JAMES MACK, Individually v. Amerisourcebergen Drug Corporation, d/b/a Amerisource Bergen

UNPUBLISHED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Affirmed by unpublished per curiam opinion. Judge Gregory wrote
a separate concurring opinion.

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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Unpublished opinions are not binding precedent in this circuit.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. Remicade is typically prescribed, as it was
in Crystal’s case, to treat Crohn’s disease. The medical
examiner, following an autopsy, opined that Crystal died from an
intestinal hemorrhage attributable to her underlying disease,
exacerbated by her diabetes. The Macks contend that Crystal
instead succumbed to cardiac arrhythmia 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
law. See Phipps v. General Motors Corp., 363 A.2d 955, 959 (Md.
1976). The court also concluded that the Macks had failed to
identify 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

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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 in the opinion, however I write separately to
express a more fulsome perspective on the standard of proof
surrounding this tragic case. It bears restating that we need
not reach the issue of causation – namely, whether Remicade
caused Mack’s death – since there is evidence in the record that
could arguably survive summary judgment on such a standard.
See, e.g., S.A. 243, 284-85 (Mack suffered a 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: (1) the existence of a defect; (2) the
attribution of the defect to the seller; and (3) a causal
relation between the defect and the injury. 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 noted significant improvement after
taking the drug. Furthermore, Remicade was initially approved
for the 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, ankylosing spondylitis, psoriatic arthritis,
ulcerative colitis, and plaque psoriasis, among 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.*
* 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.
Accordingly, I
concur in the opinion.

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