Laderbush et al v. Ethicon, Inc. et al

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW HAMPSHIRE
Bonnie Laderbush
and George Laderbush
v. Civil No. 20-cv-62-JD
Opinion No. 2020 DNH 067
Ethicon, Inc., and
Johnson & Johnson
O R D E R
Defendants Ethicon, Inc., and Johnson & Johnson
(collectively, “Ethicon”) move to exclude the testimony of Dr.
Bruce Rosenzweig, M.D., under Daubert v. Merrell Dow Pharm.,
Inc., 509 U.S. 579 (1993). Doc. 58. The plaintiffs, Bonnie and
George Laderbush, object.
Standard of Review
To testify as an expert, a witness must be qualified to do
so “by knowledge, skill, experience, training, or education.”
Fed. R. Evid. 702. A qualified expert witness “may testify in
the form of an opinion or otherwise” if the witness’s
“scientific, technical, or other specialized knowledge will help
the trier of fact to understand the evidence or to determine a
fact in issue;” if “the testimony is based on sufficient facts
or data;” if “the testimony is the product of reliable
principles and methods;” and if “the expert has reliably applied
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the principles and methods to the facts of the case.” Id. Once
the expert’s qualifications are established, the opinion is
shown to be relevant, and the bases for the opinion are both
sufficient and reliable, “the credibility and weight of the
expert’s opinion [are] for the factfinder.” United States v.
Jordan, 813 F.3d 442, 446 (1st Cir. 2016); see also Daubert, 509
U.S. at 597.
Background
The Laderbushes’ products liability case revolves around
the safety of an implant called “TVT Exact,” which is marketed
by Ethicon as a treatment for stress urinary incontinence. TVT
Exact is constructed with a synthetic polypropylene mesh known
as “Prolene”. The Laderbushes allege that the Prolene mesh used
in TVT Exact is not suitable for use in treating stress urinary
incontinence.
Dr. Bruce Rosenzweig is a pelvic surgeon and
urogynecologist. In his expert reports, Dr. Rosenzweig offered
several criticisms of the Prolene mesh, concluding that the
Prolene mesh as used in the TVT Exact product was not suitable
for treatment of stress urinary incontinence. Dr. Rosenzweig
faulted the Prolene mesh in part because it was laser cut and
therefore excessively rigid. Dr. Rosenzweig opined that a
mechanically cut mesh would be less rigid. Dr. Rosenzweig
asserted that the stiffness and rigidity of the mesh increases
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complications such as chronic pain, chronic dyspareunia,
erosions, and urinary dysfunction. Dr. Rosenzweig also offered
opinions regarding Ethicon’s reporting of adverse events and its
furnishing of product warnings. He also outlined the various
potential complications to implant recipients that could be
caused, in his opinion, by the defects in TVT Exact.
Discussion
Ethicon challenges Dr. Rosenzweig’s opinion in four parts.
In Part I of its motion, Ethicon challenges the reliability of
Dr. Rosenzweig’s opinion about how the Prolene mesh is cut. In
Parts II and III, Ethicon challenges Dr. Rosenzweig’s opinion
about Ethicon’s product warnings and adverse event reporting.
In Part IV, Ethicon argues that expert testimony about
complications that Ms. Laderbush did not suffer is irrelevant.
The Laderbushes object to exclusion on the grounds raised in
Parts I, II, and IV, but not to exclusion on the grounds raised
in Part III. Ethicon did not file a reply.
A. Laser/Mechanical Mesh Cutting Opinion
In Part I of its motion to exclude, Ethicon argues that Dr.
Rosenzweig’s opinion about the inadequacy of a laser-cut mesh is
unreliable because, in other cases, he has opined that a
mechanically-cut mesh can cause the same complications as a
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laser-cut mesh. The Laderbushes respond, arguing that Dr.
Rosenzweig’s criticisms of laser-cut meshes and mechanically-cut
meshes are independent of each other. They contend that Dr.
Rosenzweig’s opinion has been that each type of cutting
procedure presents unique issues that can, through different
mechanisms, cause the same complications. They add that, even
if Dr. Rosenzweig’s opinions in other cases were contradictory,
it would be an issue to be explored during cross-examination,
not an issue warranting exclusion of the expert.
In support of its Daubert motion, Ethicon offered two brief
excerpts of Dr. Rosenzweig’s depositions in different cases. In
one deposition, Dr. Rosenzweig merely notes that a laser-cut
mesh and a mechanically-cut mesh can cause the same
complications through different mechanisms. See doc. 58-6 at 4.
In another deposition, Dr. Rosenzweig affirms that he has
testified that both mechanically-cut and laser-cut meshes can be
defective. Doc. 58-5 at 4. This testimony does not render Dr.
Rosenzweig’s opinion about the mesh cutting procedure
unreliable. See Campos v. Safety-Kleen Systems, Inc., 98 F.
Supp. 3d 372, 381 (D.P.R. 2015) (finding that expert’s
presentation of a contradictory opinion in a prior proceeding is
not a challenge to the principles or methodology underlying an
opinion but rather to the conclusion generated by the principles
or methodology).
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Ethicon further argues that Dr. Rosenzweig failed to cite
any studies in support of his opinion, rendering it unreliable.
Dr. Rosenzweig’s opinion, however, is based on his own
experience. Doc. 58-3 at 15 (“Based on my experience, training,
review of the literature, and review of Ethicon’s internal
documents, the laser cut mesh in the TVT Exact is defective
because it is too stiff and rigid.”). Citation of studies in
support of an opinion is a factor in determining reliability,
but it is not a dispositive requirement, and Ethicon does not
offer any developed argument challenging whether Dr.
Rosenzweig’s experience is sufficient. Granfield v. CSX
Transp., Inc., 597 F.3d 474, 486 (1st Cir. 2010) (“CSXT makes
much of the fact that Dr. Spector did not rely on peer-reviewed
studies in his causation diagnosis. The mere fact of
publication, or lack thereof, in a peer-reviewed journal is not
a determinative factor in assessing the scientific validity of a
technique or methodology on which an opinion is premised.”).
Ethicon advances one final argument about Dr. Rosenzweig’s
cutting mechanism opinion, contending that the manner in which
the Prolene mesh is cut is irrelevant to the claims in this
case. The court, however, declines to decide whether, at this
early stage, Dr. Rosenzweig’s testimony on this point is
irrelevant to the claims in this case. The court denies
Ethicon’s motion to exclude Dr. Rosenzweig’s testimony on this
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matter without prejudice to the filing of a motion in limine
more fully addressing the issue at the appropriate time prior to
trial.
B. Product Warnings Opinion
In Part II of its motion to exclude, Ethicon argues that
Dr. Rosenzweig is not qualified to offer an opinion about the
adequacy of the product warnings provided by Ethicon. The
Laderbushes respond, arguing that Dr. Rosenzweig is qualified to
opine about the adequacy of Ethicon’s warnings.
In a similar MDL case, Judge Goodwin found that Dr.
Rosenzweig was qualified to opine generally about the adequacy
of the warnings provided with a mesh product similar to TVT
Exact. Huskey v. Ethicon, 29 F. Supp. 3d 691, 704 (S.D.W.Va.
2014) (“[A]s a urogynecologist, Dr. Rosenzweig is qualified to
opine about the risks of the TVT-O and pelvic mesh surgery and
whether those risks were adequately expressed on the TVT-O’s
[Instructions for Use].”). The court likewise finds that Dr.
Rosenzweig is qualified to opine generally on the adequacy of
Ethicon’s warnings for TVT Exact. See id.; see also Armstead v.
Coloplast Corp., 2020 WL 353576, at *3 (M.D.N.C. Jan. 21, 2020)
(“Dr. Rosenzweig has testified on the adequacy of [Instructions
for Use] in past cases involving pelvic mesh devices, and there
is no reason to think he has suddenly become unqualified to
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render an opinion on the topic now.”) (citations omitted).
Therefore, Ethicon’s motion to exclude Dr. Rosenzweig is denied
as to its argument that Dr. Rosenzweig is unqualified to offer
opinions about the adequacy of the warnings accompanying TVT
Exact.
Ethicon also argues that Dr. Rosenzweig’s product warnings
opinion should be excluded because the Laderbushes’ failure to
warn claims should be dismissed. The court, however, has not
dismissed the Laderbushes’ failure to warn claims. Ethicon may
renew its argument that Dr. Rosenzweig’s opinion about the
adequacy of TVT Exact’s warnings is irrelevant if the court
dismisses the failure to warn claims prior to trial.
C. Adverse Event Reporting Opinion
In Part III of its motion to exclude, Ethicon argues that
the court should exclude Dr. Rosenzweig’s adverse event
reporting opinion. The Laderbushes do not contest Ethicon’s
motion to exclude on this ground. Doc. 64 at 6. Therefore,
Ethicon’s motion to exclude Dr. Rosenzweig’s adverse event
reporting opinions is granted.
D. Testimony About Complications (Part IV)
In Part IV of its motion to exclude, Ethicon contends that
Dr. Rosenzweig’s opinion should be excluded to the extent he
asserts that TVT Exact can cause complications that Ms.
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Laderbush did not experience. The Laderbushes respond, arguing
that Ethicon’s argument relates to relevance, which is outside
the scope of a Daubert motion. They also contend that evidence
of other complications is relevant, with the exception of the
risk of cancer, which the Laderbushes concede should not be
introduced.
As with Ethicon’s argument about relevance in Part I of its
motion to exclude, the relevance of testimony about possible
complications of TVT Exact that Ms. Laderbush did not suffer is
a matter that should be raised, if warranted, through a motion
in limine closer to trial. Accordingly, the court denies Part
IV of Ethicon’s motion to exclude without prejudice.
Conclusion
Ethicon’s motion to exclude the testimony of Dr. Rosenzweig
under Daubert (doc. no. 58) is denied as to Part I
(laser/mechanical mesh cutting opinion). The motion is denied
with prejudice as to Ethicon’s argument that Dr. Rosenzweig’s
opinions about the risks and benefits of laser cut and
mechanically cut meshes are unreliable because he did not rely
on peer-reviewed studies, but the motion is denied without
prejudice as to the argument that the opinion is irrelevant.
The motion is denied with prejudice as to Part II (product
warning opinion), except Ethicon may renew its argument that the
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opinion is irrelevant if the court dismisses the Laderbushes’
failure to warn claims. The motion is granted as to Part III
(adverse event reporting opinion). Finally, the motion is
denied without prejudice as to Part IV (testimony about
complications).
SO ORDERED.
__________________________
Joseph A. DiClerico, Jr.
United States District Judge
June 4, 2020
cc: Counsel of Record.
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