United States District Court, S.D. Florida
P. GAYLES UNITED STATES DISTRICT JUDGE
CAUSE comes before the Court upon Defendant's
Motion to Exclude Opinions of Plaintiffs' Expert Witness,
Richard J. Daken, Jr., P.E. [ECF No. 63]. The Court has
reviewed the Motion and the record and is otherwise fully
advised. For the reasons set forth below, the Motion is
Zoll Services, Inc. (“Zoll”) designs,
manufactures, and markets the LifeVest, a wearable
defibrillator for patients at risk for sudden cardiac arrest.
The LifeVest is made to detect life-threatening heart rhythms
and automatically deliver a shock to restore the rhythm. The
LifeVest is a Class III medical device, initially approved
for sale in 2001 by the Food and Drug Administration
November 2013, after recovering from a cardiac operation,
Debra Godelia began using the LifeVest. On November 18, 2013,
Mrs. Godelia experienced a defibrillation event and lost
consciousness. Although the parties dispute why, Mrs.
Godelia's LifeVest did not administer a shock. Mrs.
Godelia remained unconscious until she died in the hospital
on November 20, 2013. Plaintiffs then filed this action
against Defendant asserting claims for strict products
liability, negligence, fraudulent misrepresentation,
fraudulent marketing and promotion, breach of express
warranty, negligent misrepresentation, and negligent
infliction of emotional distress arising out of Mrs.
Godelia's use of the LifeVest.
has now moved to exclude the opinions of Plaintiffs'
expert witness, Richard J. Daken, Jr. In his Report, Mr.
Daken opines that “the cable connecting the rear
therapy electrode set to the distribution network (DN) was
separated from the circuit board within the DN. This
separation was the result of defective soldering.”
Daken Rpt. 2, ¶ 2. In addition, Mr. Daken opines that
“Zoll failed to implement regulatory-required processes
to ensure that its manufacturing of the subject LifeVest, and
in particular, the soldering at issue, was non-defective,
” and “[t]he defect . . . was a direct result of
Zoll's failure to implement such manufacturing
processes.” Id. at ¶ 3.Defendant contends
that Mr. Daken's Report and testimony must be excluded
because (1) he is not qualified to render such opinions; (2)
his opinions are not reliable; and (3) his opinions will not
assist the trier of fact. The Court disagrees and finds that
Defendant's primary arguments go to the credibility of
Mr. Daken's opinions and the weight the jury should
afford them rather than their admissibility.
Rule of Evidence 702, amended in 2000 in response to the
Supreme Court's decision in Daubert v. Merrell Dow
Pharmaceuticals, Inc., 509 U.S. 579 (1993), states 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 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(a)-(d). “As the
Supreme Court made abundantly clear in Daubert, Rule
702 compels the district courts to perform the critical
‘gatekeeping' function concerning the admissibility
of expert scientific evidence.” United States v.
Frazier, 387 F.3d 1244, 1260 (11th Cir. 2004) (quoting
Daubert, 509 U.S. 589 n.7).
perform it's gatekeeping duty, the Court must conduct a
“rigorous three-part inquiry” under Rule 702,
(1) the expert is qualified to testify competently regarding
the matters he intends to address; (2) the methodology by
which the expert reaches his conclusions is sufficiently
reliable as determined by the sort of inquiry mandated in
Daubert; and (3) the testimony assists the trier of fact,
through the application of scientific, technical, or
specialized expertise, to understand the evidence or to
determine a fact in issue.
Frazier, 387 F.3d at 1260. The proponent of the
expert bears the burden of showing, by a preponderance of the
evidence, that each of these requirements is met.
the Court's gatekeeping function ensures that unreliable
testimony does not reach the jury, the Court must not make
determinations on the credibility or persuasiveness of the
proffered opinions; “vigorous cross-examination,
presentation of contrary evidence, and careful instruction on
the burden of proof are the traditional and appropriate means
of attacking shaky but admissible evidence.” Quiet
Tech. DC-8, Inc. v. Hurel-Dubois UK Ltd., 326 F.3d 1333,
1341 (11th Cir. 2003).
Daken is Qualified
witness who possesses general knowledge of a subject may
qualify as an expert despite lacking specialized training or
experience, so long as his testimony would likely assist a
trier of fact.” Whelan v. Royal Caribbean Cruises
Ltd., 976 F.Supp.2d 1328, 1331 (S.D. Fla. 2013). This is
not a stringent standard. If the expert is “minimally
qualified, objections to the level of the expert's
expertise go to credibility and weight, not
admissibility.” Nat'l Union Fire Ins. Co. of
Pittsburgh v. Tyco Integrated Sec., LLC, No.