THE SECURITY NATIONAL BANK OF SIOUX CITY, IOWA, as Conservator for J.M.K, a Minor, Plaintiff,
ABBOTT LABORATORIES, Defendant.
MEMORANDUM OPINION AND ORDER REGARDING THE DEFENDANT'S MOTIONS FOR SUMMARY JUDGMENT, TO EXCLUDE PLAINTIFF'S CAUSATION EXPERTS, AND TO STRIKE AFFIDAVIT
MARK W. BENNETT, District Judge.
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 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.
A. Factual Background
As general background,  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 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. 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 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 of only liquid formula are plausible, reasonable alternative designs to Abbott's PIF; 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 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."
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.
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. The Challenge To The Affidavit
1. 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 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.
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 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 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 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). 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.
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 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 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 ...