United States District Court, D. Delaware
INTEGRA LIFESCIENCES CORP., INTEGRA LIFESCIENCES SALES LLC, CONFLUENT SURGICAL, INC., and INCEPT LLC, Plaintiffs,
HYPERBRANCH MEDICAL TECHNOLOGY, INC., Defendant.
CHRISTOPHER J. BURKE, UNITED STATES MAGISTRATE JUDGE
action filed by Plaintiffs Integra LifeSciences Corp.,
Integra LifeSciences Sales LLC, Confluent Surgical, Inc. and
Incept LLC (collectively, "Plaintiffs" or
"Integra") against Defendant HyperBranch Medical
Technology, Inc. ("Defendant" or
"HyperBranch"), presently before the Court are: (1)
Defendant's Daubert Motion to exclude testimony
offered by Plaintiffs' proffered expert, Dr. Dennis J.
Rivet, II, (D.I. 394) ("Defendant's Motion");
(2) Plaintiffs' Daubert Motion to exclude
testimony offered by Defendant's proffered expert, Dr.
Jonathan Flombaum, (D.I. 396); and (3) Plaintiffs'
Daubert Motion to exclude testimony offered by
Defendant's proffered expert, Dr. Anthony Lowman,
(id.) ("Plaintiffs' Motion Regarding Dr.
Flombaum and Dr. Lowman" and together with
Defendant's Motion, "the Motions"). For the
following reasons, the Court DENIES Defendant's Motion
and GRANTS-IN-PART Plaintiffs' Motion Regarding Dr.
Flombaum and Dr. Lowman, as set out below.
filed the instant case on September 15, 2015. (D.I. 1)
Plaintiffs allege infringement of United States Patent Nos.
7, 009, 034, 7, 332, 566, 7, 592, 418, 8, 003, 705 and 8,
535, 705 ("the asserted patents"). On September 25,
2015, Chief Judge Leonard P. Stark referred this case to the
Court to hear and resolve all pretrial matters, up to and
including the resolution of case-dispositive motions. (D.I.
on the instant Motions were completed on December 21, 2017.
(D.I. 460, 463) A 7-day trial is set to begin on May 29,
2018. (D.I. 660)
STANDARD OF REVIEW
Rule of Evidence 702 governs the admissibility of qualified
expert testimony, providing that an expert witness may
testify 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. Rule
702's requirements have been examined in detail by the
Supreme Court of the United States in Daubert v. Merrell
Dow Pharms., Inc., 509 U.S. 579 (1993), and have been
said to embody "three distinct substantive restrictions
on the admission of expert testimony: qualifications,
reliability, and fit." Elcock v. Kmart Corp.,
233 F.3d 734, 741 (3d Cir. 2000); see also B. Braun
Melsungen AG v. Terumo Med. Corp., 749 F.Supp.2d 210,
222 (D. Del. 2010).
terms of expert qualifications, an inquiry under Rule 702
must address whether the expert witness has
'"specialized knowledge' regarding the area of
testimony." Elcock, 233 F.3d at 741 (quoting
Waldorf v. Shuta, 142 F.3d 601, 625 (3d Cir. 1998)).
The basis of this specialized knowledge may be
"practical experience as well as academic training and
credentials." Id. (internal quotation marks and
citations omitted). At a minimum, however, "a proffered
expert witness ... must possess skill or knowledge greater
than the average layman." Id. (internal
quotation marks and citations omitted). The United States
Court of Appeals for the Third Circuit has tended to apply
this standard liberally. Id.; see also Schneider
ex rel. Estate of Schneider v. Fried, 320 F.3d 396, 404
(3d Cir. 2003).
regard to the second requirement of reliability, Rule 702
mandates that the relevant expert testimony "must be
supported by appropriate validation-i.e., 'good
grounds, ' based on what is known."
Daubert, 509 U.S. at 590; see also
Schneider, 320 F.3d at 404. The information provided by
experts should be "ground[ed] in the methods and
procedures of science" and be "more than subjective
belief or unsupported speculation." Daubert,
509 U.S. at 590; see also Schneider, 320 F.3d at
In examining this requirement, a court's focus must be on
"principles and methodology" rather than on the
conclusions generated by the expert. Daubert, 509
U.S. at 595; see also Daddio v. Nemours Found, 399
Fed.Appx. 711, 713 (3d Cir. 2010).
third requirement of expert testimony, the "fit"
requirement, "goes primarily to relevance" as the
testimony must "assist the trier of fact to understand
the evidence or to determine a fact in issue" and have
"a valid scientific connection to the pertinent inquiry
as a precondition to admissibility." Daubert,
509 U.S. at 591-92 (internal quotation marks omitted);
see also Schneider, 320 F.3d at 404. The standard
for fit, however, is not a high one; it is met "when
there is a clear 'fit' connecting the issue in the
case with the expert's opinion that will aid the jury in
determining an issue in the case." Meadows v. Anchor
Longwall & Rebuild, Inc., 306 Fed.Appx. 781, 790 (3d
Cir. 2009) (citations omitted).
"Rule 702 embodies a 'liberal policy of
admissibility.'" B. Braun Melsungen AG, 749
F.Supp.2d at 222 (quoting Pineda v. Ford Motor Co.,
520 F.3d 237, 243 (3d Cir. 2008)). Nonetheless, the burden is
placed on the party offering expert testimony to show, by a
preponderance of proof, that it meets each of the standards
for admissibility. Id. (citing Daubert, 509
U.S. at 592 n.l0).
A. Defendant's Motion
Defendant moves to exclude those portions of Dr. Rivet's
testimony in which he opines on whether the use of
Defendant's products (the "Accused
Products") by other neurosurgeons would be covered by
the asserted patents, and what other neurosurgeons would
understand from Defendant's training materials. (D.I. 402
at 52-53; D.I. 463 at 28) Defendant's assault on Dr.
Rivet's testimony is presented via two different lines of
Defendant asserts that Dr. Rivet's testimony is not based
on a scientific methodology and should be excluded as
unreliable, chiefly because Dr. Rivet has never personally
used the Accused Products. (D.I. 402 at 52-53; see
also D.I. 463 at 30) Instead, Dr. Rivet: (1) reviewed
the Instructions for Use ("IFUs") for the Accused
Products, as well as two videos depicting assembly and use of
the Adherus AutoSpray Dural Sealant in a cranial operation,
and (2) relied upon conversations with colleagues who used
the accused Adherus AutoSpray Extended Tip (ET) Dural
Sealant. (D.I. 417, ex. 165 at ¶¶ 31-35) Defendant
asserts, with little supporting explanation, that such
evidence is either "unreliable or irrelevant[.]"
(D.I. 402 at 53)
not clear to the Court, however, why it is that this
evidence is "unreliable or irrelevant." The
above-referenced evidence relates (fairly directly) to how
the Accused Products work and how they are used. To be sure,
that evidence does not include Dr. Rivet's own firsthand
experience with using the products at issue. But while having
such experience might be beneficial for an expert testifying
about whether a product infringes a patent claim, it is not a
prerequisite to offering such testimony. (D.I. 443 at 38-39
(citing cases)); see also Tormenia v. First Inv'rs
Realty Co.,251 F.3d 128, 13 5 (3d Cir. 2000)
("Rule 702 does not require that experts have personal
experience with the object of the litigation in which they
testify, nor does it require that experts eschew reliance on
a plaintiffs account of factual events that the experts
themselves did not observe."). Defendant may explore any
concerns regarding what Dr. Rivet did and did not observe, or
what he did or did not consider, via cross-examination.
See, e.g., Iplearn, LLC v. Blackboard Inc., C.A. No.
11-876 (RGA), 2014 WL 4954462, at *2 (D. Del. Sept. 29, 2014)
(noting that an expert "need not use the [allegedly
infringing product] if, as here, he has familiarized ...