The opinion
UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF FLORIDA
PENSACOLA DIVISION
JUDY L. TEDDER,
Plaintiff,
v. CASE NO. 3:20cv5611-MCR-MJF
ETHICON, INC. and
JOHNSON & JOHNSON,
Defendants.
________________________/
ORDER1
This case is before the Court on remand from the Southern District of West
Virginia, In re: Ethicon, Inc., Pelvic Repair Sys. Prod. Liab. Litig., No. 2012-MD-
2327-JRG. On May 15, 2007, and May 25, 2010, respectively, Plaintiff Judy L.
Tedder had two pelvic mesh devices surgically implanted by Dr. Basil D. Fossum—
TVT-Secur (TVT-S) and TVT-Oturator (TVT-O), both of which were manufactured
and sold by Defendant Ethicon, Inc.2 Tedder alleges she was injured as a result of
defects in the devices. Currently before the Court is Defendants’ Motion to Exclude
Certain General Opinions of Jerry Blaivas, M.D. (ECF No. 131).
1 The Court assumes the parties’ familiarity with the nature of this litigation, the claims and
defenses, and the current evidentiary record. Thus, this Order sets out only what is necessary to
explain the Court’s rulings.
2 Ethicon is a part of the Johnson & Johnson Medical Device Companies. See
https://www.jnjmedicaldevices.com/en-US/companies/ethicon.
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Tedder designated Dr. Blaivas, a board certified urologist and surgeon, to
provide general opinions about TVT-S and TVT-O. The MDL court ruled on a
number of Defendants’ challenges to Dr. Blaivas’s testimony but reserved ruling on
two issues Defendants raise in the instant motion—the relevance and reliability of
Dr. Blaivas’s opinions that non-synthetic mesh procedures present a safer alternative
to TVT-S and TVT-O and the reliability of Dr. Blaivas’s opinions regarding the
distinction between mechanical-cut and laser-cut mesh. Defendants raise two
additional issues as well.3
I. Legal Standard
Rule 702, as explained by Daubert and its progeny, governs the admissibility
of expert testimony. Rink v. Cheminova, Inc., 400 F.3d 1286, 1291 (11th Cir. 2005).
Under Rule 702 and Daubert, district courts must act as “‘gatekeepers’” to ensure
the reliability and relevancy of expert testimony. Id. (citing Daubert, 509 U.S. at
589, 113 S. Ct. 2795). Expert testimony is reliable and relevant—and, therefore,
admissible—when the following criteria are met: (1) the expert is sufficiently
qualified to testify about the matters he intends to address; (2) the methodology used
3 Defendants also argue that the Court should preclude Dr. Blaivas from offering opinions that the
MDL court excluded. The motion is DENIED as moot in that respect, as Tedder is not asking
that the Court reconsider any of the MDL orders regarding Dr. Blaivas. See ECF No. 152 at 1.
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is “sufficiently reliable as determined by the sort of inquiry mandated in Daubert;
and (3) the testimony assists the trier of fact, through the application of scientific,
technical, or specialized expertise, to understand the evidence or to determine a fact
in issue.” Id. The Eleventh Circuit refers to these criteria separately as
“qualification, reliability, and helpfulness,” United States v. Frazier, 387 F.3d 1244,
1260 (11th Cir. 2004), and has emphasized that they are “distinct concepts that courts
and litigants must take care not to conflate,” Quiet Tech. DC-8, Inc. v. Hurel–Dubois
UK Ltd., 326 F.3d 1333, 1341 (11th Cir. 2003). The party offering the expert has
the burden of showing, by a preponderance of the evidence, that each of these
requirements is met. Rink, 400 F.3d at 1292.
To meet the qualification requirement, a party must show that its expert has
sufficient “knowledge, skill, experience, training, or education” to form a reliable
opinion about an issue that is before the court. Hendrix ex. Rel. G.P. v. Evenflo Co.,
Inc., 609 F.3d 1183, 1193 (11th Cir. 2010) (citing Fed. R. Evid. 702) (“Hendrix
II”), aff’g 255 F.R.D. 568 (N.D. Fla. 2009) (“Hendrix I”). If a “‘witness is relying
solely or 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
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at 1261 (quoting Fed. R. Evid. 702 advisory committee’s note to 2000 amendments).
The qualifications standard for expert testimony is “not stringent,” and “[s]o long as
the witness is minimally qualified, objections to the level of [his] expertise [go] to
credibility and weight, not admissibility.” Hendrix I, 255 F.R.D. at 585 (internal
marks omitted).
To meet the reliability requirement, an expert’s opinion must be based on
scientifically valid principles, reasoning, and methodology that are properly applied
to the facts at issue. Frazier, 387 F.3d at 1261–62. The reliability analysis is guided
by several factors, including: (1) whether the scientific technique can be or has been
tested; (2) whether the theory or technique has been subjected to peer review or
publication; (3) whether the technique has a known or knowable rate of error; and
(4) whether the technique is generally accepted in the relevant community. Daubert,
509 U.S. at 593–94, 113 S. Ct. 2786. “[T]hese factors do not exhaust the universe
of considerations that may bear on the reliability of a given expert opinion, and a
federal court should consider any additional factors that may advance its Rule 702
analysis.” Quiet Tech., 326 F.3d at 1341. The court’s focus must be on the expert’s
principles and methodology, not the conclusions they generate. Daubert, 509 U.S.
at 595, 113 S. Ct. 2786. The test for reliability is “flexible,” and courts have “broad
Case No. 3:20cv5611-MCR-MJF
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latitude” in determining both how and whether this requirement is met. Kumho Tire
Co., Ltd. v. Carmichael, 526 U.S. 137, 141–42 (1999).
Finally, to satisfy the helpfulness requirement, expert testimony must be
relevant to an issue in the case and offer insights “beyond the understanding and
experience of the average citizen.” United States v. Rouco, 765 F.2d 983, 995 (11th
Cir. 1985). Relevant expert testimony “‘logically advances a material aspect’” of
the proposing party’s case and “‘fit[s]’” the disputed facts. McDowell v. Brown, 392
F.3d 1283, 1298–99 (11th Cir. 2004) (quoting Daubert, 509 U.S. at 591, 113 S. Ct.
2786). Expert testimony does not “fit” when there is “too great an analytical gap”
between the facts and the proffered opinion. Gen. Elec. Co. v. Joiner, 522 U.S. 136,
146 (1997).
“Because of the powerful and potentially misleading effect of expert evidence,
sometimes expert opinions that otherwise meet the admissibility requirements may
still be excluded [under Federal Rule of Evidence] 403.” Frazier, 387 F.3d at 1263
(internal citation omitted). “Exclusion under Rule 403 is appropriate if the probative
value of otherwise admissible evidence is substantially outweighed by its potential
to confuse or mislead the jury, or if the expert testimony is cumulative or needlessly
time consuming,” or if it is otherwise unfairly prejudicial. Id. (internal citation
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omitted). “Indeed, the judge in weighing possible prejudice against probative force
under Rule 403 . . . exercises more control over experts than over lay witnesses.” Id.
(internal marks omitted). “Simply put, expert testimony may be assigned talismanic
significance in the eyes of lay jurors, and, therefore, . . . district courts must take care
to weigh the value of such evidence against its potential to mislead or confuse.” Id.
When scrutinizing the reliability, relevance, and potential prejudice of expert
testimony, a court must remain mindful of the delicate balance between its role as a
gatekeeper and the jury’s role as the ultimate factfinder. Id. at 1272. The court’s
gatekeeping role “is not intended to supplant the adversary system or the role of the
jury.” Allison v. McGhan Med. Corp., 184 F.3d 1300, 1311 (11th Cir. 1999). Only
the jury may determine “where the truth in any case lies,” and the court “may not
usurp this function.” Frazier, 387 F.3d at 1272. Thus, a court may not “evaluate
the credibility of opposing experts” or the persuasiveness of their conclusions, Quiet
Tech., 326 F.3d at 1341; instead, the court’s duty is limited to “ensur[ing] that the
fact-finder weighs only sound and reliable evidence,” Frazier, 387 F.3d at 1272.
Case No. 3:20cv5611-MCR-MJF
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II. Discussion
A. Non-synthetic mesh procedures as a safter alternative
Dr. Blaivas opined that fewer serious complications occur “‘in the alternative
surgical treatments for stress urinary incontinence (such as biologic slings, or the
polypropylene sutures used in the Burch procedure or autologous fascia pubovaginal
slings)’” than in procedures using TVT-S or TVT-O. ECF No. 131 at 3. Defendants
argue that any alleged comparative benefit of the procedures is not relevant to
Tedder’s design defect claims because they are surgical approaches, not medical
devices, and do not entail altering the design of the devices at issue. Defendants also
argue that Dr. Blaivas’s opinions are grounded on his unreliable perception of
complication rates associated with TVT-S and TVT-O and that Dr. Blaivas
improperly bases his opinions regarding the benefits of autologous slings solely on
his personal experience. The MDL court determined that the relevance of Dr.
Blaivas’s testimony regarding alternative procedures should be decided on a case-
by-case basis and thus reserved ruling on the issue.
Tedder does not contend the different surgical mesh treatments Dr. Blaivas
proposes constitute alternative designs; rather, Tedder argues Dr. Blaivas’s opinions
regarding alternative treatments are relevant to whether Ethicon was negligent in
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placing its products on the market and whether the risks associated with the products
outweigh their utility. “In Florida, a plaintiff need not demonstrate the existence of
a reasonable alternative design for a strict liability design defect claim.” 4 Geery v.
Ethicon, Inc., No. 6:20-CV-1975-RBD-LRH, 2021 WL 2580144, at *5 (M.D. Fla.
Apr. 9, 2021) (citing Aubin v. Union Carbid Corp., 177 So. 3d 489, 511 (Fla. 2015)).
“In proving strict liability, Florida courts use both the consumer expectations test
and the risk utility test.” Id. (citing Aubin, 177 So. 3d at 511; Messina v. Ethicon,
Inc., No. 6:20-cv-1170-Orl-40LRH, 2020 WL 7419586, at *4 (M.D. Fla. Dec. 17,
2020)). “Under the consumer expectation test, a product is defectively designed if
it fails to perform as safely as the ordinary consumer would expect.” Id. “And under
the risk utility test, a ‘product is considered unreasonably dangerous” when “the risk
of danger in the design outweighs the benefits.’” Id. (quoting Pierre v. Intuitive
Surgical, Inc., 476 F. Supp. 3d 1260, 1271 (S.D. Fla. 2020)).
The Court need not decide whether Dr. Blaivas’s opinions regarding
alternative procedures are relevant to the risk utility test because the Court finds the
opinions lack reliability. As Defendants assert, Dr. Blaivas’s opinions regarding
4 The Court is exercising diversity jurisdiction over this matter, so it applies state substantive law.
See Bravo v. United States, 577 F.3d 1324, 1325 (11th Cir. 2009).
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alternative procedures are based, at least in part, on conclusions regarding
complication rates associated with TVT-S and TVT-O, which Dr. Blaivas never
implanted. Dr. Blaivas bases his opinions regarding complication rates on his
experience with the biologic sling and treating women who have suffered
complications from synthetic mesh slings, which he effectively acknowledges is not
representative of complication rates in general. Dr. Blaivas also relies on an article
that reports his own personal experiences and another article that describes
complications associated with use of transvaginal mesh to treat pelvic organ
prolapse.
The MDL court excluded Dr. Blaivas’s opinions in that regard, finding as
follows:
Ethicon challenges the reliability of Dr. Blaivas’s expert testimony
about safety and efficacy and complication rates by pointing out
numerous perceived flaws in the foundation of Dr. Blaivas’s expert
testimony. Two primary problems render this expert testimony
unreliable. First, Dr. Blaivas continues to rely quite heavily on
complication rates this court has excluded time and again. E.g., Huskey
v. Ethicon, Inc., 29 F. Supp. 3d 691, 721 (S.D. W. Va. 2014). In
Huskey, I excluded this expert testimony because “Dr. Blaivas did not
explain his methodology and admitted that it was impossible to
calculate an accurate complication rate.” Id. He has not remedied these
shortcomings. Second, Dr. Blaivas does not provide a reasonable
explanation for his disagreement with guidelines that he helped author
and that conclude mesh products are suitable surgical options. See, e.g.,
Bethune v. Bos. Sci. Corp., No. 2:13-cv-6199, 2016 WL 2983697, at *4
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(S.D. W. Va. May 20, 2016) (noting an expert’s methodology “may be
flawed if he does not provide an adequate explanation for why he
disagrees with [contrary] studies”). Accordingly, the expert testimony
is EXCLUDED.
In re Ethicon Inc. Pelvic Repair Sys. Prod. Liab. Litig., MDL No. 2327, 2016 WL
8737388, at *4 (S.D.W. Va. Aug. 26, 2016). As another court noted in a case on
remand from the MDL,
Dr. Blaivas explains that he relied on a case study he conducted himself
to support his opinion that the complication rate of women implanted
with pelvic mesh devices exceeds 15%. However, Dr. Blaivas later
revises this figure to “greater or equal” to 15% and cannot explain how
he arrived at this statistic, testifying instead that “these things are not as
precise, none of this stuff.”
Boneta v. Am. Med. Sys., Inc., No. 20-CIV-60409-RAR, 2021 WL 6134790, at *6
(S.D. Fla. Sept. 27, 2021) (internal citation omitted). “Multiple courts have
previously identified similar shortcomings in Dr. Blaivas’s complication rate
testimony.” Id. (citing Wood v. Am. Med. Sys. Inc., No. 1:20-cv-00441-DDD-KLM,
2021 WL 1178547, at *8 (D. Colo. March 26, 2021) (agreeing that Dr. Blaivas’s
opinion regarding complication rates is unreliable and noting that such conclusion
“is consonant with the MDL court’s exclusion of Dr. Blaivas’s complication-rate
testimony”); see also Swintelski v. Am. Med. Sys., Inc., No. 20-60410-CIV, 2021
WL 4527451, at *6 (S.D. Fla. Aug. 6, 2021) (finding Dr. Blaivas’s testimony
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regarding complication rates of women who undergo implantation of pelvic mesh
devices unreliable, noting “Dr. Blaivas explains that he relied on the findings of
multiple medical researchers and his own calculations to support his opinion that the
complication rate of women who are implanted with pelvic mesh devices exceeds
15%” but “does not describe the method used for arriving at this complication rate
figure . . . and . . . concedes that ‘[e]valuating the incidence, severity and
consequence’ of various pelvic mesh devices is a ‘daunting task’”). This Court
discerns no basis upon which to reach a different conclusion.
The motion to exclude Dr. Blaivas’s opinions regarding alternative
procedures is GRANTED.
B. Dr. Blaivas’s opinions regarding mechanically-cut and laser-cut
mesh
According to Defendants, “Dr. Blaivas suggests that either laser-cut mesh or
mechanically-cut mesh is preferable, apparently depending on which type of mesh
was not implanted in a plaintiff.” ECF No. 131 at 13. Defendants argue that any
suggestion that either mechanically-cut or laser-cut mesh provides a safer alternative
lacks a reliable, scientific foundation. Defendants point out that Dr. Blaivas has
never compared mechanically-cut mesh with laser-cut mesh and cites no scientific
studies or experiences in support of his opinions regarding the cutting of mesh.
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Defendants say Dr. Blaivas “has been playing both sides of the fence on this issue”
and request that if the Court allows Dr. Blaivas to critique laser-cut mesh, it preclude
him from referencing mechanically-cut mesh as a viable alternative design.
Tedder argues that Dr. Blaivas’s report explains the problems caused by
mechanically-cut mesh and laser-cut mesh, supported by Ethicon’s internal
documents and scientific literature. Tedder maintains that each method has it owns
issues and that Dr. Blaivas’s opinions are not contradictory. Tedder asserts that the
MDL court has consistently held that urologists and urogynecologists who have
extensive experience with mesh devices are qualified to proffer opinions on the
design aspects of mesh devices, including the polypropylene used to construct them.
Tedder maintains that Dr. Blaivas is qualified to render such opinions and does not
intend to testify that one cut is safer than the other; instead, Dr. Blaivas will describe
the particular problems that each type of cut presents—specifically, that
mechanically cut mesh can have fraying and particle loss, as well as curling, roping,
deformation, loss of pore size, and sharp edges, and laser cut mesh is approximately
three times stiffer when stretched and thus difficult to insert and can lead to erosion.
Tedder says that Ethicon’s original clinical studies were performed with
mechanically cut mesh and that Ethicon never studied the impacts of laser-cut mesh.
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The MDL court noted that Dr. Blaivas cited in his report internal Ethicon
documents, which the court found offer some support for his opinions regarding cut
mesh. The court also noted that Dr. Blaivas’s opinions seemed to be based on his
experience and concluded that it lacked sufficient information to assess whether
there was a reliable foundation for Dr. Blaivas’s opinions in that regard. The court
thus reserved ruling “‘until further testimony [could] be offered and evaluated
firsthand at trial.’” ECF No. 152 at 15.
Criticizing both methods of cutting mesh does not alone render Dr. Blaivas’s
opinions on cut mesh unreliable. See, e.g., Geery, 2021 WL 2580144, at *4 (noting
that in his general report, Dr. Rosenzweig notes complications with both mechanical
and laser-cut mesh and concluding that “finding issues with both methods does not
make his opinion unreliable”) (citing Laderbush v. Ethicon, No. 20-cv-62-JD, 2020
WL 3001958, at *2 (D.N.H. June 4, 2020); Herrera v. Nevarez by Springer v.
Ethicon, Inc., No. 17 C 3930, 2017 WL 3381718, at *8 (N.D. Ill. Aug. 6, 2017)).
The motion, therefore, is DENIED.
C. Testimony about chronic mesh pain syndrome
Defendants urge the Court to preclude Dr. Blaivas from testifying about the
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alleged existence of “Chronic Mesh Pain Syndrome.” Defendants say Dr. Blaivas
claims that such a condition is “‘described in the medical literature’” but cites only
a single article that has used the term. ECF No. 131 at 14. The MDL court found
the single citation sufficient to support Dr. Blaivas’s use of the term, which Ethicon
argues was erroneous.
In support of their position, Defendants state that in his deposition, Dr. Blaivas
acknowledged that he is unaware of chronic mesh pain syndrome being recognized
as a diagnostic code for billing purposes. Defendants thus argue that the syndrome
is not generally accepted in the medical profession and has negative connotations
that would prejudice Ethicon.
Tedder urges the Court to abide by the MDL court’s ruling on the issue, stating
Dr. Blaivas explained the syndrome in detail, including that it is “‘characterized by
the transformation of vaginal pain into a multi-organ system process.’” ECF No.
152 at 18. According to Tedder, new treatment methods have been developed to
address the issue, and Dr. Blaivas “cites to several scientific articles in further
describing this process.” ECF No. 152 at 19. Tedder says Dr. Blaivas’s clinical
experience further supports his opinion, as he has treated hundreds of women who
had mesh complications.
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The Court agrees with the MDL court and finds that Dr. Blaivas is qualified
based on his experience to testify to chronic mesh pain syndrome. The motion thus
is DENIED.
D. Bias in clinical trials and “industry manipulation”
Finally, Defendants seek to exclude what they characterize as broad
statements Dr. Blaivas includes in his report that the medical literature concerning
TVT-S and TVT-O is “‘seriously flawed,’ due to alleged bias, ‘industry
manipulation of data,’ and other alleged factors.” ECF No. 131 at 14. Defendants
say Dr. Blaivas does not provide any support for the allegation of “‘industry
manipulation’” and that other statements are not supported by Dr. Blaivas’s
citations, such as his assertion that Ethicon has contracts with unidentified medical
literature authors that “‘often contain language that prevents company consultants
from reporting or discussing device complications without written company
approval.’” ECF No. 131 at 15. In any event, Defendants assert, Dr. Blaivas has no
expert qualifications to testify about the potential bias that a financial incentive may
play in medical research and sets forth no methodology, instead providing only a
narrative summary of events. According to Defendants, the MDL court excluded
sweeping statements by Dr. Blaivas that “‘Ethicon colluded with other
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manufacturers to influence reimbursement.’” Id. Defendants ask this Court to
“clarify that ruling and explicitly exclude any testimony that suggests ‘industry
manipulation’ on the part of Ethicon.” Id.
According to Tedder, Dr. Blaivas cites scientific articles and internal Ethicon
documents in rendering the opinion that the medical literature regarding Ethicon’s
products is flawed due to bias and industry manipulation of data. As two examples,
Tedder cites the fact that the original contract between the TVT inventor and Ethicon
made certain payments contingent on particular study outcomes and one of the TVT-
O study authors had a royalty interest in the device. Tedder agues the MDL court
did not err in allowing Dr. Blaivas’s opinions in that regard and urges the Court to
“reject Ethicon’s effort to reconstruct the MDL Court’s Order as to testimony about
the mesh manufacturing industry.” ECF No. 152 at 19. Tedder explains that in its
order, the MDL court excluded Dr. Blaivas’s opinion that Ethicon colluded with
other mesh manufacturers to influence reimbursement but allowed Dr. Blaivas’s
opinion that certain studies in the medical literature are biased. Tedder says despite
the manner in which Ethicon characterizes the request, it is seeking reconsideration
of the latter decision.
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The motion is DENIED. The parties are cautioned, however, against
attempting to offer unsupported and patently inadmissible expert testimony at trial.
SO ORDERED this 31st day of March 2022.
M. Casey Rodgers
M. CASEY RODGERS
UNITED STATES DISTRICT JUDGE
Case No. 3:20cv5611-MCR-MJF