SCHORK v. BAXTER HEALTHCARE CORPORATION

Filing 76

ENTRY ON BAXTER HEALTHCARE CORPORATION'S MOTION FOR SUMMARY JUDGMENT - 36 Motion for Summary Judgment is GRANTED. See Entry for details. Signed by Judge Richard L. Young on 9/22/2011. (LBT)

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF INDIANA
NEW ALBANY DIVISION

DEBBIE S. SCHORK,
Plaintiff,
vs.
BAXTER HEALTHCARE CORPORATION,
Defendant.

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4:10-cv-00005-RLY-WGH

ENTRY ON BAXTER HEALTHCARE CORPORATION’S MOTION FOR
SUMMARY JUDGMENT
Defendant, Baxter Healthcare Corporation (“Baxter”), manufactures and sells
promethazine HCL, a generic version of Phenergan. Plaintiff, Debbie S. Schork
(“Plaintiff”), was administered a promethazine HCL injection, allegedly manufactured by
Baxter, through an IV that was placed in her artery as opposed to her vein. As a result,
Plaintiff suffered injuries that ultimately required a partial amputation of her right arm.
Plaintiff brought this lawsuit, alleging that her injuries were a direct result of the defective
and unreasonably dangerous condition of the promethazine HCL injection administered to
her and Baxter’s negligence in the manufacture and sale of its promethazine HCL
product. Baxter moves for summary judgment as to Plaintiff’s claims. For the reasons
set forth below, the court GRANTS Baxter’s motion.
I.

Facts

1.

Baxter manufactures a promethazine HCL injection, a generic product for which
the reference drug is Phenergan. (Baxter’s Ex. C, Declaration of John Kalis
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(“Kalis Decl.”) at ¶ 3).
2.

As of December 28, 2007, promethazine HCL injections were manufactured by
several other companies, including, inter alia, Hospira, Bioniche (now Mylan),
Sicor (now Teva), and Watson. (Id. at ¶ 5).

3.

On December 28, 2007, Plaintiff went to the emergency room at St. Catherine
Regional Hospital (“St. Catherine”) in Charleston, Indiana, with symptoms of
vomiting, pain in her stomach, and dehydration related to her history of Crohn’s
disease. (Plaintiff’s Ex. 1, Deposition of Debbie S. Schork (“Plaintiff Dep.”) at
22:10-17; 42:19-43:7; 44:7-10).

4.

Dr. Sesame Dijeng was assigned to Plaintiff in the emergency room on the night of
December 28, 2007, and ordered her to be treated with IV fluids, as well as IV
administered Morphine, Phenergan, and Solumedrol. (Plaintiff’s Ex. 2, Deposition
of Dr. Sesame Dijeng (“Dr. Dijeng Dep.”) at 32:7-25; 33:20-25).

5.

Tammy Wynn (“Nurse Wynn”), a nurse at St. Catherine, triaged Plaintiff and
started her IV, inserting it into the antecubital space of her right arm. (Plaintiff’s
Ex. 3, Deposition of Tammy Wynn (“Wynn Dep.”) at 44:1-22).

6.

Nurse Wynn then administered 12.5 milligrams of promethazine HCL as
prescribed by Dr. Dijeng via IV push to Plaintiff. (Id. at 32:16-20; Dr. Dijeng
Dep. at 55:15-19).

7.

Plaintiff complained of pain in her arm at the time of the promethazine HCL
injection. (Baxter’s Ex. A (Deposition of Plaintiff (“Baxter’s Plaintiff Dep.”) at
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52:4-24).
8.

After returning from the x-ray department, Plaintiff told her fiancé how much her
arm was hurting, and her fiancé went to get Dr. Dijeng. (Baxter’s Plaintiff Dep. at
54:20-55:6).

9.

Dr. Dijeng examined Plaintiff’s arm and concluded that the IV was put in
Plaintiff’s artery rather than her vein. (Baxter’s Ex. B, Deposition of Dr. Sesame
Dijeng (“Baxter’s Dr. Dijeng Dep.”) at 37:11-25).

10.

Dr. Dijeng suspected vascular injury to Plaintiff’s artery and ordered that Plaintiff
be transferred to the University of Louisville where there would be access to a
vascular surgeon. (Baxter’s Dr. Dijeng Dep. at 42:11-18).

11.

The doctors at the University of Louisville were unable to salvage Plaintiff’s right
arm, which ultimately was amputated just below the elbow. (Plaintiff Dep. at
65:18-68:25).

12.

Nurse Wynn and Dr. Dijeng do not know the identity of the manufacturer of the
promethazine HCL injection administered to Plaintiff on December 28, 2007.
(Baxter’s Ex. E, Deposition of Tammy Wynn (“Baxter’s Wynn Dep.”) at 6:6-8;
Baxter’s Dr. Dijeng Dep. at 12:1-4).

13.

William Pate (“Mr. Pate”) is currently the Director of Pharmacy at St. Catherine,
but did not hold that position on December 28, 2007. (Plaintiff’s Ex. 5, Deposition
of William Pate (“Pate Dep.”) at 7:13-8:11). He also does not know the identity of
the manufacturer of the promethazine HCL injection administered to Plaintiff on
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December 28, 2007. (Baxter’s Ex. D, Deposition of William Pate (“Baxter’s Pate
Dep.”) at 18:1-8).
14.

The charge code for the promethazine HCL injection that appears on Plaintiff’s
invoice of charges for her treatment at St. Catherine on December 28, 2007,
represents the corresponding NDC code as of December 20, 2010, for Baxter
Pharmaceuticals’ promethazine HCL 25 milligram per mil ampule box of 25
injections. (Baxter’s Ex. G, Deposition of William Pate (Vol. I) (“Pate Dep. Vol.
1”) at 31:14-32:13; Baxter’s Ex. H, Deposition of William Pate (Vol. II) (“Pate
Dep. Vol. 2”) at 47:4-48:15, p. 15).

15.

While Mr. Pate has no evidence that the corresponding NDC code for the charge
code that appeared on Plaintiff’s invoice changed from the time Plaintiff was
treated and December 20, 2010, he does not know with absolute certainty that the
codes were the same at the time Plaintiff was treated. (Pate Dep. Vol. II at 49:1621; 52:18-23).

16.

Mr. Pate says “there would be some speculation involved in” whether the NDC
code and charge code in December 2010 match the NDC code and charge code in
December 2007. (Pate Dep. Vol. II at 54:3-16).

17.

As of February 9, 2011, St. Catherine used two manufacturers of promethazine
HCL injections, Westward and Baxter; however, Mr. Pate does not know how
many manufacturers St. Catherine used in 2007. (Id. at 58:7-24).

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II.

Motion for Summary Judgment Standard
Summary judgment is appropriate if the moving party “shows that there is no

genuine dispute as to any material fact and the movant is entitled to judgment as a matter
of law.” FED. R. CIV. P. 56(a). When ruling on a motion for summary judgment, the
court must “view the record in the light most favorable to the non-moving party and draw
all reasonable inferences in that party’s favor.” Zerante v. DeLuca, 555 F.3d 582, 584
(7th Cir. 2009). Even so, the court’s favor toward the non-moving party “does not extend
to drawing inferences that are supported by only speculation or conjecture.” Singer v.
Raemisch, 593 F.3d 529, 533 (7th Cir. 2010) (internal quotations omitted).
III.

Discussion
Plaintiff alleges that Baxter manufactured the promethazine HCL injection that

was administered to Plaintiff on December 28, 2007, at St. Catherine, and that Baxter did
not adequately warn the prescribing physician of the risks associated with IV
administration of the product. According to Plaintiff, Baxter’s failure to adequately warn
of the risks of such administration caused Plaintiff’s injury. Baxter first contends that
Plaintiff cannot prove the threshold requirement that Baxter manufactured the
promethazine HCL injection that Plaintiff received. Furthermore, Baxter contends that
even if it did manufacture the injection in question, Plaintiff’s claims are preempted by
federal law.
Although an issue of fact exists regarding the manufacturer of the injury-causing
product, even assuming Baxter is the manufacturer, the court agrees with Baxter that
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Plaintiff’s claims are preempted by federal law. In a products liability action based on
negligence, “the plaintiff must identify the manufacturer of the product . . . .” Tragarz v.
Keene Corp. 980 F.2d 411, 418 (7th Cir. 1992). While no one who was present at the
time of the injection recalls the manufacturer, including Nurse Wynn and Dr. Dijeng, in
2010 the charge code for Plaintiff’s injection matches the NDC code for Baxter. (See
supra ¶¶ 12-14). On the other hand, Mr. Pate cannot say with one hundred percent
certainty that the charge code as it existed in 2010 is the same as the charge code for
Baxter at the time of Plaintiff’s treatment in 2007. (See supra ¶¶ 15-16). Accordingly,
Plaintiff has raised a triable issue concerning Baxter’s status as the manufacturer of the
promethazine HCL injection administered to Plaintiff at St. Catherine on December 28,
2007.
Unfortunately for Plaintiff, even if a trier of fact found that Baxter manufactured
the injection given to Plaintiff, her claims are preempted by federal law. At the time this
Motion for Summary Judgment was briefed, the United States Supreme Court had ruled
in Wyeth v. Levine that state law claims against manufacturers of brand name drugs for
failure to warn are not preempted by federal law. 555 U.S. 555, 129 S.Ct. 1187, 1200,
1204 (2009). The question of whether this holding extended to similar claims against
manufacturers of generic drugs until recently remained unanswered. In June, the
Supreme Court held in PLIVA, Inc. v. Mensing that its holding in Wyeth did not extend to
manufacturers of generic drugs. 131 S.Ct. 2567, 2577-78 (2011). In other words, the
Court found that state law claims against manufacturers of generic drugs for failure to
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warn are preempted by federal law. See id. Accordingly, assuming Baxter manufactured
the injection given to Plaintiff on December 28, 2007, Plaintiff’s claims against Baxter
are preempted.
IV.

Conclusion
For the reasons set forth above, Baxter’s Motion for Summary Judgment (Docket #

36) is GRANTED.

SO ORDERED this 22nd day of September 2011.

__________________________________

RICHARD L. YOUNG, CHIEF JUDGE
RICHARD L. YOUNG, CHIEF JUDGE
United States District Court
United District of Indiana
SouthernStates District Court
Southern District of Indiana

Electronic Copies to:

Erin A. Clancy
KIGHTLINGER & GRAY
[e-mail]
Donald Reid Forrest
[e-mail]
C. Meade Hartfield
BAKER, DONELSON, BEARMAN, CALDWELL & BERKOWITZ, PC
[e-mail]
Jennifer Marie Herrmann
KIGHTLINGER & GRAY
[e-mail]
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J. Todd Spurgeon
KIGHTLINGER & GRAY, LLP
[e-mail]
J. Carter Thompson Jr.
BAKER, DONELSON, BEARMAN, CALDWELL & BERKOWITZ, PC
[e-mail]

Copy to:

Michael J. McDaniel
420 E Main St
New Albany, IN 47150

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