2009 Decisions

Opinions of the United

States Court of Appeals

for the Third Circuit

7-24-2009

Colleen Grobelny v. Baxter Healthcare

Precedential or Non-Precedential: Non-Precedential

Docket No. 08-3475

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Recommended Citation

"Colleen Grobelny v. Baxter Healthcare" (2009). 2009 Decisions. Paper 952.

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NOT PRECEDENTIAL

UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

___________

No. 08-3475

___________

COLLEEN MARY GROBELNY;

ROBERT GROBELNY,

Appellants

v.

BAXTER HEALTHCARE CORPORATION; THE AMERICAN RED CROSS; DR.

GLENN DUBOV; R.N. NURSE JAYSHE DOE, last name being fictitious; ROBERT

WOOD JOHNSON HOSPITAL; JOHN DOES 1-5, said names being fictitious

____________________________________

On Appeal From the United States District Court

For the District of New Jersey

(D.C. Civ. No. 05-cv-04645)

District Judge: Honorable Peter G. Sheridan

_______________________________________

Submitted Pursuant to Third Circuit LAR 34.1(a)

JULY 22, 2009

Before: RENDELL, FUENTES AND ALDISERT, Circuit Judges

(Opinion Filed: July 24, 2009)

_________

 OPINION

_________

PER CURIAM

Colleen Mary Grobelny and Robert Grobelny, wife and husband, appeal pro se
 There is some question regarding which precise product Colleen received. She first 1

alleged that she was given either Baxter’s Gammagard S/D or the Red Cross’s Polygam

S/D. She later claimed to have identified the lot number of the IGIV treatment as

containing Polygam, but defendants claim that that lot was not cleared for release until the

month after she received the treatment. In any event, the warnings for both Gammagard

and Polygam are contained in the record and the operative language of each is identical. 

The defendants and the District Court thus assumed that Colleen received Polygam as

plaintiffs assert, and so will we. 

2

from the District Court’s entry of summary judgment in favor of Baxter Healthcare

Corporation (“Baxter”) and The American Red Cross (the “Red Cross”). For the

following reasons, we will affirm.

I.

The Grobelnys were represented by counsel at all relevant times prior to this

appeal. In 2005, they filed a complaint in the New Jersey Superior Court for Middlesex

County, alleging that Colleen suffered severe adverse reactions to intravenous

immunoglobulin (“IGIV”) treatments administered on February 7 and 8, 2002. Her

treating physician, Dr. Bruno Fang, prescribed those treatments in preparation for the

removal of her spleen, which Dr. Fang recommended to combat a bleeding disorder called

Idiopathic Thrombocytopenic Purpura (“ITP”). The treatments caused her to suffer

multiple “thrombotic events”—i.e., the formation of blood clots in a blood vessel, artery

or vein. Those events resulted, inter alia, in the permanent reduction of her left kidney

function and a pulmonary embolism. 

Among the defendants named in the complaint were Baxter and the Red Cross,

which allegedly manufactured and distributed the IVIG treatment at issue, and Dr. Fang. 

1
 Defendants renew this argument on appeal. In light of our disposition, we need not 2

reach it.

3

Plaintiffs alleged that Baxter and the Red Cross failed to adequately warn of the IVIG

treatment’s potential adverse reactions and that Dr. Fang committed malpractice in

various respects. The state court dismissed the claims against Dr. Fang for

noncompliance with New Jersey’s affidavit of merit requirement, N.J.S.A. 2A:53A-27,

and two other defendant physicians were dismissed in state court as well. The Red Cross,

after later being served with the complaint, timely removed the suit to federal court under

28 U.S.C. §§ 1441 and 1446 pursuant to the terms of its federal charter. See 36 U.S.C. §

300105(a)(5) (formerly 36 U.S.C. § 2); American Nat’l Red Cross v. S.G., 505 U.S. 247,

257 (1992); Doe v. American Red Cross, 14 F.3d 196, 197-98 (3d Cir. 1993). Thereafter,

plaintiffs voluntarily dismissed their claims against all remaining defendants except

Baxter and the Red Cross. 

Baxter and the Red Cross filed a motion for summary judgment, arguing that the

warnings they issued had been approved by the Food and Drug Administration, that such

warnings were thus presumed adequate under New Jersey law, see N.J.S.A. 2A:58C-4,

and that plaintiffs had failed to present evidence sufficient to rebut that presumption.2

Plaintiffs opposed the motion, and to their response attached the report of their expert, Dr.

John N.D. Wurpel, who opined that the IVIG treatment caused Colleen’s injuries but

offered no opinion on the adequacy of the warnings. The District Court denied

defendants’ motion by order entered August 12, 2007, after finding, in an oral opinion
 The operative order is docketed at Docket No. 55 and states that it supercedes the 3

order dated May 22, 2008, and docketed at Docket No. 54.

4

rendered on Aust 3, 2007, that defendants had presented no proof that the warnings had

been approved by the FDA.

Defendants moved for reconsideration, arguing that plaintiffs were required to

support their inadequate warning claim with expert testimony but that Dr. Wurpel had

offered no opinion on that issue. By order entered April 7, 2008, the District Court

concluded that expert testimony was indeed required to show that the warnings were

inadequate. The District Court also construed defendants’ motion for reconsideration as

“more akin” to a motion in limine and scheduled a Daubert hearing, see Daubert v.

Merrell Dow Pharms., Inc., 509 U.S. 579 (1993), at which it directed plaintiffs to proffer

Dr. Wurpel’s testimony.

The hearing was conducted on May 15, 2008, and the District Court entered an

opinion and order on May 23, 2008. The District Court ruled once again that expert 3

testimony was required to demonstrate the inadequacy of the warnings. The District

Court further ruled that Dr. Wurpel was qualified to testify that the IVIG treatment caused

Colleen’s injuries and to “explain technical aspects” of the warnings, such as defining the

relevant terms, but not to offer an opinion on their overall adequacy. The District Court

concluded, however, that plaintiffs could meet their burden of proof with Dr. Wurpel’s

testimony in conjunction with the expected factual testimony of Dr. Fang (the treating

physician, whom the state court had dismissed as a defendant) regarding his
 The transcript of the argument and the District Court’s oral ruling erroneously refers to 4

Dr. Fang as “Dr. Frank” throughout.

5

understanding of the warnings. (The District Court wrote that plaintiffs’ counsel had

made certain representations to it about Dr. Fang’s expected testimony. Those

representations do not appear of record, and defendants state that they were “not privy” to

them.)

Thereafter, the parties deposed Dr. Fang. Defendants then renewed their motion

for summary judgment, arguing that Dr. Fang’s testimony demonstrates that the warnings

were adequate and that plaintiffs had presented no evidence to the contrary. Defendants

filed their motion on July 16, 2008, requesting that the District Court hear argument on

July 18, 2008 (three days before the case was scheduled for trial). Plaintiffs’ counsel did

not file a brief in opposition or submit any additional documents to the District Court, but

he did not object to this procedure and the parties presented oral argument on July 18. 

The District Court granted defendants’ motion from the bench that same day. Plaintiffs 4

appeal.

II.

We have jurisdiction under 28 U.S.C. § 1291. “Our review of the District Court’s

decision is plenary, and we apply the same standard as the District Court to determine

whether summary judgment was appropriate. A grant of summary judgment is

appropriate ‘if the pleadings, the discovery and disclosure materials on file, and any

affidavits show that there is no genuine issue as to any material fact and that the movant
6

is entitled to judgment as a matter of law.’” State Auto Prop. & Cas. Ins. Co. v. Pro

Design, P.C., 566 F.3d 86, 89 (3d Cir. 2009) (quoting Fed. R. Civ. P. 56(c)) (internal

citation omitted). In response to a properly-supported motion for summary judgment,

“the non-moving party must point to some evidence in the record that creates a genuine

issue of material fact” and “must rebut the motion with facts in the record and cannot rest

solely on assertions made in the pleadings, legal memoranda, or oral argument.” 

Berckeley Inv. Group, Ltd. v. Colkitt, 455 F.3d 195, 201 (3d Cir. 2006) (citations

omitted). Our plenary review is necessarily limited to the record that was before the

District Court. See Caver v. City of Trenton, 420 F.3d 243, 257 (3d Cir. 2005); Fassett v.

Delta Kappa Epsilon (New York), 807 F.2d 1150, 1165 (3d Cir. 1986). We review the

District Court’s rulings regarding the admissibility of expert testimony for abuse of

discretion. See Pineda v. Ford Motor Co., 520 F.3d 237, 243 (3d Cir. 2008).

The parties and the District Court assumed that this case is governed by the

substantive law of New Jersey, where the Grobelnys reside and Colleen received the

treatments at issue, and we see no basis to question that assumption. “[T]he New Jersey

Product Liability Act . . . is ‘the sole basis of relief under New Jersey law available to

consumers injured by a defective product.’” Port Auth. of N.Y. & N.J. v. Arcadian Corp.,

189 F.3d 305, 313 (3d Cir. 1999) (citations omitted). The Act provides in relevant part: 

[T]he manufacturer or seller shall not be liable for harm caused by a failure

to warn if the product contains an adequate warning. . . . An adequate

product warning or instruction is one that a reasonably prudent person in the

same or similar circumstances would have provided with respect to the
 The New Jersey Supreme Court has held that this doctrine does not apply to 5

pharmaceutical products that manufacturers market directly to consumers, see Perez v.

Wyeth Labs. Inc., 734 A.2d 1245, 1257 (N.J. 1999), but there has been no suggestion that

the IVIG product at issue here qualifies for that exception.

7

danger and that communicates adequate information on the dangers and

safe use of the product, . . . in the case of prescription drugs, taking into

account the characteristics of, and the ordinary knowledge common to, the

prescribing physician. 

N.J.S.A. 2A:58-C-4. This provision codifies the “learned intermediary” doctrine, under

which “a pharmaceutical manufacturer generally discharges its duty to warn the ultimate

user of prescription drugs by supplying physicians with information about the drug’s

dangerous propensities.” Niemiera v. Schneider, 555 A.2d 1112, 1117 (N.J. 1989).5

Accordingly, the crucial question is whether the warning was adequate to apprise a

physician, not a consumer, of the risks. See id. 

We agree that plaintiffs failed to present the District Court with evidence on that

question sufficient to raise a genuine issue for trial. The warnings at issue, contained in a

package insert, read in relevant part:

Precautions

General

There is clinical evidence of a possible association between Immune

Globulin Intravenous (Human) (IVIG) administration and thrombotic events. 

The exact cause of this is unknown; therefore, caution should be exercised in

the prescribing and infusion of IVIG in patients with a history of

cardiovascular disease or thrombotic episodes.

***

Adverse Reactions
8

***

In general, reported adverse reactions to . . . Polygam ®, in patients with

either congenital or acquired immunodeficiencies are similar in kind and

frequency. Various minor reactions, such as headache, fatigue, chills,

backache, leg cramps, lightheadedness, fever, urticaria, flushing, slight

elevation of blood pressure, nausea and vomiting may occasionally occur.

***

Idiopathic Thrombocytopenic Purpura (ITP)

During the clinical study of Polygam ® for the treatment of [ITP], the only

adverse reaction reported was headache which occurred in 12 out of 16

patients (75%).

(Defs.’ Mot. for Summ. J., Richard I. Schiff, M.D., Ph.D. Declaration, Ex. 1 at 6-7.)

Plaintiffs argue that these warnings are insufficient because they (1) limit the risk

of thrombotic events to patients “with a history of cardiovascular disease or thrombotic

episodes,” neither of which Colleen had, and (2) convey the impression that the only

potential adverse reactions are mild ones such as headaches, which was the only reported

reaction for those, like Colleen, with ITP. The question, however, is not how an ordinary

consumer might have read these warnings, but how a prescribing physician would read

them, “taking into account the characteristics of, and the ordinary knowledge common to,

the prescribing physician.” N.J.S.A. 2A:58-C-4. The District Court properly concluded

that evidence in addition to the warnings themselves was necessary to answer that

question. The District Court concluded that plaintiffs could meet their burden with (1)

the expert testimony of Dr. Wurpel regarding the meaning of terms contained in the

warnings (though not their adequacy), and (2) the testimony of Dr. Fang, apparently as a

fact witness, regarding his understanding of the warnings. On appeal, plaintiffs challenge
 Dr. Wurpel’s report offers no opinion on the adequacy of the warnings. Plaintiffs 6

quote a portion of Dr. Wurpel’s deposition testimony, in which he later opined that “I

don’t believe that these warnings . . . would be sufficient to adequately alert the physician

that thrombotic events and renal events were highly likely.” That portion of Dr. Wurpel’s

deposition is not contained in the record, but he testified to the same effect during the

Daubert hearing. (May 15, 2009 Trans. at 23.) He also testified, however, that

pharmaceutical warnings were not within his expertise, that he has no experience with the

FDA or applicable regulations, and that he is not a clinician and has never prescribed

medication. (Id. at 27-33.) Moreover, he “waffled” (as the District Court characterized

it) on his opinion of the warnings’ adequacy, and his final words on the subject were that

“it’s difficult to make an opinion.” (Id. at 51.) For those reasons, the District Court did

not abuse its discretion in precluding Dr. Wurpel from testifying to the adequacy of the

warnings. Cf. Pineda, 520 F.3d at 254 & n.12 (holding that District Court abused its

discretion in preventing engineer from testifying to the necessity of a warning where no

warning was given, but opining that if plaintiff’s claim was “that an existing warning or

instruction was ineffective, misleading, or otherwise defective, a true ‘warnings’ expert

might be required”).

9

neither the District Court’s ruling that expert testimony was required nor its preclusion of

Dr. Wurpel from testifying as to the adequacy of the warnings, and we perceive no error

in those rulings.6

Those rulings left Dr. Fang’s still-unreceived testimony as the only evidence

potentially relevant to the adequacy of the warnings. Plaintiffs’ counsel apparently

represented to the District Court that Dr. Fang would testify that he believed the warnings

were inadequate. Dr. Fang, however, did not testify to that effect at his deposition.

Instead, he testified that, before he prescribed IVIG treatment for Colleen, he had read the

warnings and knew, both from the warnings and from other medical sources, that there

was an association between IVIG treatment and thrombotic events. (Defs.’ Renewed

Mot. for Summ. J., Ex. 1 at 15:18-16:9, 17:5-9, 55:21-56:2, 75:6-12.) He further testified
 The record contains only those portions of the transcript of Dr. Fang’s deposition 7

testimony that defendants filed with their renewed motion for summary judgment. 

Plaintiffs did not file any other portions of the transcript with the District Court, and did

not argue that any other portion of Dr. Fang’s testimony supported their case.

10

that, contrary to plaintiffs’ argument, he did not understand the warnings to limit that risk

to patients with a history of cardiovascular disease or thrombotic episodes, but read them

instead to state that the risk was present for all patients, “with or without” that history. 

(Id. at 113:8-114:7.) Finally, he testified that he prescribed IVIG treatment

notwithstanding the risk of thrombotic events because Colleen had responded positively

to the treatment in the past and he believed the risks of treatment were outweighed by the

benefits. (Id. at 53:1-54:18, 55:21-56:11, 125:17-126:5.)7

In sum, there is no testimony from Dr. Fang in the record that the warnings at issue

were inadequate in any way, and the only reasonable inference from his testimony is to

the contrary. Plaintiffs came forward with no evidence that might have undermined that

testimony, and it raises no issue regarding Dr. Fang’s credibility on its face. See

Waskovich v. Morgano, 2 F.3d 1292, 1296 (3d Cir. 1993) (facts testified to in

“‘deposition testimony . . . if there is no contradictory evidence . . . may be accepted as

true for summary judgment purposes without an assessment of the credibility of the

witness’”) (citation omitted). We agree that, in light of Dr. Fang’s testimony, and

plaintiffs’ failure to present any other evidence regarding the adequacy of the warnings,

defendants were entitled to summary judgment.

Plaintiffs raise three arguments on appeal. First, plaintiffs assert that Dr. Fang
 For that reason, defendants’ motion to strike portions of plaintiffs’ appellate appendix, 8

including Dr. Fang’s office note and other documents presented for the first time on

appeal, is granted. Plaintiffs’ motion to expand the record on appeal is denied.

11

initially believed that Colleen’s adverse reaction was caused by a kidney stone. They

further assert that Colleen then presented him with an FDA warning regarding the link

between IVIG and “clot-related problems,” and that Dr. Fang said the information was

“very interesting” and that he previously had not been aware of it. On appeal, plaintiffs

have presented Dr. Fang’s July 17, 2002 note of the office visit memorializing that

exchange. Plaintiffs also purport to quote in their reply brief from a portion of Dr. Fang’s

deposition, at which he apparently acknowledged the contents of that note. Plaintiffs,

however, submitted neither Dr. Fang’s office note nor that portion of his deposition to the

District Court. Plaintiffs nevertheless argue that Dr. Fang’s note and other documents are

part of the record, apparently because they were produced during discovery or marked as

exhibits at depositions. Because none of the parties filed these documents with the

District Court, however, they are not included in the record on appeal. See Fed. R. App.

P. 10(a). Thus, we may not consider them. See, e.g., Fassett, 807 F.2d at 1165. In 8

addition, plaintiffs did not raise these arguments in the District Court, so they are waived

on appeal. See In re Stone & Webster, Inc., 558 F.3d 234, 241 n.8 (3d Cir. 2009).

Second, plaintiffs rely on McNeil v. Wyeth, 462 F.3d 364 (5th Cir. 2007), in which

the court reversed the entry of summary judgment after a district court found a

pharmaceutical warning label adequate as a matter of law. In that case, however, the
12

treating physician gave conflicting testimony about whether he would have prescribed the

drug at issue if the pharmaceutical defendant had given him the warnings that the plaintiff

claimed it should have given. See id. at 372. The record contains no such conflicting

testimony by Dr. Fang here. The legal context is also distinct. In McNeil, the plaintiff

presented substantial evidence on the issue of whether the warnings were adequate, and

the treating physician’s testimony did not relate to that issue. Instead, it related to the

issue of causation—i.e., whether the physician would have prescribed the medication if

he had been given an adequate warning. In this case, the District Court did not reach that

issue, and we need not do so, because plaintiffs failed to present sufficient evidence that

the warning was inadequate in the first place.

Finally, plaintiffs devote much of their briefs to arguing that Dr. Fang’s decision to

prescribe IVIG treatment was unreasonable. Dr. Fang, however, was dismissed as a party

before this suit was removed to federal court and that dismissal is not before us for

review. Those arguments are not relevant to any issue on appeal, and we express no

opinion on them.

Accordingly, the judgment of the District Court will be affirmed.