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                                                        [DO NOT PUBLISH]



           IN THE UNITED STATES COURT OF APPEALS

                   FOR THE ELEVENTH CIRCUIT
                     ________________________

                           No. 14-12603
                       Non-Argument Calendar
                     ________________________

              D.C. Docket No. 6:11-cv-01582-RBD-GJK



ANTHONY PAYNE,
JOHNITA PAYNE,
his wife,

                                            Plaintiffs - Appellants,

versus

C.R. BARD, INC.,
BARD PERIPHERAL VASCULAR, INC.,

                                            Defendants - Appellees.



                     ________________________

              Appeal from the United States District Court
                  for the Middle District of Florida
                    ________________________

                           (March 31, 2015)
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Before JULIE CARNES, FAY, and EDMONDSON, Circuit Judges.



PER CURIAM:



      In this products liability case, Plaintiffs Anthony and Johnita Payne appeal

the district court’s exclusion of the testimony of their expert witness, Fredrick

Hetzel, Ph.D., and the consequent grant of summary judgment in favor of

Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc. (“Bard”). No

reversible error has been shown; we affirm.

      Bard manufactures a medical device -- called the Bard G2 inferior vena cava

filter (“G2 Filter”) -- that is designed to be placed inside a person’s inferior vena

cava (“IVC”) to prevent pulmonary embolisms. The device, which consists of a

central shaft with twelve protruding “struts,” anchors into the walls of the IVC and

serves as a mechanical barrier to prevent clots from reaching the heart or lungs.

      In 2007, Anthony Payne (“Payne”) suffered from recurrent bilateral lower-

extremity deep-vein thrombosis, putting him at increased risk of suffering a

pulmonary embolism. In September 2007, Payne’s doctor implanted a G2 Filter

into Payne’s IVC. In January 2008, scans showed that the struts of the G2 Filter

had perforated Payne’s IVC. In February 2009, more scans showed that Payne had


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suffered a pulmonary embolism. Scans also showed that the G2 Filter had

fractured and that one of the struts had detached. Doctors have been unable to

remove the G2 Filter or the fractured strut. Payne continues to suffer chest pain

and shortness of breath.

          Plaintiffs filed this civil action against Defendants, asserting four claims: (1)

strict liability based on defective design; (2) strict liability based on defective

manufacturing; (3) negligence; and (4) loss of consortium. Plaintiffs seek

compensatory and punitive damages.



Daubert1 Motion



          In support of their claims, Plaintiffs sought to introduce the testimony of

expert witness Dr. Hetzel. Dr. Hetzel’s testimony was proffered mainly to

establish that the G2 Filter implanted in Payne was defective and that Defendants’

warnings and labels were inadequate.

          Following a Daubert hearing, the district court concluded that Dr. Hetzel

was unqualified to testify competently about matters in the case and that Dr.

Hetzel’s methodologies were not sufficiently reliable or helpful. As a result, the

1
    Daubert v. Merrell Dow Pharm. Inc., 113 S.Ct. 2786 (1993).

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district court -- with a reasoned written opinion -- granted Defendants’ motion to

exclude Dr. Hetzel’s testimony. 2

       We review a district court’s ruling on the admissibility of expert testimony

for abuse of discretion. United States v. Frazier, 387 F.3d 1244, 1258 (11th Cir.

2004) (en banc). “[T]he deference that is the hallmark of abuse-of-discretion

review requires that we not reverse an evidentiary decision of a district court unless

the ruling is manifestly erroneous. Thus, it is by now axiomatic that a district court

enjoys ‘considerable leeway’ in making these determinations.” Id. (citations and

quotation marks omitted). Even when a ruling on the admissibility of expert

testimony may be “outcome determinative,” resulting in summary judgment, “we

do not apply a stricter standard.” McDowell v. Brown, 392 F.3d 1283, 1294 (11th

Cir. 2004).

       Expert testimony is admissible under Fed.R.Evid. 702 if (1) “the expert is

qualified to testify competently” about the subject of the testimony; (2) the expert’s

methodology “is sufficiently reliable as determined by the sort of inquiry mandated

in Daubert;” and (3) the expert’s testimony will “assist[] 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 party

2
  At the Daubert hearing, Plaintiffs presented no live testimony and relied solely on excerpts
from Dr. Hetzel’s video deposition.
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offering the expert testimony bears the burden of establishing, by a preponderance

of the evidence, the expert’s qualification, reliability, and helpfulness. Id.;

Kilpatrick v. Breg, Inc., 613 F.3d 1329, 1335 (11th Cir. 2010).

       On appeal, Plaintiffs contend that Dr. Hetzel is qualified to testify based on

his experience.3 Plaintiffs point mainly to Dr. Hetzel’s experience analyzing

medical devices, including his participation in one project involving an IVC filter.

When an expert witness relies mainly on experience to show he is qualified to

testify, “the witness must explain how that experience leads to the conclusion

reached, why that experience is a sufficient basis for the opinion, and how that

experience is reliable applied to the facts.” Frazier, 387 F.3d at 1261.

       The district court noted that Dr. Hetzel’s sole experience working with an

IVC filter “occurred more than twenty years ago, lasted only three to six months,

and was only ‘conceptual.’” In addition, Dr. Hetzel has never designed, tested, or

manufactured an IVC filter and has taught no seminars and published no articles

about IVC filters. Because Plaintiffs failed to establish a sufficient nexus between

Dr. Hetzel’s “limited and dated” experience with IVC filters and the opinions he

offered in this case, the district court concluded that Dr. Hetzel was unqualified to

testify. The district court did not abuse its discretion.

3
 Plaintiffs do not assert on appeal that Dr. Hetzel (who holds a Ph.D. in organic chemistry), is
qualified to testify based only upon his educational training.
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       The opinions contained in Dr. Hetzel’s Supplemental Report can be broken

into four main categories: (1) medical opinions about the in vivo forces inside the

IVC and the migration of Payne’s G2 Filter and fractured strut; (2) opinions about

the design and testing of the G2 Filter; (3) opinions about metallurgy, including the

properties of Nitinol (the metal used to construct the G2 Filter); and (4) opinions

about the adequacy of the warning labels on the G2 Filter.

       Plaintiffs failed to satisfy their burden of proof; the district court committed

no manifest error in concluding that Dr. Hetzel was unqualified to testify. First,

because Dr. Hetzel lacks medical training or experience, he is unqualified to testify

as an expert on medical issues. Plaintiffs have also failed to show how Dr.

Hetzel’s limited experience working with a “conceptual” IVC filter over 20 years

ago led to, or is pertinent to, the opinions he has reached in this case about the

design, testing, or labeling of the G2 Filter. Dr. Hetzel also lacks the necessary

training and experience to testify as an expert in metallurgy. 4

       Under the deferential standard of review applicable to the district court’s

exclusion of expert testimony, we see no reversible error. The district court

analyzed carefully and thoroughly Dr. Hetzel’s proffered testimony, qualifications

and methodologies. Nothing evidences that the district court committed manifest
4
 For example, the record shows that, during a 2010 deposition in an unrelated case, Dr. Hetzel
testified that he lacked sufficient expertise to testify as an expert about medical devices that have
a metallurgical failure.
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error in determining that Dr. Hetzel’s expert testimony -- in its entirety 5 -- was

inadmissible.



Motion to Reopen



       After the district court excluded Dr. Hetzel’s testimony, Plaintiffs moved to

reopen the deadline for expert disclosures so they could identify a replacement

expert witness. The district court granted the motion, but only for the limited

purpose of allowing Plaintiffs to disclose, as an expert witness, Murray Asch, M.D.

(whom Plaintiffs had already identified as a “rebuttal” witness).6 The district court

explained that “it appears that Dr. Asch -- who is well-known to Defendants --

might be used as an expert in Plaintiffs’ case-in-chief without undue delay of the

proceedings or prejudice to Defendants.” Plaintiffs were given five days from the



5
 Contrary to Plaintiffs’ assertions, the district court considered expressly Dr. Hetzel’s
qualifications to render an opinion about Defendants’ filings with the Food and Drug
Administration (“FDA”) at the Daubert hearing. The district court acknowledged that Dr. Hetzel
had some experience preparing FDA applications, but concluded that he was unqualified -- by
education or experience -- to testify about Defendants’ FDA filings in this case.
        On the record before us, we also reject Plaintiffs’ contention that the district court had an
improper “inherent mistrust for Dr. Hetzel.” And we also reject the contention that such alleged
distrust colored improperly the court’s determination that Dr. Hetzel was unqualified to testify
about the adequacy of Defendants’ warning labels.
6
 The district court noted that its ruling was consistent with an earlier order by the magistrate
judge, granting Plaintiffs additional time to disclose properly Dr. Asch as a rebuttal witness.
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date of the district court’s order to complete their disclosure and to notify the court

about whether Dr. Asch would testify during Plaintiffs’ case-in-chief.

      We review a district court’s ruling on a motion to extend a deadline for an

abuse of discretion. Oravec v. Sunny Isles Luxury Ventures, L.C., 527 F.3d 1218,

1231 (11th Cir. 2008). A party seeking the extension of an already-expired

scheduling order deadline must show both good cause and excusable neglect.

Fed.R.Civ.P. 6(b)(1), 16(b)(4). To establish “good cause” a party must show that

“the schedule cannot be met despite the diligence of the party seeking the

extension.” Oravec, 527 F.3d at 1232. In determining whether a party has shown

“excusable neglect” warranting an extension, a court must consider all pertinent

circumstances, including “the danger of prejudice to the nonmovant, the length of

the delay and its potential impact on judicial proceedings, the reason for the delay,

including whether it was within the reasonable control of the movant, and whether

the movant acted in good faith.” Advanced Estimating Sys. v. Riney, 77 F.3d

1322, 1325 (11th Cir. 1996) (alteration omitted).

      The district court abused no discretion in granting Plaintiffs an extension

that was limited both in time and in scope. The district court had already extended

several of its scheduling deadlines, including granting the parties a 60-day

extension for the disclosure of expert reports. Allowing Plaintiffs to identify and

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to disclose an entirely new expert so late in the proceedings would have likely

resulted in substantial delay to the judicial proceedings and in prejudice to

Defendants. And, having an expert witness stricken under Daubert, in and of itself,

is insufficient to warrant an extension. Cf. Rink v. Cheminova, 400 F.3d 1286,

1296 (11th Cir. 2005) (concluding that the district court abused no discretion in

denying a continuance to allow for the replacement of an expert witness stricken

under Daubert). Plaintiffs failed to demonstrate good cause or excusable neglect

justifying an extension greater than the one granted by the district court.



Summary Judgment



      Under Florida law, a plaintiff asserting a product liability claim against a

product manufacturer must show, among other things, that the product was

defective and that the defect proximately caused plaintiff’s injuries. See West v.

Caterpillar Tractor Co., 336 So. 2d 80, 86-87 (Fla. 1976). “[E]xpert testimony is

often required to establish defective design of a product.” Worsham v. A.H.

Robins Co., 734 F.2d 676, 685 n.8 (11th Cir. 1984).

      After the district court properly excluded Dr. Hetzel’s testimony and granted

Plaintiffs’ motion to reopen, Plaintiffs notified the district court that Dr. Asch

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would not testify as an expert in their case-in-chief. Thus, Plaintiffs had no expert

testimony establishing that the G2 Filter implanted in Payne was defective.

Because Plaintiffs failed to present admissible evidence establishing a necessary

element of their claims against Defendants, Defendants were entitled to summary

judgment. 7

       AFFIRMED.




7
  Plaintiffs argue that the district court abused its discretion by ruling on Defendants’ summary
judgment motion without first waiting for a final ruling on a discovery issue. Defendants had
filed a motion for a protective order, asserting that an internal report prepared by Defendants’
litigation consultant (the “Lehmann Report”) was inadmissible. Meanwhile, Defendants had
filed a similar motion for a protective order about the Lehmann Report in a related case against
Defendants that was pending before the Middle District of Florida’s Jacksonville Division (the
“Tillman Case”). In the interest of judicial economy, the district court in this case referred
Defendants’ motion to the magistrate judge assigned to the Tillman case.
         After the exclusion of Dr. Hetzel’s testimony, Plaintiffs sought, among other things, to
postpone consideration of Defendants’ motion for summary judgment until after a final ruling on
the Lehmann Report. The district court did not rule expressly on Plaintiffs’ motion. Instead, the
district court said it would reserve ruling on Defendants’ motion for summary judgment if
Plaintiffs timely filed a complete expert disclosure about Dr. Asch.
         The district court abused no discretion in granting Defendants’ summary judgment
motion before a final ruling on the Lehmann Report in the Tillman case. First, Plaintiffs failed to
satisfy the district court’s stated precondition for postponing a ruling on summary judgment.
Second, the ruling on the Lehmann Report would not have changed the outcome of this case.
The Lehmann Report (prepared before the G2 Filter was on the market) discusses a different
Bard filter and says nothing about the G2 Filter. Thus, even if ruled admissible, the Lehmann
Report could not, by itself, have established the defect element of Plaintiffs’ case.
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