Jo Huskey v. Ethicon, Inc.
Filing
PUBLISHED AUTHORED OPINION filed. Originating case number: 2:12-cv-05201,2:12-md-02327. [1000010839]. [15-2118]
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PUBLISHED
UNITED STATES COURT OF APPEALS
FOR THE FOURTH CIRCUIT
No. 15-2118
JO HUSKEY; ALLEN HUSKEY,
Plaintiffs - Appellees,
v.
ETHICON, INC.; JOHNSON & JOHNSON,
Defendants - Appellants.
Appeal from the United States District Court for the Southern
District of West Virginia, at Charleston.
Joseph R. Goodwin,
District Judge. (2:12-cv-05201; 2:12-md-02327)
Argued:
December 8, 2016
Decided:
January 26, 2017
Before MOTZ and DIAZ, Circuit Judges, and DAVIS, Senior Circuit
Judge.
Affirmed by published opinion. Judge Motz wrote the opinion, in
which Judge Diaz and Senior Judge Davis joined.
ARGUED: David B. Thomas, THOMAS COMBS & SPANN, PLLC, Charleston,
West Virginia, for Appellants.
Edward Anthony Wallace, WEXLER
WALLACE LLP, Chicago, Illinois; Fidelma Louise Fitzpatrick,
MOTLEY RICE LLC, Providence, Rhode Island, for Appellees.
ON
BRIEF: Charles C. Lifland, Los Angeles, California, Stephen D.
Brody, David K. Roberts, O’MELVENY & MYERS LLP, Washington,
D.C.; Philip J. Combs, THOMAS COMBS & SPANN, PLLC, Charleston,
West Virginia; Christy D. Jones, BUTLER SNOW LLP, Ridgeland,
Mississippi, for Appellants.
Mark R. Miller, WEXLER WALLACE
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LLP, Chicago, Illinois; Jeffrey Kuntz, Adam Davis, WAGSTAFF &
CARTMELL LLP, Kansas City, Missouri, for Appellees.
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DIANA GRIBBON MOTZ, Circuit Judge:
After
Jo
Huskey
experienced
complications
from
the
implantation of a transvaginal mesh medical device, she and her
husband
Allen
against
Ethicon,
“Ethicon”).
Huskey
filed
Inc.
and
this
products
Johnson
&
liability
Johnson
action
(collectively
Following a nine-day trial, the jury returned a
general verdict for the Huskeys on their design defect, failure
to warn, and loss of consortium claims.
Ethicon now appeals the
denial of its post-trial renewed motion for judgment as a matter
of law or, in the alternative, for a new trial.
The Huskeys
offered sufficient evidence to sustain the jury’s verdict and
the district court committed no reversible error.
Accordingly,
we affirm.
I.
A.
In
Urinary
2008,
Mrs. Huskey
Incontinence
began
suffering
(“SUI”).
In
symptoms
January
2011,
of
Stress
after
her
condition had worsened, she discussed treatment options with her
doctor,
Dr. Gretchen
Byrkit.
By
this
time,
Mrs. Huskey
was
regularly leaking urine while coughing, laughing, and sneezing,
and
she
also
experienced
pain
during
intercourse.
At
Dr. Byrkit’s suggestion, Mrs. Huskey agreed to have Dr. Byrkit
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surgically
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implant
a
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medical
device
called
the
Tension-Free
Vaginal Tape-Obturator (“TVT-O”).
The TVT-O is a mid-urethral sling that uses a heavy-weight
laser-cut mesh.
Drug
Ethicon received clearance from the Food and
Administration
2003.
TVT-O
(“FDA”)
to
market
the
TVT-O
in
December
Ethicon uses polypropylene for the TVT-O’s mesh.
was
not
the
first
mid-urethral
sling
The
Ethicon
had
manufactured; rather, it was a second-generation version of an
earlier Ethicon device called the Gynecare TVT and is one of
multiple slings that Ethicon has manufactured and sold.
On
February
23,
2011,
implantation surgery.
Dr. Byrkit’s
office
Dr. Byrkit
performed
Mrs. Huskey’s
A few weeks later, Mrs. Huskey visited
for
a
post-operative
check-up.
At
this
visit, Dr. Byrkit examined Mrs. Huskey and found that some mesh
on
her
right
side
had
eroded.
This
eroded
mesh
caused
Mrs. Huskey to experience pelvic pain.
On June 24, 2011, after various alternative treatments that
Dr. Byrkit had recommended failed, Mrs. Huskey agreed to have a
second surgical operation to cover the exposed mesh.
performed this operation on June 29, 2011.
Dr. Byrkit
Unfortunately, this
operation was not successful and did not relieve Mrs. Huskey’s
pain.
Dr. Byrkit
then
referred
Mrs. Huskey
to
Siddique, a urogynecologist, for further treatment.
4
Dr. Sohail
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On
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November
18,
2011,
excise Mrs. Huskey’s mesh.
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Dr. Siddique
performed
surgery
to
He found that she had an infection
and that the mesh on Mrs. Huskey’s right side had completely
eroded.
He could not remove all the mesh because some had
retracted behind Mrs. Huskey’s pubic bone.
To this day, the remaining mesh and scar tissue from her
operations
cause
Mrs. Huskey
to
engaging
physical
severe
when
intercourse.
Additionally, her SUI symptoms have returned.
the
her
of
life,
she
will
require
activity
and
pain,
particularly
rest
in
experience
medication
sexual
for
For
pain
management; no surgical intervention can permanently cure her.
B.
On September 6, 2012, the Huskeys filed the operative Short
Form Complaint in the Southern District of West Virginia in the
instant
multidistrict
litigation,
In
Re
Ethicon
Repair Sys. Prods. Liab. Litig., MDL No. 2327.
Inc.,
Pelvic
The Huskeys,
Illinois residents, brought all of their claims under Illinois
law.
After the district court granted Ethicon partial summary
judgment, five claims remained for trial:
strict liability and
negligent design defect; strict liability and negligent failure
to warn; and Mr. Huskey’s loss of consortium.
Beyond actual
damages, Mrs. Huskey sought punitive damages for the substantive
claims.
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Trial began on August 22, 2014 and lasted nine days.
The
Huskeys presented their case, which consisted of testimony from
thirteen witnesses and the introduction of numerous documents,
over the first six trial days.
Ethicon
orally
moved
for
At the conclusion of their case,
judgment
as
a
matter
of
law
under
Federal Rule of Civil Procedure 50(a).
The court granted the
motion
punitive
as
to
Mrs. Huskey’s
claim
for
otherwise deferred ruling on the motion.
damages
but
Ethicon renewed its
motion at the close of its case, and the court, again deferring
a ruling, submitted the case to the jury.
The
jury
returned
a
unanimous
Huskeys on all five claims.
general
verdict
for
the
The jury awarded Mrs. Huskey $3.07
million in total damages, allocated between past expenses for
medical care, previous pain and suffering, and future pain and
suffering.
The jury awarded Mr. Huskey an additional $200,000
for his loss of consortium.
After the jury returned its verdict, Ethicon again renewed
its motion for judgment as a matter of law.
In the alternative,
Ethicon sought a new trial pursuant to Rule 59(a)(1)(A).
court
Huskey
issued
v.
a
thorough
Ethicon,
Inc.,
written
No.
(S.D. W. Va. Aug. 19, 2015).
order
denying
2:12-cv-05201,
2015
The
the
motion.
WL
4944339
Ethicon subsequently noted this
timely appeal.
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II.
A.
Ethicon initially contends that the district court erred in
denying it judgment as a matter of law.
denial of Ethicon’s motion.
(4th Cir. 2013).
We review de novo the
Durham v. Jones, 737 F.3d 291, 298
A court “may grant judgment as a matter of law
only if, viewing the evidence in a light most favorable to the
non-moving party and drawing every legitimate inference in that
party’s favor, . . . the only conclusion a reasonable jury could
have reached is one in favor of the moving party.”
Saunders v.
Branch Banking & Tr. Co. of Va., 526 F.3d 142, 147 (4th Cir.
2008).
If, upon the conclusion of a party’s case, “a reasonable
jury would not have a legally sufficient evidentiary basis to
find for the party on that issue,” a court may grant a motion
from the opposing party for judgment as a matter of law.
R.
Civ.
P.
50(a).
When
the
court
defers
ruling
on
Fed.
such
a
motion, Rule 50(b) allows a party to renew it after the jury
returns a verdict.
Ethicon moved for judgment as a matter of law on all five
of the Huskeys’ claims.
argument,
reverse
since
the
the
court’s
jury
As Ethicon’s counsel conceded at oral
returned
denial
of
a
general
Ethicon’s
verdict,
motion
only
we
can
if
the
Huskeys failed, as a matter of law, to prove both their design
defect and failure to warn claims.
7
Given our resolution of the
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Huskeys’ design defect claims, we need not discuss their failure
to warn claims.
Moreover, because their negligent design defect
claim relies on the same facts and arguments as their strict
liability design defect claim, we address those claims together.
Similarly,
claims,
we
because
do
it
not
consortium claim.
is
wholly
separately
derivative
consider
Mr.
of
Mrs.
Huskey’s
Huskey’s
loss
of
See Blagg v. Ill. F.W.D. Truck & Equip. Co.,
572 N.E.2d 920, 926 (Ill. 1991).
B.
To prevail on their design defect claims, the Huskeys had
to
demonstrate:
1)
that
a
certain
condition
of
the
TVT-O
resulted from Ethicon’s design, 2) that this condition made the
product unreasonably dangerous, 3) that the dangerous condition
existed when Mrs. Huskey’s TVT-O left Ethicon’s control, and 4)
that the dangerous condition in the TVT-O proximately caused
harm to Mrs. Huskey.
See Mikolajczyk v. Ford Motor Co., 901
N.E.2d 329, 345 (Ill. 2008).
Ethicon makes two arguments in
support of its contention that the court erred in denying it
judgment as a matter of law:
1) that the Huskeys failed to
prove a specific flaw in the TVT-O’s design -- as opposed to a
general
complication
flowing
from
implantation,
and
2)
that
comment k of the Restatement (Second) of Torts § 402A shields it
from liability.
We address these arguments in turn.
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1.
The
record
belies
Ethicon’s
assertion
that
the
Huskeys
failed to prove that a specific defect of the TVT-O’s design
caused harm
to
Mrs. Huskey.
As
the
district
court
properly
held, the Huskeys offered sufficient evidence for a reasonable
jury to find that Ethicon’s use of heavyweight polypropylene
mesh in the TVT-O caused Mrs. Huskey’s injuries.
First,
Dr. Scott
Guelcher,
an
associate
professor
of
chemical engineering at Vanderbilt University and one of the
Huskeys’ expert witnesses, testified about the body’s reaction
to polypropylene and the consequences that ensue.
He explained
that “the body recognizes [the polypropylene mesh] as a foreign
material, and . . . will continue to attack it in this way until
it’s
removed
or
destroyed
or
it’s
gone.”
And
Dr. Guelcher
testified, based on his research, that “it’s best to minimize
the amount of polypropylene that’s present in the mesh,” because
“the
more
polypropylene
surface
that’s
present,
the
greater
those changes would be, [and] the more hazardous they could be.”
Next, Dr. Bruce Rosenzweig, a urogynecologist and another
of
the
Huskeys’
testimony.
expert
witnesses,
Dr. Rosenzweig
bolstered
testified
that
Dr. Guelcher’s
Ethicon
used
a
heavyweight mesh and “[t]he more mesh there is in the pelvis,
the
more
of
a
foreign
body
response.”
He
explained
that
heavyweight mesh can lead to a foreign body response in an area
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near the inner thigh called the obturator space, and that these
foreign bodies can “irritate the nerve [that passes nearby] and
lead to pain.”
Additionally,
employee,
testified
lightweight
mesh
Dr. Hellhammer
Dr. Brigitte
that
she
could
explained
Hellhammer,
had
not
that
no
a
reason
former
to
risk
of
believe
that
treat
effectively
one
Ethicon
SUI.
implanting
mesh
devices in patients was that the mesh would shrink, and that the
weight of the mesh helps determine the likelihood of shrinkage.
Dr. Hellhammer testified to a generally-recognized understanding
that lightweight mesh “would help in reducing a foreign body
response,
inflammatory
response,
and
would
reduce
the
potentiation for scar plating.”
Finally, Dr. Jerry Blaivas, a urologist and another expert
witness for the Huskeys who had conducted a pelvic examination
of Mrs. Huskey, testified that Mrs. Huskey had severe scarring
and suffered from “chronic pelvic pain.”
Dr. Blaivas believed
Mrs. Huskey’s symptoms were “a reaction to the mesh” and that he
did
not
“know
of
anything
else
that
can
cause . . . this
particular constellation of symptoms.”
Drawing all inferences in the Huskeys’ favor, a reasonable
jury could conclude from this expert testimony that Ethicon’s
use of a heavyweight quantity of polypropylene mesh in the TVT-O
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constituted
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a
design
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defect
that
caused
Mrs. Huskey’s
inflammation and pelvic pain.
2.
Ethicon next argues that an exception to strict liability
found in comment k to § 402A of the Restatement (Second) of
Torts, on which Illinois courts rely, nevertheless shields it
from liability.
513
N.E.2d
387,
See Kirk v. Michael Reese Hosp. & Med. Ctr.,
392
(Ill.
1987)
(citing
comment
k
in
a
recitation of applicable law).
Comment
k,
which
is
captioned
“[u]navoidably
unsafe
products,” recognizes that “some products . . . , in the present
state of human knowledge, are quite incapable of being made safe
for their intended and ordinary use.”
Restatement (Second) of
Torts § 402A cmt. k (Am. Law Inst. 1965).
that
such
products,
“with
the
Comment k recommends
qualification
that
they
are
properly prepared and marketed, and proper warning is given,”
not
trigger
strict
liability.
Id.
This
is
because
“the
marketing and the use of [unavoidably unsafe products] are fully
justified, notwithstanding the unavoidable high degree of risk
which
they
involve.”
Id.
Such
products,
it
explains,
neither “defective, nor . . . unreasonably dangerous.”
are
Id.
Although comment k notes that unavoidably unsafe products
“are
especially
common
in
the
field
of
drugs,”
id.,
under
Illinois law, courts determine “on a case by case basis” if a
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particular product falls within comment k, Glassman v. Wyeth
Labs., Inc., 606 N.E.2d 338, 342 (Ill. App. Ct. 1992).
Whether
a product is unavoidably unsafe is a question of fact on which
the defendant bears the burden of proof.
Id. at 343.
If a
reasonable jury could find that the TVT-O did not meet comment
k’s parameters, Ethicon’s reliance on comment k fails.
Much
of
the
trial
evidence
indicating
that
the
use
of
heavyweight polypropylene mesh constituted a design defect also
suggests
that
comment
Specifically,
the
Dr. Guelcher’s
testimony
k
jury
provides
could
that
the
Ethicon
reasonably
greater
no
defense.
infer
quantity
of
from
mesh
Ethicon used in the TVT-O, the greater the chance that a patient
would experience an adverse foreign body response.
The jury
could also reasonably infer from Dr. Hellhammer’s testimony that
had Ethicon used lightweight mesh, the TVT-O would have remained
effective and patients would have a reduced risk of an adverse
foreign body response.
Taken together, the expert testimony
allowed the jury to infer that Ethicon could have designed the
TVT-O with lightweight mesh without sacrificing any performance.
Consequently, the jury could reasonably conclude that the TVT-O
was not unavoidably unsafe.
Comment k does not shield Ethicon
from liability.
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III.
We
next
address
Ethicon’s
contention
court should have granted it a new trial.
that
the
district
Federal Rule of Civil
Procedure 59(a)(1)(A) allows a court to grant a party’s motion
for a new trial if the verdict is contrary to the clear weight
of the evidence, rests upon false evidence, or will cause a
miscarriage of justice.
Minter v. Wells Fargo Bank, N.A., 762
F.3d 339, 346 (4th Cir. 2014).
We review a denial of a new trial for abuse of discretion.
United States ex rel. Drakeford v. Tuomey, 792 F.3d 364, 375
(4th Cir. 2015).
incorrect
fact.
legal
A court abuses its discretion if it relies on
conclusions
or
clearly
erroneous
findings
of
Belk, Inc. v. Meyer Corp., U.S., 679 F.3d 146, 161 (4th
Cir. 2012).
Moreover, we can reverse even without such errors
“if we have ‘a definite and firm conviction that the court below
committed a clear error of judgment in the conclusion it reached
upon
a
weighing
of
the
relevant
factors.’”
Id.
(quoting
Westberry v. Gislaved Gummi AB, 178 F.3d 257, 261 (4th Cir.
1999)).
Ethicon raises two grounds for a new trial.
First, it
contends that the district court improperly refused to instruct
the
jury
on
comment
k.
Next,
it
asserts
that
the
court
improperly excluded multiple pieces of evidence involving the
FDA.
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A.
We turn first to the comment k instruction.
at
trial
that
comment
k
entitled
appropriate jury instruction.”
it
to
“at
Ethicon argued
a
minimum,
an
After considering briefing and
oral argument on the question, the district court declined to
include the requested comment k instruction. 1
Instead, the court
instructed the jury that it could find Ethicon liable on the
design
defect
claim
only
unreasonably dangerous.
if
it
found
that
the
TVT-O
was
The court then defined an “unreasonably
dangerous” product as one in which the “risk of danger inherent
in the design outweighs the benefits of the design when the
product
is
put
to
a
use
that
is
reasonably
foreseeable
considering the nature and function of the product.”
1
Ethicon titled the instruction it
Risks,” and the proposed instruction read:
requested
“Inherent
Some useful products are inherently dangerous and
cannot be made safe for their intended and ordinary
use.
An example is a prescription drug.
A
prescription drug is not defective simply because it
. . . has unavoidable side effects.
Products that contain inherent dangers are not
defectively designed or unreasonably dangerous so long
as they are accompanied by proper directions and
warning.
If you find that the risks that allegedly injured
Mrs. Huskey . . . were unavoidable, inherent risks of
the product, and that the product was accompanied by
proper directions and warnings, you should find that
the product is not defective.
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We review the district court’s refusal to provide Ethicon’s
proposed instruction for abuse of discretion.
Rowland v. Am.
Gen. Fin., Inc., 340 F.3d 187, 191 (4th Cir. 2003).
We evaluate
the jury charge as a whole, and an instructional error warrants
a
new
trial
only
if
it
fails
controlling legal principles.
Id.
prejudice the challenging party.
Again,
to
show
that
a
to
inform
the
jury
of
the
Any lack of clarity must
Id.
product
falls
within
comment
k’s
protection, the defendant must prove that a product’s “marketing
and . . . use . . . are
unavoidable
high
fully
degree
of
justified,
risk
which
notwithstanding
[it]
Restatement (Second) of Torts § 402A cmt. k.
the
involve[s].”
We can discern
only one difference between comment k and the jury instruction
the court gave. 2
That difference is the burden of proof, which
of course shifts to the defendant for comment k.
Even assuming
that Ethicon had produced sufficient evidence to justify the
issuance of a comment k instruction, we cannot hold that it
suffered prejudice from the absence of that instruction.
As the
district court correctly observed, the failure to provide an
instruction that shifts the burden to Ethicon would not likely
2
Ethicon
argues
that
the
district
court’s
actual
instruction did not capture “the policy rationale underlying
comment k,” namely, that of encouraging medical innovations.
This argument fails however, given that defendants must prove
comment k’s applicability “on a case by case basis.” Glassman,
606 N.E.2d at 342.
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have provided Ethicon with a more favorable outcome.
Without
any prejudice, the district court did not abuse its discretion
in denying Ethicon a new trial on that basis.
B.
We next address Ethicon’s evidentiary contentions.
Ethicon
posits that the district court’s exclusion of four pieces of FDA
evidence warrants a new trial.
are:
Those four pieces of evidence
evidence of the TVT-O’s compliance with the FDA’s Section
510(k) evaluation process; evidence that a 2011 FDA Advisory
Committee
deemed
effective;
a
mesh
2013
slings,
including
published
guidance,
the
TVT-O,
which
safe
reported
and
the
Advisory Committee’s conclusions; and the regulatory history of
the Prolene suture, an Ethicon product that contains the same
polypropylene as the TVT-O’s mesh.
The
court
relied
on
excluding this evidence.
relevant
evidence
when
Federal
Rule
of
Evidence
403
in
That Rule allows a court to exclude
its
“probative
value
is
substantially
outweighed by a danger of one or more of the following: unfair
prejudice,
delay,
confusing
wasting
evidence.”
the
time,
or
issues,
misleading
needlessly
Fed. R. Evid. 403.
the
jury,
presenting
undue
cumulative
We review a decision to exclude
evidence on this basis for abuse of discretion.
v. Davis, 690 F.3d 226, 257 (4th Cir. 2012).
United States
Improper exclusion
of evidence warrants a new trial only if it results in “a high
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probability
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that
the
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error . . . affect[ed]
the
judgment.”
Drakeford, 792 F.3d at 375.
We will address each exclusion in turn.
so,
we
consider
whether
Ethicon
has
But before doing
waived
any
pertaining to the latter three pieces of evidence.
challenge
The Huskeys
argue that Ethicon never sought to introduce these three pieces
of
evidence,
and
that
Ethicon
thus
cannot
now
exclusion of this evidence to gain a new trial.
rely
on
the
To the extent
this accurately represents the proceedings below -- a notion
Ethicon
strongly
contests
--
the
Huskeys
have
waived
this
argument.
Ethicon’s memorandum in support of its post-trial motion
contended that the exclusion of all of the evidence it invokes
on appeal justified a new trial.
The Huskeys’ only response to
this argument in their briefing was to incorporate by reference
their pre-trial filing to exclude the 510(k) evidence.
Nowhere
did they contend that Ethicon had not sufficiently sought to
introduce the other FDA evidence, or had otherwise waived its
ability to assert that the exclusion of this evidence compelled
a new trial.
it
from
The Huskeys thus waived this argument by omitting
their
post-trial
briefing.
Cf.
United
States
v.
Carthorne, 726 F.3d 503, 509 n.5 (4th Cir. 2013) (holding that
the Government “waived the waiver argument” when it failed to
argue that plain error review applied to a particular appellate
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challenge).
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Having
resolved
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this
issue,
we
now
examine
the
evidence in question.
1.
We begin with the evidence of the TVT-O’s compliance with
the 510(k) process.
Under the Federal Food, Drug, and Cosmetic
Act, a manufacturer seeking to market a new medical device may
attempt to bypass the FDA’s normal premarket approval process by
submitting a “§ 510(k) notification.”
518 U.S. 470, 478 (1996).
new
device
device.”
is
Id.
Medtronic, Inc. v. Lohr,
The FDA then evaluates whether the
“‘substantially
equivalent’
to
a
pre-existing
If the FDA finds substantial equivalence, the new
device “can be marketed without further regulatory analysis.”
Id.
The district court refused to permit Ethicon to introduce
evidence that it had cleared the 510(k) process and evidence
explaining that process.
We recently held in Cisson v. C.R. Bard, Inc. (In re C.R.
Bard, Inc.), 810 F.3d 913, 919 (4th Cir. 2016), a bellwether
case from a related MDL, that this same district judge did not
abuse his discretion when he excluded evidence that the device
in question had complied with the 510(k) process.
We noted that
the 510(k) process focuses mostly on the equivalence between the
product in question and an older one, and only “tangentially”
examines the safety of the product going through the process.
Id. at 922 (emphasis added).
We rejected the view that “[b]ald
18
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assertions
Filed: 01/26/2017
by
the
FDA”
as
to
probative of a product’s safety.
Pg: 19 of 23
510(k)
compliance
Id. at 921.
are
highly
Given its limited
probative value and the risk of confusing the jury by, inter
alia, causing a battle of the experts over the robustness of the
510(k) process’s safety examinations, we held that exclusion of
the 510(k) compliance evidence was not improper.
We
see
no
reason
to
distinguish
Id. at 921-22.
Cisson
here.
The
information Ethicon sought to introduce would, at best, have had
“tangential[]” relevance to the case.
This relative lack of
probative value, especially given a possible battle of experts
over the 510(k) process, underscores the risks of confusion and
wasted time that would follow the introduction of this evidence.
Ethicon’s effort to distinguish Cisson on the ground that the
TVT-O’s 510(k) compliance process actually did focus heavily on
safety would only amplify the risk, as the trial would then
likely face a substantial diversion into just how rigorous those
safety considerations were, how forthcoming Ethicon was to the
FDA, and how robust the 510(k) process is.
The district court
did not abuse its discretion in excluding this evidence.
2.
We next address the FDA Advisory Committee evidence.
In
2011, an Obstetrics and Gynecology Devices Advisory Committee
(the “FDA Advisory Committee”) conducted an examination of the
“risks
and
benefits
of
surgical
19
mesh . . . based
on
the
Appeal: 15-2118
Doc: 55
Filed: 01/26/2017
published
literature
database,
and
clinical
published
that
noted
trials,
for
provide
and
the
adverse
that
as
“[a]
well
first
evidence
Pg: 20 of 23
as
event
substantial
systematic
generation
of
data
safety
number
an
of
reviews,
minimally
and
from”
quality
have
invasive
effectiveness
FDA
been
slings
of
these
devices.”
FDA Advisory Committee, Surgical Mesh for Treatment
of
with
Women
Incontinence:
Pelvic
Organ
Prolapse
and
Stress
FDA Executive Summary 1, 28 (2011).
Urinary
In 2013, the
FDA issued a published guidance reiterating these conclusions.
While the district court did not permit Ethicon to present
evidence as to the FDA’s view of the underlying studies, it did
permit Ethicon to introduce those studies themselves.
The FDA
did not use its own analysis of the TVT-O to reach a conclusion
regarding the device’s safety and efficacy.
opined on the work others had done.
Rather, it simply
The underlying studies
themselves enabled Ethicon to obtain most of the probative value
from
the
FDA
Advisory
Committee
evidence
without
risking
a
usurpation of the jury’s essential role in determining if the
Huskeys had adequately proven their claims.
Additionally,
the
FDA’s
use
of
the
510(k)
process
to
approve the TVT-O layers on another risk of introducing the FDA
Advisory Committee evidence.
As discussed above, the 510(k)
process focuses on a particular device’s equivalence to an older
device.
Thus, the FDA’s only original conclusion regarding the
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TVT-O
Doc: 55
did
Filed: 01/26/2017
not
address
its
Pg: 21 of 23
safety.
This
dynamic
creates
a
potentially confusing disjunction for the jury between what the
FDA deems other literature has to say about the TVT-O’s safety
and what the FDA itself found about the TVT-O’s equivalence to
an earlier device.
This goes beyond the mere specter of too
much jury deference to the FDA and tacks on the prospect of the
jury
misunderstanding
conclusions.
the
FDA
Advisory
Committee’s
actual
In these circumstances, therefore, the court did
not abuse its discretion in excluding the FDA Advisory Committee
evidence.
3.
Finally, we consider the evidence of the regulatory history
of Prolene used in the Prolene sutures -- the same polypropylene
used in the TVT-O’s mesh also makes up part of the Prolene
suture.
Ethicon wanted to introduce evidence that the FDA had
approved the Prolene suture not only in an initial application,
but
also
in
over
thirty
subsequent
New
Drug
Applications.
Ethicon also sought to introduce evidence that the “FDA approved
language indicating that Prolene [in the suture] is not subject
to degradation via tissue enzymes.”
As
regarding
the
district
the
FDA
court
correctly
process
that
explained,
the
Prolene
“evidence
suture
underwent . . . says little about the safety and effectiveness
of the final product, the TVT-O.”
21
Huskey, 2015 WL 4944339, at
Appeal: 15-2118
*13
Doc: 55
Filed: 01/26/2017
(emphasis
added).
The
Pg: 22 of 23
jury
ultimately
had
to
make
a
determination about the entire device that Mrs. Huskey received,
not just a component of it.
Introducing the evidence regarding
Prolene sutures alone could quite plausibly cause a diversion
into how similar and integral the Prolene sutures are to the
TVT-O end product and the role that other components of the TVTO might play in triggering foreign body responses or interacting
with the Prolene sutures to mitigate safeguards against such
responses.
And that is to say nothing of the risk, also present
with the FDA Advisory Committee evidence, that the jury might
draw too strong a conclusion from the fact that the evidence of
Prolene’s safety comes from the FDA.
These drawbacks underscore
that the court acted within its discretion.
Moreover,
even
without
the
evidence
of
the
regulatory
history of the Prolene sutures, the court permitted Ethicon to
introduce evidence of their robust safety record.
examination,
Ethicon’s
Dr. Guelcher
composition
that
to
Prolene
the
counsel
sutures
Prolene
elicited
have
Ethicon
uses
meshes and in its TVT meshes to treat SUI.
questioning,
Dr. Guelcher
also
an
On cross-
testimony
identical
in
both
from
chemical
its
hernia
In that same line of
acknowledged
that
his
research
had uncovered no “problem[s] with polypropylene mesh.”
Ethicon
was thus able to extract the same information that would have
made
up
the
core
probative
value
22
of
the
Prolene
suture’s
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Pg: 23 of 23
regulatory history without bringing in the potential negative
effects of introducing that evidence.
The court did not abuse
its discretion in excluding evidence of that other product’s
regulatory history.
IV.
Accordingly, for the reasons set forth above, the judgment
of the district court is
AFFIRMED.
23
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