it was

case,

to

treat

Crohn’s

disease.

The

medical

examiner, following an autopsy, opined that Crystal died from an
intestinal

hemorrhage

attributable

exacerbated by her diabetes.
instead

succumbed

to

to

her

underlying

disease,

The Macks contend that Crystal

cardiac

arrhythmia
3

stemming

from

her

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treatment regimen, and that the Defendants misrepresented the
safety and efficacy of Remicade.
The district court, however, declined to reach the question
of causation, ruling that the Macks had not adduced sufficient
evidence at the summary judgment stage to support a threshold
showing

that

Remicade

was

defective

in

its

design

or

manufacture, such that a reasonable juror could determine that
the drug was “unreasonably dangerous” as defined by Maryland
See Phipps v. General Motors Corp., 363 A.2d 955, 959 (Md.

law.
1976).

identify

The court also concluded that the Macks had failed to
any

actionable

misrepresentation

or

to

demonstrate

their detrimental reliance thereon.
Having considered the parties’ written submissions and the
arguments of counsel, we now affirm the judgment of the district
court for the reasons it stated from the bench and set forth in
its

written

opinions

and

orders.

See

Transcript

of

Motions

Hearing at 69-88, Mack v. AmerisourceBergen Drug Corp. (D. Md.
Aug. 20, 2009) (No. 1:08-cv-00688) (granting Defendants’ motion
in limine to exclude testimony of James T. O’Donnell); Mack v.
AmerisourceBergen Drug Corp., No. 1:08-cv-00688, Letter Order at
1 (D. Md. Aug. 25, 2009) (memorializing oral rulings of August
20, 2009 hearing); Mack v. AmerisourceBergen Drug Corp., No.
1:08-cv-00688,

Memorandum

Order

at

4

(D.

Md.

Aug.

25,

2009)

(denying Macks’ motion for remand to Circuit Court for Baltimore
4

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City); Mack v. AmerisourceBergen Drug Corp., No. 1:08-cv-00688,
Memorandum

Opinion

at

6-12

(D.

Md.

Nov.

24,

2009)

(granting

Defendants’ motion for summary judgment as to products liability
and misrepresentation claims).
AFFIRMED

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GREGORY, Circuit Judge, concurring:
I

concur

express

a

in

more

the

opinion,

fulsome

however

perspective

surrounding this tragic case.
not

reach

the

issue

of

I

on

write

the

separately

standard

of

to

proof

It bears restating that we need

causation

–

namely,

whether

Remicade

caused Mack’s death – since there is evidence in the record that
could

arguably

See,

e.g.,

survive

S.A.

243,

summary

judgment

284-85

(Mack

on

such

suffered

a

a

standard.

ventricular

fibrillation arrhythmia immediately prior to her death); S.A.
271, 287, 291 (testimony of Dr. Marks that the death was more
likely the result of an arrhythmia than Crohn’s disease); S.A.
214-15

(testimony

of

Dr.

Marks

that

there

is

a

correlation

between Remicade and arrhythmias).
Rather, the key issue is whether, as a threshold matter,
Remicade is an unreasonably dangerous drug under Maryland law.
Because the plaintiffs failed to prove that the drug’s risks
outweigh its benefits, the district court’s holding that the
drug is not unreasonably dangerous was supported by the record,
even

assuming

that

Remicade

caused

Mack’s

fatal

arrhythmia.

Under Maryland law, to prevail on a products liability claim the
plaintiff’s must show:
attribution

of

the

(1) the existence of a defect; (2) the

defect

to

the

seller;

relation between the defect and the injury.

and

(3)

a

causal

Jensen v. American

Motors Corp., 50 Md. App. 226, 234 (1981); see also Banks v.
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Iron Hustler Corp., 59 Md. App. 408 (1984) (adopting § 402A of
the Restatement (Second) of Torts).
Here, the plaintiffs have not met their burden to show that
Remicade was defective.

The cited study — which the defendants

criticize as studying patients with arthritis, not Crohn’s —
does not call into question the efficacy of the drug as a whole.
Mack

herself

initially

taking the drug.
for

the

noted

significant

improvement

after

Furthermore, Remicade was initially approved

treatment

of

Crohn’s

disease

back

in

1998

and

has

subsequently been approved by the FDA for use in alleviating the
symptoms of a variety of other conditions, including rheumatoid
arthritis,
ulcerative

ankylosing
colitis,

and

spondylitis,
plaque

psoriatic

psoriasis,

among

arthritis,
others.

In

total, Remicade has undergone evaluation by the FDA fourteen
times and has been found to be a safe and effective treatment
whose benefits outweigh its risks.

The plaintiffs conceded at

the hearing for summary judgment that Dr. Marks would not view
the drug as unreasonably dangerous since he has supervised its
administration to other patients.

J.A. 272.

There are many

drugs that are high risk – a quintessential example would be

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chemotherapy – yet ultimately may be justified. *

Accordingly, I

concur in the opinion.

*

The plaintiffs have not brought a failure to warn case
against the manufacturer.
The drug contained a statement that
it should not be used unless conventional therapy has failed. I
take no position on whether Remicade was properly prescribed to
treat Mack.

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