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 096
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.
Uwe Klinge, M.D., under Daubert v. Merrell Dow Pharm., Inc., 509
U.S. 579 (1993). Doc. 54. Ethicon challenges Dr. Klinge’s
opinion on two matters. It asserts that his opinion about
alternative designs should be excluded as unreliable. Ethicon
also challenges the reliability of Dr. Klinge’s opinion that the
“Prolene” mesh used in the construction of its “TVT Exact”
product is defective due to fraying and particle loss. The
plaintiffs, Bonnie and George Laderbush, object to the exclusion
of Dr. Klinge’s opinion about alternative designs, but they will
not introduce Dr. Klinge’s opinion about fraying and particle
loss. Ethicon did not file a reply.
Standard of Review
To testify as an expert, a witness must be qualified to do
so “by knowledge, skill, experience, training, or education.”
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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
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.
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In his expert report, Dr. Uwe Klinge opined that the
relatively large surface area of the Prolene mesh increases
post-implant inflammation, which causes unnecessary
complications for implant recipients. Dr. Klinge asserted that
a mesh design with a smaller surface area would be sufficient to
treat stress urinary incontinence while reducing the risk of
inflammation and foreign body response. Dr. Klinge also opined
that the distance between the fibers of the mesh (i.e., its
“pore size”) is smaller in the Prolene mesh than is necessary,
which increases the risk of injury to implant recipients.
Further, Dr. Klinge explained that the Prolene mesh used in
TVT Exact was designed in the 1970s. He asserted that in the
late 1990s and early 2000s, synthetic meshes with a smaller
surface area and a larger pore size were developed and marketed
by Ethicon. Dr. Klinge noted the “Ultrapro” mesh as an example
of a mesh with a smaller surface and larger pore size.
Discussion
A. Alternative Designs
Ethicon argues that Dr. Klinge’s opinion that Ultrapro is a
safer alternative to Prolene should be excluded as unreliable.
Ethicon argues that Dr. Klinge’s expert report in this case “is
essentially identical” to Dr. Klinge’s expert report about
alternative designs that was excluded as unreliable in a similar
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mesh products liability case, Bellew v. Ethicon, Inc., No. 2:13-
cv-22473, 2014 WL 12685965 (S.D. W.Va. Nov. 20, 2014). Ethicon
contends that, in that case, the court found that Dr. Klinge
failed to cite peer-reviewed studies to support his opinion
about alternative designs, which rendered it unreliable.
The Laderbushes respond that the expert opinion excluded in
Bellew and referenced by Ethicon is different from the opinion
Dr. Klinge produced in this case. While the opinion excluded in
Bellew did address alternative designs to Prolene, the portion
excluded related only to the use of a design known as “PVDF” as
an alternative, while the opinion relied upon by the Laderbushes
in this case suggests Ultrapro as an alternative. The
Laderbushes argue that Dr. Klinge’s current report rectifies the
issue that resulted in its exclusion in Bellew. The Laderbushes
assert that Dr. Klinge provides a detailed and scientifically-
based explanation about the advantages of Ultrapro over Prolene.
Bellew is distinguishable from this case. In Bellew, the
court excluded Dr. Klinge’s opinion about a specific alternative
design, namely, PVDF. Bellew, 2014 WL 12685965 at *9. The
opinion about that design was excluded because Dr. Klinge failed
to explain why PVDF was a superior alternative or support his
opinion with any reliable scientific basis, such as peer-
reviewed studies. Id. By contrast, in this case, Dr. Klinge’s
basis for asserting that Ultrapro is a superior alternative
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design to Prolene is explained. He notes that Ultrapro has a
smaller surface area and larger pores. His opinion that meshes
with smaller surface areas and larger pores are preferable to
Prolene is supported by a comprehensive discussion and
references to his research, experience, and peer-reviewed
studies.
Ethicon also contends that Dr. Klinge’s opinion about
alternative designs should be excluded because, in his
deposition, Dr. Klinge could not identify any mesh that was
“appropriate for use in the pelvic floor for the repair of
pelvic organ prolapse” or any mesh with benefits that exceed
their risks. Doc. 55 at 3. The Laderbushes respond, arguing
that Ethcion mischaracterizes Dr. Klinge’s position. The
Laderbushes assert that Dr. Klinge merely acknowledged that the
Ultrapro mesh is not perfect.
Ethicon misunderstands Dr. Klinge’s deposition testimony.
Dr. Klinge did not say that there are no meshes that are
suitable for use in the treatment of pelvic organ prolapse.
Rather, in the portion of the deposition identified by Ethicon,
Dr. Klinge responded that Ethicon’s question “doesn’t make any
sense” because it is “a general statement.” Doc. 55-3 at 43,
48. Just prior to this question and response, Dr. Klinge had
explained that he does not think there is any single mesh device
that is suitable for treatment of every disease in the pelvic
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floor. Id. (“There is never one device for all diseases in the
pelvic floor. No, it’s not done. It has to be very carefully
designed for the specific purpose.”). The court denies
Ethicon’s motion to exclude Dr. Klinge’s opinion about Ultrapro
as an alternative design.
B. Fraying and Particle Loss
Ethicon also argues that Dr. Klinge should be prohibited
from testifying about “fraying and particle loss.” Doc. 55 at
4. The Laderbushes respond that they will not ask Dr. Klinge to
opine about fraying and particle loss. Accordingly, this ground
for exclusion is denied as moot.
Conclusion
Ethicon’s motion to exclude the testimony of Dr. Uwe Klinge
(doc. no. 54) is denied in part and denied as moot in part. The
motion is denied as to Dr. Klinge’s opinion regarding Ultrapro
as an alternative design. It is denied as moot as to Dr.
Klinge’s opinion regarding fraying and particle loss.
SO ORDERED.
__________________________
Joseph A. DiClerico, Jr.
United States District Judge
June 4, 2020
cc: Counsel of Record.
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