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Godelia v. Zoll Services, LLC

United States District Court, S.D. Florida

August 16, 2019




         THIS 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.

         Defendant 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”).

         In November 2013, after recovering from a cardiac operation, Debra Godelia began using the LifeVest. On November 18, 2013, Mrs. Godelia experienced a defibrillation event[1] 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.[2]

         Defendant now moves to exclude several matters from trial. The Court addresses each in turn.

         I. Norman Wong's Analysis and “Audit Report”

         Defendant 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.

         Following 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.

         The 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 precautionary measures.

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.[3]

         However, 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 Defendant.

         Finally, 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).

         II. Evidence of Incidents Described ...

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