In re EpiPen (Epinephrine Injection, USP) Mktg., Sales Practices & Antitrust Litig.

Decision Date27 February 2020
Docket NumberCase No. 17-md-2785-DDC-TJJ,MDL No: 2785
PartiesIN RE: EpiPen (Epinephrine Injection, USP) Marketing, Sales Practices and Antitrust Litigation (This Document Applies to Consumer Class Cases)
CourtU.S. District Court — District of Kansas
MEMORANDUM AND ORDER

This multi-district litigation ("MDL") involves antitrust, civil RICO, consumer protection, and unjust enrichment claims asserted by a putative class of plaintiffs. The putative class members assert these claims against suppliers and manufacturers of the EpiPen ("the Mylan and Pfizer defendants"). The EpiPen is an epinephrine auto-injector ("EAI") that delivers epinephrine to treat severe allergic reactions known as anaphylaxis. The putative class members—i.e., end-payors who purchased the EpiPen—have filed a motion seeking class certification under Fed. R. Civ. P. 23. Doc. 1353. Contemporaneously, the parties have filed motions seeking to exclude certain expert testimony offered either to support or oppose the putative class members' Motion for Class Certification. This Order rules those Daubert motions.

As explained more fully below, the court rules the parties' motions as follows:

The putative class plaintiffs' motions:
Motion to Strike the Partial Testimony of Dr. Michael Blaiss (Doc. 1584) is denied.
Motion to Strike the Testimony of Professor James Hughes (Doc. 1852) is denied.

The Mylan and Pfizer defendants' motions:

Motion to Exclude Expert Opinions of Professor Meredith Rosenthal (Doc. 1602) is denied.
Motion to Exclude Expert Opinions of Professor Einer Elhauge (Doc. 1604) is granted in part and denied in part. The court grants the motion to exclude Professor Elhauge's opinions about Auvi-Q market foreclosure based on Mylan's EpiPens4Schools program because plaintiffs since have abandoned this theory. The court denies the motion in all other respects.
Motion to Exclude Opinions and Proposed Testimony of Andrew K. Torrance (Doc. 1847) is denied.
I. Legal Standard

The court has a "gatekeeping obligation" to determine whether expert testimony is admissible. Kumho Tire Co. v. Carmichael, 526 U.S. 137, 147 (1999) (citing Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 589 (1993)). When performing this gatekeeping role, the court has broad discretion. Kieffer v. Weston Land, Inc., 90 F.3d 1496, 1499 (10th Cir. 1996) (citing Orth v. Emerson Elec. Co., 980 F.2d 632, 637 (10th Cir. 1992)). Courts exercise this discretion under Federal Rule of Evidence 702. It provides:

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if:
(a) the expert's scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue;
(b) the testimony is based on sufficient facts or data;
(c) the testimony is the product of reliable principles and methods; and(d) the expert has reliably applied the principles and methods to the facts of the case.

Fed. R. Evid. 702.

The Tenth Circuit has not yet ruled whether a court must conduct a full Daubert analysis at the class certification stage. One federal court has noted that "[t]he issue of how to evaluate expert testimony at the class-certification stage 'ha[s] beguiled the federal courts.'" Campbell v. Nat'l R.R. Passenger Corp., 311 F. Supp. 3d 281, 294 (D.D.C. 2018) (quoting 3 William B. Rubenstein, Newberg on Class Actions § 7:24 (5th ed. 2014)). In dictum, the Supreme Court has expressed "doubt" about the notion that "Daubert [does] not apply to expert testimony at the certification stage of class-action proceedings." Wal-Mart Stores, Inc. v. Dukes, 564 U.S. 338, 354 (2011). But the Court has not yet ruled the question definitively.

Previously, this court recognized that "the case law contains some dissonance about the proper breadth of Daubert-style challenges at the class certification stage." Doc. 1532 at 4. As one leading treatise has explained, "two approaches . . . have emerged in the case law." 3 William B. Rubenstein, Newberg on Class Actions § 7:24 (5th ed. 2013). Some Circuits have held that a court must perform a "full Daubert analysis" before certifying a class. See Am. Honda Motor Co. v. Allen, 600 F.3d 813, 815-16 (7th Cir. 2010) (per curiam) ("We hold that when an expert's report or testimony is critical to class certification, . . . the district court must perform a full Daubert analysis before certifying the class . . . ."); see also In re Carpenter Co., No. 14-0302, 2014 WL 12809636, at *3 (6th Cir. Sept. 29, 2014) (holding district court did not abuse its discretion by applying Daubert to determine admissibility of expert testimony offered to support class certification); Sher v. Raytheon Co., 419 F. App'x 887, 890-91 (11th Cir. 2011) ("Here the district court refused to conduct a Daubert-like critique of the proffered experts'qualifications. This was error.").1 The Eighth Circuit has adopted a different approach. It directs trial courts to apply a "focused Daubert analysis" instead of a "full and conclusive Daubert inquiry before certification." In re Zurn Pex Plumbing Prods. Liab. Litig., 644 F.3d 604, 610-11 (8th Cir. 2011). The Third Circuit has considered both approaches and recognized that some differences might exist between these two approaches. Nonetheless, the Third Circuit has declined "to examine whether there might be some variation between the Seventh and Eighth Circuit formulations" because "both courts limit the Daubert inquiry to expert testimony offered to prove satisfaction of Rule 23's requirements." In re Blood Reagents Antitrust Litig., 783 F.3d 183, 187, 188 n.8 (3d Cir. 2015) (joining with "sister courts to hold that a plaintiff cannot rely on challenged expert testimony, when critical to class certification, to demonstrate conformity with Rule 23 unless the plaintiff also demonstrates, and the trial court finds, that the expert testimony satisfies the standard set out in Daubert").

Here, the court likewise declines to decide whether the two approaches differ in a material fashion. Instead, because the parties' motions seek to exclude expert opinions used to support or oppose Rule 23's class certification requirements, the court applies the Daubert standard to those proffered opinions to determine whether the court should consider them at the class certification stage.

Outside the class certification phase, our Circuit has directed trial judges to apply a two-part test when determining the admissibility of expert testimony under Daubert and Rule 702. Conroy v. Vilsack, 707 F.3d 1163, 1168 (10th Cir. 2013). First, the court must determine "whether the expert is qualified 'by knowledge, skill, experience, training, or education' to render an opinion." United States v. Nacchio, 555 F.3d 1234, 1241 (10th Cir. 2009) (quoting Fed. R. Evid. 702). Second, the court "'must satisfy itself that the proposed expert testimony is both reliable and relevant, in that it will assist the trier of fact, before permitting a jury to assess such testimony.'" Id. (quoting United States v. Rodriguez-Felix, 450 F.3d 1117, 1122 (10th Cir. 2006) (further citations omitted)).

To qualify as an expert witness, the witness must possess "such skill, experience or knowledge in that particular field as to make it appear that his opinion would rest on substantial foundation and would tend to aid the trier of fact in his search for truth." LifeWise Master Funding v. Telebank, 374 F.3d 917, 928 (10th Cir. 2004) (citation and internal quotation marks omitted). To determine whether the expert's testimony is reliable, the court must assess "whether the reasoning or methodology underlying the testimony is scientifically valid and . . . whether that reasoning or methodology properly can be applied to the facts in issue." Daubert, 509 U.S. at 592-93.

In Daubert, the Supreme Court identified four factors that—though not exhaustive—trial courts should consider when determining the reliability of proffered expert testimony under Fed. R. Evid. 702. They are: (1) whether the theory used can be and has been tested; (2) whether it has been subjected to peer review and publication; (3) the known or potential rate of error; and (4) general acceptance in the scientific community. Id. at 593-94. The Supreme Court has emphasized, however, that these four factors are not a "definitive checklist or test," and that acourt's gatekeeping inquiry about reliability "must be tied to the facts of a particular case." Kumho Tire, 526 U.S. at 150 (citations and internal quotation marks omitted).

But in some cases, "the relevant reliability concerns may focus upon personal knowledge or experience," rather than the Daubert factors and scientific foundation. Id. For such testimony to satisfy the reliability standard, it "must be 'based on actual knowledge, and not mere "subjective belief or unsupported speculation."'" Pioneer Ctrs. Holding Co. Emp. Stock Ownership Plan & Tr. v. Alerus Fin., N.A., 858 F.3d 1324, 1341-42 (10th Cir. 2017) (quoting Mitchell v. Gencorp, Inc., 165 F.3d 778, 780 (10th Cir. 1999) (quoting Daubert, 509 U.S. at 590)). "When expert opinion 'is not supported by sufficient facts to validate it in the eyes of the law, or when indisputable record facts contradict or otherwise render the opinion unreasonable, it cannot support a jury's verdict' and will be excluded." Id. at 1342 (quoting Brooke Grp. Ltd. v. Brown & Williamson Tobacco Corp., 509 U.S. 209, 242 (1993)).

"The proponent of expert testimony bears the burden of showing that the testimony is admissible." Conroy, 707 F.3d at 1168 (citing Nacchio, 555 F.3d at 1241). "[R]ejection of expert testimony is the exception rather than the rule." Fed. R. Evid. 702 advisory committee's notes to 2000 amendments. While Daubert makes the court the gatekeeper for expert testimony, "[v]igorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof" remain "the...

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