Judith A. Shears; Gary F. Shears, Jr. v. Ethicon, Inc.; Johnson & Johnson

PUBLISHED
UNITED STATES COURT OF APPEALS
FOR THE FOURTH CIRCUIT
No. 22-1399
JUDITH A. SHEARS; GARY F. SHEARS, JR.,
Plaintiffs – Appellants,
v.
ETHICON, INC.; JOHNSON & JOHNSON,
Defendants – Appellees,
and
ETHICON, L.L.C.,
Defendant.
Appeal from the United States District Court for the Northern District of West Virginia, at
Clarksburg. Irene M. Keeley, Senior District Judge. (1:20-cv-00264-IMK)
Argued: January 24, 2023 Decided: July 22, 2024
Before KING, AGEE, and HEYTENS, Circuit Judges.
Vacated and remanded by published opinion. Judge King wrote the opinion, in which
Judge Agee and Judge Heytens joined.
ARGUED: Jason Patrick Foster, THE SEGAL LAW FIRM, Charleston, West Virginia,
for Appellants. Amy M. Pepke, BUTLER SNOW LLP, Memphis, Tennessee, for

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Appellees. ON BRIEF: Scott S. Segal, Robin Jean Davis, THE SEGAL LAW FIRM,
Charleston, West Virginia, for Appellants. Natalie Rose Atkinson, THOMAS COMBS &
SPANN, PLLC, Charleston, West Virginia, for Appellees.

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KING, Circuit Judge:
In this “pelvic mesh” products liability action on appeal from the Northern District
of West Virginia, the federal trial court entered judgment against the plaintiffs following a
March 2022 jury trial. Pursuant to an Order of Certification of April 2023, we certified a
question of law to the Supreme Court of Appeals of West Virginia regarding the plaintiffs’
strict liability design defect claim. See Shears v. Ethicon, Inc., 64 F.4th 556 (4th Cir. 2023)
(the “Certification Order”). As explained herein, having now received the state supreme
court’s answer to our certified question, we vacate the trial court’s judgment and remand
for further proceedings.
I.
A.
1.
In our April 2023 Certification Order, we outlined the facts and procedural history
of this civil action, including the following:
Beginning in October 2008, plaintiff Judith Shears — a resident of
Monongalia County, West Virginia — presented to her physician with
complaints of stress urinary incontinence and a host of other abdominal
complications. Mrs. Shears was eventually referred to a urogynecologist,
who treated her conditions by placing a synthetic surgical mesh sling called
“Tension-Free Vaginal Tape” (hereinafter “TVT” or the “TVT mesh”)
beneath her urethra. Mrs. Shears’s symptoms at first abated, but in the years
following the TVT implantation, she began experiencing renewed
incontinence, urinary tract infections, and pelvic pain, along with urinary
frequency and urgency. In October 2013, a urologist discovered that the
TVT mesh had partially eroded into Mrs. Shears’s bladder, and an operation
was performed to remove the eroded mesh and an attached bladder stone.
Additional eroded mesh was discovered in Mrs. Shears’s bladder in 2014,

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and she has since experienced recurrent bladder stones and severe associated
bladder and urinary difficulties.
Along with her husband Gary Shears, Mrs. Shears initiated this civil
action in July 2013 against Ethicon, Inc. — the manufacturer and seller of
the TVT mesh and its parent company Johnson & Johnson.1 The Shearses
filed their lawsuit in the Southern District of West Virginia as part of a
multidistrict litigation captioned In re: Ethicon, Inc., Pelvic Repair System
Products Liability Litigation, No. 2:12-md-02327 (the “MDL”), which was
assigned by the federal judicial system’s Judicial Panel on Multidistrict
Litigation to the Honorable Joseph R. Goodwin.2 Contending that the TVT’s
erosion was to blame for Mrs. Shears’s injuries, the Shearses pursued
numerous claims for relief, including — as relevant to this appeal — a strict
product liability claim alleging a design defect in the TVT, as well as a claim
for negligent design thereof. Mr. Shears, for his part, joined in the lawsuit
by suing for loss of consortium.
See Shears, 64 F.4th at 558-59 (footnotes in original). After several years of extensive
pretrial proceedings before the MDL court, more fully described in our Certification Order,
the Shearses’ lawsuit was transferred to the Northern District of West Virginia in December
2020. See id. at 559-61.
2.
Upon transfer, the federal trial court in northern West Virginia began addressing
pretrial motions, including Daubert motions regarding expert witnesses for both the
Shearses and Ethicon. See Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993)
1 We refer to defendants Ethicon and Johnson & Johnson collectively as “Ethicon.”
2 The Shearses’ lawsuit was filed as part of the specific Ethicon MDL, which
comprised nearly 28,000 cases filed against Ethicon relating to the company’s TVT mesh.
Six other pelvic mesh-related product liability MDLs were also assigned to Judge
Goodwin, and at the time of the proceedings described herein, the seven MDLs together
encompassed some 58,000 cases.

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(establishing standard for admissibility of expert testimony under Federal Rule of Evidence
702). Critically, as highlighted in our Certification Order:
One of Ethicon’s Daubert motions sought to limit the testimony of Dr. Uwe
Klinge, the Shearses’ design and materials expert. Dr. Klinge’s expert report
spoke to two possible alternatives to the design of Ethicon’s TVT mesh —
specifically, polyvinylidene fluoride and “Ultrapro.” Dr. Klinge expressed
that, in his professional opinion, those materials posed a far lower risk of
erosion in pelvic tissue than the TVT mesh and represented “safer alternative
mesh materials for treatment of stress urinary incontinence than Ethicon’s
TVT Prolene mesh.”
See Shears, 64 F.4th at 561-62 (alteration and citations omitted).
During a hearing on the Daubert motions on February 11, 2022, the federal trial
court questioned the Shearses’ lawyer regarding Section 411 of the Supreme Court of
Appeals of West Virginia’s recently published West Virginia Pattern Jury Instructions for
Civil Cases (the “PJI”). Section 411, entitled “Design Defect — Necessity of an
Alternative, Feasible Design,” provides as follows:
There are many designs which, although they may eliminate a particular risk,
are not practicable to produce. To prove that a design is defective, [name of
plaintiff] must prove that there was an alternative, feasible design that
eliminated the risk that injured [him/her].
See J.A. 69.3 The language of Section 411 reflects a so-called “Elimination Mandate,” that
is, a requirement that an identified alternative, feasible product design “eliminate the risk”
of harm suffered by the plaintiff.
3 Citations herein to “J.A. __” refer to the contents of the Joint Appendix filed by
the parties in this appeal.

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Focusing on the Elimination Mandate, the federal trial court expressed its concern
“about the requirement under West Virginia products liability law . . . that the alternative
feasible design must eliminate the risk of which the plaintiff complains that caused the
injuries.” See J.A. 5464. The court accepted the legal soundness of Section 411’s
requirements, observing that it “saw [in Dr. Klinge’s expert report] fulsome discussions
about this is better, this is safer,” but Dr. Klinge “never said [the alternative mesh designs]
eliminated the risk but rather reduced the risk.” Id. at 5465. Ultimately, because Dr.
Klinge’s expert testimony would not have aided the Shearses in satisfying the Section 411
Elimination Mandate — that is, because his proposed testimony simply did “not meet the
standard under West Virginia law” — the court granted Ethicon’s Daubert motion and
barred Dr. Klinge from testifying about his proffered alternative mesh designs. Id. at 5569.
3.
In March 2022, the Shearses proceeded to a jury trial against Ethicon in Clarksburg
— continuing to press their strict liability design defect claim, as well as a claim alleging
negligent design of the TVT mesh. Critically, the federal trial court’s Daubert ruling
required the Shearses to alter their trial strategy. That is, “[r]ecognizing . . . that the trial
court’s restraint of Dr. Klinge’s testimony essentially foreclosed their ability to establish a
defective product design under the standard of Section 411, the Shearses pursued their
design defect claim under an alternative, so-called ‘malfunction theory’ of liability.” See
Shears, 64 F.4th at 562. As we further explained in our Certification Order:
Under West Virginia law, the malfunction theory permits success on
a strict product liability claim using only circumstantial evidence, so long as
the plaintiff “shows that a malfunction in the product occurred that would not

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ordinarily happen in the absence of a defect.” See Anderson v. Chrysler
Corp., 403 S.E.2d 189, 194 (W. Va. 1991). The trial court promptly ended
the Shearses’ reliance on the malfunction theory, however, granting
Ethicon’s motion for judgment as a matter of law on the design defect claim
at the close of the Shearses’ case-in-chief. . . . Following the presentation
of Ethicon’s evidence, the court instructed the jury on the Shearses’ sole
remaining negligent design claim, and the jury returned a verdict for Ethicon
on that claim later the same day.
Id. at 562-63. After the entry of a final judgment on the verdict, the Shearses timely noticed
this appeal, and we possess jurisdiction pursuant to 28 U.S.C. § 1291.
B.
On April 5, 2023, after obtaining briefing from the parties and conducting oral
argument, this Court sua sponte availed itself of the privilege afforded by the State of West
Virginia through the Uniform Certification of Questions of Law Act, see W. Va. Code
§§ 51-1A-1 to 51-1A-13, and requested that the Supreme Court of Appeals of West
Virginia resolve a certified question of law. Focusing on Section 411 and the elements of
a strict liability design defect claim under West Virginia law, we certified the following
question:
Whether Section 411 of the West Virginia Pattern Jury Instructions for Civil
Cases, entitled “Design Defect — Necessity of an Alternative, Feasible
Design,” correctly specifies the plaintiff’s burden of proof for a strict liability
design defect claim pursued under West Virginia law.
More specifically, whether a plaintiff alleging a West Virginia strict liability
design defect claim is required to prove the existence of an alternative,
feasible product design — existing at the time of the subject product’s
manufacture — in order to establish that the product was not reasonably safe
for its intended use. And if so, whether the alternative, feasible product
design must eliminate the risk of the harm suffered by the plaintiff, or
whether a reduction of that risk is sufficient.
See Shears, 64 F.4th at 558.

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In a unanimous June 2024 Opinion delivered by Justice C. Haley Bunn, the Supreme
Court of Appeals of West Virginia exercised its discretion to accept and rephrase our
certified question of law. See Shears v. Ethicon, Inc., No. 23-192, slip op. at 1 (W. Va.
June 11, 2024) (the “Opinion”). Justice Bunn explained:
The United States Court of Appeals for the Fourth Circuit certified
questions asking this Court to clarify certain elements of proof required to
establish a prima facie case in a strict liability claim based upon a design
defect. We answer as follows:
Whether Section 411 of the West Virginia Pattern Jury
Instructions for Civil Cases, entitled “Design Defect —
Necessity of an Alternative, Feasible Design,” correctly
specifies the plaintiff’s burden of proof for a strict liability
design defect claim pursued under West Virginia law.
Answer: No.
More specifically, whether a plaintiff alleging a West
Virginia strict liability design defect claim is required to prove
the existence of an alternative, feasible product design —
existing at the time of the subject product’s manufacture — in
order to establish that the product was not reasonably safe for
its intended use.
Answer: Yes
If so, whether the alternative, feasible product design
must eliminate the risk of the harm suffered by the plaintiff, or
whether a reduction of that risk is sufficient.
Answer: As part of a prima facie case of strict product
liability based upon a design defect, a plaintiff is required to
prove that an alternative, feasible design existing at the time
the subject product was made would have substantially
reduced the risk of the specific injury suffered by the plaintiff.
Id. at 1 (footnote and alteration omitted).

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Significantly, the Opinion contains two original syllabus points concerning Section
411 and the elements of a strict liability design defect claim. See State v. McKinley, 764
S.E.2d 303, 309 (W. Va. 2014) (explaining that “[o]riginal syllabus points announce an
important new point of law decided in the case”). Those syllabus points — Syllabus Points
1 and 5 — provide as follows:
1. West Virginia Pattern Jury Instructions for Civil Cases § 411
(2017) does not correctly specify a plaintiff’s burden of proof in a strict
liability claim based upon a design defect.
* * *
5. As part of a prima facie case of strict product liability based
upon a design defect, a plaintiff is required to prove that an alternative,
feasible design existing at the time the subject product was made would have
substantially reduced the risk of the specific injury suffered by the plaintiff.
See Syl. Pts. 1 & 5, Opinion at i-ii.
II.
In view of, and having hereby adopted the Opinion of the Supreme Court of Appeals
of West Virginia, we now resolve this appeal. The Shearses challenge the federal trial
court’s embrace of Section 411 of the PJI, insisting that Section 411’s framing of the
standard of proof for a strict liability design defect claim lacks support in controlling West
Virginia law. Specifically, the Shearses assert that the trial court’s Daubert ruling is legally
unsound, because it restricted Dr. Klinge’s expert testimony based on a requirement that
does not exist in West Virginia law — the Elimination Mandate.

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It is settled that we review a trial court’s decision on the admissibility of expert
testimony for abuse of discretion. See United States v. Campbell, 963 F.3d 309, 313 (4th
Cir. 2020). A court abuses its discretion when its conclusions are “guided by erroneous
legal principles.” See In re Jemsek Clinic. P.A., 850 F.3d 150, 156 (4th Cir. 2017) (internal
quotation marks omitted). Even when the trial court has committed an error in ruling on
the admission or exclusion of evidence, that error is subject to harmless error review. See
Fed. R. Civ. P. 61; see also Wickersham v. Ford Motor Co., 997 F.3d 526, 531 (4th Cir.
2021). And an error is harmless when this Court is satisfied “with fair assurance, after
pondering all that happened without stripping the erroneous action from the whole, that the
judgment was not substantially swayed by the errors.” See Wickersham, 997 F.3d at 531
(internal quotation marks omitted).
Here, by its Daubert ruling, the federal trial court excluded the proposed testimony
of Dr. Klinge regarding two mesh designs that posed a lower risk of erosion in pelvic tissue.
See J.A. 3011-14. In ruling that Dr. Klinge’s testimony “does not meet the standard under
West Virginia law,” the court relied on Section 411, and its Elimination Mandate. Id. at
5569.
The Opinion of the Supreme Court of Appeals of West Virginia in response to our
Certification Order establishes that the federal trial court abused its discretion by relying
on an erroneous legal principle. That is, there is “no support in West Virginia law for PJI
[Section] 411’s requirement for an alternative feasible design that ‘eliminated the risk’ that
injured the plaintiff.” See Opinion at 14. Rather, a plaintiff asserting a strict product
liability claim based upon a design defect — although required to “prove that an alternative,

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feasible design was available to the manufacturer at the time the product in question was
manufactured” — need only show that such design “substantially reduces the risk of the
specific injury suffered.” Id. at 17-18.
We are also satisfied that the federal trial court’s exclusion of Dr. Klinge’s
testimony readily satisfies harmless error review. The Daubert ruling essentially required
the Shearses to pursue their strict product liability claim by using only circumstantial
evidence under the alternative “malfunction theory” of liability. See Shears, 64 F.4th at
562. And proceeding under the malfunction theory was not fruitful for the Shearses,
resulting in judgment as a matter of law in favor of Ethicon on their strict product liability
claim.
III.
Pursuant to the foregoing, we vacate the judgment of the federal trial court and
remand for such other and further proceedings as may be appropriate.4
VACATED AND REMANDED
4 We acknowledge that the Shearses also maintain in this appeal that the trial court
(1) improperly granted Ethicon judgment as a matter of law on their strict liability design
defect claim under the malfunction theory and (2) incorrectly instructed the jury on their
negligence-based product liability claim. We express no view on either contention,
recognizing that further proceedings on remand may render review of those issues
unnecessary.

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