UNPUBLISHED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Affirmed by unpublished per curiam opinion.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.
2

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Unpublished opinions are not binding precedent in this circuit.
3

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 
4

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 
5

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
6

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. 
7

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 
8

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.