Payne et al v. C.R. Bard, Inc.
Filing
136
ORDER granting 74 Motion to Exclude the Expert Opinion and Testimony of Fredrick Hetzel, Ph.D.; denying 75 Motion to Exclude the Expert Opinion and Testimony of Timothy Harward, M.D.; granting 105 Motion to Delete Duplicative Filing. On or before March 31, 2014, Plaintiffs are granted leave to file a motion to reopen the deadline to disclose expert witnesses. Signed by Judge Roy B. Dalton, Jr. on 3/12/2014. (VMF)
UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF FLORIDA
ORLANDO DIVISION
ANTHONY PAYNE; and JOHNITA
PAYNE,
Plaintiffs,
v.
Case No. 6:11-cv-1582-Orl-37GJK
C.R. BARD, INC.; and BARD
PERIPHERAL VASCULAR, INC.,
Defendants.
ORDER
This matter comes before the Court on the following:
1.
Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.’s
Dispositive Daubert Motion to Exclude the Expert Opinion and Testimony
of Fredrick Hetzel, Ph.D. (Doc. 74), filed December 31, 2013;
2.
Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.’s
Dispositive Daubert Motion to Exclude the Expert Opinion and Testimony
of Timothy Harward, M.D. (Doc. 75), filed December 31, 2013;
3.
Plaintiffs’ Response to Defendants’ Dispositive Daubert Motion to Exclude
the Expert Opinion and Testimony of Timothy Harward, M.D., and
Incorporated Memorandum of Law (Doc. 93), filed January 24, 2014;
4.
Plaintiffs’ REDACTED Response Seeking to Oppose Defendants’
Dispositive Daubert Motion to Exclude the Expert Opinion and Testimony
of Frederick Hetzel, Ph.D, and Incorporated Memorandum of Law
(Doc. 95), file January 24, 2013;
5.
Plaintiffs’ SEALED Response Seeking to Oppose Defendants’ Dispositive
Daubert Motion to Exclude the Expert Opinion and Testimony of Frederick
Hetzel, Ph.D, and Incorporated Memorandum of Law (Doc. 97), file
January 27, 2013;
6.
Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.’s
Unopposed Motion to Delete Duplicative Filing (Doc. 105), filed February
4, 2014;
7.
Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.’s Reply in
Support of Its Dispositive Daubert Motion to Exclude the Expert Opinion
and Testimony of Frederick Hetzel, Ph.D (Doc. 107), filed February 6,
2014;
8.
Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.’s Reply in
Support of Its Dispositive Daubert Motion to Exclude the Expert Opinion
and Testimony of Timothy Harward, M.D. (Doc. 108), filed February 6,
2014; and
9.
Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.’s Reply
Brief in Further Support of Defendants’ Motion for Summary Judgment
(Doc. 126), filed February 28, 2014.
For the reasons stated on the record during the Daubert Hearing on March 6,
2014 (Doc. 133), and for the reasons set forth below, the Court finds that Defendants’
Daubert Motion to Exclude the Expert Opinion and Testimony of Fredrick Hetzel, Ph.D.
(Doc. 74) is due to be granted, and Defendants’ Daubert Motion to Exclude the Expert
Opinion and Testimony of Timothy Harward, M.D. (Doc. 75) is due to be denied.
2
BACKGROUND
I.
The G2 Filter
This is a medical device products liability action involving the failure of a Bard G2
inferior vena cava filter (the “G2 Filter”). (Doc. 11.) Made of nitinol (which is a metal alloy
of nickel and titanium), and comprised of twelve struts that make up its six arms and six
legs, the G2 Filter is designed to be placed in a person’s inferior vena cava (“IVC”) as a
mechanical barrier to prevent thrombi from reaching the heart or lungs and becoming a
life-threatening pulmonary embolism (“PE”). (Doc. 20, ¶ 20; Doc. 76, pp. 2–3; Doc. 76-2,
pp. 20, 45–46; Doc. 74-14, p. 2.) The G2 Filter is part of a placement system that was
manufactured and distributed by Defendants C.R. Bard, Inc. (“Bard”) and Bard
Peripheral Vascular, Inc. (“Bard PV”). (Doc. 20, ¶¶ 5, 8, 18; Doc. 74-2.) The G2 Filter is
designed to be retrievable, but it may also act as a permanent IVC filter. (Doc. 74-2, p. 2
(“The G2 Filter System – Femoral is indicated for use in the prevention of recurrent
pulmonary embolism via permanent placement in the vena cava . . . .”).)
The G2 Filter is a Class III medical device under the Medical Device
Amendments of 1976 (“MDA”). In accordance with the MDA, Defendants obtained
clearance for the G2 Filter from the Food and Drug Administration (“FDA”) pursuant to a
§ 510(k) application. Carr v. C.R. Bard, Inc., No. 3:13-cv-824, 2014 WL 463347, at *1
(N.D. Ohio Feb. 5, 2014) (citing 21 U.S.C. § 360c(i)). In their application, Defendants
represented that the G2 Filter was substantially equivalent to a predecessor device—
the Recovery Filter. Id.; Linsday v. C.R. Bard, Inc., No. 1:MC-10-441, 2011 WL 240104,
at *1 (M.D. Pa. Jan. 24, 2011).
Before introducing the G2 Filter to the market in 2005, Defendants had received
reports of adverse events in relation to the Recovery Filter. Carr, 2014 WL 463347, at
3
*1, *6 (finding that information about the Recovery Filter’s design flaws may be relevant
to products liability claims arising from a G2 Filter). In November 2004, Defendants
drafted a Health Hazard Evaluation (“HHE”) concerning reports of limb fractures in the
Recovery Filter. (Doc. 120-16 (noting that based on limited data, “fracture rates for
Recovery appear to be higher than those for other filters”).) In December 2004,
Defendants created a Remedial Action Plan due to the adverse data (Doc. No. 120-17),
and they authored another HHE for the Recovery Filter. (Doc. 120-6, pp. 5–9 (noting
that “Recovery reporting rates are significantly higher than those of other filters”).)
Soon after the G2 Filter was introduced to the market, Defendants received
adverse reports of migration (movement) of the filter in the IVC, and Defendants
authored an HHE on the issue. (Doc. 120-9.) Further, early data indicated that the G2
Filter had perforation issues similar to the Recovery Filter (Doc. 120-11), and articles
have been published concerning the failures of the two filters. (See Docs. 116-1 to 1165 (providing copies of six journal articles).) Further, a number of lawsuits have been filed
against Defendants related to the G2 Filter and the Recovery Filter. 1 Finally, in August
2010, the FDA issued an Alert that physicians and clinicians responsible for the care of
patients with retrievable IVC filters should “consider removing the filter as soon as
protection from PE is no longer needed.” (Doc. 74-14, p. 2.) The Alert mentioned “filter
fracture, filter migration, filter embolization and IVC perforation” as risks associated with
IVC filters; however, it did not explicitly reference Defendants or the G2 Filter. (See id.)
1
See Brown v. C.R. Bard., Inc., 942 F. Supp. 2d 549 (E.D. Pa. 2013) (involving
medical monitoring class action); Bouldry v. C.R. Bard, Inc., 909 F. Supp. 2d 1371 (S.D.
Fla. 2012) (same); see also Carr, 2014 WL 463447; Phillips v. C.R. Bard, Inc., 290
F.R.D. 615, 671 (D. Nev. 2013); Davis v. C.R. Bard, Inc., No. 11-12556, 2012 WL
6082993 (E.D. Mich. Dec. 6, 2012) (involving fracture and embolization of a strut from a
G2 filter); Linsday, 2011 WL 240104 (M.D. Pa. Jan. 24, 2011).
4
II.
Mr. Payne
In 2007, Plaintiff Anthony Payne was suffering from recurrent bilateral lower
extremity deep vein thrombosis (“DVT”), which puts one at risk of suffering PE. (Doc.
115, p. 4.) On September 28, 2007, to manage this risk, Dr. Robert Schultz deployed a
G2 Filter below the level of the renal veins in Mr. Payne’s IVC. (Id.; Doc. 74-1; see also
Doc. 93, ¶ 3.) A medical report related to the procedure provides that Mr. Payne and his
wife discussed with Mr. Payne’s physician “the procedure, indications, alternatives and
possible complications including . . . filter failure, filter migration, perforation or fracture.”
(Doc. 74-1; see also Doc. 76-2, pp. 18–21, 25, 32–35, 39; Doc. 76-3.) Mr. Payne’s
physician wrote that the Paynes “understand it is permanent. They understood and
consented.” (Doc. 74-1; see also Doc. 76-2, pp. 34–35, 37–38 (identifying additional
warnings that Mr. Payne received before the procedure).)2
In January 2008, an abdominal and pelvic computed tomography exam (“CT”) of
Mr. Payne revealed that struts of his G2 Filter had perforated his IVC. (Doc. 76-1, p. 12;
Doc. 115, p. 4; Doc. 11, ¶ 13.) Testing also revealed a “filling defect” caudal to the G2
Filter, which may be “secondary to caval thrombosis,” or a trapped clot. (Doc. 76-1, p.
12.) In February 2009, Mr. Payne “developed a one week history of left [lower extremity]
swelling followed by sudden-onset chest pain and shortness of breath.” (Doc. 115, p. 4;
see also Doc. 74-3; Doc. 11, ¶ 15.) CT exams revealed that Mr. Payne had suffered
both DVT and a right-sided PE. (Doc. 76-1, p. 12; see also Doc. 74-3.) In addition, the
2
Mr. Payne’s treating physician explained that he told Mr. Payne that the G2
Filter would likely be permanent because Mr. Payne “likely was going to have recurrent
problems with deep venous thrombosis and pulmonary emboli.” (Doc. 117, p. 5
(explaining that Mr. Payne “had evidence of significant venous thrombosis disease. He
had recurrent disease in his lower extremities . . . he had pulmonary emboli, blood clots
in the lung, despite the fact that he had been anticoagulated”).)
5
G2 Filter was tilted in his IVC, and it had fractured. (Doc. 74-3; see also Doc. 76-1,
p. 13; Doc. 76-4; Doc. 93, ¶¶ 4–5; Doc. 75, p. 1; Doc. 11, ¶ 16.) A fractured strut from
the G2 Filter was seen in Mr. Payne’s renal vein. (Doc. 115, p. 4; Doc. 11, ¶ 16.) An
“unsuccessful attempt was made to retrieve” the G2 Filter and the fractured strut, and a
second IVC filter was successfully placed in Mr. Payne’s IVC cephalad to the G2 Filter.
(Doc. 115, p. 4; see also Doc. 97, p. 2.) Later in 2009, Mr. Payne again experienced
chest pain. (Doc. 115, p. 4.) A chest x-ray and CT angiogram revealed that the fractured
strut from the G2 Filter had migrated to the lower lobe of Mr. Payne’s left lung. (Id.; see
also Doc. 74-4; Doc. 76-1, p. 12; Doc. 76-6, pp. 27, 35–36.) An unsuccessful attempt
was made to remove the “strut from the posterior basilar branch of the left lower lobe
pulmonary artery.” (Doc. 115, p. 4.) Mr. Payne continues to have left-sided chest pain
and shortness of breath. (Doc. 115.)
III.
Instant Action
Plaintiffs assert three claims: (1) strict liability based on defective design (Doc.
11, ¶¶ 23–31); (2) strict liability based on defective manufacturing (id. ¶¶ 32–43); and
(3) negligence (id. ¶¶ 44–55). Plaintiffs seek compensatory and punitive damages and
their costs. (Id. ¶¶ 56–60.) Mrs. Payne alleges loss of consortium. (Id.) Plaintiffs have
identified two expert witnesses—Drs. Hetzel and Harward. (See Docs. 74, 75.)
Defendants filed motions challenging the admissibility of the opinion testimony of both
experts. (Docs. 74, 75.) Defendants also filed a Motion for Summary Judgment. (Doc.
76.) Plaintiffs filed responses to all three motions (Docs. 93, 97, 120), and Defendants
filed replies. (Docs. 107, 108, 126.) A Daubert hearing was held in this matter on March
6, 2014; however, Plaintiffs did not present live testimony from either of their proposed
expert witnesses. The Daubert motions are now ripe for adjudication.
6
STANDARDS
Before permitting expert opinion testimony, the court must make certain that the
expert employs “in the courtroom the same level of intellectual rigor that characterizes
the practice of the expert in the field.” Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152
(1999). This requirement comes from Federal Rule of Evidence 702, which provides:
If scientific, technical, or other specialized knowledge will assist the trier of
fact to understand the evidence or to determine a fact in issue, a witness
qualified as an expert by knowledge, skill, experience, training, or
education, may testify thereto in the form of an opinion or otherwise if
(1) the testimony is based upon sufficient facts or data, (2) the testimony is
the product of reliable principles and methods, and (3) the witness has
applied the principles and methods reliably to the facts of the case.
Fed. R. Evid. 702; see also McClain v. Metabolife Int’l, Inc., 401 F.3d 1233, 1237 (11th
Cir. 2005). Under Rule 702 and the Supreme Court decision governing its application,
Daubert v. Merrell Dow Pharm., 509 U.S. 579 (1993), district courts must act as
gatekeepers to prevent speculative and unreliable “expert” testimony from reaching the
jury. Rink v. Cheminova, Inc., 400 F.3d 1286, 1291 (11th Cir. 2005) (noting that the
“task of evaluating the reliability of expert testimony is uniquely entrusted to the district
court under Daubert”); McClain, 401 F.3d at 1237–38. The gatekeeping role is
“significant” because an “expert’s opinion ‘can be both powerful and quite misleading.’”
United States v. Frazier, 387 F.3d 1244, 1260 (11th Cir. 2004) (quoting Daubert, 509
U.S. at 595).
As gatekeeper, the district court makes three inquiries: (1) first, whether the
expert is qualified to testify competently regarding the matters that he intends to
address; (2) second, whether the methodology by which the expert reaches his
conclusions is sufficiently reliable as determined by the sort of inquiry mandated in
Daubert; and (3) third, whether the testimony will assist the trier of fact, through the
7
application of scientific, technical, or specialized expertise, to understand the evidence
or to determine a fact in issue. See City of Tuscaloosa v. Harcros Chems., Inc., 158
F.3d 548, 562–63 (11th Cir. 1998); see also Cooper v. Marten Transp., Ltd., 539 F.
App’x 963, 965–67 (11th Cir. 2013). The party offering the expert opinion testimony
bears the burden of establishing, by a preponderance of the evidence, the expert’s
qualification, reliability, and helpfulness. See Kilpatrick v. Breg, Inc., 613 F.3d 1329,
1335 (11th Cir. 2010) (citing McCorvey v. Baxter Healthcare Corp., 298 F.3d 1253,
1256 (11th Cir. 2002)); see also Sumner v. Biomet, Inc., 434 F. App’x 834, 841 (11th
Cir. 2011); Frazier, 387 F.3d at 1260.
While stringent, the standards set forth in Daubert and Rule 702 are not
guarantees of correctness. When the methodology is sound and the evidence relied
upon is sufficiently related to the case at hand, disputes about the degree of relevance
or accuracy (above this minimum threshold) may go to the testimony’s weight, but not
its admissibility. See United States v. Ala. Power Co., 730 F.3d 1278, 1282–85
(11th Cir. Sept. 19, 2013) (explaining that the Daubert inquiry “is not intended to
supplant” cross-examination and presentation of contrary evidence); see also Costa v.
Wyeth, Inc., No. 8:04-cv-2599-T-27MAP, 2012 WL 1069189, at *2 (M.D. Fla. Mar. 29,
2012).
8
DISCUSSION
I.
Frederick Hetzel, Ph.D
Plaintiffs retained Dr. Hetzel in June 2011 to “assess (1) the device failure
mode(s) implanted into Mr. Payne, (2) the adequacy of warnings and labeling for the
implanted BARD G-2 IVC clot filter, (3) design/safety factors as related to the cause of
the product failure(s), [and] (4) the adequacy of Bard’s 510(k) for the G-2 device.” (Doc.
74-8, p. 6.) On November 22, 2013, Dr. Hetzel produced a Supplemental Report. (Id.)
Defendants deposed Dr. Hetzel on November 25, 2013 (Doc. 74-17), and they filed their
Daubert Motion on December 31, 2013 (Doc. 74.) On January 27, 2014, Plaintiffs filed
their Response and an Affidavit of Dr. Hetzel. (Doc. 97; Doc. 97-1.) Defendants filed
their Reply on February 6, 2014. (Doc. 107.) Finally, on March 3, 2014, Plaintiffs filed an
errata sheet for Dr. Hetzel’s deposition. (Doc. 127-1.) During the Daubert hearing, Dr.
Hetzel did not testify; however, Defendants exhibited excerpts of his videotaped
deposition to the court. (Doc. 133.)
A.
Supplemental Report
In the first three pages of Dr. Hetzel’s thirteen-page Supplemental Report, he
provides a summary of Mr. Payne’s medical history starting in May 2007. (Doc. 74-8,
pp. 2–4.) The fourth page of the Report is a brief summary of Dr. Hetzel’s “Credentials.”
(Id. at 5.) Pages five through ten provide a “Background” section describing the G-2
Filter and summarizing certain evidence concerning product development, complaints,
and Defendants’ interaction with the FDA. 3 (Id. at 6–11.) Finally, pages eleven to
3
This section contains mainly plaintiff-slanted summaries and characterizations
of the evidence which should be excluded as unhelpful to the jury. See In re Baycol
Prods. Litig., 532 F. Supp. 2d 1029, 1067–69 (D. Minn. 2007) (finding that expert’s
criticism of defendant “for inadequately evaluating the potential toxicity of Baycol, and
9
thirteen recite Dr. Hetzel’s twenty “Opinions.” (Id. at 12–14.) Generally, Dr. Hetzel
opines that:
(a)
high rates of G2 Filter failures were due to “flawed product design,”
and inadequate testing (id. ¶¶ 1, 4, 14);
(b)
Defendants employed inadequate quality
management techniques (id. ¶¶ 6–13);
(c)
electropolishing would have resulted in “a safer product” (id. ¶¶ 13,
16);
(d)
“[a]lternative designs and materials are available and described as
specified in industry standards and identified in competitors’ various
regulatory submissions” (id. ¶ 18);
(e)
“[a]dditional warnings either in IFUs, Package Inserts or instructive
material are needed to adequately inform surgeons as to the design
limits” of the G2 Filter (id. ¶ 19); and
(f)
Defendants’ “faulty” assurances and submissions to the FDA render
the G2 Filter “adulterated within the meaning as applied by the FDA”
(id. ¶¶ 17, 18).
control
and
risk
Because they have been withdrawn, the foregoing omits Dr. Hetzel’s opinions
concerning manufacturing defects and Defendants’ corporate misconduct, which were
asserted by Dr. Hetzel and objected to by Defendants. 4 (Doc. 97, p. 2 (providing that
Plaintiffs have withdrawn “Dr. Hetzel as an expert with respect to . . . the existence of a
manufacturing defect” in the G2 Filter, and representing that Dr. Hetzel will “refrain from
giving any opinions regarding his perceptions of [Defendants’] ‘bad behavior’”).)
asserting that [defendant] ignored warnings is legal argument that does not qualify as
expert testimony under Rule 702”); In re Fosamax Prods. Liab. Litig., 645 F. Supp. 2d
164, 192 (S.D.N.Y. 2009) (holding that expert’s “commentary on any documents and
exhibits” would be limited to “drawing inferences that would not be apparent without the
benefit of experience or specialized knowledge”); see also In re Trasylol Prods. Liab.
Litig., 709 F. Supp. 2d 1323, 1345–47 (S.D. Fla. 2010).
4 During the Daubert hearing, Plaintiffs’ counsel confirmed the remaining topics
on which Dr. Hetzel would opine. (Doc. 133.)
10
B.
Defendants’ Motion
Defendants persuasively argue that the Court should completely preclude
Dr. Hetzel from testifying in this action because: (1) he “lacks sufficient knowledge, skill,
experience, training, and education to qualify as an expert regarding medicine;
metallurgy; and [IVC] filter design, manufacturing and labeling” (Doc. 74, pp. 2, 4–9);
(2) his opinions are unhelpful, plaintiff-slanted summaries (id. at 2, 9–11); and (3) his
litigation-driven opinions are unreliable because they are “based on a cursory review of
the barest materials” and do not satisfy the Daubert factors (id. at 2, 11–22). Defendants
cite numerous pertinent medical device product liability cases where other federal
courts precluded testimony in circumstances similar to those presented here—including
two cases in which Dr. Hetzel was precluded from offering product-defect and deficientlabeling opinions because his qualifications were not sufficiently pertinent to the hip and
knee implant products in those cases. (Id. (discussing Soufflas v. Zimmer, Inc., 474 F.
Supp. 2d 737 (E.D. Pa. 2007), and Swank v. Zimmer, Inc., No. 03-cv-60-B, 2004 WL
5254312 (D. Wyo. Apr. 20, 2004).) 5
C.
Plaintiffs’ Response
Plaintiffs’ Response is markedly unpersuasive. At the outset, Plaintiffs misstate
the standard for assessing the admissibility of Dr. Hetzel’s opinions. Rather than
acknowledge Plaintiffs’ obligation to establish admissibility by a preponderance of the
evidence, Plaintiffs argue that the Court should deny Defendants’ attempts to
5
The Swank court held that “Dr. Hetzel is not qualified to testify on the alleged
inadequacies in Defendant’s warnings,” and “[h]e is not qualified to testify on the design
of the device because he has no experience or education in designing hip implants.”
Swank, 2004 WL 5254312, at *3. The Soufflas court similarly held that “Dr. Hetzel is not
qualified to opine about the alleged inadequacies of Zimmer’s warnings,” and he “is not
qualified as an expert to opine on” the common practices of those in the industry of
“manufacturing prescription medical devices.” Soufflas, 474 F. Supp. 2d at 744.
11
“disqualify” Dr. Hetzel because Defendants have “failed to demonstrate that Dr. Hetzel
lacks the minimal qualifications to testify.” (Doc. 97, pp. 2, 9 (arguing that Defendants
have “fallen short of convincing this Honorable Court to believe that Dr. Hetzel . . . is
‘unqualified’ to opine regarding the defective design of the IVC filter”).) Further, Plaintiffs
cite only nine cases, including four cases cited in an unsuccessful attempt to distinguish
them. The remaining cited cases are similarly unhelpful. Indeed, aside from Daubert
and Frazier, Plaintiffs cite only insurance coverage cases concerning expert claims
adjusters—not complex products liability actions involving defective device and
causation experts.
D.
Analysis
1.
Qualifications
“[I]n determining whether a proffered expert is ‘qualified’ to offer an opinion,
courts generally look to evidence of the witness’s education and experience and ask
whether the subject matter of the witness’s proposed testimony is sufficiently within the
expert’s expertise.” In re Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig.,
711 F. Supp. 2d 1348, 1367 (M.D. Ga. 2010). Here, Dr. Hetzel earned a B.S. in
chemistry at Penn State University in 1964; three years later, he earned an M.S. in
chemistry from Ohio State University; and in 1968, he earned a Ph.D. in organic
chemistry from Ohio State University. (Doc. 74-11, p. 3.) Although impressive,
Dr. Hetzel’s education does not qualify him to testify in this case because chemistry is
not implicated by Plaintiff’s claims. The Court rejects Plaintiffs’ argument that Dr.
Hetzel’s chemistry background somehow qualifies him to opine on metallurgy issues
because “the materials in metallurgy are part of the periodic chart of the elements which
12
is what chemistry is all about.” 6 (Doc. 97, p. 5; see also Doc. 94-17, p. 12.)
Because Dr. Hetzel’s education does not fit with this case, Plaintiffs focus on his
“experience” with “medical device technology” as rendering him “eminently qualified to
testify.” (Doc. 97, p. 4; see also Doc. 97-1.) In particular, Plaintiffs emphasize Dr.
Hetzel’s “experience in actually consulting specifically with [IVC] filters.” (Doc. 97, pp. 7–
8.) However, that project occurred more than twenty years ago, lasted only three to six
months, and was only “conceptual.” (Doc. 97, pp. 7–8; see also Doc. 74-17, pp. 20–21.)
As such, it does not qualify him to render his opinions in this case. 7 See Walker v. CSX
Transp. Inc., 650 F.3d 1392, 1397 n.19 (11th Cir. 2011) (affirming exclusion of expert
whose limited experience with the product at issue had “occurred over thirty to forty
years” before the case arose).
Where, as here, a witness relies “primarily on experience, then 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 reliably applied to the facts.”
Frazier, 387 F.3d at 1261 (citing Fed. R. Evid. 702 advisory committee’s note (2000
amends.)). Plaintiffs have failed to properly tie Dr. Hetzel’s limited and dated experience
as a consultant and his extensive experience as a plaintiff’s expert in myriad product
liability cases to the opinions that he has offered in this case. Therefore, Plaintiff has not
established Dr. Hetzel’s qualifications by a preponderance of the evidence. See Walker,
650 F.3d at 1397 n.19 (affirming exclusion of expert evidence who “may have extensive
6
Plaintiffs’ argument is at odds with Dr. Hetzel’s testimony in another case that a
metallurgical failure is one issue where he might be unqualified to render an opinion.
(Doc. 74-9.)
7 Defendants aptly note that Dr. Hetzel “admits that he has never designed an
IVC filter, he has never tested an IVC filter, he has never manufactured an IVC filter, he
has never taught any seminars regarding IVC filters, and he has never published any
articles regarding IVC filters.” (Doc. 74, p. 6.)
13
experience in the railway industry,” but was “not qualified . . . to offer opinions regarding
the design, operation, and alleged safety features of the subject bulkhead door
system”); see also Polston v. Boomershine Pontiac-GMC Truck, Inc., 952 F.2d 1304,
1309 (11th Cir. 1992) (agreeing with district court that mechanical engineer was not
qualified to testify as to medical probabilities); In re Breast Implant Litig., 11 F. Supp. 2d
1217, 1241–43 (D. Colo. 1998) (holding that a chemist’s “asserted expertise in
biomaterials does not make him qualified in the many areas of medical science in which
he opines” and the “design, manufacturing, marketing, or labeling of silicone breast
implants”).
2.
Reliability & Helpfulness
The district court has substantial discretion in deciding how to assess whether an
expert’s “reasoning or methodology underlying the testimony is scientifically valid” and
can be applied to the facts of the case. Kilpatrick, 613 F.3d at 1335; see also Rink, 400
F.3d at 1292. For instance, if appropriate, the Court may consider: “(1) whether the
experts’ methodology can be tested; (2) whether the expert’s scientific technique has
been subjected to peer review and publication; (3) whether the method has a known
rate of error; and (4) whether the technique is generally accepted by the scientific
community.” Rink, 400 F.3d at 1292; e.g., Sumner, 434 F. App’x at 841. A district court
may find unreliable an expert’s opinion that is “connected to existing date only by the
ipse dixit of the expert.” Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997) (explaining
that if there is “too great an analytical gap between the data and the opinion proffered,”
then the opinion may be excluded); see also Cook ex rel. Estate of Tessier v. Sheriff of
Monroe Cnty., 402 F.3d 1092, 1111 (11th Cir. 2005) (holding that opinions that are
“imprecise and unspecific, or whose factual basis is not adequately explained” should
14
be excluded); Rydzewski v. DePuy Orthopaedics, Inc., No. 11-80007-CIV, 2012 WL
7997961, at *6 (S.D. Fla. Aug. 14, 2012) (criticizing Dr. Hetzel for his “factually
unsupported” opinions). Further, where an opinion is advanced solely for the purpose of
litigation, the Court may weigh this fact “heavily against the admissibility” of the opinion.
Sumner, 434 F. App’x at 842–43.
Here, the methodology that Dr. Hetzel applied in reaching his opinions does not
support a finding of reliability. As noted by Defendants, Dr. Hetzel reviewed only three
deposition transcripts, and he referenced only a small fraction of the scholarly articles
concerning IVC filters and the G2 Filter in particular. (Doc. 74, pp. 13, 17–18; see also
Doc. 74-12; Doc. 74-17, pp. 45, 57–58, 86–89, 129–31, 145.) Further, in his list of
matters considered in forming his opinions, Dr. Hetzel lists largely inapplicable
materials—including articles regarding hip implants. (Doc. 74, p. 13; see also Doc. 7412, ¶¶ 11, 13, 14.) Defendants correctly characterize Dr. Hetzel’s work in this matter as
a “slipshod” approach that does not match the level of intellectual rigor that scientists
typically employ. (Doc. 7, p. 4.) That Dr. Hetzel’s opinions were developed solely in the
context of this litigation provides further support for a finding that his opinions are
unreliable and unhelpful. See Sumner, 434 F. App’x at 842–43 (affirming exclusion of
opinion absent evidence that the proposed expert “developed his theory during research
conducted independent” of the litigation). 8 Accordingly, even if Dr. Hetzel’s qualifications
were sufficient, his methodology is not. See McCorvey, 298 F.3d at 1256–57 (affirming
8
See also Lust ex rel. Lust v. Merrell Dow Pharm., Inc., 89 F.3d 594, 597–98 (9th
Cir. 1998) (finding it “not unreasonable to presume” that professional plaintiff’s witness’s
opinions were unreliable); Tokio Marine & Fire Ins. Co. v. Grove Mfg. Co., 958 F.2d
1169, 1173–75 (1st Cir. 1992) (noting that expert witness’ “hired gun background as an
expert in an astonishing number of other areas suggested he ‘would not possess the
professional safeguards ensuring objectivity’”).
15
exclusion of expert opinion absent testing and a command of the pertinent literature).
For all of the foregoing reasons, and for the reasons stated on the record during the
hearing on March 6, 2014 (Doc. 133), Defendants’ Daubert motion concerning Dr.
Hetzel is due to be granted.
II.
Timothy Harward, M.D.
Dr. Harward opines that Mr. Payne’s symptoms are caused by an “inflammatory
response” to the strut in his left lung and “chronic fibrosis in the pulmonary arteries,”
which was exacerbated by “recurrent pulmonary emboli” that occurred when
Mr. Payne’s IVC “was no longer properly covered” due to the failure of the G2 Filter. (Id.
at 4–5.) Defendants’ expert, Clement J. Grassi, M.D., opines that Mr. Payne’s
“pulmonary symptoms are most likely due to chronic pulmonary hypertension from
chronic PE, acquired over a long period of time.” (Doc. 76-1, pp. 14–15 (opining that the
symptoms are not caused or aggravated by the strut or the body of the G2 Filter).)
Defendants raise no challenge to Dr. Harward’s qualifications; rather, they argue that
his testimony should be excluded because he did not reliably apply a differential
diagnosis in reaching his opinions. (Doc. 75, pp. 7–11.)
“Differential diagnosis ‘is accomplished by determining the possible causes for
the patient’s symptoms and then eliminating each of these potential causes until
reaching one that cannot be ruled out or determining which of those that cannot be
excluded is the most likely.’” Guinn v. AstraZeneca Pharm. LP, 602 F.3d 1245, 1253
(11th Cir. 2010) (quoting Westberry v. Gislaved Gummi AB, 178 F.3d 257, 262 (4th Cir.
1999)). While an expert need not “rule out all possible alternative causes” of an injury,
she must “at least consider other factors that could have been the sole cause of the
plaintiff’s injury.” Guinn, 602 F.3d at 1253. The expert also must “’provide a reasonable
16
explanation as to why he or she has concluded that [any alternative cause suggested by
the defense] was not the sole cause’ of the plaintiff’s injury.” Id. (quoting Best v. Lowe’s
Home Ctrs., Inc., 563 F.3d 171, 179 (6th Cir. 2009)). Finally, an expert may not rely
solely on the temporal proximity of an injury to establish medical causation. See id.
(noting that in some circumstances, “temporal proximity may constitute probative
evidence” of causation); Kilpatrick, 61 F.3d at 1343 (holding that plaintiff “cannot
overcome the fact” that her expert’s “causation testimony is rooted in a temporal
relationship”).
Here, Dr. Harward did not rely solely on the temporal relationship between the
G2 Filter failure and the onset of Mr. Payne’s symptoms as a basis for his causation
opinion. (Doc. 75-3, p. 38.) Further, although Dr. Harward intimates that his opinions
are, by necessity, based on speculation (id. at 37–39), there is no indication that Dr.
Harward departed from his normal practice of diagnosis in his assessment of Mr.
Payne. Further, Dr. Harward’s opinion is consistent, in part, with Dr. Grassi’s opinion.
Accordingly, the Court is persuaded that Dr. Harward’s opinions were reached through
a reliable application of an accepted methodology—the differential diagnosis. See Costa
v. Wyeth, Inc., No. 8:04-cv-2599, 2012 WL 1069189, at *2 (M.D. Fla. Mar. 29, 2012)
(permitting expert to opine regarding causation based on differential diagnosis).
Defendants’ Daubert motion regarding Dr. Harward is due to be denied.
III.
Summary Judgment
Defendants seek summary judgment in their favor on numerous grounds—
including that Plaintiffs cannot establish the requisite elements of defect and causation
absent the opinion testimony of Dr. Hetzel. (Doc. 76.) During the Daubert Hearing,
Plaintiffs conceded that summary judgment may be appropriate absent expert
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testimony, and they moved ore tenus for leave to reopen the deadline to disclose an
expert witness on the pertinent issues. (Doc. 133.) The Court advised that it would
consider such a motion if filed, but Plaintiffs have not yet filed the motion. The Court will
reserve ruling on Defendants’ summary judgment motion pending a brief additional
period of time for Plaintiffs to file their motion.
CONCLUSION
Accordingly, it is hereby ORDERED AND ADJUDGED:
1.
Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.’s
Unopposed Motion to Delete Duplicative Filing (Doc. 105) is GRANTED.
2.
Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.’s
Dispositive Daubert Motion to Exclude the Expert Opinion and Testimony
of Fredrick Hetzel, Ph.D. (Doc. 74) is GRANTED.
3.
Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.’s
Dispositive Daubert Motion to Exclude the Expert Opinion and Testimony
of Timothy Harward, M.D. (Doc. 75) is DENIED.
4.
On or before March 31, 2014, Plaintiffs are granted leave to file a motion
to reopen the deadline to disclose expert witnesses.
5.
Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.’s Motion for
Summary Judgment (Doc. 76) will be TAKEN UNDER ADVISEMENT on
March 31, 2014.
DONE AND ORDERED in Chambers in Orlando, Florida, on March 12, 2014.
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Copies:
Counsel of Record
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