Dixon v. Johnson & Johnson et al

Filing 118

MEMORANDUM OPINION AND ORDER (Daubert Motion re: Marc Toglia, M.D.) The court DENIES in part, GRANTS in part, and RESERVES in part the Motion filed in MDL 2327 by Certain Plaintiffs in Wave 1 Cases to Exclude the Opinions and Testimony of Marc Toglia, M.D., as more fully set forth herein. Signed by Judge Joseph R. Goodwin on 8/25/2016. (cc: attys; any unrepresented party) (REF: MDL 2327; Cases Listed on Exhibit) (jld)

IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA
CHARLESTON DIVISION
IN RE:

ETHICON, INC.
PELVIC REPAIR SYSTEMS
PRODUCT LIABILITY LITIGATION
MDL No. 2327
______________________________________________________________________________
THIS DOCUMENT RELATES TO:
Cases Identified in the Exhibit
Attached Hereto
MEMORANDUM OPINION AND ORDER
(Daubert Motion re: Marc Toglia, M.D.)
Pending before the court is the Motion to Exclude the Opinions and Testimony
of Marc Toglia, M.D. [ECF No. 2023] filed by the plaintiffs. The Motion is now ripe
for consideration because briefing is complete.
I.

Background

This case resides in one of seven MDLs assigned to me by the Judicial Panel
on Multidistrict Litigation concerning the use of transvaginal surgical mesh to treat
pelvic organ prolapse (“POP”) and stress urinary incontinence (“SUI”). In the seven
MDLs, there are more than 75,000 cases currently pending, approximately 30,000 of
which are in this MDL, which involves defendants Johnson & Johnson and Ethicon,
Inc. (collectively “Ethicon”), among others.
In this MDL, the court’s tasks include “resolv[ing] pretrial issues in a timely
and expeditious manner” and “resolv[ing] important evidentiary disputes.” Barbara
J. Rothstein & Catherine R. Borden, Fed. Judicial Ctr., Managing Multidistrict

Litigation in Products Liability Cases 3 (2011). To handle motions to exclude or to
limit expert testimony pursuant to Daubert v. Merrell Dow Pharmaceuticals, Inc.,
509 U.S. 579 (1993), the court developed a specific procedure. In Pretrial Order
(“PTO”) No. 217, the court instructed the parties to file only one Daubert motion per
challenged expert, to file each motion in the main MDL—as opposed to the individual
member cases—and to identify which cases would be affected by the motion. PTO No.
217, at 4.1
II.

Preliminary Matters

Before plunging into the heart of the Motion, a few preliminary matters need
to be addressed.
I am compelled to comment on the parties’ misuse of my previous Daubert
rulings on several of the experts offered in this case. See generally Sanchez v. Bos.

Sci. Corp., No. 2:12-cv-05762, 2014 WL 4851989 (S.D. W. Va. Sept. 29, 2014); Tyree
v. Bos. Sci. Corp., 54 F. Supp. 3d 501 (S.D. W. Va. 2014); Eghnayem v. Bos. Sci. Corp.,
57 F. Supp. 3d 658 (S.D. W. Va. 2014). The parties have, for the most part, structured
their Daubert arguments as a response to these prior rulings, rather than an
autonomous challenge to or defense of expert testimony based on its reliability and
relevance. In other words, the parties have comparatively examined expert testimony
and have largely overlooked Daubert’s core considerations for assessing expert
testimony. Although I recognize the tendency of my prior evidentiary determinations

The plaintiffs identified the Wave 1 cases affected by this Motion in their attached Exhibit A [ECF
No. 2023-1], which the court has attached to this Memorandum Opinion and Order. At the time of
transfer or remand, the parties will be required to designate relevant pleadings from MDL 2327,
including the motion, supporting memorandum, response, reply, and exhibits referenced herein.
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to influence subsequent motions practice, counsels’ expectations that I align with
these previous rulings when faced with a different record are misplaced, especially
when an expert has issued new reports and given additional deposition testimony.
Mindful of my role as gatekeeper for the admission of expert testimony, as well
as my duty to “respect[ ] the individuality” of each MDL case, see In re

Phenylpropanolamine Prods. Liab. Litig., 460 F.3d 1217, 1231 (9th Cir. 2006), I refuse
to credit Daubert arguments that simply react to the court’s rulings in Sanchez and
its progeny. Indeed, I feel bound by these earlier cases only to the extent that the
expert testimony and Daubert objections presented to the court then are identical to
those presented now. Otherwise, I assess the parties’ Daubert arguments anew. That
is, in light of the particular expert testimony and objections currently before me, I
assess “whether the reasoning or methodology underlying the testimony is
scientifically valid” and “whether that reasoning or methodology properly can be
applied to the facts in issue.” Daubert, 509 U.S. at 592–93. Any departure from

Sanchez, Eghnayem, or Tyree does not constitute a “reversal” of these decisions and
is instead the expected result of the parties’ submission of updated expert reports and
new objections to the expert testimony contained therein.
Finally, I have attempted to resolve all possible disputes before transfer or
remand, including those related to the admissibility of expert testimony pursuant to

Daubert. Nevertheless, in some instances I face Daubert challenges where my
interest in accuracy counsels reserving ruling until the reliability of the expert
testimony may be evaluated at trial. At trial, the expert testimony will be tested by

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precise questions asked and answered. The alternative of live Daubert hearings is
impossible before transfer or remand because of the numerosity of such motions in
these seven related MDLs. As these MDLs have grown and the expert testimony has
multiplied, I have become convinced that the critical gatekeeping function permitting
or denying expert testimony on decisive issues in these cases is best made with a live
expert on the witness stand subject to vigorous examination.
In the course of examining a multitude of these very similar cases involving
the same fields of expertise, I have faced irreconcilably divergent expert testimony
offered by witnesses with impeccable credentials, suggesting, to me, an unreasonable
risk of unreliability. The danger—and to my jaded eye, the near certainty—of the
admission of “junk science” looms large in this mass litigation.
The parties regularly present out-of-context statements, after-the-fact
rationalizations of expert testimony, and incomplete deposition transcripts. This,
combined with the above-described practice of recycling expert testimony, objections,
and the court’s prior rulings, creates the perfect storm of obfuscation. Where further
clarity is necessary, I believe it can only be achieved through live witnesses—not
briefing—I will therefore reserve ruling until expert testimony can be evaluated
firsthand.
III.

Legal Standard

By now, the parties should be intimately familiar with Rule 702 of the Federal
Rules of Evidence and Daubert, so the court will not linger for long on these
standards.

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Expert testimony is admissible if the expert is qualified and if his or her expert
testimony is reliable and relevant. Fed. R. Evid. 702; see also Daubert, 509 U.S. at
597. An expert may be qualified to offer expert testimony based on his or her
“knowledge, skill, experience, training, or education.” Fed. R. Evid. 702. Reliability
may turn on the consideration of several factors:
(1) whether a theory or technique can be or has been tested;
(2) whether it has been subjected to peer review and
publication; (3) whether a technique has a high known or
potential rate of error and whether there are standards
controlling its operation; and (4) whether the theory or
technique enjoys general acceptance within a relevant
scientific community.

Cooper v. Smith & Nephew, Inc., 259 F.3d 194, 199 (4th Cir. 2001) (citing Daubert,
509 U.S. at 592–94). But these factors are neither necessary to nor determinative of
reliability in all cases; the inquiry is flexible and puts “principles and methodology”
above conclusions and outcomes. Daubert, 509 U.S. at 595; see also Kumho Tire Co.

v. Carmichael, 525 U.S. 137, 141, 150 (1999). Finally, and simply, relevance turns on
whether the expert testimony relates to any issues in the case. See, e.g., Daubert, 509
U.S. at 591–92 (discussing relevance and helpfulness).
At bottom, the court has broad discretion to determine whether expert
testimony should be admitted or excluded. Cooper, 259 F.3d at 200.
IV.

Discussion

Dr. Toglia is currently serving as the Chief of Female Pelvic Medicine and
Reconstruction Surgery for the Main Line Heath System in Philadelphia. He is boardcertified in female pelvic medicine and reconstructive surgery and obstetrics and

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gynecology.
a. Properties
The plaintiffs seek to exclude Dr. Toglia’s opinions regarding polypropylene
safety, durability, biocompatibility, and materials because he is unqualified and has
not employed a reliable methodology.
The plaintiffs argue Dr. Toglia is unqualified because he is neither a chemical
nor biomechanical engineer and does not possess a “basic understanding of what is
meant by the terms ‘lightweight’ and ‘heavyweight.’” Mem. 7 [ECF No. 2028]. This
challenge is without merit. Dr. Toglia is a board-certified urogynecologist who has
performed thousands of SUI and POP surgeries over decades of clinical experience,
in addition to conducting his own clinical studies on mesh products. This extensive
clinical and research experience qualifies Dr. Toglia to opine on mesh’s reaction to
and effect on the human body, and relatedly, the safety and efficacy of mesh products.
Moreover, the plaintiffs’ disagreement with Dr. Toglia’s characterization of the terms
lightweight and heavyweight does not render Dr. Toglia unqualified to opine on mesh
properties; such concerns are better suited for cross-examination. See Kopf v. Skyrm,
993 F.2d 374, 377 (4th Cir. 1993)(“One knowledgeable about a particular subject need
not be precisely informed about all details of the issues raised in order to offer an
opinion.” (citing Thomas J. Kline, Inc. v. Lorillard, Inc., 878 F.2d 791, 799 (4th Cir.
1989))). The plaintiffs’ Motion is DENIED on this matter.
It is not clear to the court on what grounds the plaintiffs are challenging
reliability beyond asserting that Dr. Toglia is unqualified. Accordingly, insofar as the

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plaintiffs’ Motion is challenging the reliability of Dr. Toglia’s opinions on
polypropylene safety, durability, biocompatibility, and materials, it is DENIED.
b. Complications
The plaintiffs challenge Dr. Toglia’s opinions regarding complications and
complication rates. The plaintiffs object to Dr. Toglia’s reference to his alleged high
rates of patient follow up and low complication rate in his own clinical practice as
having an unreliable foundation. When asked at his deposition how he keeps track of
the products he uses, Dr. Toglia responded, “I have a very good memory.” Toglia Dep.
65:22–24, Oct. 2, 2015 [ECF No. 2023-4]). When asked how he would determine which
complications occurred with various products, Dr. Toglia responded:
I would have to sit down and try and figure that out, counselor. I can’t
tell you off the top of my head that I have an accurate way of—I mean,
there may be ways, through the billing system, to capture certain
complications based upon—by diagnosis codes.

Id. at 69:12–21. Additionally, in response to a question at his deposition, Dr. Toglia
stated that his practice has “a rate of follow-up that is over 90 percent.” Id. at 163:11–
12. In explaining what “records [he] would rely on to produce that,” Dr. Toglia agreed
with the statement that “someone would have to go through each record to determine
when the patient last saw you, when she was contacted, what problems she was
having.” Id. at 162:1–11.
Dr. Toglia’s statements suggesting he is simply making estimates and relying
on “good memory” alone to recall the details of more than 2,500 surgeries demonstrate
the unreliability of his opinions. “Good memory” may be sufficient in some
circumstances to relate general conclusions, but not here. Just because a reliable
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method exists to verify his opinions does not mean that a reliable method was actually
employed. Accordingly, Dr. Toglia’s opinions on complication rates and patient followup rates in his own practice are EXCLUDED.
The plaintiffs next assert that Dr. Toglia is unqualified to testify about the
complication rates and risk of the Burch and autologous fascial sling procedures and
that his testimony on this subject is unsupported by a reliable methodology.
It appears that the plaintiffs are challenging Dr. Toglia’s qualifications on the
basis that he has not used the Burch or autologous fascial sling procedures in his
practice for at least the “last several years.” He does not become unqualified to opine
on the relative risks of a group of procedures because he has used his knowledge,
experience, and judgment to stop using some of the procedures. Moreover, Dr. Toglia
is not relying on personal experience alone; he has engaged in an extensive review of
the scientific literature. Accordingly, to the extent the plaintiffs ask the court to find
Dr. Toglia unqualified to testify about the risks and complication rates of alternative
procedures, their Motion is DENIED.
Turning to reliability, the plaintiffs’ argument that Dr. Toglia’s opinions are
not well-supported focuses on Dr. Toglia’s inability to cite to specific studies during
his deposition. Dr. Toglia evidently fumbled to find literature to support this opinion,
taking nearly ten minutes to find a study that he believed supported his opinion. And
the plaintiffs contend that the referenced study did not actually support his opinion.
The plaintiffs overlook, however, Dr. Toglia’s extensive and specific citation to
scientific studies in his report. Dr. Toglia’s failure to identify, on the spot, a study to

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support a very specific sub-issue is not enough to undermine the reliability of his
methodology as demonstrated in his expert report. Accordingly, to the extent the
plaintiffs seek the exclusion of Dr. Toglia’s opinions on complications rates and risks
of alternative procedures as unreliable, the Motion is DENIED.
The plaintiffs also challenge the reliability of Dr. Toglia’s methodology with
respect to his opinion that there is no immunologic response to TVT. Dr. Toglia’s
difficulty naming studies on the spot during a deposition does not necessarily negate
the studies and reasons articulated in his expert report. In his report, Dr. Toglia
makes general reference to studies, meta-analyses, and systematic reviews; he also
specifically cites several studies and explains that the studies are consistent with his
own personal observations. The plaintiffs’ objection addresses the weight, rather than
the admissibility, of the opinion. Accordingly, to the extent the plaintiffs seek to
exclude Dr. Toglia’s opinions on immunologic response, their motion is DENIED.
c. Warnings
The plaintiffs claim Dr. Toglia is not qualified to offer expert testimony about
product warnings, which includes expert testimony about the adequacy of the
relevant Instructions for Use (“IFU”). According to the plaintiffs, Dr. Toglia is not an
expert in the development of warnings labels and thus is not qualified to offer expert
testimony about warnings. While an expert who is a gynecologist may testify about
the specific risks of implanting mesh and whether those risks appeared on the
relevant IFU, the same expert must possess additional expertise to offer expert
testimony about what information should or should not be included in an IFU. Wise

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v. C. R. Bard, Inc., No. 2:12-cv-1378, 2015 WL 521202, at *14 (S.D. W. Va. Feb. 7,
2015). Dr. Toglia does not possess the additional expertise to offer expert testimony
about what an IFU should or should not include.2 Accordingly, Dr. Toglia’s expert
testimony about these matters is EXCLUDED.
d. MSDS
The plaintiffs seek to exclude Dr. Toglia’s opinions related to the MSDS,
specifically his characterization of the MSDS as regulatory paperwork, non-clinical,
not relevant or reliable, and not something on which Dr. Toglia would rely in forming
his opinions. The plaintiffs argue, with little elaboration, that Dr. Toglia is not
qualified and his opinions are not based on any reliable methodology.
The plaintiffs have manufactured the problem they now ask the court to
resolve. The opinions to which the plaintiffs object appear only in deposition
testimony, and only in response to questions about the MSDS posed initially by the
plaintiffs’ counsel. Dr. Toglia does not include any MSDS opinions in his expert
report, suggesting either Dr. Toglia does not intend to offer the opinions in question,
or that they are subject to exclusion for his failure to disclose them pursuant to Rule
26. Either way, the plaintiffs’ request for exclusion on reliability and qualifications

In relation to the expert testimony about the adequacy of the IFU, Ethicon claims Dr. Toglia is
qualified to testify about whether certain risks were commonly known in the medical community. In
my view, this is not the subject of the plaintiffs’ motion. The plaintiffs’ motion focuses on whether Dr.
Toglia is qualified to offer expert testimony about what should be included in or what may be excluded
from an IFU. So I offer no opinion on whether Dr. Toglia may testify about whether certain risks were
common knowledge. However, an expert cannot testify about whether any risks should have been
included in an IFU unless he or she possess additional expertise—expertise Dr. Toglia does not
possess.
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grounds is moot and their Motion on this matter is DENIED as moot.

V.

Recurring Issues

Many of the Daubert motions filed in this MDL raise the same or similar
objections.
One particular issue has been a staple in this litigation, so I find it best to
discuss it in connection with every expert. A number of the Daubert motions seek to
exclude FDA testimony and other regulatory or industry standards testimony. To the
extent this Motion raises these issues it is GRANTED in part and RESERVED in
part as described below.
I have repeatedly excluded evidence regarding the FDA’s section 510(k)
clearance process in these MDLs, and will continue to do so in these case, a position
that has been affirmed by the Fourth Circuit. In re C. R. Bard, Inc., 81 F.3d 913,
921–23 (4th Cir. 2016) (upholding the determination that the probative value of
evidence related to section 510(k) was substantially outweighed by its possible
prejudicial impact under Rule 403). Because the section 510(k) clearance process does
not speak directly to safety and efficacy, it is of negligible probative value. See In re

C. R. Bard, 81 F.3d at 920 (“[T]he clear weight of persuasive and controlling authority
favors a finding that the 510(k) procedure is of little or no evidentiary value.”).
Delving into complex and lengthy testimony about regulatory compliance could
inflate the perceived importance of compliance and lead jurors “to erroneously
conclude that regulatory compliance proved safety.” Id. at 922. Accordingly, expert

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testimony related to the section 510(k) process, including subsequent enforcement
actions and discussion of the information Ethicon did or did not submit in its section
510(k) application, is EXCLUDED. For the same reasons, opinions about Ethicon’s
compliance with or violation of the FDA’s labeling and adverse event reporting
regulations are EXCLUDED. In addition to representing inappropriate legal
conclusions, such testimony is not helpful to the jury in determining the facts at issue
in these cases and runs the risk of misleading the jury and confusing the issues.
Insofar as this Motion challenges the FDA-related testimony discussed here, the
Motion is GRANTED.
A number of experts also seek to opine on Ethicon’s compliance with design
control and risk management standards. Some of this testimony involves the FDA’s
quality systems regulations, and some—likely in an attempt to sidestep my
anticipated prohibition on FDA testimony—involve foreign regulations and
international standards. I find all of this proposed testimony of dubious relevance.
Although these standards relate to how a manufacturer should structure and
document risk assessment, the standards do not appear to mandate any particular
design feature or prescribe the actual balance that must be struck in weighing a
product’s risk and utility. Nor is it clear that the European and other international
standards discussed had any bearing on the U.S. medical device industry when the
device in question was being designed.
Nevertheless, because the nuances of products liability law vary by state, I will
refrain from issuing a blanket exclusion on design process and control standards

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testimony, whether rooted in the FDA or otherwise. Each standard must be assessed
for its applicability to the safety questions at issue in this litigation, consistent with
state law. I am without sufficient information to make these findings at this time.
Accordingly, I RESERVE ruling on such matters until a hearing, where the trial
judge will have additional context to carefully evaluate the relevance and potential
prejudicial impact of specific testimony.
Similarly, I doubt the relevance of testimony on the adequacy of Ethicon’s
clinical testing and research, physician outreach, or particular product development
procedures and assessments otherwise not encompassed by the above discussion.
Again, such matters seem to say very little about the state of the product itself (i.e.,
whether or not it was defective) when it went on the market. But because the scope
of relevant testimony may vary according to differences in state products liability law,
I RESERVE ruling on such matters until they may be evaluated in proper context at
a hearing before the trial court before or at trial.
Additional—and more broad—matters also warrant mention. While some of
these concerns may not apply to this particular expert, these concerns are raised so
frequently that they are worth discussing here.

First, many of the motions seek to exclude state-of-mind and legal-conclusion
expert testimony. Throughout these MDLs, the court has prohibited the parties from
using experts to usurp the jury’s fact-finding function by allowing testimony of this
type, and I do the same here. E.g., In re C. R. Bard, Inc., 948 F. Supp. 2d 589, 611
(S.D. W. Va. 2013); see also, e.g., United States v. McIver, 470 F.3d 550, 562 (4th Cir.

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2006) (“[O]pinion testimony that states a legal standard or draws a legal conclusion
by applying law to the facts is generally inadmissible.”); In re Rezulin Prods. Liab.

Litig., 309 F. Supp. 2d 531, 546 (S.D.N.Y. 2004) (“Inferences about the intent and
motive of parties or others lie outside the bounds of expert testimony.”). Additionally,
an expert may not offer expert testimony using “legal terms of art,” such as
“defective,” “unreasonably dangerous,” or “proximate cause.” See Perez v. Townsend

Eng’g Co., 562 F. Supp. 2d 647, 652 (M.D. Pa. 2008).
Second, and on a related note, many of the motions seek to prohibit an expert
from parroting facts found in corporate documents and the like. I caution the parties
against introducing corporate evidence through expert witnesses. Although an expert
may testify about his review of internal corporate documents solely for the purpose
of explaining the basis for his or her expert opinions—assuming the expert opinions
are otherwise admissible—he or she may not offer testimony that is solely a conduit
for corporate information.

Third, many of the motions also ask the court to require an expert to offer
testimony consistent with that expert’s deposition or report or the like. The court will
not force an expert to testify one way or another. To the extent an expert offers
inconsistent testimony, the matter is more appropriately handled via crossexamination or impeachment as appropriate and as provided by the Federal Rules of
Evidence.

Fourth, in these Daubert motions, the parties have addressed tertiary
evidentiary matters like whether certain statements should be excluded as hearsay.

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The court will not exclude an expert simply because a statement he or she discussed
may constitute hearsay. Cf. Daubert, 509 U.S. at 595. Hearsay objections are more
appropriately raised at trial.

Finally, in some of the Daubert motions, without identifying the specific expert
testimony to be excluded, the parties ask the court to prevent experts from offering
other expert testimony that the moving party claims the expert is not qualified to
offer. I will not make speculative or advisory rulings. I decline to exclude testimony
where the party seeking exclusion does not provide specific content or context.
VI.

Conclusion

The court DENIES in part, GRANTS in part, and RESERVES in part the
Motion to Exclude the Opinions and Testimony of Marc Toglia, M.D. [ECF No. 2023].
The court DIRECTS the Clerk to file a copy of this Memorandum Opinion and
Order in 2:12-md-2327 and in the Ethicon Wave 1 cases identified in the Exhibit
attached hereto.

ENTER:

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August 25, 2016

EXHIBIT A TOGLIA
THIS DOCUMENT RELATES TO
PLAINTIFFS:
Betty Funderburke
Case No. 2:12-cv-00957
Patricia Conti
Case No. 2:12-cv-00516
Donna Massey
Case No. 2:12-cv-00880
Amanda Deleon
Case No. 2:12-cv-00358
Wilma Johnson
Case No. ----------------- 2:11-cv-809
2:12-cv-00809
Harriet Beach
Case No. 2:12-cv-00476
_______
Dennis W.
Virginia Dixon
Case No. 2:12-cv-01081

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