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  • Case Opinion

United States v. Biogen Idec, Inc.

United States v. Biogen Idec, Inc.

United States District Court for the District of Massachusetts

July 8, 2022, Decided; July 8, 2022, Filed

Civil Action No. 1:12-cv-10601-IT

Opinion

MEMORANDUM & ORDER

July 8, 2022

TALWANI, D.J.

Plaintiff-Relator Michael Bawduniak's Third Amended Complaint ("Complaint") [Doc. No. 132] charged Defendant Biogen Idec, Inc. [*4]  ("Biogen") with causing healthcare providers ("HCPs") to file fraudulent Medicare and Medicaid reimbursement claims in violation of the False Claims Act, 31 U.S.C. § 3729, et seq., and various state laws, by paying kickbacks to influence them to prescribe Biogen's multiple sclerosis ("MS") products in violation of Anti-Kickback Statute ("AKS"), 42 U.S.C. § 1320a-7b.

Pending before the court are Relator's Daubert Motions [Doc. Nos. 497, 498, 499, 500, and 501] and Biogen's Daubert Motions [Doc. Nos. 509, 510, 511, 512, 513, 514, and 515]. In this Memorandum and Order, the court addresses common issues raised in the Daubert motions. The court then addresses several of Biogen's motions individually, and will address the remainder of the motions separately.

I. Legal Standard

At the outset, "[t]he court must decide any preliminary question about whether a witness is qualified, a privilege exists, or evidence is admissible." Fed. R. Evid. 104(a). A witness "qualified as an expert by knowledge, skill, experience, training or education" may offer expert testimony only 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 [*5]  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 party proffering expert testimony must show, by a preponderance of the evidence, that the testimony satisfies the requirements of Rule 702. See Bricklayers & Trowel Tr ades Int'l Pens ion Fund v. Credit Suisse Secs. (U SA) LLC, 752 F.3d 82, 96 (1st Cir. 2014). Courts have a "gatekeeping responsibility" to determine whether the testimony an expert seeks to offer satisfies these criteria. Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 589 n.7, 592 n.10, 113 S. Ct. 2786, 125 L. Ed. 2d 469 (1993).

The district court has "considerable latitude" in "deciding whether expert testimony is helpful to the jury." United States v. Monell, 801 F.3d 34, 45 (1st Cir. 2015). Further, "trial judges may evaluate the data offered to support an expert's bottom-line opinions to determine if that data provides adequate support to mark the expert's testimony as reliable." Ruiz-Troche v. Pepsi Cola of P.R. Bottling Co., 161 F.3d 77, 81 (1st Cir. 1998). "Nothing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence that is connected to existing data only by the ipse dixit of the expert. A court may conclude that there is simply too great an analytical gap between the data and the opinion proffered." GE v. Joiner, 522 U.S. 136, 146, 118 S. Ct. 512, 139 L. Ed. 2d 508 (1997).

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2022 U.S. Dist. LEXIS 120549 *; 2022 WL 2662678

UNITED STATES OF AMERICA, et al., ex rel. MICHAEL BAWDUNIAK, Plaintiff-Relator, v. BIOGEN IDEC, INC., Defendant.

CORE TERMS

programs, expert testimony, opine, educational value, motion to exclude, attendance, contends, portions, markers, reliability, principles, expertise, threshold, witnesses, motions, moves, scientific, expert report, determinations, Marketing, attendees, documents, narrative, cross-examination, credibility, designing, practices, quotation, indicia, studies