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Allen v. American Capital Ltd.

United States District Court, D. Arizona

December 22, 2017

Charlisa Allen, et al., Plaintiffs,
American Capital Limited, et al., Defendants.


          James A. Teilborg Senior United States District Judge.

         Three sets of motions are pending before the Court. First are Defendants Baxter Healthcare Corporation (“Baxter”), Scientific Protein Laboratories, LLC (“SPL”), and American Capital Limited's (“ACAS”) (collectively “Defendants”) motions to exclude Plaintiffs Charlisa, Joshua, and Jennifer Allen's (collectively “Plaintiffs”) expert witnesses Ronald Moore, (Doc. 149), Suzanne Parisian, (Doc. 150), Clifford Siporin, (id.), and all three of Plaintiffs' causation experts, (Doc. 151.) Second are Defendants' motions for summary judgment. (Docs. 162 & 164.) Third is Plaintiffs' motion to exclude Defense expert Dan Fintel. (Doc. 147.) All parties have responded, (Docs. 153, 154, 155, 156, 181, 183), and replied, (Docs. 157, 158, 159, 160, 188, 189.)

         I. Background

         Plaintiffs are the wife and children of Dr. Robert Allen, who they claim was injured and killed by allegedly contaminated heparin produced, marketed, and sold by Defendants. (Doc. 123.) They claim that Defendants are liable under theories of strict liability due to a manufacturing defect, negligence, breach of implied warranty, breach of express warranty, statutory wrongful death, and statutory survival. (Id. at 7-12.) Heparin is an anticoagulant and is one of the most commonly used medical therapies. (Doc. 151 at 4.)

         On December 1, 2007, Dr. Allen, a forty-five-year-old radiologist, entered the Mayo Clinic in Scottsdale, Arizona (“Mayo”) with abdominal pain and self-diagnosed gastrointestinal disease. (Doc. 155 at 3.) He continued to suffer from this pain throughout the night. (Id. at 4.) At around 6:00 a.m. on December 2, 2007, Dr. Allen was given a subcutaneous dose of heparin. (Id.) Between 10:15 a.m. and 10:30 a.m., Dr. Allen received a bolus dose of heparin. (Id. at 5.) Just before 10:30 a.m., Dr. Allen's ECG strip recorded the beginning of a myocardial infarction, or heart attack, and his telemetry alarm began to sound. (Id.) An echocardiogram performed at 10:34 a.m. indicated that there was significant damage to the heart. (Id.) Dr. Allen was brought to the cardiac catheterization laboratory at around 11:24 a.m., where he underwent a thrombectomy to extract clots from his heart. (Id.) At around 11:53 a.m., in the midst of the thrombectomy, Dr. Allen received two more bolus doses of heparin. (Id. at 5-6.) Eventually, Dr. Allen became hypotensive, he vomited blood, and he suffered from cardiogenic shock. (Id. at 6.) Following this procedure, he developed heparin-induced thrombocytopenia (“HIT”). (Id.) On December 6, 2007, doctors replaced Dr. Allen's heart with a total artificial heart. (Id. at 7.) Dr. Allen began to suffer from end organ failure, and on February 27, 2008, doctors replaced the total artificial heart with a human transplant and replaced Dr. Allen's kidneys. (Id.) The transplanted heart failed and, despite further procedures, Dr. Allen died on March 7, 2008. (Id.)

         SPL is a limited liability company that primarily produces heparin active pharmaceutical ingredient (“API”), a precursor to usable heparin medication. (Doc. 162 at 3-4.) It creates API in processing facilities in Wisconsin and in China using crude heparin. (Id.) The primary raw material in crude heparin is porcine intestinal mucosa, which SPL sources from intermediaries, who in turn gather intestines from slaughtered pigs in North America and China. (Id.) ACAS is a majority shareholder in SPL Acquisition Corp., the sole member of SPL. (Doc. 164 at 6-7.) In 2007, Baxter used SPL heparin API to produce usable heparin medication, which it distributed to wholesalers, who passed it on to end users, such as Mayo. (Id. at 4.)

         Toward the end of December 2007, Baxter observed an increase in adverse events from particular lots of their heparin. (Doc. 151 at 4.) Baxter notified the authorities of these issues, who launched an investigation. (Doc. 151 5.) Public health authorities ultimately concluded that these adverse events were caused by a third party introducing a contaminant, oversulfated chondroitin sulfate (“OSCS”), into crude heparin as a cost-saving measure. (Doc. 162 at 6.)

         Plaintiffs around the country brought suits in state and federal court for harm allegedly caused by contaminated heparin. (Doc. 151 at 8.) The federal cases were consolidated by the Judicial Panel on Multidistrict Litigation in the Northern District of Ohio (“MDL court”). (Id.) This case was before the MDL court for over eight years and is the last of the consolidated federal cases. (Id.; Doc. 155 at 2.)

         II. Legal Standards

         This Court has diversity jurisdiction under Section 1332. See 28 U.S.C. § 1332 (2012); see also U.S. Const., art. III, § 2. A court sitting in diversity applies federal procedural law and state substantive law. See Erie R. Co. v. Tompkins, 304 U.S. 64, 78 (1938). In the case of Multidistrict Litigation (“MDL”), both the MDL court and the non-MDL court apply the substantive law of the non-MDL court's forum state. See In re Korean Air Lines Co., Ltd., 642 F.3d 685, 699 & n.12 (9th Cir. 2011) (citing In re Korean Air Lines Disaster of Sept. 1, 1983, 829 F.2d 1171, 1176 (D.C. Cir. 1987)); Wahl v. Gen. Elec. Co., 786 F.3d 491, 494-99 (6th Cir. 2015) (describing the majority view that cases filed directly in an MDL apply the substantive law of the court where the case would have otherwise been brought). Choice-of-law decisions are substantive and must be settled before further analysis. See Klaxon Co. v. Stentor Elec. Mfg. Co., Inc., 313 U.S. 487, 496 (1941).

         Both parties implicitly agree, with one exception, that Arizona law applies. See, e.g., (Doc. 123 at 11-12; Doc. 124 at 21, 24; Doc. 125 at 21, 24.) Therefore, Arizona substantive law governs, except where otherwise noted.[1] See In re Korean Air Lines Disaster of Sept. 1, 1983, 932 F.2d 1475, 1495 (“[C]ourts need not address choice of law questions sua sponte”); Ind. Lumbermens Mut. Ins. Co. v. W. Or. Wood Prods., Inc., 268 F.3d 639, 644 n.3 (9th Cir. 2001) (applying Oregon law where the parties implicitly agreed that Oregon law applied due to a choice-of-law provision in the governing contract).

         Except where “a state evidence rule is ‘intimately bound up' with the rights and obligations being asserted, ” federal evidentiary rules apply. Wray v. Gregory, 61 F.3d 1414, 1417 (9th Cir. 1995) (per curiam). Neither party asserts, and this Court finds no indication, that Arizona substantive law supplants the Federal Rules of Evidence in this case. Therefore, the Federal Rules of Evidence shall govern the evidentiary matters presented in the pending motions.

         Under Federal Rule of Civil Procedure 54(b), before final judgment, a court may revise its earlier decisions that “adjudicate[] fewer than all the claims” of the parties. Fed.R.Civ.P. 54(b). This broad retrospective power to modify, however, has been narrowed by the law of the case doctrine. Under this doctrine, a court will generally not, as a matter of practice, reexamine its earlier decisions. Thomas v. Bible, 983 F.2d 152, 154 (9th Cir. 1993). “For the doctrine to apply, the issue in question must have been ‘decided either expressly or by necessary implication in [the] previous disposition.'” Id. (alteration in original) (quoting Milgard Tempering, Inc. v. Selas Corp. of Am., 902 F.2d 703, 715 (9th Cir. 1990)). Courts retain discretion to apply the doctrine, but abuse that discretion by reopening previously decided issues falling outside of five enumerated circumstances. Id. at 155. Thus, “[d]epending on the nature of the case or the issue, ” reconsideration may only occur where “(1) the first decision was clearly erroneous; (2) an intervening change in the law has occurred; (3) the evidence on remand is substantially different; (4) other changed circumstances exist; [or] (5) a manifest injustice would otherwise result.” Id.

         The United States Court of Appeals for the Ninth Circuit (“Ninth Circuit”) has suggested, however, that the law of the case does not bar a district court from reconsidering its own pretrial rulings before final judgment. Peralta v. Dillard, 744 F.3d 1076, 1088 (9th Cir. 2014) (en banc) (holding that the law of the case did not bar a court from granting judgment as a matter of law to a party despite previously rejecting that party's motion for summary judgment). In so deciding, the court reasoned that facts continue to develop as a case progresses, which may change the appropriateness of prior rulings. Id.

         The Ninth Circuit has not held that the law of the case applies to MDL cases; however, courts within this circuit have, see, e.g., Parkinson v. Novartis Pharm. Corp., 5 F.Supp.3d 1265, 1271-72 (D. Or. 2014), the doctrine applies to other forms of transfer, Christianson v. Colt Indus. Operating Corp., 486 U.S. 800, 815-16 (1988); Muth v. Fondren, 676 F.3d 815, 818-19 (9th Cir. 2012), and the policies of judicial economy and finality that justify MDL litigation, see Stanley A. Weigel, The Judicial Panel on Multidistrict Litigation, Transferor Courts and Transferee Courts, 78 F.R.D. 575, 577 (1978); 28 U.S.C. § 1407(a) (noting that transfer is for the “convenience of parties and witnesses” and must “promote . . . just and efficient conduct”), all warrant applying the doctrine to MDL cases. The parties generally accept, and the Court will generally follow, the MDL court's holdings. The few instances where the parties challenge such decisions are discussed below and only in those circumstances will this Court entertain the possibility of reconsideration.

         III. Expert Witness Admissibility

         This Court acts as a gatekeeper in considering the admissibility of expert witness testimony that involves “scientific, technical, or other specialized knowledge.” Fed.R.Evid. 702(a); Fed.R.Evid. 104(a); Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 597 (1993); Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 141 (1999). In exercising this gatekeeping function, a court must determine that the experts are qualified, that their opinions are reliable, and that their testimony fits the case. Daubert, 509 U.S. at 591-93; Fed.R.Evid. 702. The proponent of the expert bears “the burden of proving admissibility.” Lust v. Merrell Dow Pharm., 89 F.3d 594, 598 (9th Cir. 1996); see Daubert v. Merrell Dow Pharm., 43 F.3d 1311, 1316 (9th Cir. 1995) (hereinafter “Daubert II”). This analysis is meant to be flexible. Daubert, 509 U.S. at 595. In engaging in this flexible analysis, the Court must not supplant the jury's fact-finding role, see Daubert, 509 U.S. at 595; United States v. Sandoval-Mendoza, 472 F.3d 645, 654 (9th Cir. 2006); however, the Court cannot abdicate its gatekeeping role nor delegate that responsibility to the jury, Estate of Barabin v. AstenJohnson, Inc., 740 F.3d 457, 464 (9th Cir. 2014) (en banc). Ultimately, “shaky but admissible evidence” is better handled by “[v]igorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof” than by judicial exclusion. Daubert, 509 U.S. at 597; see Alaska Rent-A-Car, Inc. v. Avis Budget Grp., Inc., 738 F.3d 960, 969-70 (9th Cir. 2013).

         First, a putative expert must be qualified as an expert by “knowledge, skill, experience, training, or education.” Fed.R.Evid. 702. The qualification standard is meant to be broad and to seek a “minimal foundation” justifying the expert's role as an expert. Hangarter v. Provident Life & Accident Ins. Co., 373 F.3d 998, 1015-16 (9th Cir. 2004) (quoting Thomas v. Newton Int'l Enters., 42 F.3d 1266, 1269 (9th Cir. 1994)); see Ericson v. City of Phoenix, No. CV-14-01942-PHX-JAT, 2016 WL 6522805, at *3-4 (D. Ariz. Nov. 3, 2016) (finding a nurse practitioner qualified to testify regarding asphyxiation, despite her lack of independent research, due to her professional knowledge of, and experience with, strangulation); Heck v. City of Lake Havasu, No. CV 04-1810-PCT-NVW, 2006 WL 2460917, at *7-8 (D. Ariz. Aug. 24, 2006) (finding that a professor's extensive study of the effects of carbon monoxide poisoning qualified him to testify that such poisoning caused the decedent's death, despite the professor having no training in forensic pathology).

         Second, the reliability of an expert's opinion is determined almost exclusively by looking at their decision-making process. Daubert, 509 U.S. at 593-94. In Daubert, the Supreme Court provided four non-exclusive factors to probe the expert's methodology. Id. Under this scheme, a court asks whether the expert's methodology “can be (and has been) tested, ” whether it has been subjected to peer review and publication, what its “known or potential rate of error” is, and whether it has been generally accepted by others in the field. Id. A court need not “methodologically walkthrough” each factor, as “not every factor is relevant to reliability in every case.” Murray v. S. Route Mar. SA, 870 F.3d 915, 924 (9th Cir. 2017); see Kumho Tire, 526 U.S. at 142; Daubert II, 43 F.3d at 1316-17. Ultimately, “the significance of each factor is case-dependent.” Id. Furthermore, it is “very significant” whether the expert is testifying “about matters growing naturally and directly out of research they have conducted independent of litigation, or whether they have developed their opinions expressly for the purpose of testifying.” Daubert II, 43 F.3d at 1317. If the opinion is produced for litigation, the proffering party must provide “other objective, verifiable evidence that the testimony is based on ‘scientifically valid principles, '” such as peer review. Id. In assessing reliability, a court may peek beyond an expert's methodology to his or her conclusion where “there is simply too great an analytical gap between the data and the opinion proffered.” Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997).

         Third, fit “goes primarily to relevance.” Daubert, 509 U.S. at 591. Testimony is relevant if it “has any tendency to make a fact more or less probable than it would be without the evidence, ” and “the fact is of consequence in determining the action.” Fed.R.Evid. 401. Fit goes beyond the bare relevance standard, however, in that it further requires that the testimony or evidence “speak[] clearly and directly to an issue in dispute in the case” and “not mislead the jury.” Daubert II, 43 F.3d at 1321 n.17.

         This Court will first analyze Defendants' challenge to Plaintiffs' product identification expert. Then it will consider the parties' challenges to their opponents' causation experts. Finally, it will consider Defendants' challenge to Plaintiffs' professional standard of care experts.

         A. Plaintiffs' Product Identification Expert

         Defendants challenge the opinion of Plaintiffs' product identification expert- Ronald Moore, R.Ph-on three grounds. First, Defendants claim that Mr. Moore, by claiming that the 6:00 a.m. and 10:15 a.m.[2] doses were contaminated, contravenes the MDL court's grant of summary judgment. (Doc. 149 at 1-2.) Second, Defendants aver, Mr. Moore's product identification analysis is not reliable under Daubert. (Id. at 2.) Third, Defendants argue that Mr. Moore's product identification opinion is based on “simple math, ” which is not helpful to the jury. (Id.)

         Because the Court ultimately concludes that Mr. Moore's product identification opinion is unreliable, it does not reach the third issue of whether Mr. Moore's product identification opinion would be helpful to the jury.

         1. The 6:00 a.m. and 10:15 a.m. Doses

         Defendants claim that the MDL court has already determined, on summary judgment, that Dr. Allen was not given contaminated heparin at 6:00 a.m. and 10:15 a.m. (Id. at 1-2.) On summary judgment, the MDL court had before it two affidavits by, and the deposition of, Patricia Earl, Plaintiffs' MDL product identification expert.

         The MDL court found unpersuasive Ms. Earl's testimony that the 6:00 a.m. and 10:15 a.m. doses were contaminated. In re: Heparin Prods. Liab. Litig., No. 1:10HC60098, 2016 WL 2868684, at *5 (N.D. Ohio May 17, 2016). The MDL court explained that the Pyxis unit, a computerized pharmaceutical dispensing machine, from which the heparin was drawn records such withdrawals. Id. In particular, the machine's records have a field for a MedId., which is used for billing purposes, and a MedAltID, which can be filled in by hospital staff. Id. The MedAltID for the two doses at issue included the numbers “46912621.” Id. The MDL court determined that this sequence of numbers represented a National Drug Code (“NDC”) number that identifies a drug's manufacturer, the drug type and dosage, and the form of packaging. Id. Usually, the MDL court explained, NDC numbers are eleven units long and are broken up by hyphens in the following form: “#####-####-##.” Id. The FDA sets the manufacturer identification number constituting the first five digits of the code. Id. Baxter's manufacturer number is 00641, while 00469 is that of APP Pharmaceuticals, LLC (“APP”), one of Baxter's competitors. Id. The MDL court found unpersuasive Ms. Earl's claim that the MedAltId. numbers for the two doses at issue were an internal hospital reference number, instead finding that these were NDC codes written in shorthand without the hyphens and zeroes-an occurrence Ms. Earl conceded was possible. Id. & n.5. In particular, the MDL Court cited a Defense exhibit showing that APP produced heparin with the NDC number “00469-1262-15.” Id. at 9. Therefore, the MDL court held that there was no genuine issue of material fact regarding whether the two doses at issue were contaminated Baxter heparin-finding that the NDC number established that these doses were produced by APP-and granted summary judgment on that issue. Id. at *6.

         Plaintiffs now claim that their new product identification expert, Mr. Moore, has access to a database that their previous expert did not, and can offer proof showing that the MedAltId. “46912621” did not represent a current NDC number, thus introducing the possibility that Baxter produced the two doses at issue. (Doc. 156 at 6-9.) Mr. Moore, using information contained in the database, determined that the NDC number 00469-1262-15, which was contained in the exhibit cited by the MDL court, became obsolete on April 30, 2001, which was more than six years before Dr. Allen was given the allegedly contaminated heparin. (Id. at 9-10.) According to Plaintiffs, heparin has a shelf life of less than two years. (Id. at 8 n.5.) Furthermore, Mr. Moore cited materials provided by Mayo showing that it did not order any drugs with the NDC number 00469-1262-15 in 2007. (Id. at 8.) Therefore, Mr. Moore concluded that Dr. Allen could not have been given a drug with this NDC number. (Id. at 8-9.) Rather, Mr. Moore explained that the MedAltID field is filled manually, and is not routinely updated when hospitals switch manufacturers. (Id.) This undermines the MDL court's determination that the two relevant doses must have been produced by APP.

         Plaintiffs make two arguments as to why this Court is not bound to follow the MDL court's rulings on the two relevant doses. (Doc. 155 at 11.) First, Plaintiffs note that the MDL court only formally denied summary judgment. (Id.) Second, Plaintiffs argue that the issue is not finally decided, because Mr. Moore's review of the database produced new evidence that Dr. Allen was not definitively given APP heparin. (Id.)

         a. The Scope of Summary Judgment

         Plaintiffs' initial argument is that the MDL court's ruling is not binding because the MDL court only formally denied Defendants' motion for summary judgment. (Id.) In other words, Plaintiffs dispute Defendants' interpretation of the conclusion of the summary judgment order, which Defendants interpret to mean that summary judgment was denied only on claims stated in the conclusion and granted on all other claims discussed in the order.

         In its decision, the MDL court expressly stated that it found “no genuine issue of material fact as to whether Baxter manufactured the heparin administered at 6:00 a.m. and 10:15 a.m.; it clearly did not.” In re: Heparin Prods. Liab. Litig., 2016 WL 2868684, at *5. The MDL court expressly excluded those doses from the paragraph detailing which issues are appropriate for trial. Id. at *6-7. However, the MDL court did not restate this holding in the conclusion. Plaintiffs fail to cite authority establishing that a court only grants summary judgment on those issues expressly stated in the conclusion, rather than those explicitly made in the body of the opinion.

         If, however, Plaintiffs' argument were correct, this Court would adopt the MDL court's reasoning, based upon the evidence before it at that time, and hold that there was no genuine issue of material fact as to whether the two relevant doses were contaminated Baxter heparin.

         b. The Law of the Case

         Plaintiffs' second argument is effectively that there is substantially different evidence before this Court justifying a departure from the law of the case. (Doc. 155 at 11-12.) Defendants' primary response is that this evidence is not new; while Ms. Earl did not have access to the same database as Mr. Moore, she did have access to public sources of information, such as “RED BOOK” and she twice failed to appropriately explain the information in the Pyxis records. (Doc. 159 at 6-7.)

         As an initial matter, the law of the case likely does not bind this Court to follow pretrial rulings, Peralta v. Dillard, 744 F.3d 1076, 1088 (9th Cir. 2014) (en banc); therefore, it can discretionarily reconsider the motion for summary judgment with no further analysis. However, even applying the law of the case doctrine, Plaintiffs have shown substantially different evidence justifying departure from the prior ruling.

         Mr. Moore's explanation that the sequence of numbers in the MedAltID field represents an expired NDC number is clearly substantially different evidence than that presented by Ms. Earl. Ms. Earl did not testify that the code represented an expired NDC number, but rather that the units represented an internal Mayo reference number, which the MDL court justifiably found unpersuasive. Given its dispositive nature, Mr. Moore's testimony constitutes substantially different evidence.

         Defendants make four arguments as to why the MDL court's ruling stands. First, there is no new evidence justifying reconsideration. Second, reconsideration frustrates the purpose of the MDL procedure. Third, this Court should defer to the MDL court's expertise. Fourth, Local Rule 7.2 bars Plaintiffs' belated request for reconsideration.

         First, Defendants assert, without citation, that this evidence must be new in the sense that it was not previously discoverable and contend that Ms. Earl had the opportunity to access databases that detailed the expiration of the NDC number. (Doc. 149 at 10-11; Doc. 159 at 6-7.) In making this argument, Defendants rely primarily on equitable considerations, arguing that they have “made strategic decisions about fact depositions, decided not to name a product identification expert, prepared a medical causation expert report, filed Daubert motions, deposed plaintiffs' experts, and have been working to prepare a summary judgment motion” in reliance on the MDL court's product identification holding. (Doc. 159 at 5.)

         The equitable force of Defendants' argument is diminished by the permissive discovery scheduled set by this Court. Defendants became aware of Mr. Moore's opinion on June 9, 2017. (Doc. 126 at 2.) Defendants then had until July 7, 2017 to make their expert disclosures, August 18, 2017 to depose Mr. Moore, September 1, 2017 to file their Daubert motions, and October 6, 2017 to file their motions for summary judgment. (Doc. 144 at 2-3.) Thus, Defendants had nearly a month to assess Mr. Moore's opinion-which plainly introduces a genuine issue of material fact regarding the status of the 6:00 a.m. and 10:15 a.m. doses-and determine whether it would be prudent to retain a product identification expert. Additionally, Defendants took Mr. Moore's deposition on August 30, 2017-over two months after they received his report-and did not once inquire about his opinions regarding the two earlier doses. See (Doc. 149-2.) Furthermore, Defendants had nearly three months to address the earlier doses in their Daubert motion and four months to address the issue on summary judgment. Simply, Defendants squandered multiple opportunities, over a span of months, to address Mr. Moore's opinions regarding the 6:00 a.m. and 10:15 a.m. doses, despite awareness that discovery was still ongoing and that Plaintiffs had offered Mr. Moore to testify on the earlier doses.

         Second, Defendants' contention that the primary purpose of multidistrict litigation-to economize-would be frustrated by reconsidering these issues is unavailing. Multidistrict litigation encourages consolidation to “promote the just and efficient conduct” of actions, 28 U.S.C. § 1407(a); this goal is not met by the MDL court adjudicating issues of fact and law unique to a single action. This reasoning is bolstered by the Judicial Panel on Multidistrict Litigation's opinion consolidating the heparin cases due to “common questions of fact” involving allegedly contaminated Baxter heparin, which would serve to “eliminate duplicative discovery; avoid inconsistent pretrial rulings; and conserve the resources of the parties, their counsel and the judiciary.” In re Heparin Prods. Liab. Litig., 559 F.Supp.2d 1403, 1404 (J.P.M.L. 2008). Discovery and pretrial rulings on whether Dr. Allen received contaminated Baxter heparin at particular times do not bear on the common questions of fact that justify multidistrict litigation.

         Third, Defendants' appeal to the MDL court's specialized expertise, gained over a period of years adjudicating cases involving allegedly contaminated heparin, does not squarely bear on this issue. While the MDL court surely obtained an impressive understanding of the issues in this case, including product identification, its decision regarding the earlier doses was grounded in a different set of evidence than that before the Court today. The MDL court did not have the benefit of Mr. Moore tracking down the defunct NDC number and his equally important explanation as to why that number remained in the MedAltID field. Thus, even without the MDL court's extensive experience with scores of heparin cases, this Court is confident that Mr. Moore has unsurfaced a genuine issue of material fact regarding whether the earlier doses were contaminated Baxter heparin.

         Fourth, the Local Rules do not bar Mr. Moore's testimony for two reasons. First, this Court need not even address Defendants' invocation of the Local Rules, because Defendants raise this argument for the first time in a reply brief, depriving Plaintiffs of an opportunity to respond. See Sonoran Res., LLC v. Oroco Res. Corp., No. CV-13-01266-PHX-JJT, 2015 WL 11089497, at *7 n.4 (D. Ariz. Apr. 17, 2015); MJG Enters., Inc. v. Cloyd, No. CV-10-0086-PHX-MHM, 2010 WL 3842222, at *6 n.1 (D. Ariz. Sept. 27, 2010). Second, good cause provides an exception to the timing requirements of Local Rule 7.2(g)(2). See LRCiv 7.2(g)(2). Good cause exists for Plaintiffs' belated filing, given the irregular procedural structure of this proceeding under which the parties were subject to multiple periods of discovery.

         2. Reliability

         Defendants next argue that Mr. Moore's opinion is unreliable for four reasons. First, Mr. Moore's turnaround time calculation is unreliable. (Doc. 149 at 11.) Second, Mr. Moore improperly cherry-picked the data that he relies upon. (Id. at 15.) Third, Moore's opinion fails to satisfy the Daubert factors. (Id. at 15-16.) Fourth, Mr. Moore's experience does not make his opinion reliable. (Id. at 17.)

         a. Turnaround Time

         Mr. Moore provided two different conclusions regarding the turnaround time of heparin. First, Mr. Moore concluded that “it was more likely than not” that Dr. Allen received contaminated Baxter heparin from 1, 000U/ML in 10ML vials for order numbers 115 and 116. (Doc. 149-1 at 5.) Second, he concluded that it was “more likely than not” that Dr. Allen received contaminated Baxter heparin from 5, 000U/ML in 1ML vials for order numbers 68 and 102. (Id.) To reach these conclusions, Mr. Moore had to opine regarding the amount of time the wholesaler (“Cardinal”) held onto Baxter heparin, which lot numbers of heparin that Cardinal shipped to Mayo, and the amount of time Mayo stored heparin before using it.

         Mr. Moore's opinion is based on a number of sources. First, Mr. Moore relies on his experience in the pharmaceutical industry, with emphasis on his experience at Cardinal in particular. As part of this experience, Mr. Moore claims that pharmaceutical wholesalers and hospitals follow two industry standards: just-in-time inventory practice, under which product is ordered as needed rather than stockpiled, and first-in, first-out (“FIFO”), where drugs are shipped and utilized in chronological order to prevent expiration. (Id. at 13-14.) Second, he relies on four spreadsheets-one from Baxter describing shipments to Cardinal, one from Cardinal describing all Cardinal purchases of heparin, one from Cardinal describing all heparin shipments to Mayo, and one from Mayo showing all purchases of heparin from Cardinal. (Id. at 10-11.) The Mayo and Cardinal spreadsheets include the manufacturer name, the NDC number, the amount of heparin in each package, the order quantity, and the shipment quantity. (Id.) The Baxter spreadsheet contains the same information with the addition of lot numbers. (Id. at 11.) Third, Mr. Moore relies on a document by Baxter detailing the contaminated shipment lot numbers. (Id.) Fourth, Mr. Moore relies upon a memo produced by a Baxter employee estimating the amount of uncontaminated Baxter product remaining in the field. Fifth, Mr. Moore relies on written Mayo policies detailing drug purchase times, inventory review, and drug expiration disposal. (Id. at 12-13.) Sixth, Mr. Moore relies on a Mayo document describing how much heparin they sent back in the recall. (Id. at 26-27.)

         Defendants aver that Mr. Moore's calculations for the turnaround times for the heparin at Cardinal and Mayo are based upon speculation. (Id. at 11.) Generally, Defendants claim, Mr. Moore guesses as to how long it took for Cardinal to ship heparin to Mayo, and then guesses as to how long it took Mayo to use the heparin upon receipt. Defendants argue that Mr. Moore's reliance upon documents to justify his guesses is unfounded because he “draws unreasonable conclusions from them.” (Id.) Thus, Defendants conclude, Mr. Moore's testimony is unreliable. (Id.)

         i. 1, 000U/ML in 10ML Vials

         Mr. Moore claims that it is more likely than not that Dr. Allen received two doses of contaminated Baxter heparin contained in 1, 000U/ML in 10ML vials. To reach this conclusion, Mr. Moore tracks contaminated Baxter heparin, via the lot numbers and shipment information provided by Baxter, to Cardinal. (Id. at 16.) Once at Cardinal, Mr. Moore can no longer track lot numbers, but instead bases his opinion on industry practices-namely, just-in-time inventory and FIFO-the shipment times, the quantity, and the NDC numbers of heparin moving from Cardinal to Mayo, and the Baxter employee memo detailing the amount of uncontaminated Baxter heparin remaining in the field. (Id.) Ultimately, Mr. Moore concludes that because Cardinal only had contaminated heparin for the five weeks preceding December 2, 2007, and because Cardinal and Mayo each stored that heparin for two weeks, Dr. Allen more likely than not received contaminated Baxter heparin. (Id. at 15-17.)

         First, Defendants argue that Mr. Moore's calculation of the turnaround time of two weeks for the 1, 000U/ML in 10ML vials is unreliable, because it is based, in part, upon a post-recall Baxter document discussing average Baxter heparin supplies. (Doc. 149 at 11-12.) This Baxter memo prepared by E. DeLuise, a Baxter employee, (“DeLuise Memo”) discusses four wholesalers, including Cardinal, who make up 85% of Baxter's heparin sales for the relevant dose sizes. (Doc. 149-1 at 17.) The relevant portion of this memo states:

[F]rom a historical perspective, there is approximately 2 weeks inventory stored on average at the end user location . . . . I estimate that the existing field inventory of 10 [M]L vials to be a total of 2.2 weeks of usable Baxter product inventory at the wholesaler and end user locations.


         Defendants first contend that the DeLuise Memo does not support Mr. Moore's conclusion, because it was written after Baxter's recall of heparin, and both fails to discuss pre-recall supplies at wholesalers and hospitals and establishes a shorter turnaround time due diminishing post-recall supplies. (Doc. 149 at 11.) Plaintiffs respond that the memo expressly discusses historical averages, thus implicating pre-recall supplies of heparin. (Doc. 156 at 14.)

         The memo temporally distinguishes its conclusions as to past data-that end users, like Mayo, historically and on average have two weeks of heparin on hand-with its estimations as to the current post-recall amounts of heparin held by both wholesalers, like Cardinal, and end users. Thus, the fact that there was a recall does not affect the memo's conclusion as to the two week time period for end users at the time Dr. Allen received heparin. With regard to wholesalers, however, the memo only estimates post-recall turnaround times of 2.2 weeks.

         Plaintiffs contend that Defendants are “disingenuous” for making the argument that there would be less inventory due to the recall, because the recall occurred one day before the memo went out. (Doc. 156 at 14 n.9.) The memo, however, takes into account “usable Baxter product, ” meaning that it does not count any potentially-contaminated recalled products. (Doc. 149-1 at 17 (emphasis added.)) The practical difficulties in implementing a recall do not bear on this analysis, because the memo analytically takes into account only non-recalled product.

         Defendants next contend that the memo does not provide support for Mr. Moore's conclusion as to wholesalers, because it averages the data from four[3] different wholesalers to reach the 2.2 week turnaround time for wholesalers. (Doc. 149 at 12.) Plaintiffs do not respond to this contention. See (Doc. 156.) This certainly does cut against the appropriateness of Mr. Moore's reliance on the report, given that Cardinal's inventory could have varied greatly from that of other wholesalers, which would not be clearly reflected in the average. Although unraised by Defendants, the same logic seems to corrupt the reliability of the memo's estimation of end user inventory as well. See (Doc. 149-1 at 17 (“[T]here is approximately 2 weeks inventory stored on average at the end user location”) (emphasis added.)) Thus, without more, Mr. Moore's reliance on the memo was misplaced and lessens the reliability of his expert opinion.

         Plaintiffs contend that Mr. Moore independently corroborated the memo's conclusions through personal experience working at Cardinal and independent review of records from Cardinal and Mayo showing two week turnaround times. (Doc. 156 at 13.) As Defendants note, however, Mr. Moore's experience does not directly support his opinion, because he was not involved in Cardinal's sale of heparin to end users during 2007, he did not request information from Cardinal or Mayo on how long they stored heparin, and he was not aware of how long it took Cardinal to ship heparin to Mayo. (Doc. 149 at 17.) While his experience working at Cardinal gave him some specialized knowledge as to Cardinal's internal practices, his lack of familiarity with heparin, Cardinal's storage of heparin, and Mayo's storage practices detract from the corroborating power of his opinion. Additionally, as discussed below, Mr. Moore's independent analysis of Cardinal and Mayo turnaround times is unreliable.

         Defendants next contend that Mr. Moore improperly used the DeLuise Memo to determine that Cardinal had a two week turnaround time. (Doc. 149 at 12.) As Defendants note, and as discussed above, the memo estimates that end users historically had a two week turnaround time, while end users and wholesalers had 2.2 weeks of inventory at the time the memo was written. (Doc. 149-1 at 17.) Mr. Moore-without explanation-concluded that Cardinal, a wholesaler, had a two-week inventory of heparin, despite the report estimating 2.2 weeks. (Id.) Defendants argue that that this unexplained rounding down has a practical impact, because Cardinal had received a shipment of uncontaminated heparin “just four days before the shipment that Moore identifies as containing Robert Allen's dose.” (Doc. 149 at 12.) Plaintiffs respond that this rounding down does not affect Mr. Moore's conclusion, because he “identifies as likely containing Dr. Allen's dose” contaminated shipments “received by Cardinal on November 12 and 16, 2007.” (Doc. 156 at 14.) Plaintiffs go on to say that the prior two shipments, on November 5, 2007 and October 26, 2007, were also both contaminated. (Id.) Defendants correctly respond that Mr. Moore never limited Dr. Allen's doses to November 12 and 16, but rather concluded that Dr. Allen likely received “Baxter lot number 087095 or 087092, ” which totaled six shipments to Cardinal, and lot number 087095 was received as early as October 26, 2007. (Doc. 159 at 11; Doc. 149-1 at 17.) Just four days before that date, Cardinal received a shipment of uncontaminated Baxter heparin. (Doc. 194-2 at 76.) Plaintiffs note that Mr. Moore testified that Cardinal's practices would put them “at the lesser end of average rather than the greater.” (Doc. 156 at 14.) Mr. Moore admitted, however, that if one used the unrounded 2.2 weeks from the DeLuise Memo, it was “within the realm of possibility” that the lot 087092 would not have even been received by Mayo in time for use in Dr. Allen's procedure, (Doc. 130- 31.) The uncertainty in Mr. Moore's opinion arises from him “not knowing . . . the specifics.” (Id. at 131.) Uncertainty regarding reasonably obtainable information weighs against methodological reliability.

         Furthering this point was Mr. Moore's testimony that it was possible that “Cardinal's inventory supply [of heparin] could be 15, 16, 17, 18 days.” (Doc. 149-2 at 108.) Mr. Moore testified that this higher end was not likely, because Cardinal wanted to maintain a “thin” supply to obtain a “maximum return on” investment. (Id. at 109.) But Mr. Moore still must rely on speculation, based upon his experience with Cardinal in the past, in a different department, involving a different region of the country, with different drugs, to reach this conclusion. Thus, Mr. Moore's methodology does not reliably provide the basis for the conclusion that it was more likely than not that Dr. Allen received contaminated rather than uncontaminated heparin from the 1, 000U/ML in 10ML vials.

         ii. 5, 000U/ML in 1ML Vials

         Mr. Moore concluded that Dr. Allen more likely than not received two doses of contaminated Baxter heparin from 5, 000U/ML in 1ML vials. Mr. Moore's analysis of these doses is similar to that of the 1, 000U/ML in 10ML vials, and results in Mr. Moore finding that there is a 21-day turnaround period from Cardinal receiving the heparin from Baxter to the patient receiving the heparin at Mayo. (Doc. 149-1 at 19.) Mr. Moore determined that the two lots Baxter shipped to Cardinal closest to 21 days before Dr. Allen received heparin at Mayo were lots of contaminated Baxter heparin. (Id.) One of these shipments, received November 6, 2007, was the last contaminated shipment containing NDC number 0641-0400-25. (Id.) The next shipment, which Cardinal received on December 4, 2007, was also contaminated and included a different NDC number. (Id.) The heparin with the new NDC number was first received by Mayo on December 11, 2007, which led Mr. Moore to conclude that the turnaround time from Cardinal to Mayo was one week. (Id. at 26.)

         Defendants contend that Mr. Moore's testimony that Cardinal turned around heparin in a week conflicts with the evidence that Cardinal did not receive any heparin for a month, suggesting that Cardinal did not completely turnover its heparin within a week. (Doc. 149 at 13; Doc. 149-2 at 89.) Mr. Moore's failure to explain his departure from this evidence, Defendants contend, makes his opinion unreliable. (Id.)

         Plaintiffs attempt to defend Mr. Moore's opinion on this front by noting that Mr. Moore opined that there was a supply problem, and that past data showed a one week turnaround time. (Doc. 156 at 16.) But Mr. Moore's suggestion of a supply problem is pure speculation. According to Mr. Moore:

[There was] some problem that I guess Baxter had recognized. Because their shipments up to that point had been fairly regular, and then all of a sudden, you have something that's changed. Because the next entry after that, almost 28 days, is a brand-new NDC number, which that would have meant they were having to - they were depleting the inventory down even further . . . . [T]he only thing I can speculate on is that in that time period, knowing that they had a limited supply coming in, that they would have modified their shipping. Mayo Health being one of their probably primary customers, they would have begun parceling that and holding that inventory in stock longer than normal to ship out. But I'm having to speculate on that because I don't have that information.

(Doc. 149-2 at 90, 93-94 (emphasis added.))

         Mr. Moore, through speculation, invents a supply chain problem to explain away contrary evidence, which diminishes the reliability of his expert opinion. See Cabrera v. Cordis Corp., 134 F.3d 1418, 1423 (9th Cir. 1998) (“An opinion based on . . . unsubstantiated and undocumented information is the antithesis of the scientifically reliable expert opinion admissible under Daubert and Rule 702.”); United States v. Scholl, 959 F.Supp. 1189, 1197 (D. Ariz. 1997) (excluding as unreliable expert testimony that “barely r[ose] above mere speculation.”).

         Defendants further attack Mr. Moore's opinion regarding the 5, 000U/ML in 1ML vials by claiming that he failed to account for Cardinal receiving a large shipment of uncontaminated heparin “just four days before a smaller shipment of contaminated heparin containing the lot that Moore alleges” that Dr. Allen received. (Doc. 149 at 14 (emphasis removed.)) Plaintiffs respond by arguing that Mr. Moore did consider this larger shipment and that their disagreement with his conclusion is a matter appropriate for cross-examination rather than exclusion. (Doc. 156 at 16.)

         Specifically, Cardinal received 320 packages of uncontaminated heparin on October 22, 2007. (Doc. 149-1 at 18.) Mr. Moore opines that Dr. Allen could have received heparin from a contaminated shipment of 160 packages that Cardinal received on October 26, 2007, just four days later. (Id.) When asked why he concluded that it was more likely than not that Dr. Allen received the contaminated heparin from the smaller shipment rather than the uncontaminated heparin from the larger shipment, Mr. Moore replied that the larger shipment “would have been at the front end of anything that they were distributing out to other locations, which that's - that's information that - that is not available to me . . . . [I]t just seems reasonable that the only thing left to be distributed were two other [contaminated] lots.” (Doc. 149-2 at 98 (emphasis added.)) Defense counsel probed Mr. Moore by asking “You say it seems reasonable. But without knowing Cardinal's inventory and what other customer Cardinal was shipping” this form of heparin to “you don't know with any certainty whether Cardinal's shipment to Mayo came from” the contaminated lot “versus a prior lot?” (Id.) Mr. Moore replied that based upon Cardinal's “distribution pattern . . . it just seems reasonable that was the only thing they would have had to ship at that point.” (Id. at 99.)

         Mr. Moore never explains, beyond relying on just-in-time inventory and FIFO, why it was more likely than not that Dr. Allen received heparin from the smaller contaminated shipment rather than the larger uncontaminated shipment. Compounding this uncertainty is Mr. Moore's admission that he is unaware of the number of end users to which Cardinal sells heparin. Thus, Mr. Moore's methodology does not reliably provide the basis for the conclusion that it was more likely than not that Dr. Allen received contaminated rather than uncontaminated heparin from the 5, 000U/ML in 1ML vials.

         iii. All Vial Sizes

         With regard to both vial sizes, Defendants contend that Mr. Moore's turnaround analysis fails to account for changes in shipment size. (Doc. 149 at 14.) Plaintiffs respond that Mr. Moore did account for changes in shipment size by noting that shipment size fluctuates with expected sales. (Doc. 156 at 16.) Countering this reasonable explanation, however, is the following exchange between Mr. Moore and Defense counsel, where Mr. Moore agreed that size of a shipment affects its relevancy to the analysis:

Q. I assume you thought it was relevant and appropriate to list the September 18 shipment in Table 2 in this analysis of the 5, 000-unit dose?
A. Right. That's a good - that's a fairly high quantity, 320 times 25. That's a lot of tainted heparin to have on their shelves.

(Doc. 149-2 at 73.)

         Thus, Mr. Moore fails to take one approach to the size of shipments in his analysis. On the one hand, Mr. Moore claims to treat all shipments consistently, regardless of size, but on the other hand, Mr. Moore highlighted certain shipments as more important than others due to their size. This inconsistent approach suggests deficiencies in his methodology.

         Finally, with regard to both doses, Defendants contend that Mr. Moore's concession that he could only say more likely than not that Dr. Allen received heparin from either of two contaminated lots, rather than one specific lot, “alone warrants exclusion.” (Doc. 149 at 15; Doc. 159 at 12.) The Court disagrees that this form of conclusion diminishes the reliability of Mr. Moore's methodology. Daubert does not require certainty.

         b. Cherry Picking

         Defendants further contend that Mr. Moore cherry-picked the data for his analysis to produce a litigation-driven result. (Doc. 149 at 15.) Specifically, Mr. Moore's report includes two tables that individually list shipments from Baxter to Cardinal of 5, 000U/ML in 1ML vials and 1, 000U/ML in 10ML vials respectively. (Id.) These tables utilize different start dates and end dates that Defendants contend were chosen to exclude uncontaminated shipments. (Id.)

         Plaintiffs respond that this is a matter appropriate for cross-examination and that Mr. Moore chose as relevant start dates the time Cardinal originally received contaminated heparin from Baxter. (Doc. 156 at 12.) He did not include earlier uncontaminated shipments, Plaintiffs claim, because he did not believe that such shipments would be available for Dr. Allen on December 2, 2007. (Id.)

         Mr. Moore did effectively cherry-pick data. While he determined that the turnaround times for the 5, 000U/ML in 1 ML vials and 1, 000 U/ML in 10ML vials were three weeks and four weeks respectively, he chose to display a longer period of data for the 5, 000U/ML in 1 ML vials, which had a shorter turnaround time. The effect of this was to exclude prior shipments of uncontaminated heparin from the 1, 000 U/ML in 10ML vials table, which had a longer turnaround time. Regardless of whether the lots were actually available to Dr. Allen on ...

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