DARRIN P. GAYLES, District Judge.
Defendant 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 ("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
Defendant 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.
Federal 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).
To perform it's gatekeeping duty, the Court must conduct a "rigorous three-part inquiry" under Rule 702, considering whether:
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. Id.
While 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).
"[A] 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. 13-CIV-80371, 2015 WL 11251759, at *1 (S.D. Fla. July 6, 2015) (citing Clena Investments, Inc. v. XL Specialty Ins. Co., 280 F.R.D. 653, 661 (S.D. Fla. 2012)).
Mr. Daken is a licensed professional engineer. He has taught college courses in biomedical engineering technology and electrical engineering. Indeed, one of his courses included instruction on soldering and de-soldering. As a result, the Court finds that Mr. Daken is qualified to testify as to proper soldering and de-soldering techniques, proper solder connections, and whether, in his expert opinion, the cable connecting the rear therapy electrode set to the DN was separated from the circuit board within the DN as the result of defective soldering.
In addition, the Court finds that Mr. Daken is qualified to testify as to whether Defendant failed to implement regulatory-required processes in its manufacturing of the Life-Vest and that this failure resulted in defective soldering in Mrs. Godelia's Life-Vest. Over the course of his career, as an engineering professor and while working in the clinical engineering divisions of several hospitals, Mr. Daken obtained experience both in the assessment of solder connections and in practices that comport with Current Good Manufacturing Practices ("CGMP"). Accordingly, the Court that finds he is qualified to testify as to the limited second and third opinions set forth in his Report.
The Court also finds Mr. Daken's opinions to be reliable. To assess reliability, the Court may consider several non-exhaustive factors including: "(1) whether the expert's theory can be and has been tested; (2) whether the theory has been subjected to peer review and publication; (3) the known or potential rate of error of the particular scientific technique; and (4) whether the technique is generally accepted in the scientific community." Frazier, 387 F.3d at 1262 (internal citations omitted). This list "neither necessarily nor exclusively applies to all experts or in every case." Kumho Tire Co. v. Carmichael, 526 U.S. 137, 141 (1999). The trial court has "the same kind of latitude in deciding how to test an expert's reliability ... as it enjoys when it decides whether or not that expert's relevant testimony is reliable." Id. at 152.
The Court finds that all of Defendant's attacks on the "reliability" of Mr. Daken's opinions relate to his credibility or to the weight that should be afforded his findings and not the admissibility of his testimony. With respect to Mr. Daken's opinion on the soldering defect, Mr. Daken conducted a 10X magnified visual inspection of the separated cable's residual solder. Based on this visual inspection and his experience in soldering, Mr. Daken opined that the color ("dull gray, almost black") and the appearance of flux on the solder joint evidenced a defective solder connection. Mr. Daken also considered the lack of documented support for any theory that the LifeVest experienced abuse or excessive strain that would have caused the break. The Court finds Mr. Daken's magnified visual inspection to be reliable. To the extent that Defendant argues that Mr. Daken should have employed a more sophisticated inspection, those questions go to the weight of Mr. Daken's opinion and not whether his methodology was reliable. See Jones v. Otis Elevator Co., 861 F.2d 655, 663 (11th Cir. 1988) ("[T]he weaknesses in the underpinnings of the expert's opinion go to its weight rather than its admissibility.").
In addition, the Court finds that Mr. Daken's opinion regarding Defendant's failure to implement CGMPs is reliable. In making this opinion, Mr. Daken reviewed the FDA's warning letter, Defendant's internal reports, and a 2015 Audit Report by Mr. Norman Wong ("Mr. Wong").
For the third element, the Court must determine whether the proffered testimony "concerns matters that are beyond the understanding of the average lay person." Nat'l Union Fire Ins. Co. of Pittsburgh v. Tyco Integrated Sec., LLC, No. 13-CIV-80371, 2015 WL 11251759, at *2 (S.D. Fla. July 6, 2015) (quoting Edwards v. Shanley, 580 F. App'x. 816, 823 (11th Cir. 2014)). As solder defects and proper manufacturing practices are beyond the understanding of the average lay person, the Court finds that Mr. Daken's opinions will clearly assist the jury.
Based on the foregoing, it is