                               UNPUBLISHED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Affirmed by unpublished per curiam opinion.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.
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Unpublished opinions are not binding precedent in this circuit.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




                                         7
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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