Filed: Jan. 26, 2017
Latest Update: Mar. 03, 2020
Summary: 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
Summary: 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 ..
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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
LLP, Chicago, Illinois; Jeffrey Kuntz, Adam Davis, WAGSTAFF &
CARTMELL LLP, Kansas City, Missouri, for Appellees.
2
DIANA GRIBBON MOTZ, Circuit Judge:
After Jo Huskey experienced complications from the
implantation of a transvaginal mesh medical device, she and her
husband Allen Huskey filed this products liability action
against Ethicon, Inc. and Johnson & Johnson (collectively
“Ethicon”). 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 2008, Mrs. Huskey began suffering symptoms of Stress
Urinary Incontinence (“SUI”). In January 2011, 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
3
surgically implant a 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. Ethicon received clearance from the Food and
Drug Administration (“FDA”) to market the TVT-O in December
2003. Ethicon uses polypropylene for the TVT-O’s mesh. The
TVT-O was not the first mid-urethral sling 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, Dr. Byrkit performed Mrs. Huskey’s
implantation surgery. A few weeks later, Mrs. Huskey visited
Dr. Byrkit’s office 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. Dr. Byrkit
performed this operation on June 29, 2011. Unfortunately, this
operation was not successful and did not relieve Mrs. Huskey’s
pain. Dr. Byrkit then referred Mrs. Huskey to Dr. Sohail
Siddique, a urogynecologist, for further treatment.
4
On November 18, 2011, Dr. Siddique performed surgery to
excise Mrs. Huskey’s mesh. 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 experience severe pain,
particularly when engaging in physical activity and sexual
intercourse. Additionally, her SUI symptoms have returned. For
the rest of her life, she will require medication 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 Inc., Pelvic
Repair Sys. Prods. Liab. Litig., MDL No. 2327. 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.
5
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. At the conclusion of their case,
Ethicon orally moved for judgment as a matter of law under
Federal Rule of Civil Procedure 50(a). The court granted the
motion as to Mrs. Huskey’s claim for punitive damages but
otherwise deferred ruling on the motion. 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 general verdict for the
Huskeys on all five claims. 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). The
court issued a thorough written order denying the motion.
Huskey v. Ethicon, Inc., No. 2:12-cv-05201, 2015 WL 4944339
(S.D. W. Va. Aug. 19, 2015). Ethicon subsequently noted this
timely appeal.
6
II.
A.
Ethicon initially contends that the district court erred in
denying it judgment as a matter of law. We review de novo the
denial of Ethicon’s motion. Durham v. Jones, 737 F.3d 291, 298
(4th Cir. 2013). 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. Fed.
R. Civ. P. 50(a). When the court defers ruling on 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. As Ethicon’s counsel conceded at oral
argument, since the jury returned a general verdict, we can
reverse the court’s denial of Ethicon’s motion only if the
Huskeys failed, as a matter of law, to prove both their design
defect and failure to warn claims. Given our resolution of the
7
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, because it is wholly derivative of Mrs. Huskey’s
claims, we do not separately consider Mr. Huskey’s loss of
consortium claim. 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.
8
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’ expert witnesses, bolstered Dr. Guelcher’s
testimony. Dr. Rosenzweig testified that 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
9
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, Dr. Brigitte Hellhammer, a former Ethicon
employee, testified that she had no reason to believe that
lightweight mesh could not effectively treat SUI.
Dr. Hellhammer explained that one risk of 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
10
constituted a design 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. See Kirk v. Michael Reese Hosp. & Med. Ctr.,
513 N.E.2d 387, 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). Comment k recommends
that such products, “with the 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, are
neither “defective, nor . . . unreasonably dangerous.”
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
11
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 k provides Ethicon no defense.
Specifically, the jury could reasonably infer from
Dr. Guelcher’s testimony that the greater quantity of 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.
12
III.
We next address Ethicon’s contention that the district
court should have granted it a new trial. 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). A court abuses its discretion if it relies on
incorrect legal conclusions or clearly erroneous findings of
fact. 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.
13
A.
We turn first to the comment k instruction. Ethicon argued
at trial that comment k entitled it to “at a minimum, an
appropriate jury instruction.” 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 if it found that the TVT-O was
unreasonably dangerous. 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.”
1Ethicon titled the instruction it requested “Inherent
Risks,” and the proposed instruction read:
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.
14
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 to inform the jury of the
controlling legal principles.
Id. Any lack of clarity must
prejudice the challenging party.
Id.
Again, to show that a product falls within comment k’s
protection, the defendant must prove that a product’s “marketing
and . . . use . . . are fully justified, notwithstanding the
unavoidable high degree of risk which [it] involve[s].”
Restatement (Second) of Torts § 402A cmt. k. 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.
15
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. Those four pieces of evidence
are: evidence of the TVT-O’s compliance with the FDA’s Section
510(k) evaluation process; evidence that a 2011 FDA Advisory
Committee deemed mesh slings, including the TVT-O, safe and
effective; a 2013 published guidance, which reported 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 Federal Rule of Evidence 403 in
excluding this evidence. That Rule allows a court to exclude
relevant evidence when its “probative value is substantially
outweighed by a danger of one or more of the following: unfair
prejudice, confusing the issues, misleading the jury, undue
delay, wasting time, or needlessly presenting cumulative
evidence.” Fed. R. Evid. 403. We review a decision to exclude
evidence on this basis for abuse of discretion. United States
v. Davis, 690 F.3d 226, 257 (4th Cir. 2012). Improper exclusion
of evidence warrants a new trial only if it results in “a high
16
probability that the error . . . affect[ed] the judgment.”
Drakeford, 792 F.3d at 375.
We will address each exclusion in turn. But before doing
so, we consider whether Ethicon has waived any challenge
pertaining to the latter three pieces of evidence. The Huskeys
argue that Ethicon never sought to introduce these three pieces
of evidence, and that Ethicon thus cannot now rely on the
exclusion of this evidence to gain a new trial. 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. The Huskeys thus waived this argument by omitting
it from 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
17
challenge). Having resolved 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.” Medtronic, Inc. v. Lohr,
518 U.S. 470, 478 (1996). The FDA then evaluates whether the
new device is “‘substantially equivalent’ to a pre-existing
device.”
Id. 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
assertions by the FDA” as to 510(k) compliance are highly
probative of a product’s safety. Id. at 921. 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.
Id. at 921-22.
We see no reason to distinguish 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 mesh . . . based on the
19
published literature and adverse event data from” an FDA
database, and noted that “[a] substantial number of quality
clinical trials, as well as systematic reviews, have been
published for the first generation minimally invasive slings
that provide evidence of safety and effectiveness of these
devices.” FDA Advisory Committee, Surgical Mesh for Treatment
of Women with Pelvic Organ Prolapse and Stress Urinary
Incontinence: FDA Executive Summary 1, 28 (2011). 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. Rather, it simply
opined on the work others had done. 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
20
TVT-O did not address its 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 the FDA Advisory Committee’s actual
conclusions. 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 the district court correctly explained, “evidence
regarding the FDA process that the Prolene suture
underwent . . . says little about the safety and effectiveness
of the final product, the TVT-O.” Huskey, 2015 WL 4944339, at
21
*13 (emphasis added). The 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 TVT-
O 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. On cross-
examination, Ethicon’s counsel elicited testimony from
Dr. Guelcher that Prolene sutures have an identical chemical
composition to the Prolene Ethicon uses in both its hernia
meshes and in its TVT meshes to treat SUI. In that same line of
questioning, Dr. Guelcher also 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 of the Prolene suture’s
22
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
