United States District Court, S.D. Florida
P. GAYLES UNITED STATES DISTRICT JUDGE.
CAUSE comes before the Court upon Defendant Zoll
Services, LLC's Omnibus Motion in Limine [ECF
No. 91]. The Court has reviewed the Motion and the record and
is otherwise fully advised. For the reasons set forth below,
the Motion is granted in part.
Zoll Services, Inc. (“Defendant”) 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 deliver a shock to restore normal rhythm. The LifeVest is
a Class III medical device, initially approved for sale in
2001 by the Food and Drug Administration (“FDA”).
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 Dennis Godelia and Sterling
Youmas (“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.
now moves to exclude several matters from trial. The Court
addresses each in turn.
Norman Wong's Analysis and “Audit
seeks to exclude all evidence relating to a mock inspection
and regulatory audit performed by Norman Wong, a retired FDA
device expert. Defendant argues that the evidence is a
subsequent remedial measure and irrelevant and that its
probative value is outweighed by prejudice to Defendant.
its 2014 and 2015 routine FDA inspections, Defendant retained
Mr. Wong to perform a mock inspection and regulatory audit.
In his report (the “Audit Report”), Mr. Wong made
findings regarding Defendant's compliance with internal
operating procedures and FDA regulations. For each finding,
Mr. Wong listed his level of concern (minor or significant)
followed by his recommendation. Some of Mr. Wong's
findings relate to Defendant's corrective and
preventative action for defective solder joints.
Court does not find that the Audit Report is a subsequent
remedial measure. Federal Rule of Evidence 407 provides that:
When measures are taken that would have made an earlier
injury or harm less likely to occur, evidence of the
subsequent measures is not admissible to prove: negligence;
culpable conduct; a defect in a product or its design; or a
need for a warning or instruction. But the court may admit
this evidence for another purpose, such as impeachment or-if
disputed-proving ownership, control, or the feasibility of
Fed. R. Evid. 407. The record does not reflect that Defendant
retained Mr. Wong to conduct the audit to make the harm
suffered by Mrs. Godelia less likely to occur or to remedy
any issues Defendant had with corrective and preventative
action for defective solder joints. Rather, as
Defendant's 30(b)(6) representative testified, after the
FDA issued the results of its inspections and warning
letters, Defendant believed that there was a communication
issue with the FDA. In response to this belief, Defendant
retained Mr. Wong-not to remedy solder defects or regulatory
failures but to negate the FDA's findings. Accordingly,
this analysis and Audit Report are not subsequent remedial
measures and are admissible.
as Plaintiffs have noted that they do not intend to rely on
any of Mr. Wong's recommendations, the Court will require
that the Audit Report be redacted to remove Mr. Wong's
recommendations. See Williams v. Asplundh Tree Expert
Co., No. 3:05-cv-479-J-33MCR, 2006 WL 2868923, *5 (M.D.
Fla. Oct. 6, 2006) (“Reports prepared for a purpose
other than remedying a problem may not be excluded by Rule
407 . . . . However, portions of such reports that propose
remedies must still be excluded under Rule 407.”). The
Court also finds that the probative value of Mr. Wong's
Audit Report and analysis outweighs any prejudice to
during argument on this issue, Defendant asserted, for the
first time, that Mr. Wong's Audit Report is hearsay and
therefore inadmissible. However, the Audit Report is
admissible within the business records exception to the
hearsay rule, provided that Mr. Wong adequately certified
that the Audit Reports were made in the regular course of
business as required by Federal Rule of Evidence 803(6).
See U.S. v. Frazier, 53 F.3d 1105, 1110 (10th Cir.
1995) (Audit report prepared by independent contractor was
admissible under business records exception to the hearsay
rule). Accordingly, the Motion is denied as to this issue
with the caveat that Mr. Wong's certification satisfies
the standard set forth in Rule 803(6).
Evidence of Incidents Described ...