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Brian Sadler and Michelle Sadler, Individually and On Behalf v. Advanced Bionics

April 3, 2013



This matter is before the Court upon Defendant Advanced Bionics, LLC's Motion to Limit the Testimony of Plaintiffs' Expert Harold Pellerite. (ECF No. 119.) Plaintiffs Brian and Michelle Sadler, individually and on behalf of their minor child B.S., have responded, (ECF No. 139), and Defendant has replied, (ECF No. 159). This matter is now ripe for adjudication. For the reasons that follow, Defendant's Motion will be SUSTAINED IN PART and DENIED IN PART.


The admissibility of expert testimony is governed by Rule 702 of the Federal Rules of Evidence. Rule 702 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.

In Daubert v. Merrell Dow Pharm., Inc., "the Supreme Court established a general gatekeeping obligation for trial courts to exclude from trial expert testimony that is unreliable and irrelevant." Conwood Co. v. U.S. Tobacco Co., 290 F.3d 768, 792 (6th Cir. 2002) (alteration and internal quotation marks omitted) (quoting Hardyman v. Norfolk & W. Ry. Co., 243 F.3d 255, 260 (6th Cir. 2001) (applying Daubert, 509 U.S. 579, 597 (1993)); Kumho Tire Co. v. Carmichael, 526 U.S. 137, 147-48 (1999))). The Court must determine whether evidence proffered under Rule 702 "both rests on a reliable foundation and is relevant to the task at hand." Daubert, 509 U.S. at 597. A key consideration is "whether the reasoning or methodology underlying the testimony is sufficiently valid." Id. at 592-93. The Supreme Court advises that the inquiry is "a flexible one," and that "[t]he focus . . . must be solely on principles and methodology, not on the conclusions they generate." Id. at 594-95. A testifying expert must "employ[] in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field." Kumho Tire, 526 U.S. at 152. But Daubert did not impose any new standard, other than that already found in the Federal Rules of Evidence, for the admissibility of the testimony of nonscientific expert witnesses. See id.; see also United States v. Velasquez, 64 F.3d 844, 850 (3d Cir. 1995) (noting that Daubert did not impose a new standard other than what is already set out in the Federal Rules of Evidence "for the admissibility of the testimony of nonscientific experts such as . . . real estate appraisers"); United States v. Starzecpyzel, 880 F. Supp. 1027, 1040-41 (S.D.N.Y. 1995) (same).

Despite that there is no "definitive checklist or test" for meeting the standard of Rule 702, Daubert laid out a number of factors that typically "bear on the inquiry," including: whether the theory or method in question "can be (and has been) tested," whether it "has been subjected to peer review and publication," whether it has a "known or potential rate of error," and whether the theory or technique enjoys "general acceptance" in the "relevant scientific community." Daubert, 509 U.S. at 593-94. Although Daubert addressed scientific evidence, the Supreme Court in Kumho Tire Co. v. Carmichael held that a trial court may consider the Daubert factors for all types of expert evidence. Kumho Tire, 526 U.S. at 150. Thus, the Daubert factors are nonexhaustive and may not be pertinent in cases where "the relevant reliability concerns . . . focus upon personal knowledge or experience."*fn1 Id.; see also First Tenn. Bank Nat'l Ass'n v. Barreto, 268 F.3d 319, 335 (6th Cir. 2001).

The Sixth Circuit has developed further guidance on Rule 702 by recently outlining a number of "[r]ed flags that caution against certifying an expert." Newell Rubbermaid, Inc. v. Raymond Corp., 676 F.3d 521, 527 (6th Cir. 2012) (citing Best v. Lowe's Home Ctrs., Inc., 563 F.3d 171, 177 (6th Cir. 2009)). These include "reliance on anecdotal evidence, improper extrapolation, failure to consider other possible causes, lack of testing, and subjectivity." Id. (citing Best, 563 F.3d at 177). Also, that a purported expert's testimony was prepared solely for litigation may also be grounds for exclusion. Id. (citing Johnson v. Manitowoc Boom Trucks, Inc., 484 F.3d 426, 434 (6th Cir. 2007)).

Where the testimony of a proffered expert is challenged for insufficient "factual basis, data, principles, methods, or their application . . . the trial judge must determine whether the testimony has a reliable basis in the knowledge and experience of [his or her] discipline." Kumho Tire, 526 U.S. at 149 (quoting Daubert, 509 U.S. at 592). The Court need not necessarily hold a Daubert hearing to determine the admissibility of expert testimony but, nonetheless, must ensure that the disputed testimony is both relevant and reliable. See Clay v. Ford Motor Co., 215 F.3d 663, 667 (6th Cir. 2000). Generally, "a trial judge . . . ha[s] considerable leeway in deciding whether particular expert testimony is reliable," Kumho Tire, 526 U.S. at 152; accord Conwood, 290 F.3d at 792; Jahn v. Equine Servs., PSC, 233 F.3d 382, 388 (6th Cir. 2000), and his decision regarding the admissibility of expert testimony is reviewed for abuse of discretion, see Kumho Tire, 526 U.S. at 142; Newell Rubbermaid, 676 F.3d at 527; Hardyman, 243 F.3d at 258; see also Tamraz v. Lincoln Electric Co., 620 F.3d 665, 672 (6th Cir. 2010) ("Rule 702, we recognize, does not require anything approaching absolute certainty. And where one person sees speculation, we acknowledge, another may see knowledge, which is why the district court enjoys broad discretion over where to draw the line." (internal citations omitted)).


Plaintiffs' expert Harold Pellerite is offered as an expert in FDA regulatory matters. Pellerite worked for nearly thirty years in the FDA's Office of Compliance, Center for Devices and Radiological Health, which is responsible for enforcing laws and regulations relating to the marketing of medical devices in the United States. (See Docket No. 140.) At the FDA, Pellerite held various positions related to complaint handling and medical device reporting between 1976 and 1984. In 1984, he was appointed as Assistant to the Director of the FDA's Office of Compliance. He held that position until his retirement from the FDA in 2005. Pellerite states that during that time, he was responsible for the day-to-day operations of the Office of Compliance, as well as for reviewing and approving FDA regulatory actions such as recalls, warning letters, untitled letters, and civil money penalties. He also states that during that ...

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