                              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.




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