The opinion
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF INDIANA
INDIANAPOLIS DIVISION
JAN LEIGH BLOCK, et al. )
)
Plaintiffs, )
)
v. ) No. 1:19-cv-04546-SEB-TAB
)
ETHICON, INC., et al. )
)
Defendants. )
ORDER GRANTING IN PART AND DENYING IN PART DEFENDANTS'
MOTION TO EXCLUDE SPECIFIC-CAUSATION TESTIMONY OF
MICHAEL THOMAS MARGOLIS, M.D.
Now before the Court is Defendants' Motion to Exclude Specific-Causation
Testimony of Michael Thomas Margolis, M.D. [Dkt. 86]. Defendants Ethicon,
Inc. and Johnson & Johnson move, pursuant to Federal Rules of Evidence 702 and
703 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), to
exclude Dr. Margolis's specific causation opinions on various grounds. Plaintiffs
oppose Defendants' Motion. For the reasons detailed below, we GRANT IN
PART and DENY IN PART Defendants' Motion to Exclude.
Factual Background
On March 9, 2007, at the age of 47, Lead Plaintiff Jan Leigh Block was
implanted with transvaginal tape ("TVT") by Gregory A. Miller, M.D., to treat her
stress urinary incontinence. Ms. Block's TVT procedure was performed in
conjunction with a total vaginal hysterectomy and bilateral salpingo-
oophorectomy. She underwent mesh revision procedures in October 2007 and
December 2007 before a mesh excision on May 27, 2008. Ms. Block alleges that
her TVT caused her dyspareunia, urinary tract infections, pelvic pain, bowel and
urinary problems, vaginal scarring, muscle weakness, vaginal burning sensation,
and mental and emotional distress.
The opinion testimony of Dr. Margolis, a pelvic surgeon and
urogynecologist, is the subject of this motion. Dr. Margolis is one of a small group
of American physicians who are board-certified in the obstetrics and gynecology
subspecialty of Female Pelvic Medicine and Reconstructive Surgery. He has
observed numerous sling and mesh procedures involving the TVT and has studied
related textbooks, publications, instructions for use ("IFU"), surgical videos,
cadaver dissections, and operative reports. Dr. Margolis has also personally
performed the explantings of over 300 mesh slings and devices, including the TVT
device.
Plaintiffs have designated Dr. Margolis as their case-specific expert
regarding injuries caused by the implantation of Ethicon's Gynecare TVT device.
Dr. Margolis's findings and opinions on the cause of Mrs. Block's injuries and the
inadequacy of Defendants' IFU are set forth in his four expert reports, dated July
26, 2017, July 27, 2017, October 3, 2017, and October 25, 2017, respectively.
Legal Analysis
I. Applicable Standard
The admissibility of expert testimony is governed by the analytical
framework set out in Federal Rule of Evidence 702 and Daubert v. Merrell Dow
Pharms. Inc., 509 U.S. 579 (1993). Lewi v. CITGO Petroleum Corp., 561 F.3d
698, 705 (7th Cir. 2009). To be admissible under Rule 702 and Daubert, an
expert's testimony must be reliable and relevant, and the expert must be qualified
to give it. Fed. R. Civ. P. 702; Gayton v. McCoy, 593 F.3d 610, 616 (7th Cir.
2010). If the Daubert threshold is cleared, "the accuracy of the actual evidence is
to be tested before the jury with the familiar tools of 'vigorous cross-examination,
presentation of contrary evidence, and careful instruction on the burden of proof.'"
Lapsley v. Xtek, Inc., 689 F.3d 802, 805 (7th Cir. 2012) (quoted with unmarked
alterations Daubert, 509 U.S. at 596). The proponent of expert testimony bears the
burden of establishing admissibility by a preponderance of the evidence. Lewis,
561 F.3d at 705.
II. Discussion
Defendants seek to exclude the following expert testimony by Dr. Margolis:
his specific causation testimony, his opinions as to Mrs. Block's prognosis, his
testimony regarding the adequacy of the TVT's IFU, his opinions regarding the
state of mind of Defendants and Mrs. Block's physician, any testimony regarding
medical conditions or characteristics not identified in Mrs. Block's medical
records, and, finally, any opinions not included in his expert reports. We address
each of these arguments in turn below.
A. Specific Causation Opinions
1. Qualifications
As detailed above, Dr. Margolis is a pelvic floor surgeon and
urogynecologist with extensive experience implanting and removing sling systems.
See In re Ethicon, Inc., Master File No. 2:12-MD-02327, MDL No. 2327, 2014
WL 186872, at *17 (S.D.W.Va. Jan. 15, 2014). He is also one of a small group of
American physicians who are board certified in the obstetrics and gynecology
subspecialty of Female Pelvic Medicine and Reconstructive surgery. His
qualifications and experience in the areas of the effectiveness of Defendants' TVT
product as well as mesh reaction and its effect on the human body have been
acknowledged in prior TVT litigation and we do not understand Defendants to
challenge those qualifications here. Accordingly, we find that Dr. Margolis is
qualified to offer the opinions on specific causation set forth in his report.
2. Reliability
Defendants seek the exclusion of Dr. Margolis's specific causation opinions
on grounds that he fails to identify a reliable and trustworthy basis for those
opinions. However, it is within Dr. Margolis's knowledge and expertise to testify
regarding the particular features of Defendants' TVT product that he finds
problematic, including small pore size, deformed pores, and shrinkage. In reaching
his conclusion that Mrs. Block's injuries were caused by these features of
Defendants' TVT, Dr. Margolis utilized a technique called differential diagnosis,
which "is an accepted and valid methodology for an expert to render an opinion
about the identity of a specific ailment." Myers v. Ill. Cent. R.R. Co., 629 F.3d
639, 644 (7th Cir. 2010). In a differential diagnosis, "the doctor rules in all the
potential causes of a patient's ailment and then by systematically ruling out causes
that would not apply to the patient, the physician arrives at what is the likely cause
of the ailment." Schultz v. Akzo Nobel Paints, LLC, 721 F.3d 426, 433 (7th Cir.
2013) (quoting Meyers, 629 F.3d at 641).
Here, Dr. Margolis performed a reliable differential diagnosis as he
reviewed Mrs. Block's medical records and personally examined her to rule out any
other potential causes of her symptoms, ultimately concluding that she exhibited
no signs or symptoms in any of her medical records of any other conditions that
could result in dyspareunia or recurrent urinary tract infections. This methodology
passes scrutiny under Daubert. While Defendants clearly disagree with Dr.
Margolis's testimony, the "soundness of the factual underpinnings of the expert's
analysis and the correctness of the expert's conclusions based on that analysis are
factual matters to be determined by the trier of fact …." Smith v. Ford Motor Co.,
215 F.3d 713, 718 (7th Cir. 2000). Any perceived insufficiencies in Dr. Margolis's
testimony can be addressed by Defendants through vigorous cross-examination.
The requested exclusion or limitation of this testimony on the basis of its
unreliability is therefore denied.
3. Failure to Rely on General Causation Opinion
Defendants also argue that Dr. Margolis's specific causation opinions should
be excluded because he does not rely on any general causation opinions to support
his conclusions. It is true that Plaintiffs must show both general and specific
causation to prevail on their IPLA claim and that "a jury can't weigh evidence of
specific causation until the [plaintiffs] have first proven general causation." C.W.
v. Textron, Inc., No. 3:10 CV 87, 2014 WL 4979211, at *4 (N.D. Ind. Oct. 3, 2014)
(citations omitted). Here, however, Dr. Margolis has set forth general causation
opinions in his July 26, 2017 report and also indicated in his October 25, 2017
report that he relied on the general causation opinions of Plaintiffs' other experts in
reaching the conclusions set forth in his July 26, 2017, July 27, 2017, and October
3, 2017 reports. Dkt. 86-2 at 96 (CM-ECF page number). Accordingly, we deny
Defendants' request to exclude Dr. Margolis's testimony on grounds that he failed
to rely on any general causation opinion in reaching his specific causation opinion.
To the extent Defendants believe the foundation of Dr. Margolis's testimony is
lacking, they may, of course, cross-examine him on that issue at trial.
4. Improper Legal Conclusions
Defendants claim that Dr. Margolis's opinions referring to TVT as
"defective" or "inadequately designed" or on the basis of other similar legal terms
of art should be excluded because the MDL court, when considering an earlier
challenge to Dr. Margolis's expert opinion testimony, held that "an expert may not
offer expert testimony using 'legal terms of art,' such as 'defective,' 'unreasonably
dangerous,' or 'proximate cause.'" In re: Ethicon, Inc., Master File No. 2:12-MD-
02327, MDL No. 2327, 2016 WL 4536885, at *4 (S.D.W.Va. Aug. 30, 2016).
While we, of course, acknowledge and incorporate here the previous rulings of the
MDL court and thus accept Defendants' motion as well-taken insofar as Dr.
Margolis's testimony cannot include statements that Defendants' TVT product is
"defective," the MDL order does not require the total exclusion of this evidence.
Dr. Margolis can, and will be permitted to testify regarding the attributes of
Defendants' device that he believes caused Mrs. Block's injuries, but must stop
short of labeling them "defects." Cf. Lancaster v. Ethicon, 1:19-CV-1377
(LEK/ML), 2020 WL 819291, at *7 (N.D.N.Y. Feb. 19, 2020) ("[T]he Court sees
no obstacle to [the expert] attributing [the plaintiff's] injuries to 'features' or
'characteristics' of Defendants' mesh rather than particular 'defects.' In this way,
[the expert] could describe what attribute of Defendants' mesh caused [the
plaintiff's] injuries without straying toward the proscribed language.").
B. Testimony Regarding Prognosis and Future Treatment
Defendants next argue that Dr. Margolis's opinions regarding Mrs. Block's
prognosis and future treatment must be excluded because they are speculative and
not supported by scientific analysis or a reliable foundation. Specifically, Dr.
Margolis has opined that Mrs. Block's dyspareunia is permanent and that, even if
she were to undergo an explant of the entire sling, such a procedure would, at best,
merely diminish her pain, not fully resolve it. Dr. Margolis also has stated in his
report that a Burch procedure—a surgical procedure used to treat urinary
incontinence—would have no more than a 50% to 60% chance of success in
resolving Mrs. Block's stress incontinence.
Contrary to Defendants' characterizations of his report, Dr. Margolis
references substantial evidence in Mrs. Block's medical records and deposition
testimony to support his conclusions regarding the severity of her condition. In
addition to these documentary sources, Dr. Margolis personally examined Mrs.
Block, noting that the evidence gleaned from her examination corroborates her
complaints. Thus, we hold that Dr. Margolis's opinions regarding Mrs. Block's
prognosis reflect the results of a reliable methodology, to wit, his extensive
experience and relevant medical knowledge in the field of urogynecology as well
as a thorough review of her detailed medical history in addition to his own clinical
examination of her. Dr. Margolis's opinions as to Mrs. Block's prognosis are
therefore admissible, given the sufficient scientific basis for such testimony. See
In re Yasmin and YAZ (Drospirenone) Marketing, Sales Practices, and Products
Liability Litigation, No. 3:09-md-02100-DRH-PMF, MDL No. 2100, 2011 WL
6733952, at *6 (S.D. Ill. Dec. 16, 2011) ("[A]s [the expert] bases his opinion on a
reliable methodology; specifically, his experience and relevant medical knowledge,
the Court finds his opinions as to plaintiff's prognosis, including her possible future
harm, … admissible."). Again, Defendants' objections to the admissibility of these
opinions goes to their weight, and can be addressed on cross-examination.
C. Testimony Regarding the Adequacy of Warnings
Defendants also seek to exclude any testimony from Dr. Margolis regarding
the adequacy of the warnings included on the TVT's IFU on grounds that he is not
qualified to offer such opinions. Defendants claim that, even if he were qualified
to testify on this subject, Dr. Margolis's opinions are inadmissible because he fails
to identify any reliable data or scientific bases supporting his conclusion that the 19
alleged risks identified in his reports are, in fact, associated with the use of TVT, or
that they are statistically significant enough to have affected Mrs. Block's treating
physician's medical advice had they been included on the TVT's IFU.
With regard to Dr. Margolis's qualifications to offer opinions as to the adequacy of
warnings, the MDL Court has ruled that urogynecologists such as Dr. Margolis
may testify "about the specific risks of implanting mesh and whether those risks
appeared on the relevant IFU," but those "same expert[s] must possess additional
expertise to offer expert testimony about what information should or should not be
included in an IFU." In re: Ethicon, Inc., 2016 WL 4536885, at *2 (citation
omitted). Here, Plaintiffs have not shown that Dr. Margolis possesses any such
additional expertise, education, training, or experience in the area of drafting of
IFU warnings. They argue only that Dr. Margolis has reviewed Defendants'
corporate documents and the depositions of their corporate designees and "relied
on this knowledge, in combination with his specialized experience as a pelvic floor
surgeon and urogynecologist who has implanted over 300 mesh devices, and the
general body of literature surrounding TVT mesh devices when he formed his
opinions about the adequacy of the TVT IFU." Dkt. 86-2 at 17 (CM-ECF page
number). None of Dr. Margolis's admittedly extensive experience extends into the
field of drafting IFU warnings, however. Without such expertise, he is not
qualified to testify regarding what warnings, if any, are required relating to an IFU.
Accordingly, any such testimony from Dr. Margolis is excluded. His
testimony on the topic of IFU warnings, accordingly, must be limited to the
identification of specific risks associated with mesh implantation and whether such
risks appeared on the TVT IFU, topics which are within his knowledge and
expertise. Further, Dr. Margolis may testify only as to those risks that are related
to symptoms and conditions actually experienced by Mrs. Block. We agree with
Defendants that the relevance, if any, of broader testimony regarding potential
risks unrelated to the specific facts of this case is limited, and any probative value
is greatly outweighed by potential prejudice and jury confusion. Defendants'
remaining objections are overruled because they go to the weight of Dr. Margolis's
testimony and can be addressed on cross-examination.
D. Testimony Regarding State of Mind
Defendants next argue that Dr. Margolis should be precluded from testifying
as to: (1) the state of mind of Mrs. Block's treating physician, Dr. Miller, or
speculating as to how a different IFU would have impacted the surgeon's treatment
decisions or informed consent discussions; and (2) Ethicon's corporate conduct,
knowledge, state of mind, or alleged bad acts. Plaintiffs have not responded to
Defendants' request to exclude state of mind evidence regarding Dr. Miller.
Accordingly, that portion of Defendants' motion is granted, and Dr. Margolis is
prohibited from testifying as to Dr. Miller's state of mind or speculating as to what
information in the IFU would have been important to Dr. Miller in considering
treatment options.
With regard to testimony going to the state of mind of either Defendant,
Plaintiffs agree not to present testimony explicitly referencing Defendants' state of
mind. We agree with Plaintiffs, however, that Dr. Margolis is not precluded
entirely from testifying regarding internal corporate documents that he may have
reviewed in forming his opinions. Rather, Dr. Margolis may "testify as to a review
of internal corporate documents solely for the purpose of explaining the basis of
his … opinions—assuming the opinions are otherwise admissible …." In re C.R.
Bard, Inc., Pelvic Repair Sys. Prods. Liability Litigation, 948 F. Supp. 2d 589, 611
(S.D.W.Va. 2013).
E. Any Opinions Not Addressed in Case-Specific Expert Report
Finally, Defendants seek to have Dr. Margolis restricted from testifying as to
any opinions not addressed in his case-specific expert report. Plaintiffs rejoin that
Defendants' motion is premature and without a specific basis, arguing that, while
they do not intend to introduce any opinions not disclosed in Dr. Margolis's report,
he should be permitted to testify about the sources upon which he relied in forming
his opinions. Clearly, Dr. Margolis is prohibited from offering opinions not
properly disclosed in his expert reports. See Fed. R. Civ. P. 26(a)(2)(B)(i) ("The
[expert] report must contain: … a complete statement of all opinions the witness
will express and the basis and reasons for them …."). As for the admissibility of
potential testimony regarding the sources upon which he relied in forming the
opinions that are disclosed in his reports, we do not understand Defendants' motion
to be directed at such testimony and, thus, we will not be drawn into making any
speculative or advisory rulings. If such testimony is offered at trial, any objections
to its admissibility can be raised at that time.
III. Conclusion
For the foregoing reasons, we GRANT IN PART and DENY IN PART
Defendants' Motion to Exclude Specific-Causation Testimony of Michael Thomas
Margolis, M.D. [Dkt. 86] as detailed in this Order. The parties are reminded that
these are preliminary rulings as to the admissibility of anticipated trial evidence;
thus, if other issues remain regarding Dr. Margolis's testimony, they can be raised
and addressed in the context of the parties' motions in limine in advance of trial.
IT IS SO ORDERED.
Date: 11/2/2020, Pts, Gaus Barker
SARAH EVANS BARKER, JUDGE
United States District Court
Southern District of Indiana
13
Distribution:
Lee B. Balefsky
KLINE & SPECTER
lee.balefsky@klinespecter.com
Christopher A. Gomez
KLINE & SPECTER
chris.gomez@klinespecter.com
Kimberly C. Metzger
ICE MILLER LLP (Indianapolis)
kimberly.metzger@icemiller.com
Ellen Pactor
ICE MILLER LLP (Indianapolis)
ellen.pactor@icemiller.com
Matthew J. Schad
SCHAD & SCHAD
mschad@schadlaw.com
James J. Waldenberger
KLINE & SPECTER
jim.waldenberger@klinespecter.com