Jain et al v. Abbott Laboratories Inc. et al

Filing 147

MEMORANDUM OPINION. Signed by District Judge Michael F. Urbanski on 12/19/14. (eot)

IN THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF VIRGINIA
ROANOKE DIVISION
DEIRDRE WILLIAMSON JAIN, and
EMILY RUTH WILLIAMSON,
Individually, and as Co-Administrators of the
Estate of Joseph Seth Williamson, II, Deceased,
Plaintiffs,
v.
ABBOTT LABORATORIES, INC., et al.,
Defendants.

)
)
)
)
)
)
)
)
)
)
)
)

Civil Action No.: 7:13cv00551

By: Hon. Michael F. Urbanski
United States District Judge

MEMORANDUM OPINION
This is a products liability action brought by Deirdre Jain and Emily Williamson (collectively
“Plaintiffs”), against Abbott Laboratories, Inc., Abbott Laboratories and Hospira, Inc. (collectively
“Defendants”), concerning the alleged misprogramming of a patient-controlled analgesia pump.
Plaintiffs allege that Defendants negligently failed to provide adequate instructions for manually
programming the drug concentration into the pump, failed to warn of the defect and breached
express and implied warranties rendering the pump unreasonably dangerous and resulting in the
death of Joseph Seth Williamson, II (“Williamson”).
Before the court are several motions. In two pending motions in limine, Defendants seek to
exclude the expert testimony of Drs. Shelly Collins and Kenneth Laughery (Dkt. Nos. 73 and 71).
Defendants’ motion to exclude the expert testimony of Dr. Arden (Dkt. No. 49) is the subject of a
report and recommendation issued by the magistrate judge on October 8, 2014 (Dkt. No. 60).
Defendants’ objection to that report is currently pending before the court (Dkt. No. 67).
Defendants also move for summary judgment (Dkt. No. 69).

The issues have been fully briefed, and the court heard oral argument on November 25,
2014. For the reasons set forth below, the motions to exclude Dr. Shelly Collins (Dkt. No. 73) and
Dr. Kenneth Laughery (Dkt. No. 71) are GRANTED in part and DENIED in part. Defendants’
objection to the magistrate judge’s report and recommendation as to Dr. Jonathan Arden (Dkt.
No. 67) is OVERRULED and the report and recommendation (Dkt. No. 60) is ADOPTED in its
entirety. Finally, because genuine issues of material fact exist in this case, the motion for summary
judgment (Dkt. No. 69) is DENIED.
I.
On October 6, 2011, Williamson underwent hernia repair surgery at Montgomery Regional
Hospital (“MRH”) in Blacksburg, Virginia. In order to manage post-operative pain, Williamson’s
doctor prescribed him Dilaudid, a narcotic pain medication, to be administered via a patientcontrolled analgesia pump. Williamson’s doctor prescribed a continuous dose of Dilaudid at 0.5 mg
per hour, with a 0.2 mg patient-administered dose, a 20-minute lockout for patient-administered
doses, and a 3 mg, 4-hour limit. The pump used at MRH was the Defendants’ Hospira LifeCare
PCA® 3 Infusion System (“PCA 3”). The PCA 3 uses either a pre-filled or custom vial also
manufactured by Defendants to administer medication, and it utilizes a scanner to read a bar code
printed on the vial. After scanning the barcode, the PCA 3 either recognizes the vial as a pre-filled
vial of a particular medication or a custom vial requiring the user to provide more information about
the medication.
At the time of Williamson’s surgery, MRH used custom vials to administer Dilaudid. Thus,
after inserting a vial of Dilaudid into the PCA 3, the user, usually a nurse, would have to program
the concentration of the drug along with the dosage prescribed by the patient’s physician into the
PCA 3. The concentration of Dilaudid in the custom vials at MRH was 1.0 mg/ml. Williamson’s
primary nurse asked another on-duty nurse to assist her with the programming of the PCA 3 for
2

Williamson. While programming the PCA 3, the nurses entered “.2” for the drug concentration
rather than “1.0”. Plaintiffs contend that the instructions and warnings on the PCA 3 pump were
inadequate and misleading resulting in the programming error. Significantly, Plaintiffs point to the
fact that a screen on the PCA 3 pump states “CONFIRM CONCENTRATION TO PHYSICIAN
RX.” Plaintiffs allege that this screen misled the nurses into manually programming the wrong
concentration of Dilaudid into the pump, causing Williamson to receive a much a higher dose of
Dilaudid than that prescribed by his physician. At 1:10 a.m. on October 7, 2011, Williamson’s nurse
found him unresponsive, and he was pronounced dead shortly thereafter. Plaintiffs contend that the
overdose of Dilaudid caused Williamson’s death.
II.
Plaintiffs have identified Drs. Jonathan Arden, Shelly Collins, and Kenneth Laughery as
experts to testify at trial. Defendants have moved to exclude all three expert witnesses and also
move for summary judgment. The court will address each of these motions in turn.
A. Objection to Report and Recommendation Regarding Dr. Arden (Dkt. No. 67).
Plaintiffs seek to call Dr. Arden as a rebuttal expert witness on the cause of Williamson’s
death. Defendants have objected, claiming the identification of Dr. Arden was untimely. Finding
no surprise or prejudice to the Defendants, the magistrate judge recommended that the motion to
exclude Dr. Arden be denied. After conducting a de novo review of Defendants’ motion to exclude
Dr. Arden, the court agrees with the magistrate judge’s recommendation that the untimely disclosure
of Dr. Arden was harmless. Plaintiffs disclosed Dr. Arden in sufficient time to allow his deposition
to be taken before the close of discovery. Because Defendants had the opportunity to depose Dr.
Arden before the close of discovery, Dr. Arden’s testimony is relevant to an important issue in this
case, and finding no surprise or prejudice in allowing Dr. Arden to testify as a rebuttal witness, the
court finds that the untimely disclosure of Dr. Arden was harmless pursuant to Federal Rule of Civil
3

Procedure 37(c)(1). See Hoyle v. Freightliner, LLC, 650 F.3d 321, 329 (4th Cir. 2011). Therefore,
Defendants’ objection (Dkt. No. 67) is OVERRULED, the report and recommendation (Dkt.
No. 60) is ADOPTED in its entirety, and Defendants’ motion to exclude Dr. Arden (Dkt. No. 49)
is DENIED.
B. Daubert Motions Regarding Expert Witnesses Drs. Collins
and Laughery (Dkt Nos. 73 and 71).
When expert opinion evidence is offered, the court is obligated to serve as a gatekeeper to
determine whether an expert witness is qualified and whether an expert opinion is grounded in
objective underlying scientific methodology, as opposed to mere speculation or conjecture. Daubert
v. Merrill Dow Pharmaceuticals, Inc., 509 U.S. 579, 589–590, 595 (1993); Kumho Tire Co. v.
Carmichael, 526 U.S. 137, 141–142 (1991). The applicable rule governing admissibility of expert
testimony is Federal Rule of Evidence 702, which provides:
If scientific, technical, or other specialized knowledge will assist the
trier of fact to understand the evidence or to determine a fact in
issue, a witness qualified as an expert by knowledge, skill, experience,
training, or education, may testify thereto in the form of an opinion
or otherwise, if (1) the testimony is based upon sufficient facts or
data, (2) the testimony is the product of reliable principles and
methods, and (3) the witness has applied the principles and methods
reliably to the facts of the case.
Fed. R. Evid. 702; see also Advisory Committee Notes to Rule 702, 2000 Amendments (“A review
of the case law after Daubert shows that the rejection of expert testimony is the exception rather
than the rule.”) The applicable rule governing the legitimacy of underlying bases of opinion
testimony by experts is Federal Rule of Evidence 703, which provides in part:
The facts or data in the particular case upon which an expert bases an
opinion or inference may be those perceived by or made known to
the expert at or before the hearing. If of a type reasonably relied
upon by experts in the particular field in forming opinions or
inferences upon the subject, the facts or data need not be admissible
in evidence in order for the opinion or inference to be admitted.

4

Fed. R. Evid. 703. In other words, expert testimony that can assist the trier of fact is to be admitted
at trial where the witness is qualified and a preliminary assessment of his testimony finds “the
reasoning or methodology underlying the [proffered] testimony is scientifically valid and . . . that
reasoning or methodology properly can be applied to the facts in issue.” Daubert, 509 U.S. at 592593.
In order to qualify as an expert, an individual must possess the requisite knowledge, skill,
experience, training or education. Virginia Vermiculite, Ltd. v. W.R. Grace & Co.-Conn. & The
Historic Green Springs, Inc., 98 F. Supp. 2d 729, 732 (W.D. Va. 2000). An expert need not
“possess all five requisites—as long as he possesses one, he may be deemed an expert.” Id. “Rule
702 was intended to liberalize the introduction of relevant expert evidence.” Westberry v. Gislaved
Gummi AB, 178 F.3d 257, 261 (4th Cir. 1999); see also Thomas J. Kline, Inc. v. Lorillard, Inc., 878
F.2d 791, 799 (4th Cir. 1989) (recognizing that the test for exclusion of an expert is a strict one). As
such, a court need not determine whether the experts’ testimony is correct but should leave such
conclusions to the jury after “vigorous cross-examination, presentation of contrary evidence, and
careful instruction on the burden of proof.” Westberry, 178 F.3d at 261 (quoting Daubert, 509 U.S.
at 596). However, courts must be mindful that experts have the potential to be misleading if their
testimony is not reliable. Expert testimony with a greater potential to mislead than to aid the jury
should be excluded. See Westberry, 178 F.3d at 261 (citing United States v. Dorsey, 45 F.3d 809,
815–16 (4th Cir. 1995)).
1.
Defendants ask the court to prevent Dr. Collins from “proffering any testimony on the
adequacy of the instructions and warnings accompanying the PCA 3, how nurses would or did
interpret them, and that any different warning would have prevented the misprogramming . . . of the
PCA 3.” Dkt. No. 74, at 10. Dr. Shelly Collins possesses the requisite knowledge, skill, experience,
5

training, and education to qualify as an expert in the field of clinical pharmacology in this case. She
holds a Ph.D. in pharmacy and has more than twenty-eight years of clinical pharmacy experience.
She spent the last eighteen years as Clinical Specialist/Clinical Coordinator at the Chesapeake
Regional Medical Center where she was responsible for managing drug errors with pharmacists and
technicians with areas of emphasis in medication safety and quality improvement. Dkt. No. 74-3.
She has given numerous presentations in her field, including ones on protecting patients with sleep
apnea,1 and co-authored a text on pharmacology and nursing. Finally, Dr. Collins has had ample
interactions with PCA pumps generally throughout her career, although not the one at issue in this
case.
At oral argument, the court indicated that Dr. Collins ought not be permitted to testify that
Williamson died as a result of an overdose of Dilaudid. As Dr. Collins is not a medical doctor, she
is not qualified to testify as to the cause of Williamson’s death. At the same time, however, Dr.
Collins plainly is qualified to testify that Williamson received an overdose of Dilaudid and that the
“overdose occurred due to the programming of the wrong concentration of Dilaudid into the PCA
pump,” Dkt. No. 74-1, as well as to testify consistent with the opinions set forth at paragraphs 2-10
of her June 27, 2014 report. Dkt. No. 74-1. As such, the motion in limine regarding Dr. Collins’
testimony (Dkt. No. 73) is GRANTED in part and DENIED in part.
2.
Defendants also move to exclude Dr. Kenneth Laughery from testifying on the adequacy of
the warnings and instructions on the PCA 3. Dr. Laughery holds a bachelor’s degree in metallurgical
engineering and master’s and doctoral degrees in psychology. Dr. Laughery is a certified human
factors engineering professional and past president of the National Human Factors and Ergonomics
Society. He has taught graduate and undergraduate level courses in the field of human factors and
1

Williamson suffered from sleep apnea, and this condition will be an issue in this case.

6

published articles on warnings, human factors and ergonomics. Despite Dr. Laughery’s training,
education, and skill, however, he has not seen the PCA 3 in person, seen it programmed, or even
talked to someone who has programmed it. Laughery Dep., Dkt. No. 72-2, at 53:19-54:10, 162:4-9.
Laughery has no experience in the design of medical devices or their warnings. Id. at 62:22-64:4.
Laughery did not conduct any testing as to the particular warnings and labels on the PCA 3. Id. at
128:10-129:2. Moreover, a portion of Dr. Laughery’s expert opinion appears to be based on a
mistaken understanding of the PCA 3 and a prior PCA manufactured by Defendants. Compare
Dkt. No. 72-1 at *8 with Dkt. No. 72-1 at 94:5-101:1, 119:14-20. Finally, Dr. Laughery consistently
discounts testimony provided in this case in order to support his opinion. See Laughery Dep., Dkt.
No. 72-2 at 149:5-153:2. It is the role of the jury, not expert witnesses, to make credibility
determinations.
The gravamen of Dr. Laughery’s opinion is that the warnings contained on the side of the
pump and in the operator’s manual were insufficient from a human factors perspective, and that the
pump’s on-screen instructions were misleading and lacked an adequate warning of the dangers of
misprogramming the wrong drug concentration. For their part, Defendants have identified Alan
Lipshultz, a professional engineer and certified safety professional, whose expert opinion disagrees
with Dr. Laughery’s. Moreover, Defendants themselves considered human factors issues when
developing and evaluating the PCA 3. As the deposition of Ella Cozmi, Director of Human Factors
Engineering for Hospira, Inc., makes clear, human factors engineering has played a role in the
design of the PCA 3. As such, Dr. Laughery will be permitted to testify on the adequacy of the
instructions and warnings associated with the PCA 3, to the extent those opinions are well grounded
in his training, education and experience as well as recognized research and literature in the field of
human factors engineering.

7

At the same time, Dr. Laughery is not qualified by anything other than conjecture to render
an opinion as to causation in this case. He will not be permitted to opine that the instructions and
warnings associated with the PCA 3 caused the nurses to misprogram the PCA 3 resulting in the
overdose and death of Williamson. By the same token, in his deposition, Dr. Laughery testified that
he believed that certain of the nurses’ testimony reflected their knowledge obtained in hindsight
rather than what they knew at the time of Williamson’s death. Dr. Laughery’s speculation in this
regard is inadmissible. Dr. Laughery will not be permitted to opine or otherwise offer testimony to
question what a fact witness did or did not see, did or did not know, did or did not understand, or
did or did not do at a given point in time. Nor may he take issue with the credibility or accuracy of
the testimony of a fact witness in this case.
Given the fact that human factors engineering has played a role in the development of the
PCA 3 and each side seeks to introduce expert testimony in the field of human factors engineering,
the court will allow its admission appropriately cabined in a manner to assist the jury. Accordingly,
the motion in limine regarding Dr. Laughery (Dkt. No. 71) is GRANTED in part and DENIED
in part.
C. Defendants’ Motion for Summary Judgment (Dkt. No. 69).
Defendants move for summary judgment on the following grounds: (1) the warnings
accompanying the PCA 3 are adequate as a matter of law; (2) learned intermediaries were aware of
the dangers of misprogramming the concentration in the PCA 3; (3) the misprogramming of the
concentration was an open and obvious danger; (4) Plaintiffs have failed to produce evidence that an
inadequate warning proximately caused Williamson’s death; (5) MRH’s failure to adequately monitor
Williamson was the intervening and superseding cause of his death; and (6) Plaintiffs have failed to
produce evidence of an express warranty. Because there are genuine issues of material fact
concerning each of these issues, summary judgment will be denied.
8

1.
Pursuant to Federal Rule of Civil Procedure 56(a), the court must “grant summary judgment
if the movant 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); Celotex Corp. v. Catrett, 477 U.S.
317, 322 (1986); Glynn v. EDO Corp., 710 F.3d 209, 213 (4th Cir. 2013). When making this
determination, the court should consider “the pleadings, depositions, answers to interrogatories, and
admissions on file, together with . . . [any] affidavits” filed by the parties. Celotex, 477 U.S. at 322.
Whether a fact is material depends on the relevant substantive law. Anderson v. Liberty Lobby,
Inc., 477 U.S. 242, 248 (1986). “Only disputes over facts that might affect the outcome of the suit
under the governing law will properly preclude the entry of summary judgment. Factual disputes
that are irrelevant or unnecessary will not be counted.” Id. (citation omitted). The moving party
bears the initial burden of demonstrating the absence of a genuine issue of material fact. Celotex,
477 U.S. at 323. If that burden has been met, the non-moving party must then come forward and
establish the specific material facts in dispute to survive summary judgment. Matsushita Elec. Indus.
Co. v. Zenith Radio Corp., 475 U.S. 574, 586–87 (1986).
In determining whether a genuine issue of material fact exists, the court views the facts and
draws all reasonable inferences in the light most favorable to the non-moving party. Glynn, 710
F.3d at 213 (citing Bonds v. Leavitt, 629 F.3d 369, 380 (4th Cir. 2011)). Indeed, “[i]t is an ‘axiom
that in ruling on a motion for summary judgment, the evidence of the nonmovant is to be believed,
and all justifiable inferences are to be drawn in [her] favor.’” McAirlaids, Inc. v. Kimberly-Clark
Corp., No. 13-2044, 2014 WL 2871492, at *1 (4th Cir. June 25, 2014) (internal alteration omitted)
(citing Tolan v. Cotton, 134 S.Ct. 1861, 1863 (2014) (per curiam)). Moreover, “[c]redibility
determinations, the weighing of the evidence, and the drawing of legitimate inferences from the
facts are jury functions, not those of a judge . . . .” Anderson, 477 U.S. at 255. However, the non9

moving party “must set forth specific facts that go beyond the ‘mere existence of a scintilla of
evidence.’” Glynn, 710 F.3d at 213 (quoting Anderson, 477 U.S. at 252). Instead, the non-moving
party must show that “there is sufficient evidence favoring the non[-]moving party for a jury to
return a verdict for that party.” Res. Bankshares Corp. v. St. Paul Mercury Ins. Co., 407 F.3d 631,
635 (4th Cir. 2005) (quoting Anderson, 477 U.S. at 249). “In other words, to grant summary
judgment the Court must determine that no reasonable jury could find for the non[-]moving party
on the evidence before it.” Moss v. Parks Corp., 985 F.2d 736, 738 (4th Cir. 1993) (citing Perini
Corp. v. Perini Const., Inc., 915 F.2d 121, 124 (4th Cir. 1990)).
2.
Summary judgment fails in this case for a number of reasons. First, drawing all reasonable
inferences in the light most favorable to Plaintiffs, there are disputes over multiple facts that could
affect the outcome of this case. For example, it is clear to the court that reasonable minds could
differ as to whether the instructions and labels on the PCA 3 were adequate, particularly given the
screen stating “CONFIRM CONCENTRATION TO PHYSICIAN RX.” Additionally, based on
the differing testimony of the MRH nurses, a dispute exists as to whether the nurses were actually
aware of the potential dangers of misprogramming the drug concentration in the PCA 3, or whether
the danger was open and obvious. See Caldwell Dep., Dkt. No. 70-3, at 48:10-49:4; Via Dep., Dkt.
No. 93-12, at 71:25-72:5. There is also a factual question as to whether the MRH staff failed to
adequately monitor Williamson and, if so, whether that failure was an intervening and superseding
cause of his death.
Defendants further argue that they are entitled to summary judgment because Plaintiffs
cannot prove their case without expert testimony showing the inadequate instructions and warnings
associated with the PCA 3 were the proximate cause of Williamson’s death. Because this is a
medical device case, Defendants claim “‘proof of legal causation . . . must be by expert testimony
10

and the expert’s opinion must be stated in terms of reasonable probability.’” Defs.’ Mot. Summ. J.,
Dkt. No. 70, at *17 (emphasis omitted) (quoting Hartwell v. Danek Medical Inc., 47 F. Supp. 2d
703, 707 (W.D. Va. 1999)).
To be sure, the court has limited the testimony of Drs. Laughery and Collins. But these
rulings are not dispositive of the entirety of Plaintiffs’ case. Plaintiffs will present evidence as to the
cause of Williamson’s death from Robert C. Murrell, M.D. and Jonathan L. Arden, M.D. These
doctors are expected to testify based on the facts of this case and their expertise as to the amount of
Dilaudid received by Williamson and the effect of that drug on him. Dr. Collins may offer expert
opinions regarding medication safety in a hospital setting, the dosage of Dilaudid received by
Williamson, the programming of the PCA 3 pump and the adequacy of the instructions and
warnings thereon. Employing principles of human factors engineering, Dr. Laughery may testify as
to the adequacy of the instructions and warnings associated with the PCA 3 pump. Certainly, these
issues will be contested by Defendants. However, it appears at this stage that there is sufficient
testimony, including expert testimony, as to causation to create a genuine issue of material fact
precluding entry of summary judgment.
Finally, Defendants seek summary judgment on Count III of the Amended Complaint
alleging breach of express warranty. Defendants argue that there were no express warranties made
by the manufacturer of the PCA 3 that the machine would prevent misprogramming errors
altogether, and there is no evidence in the record that such a warranty formed the basis of the
bargain between the seller and purchaser of the PCA 3.
Express warranties are “[a]ny affirmation of fact or promise made by the seller to the buyer
which relates to the goods” and “[a]ny description of the good” that forms the “basis of the
bargain” between the buyer and seller that the goods will conform to the affirmation, promise, or
description. Va. Code Ann. § 8.2-313. While the creation of an express warranty does not require
11

the use of any magic words, there must be “at least some affirmative statement or promise regarding
the condition of the item sold . . . by the product’s manufacturer or seller.” Richard v. Wal-Mart
Stores, Inc., No. CIV. A. 96-0011-C, 1997 WL 578710, at *7 (W.D. Va. Aug. 25, 1997). The buyer
need not rely on the seller’s description of the goods, but the description must be more than “the
seller’s mere opinion.” Martin v. Am. Med. Sys., Inc., 116 F.3d 102, 105 (4th Cir. 1997) (citing
Daughtrey v. Ashe, 243 Va. 73, 413 S.E. 2d 336 (1992)). The “inquiry focuses on what it is that the
seller agreed to sell” and whether the parties intended for “their bargain to include the seller’s
description of the goods . . . .” Id. Thus, “whether a particular affirmation of fact made by the
seller constitutes an express warranty is generally a question of fact.” Bayliner Marine Corp. v.
Crow, 257 Va. 121, 127, 509 S.E.2d 499, 502 (1999).
Exhibits U and V to Plaintiffs’ Opposition to Defendants’ Motion for Summary Judgment
are sufficient at this stage to defeat summary judgment on the express warranty claim. Exhibit U is a
news release from Abbott Laboratories regarding the PCA 3. Dkt. No. 93-18 at *3. That release
discusses the new features of the PCA 3, including:
A built-in bar code reader – one that works in concert with bar-code
labeled Abbott prefilled vials that snap into the pump – makes PCA3
the first PCA pump to incorporate this integrated safety feature. The
second significant advancement is that the PCA3 identifies drug
name and concentration within the vial and automatically inputs the
information into the pump program. These two “firsts” should help
address many preventable errors as less manual programming is
required.
....
“When used with Abbott bar-coded syringes, the PCA3 becomes the
first pump to fully integrate bar coding into the device. No other
PCA pump has that feature.”
Id. at *2 (emphasis added). Exhibit V appears to be a PCA 3 brochure. It states:
Designed specifically to help prevent medication errors that
commonly arise in patient-controlled analgesia, the LifeCare PCA
pump features an integrated bar code reader and other features to
enhance safe delivery.
12

....
Integrated bar code reader confirms drug and concentration
Pre-filled, bar –coded medication vials with colored labels or
custom-filled vials with pharmacy-generated bar codes
Confirmation screens to add an extra level of safety
Dkt. No. 93-19. Whether these statements were part of the basis of the bargain creating an express
warranty is a question for the jury. As such, the court cannot decide the express warranty claim at
this stage.
In sum, Defendants’ motion for summary judgment must be denied.
III.
For these reasons, Defendants’ motions in limine concerning Dr. Laughery (Dkt. No. 71)
and Dr. Collins (Dkt. No. 73) are GRANTED in part and DENIED in part; Defendants’
objection to the report and recommendation concerning Dr. Arden (Dkt. No. 67) is
OVERRULED, the report (Dkt. No. 60) is ADOPTED in its entirety and Defendants’ motion to
exclude Dr. Arden (Dkt. No. 49) is DENIED; and Defendants’ motion for summary judgment
(Dkt. No. 69) is DENIED.
An appropriate Order will be entered.
Entered: December 19, 2014

Michael F. Urbanski
Michael F. Urbanski
United States District Judge

13