Security National Bank of Sioux City, IA, The v. Abbott Laboratories

Filing 108

MEMORANDUM Opinion and Order granting in part and denying in part 86 SEALED Motion for Summary Judgment filed by Abbott Laboratories, denying without prejudice 87 SEALED Motion to Exclude Plaintiff's Proposed Expert Testimony on Med ical and Scientific Causation filed by Abbott Laboratories, denying 99 SEALED Motion To Strike Megan Surber's 9/19/2012 Affidavit filed by Abbott Laboratories, denying 100 MOTION for Oral Argument re 86 and 87 SEALED Motions f iled by The Security National Bank of Sioux City IA (See Order Text). Therefore, this matter will proceed to jury trial, currently scheduled to begin on 9/3/2013, on the Conservator's product defect claims in Count 1 (manufacturing defect), 2 (design defect), and 3 (warning defect). Signed by Judge Mark W Bennett on 6/3/2013. (des)

IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF IOWA
WESTERN DIVISION
THE SECURITY NATIONAL BANK OF
SIOUX CITY, IOWA, as Conservator for
J.M.K, a Minor,
No. C 11-4017-MWB
Plaintiff,
vs.
ABBOTT LABORATORIES,
Defendant.

MEMORANDUM OPINION AND
ORDER REGARDING THE
DEFENDANT’S MOTIONS FOR
SUMMARY JUDGMENT, TO
EXCLUDE PLAINTIFF’S
CAUSATION EXPERTS, AND TO
STRIKE AFFIDAVIT1

___________________________
TABLE OF CONTENTS
I. 

INTRODUCTION........................................................................... 3 
A. 
Factual Background ............................................................... 3 
B. 
Procedural Background ........................................................... 5 

II. 

LEGAL ANALYSIS ........................................................................ 8 
A. 
The Challenge To The Affidavit ................................................. 8 
1. 
Arguments of the parties .................................................. 8 
2. 
Analysis ...................................................................... 9 
B. 
The Daubert Challenge To The Conservator’s Causation
Experts .............................................................................. 13 
1. 
Arguments of the parties ................................................ 13 
2. 
Analysis .................................................................... 16 
C. 
Abbott’s Motion For Summary Judgment.................................... 20 
1

All of the parties’ submissions in support of and opposition to the pending
substantive motions addressed in this Opinion were filed under seal. Nevertheless, I do
not believe that this Opinion discloses any information that should remain under seal, so
it will not be filed under seal.

1. 
2. 
3. 
4. 
5. 

III. 

Standards for summary judgment ..................................... 21 
The challenge to the causation element for all claims ............ 22 
The challenge to the warranty claims ................................ 23 
a. 
Arguments of the parties ....................................... 23 
b. 
Analysis ............................................................ 24 
The challenge to the fraud claim ...................................... 25 
a. 
Arguments of the parties ....................................... 25 
b. 
Analysis ............................................................ 26 
The challenge to the warning defect claim .......................... 29 
a. 
Arguments of the parties ....................................... 29 
b. 
Analysis ............................................................ 29 

CONCLUSION ............................................................................ 35 

In this action, plaintiff Security National Bank, as Conservator for a child, JMK,
who suffered severe brain damage from bacterial meningitis as a neonate, asserts
product defect, breach of warranty, and fraud claims against Abbott Laboratories, the
manufacturer of the powdered infant formula (PIF) that was allegedly the source of the
bacteria that caused JMK’s injuries. Abbott seeks summary judgment on the ground
that the Conservator cannot generate genuine issues of material fact on key elements of
its claims, including whether Abbott’s PIF was even a source of the bacteria that
infected JMK. In addition, Abbott seeks to exclude evidence from the Conservator’s
causation experts pursuant to Rule 702 of the Federal Rules of Evidence and Daubert v.
Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), and to strike a “sham”
affidavit by JMK’s mother, which Abbott argues contradicts her prior deposition
2

testimony about the onset and progression of JMK’s symptoms of infection and,
consequently, is submitted for the sole purpose of creating a fact issue where none
exists. I must determine whether or not I can consider the challenged affidavit and the
challenged experts’ opinions, then determine whether or not the Conservator has
generated genuine issues of material fact on the challenged elements of its claims in
light of admissible evidence.
I.
A.

INTRODUCTION
Factual Background

As general background,2 the undisputed record shows that JMK, a baby girl, was
the first of non-identical twins born to Megan Surber and Troy Kunkel on April 14,
2008, at St. Luke’s Hospital in Sioux City, Iowa. JMK and her twin brother were
electively delivered by scheduled Caesarean section, without complications, prior to
their estimated due date of May 5, 2008. JMK and her mother remained at the hospital
until the morning of April 17, 2008; her twin brother remained in the hospital until
April 24, 2008. The parties dispute the precise number and identity of friends and
relatives, besides treating physicians, hospital nurses, and hospital staff members, who
had physical contact with JMK during her stay at the hospital. The parties agree,
however, that while JMK remained at the hospital, she was fed only ready-to-feed
(RTF) liquid formula from 2-ounce, single-feeding bottles, with a new bottle used for
each feeding, and that she was only fed by Ms. Surber or the nurses.
At the time that JMK and her mother were discharged from the hospital on April
17, 2008, Ms. Surber received a “gift bag” containing several small bottles of Similac
2

I do not find it necessary to my disposition of any of the pending motions to set
out here an exhaustive dissertation of the facts, whether disputed or undisputed,
asserted by the parties. Where specific factual disputes become critical, I will address
them in my legal analysis to follow.
3

NeoSure RTF liquid formula, one larger bottle of Similac NeoSure RTF liquid formula,
and a 12.8-ounce container of Similac NeoSure PIF, all made by Abbott. The parties
dispute whether the bag also contained other information about Similac formulas, and
Abbott denies that it ever assembled such “gift bags” or that it provided the Similac in
the gift bag in return for any monetary or other consideration from the hospital.
After JMK’s discharge from the hospital, Ms. Surber took JMK to the family’s
residence in Sioux City, Iowa, where JMK remained until April 24, 2008. The parties
again dispute the number and identity of family members and other individuals with
whom JMK had physical contact during her first week at home. During JMK’s first
week at home, Ms. Surber only fed JMK the formula that Ms. Surber had received
upon her discharge from the hospital.3 Ms. Surber was the only person to feed JMK.
Ms. Surber first fed JMK with single-use bottles of RTF liquid formula, then with RTF
liquid formula from the larger bottle, which was refrigerated after opening, and only

3

Abbott disputes this factual allegation as “misleading/confusing and
immaterial,” but the basis for Abbott’s dispute appears to be the “suggest[ion] that RTF
formula cannot be extrinsically contaminated (post-manufacture) while in the possession
of a consumer.” Defendant’s Reply To Plaintiff’s Statement Of Additional Material
Facts (docket no. 97-1) at ¶¶ 3 and 9. Because the pertinent statement of fact is that
JMK was only fed the formula from the gift bag during her first week at home,
whatever else it may seem to “suggest” to Abbott, the statement is deemed admitted for
lack of a proper response. See N.D. IA. L.R. 56.d. (the moving party must “expressly
admit[ ], den[y], or qualif[y] each of the resisting party’s numbered statements of
additional fact,” and a response that fails to do so is deemed admitted); see also
Habben v. City of Fort Dodge, 472 F. Supp. 2d 1142, 1147-48 (N.D. Iowa 2007)
(concluding that objections to “implications” or “inferences” from facts stated by an
opposing party are not properly responsive and the facts stated may be deemed
admitted). It does not appear that Abbott’s objection is that JMK was fed some other
formula. Thus, Abbott could properly have responded by admitting that JMK was not
fed anything other than formula from the hospital gift bag, but qualifying the admission
by asserting that such formula could have been extrinsically contaminated in storage or
handling.
4

then with PIF, beginning with the evening feeding about 9:00 p.m. on April 23, 2008.
The parties dispute whether JMK was already showing symptoms of an infection that
evening.
JMK also received PIF feedings at midnight, 4:00 a.m., and 8:30 a.m. on April
24, 2008. At the 8:30 a.m. feeding, JMK was not feeding well and cried throughout
the rest of the day. At some point on the morning of April 24, 2008, Ms. Surber took
JMK’s temperature, which was less than 100 degrees. JMK continued to be fussy, cry,
and refuse to eat. When Ms. Surber took JMK’s temperature again in the afternoon, it
was slightly elevated, so Ms. Surber called JMK’s doctor. Ms. Surber took JMK to the
pediatrician’s office, but was redirected to St. Luke’s Hospital, apparently before JMK
was examined. JMK was admitted to the hospital shortly after 6:00 p.m. on April 24,
2008. JMK was later transferred to Children’s Hospital in Omaha, Nebraska, on April
26, 2008.

The parties agree that JMK was diagnosed with meningitis from

Enterobacter sakazakii, a Cronobacter, usually referred to in shortened form as E. sak
or C. sak, but dispute whether the diagnosis was first made at St. Luke’s Hospital or
Children’s Hospital. The Conservator contends that Abbott’s PIF was the source of the
C. sak that infected JMK.

B.

Procedural Background

In a Second Amended Complaint (docket no. 46), filed June 27, 2011, the
Conservator asserted seven causes of action against Abbott:

In Count 1, a

manufacturing defect claim, premised on the allegation that the presence of C. sak in
Abbott’s PIF was a departure from the intended design of the PIF; in Count 2, a design
defect claim, premised on allegations that biocidal treatment of the PIF or distribution

5

of only liquid formula are plausible, reasonable alternative designs to Abbott’s PIF;4 in
Count 3, a warning defect claim, premised on allegations that Abbott’s warning label
on its PIF is inadequate in such a manner as to make its PIF not reasonably safe; in
Count 4, a claim of breach of express warranties; in Count 5, a claim of breach of
implied warranty of fitness for a particular purpose; in Count 6, a claim of breach of
implied warranty of merchantability; and in Count 7, a claim of fraud. In his February
1, 2012, ruling on Abbott’s Motion To Dismiss, however, Senior District Judge Donald
E. O’Brien, to whom this case was originally assigned, dismissed the Conservator’s
claim of breach of the implied warranty of fitness for a particular purpose in Count 5.
See Memorandum Opinion And Order (docket no. 64) at 52-53 & 62, Security Nat’l
Bank of Sioux City, Iowa v. Abbott Labs., 2012 WL 327863, *18 & *21 (N.D. Iowa
Feb. 1, 2012). A jury trial in this matter is set to begin on September 3, 2013.
On March 20, 2013, Abbott filed its Motion For Summary Judgment (docket no.
86), seeking summary judgment on all of the Conservator’s remaining claims, with a
request for oral arguments, and its Motion To Exclude Or Limit Plaintiff’s Proposed
Expert Testimony On Medical And Scientific Causation (Abbott’s Daubert Motion)
(docket no. 87). On May 3, 2013, Abbott filed its Motion To Strike Megan Surber’s
September 19, 2012, Affidavit (docket no. 99). The Conservator duly resisted each of
these motions, and Abbott filed replies in further support of them. On May 14, 2013,
the Conservator filed a Request For Oral Argument (docket no. 100), seeking oral
arguments on Abbott’s Motion For Summary Judgment and Abbott’s Daubert Motion.
This case was reassigned to me on May 21, 2013. See Order (docket no. 102).
By Order (docket no. 104), filed May 25, 2013, I requested information from the
4

The description of this claim indicates the allegations found adequate by Senior
District Judge O’Brien in his ruling on Abbott’s Motion To Dismiss.
See
Memorandum Opinion And Order (docket no. 64), 33, Security Nat’l Bank of Sioux
City, Iowa v. Abbott Labs., 2012 WL 327863, *12 (N.D. Iowa Feb. 1, 2012).
6

parties concerning Abbott’s Daubert Motion, including, inter alia, whether the parties
were requesting an evidentiary hearing or only oral arguments on that motion. In their
e-mail responses to my judicial assistant, both parties indicated that they were only
requesting oral arguments, not an evidentiary hearing, on Abbott’s Daubert Motion, but
they requested that the oral arguments be “live.”5
I have decided that it is unnecessary to hear oral arguments on any of the
pending motions. First, I find it unnecessary to impose upon the parties the expense of
appearing for “live” oral arguments.

Second, where the parties do not want an

evidentiary hearing on a Daubert motion, I do not find that oral arguments are likely to
be helpful, at least not where, as here, the parties’ positions are well-briefed. An
evidentiary hearing is not required prior to a Daubert determination on expert evidence;
rather, what is required is that the parties “have an adequate opportunity to be heard”
before the court makes its decision. Group Health Plan, Inc. v. Philip Morris USA,
Inc., 344 F.3d 753, 761 n.3 (8th Cir. 2003). The parties’ written submissions have
provided them with such “an adequate opportunity to be heard” on Abbott’s Daubert
Motion. Third, because the parties’ briefing on Abbott’s other pending motions is
thorough, I find it unnecessary to hear oral arguments on those motions, either.
Therefore, Abbott’s request for oral arguments on its Motion For Summary Judgment
(docket no. 86) is denied; the Conservator’s May 14, 2013, Request For Oral
Argument (docket no. 100), seeking oral arguments on Abbott’s Motion For Summary
Judgment and Abbott’s Daubert Motion, is denied; and I will resolve Abbott’s pending
motions on the parties’ written submissions.
5

In his e-mail response to my Order (docket no. 102), the Conservator’s counsel
felt compelled to remind me that there are three motions pending. My Order (docket
no. 102) concerned only whether or not the parties wanted an evidentiary hearing or
oral arguments on Abbott’s Daubert Motion, as that is the only motion on which an
evidentiary hearing would be permissible.
7

II.

LEGAL ANALYSIS

I conclude that Abbott’s motions should be considered in the reverse order from
their filing. This course is appropriate, because the second and third motions go to the
evidence that I may properly consider in deciding the motion for summary judgment.

A.
1.

The Challenge To The Affidavit

Arguments of the parties

In its May 3, 2013, Motion To Strike Megan Surber’s September 19, 2012,
Affidavit (docket no. 99), Abbott contends that Ms. Surber’s statements to JMK’s
treating physicians and her mother, as well as her July 5, 2012, deposition testimony,
show that JMK was already exhibiting symptoms of bacterial meningitis infection on
April 23, 2008, before she ever consumed any of Abbott’s PIF. Abbott contends,
however, that Ms. Surber has done an “about face” in an affidavit dated September 19,
2012—which the Conservator’s experts then used as part of the basis for their causation
opinions, before it was disclosed to Abbott—by averring that the evening of April 23,
2008, was “routine” and that JMK did not show any unusual behavior, symptomatic of
infection, until the morning of April 24, 2008, after JMK had been fed Abbott’s PIF.
Abbott argues that such a “sham” affidavit cannot generate genuine issues of material
fact to preclude summary judgment.
In response, the Conservator argues that Ms. Surber’s affidavit does not conflict
with or contradict any portion of her own deposition, nor any other deposition or
discovery response. Rather, the Conservator contends that the affidavit was prepared
to provide its experts with additional information that was not elicited by Abbott during
Ms. Surber’s deposition. Relying on comparisons of quotations from Ms. Surber’s
deposition and her affidavit, the Conservator argues that there is no conflict or
8

contradiction between the deposition and the later affidavit, only elaboration in the
affidavit. The Conservator argues that any apparent differences between Ms. Surber’s
affidavit and the medical records arise from the vagueness of statements in the medical
records about the timing of certain events or symptoms.

Thus, the Conservator

contends that it has either shown the lack of conflicts or adequately explained them, so
that Ms. Surber’s affidavit is admissible. The Conservator also contends that it was not
until after Abbott disclosed its experts in January 2013, well after Ms. Surber’s
deposition and affidavit, that the Conservator learned that Abbott intended to argue that
JMK was already ill before she consumed her first PIF on the evening of April 23,
2008.
In reply, Abbott argues that Ms. Surber’s affidavit does not fall within the
narrow circumstances in which it would be admissible—such as raising a new matter,
explaining vague aspects of prior deposition testimony, or remedying confusion at the
deposition—but simply contradicts Ms. Surber’s previous unambiguous deposition
testimony and her statements to family members and treating physicians.
2.

Analysis

The Eighth Circuit Court of Appeals has reiterated, “In Camfield Tires, Inc. v.
Michelin Tire Corp., 719 F.2d 1361, 1365 (8th Cir. 1983), this court held where a
party creates an issue of fact by filing an affidavit contradicting earlier testimony in
order to avoid summary judgment, the party raises a ‘sham issue of fact instead of a
genuine one.’” Lykken v. Brady, 622 F.3d 925, 933 (8th Cir. 2010). The court in
Lykken noted some exceptions to the “sham issue of fact” rule, including clarification
of the prior testimony or explanation of the deponent’s confusion.

Id.

I have

recognized others, including supplementation that does not contradict factual assertions
in a prior deposition, see Knutson v. AG Processing, Inc., No. C01–3015–MWB, 2002
WL 31422858, *11 (N.D. Iowa Oct. 29, 2002), and recent refreshment of the affiant’s
9

memory by photographs that he had not been shown during the deposition, see Rowson
v. Kawasaki Heavy Indus., Ltd., 866 F. Supp. 1221, 1229–31 (N.D. Iowa 1994).
Thus, the question is whether any exceptions appear to be applicable here, or
whether the affidavit is, instead, an “unexpected revision” to create a fact issue where
none existed before, with no attempt to explain the difference. See Marathon Ashland
Petroleum, L.L.C. v. International Bhd. of Teamsters, 300 F.3d 945, 951 (8th Cir.
2002); see also Frevert v. Ford Motor Co., 614 F.3d 466, 474 (8th Cir. 2010) (“We
have previously ‘held that the plaintiff did not create a genuine issue of material fact
simply by submitting an affidavit that contradicted testimony at a prior deposition,
where there were no “legitimate reasons” for the filing of an inconsistent affidavit.’
Roberts v. Park Nicollet Health Serv., 528 F.3d 1123, 1126 (8th Cir. 2008) (quoting
Camfield Tires, Inc. v. Michelin Tire Corp., 719 F.2d 1361, 1365 (8th Cir. 1983)).”);
Bass v. City of Sioux Falls, 232 F.3d 615, 619 (8th Cir. 1999) (“‘Ambiguities and even
conflicts in a deponent’s testimony are generally matters for the jury to sort out, but a
district court may grant summary judgment where a party’s sudden and unexplained
revision of testimony creates an issue of fact where none existed before. Otherwise,
any party could head off a summary judgment motion by supplanting previous
depositions ad hoc with a new affidavit, and no case would ever be appropriate for
summary judgment.’” (quoting Wilson v. Westinghouse Elec. Corp., 838 F.2d 286,
289 (8th Cir. 1988)). The Eighth Circuit Court of Appeals has also cautioned “that
district courts should examine alleged inconsistencies between an affidavit and previous
deposition testimony ‘with extreme care.’” Baker v. Silver Oak Senior Living Mgmt.
Co., L.C., 581 F.3d 684, 690 (8th Cir. 2009) (quoting Camfield Tires, Inc., 719 F.2d
at 1366).
Proceeding with the requisite “extreme care” here, see id., I conclude that
Abbott has made a colorable “jury argument” that Ms. Surber changed her story about
10

the progression of JMK’s symptoms, see Bass, 232 F.3d at 619 (“Ambiguities and even
conflicts in a deponent’s testimony are generally matters for the jury to sort out. . . .”
(internal quotation marks and citations omitted), but has failed to show that there is any
unexplained “conflict” or “contradiction” rather than elaboration, clarification, or new
matter raised in Ms. Surber’s affidavit, as compared to her deposition testimony. See
Marathon Ashland Petroleum, L.L.C., 300 F.3d at 951 (considering these factors in
determining whether or not to exclude a later affidavit). Indeed, my comparison of the
deposition testimony and the affidavit suggests that Abbott too avidly asserts that its
interpretations of the deposition testimony are the only possible ones. In contrast, the
Conservator has shown, by pointing to specific statements in Ms. Surber’s and her
mother’s depositions, and comparing them with the statements in Ms. Surber’s
affidavit, that details in the affidavit are either consistent with, clarify, or supplement
details in Ms. Surber’s deposition in such a way that the affidavit can reasonably be
read as consistent with, not contradictory to, Ms. Surber’s deposition testimony. See
Lykken, 622 F.3d at 933 (recognizing that an affidavit need not be excluded where it
provides clarification of the prior testimony or explanation of the deponent’s
confusion); Knutson, No. C01–3015–MWB, 2002 WL 31422858 at *11 (recognizing as
an exception to the Camfield rule an affidavit that supplements but does not contradict
factual assertions in a prior deposition).
Furthermore, the Conservator has offered a credible explanation for any
apparent conflicts between the more detailed chronology of symptoms (such as the
degrees of JMK’s “fussiness” and the nature of JMK’s crying or whining) that JMK
displayed from April 23 to April 24, 2008, in Ms. Surber’s affidavit, on the one hand,
and her mother’s deposition testimony and the much more vague summaries in medical
records. Specifically, the Conservator has shown, by pointing to specific statements in
Ms. Surber’s mother’s deposition, and comparing them with the statements in
11

Ms. Surber’s affidavit, that details in the affidavit are either consistent with, clarify, or
supplement details in Ms. Surber’s mother’s deposition testimony, in such a way that
the affidavit can reasonably be read as consistent with, not contradictory to,
Ms. Surber’s mother’s deposition testimony. The Conservator also explains that the
medical records do not necessarily accurately reflect her statements at the time. See,
e.g., Marathon Ashland Petroleum, L.L.C., 300 F.3d at 951 (considering whether the
proffering party has attempted to explain apparent inconsistencies between an affidavit
and prior deposition testimony).6

Thus, the Conservator’s explanation should be

considered by the jury, not by the court, in deciding the truth of the matter.
The apparent differences between Ms. Surber’s affidavit and her prior deposition
testimony or other evidence, are not only shown to be elaborations or otherwise
explained, but can hardly be considered “unexpected revisions” simply to attempt to
avoid summary judgment. See, e.g., id. (emphasis added). Although the allegedly
“revisionist” affidavit appeared after Ms. Surber’s deposition, and was disclosed to the
Conservator’s experts before it was disclosed to Abbott, the Conservator points out that
the affidavit was disclosed with its experts and their reports on October 24, 2012, well
before Abbott disclosed its experts and their reports in January 2013, and well before
Abbott filed its Motion For Summary Judgment on May 3, 2013. The affidavit was not
created and offered only after and in response to Abbott’s Motion For Summary
Judgment, nor was the version of the facts in the affidavit in any sense “sudden” or
“unexpected” by the time that Abbott filed its Motion For Summary Judgment.

6

I am not convinced that any inconsistency between one witness’s affidavit and
another witness’s deposition testimony, or apparent inconsistencies between a witness’s
affidavit and medical records prepared by a third party, even if the records supposedly
reflected the witness’s statements at the time, would warrant striking the affidavit. It
seems to me that such inconsistency or conflict is the stuff of which genuine issues of
material fact are made.
12

Abbott’s May 3, 2013, Motion To Strike Megan Surber’s September 19, 2012,
Affidavit (docket no. 99) is denied.

B.

The Daubert Challenge To The Conservator’s
Causation Experts

I will consider, next, Abbott’s May 3, 2013, Motion To Exclude Or Limit
Plaintiff’s Proposed Expert Testimony On Medical And Scientific Causation (Abbott’s
Daubert Motion) (docket no. 87). This motion is of critical importance to whether or
not the Conservator can support any of its claims sufficiently to preclude summary
judgment.
1.

Arguments of the parties

Abbott seeks to exclude or limit the testimony of the Conservator’s three
experts—Drs. Catherine Donnelly (a food safety scientist), James Farmer (a
microbiologist), and Janine Jason (a pediatrician)—regarding the medical and scientific
causation of JMK’s bacterial meningitis, on the ground that their testimony fails to meet
the standards of admissibility for expert opinions under Rule 702 of the Federal Rules
of Evidence and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).
Abbott challenges the reliability of both the experts’ “ruling in” methodology, to show
that Abbot’s PIF was a potential source of the C. sak that infected JMK, and their
“ruling out” methodology, to eliminate other potential sources of C. sak, to
demonstrate that the PIF was the most likely source of the C. sak.
Somewhat more specifically, as to “ruling in” methodology, Abbott argues that
these experts fail to consider evidence that Abbott argues “eliminates” PIF as a
potential source of C. sak, including testing by the Centers for Disease Control (CDC)
and the Food and Drug Administration (FDA) that confirmed the absence of C. sak in
either the container of PIF used to feed JMK or other samples from the same lot of PIF
13

prepared within minutes of the PIF in the container used to feed JMK; they
acknowledge that there is no microbiological, statistical, or other scientific evidence
suggesting the presence of C. sak in Abbott’s PIF or evidence that could otherwise
“rule in” Abbott’s PIF as a potential source of JMK’s illness; they rely, instead, on a
supposed epidemiological association between PIF and certain C. sak infections, which
is insufficient to “rule in” Abbott’s PIF in any particular case, such as JMK’s infection;
and they reason from a desired result backwards to “rule in” Abbott’s PIF, assuming
the presence of C. sak in Abbott’s PIF simply because they believe it to be the most
likely source of Cronobacter in a PIF-fed infant. In addition, Abbott contends that
Dr. Jason’s “ruling in” methodology is premised on a faulty opinion regarding the
incubation period of C. sak and a faulty timeline for the progression of JMK’s
symptoms. Similarly, Abbott argues that these experts used faulty methodology in
“ruling out” a host of alternative sources of JMK’s C. sak infection, where inadequate
and limited testing was done to assess whether C. sak was present in JMK’s
environment and whether the source of the bacteria might have been person-to-person
contact.
In response, the Conservator argues that its experts’ opinions are reliable and
relevant and, indeed, their methodology surpasses the Daubert standard.

The

Conservator contends that it is undisputed that PIF can contain C. sak and cause
bacterial infections in infants. The Conservator argues that it has presented evidence
and expert testimony that, despite the testing performed by the CDC and the FDA,
JMK was exposed to C. sak in Abbott’s PIF, based, among other things, on expert
opinions that C. sak is not necessarily homogeneously distributed throughout PIF, but
may be found in clumps and clusters, and, consequently, can evade the kinds of testing
done in this case. The Conservator also argues that its experts’ opinions are relevant,
because those opinions make JMK’s infection with C. sak from Abbott’s PIF more
14

probable. The Conservator also points out that, while Abbott has relied only on district
court decisions excluding its experts’ “causation” opinions regarding C. sak infections
from PIF, Abbott has ignored district court decisions finding that its experts’ opinions
on these issues met Daubert standards. The Conservator argues that, while these cases
all involved the same experts and cannot readily be distinguished, the district courts
simply reached different results, leaving this court to choose for itself.

As to its

experts’ “ruling in” and “ruling out” methodologies, the Conservator argues that
Abbott has simply cherry-picked and distorted the methodologies that they employed.
In contrast, the Conservator contends, its experts have directly confronted Abbott’s
distortions and demonstrated the soundness of their methodologies and opinions. The
Conservator contends that mere disagreement among the parties’ experts does not mean
that its experts should be excluded from the jury’s consideration.
In reply, Abbott contends that the Conservator has still not shown any reliable
basis for its experts’ “ruling in” opinions. As to Dr. Jason, Abbott contends that parts
of her “ruling in” methodology are not scientifically valid, but even if they were, there
is still no evidence of any kind suggesting that Abbott’s PIF contained C. sak, which
means that her differential diagnosis is fatally flawed.

Abbott also argues that

Dr. Jason improperly conflates the “ruling in” and “ruling out” steps, simply “ruling
in” whatever is left after inadequately “ruling out” other possible causes. Abbott also
disputes the validity of and factual basis for Dr. Jason’s opinion concerning the
incubation period for Cronobacter meningitis, the validity of her “ruling out” of RTF
formula, her failure to consider the tests by the CDC and FDA showing no
Cronobacter

contamination

of

Abbott’s

PIF—and

evidence

that

supposed

contaminations with Cronobacter in areas unrelated to PIF production were ultimately
shown not to be Cronobacter—and her non-expert beliefs that Cronobacter may not be
evenly distributed in PIF. Abbott contends that Dr. Donnelly’s opinions remain equally
15

unrealiable, because she relies on case reports and epidemiological associations between
Cronobacter and non-Abbott PIF products that are irrelevant to causation in this case;
her differential diagnosis works backward from the desired result to the desired source
of the C. sak; she fails to consider probative CDC and FDA test results; and she relies
on isolated and irrelevant environmental samples from non-product areas of Abbott’s
plant where JMK’s PIF was manufactured. As to Dr. Farmer, Abbott contends that he
offers no explanation of a methodology that characterizes sampling data from a nonproduction area as a “smoking gun,” when the samples were ultimately shown not to be
Cronobacter and could not be “traced back” to any manufacturing equipment or PIF.
Abbott also reiterates its challenge to the Conservator’s experts’ “ruling out” of
numerous plausible causes of JMK’s C. sak infection on what Abbott calls “the
slimmest of pretexts” and the lack of any reliable basis.
2.

Analysis

Rule 702 of the Federal Rules of Evidence provides that expert testimony should
be admitted if [1] the expert’s specialized knowledge “will help the trier of fact to
understand the evidence or to determine a fact in issue,” [2] it “is based on sufficient
facts or data”, [3] it “is the product of reliable principles and methods,” and [4] “the
witness has applied the principles and methods reliably to the facts of the case.” FED.
R. EVID. 702; see also General Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997). In
Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), the Supreme
Court explained that the district court must perform a “gatekeeper” function, under
Rule 702, so that only expert testimony that is relevant and reliable is admitted. 509
U.S. at 589. The Eighth Circuit Court of Appeals has explained how the district court
is to perform its “gatekeeper” function under Daubert, as follows:
First, the trial court must make a “preliminary assessment of
whether the reasoning or methodology underlying the
testimony is scientifically valid and of whether that
16

reasoning or methodology properly can be applied to the
facts in issue.” [Daubert, 509 U.S. at 592-93, 113 S.Ct.
2786, 125 L.Ed.2d 469]. The Court cautioned that the trial
court must focus “on [the] principles and methodology, not
on the conclusions that they generate.” Id. at 595, 509 U.S.
579, 113 S.Ct. 2786, 125 L.Ed.2d 469. Second, the court
must ensure that the proposed expert testimony is relevant
and will serve to aid the trier of fact. Id. at 592, 509 U.S.
579, 113 S.Ct. 2786, 125 L.Ed.2d 469. Expert testimony
assists the trier of fact when it provides information beyond
the common knowledge of the trier of fact. Id. at 591, 509
U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469. The Court, in
Kumho Tire Co. v. Carmichael, 526 U.S. 137, 119 S.Ct.
1167, 143 L.Ed.2d 238 (1999), clarified that the district
court’s gatekeeper function applies to all expert testimony,
not just testimony based in science. Id. at 147, 526 U.S.
137, 119 S.Ct. 1167, 143 L.Ed.2d 238.
Kudabeck v. Kroger Co., 338 F.3d 856, 860 (8th Cir. 2003). However, “[a]s the
Supreme Court emphasized in Daubert, 509 U.S. at 595-96, 113 S.Ct. 2786, 125
L.Ed.2d 469, ‘Vigorous cross-examination, presentation of contrary evidence, and
careful instruction on the burden of proof are the traditional and appropriate means of
attacking shaky but admissible evidence.’” United States v. Vesey, 338 F.3d 913, 917
(8th Cir. 2003).
In this case, I am informed—if not actually aided—by three prior district court
decisions considering whether or not to exclude essentially the same opinions from the
very same experts based on essentially the same methodologies. See Johnson v. Mead
Johnson & Co., No. 11-225 (JNE/LIB), 2013 WL 716816 (D. Minn. Feb. 27, 2013)
(concluding that Dr. Jason reliably “ruled in” another maker’s PIF as a possible source
of an infant’s C. sak infection, but concluding that her “ruling out” methodology was
“fundamentally unsound and not supported by any factual basis,” and that she
unreliably “ruled out” two possible causes; excluding her proposed testimony on her
17

differential diagnosis and her opinion that the PIF caused the infant’s infection;
concluding that Dr. Farmer’s “ruling out” methodology was flawed for the same
reasons as Dr. Jason’s, and excluding his proposed testimony on his differential
diagnosis and his corresponding opinion that the PIF caused the infant’s infection; and
excluding Dr. Donnelly’s opinions on the cause of the infant’s infection for the same
reasons); Burks v. Abbott Labs., ___ F. Supp. 2d ___, 2013 WL 101831 (D. Minn.
Jan. 8, 2013) (denying Abbott’s motion to exclude the same experts’ opinions on
causation, because Louisiana law would recognize “alternative liability”—which
relieves the plaintiff of the burden of proving that it is more likely than not that a
particular defendant, either Abbott or another maker of PIF, caused the infant’s death,
but does require the plaintiff to prove only that it is more likely than not that the
contaminated PIF manufactured by one of the defendants caused the infant’s illness—
and “[p]laintiffs' experts’ opinions that it is more likely than not that contaminated PIF
manufactured by one of the defendants caused [the infant’s] illness has a tend[ency] to
make this fact more probable”; and also denying the other PIF manufacturer’s motion
to exclude these experts, with certain exceptions, because the experts’ specific causation
opinions were relevant and reliable); Korte v. Mead Johnson & Co., 824 F. Supp. 2d
877 (S.D. Iowa 2010) (granting summary judgment in favor of another PIF
manufacturer, because the same three experts (and additional ones) could not reliably
show that the PIF caused the infant’s illness, where the experts had not adequately
“ruled out” other possible causes, even though neither party had requested a Daubert
hearing on the qualifications of the experts as a part of the summary judgment motion
or resistance).

As the Conservator suggests, these decisions do not appear to be

ultimately reconcilable with or convincingly distinguishable from each other.7 Thus, I
cannot simply adopt the position of the court or courts in one or more prior decisions.
7

After the Conservator pointed out Abbott’s failure to cite Burks, and relied on
18

Turning to my own “preliminary assessment” in this case, from my review of
the submissions in support of and resistance to Abbott’s Daubert Motion, I conclude—
albeit with some reluctance and uncertainty—that the reasoning and methodology
underlying the challenged opinions are scientifically valid and that the challenged
experts’ reasoning and methodology can be applied to the facts in issue. See Daubert,
509 U.S. at 592-93 (first step in the court’s “gatekeeper” function under Rule 702);
Kudabeck, 338 F.3d at 860 (same).

Although Abbott is clearly unhappy with the

opinions of the Conservator’s causation experts, and has cloaked that unhappiness in
challenges to “factual basis” and “reasoning and methodology,” I find that the
Conservator has shown that its causation experts’ reasoning and methodology are
appropriate, and apply proper scientific principles.

Moreover, I find that the

challenged opinions have an adequate factual basis, including those facts identified by
that case extensively in its resistance to Abbott’s Daubert Motion, Abbott still only
cited Burks in a footnote on the final page of its Reply, in which it attempted to
demonstrate that Burks was “irrelevant,” because it involved “alternative liability”
under Louisiana law and because the court in that case purportedly did not consider
how each of the three experts applied his or her methodology. While Abbott’s failure
to cite a contrary, but non-controlling decision did not violate any ethical obligation,
ethical obligations establish only the barest minimum floor for attorney conduct. What
attorney would want to be known as a minimally ethical lawyer rather than a highly
professional one? Where the pool of decisions considering the same experts and
methods is so limited, it is inconceivable to me that reasonably conscientious and highly
professional counsel would not cite contrary authority, then meet it head on and attempt
to distinguish it, not simply hope neither the opposing party nor the court would notice
it—a vain hope, here, where the plaintiffs in Burks were represented by the same
attorneys who represent the Conservator, and Abbott was represented by the same
attorneys who represent Abbott here. Defense counsels’ lack of candor is troubling.
Hide and seek litigation strategy seldom works and did not work here. As a result, I
will find it more difficult to rely on the trustworthiness of defense counsel—a trial
lawyer’s most important asset. This is not an auspicious beginning for counsel before a
judge newly assigned to the case.
19

the Conservator and the experts in the experts’ reports, and that the experts have
confronted Abbott’s complaints about their methodology and the factual basis for their
decisions, such that submission of the experts’ opinions to a jury is warranted. I am
also convinced that the proposed expert testimony is relevant and will aid the trier of
fact. Daubert, 509 U.S. at 592 (second step in the analysis); Kudabeck, 338 F.3d at
860 (same).

Plainly, the Conservator’s causation experts will provide information

beyond the common knowledge of the trier of fact regarding the circumstances that
can—and they believe did, in this case—cause an infant’s bacterial meningitis. See id.
at 591 (explaining that expert testimony assists the trier of fact when it provides
information beyond the common knowledge of the trier of fact).
Ultimately, I believe that to exclude the Conservator’s causation experts’
opinions from this case would “invade the province of the jury, whose job it is to
decide issues of credibility and to determine the weight that should be accorded
evidence.”

Vesey, 338 F.3d at 916-17.

This is a case in which vigorous cross-

examination, presentation of contrary evidence, and careful instruction on the burden of
proof are not only traditional, but appropriate means of attacking what Abbott contends
are shaky causation opinions by the Conservator’s experts. Daubert, 509 U.S. at 59596; Vesey, 338 F.3d at 917.
Abbott’s May 3, 2013, Motion To Exclude Or Limit Plaintiff’s Proposed Expert
Testimony On Medical And Scientific Causation (Abbott’s Daubert Motion) (docket no.
87) is denied, without prejudice to challenges during trial to the jury’s consideration of
the experts’ opinions.

C.

Abbott’s Motion For Summary Judgment

Having resolved whether I can properly consider either Ms. Surber’s affidavit or
the opinions of the Conservator’s causation experts, I turn to consideration of Abbott’s
20

March 20, 2013, Motion For Summary Judgment (docket no. 86), seeking summary
judgment on all of the Conservator’s remaining claims. I begin my analysis of this
motion with a summary of the standards applicable to motions for summary judgment,
then turn to Abbott’s arguments for summary judgment on particular claims.
1.

Standards for summary judgment

Summary judgment is only appropriate when “the pleadings, depositions,
answers to interrogatories, and admissions on file, together with affidavits, if any, show
that there is no genuine issue of material fact and that the moving party is entitled to a
judgment as a matter of law.” FED. R. CIV. P. 56(c) (emphasis added); see Woods v.
DaimlerChrysler Corp., 409 F.3d 984, 990 (8th Cir. 2005) (“Summary judgment is
appropriate if viewing the record in the light most favorable to the nonmoving party,
there are no genuine issues of material fact and the moving party is entitled to judgment
as a matter of law.”); see generally Celotex Corp. v. Catrett, 477 U.S. 317, 323-24
(1986). As the Eighth Circuit Court of Appeals has explained,
“On a motion for summary judgment, ‘facts must be viewed
in the light most favorable to the nonmoving party only if
there is a genuine dispute as to those facts.’” Ricci v.
DeStefano, –––U.S. ––––, 129 S. Ct. 2658, 2677, 174 L.
Ed. 2d 490 (2009) quoting Scott v. Harris, 550 U.S. 372,
380, 127 S. Ct. 1769, 167 L. Ed. 2d 686 (2007) (internal
quotations omitted).
“Credibility determinations, the
weighing of the evidence, and the drawing of legitimate
inferences from the facts are jury functions, not those of a
judge.” Reeves v. Sanderson Plumbing Prods., Inc., 530
U.S. 133, 150, 120 S. Ct. 2097, 147 L. Ed. 2d 105 (2000),
quoting Anderson v. Liberty Lobby, Inc., 477 U.S. 242,
255, 106 S. Ct. 2505, 91 L. Ed. 2d 202 (1986). The
nonmovant “must do more than simply show that there is
some metaphysical doubt as to the material facts,” and must
come forward with “specific facts showing that there is a
genuine issue for trial.” Matsushita Elec. Indus. Co. v.
Zenith Radio Corp., 475 U.S. 574, 586–87, 106 S. Ct.
21

1348, 89 L. Ed. 2d 538 (1986). “‘Where the record taken
as a whole could not lead a rational trier of fact to find for
the nonmoving party, there is no genuine issue for trial.’”
Ricci, 129 S. Ct. at 2677, quoting Matsushita, 475 U.S. at
587, 106 S. Ct. 1348.
Torgerson v. City of Rochester, 643 F.3d 1031, 1042-43 (8th Cir. 2011) (en banc).
Summary judgment is particularly appropriate when only questions of law are involved,
rather than factual issues that may or may not be subject to genuine dispute. See, e.g.,
Cremona v. R.S. Bacon Veneer Co., 433 F.3d 617, 620 (8th Cir. 2006).
2.

The challenge to the causation element for all claims

Abbott argues that each of the Conservator’s remaining claims requires proof
that Abbott’s product was the cause of JMK’s alleged injury. Abbott seeks summary
judgment on all of these claims, on the ground that there is no evidence that Abbott’s
PIF was the cause of JMK’s injury. Abbott’s argument in support of this portion of its
motion for summary judgment is, in essence, that the Conservator’s causation experts’
opinions must be excluded and, consequently, that the Conservator cannot generate
genuine issues of material fact on whether Abbott’s PIF can be “ruled in” or “ruled
out” as a cause of JMK’s injury. In response, the Conservator contends, in essence,
that its experts’ causation opinions are sufficient to generate genuine issues of material
fact on the “causation” element of its claims.
I have already determined, above, that the opinions of the Conservator’s
causation experts should not be excluded. Therefore, I now conclude that, viewing
their opinions in the light most favorable to the Conservator, their opinions are
sufficient to generate genuine issues of material fact on the element, in each of the
Conservator’s causes of action, that requires the Conservator to show that Abbott’s PIF
caused JMK’s injury. Torgerson, 643 F.3d at 1042-43 (explaining that, on a motion
for summary judgment, the non-movant must come forward with specific facts showing
22

that there is a genuine issue for trial, and the court must consider the evidence in the
light most favorable to the non-movant); see also FED. R. CIV. P. 56(c); Woods, 409
F.3d at 990; see generally Celotex Corp., 477 U.S. at 323-24.
The part of Abbott’s Motion For Summary Judgment seeking summary judgment
on the ground that the Conservator cannot establish the required causation of injury to
support any of its claims is denied.
3.

The challenge to the warranty claims
a.

Arguments of the parties

Abbott challenges both of the Conservator’s remaining warranty claims on the
ground that the Conservator has not and cannot present any evidence that Abbott’s PIF
was “sold” by Abbott to St. Luke’s Hospital in exchange for any kind of consideration,
because the PIF was a gift. Abbott argues that, even after extensive discovery, there is
no evidence of any agreement between St. Luke’s Hospital and Abbott concerning the
PIF, nor any evidence that Abbott assembled or provided any gift bags to St. Luke’s
Hospital, nor any evidence that Abbott asked or instructed St. Luke’s Hospital to make
or give gift bags to patients. Abbott also argues that the Conservator has not identified
any evidence, in support of its express warranty claim, that St. Luke’s Hospital relied
on any express affirmation of fact or promise by Abbott. Abbott contends that there is
no evidence that, when St. Luke’s Hospital received the PIF as a gift, Abbot made or
the hospital relied on any representations.
In response, the Conservator argues that one of its experts, Dr. Jason, has
opined that Abbott provided the PIF and other formula to St. Luke’s Hospital as a
marketing tool. The Conservator also contends that, in his ruling on Abbott’s motion
to dismiss, Judge O’Brien ruled that Abbott’s provision of PIF to St. Luke’s Hospital
was a sale. The Conservator also argues that the label of the PIF, itself, contained
express representations that the PIF was safe and suitable for infants of all ages,
23

including neonates like JMK, and that the hospital relied on these warranties when it
supplied the product to its customers, including neonates.
b.

Analysis

I conclude that Abbott is entitled to summary judgment on both of the
Conservator’s remaining breach of warranty claims. First, nothing in Judge O’Brien’s
ruling on Abbott’s motion to dismiss is dispositive of whether or not there was actually
a “sale” within the meaning of Iowa law that would support a warranty claim. Rather,
Judge O’Brien found that the Conservator’s allegations that Abbott provided PIF to St.
Luke’s Hospital in return for consideration plausibly suggested a “sale” within the
meaning of Iowa law, assuming that Abbott would ultimately be able to show that it
received some type of consideration for providing its product to the hospital.

See

Memorandum Opinion And Order (docket no. 64) at 39-46, Security Nat’l Bank of
Sioux City, Iowa, 2012 WL 327863 at *14-*16.

Abbott now makes a different

argument: That there was no “sale,” because the formula was given to the hospital as a
gift, not for any consideration. Thus, Judge O’Brien’s ruling does not bar summary
judgment on the remaining warranty claims in this case.
Second, the Conservator has cited no case law, and I have found none,
suggesting that a donor’s mere anticipation of some economic benefit from a gift, as a
matter of marketing strategy, satisfies the “consideration” requirement of a “sale”
within the meaning of Iowa law—or any other state’s law—sufficient to support a
breach of warranty claim.

The lack of any legal authority for the Conservator’s

argument makes summary judgment on the remaining warranty claims particularly
appropriate. See, e.g., Cremona, 433 F.3d at 620 (explaining that summary judgment
is particularly appropriate when only questions of law are involved, rather than factual
issues that may or may not be subject to genuine dispute).

24

Third, the Conservator has not attempted to show that Dr. Jason is qualified to
offer expert opinions about marketing strategies of baby formula manufacturers or
about marketing strategies behind corporate “gifts,” more generally. Thus, I conclude
that Dr. Jason’s opinion would not generate a genuine issue of material fact on its
“marketing strategy as consideration” contention, even if that contention were legally
viable. Fourth, the Conservator has not pointed to any factual basis for any assertion
that Abbott received any other “consideration” for its “gift” of baby formula to the
hospital.
Thus, the Conservator has failed to carry its burden in response to Abbott’s
motion for summary judgment on the remaining breach of warranty claims to “come
forward with specific facts showing that there is a genuine issue for trial.” Torgerson,
643 F.3d at 1042-43 (internal quotation marks and citations omitted).8 That part of
Abbott’s March 20, 2013, Motion For Summary Judgment (docket no. 86) seeking
summary judgment on the Conservator’s remaining breach of warranty claims is
granted.
4.

The challenge to the fraud claim
a.

Arguments of the parties

Abbott seeks summary judgment on the Conservator’s fraud claim on the
additional grounds that there is no evidence that JMK’s caregiver, Ms. Surber, viewed
any advertisements for Abbott’s PIF or even the label on the PIF can before preparing
PIF feedings, and there is no evidence that Ms. Surber justifiably relied on the labeling
when deciding to use the PIF to feed JMK. Indeed, Abbott argues that Ms. Surber
testified that she never read any ads, direct mailings, or on-line information regarding
8

I find it unnecessary to reach Abbott’s argument that it is also entitled to
summary judgment on the Conservator’s express warranty claim on the ground that the
Conservator cannot show that the hospital relied on any promise.
25

Abbott’s NeoSure PIF, or any other infant formula, before using the PIF on April 23,
2008; she confirmed that she did not discuss Abbott’s NeoSure PIF or PIF in general
with anyone before feeding the PIF to JMK; and she testified that she had no
recollection of reviewing portions of the label that contained information about the
product, warnings about the product’s sterility, or warnings to use the product only
under the supervision of a doctor. Similarly, Abbott argues that there is no evidence
that Ms. Surber relied on the allegedly false statements in any information on Abbott’s
PIF label, where the Conservator cannot even show that Ms. Surber was aware of the
statements on the label; Ms. Surber testified that she had previously used PIF products
for her older child and had decided to use PIF for JMK before she was born; she did
nothing to assure herself that PIF products were “safe and healthy” before using them;
she simply used whatever formula the hospital had sent home with her; she relied on
the doctor’s prescription instructing her to use NeoSure for JMK; she had no other
formula available after exhausting the RTF formula on April 23, 2008; and she had
already begun preparing the PIF for a feeding before she ever glanced at any portion of
the label.
The Conservator’s brief response to these arguments is that Ms. Surber testified
that she read the NeoSure PIF label; that she believed that NeoSure PIF was safe for
JMK and did not contain harmful bacterial; and that she would not have fed JMK the
NeoSure PIF if the label had stated that it was unsuitable for an infant under 28 days of
age, that it may contain harmful bacteria, or that liquid formula was safer for JMK.
b.

Analysis

The Iowa Supreme Court has made clear that, among other elements, “[t]o bring
a fraud claim, the plaintiff must have justifiably relied on the false representation.”
Dier v. Peters, 815 N.W.2d 1, 9 (Iowa 2012) (citing Spreitzer v. Hawkeye State Bank,
779 N.W.2d 726, 737 (Iowa 2009)). More specifically, “the plaintiff must not only act
26

in reliance on the misrepresentation, but the reliance must be justified.” Spreitzer, 779
N.W.2d at 736 (citing Gibson v. ITT Hartford Ins. Co., 621 N.W.2d 388, 400 (Iowa
2001)). Abbott challenges the Conservator’s fraud claim only on the issue of whether
Ms. Surber “actually” or “in fact” relied on any alleged misrepresentations, not on
whether any reliance was “justified.” Abbott’s challenge to “actual” reliance has two
prongs: Ms. Surber never read any alleged misrepresentation, and Ms. Surber did not
rely on any alleged misrepresentation in deciding to use the PIF, because her decision
to use the PIF was based entirely on other considerations.
I conclude that, contrary to Abbott’s contentions, the Conservator has generated
genuine issues of material fact that Ms. Surber did, in fact, read the label of the PIF at
the time that she prepared JMK’s first PIF feeding. Torgerson, 643 F.3d at 1042-43
(explaining that the non-movant must “come forward with specific facts showing that
there is a genuine issue for trial” (internal quotation marks and citations omitted)). As
the Conservator contends, when asked in deposition, “So when you took out the can [to
make JMK’s first PIF feeding], did you read the label?”, Ms. Surber answered, “Yes.”
Defendant’s Appendix at 313 (Surber Deposition at 348:24—349:1). The extent to
which Ms. Surber later recalled the content of any particular statements on the label
only generates a fact question on whether or not Ms. Surber was actually aware of
those statements at the time that she prepared JMK’s first PIF feeding.
Nor am I persuaded that it is “undisputed” that Ms. Surber did not actually rely
on the statements on the label simply because she did not read it until she was already
boiling water to sterilize the bottle for JMK’s first PIF feeding or even because the PIF
was the only baby formula left in the house at that time, as Abbott seems to suggest. A
reasonable jury could conclude that a reasonable parent who discovered information on
a baby formula label indicating that use of the formula was inappropriate for their child
would not use the formula, no matter how advanced their preparation of the feeding
27

was, and would make every effort to get other formula, even if the inappropriate
formula was the only formula left in the house.
Nevertheless, the Conservator has failed to generate genuine issues of material
fact on the “actual reliance” element of its “fraud” claim, because the Conservator has
not pointed to any evidence that Ms. Surber relied on statements on the label in
deciding to use the PIF. This is so, because the portions of Ms. Surber’s deposition
that the Conservator cites as demonstrating that Ms. Surber “believed the Similac PIF
was safe for [JMK] and did not contain harmful bacteria” simply do not support that
allegation, where they do not even mention safety or lack of harmful bacteria at all.
See Defendant’s Appendix at 282, 288 (Surber Deposition at 174, 198-199); Plaintiff’s
Appendix at 710-15 (including no amendments to the cited pages of Ms. Surber’s
deposition, nor any corrections of testimony regarding a belief that PIF was safe and
did not contain harmful bacteria). Furthermore, even if the citations supported the
allegation about Ms. Surber’s beliefs, the Conservator has not cited any evidence that
Ms. Surber developed these beliefs from representations on the PIF label. Similarly,
although the Conservator has cited a somewhat belated affidavit by Ms. Surber, dated
April 12, 2013, that does support allegations that “she would not have fed [JMK] the
NeoSure PIF if the label stated it was unsuitable for an infant under 28 days, that it may
contain harmful bacteria, or that liquid formula was safer for [JMK],” see Plaintiff’s
Appendix at 620-21, the Conservator has not cited any evidence that Ms. Surber
developed a contrary belief from any representation on the label. The lack of such
evidence forecloses the Conservator’s “fraud” claim, whether that claim is premised on
fraudulent misrepresentation or fraudulent non-disclosure.9

9

Indeed, these allegations more readily support a claim that the warnings given
were defective than they do a fraud claim. I will turn to Abbott’s motion for summary
judgment on the Conservator’s warning defect claim, next.
28

Therefore, that part of Abbott’s March 20, 2013, Motion For Summary
Judgment (docket no. 86) seeking summary judgment on the Conservator’s fraud claim
is granted.
5.

The challenge to the warning defect claim
a.

Arguments of the parties

Abbott seeks summary judgment on the Conservator’s warning defect claim on
the ground that, regardless of the adequacy of Abbott’s warning, the warning did not
proximately cause JMK’s illness. This is so, Abbott contends, again, because JMK’s
mother’s decision to feed JMK the PIF was entirely independent of Abbott’s warning.
Abbott again asserts that the record shows that Ms. Surber did not read the label
warnings nor rely upon them when making the decision to use the PIF. In other words,
Abbott contends that the warning language did not enter into Ms. Surber’s decisionmaking process when deciding to feed the PIF to JMK.
In response, the Conservator argues that, in support of what it calls its
“negligent failure to warn” claim, it has cited sufficient evidence that an adequate
warning would have altered Ms. Surber’s conduct and avoided the injury. Indeed, the
Conservator argues that, where it has shown that the warning given was inadequate,
either in content or presentation, it is entitled to a presumption that Ms. Surber would
have heeded an adequate warning, and Abbott has not rebutted that presumption.
b.

Analysis

Although the Conservator characterizes its warning claim as a “negligent failure
to warn” claim in its resistance to Abbott’s Motion For Summary Judgment, the
Conservator and Abbott both apparently overlook that, in 2002, the Iowa Supreme
Court “adopted the Restatement (Third) of Torts: Products Liability sections 1 and 2
(1998).”

Scott v. Dutton-Lainson Co., 774 N.W.2d 501, 504 (Iowa 2009) (citing

Wright v. Brooke Group Ltd., 652 N.W.2d 159, 169 (Iowa 2002)). I will refer to the
29

cited version of the RESTATEMENT as RESTATEMENT (THIRD): PRODUCTS LIABILITY.
Although the Iowa Supreme Court has reiterated that “[f]ailure to warn claims cannot
be brought under a theory of strict liability,” and that, under the RESTATEMENT
(THIRD): PRODUCTS LIABILITY, “negligence principles” are “suitable” for warning
defect claims, id., “Iowa tort law no longer supports [a] distinction [between strict
liability claims and negligence] in the context of design defect and failure to warn
claims.” Id. at 506. Consequently, the proper formulation of a “warning defect” claim
under Iowa law is pursuant to RESTATEMENT (THIRD): PRODUCTS LIABILITY § 2(c),
and should not identify the claim as a “negligence” claim, but as a “warning defect”
claim. Id. at 504-06.
Under RESTATEMENT (THIRD): PRODUCTS LIABILITY § 2(c),
A product is defective when, at the time of sale or
distribution, it contains a manufacturing defect, is defective
in design, or is defective because of inadequate instructions
or warnings. A product:
***
(c) is defective because of inadequate instruction or
warnings when the foreseeable risks of harm posed by the
product could have been reduced or avoided by the
provision of reasonable instructions or warnings by the
seller or other distributor, or a predecessor in the
commercial chain of distribution, and the omission of the
instructions or warnings renders the product not reasonably
safe.
RESTATEMENT (THIRD): PRODUCTS LIABILITY § 2(c). Another section of this version
of the RESTATEMENT explains the general standard for causation under products
liability law:
One engaged in the business of selling or otherwise
distributing products who sells or distributes a defective
30

product is subject to liability for harm to persons or property
caused by the defect.
RESTATEMENT (THIRD): PRODUCTS LIABILITY § 1. Somewhat more specifically,
Whether a product defect caused harm to persons or
property is determined by the prevailing rules and principles
governing causation in tort.
RESTATEMENT (THIRD) § 15.
The “prevailing rules and principles governing causation in tort” under Iowa law
were recently clarified in Thompson v. Kaczinski, 774 N.W.2d 829 (Iowa 2009). In
Thompson, the Iowa Supreme Court adopted the “causation” analysis of RESTATEMENT
(THIRD) OF TORTS: LIABILITY FOR PHYSICAL HARM Ch. 6. Thompson, 774 N.W.2d at
836-39. The court first explained,
We have held causation has two components: cause
in fact and legal cause. Faber v. Herman, 731 N.W.2d 1, 7
(Iowa 2007). The decisions of this court have established it
is the plaintiff’s burden to prove both cause in fact and legal
(proximate) cause. See City of Cedar Falls v. Cedar Falls
Cmty. Sch. Dist., 617 N.W.2d 11, 17 (Iowa 2000). The
latter component requires a policy determination of whether
“the policy of the law must require the defendant to be
legally responsible for the injury.” Gerst v. Marshall, 549
N.W.2d 810, 815 (Iowa 1996). Causation is a question for
the jury, “‘save in very exceptional cases where the facts are
so clear and undisputed, and the relation of cause and effect
so apparent to every candid mind, that but one conclusion
may be fairly drawn therefrom.’” Lindquist v. Des Moines
Union Ry., 239 Iowa 356, 362, 30 N.W.2d 120, 123 (1947)
(quoting Fitter v. Iowa Tel. Co., 143 Iowa 689, 693–94, 121
N.W. 48, 50 (1909)).
Thompson, 774 N.W.2d at 836 (emphasis in first two sentences added; other emphasis
in the original). The court then noted that “[t]he formulation of legal or proximate
cause outlined above has been the source of significant uncertainty and confusion” and
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that “[t]his court’s adherence to the formulation has been less than consistent.” Id.
Therefore, the court took “the opportunity to clarify this area of law.” Id. at 837.
In the part of that clarification most pertinent here, the court explained,
“Tort law does not impose liability on an actor for all
harm factually caused by the actor’s tortious conduct.”
Restatement (Third) ch. 6 Special Note on Proximate Cause,
at 574. This concept has traditionally been designated
“proximate cause.” While this term is used extensively and
appropriately by courts, practitioners, and scholars, it causes
considerable confusion for juries because it does not clearly
express the idea it is meant to represent. See id. § 29 cmt. b,
at 576–77. The confusion arises when jurors understand
“proximate cause” as implying “there is but one cause—the
cause nearest in time or geography to the plaintiff’s harm—
and that factual causation bears on the issue of scope of
liability.” Id. § 29 cmt. b, at 577. Thus, in an attempt to
eliminate unnecessary confusion caused by the traditional
vernacular, the drafters of the third Restatement refer to the
concept of proximate cause as “scope of liability.”
The drafters of the Restatement (Third) explain that
the “legal cause” test articulated in the second Restatement
included both the “substantial factor” prong and the “rule of
law” prong because it was intended to address both factual
and proximate cause. Id. ch. 6 Special Note on Proximate
Cause, at 574. Although the “substantial factor” requirement
has frequently been understood to apply to proximate cause
determinations, see Gerst, 549 N.W.2d at 815–16, the
drafters contend it was never intended to do so. Restatement
(Third) § 29 cmt. a, at 576. Accordingly, to eliminate the
resulting confusion of factual and policy determinations
resulting from the Restatement (Second) formulation of legal
cause, the drafters have opted to address factual cause and
scope of liability (proximate cause) separately. Restatement
(Third) ch. 6 Special Note on Proximate Cause, at 575. The
assessment of scope of liability under the Restatement
(Third) no longer includes a determination of whether the
actor’s conduct was a substantial factor in causing the harm
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at issue, a question properly addressed under the factual
cause rubric. See id. § 27 cmt. j, at 427–29.
Thompson, 774 N.W.2d at 837-38 (emphasis added). The court expressly adopted the
clarification of causation, as consisting of separate questions of scope of liability and
factual cause, in the RESTATEMENT (THIRD) OF TORTS: LIABILITY FOR PHYSICAL
HARM Ch. 6. Id. at 839.
Iowa Civil Jury Instruction No. 1000.3 (2012) has been revised to be consistent
with Thompson and the RESTATEMENT (THIRD): PRODUCTS LIABILITY §§ 1 and 2,
because it casts the “factual causation” element of a warning defect claim in terms of
whether “[t]he omission of the instruction(s) or warning(s) was a cause of plaintiff’s
damages,” then separately addresses the “legal” or “proximate” causation questions in
“scope of liability” elements considering foreseeability and risk.

Iowa Civil Jury

Instruction No. 1000.3 (2012). This model instruction does not use “proximate cause”
at all. The model instruction defining “causation,” Iowa Civil Jury Instruction No.
1000.8, is still stated in terms of “proximate cause”—erroneously, in my view, in light
of Thompson, and inconsistently with the “cause” elements of the other instructions on
product defect claims.

Nevertheless, with the exception of erroneous inclusion of

“proximate,” the definition provided in that model is now consistent with the definition
of “factual cause” in RESTATEMENT (THIRD) OF TORTS: LIABILITY FOR PHYSICAL AND
EMOTIONAL HARM § 26. Compare Iowa Civil Jury Instruction No. 1000.8 (“A defect
in a product is a proximate cause of [damage] when the damage would not have
happened except for the defect.”) with RESTATEMENT (THIRD) OF TORTS: LIABILITY
FOR

PHYSICAL AND EMOTIONAL HARM § 26 (“Conduct is a factual cause of harm when

the harm would not have occurred absent the conduct.”).
Although Abbott has cast its argument for summary judgment on the
Conservator’s warning defect claim in terms of lack of any evidence of “proximate
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cause,” the nature of the challenge is actually to “factual cause.” This is so, because
Abbott’s argument is that the record shows, as a matter of undisputed fact, that
Ms. Surber did not read the label warnings nor rely upon them when making the
decision to use the PIF.
This argument fails, however, because it misconstrues the nature of “factual
causation” in a warning defect case. The question is whether the product was defective
because it provided inadequate warnings and whether the omission of reasonable
instructions caused the harm. See RESTATEMENT (THIRD): PRODUCTS LIABILITY §§ 1
(defining causation) and 2(c) (defining a warning defect); Iowa Civil Jury Instruction
No. 1000.3 (2012). Furthermore, nothing in the adoption of RESTATEMENT (THIRD) OF
TORTS: LIABILITY FOR PHYSICAL AND EMOTIONAL HARM Ch. 6 indicates an intent by
the Iowa Supreme Court to abrogate its rule that, “‘[i]n the context of a failure to warn
claim, [factual] cause can be established by showing a warning would have altered the
plaintiff’s conduct so as to avoid injury.’” Mercer v. Pittway Corp., 616 N.W.2d 602,
624 (Iowa 2000) (quoting Lovick v. Wil-Rich, 588 N.W.2d 688, 700 (Iowa 1999)).
Indeed, this rule is entirely consistent with RESTATEMENT (THIRD): PRODUCTS
LIABILITY § 2(c), which frames the definition of a warning defect, in part, in terms of
whether “the foreseeable risks of harm posed by the product could have been reduced
or avoided by the provision of reasonable instructions or warnings,” and RESTATEMENT
(THIRD): PRODUCTS LIABILITY § 1, which frames the causation element in terms of
whether the omission of reasonable instructions or warnings caused the harm.
Here, Abbott’s assertion that Ms. Surber purportedly did not read the label at
all—an issue on which I concluded, above, that the Conservator has generated a
genuine issue of material fact—or did not consider the warnings on the label in her
decision-making process simply is not dispositive of the Conservator’s “warning
defect” claim.

To the contrary, the Conservator has generated a genuine issue of
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material fact on the “causation” element of the “warning defect” claim by pointing to
evidence, in the form of the somewhat belated affidavit by Ms. Surber, dated April 12,
2013, in which Ms. Surber avers that she “would not have fed [JMK] the NeoSure PIF
if the label stated it was unsuitable for an infant under 28 days, that it may contain
harmful bacteria, or that liquid formula was safer for [JMK].” See Plaintiff’s Appendix
at 620-21; Torgerson, 643 F.3d at 1042-43 (explaining that the non-movant must
“come forward with specific facts showing that there is a genuine issue for trial”
(internal quotation marks and citations omitted)). This evidence is sufficient to raise a
jury question on the “causation” element. See Mercer, 616 N.W.2d at 624; Lovick,
588 N.W.2d at 700.
Therefore, that part of Abbott’s March 20, 2013, Motion For Summary
Judgment (docket no. 86) seeking summary judgment on the Conservator’s “warning
defect” claim is denied.
III.

CONCLUSION

Upon the foregoing,
1.

Abbott’s request for oral arguments on its Motion For Summary Judgment

(docket no. 86) is denied;
2.

The Conservator’s May 14, 2013, Request For Oral Argument (docket

no. 100), seeking oral arguments on Abbott’s Motion For Summary Judgment and
Abbott’s Daubert Motion, is denied;
3.

Abbott’s May 3, 2013, Motion To Strike Megan Surber’s September 19,

2012, Affidavit (docket no. 99) is denied;
4.

Abbott’s May 3, 2013, Motion To Exclude Or Limit Plaintiff’s Proposed

Expert Testimony On Medical And Scientific Causation (Abbott’s Daubert Motion)

35

(docket no. 87) is denied, but without prejudice to challenges during trial to the jury’s
consideration of the experts’ opinions; and
5.

Abbott’s March 20, 2013, Motion For Summary Judgment (docket no.

86), seeking summary judgment on the Conservator’s fraud claim is granted in part
and denied in part, as follows:
a.

That part of the Motion seeking summary judgment on all of the

Conservator’s claims on the ground that the Conservator cannot establish the
required causation of injury to support any of its claims is denied;
b.

That part of the Motion seeking summary judgment on the

Conservator’s remaining breach of warranty claims (Counts 4 and 6) is granted;
c.

That part of the Motion seeking summary judgment on the

Conservator’s fraud claim (Count 7) is granted; and
d.

That part of the Motion seeking summary judgment on the

Conservator’s “warning defect” claim (Count 3) is denied.
THEREFORE, this matter will proceed to jury trial, currently scheduled to
begin on September 3, 2013, on the Conservator’s product defect claims in Counts 1
(manufacturing defect), 2 (design defect), and 3 (warning defect).
IT IS SO ORDERED.
DATED this 3rd day of June, 2013.

______________________________________
MARK W. BENNETT
U.S. DISTRICT COURT JUDGE
NORTHERN DISTRICT OF IOWA

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