Paula Donalds v. Ethicon, Inc. ( 2023 )

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UNPUBLISHED
UNITED STATES COURT OF APPEALS
FOR THE FOURTH CIRCUIT
No. 22-1737
PAULA M. DONALDS,
Plaintiff - Appellant,
v.
ETHICON, INC.; JOHNSON & JOHNSON,
Defendants - Appellees.
Appeal from the United States District Court for the District of Maryland, at Baltimore.
George L. Russell, District Judge. (1:20-cv-01659-GLR)
Submitted: January 18, 2023 Decided: March 10, 2023
Before AGEE and DIAZ, Circuit Judges, TRAXLER, Senior Circuit Judge.
Affirmed by unpublished per curiam opinion.
ON BRIEF: Kevin P. Sullivan, SALSBURY SULLIVAN, LLC, Baltimore, Maryland, for
Appellant. Amy M. Pepke, Susanna M. Moldoveanu, Memphis, Tennessee, M. Elizabeth
Roper, BUTLER SNOW LLP, Ridgeland, Mississippi; Shannon E. Beamer, VENABLE
LLP, Los Angeles, California, for Appellees.
Unpublished opinions are not binding precedent in this circuit.
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PER CURIAM:
Paula Donalds brought this diversity products-liability suit against defendants
Ethicon, Inc. and Johnson & Johnson (collectively “Ethicon”), seeking damages for
injuries she claims were caused by a TVT Abbrevo pelvic mesh device produced by
Ethicon. Donalds appeals the district court’s decision excluding the testimony of her expert
witness on causation, granting summary judgment to Ethicon on her design defect claims,
and denying her motion for reconsideration. 1 We affirm.
I.
On July 17, 2014, Donalds’ treating physician, Dr. Christine O’Connor, implanted
a TVT Abbrevo device to treat Donalds’ urinary incontinence. In 2016, Donalds began
experiencing bladder spasms, pain, burning sensations, and a recurrence of her urinary
incontinence. On July 25, 2016, Dr. Richard Ellerkmann removed portions of the TVT
Abbrevo device, and, on October 3, 2016, he implanted Donalds with the TVT Exact
device, another mesh device produced by Ethicon. 2
On April 3, 2017, Donalds filed suit against Ethicon in the United States District
Court for the Southern District of West Virginia, as part of a multi-district litigation
1
Donalds voluntarily withdrew several of her counts during the district court
proceedings. The district court granted summary judgment on the remaining counts, which
included her design defect claims, failure to warn claims, breach of warranty claims, fraud
and negligent misrepresentation claims, and consumer protection law claims. Donalds
appeals only the district court’s ruling on her design defect claims under the theories of
negligence (Count I), gross negligence (Count XIV), and strict liability (Count V).
2
Donalds’ lawsuit only raised claims pertaining to the TVT Abbrevo device.
2
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captioned In Re: Ethicon Inc., Pelvic Repair System Products Liability Litigation, MDL
No. 2327 (the “MDL litigation”). Donalds alleged, inter alia, that the TVT Abbrevo device
was defectively designed. Pursuant to the Pretrial Order issued in the MDL litigation,
Donalds’ Rule 26 expert disclosures were due by July 13, 2018; Ethicon’s expert
disclosures were due by August 13, 2018; and Donald’s rebuttal expert disclosures were
due by August 20, 2018.
Donalds designated four retained expert witnesses. Three of the retained experts
were offered to testify generally as to alleged defects in the TVT Abbrevo. 3 The fourth
was Richard L. Luciani, M.D., and he was the only expert designated to testify as to case-
specific causation. In his one-and-a-half-page report, Dr. Luciani summarily set forth his
qualifications, Donalds’ surgical history and symptoms, and offered the following one-
sentence opinion on causation:
It is my opinion to a reasonable degree of medical probability that the
complications Ms. Donalds endured following implantation of the TVT
ABBREVO mesh product, as described above, were proximately caused by
the erosion of the mesh product.
J.A. 909. Ethicon designated Nina Bhatia, M.D., as its expert witness on causation. Dr.
Bhatia took issue with Dr. Luciani’s failure to address and rule out other causes of Donalds’
symptoms, including a scissor puncture that occurred when Dr. O’Connor implanted the
TVT Abbrevo device on July 17, 2014, and a work-related accident that Donalds suffered
3
The three expert witnesses designated were Jerry Blaivas, M.D.; Uwe Klinge,
Ph.D., M.D.; and Vladamir Iakovlev, M.D.
3
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on August 9, 2014. 4 Donalds filed no rebuttal disclosures. The deadline to complete
discovery was October 4, 2018.
On June 8, 2020, the MDL judge remanded Donalds’ case to the United States
District Court for the District of Maryland. The MDL court order noted that discovery had
been completed in the MDL litigation and “urg[ed] the receiving court to immediately set
the[] case[] for trial without reopening discovery.” J.A. 330. The MDL court explained
that “[f]urther discovery will only result in unjust delay. Extensive development of these
cases over a period of years has made such further action completely unnecessary.” J.A.
330 (emphasis in original).
On June 23, 2021, after mediation efforts failed, Ethicon sought summary judgment.
Ethicon argued that Donalds could not establish her design defect claim because Dr.
Luciani had not performed a proper differential diagnosis on causation but instead ipse
dixit concluded that the TVT Abbrevo was the cause of Donalds’ injuries. Ethicon also
pointed out that Dr. Luciani had failed to specify any defect in the design of the TVT
Abbrevo, and had offered no opinion that Donalds’ injuries were caused by a design defect.
Shortly thereafter, Donalds filed her memorandum in opposition.
On November 17, 2021, the district court directed supplemental briefing on the
question of whether Dr. Luciani’s opinion was admissible under Federal Rule of Evidence
702. Donalds filed her supplemental brief on November 29, 2021, and attached a
4
Donalds, a flight attendant, was injured when the pilot engaged the emergency
brake on the runway, causing her to bang against areas of the plane and fall. As a result of
her injuries, Donalds was awarded Social Security disability benefits.
4
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supplemental affidavit from Dr. Luciani. The affidavit expounded on Dr. Luciani’s initial
opinion in an obvious attempt to address the alleged deficiencies in his initial report.
Ethicon argued that the supplemental affidavit was grossly untimely and that it, in fact,
bolstered their argument that Dr. Luciani should not be permitted to testify because the
original disclosure was insufficient.
The district court excluded Dr. Luciani from testifying under Rule 702 and Daubert
v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), and declined to consider Dr.
Luciani’s belated affidavit. And because Donalds could not establish that an alleged design
defect was the proximate cause of her injuries, the district court granted summary judgment
to Ethicon. Donalds then filed a motion for reconsideration arguing, for the first time, that
the district court should have considered Dr. Ellerkmann to be a causation expert before
granting summary judgment. The district court denied the motion for reconsideration. This
appeal followed.
II.
Under her products-liability theory of recovery, Donalds was required to “show
three product litigation basics—defect, attribution of defect to the seller, and a causal
relationship between the defect and the injury.” Laing v. Volkswagen of Am., Inc., 949
A.2d 26, 39 (Md. Ct. Spec. App. 2008) (cleaned up). It is undisputed that Maryland law
governs this diversity action, and that expert testimony was required to establish a design
defect and its causal connection to Donalds’ alleged injuries. See Wood v. Toyota Motor
Corp., 760 A.2d 315, 319 (Md. Ct. Spec. App. 2000).
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We review the district court’s decision to grant summary judgment to Ethicon de
novo. Viewing the facts and all reasonable inferences in the light most favorable to the
nonmoving party, “[s]ummary judgment is appropriate only ‘when there is no genuine
dispute as to any material fact and the movant is entitled to judgment as a matter of law.’”
Dash v. Mayweather, 731 F.3d 303, 310-11 (4th Cir. 2013) (quoting Fed. R. Civ. P. 56(a)).
To withstand a motion for summary judgment, “the nonmoving party must rely on more
than conclusory allegations, mere speculation, the building of one inference upon another,
or the mere existence of a scintilla of evidence.” Id. at 311.
“[T]he admissibility of expert testimony in federal court sitting in the diversity
jurisdiction is controlled by federal law.” Bryte ex rel. Bryte v. Am. Household, Inc., 429
F.3d 469, 476 (4th Cir. 2005) (cleaned up). Rule 26 of the Federal Rules of Civil Procedure
governs the disclosures required prior to trial. Among other things, each “party must
disclose to the other parties the identity of any witness it may use at trial to present evidence
under Federal Rule of Evidence 702, 703, or 705.” Fed. R. Civ. P. 26(a)(2)(A). The
“disclosure must be accompanied by a written report—prepared and signed by the
witness—if the witness is one retained or specially employed to provide expert testimony
in the case.” Fed. R. Civ. P. 26(a)(2)(B). This report must contain, inter alia, “a complete
statement of all opinions the witness will express and the basis and reasons for them.” Fed.
R. Civ. P. 26(a)(2)(B)(i). “If a party fails to provide information or identify a witness as
required by Rule 26(a) or (e), the party is not allowed to use that information or witness to
supply evidence on a motion, at a hearing, or at a trial, unless the failure was substantially
justified or is harmless.” Fed. R. Civ. P. 37(c)(1).
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Rule 702 of the Federal Rules of Evidence governs the admissibility of expert
testimony. A qualified expert witness “may testify in the form of an opinion or otherwise
if . . . the expert’s scientific, technical, or other specialized knowledge will help the trier of
fact to understand the evidence or to determine a fact in issue.” Fed. R. Evid. 702(a). The
expert's testimony must be “based on sufficient facts or data” and be “the product of reliable
principles and methods,” Fed. R. Evid. 702(b), (c), and those principles and methods must
have been “reliably applied” by the expert “to the facts of the case,” Fed. R. Evid. 702(d).
It is the district court's responsibility to “ensure that an expert's opinion is based on
scientific, technical, or other specialized knowledge and not on belief or speculation.”
Sardis v. Overhead Door Corp., 10 F.4th 268, 281 (4th Cir. 2021) (cleaned up). This
“gatekeeping function” serves to protect jurors from “being swayed by dubious scientific
testimony.” Nease v. Ford Motor Co., 848 F.3d 219, 231 (4th Cir. 2017) (cleaned up).
It is the plaintiff’s burden to establish the admissibility of her proposed expert
testimony. See Cooper v. Smith & Nephew, Inc., 259 F.3d 194, 199 (4th Cir. 2001). On
appeal, we review evidentiary rulings, including rulings on the admissibility of expert
testimony, for abuse of discretion only. See General Electric Co. v. Joiner, 522 U.S. 136,
141 (1997). “On a motion for summary judgment, disputed issues of fact are resolved
against the moving party.” Id. at 143. “But the question of admissibility of expert
testimony is not such an issue of fact, and is reviewable under the abuse-of-discretion
standard.” Id.A.
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We hold that the district court did not abuse its discretion in excluding Dr. Luciani’s
proffered testimony on causation. Dr. Luciani’s disclosed report was comprised of a
summary review of his qualifications and Donalds’ treatment records, followed by an ipse
dixit conclusion that Donalds’ symptoms “were proximately caused by the erosion of the
mesh product.” J.A. 909. He did not identify a specific defect that could have caused
erosion of the mesh, nor did he address the other possible causes of Donalds’ symptoms,
even though Donalds had been alerted to the presence of these alleged deficiencies in Dr.
Luciani’s report well prior to the expiration of her time to file a rebuttal disclosure in the
MDL proceedings. Because Dr. Luciani’s opinion failed to supply the basis and reasons
for his opinion and he offered no explanation of his methods or how he reached his
conclusion, the district court held, “his opinion does not rise above the level of ‘belief or
speculation’ and is ipse dixit.” J.A. 1169. “[N]othing in either Daubert or the Federal
Rules of Evidence requires a district court to admit opinion evidence that is connected to
existing data only by the ipse dixit of the expert. A court may conclude that there is simply
too great an analytical gap between the data and the opinion offered.” Joiner, 522 U.S. at
146; see also Daubert, 509 U.S. at 590 (The “knowledge” required under Rule 702
“connotes more than subjective belief or unsupported speculation.”); Sardis, 10 F.4th at
290 (“The trial court’s gatekeeping function requires more than simply taking the expert’s
word for it.”) (cleaned up).
This is precisely what the district court did in this case, and we see no abuse of
discretion in its ruling. And because Dr. Luciani was Donalds’ only case-specific expert
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on causation—a necessary element of her design defect claims—the district court did not
err in granting summary judgment to Ethicon.
B.
We review a district court’s decision to reject untimely disclosures of evidence for
abuse of discretion as well, see Bresler v. Wilmington Tr. Co., 855 F.3d 178, 189-90 (4th
Cir. 2017), and we also find no abuse of discretion in the district court’s refusal to consider
Dr. Luciani’s untimely, supplemental affidavit.
As noted above, a party who fails to properly designate an expert witness as required
by Rule 26(a) or Rule 26(e) may not use the expert at trial unless the party can show that
the “failure was substantially justified or harmless.” Fed. R. Civ. P. 37(c)(1). “[T]he basic
purpose of Rule 37(c)(1) [is to] prevent[] surprise and prejudice to the opposing party.”
Southern States Rack & Fixture, Inc. v. Sherwin-Williams Co., 318 F.3d 592, 596 (4th Cir.
2003). And “it is the obligation of the party facing sanctions for belated disclosure to show
that its failure to comply with Rule 37(c)(1) was either justified or harmless.” Id. (cleaned
up).
Under the MDL scheduling order, Donalds had until July 13, 2018, to serve her
expert disclosure and reports, and until August 20, 2018, to file rebuttal expert disclosures.
The time for additional discovery ended on October 4, 2018, after which the MDL court
referred the case to the Maryland district court and urged it to proceed to trial without
further discovery. Dr. Luciani’s supplemental report was not prepared or disclosed until
November 29, 2021, over three years after the close of discovery.
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On appeal, Donalds asserts that the district court erred in refusing to accept Dr.
Luciani’s supplemental affidavit under Rule 26(e) and erred in failing to examine whether
the supplemental disclosure was substantially justified or harmless under Rule 37(c)(1).
But once again, Donalds’ arguments are too little and too late. Donalds did not seek the
district court’s permission to file a supplemental report under Rule 26(e), nor did she
purport to offer it under that rule. Donalds also offered no argument that the late
submission was substantially justified or harmless under Rule 37(c)(1). She simply
attached it to her supplemental response in opposition to Ethicon’s motion for summary
judgment and persistently argued only that presentation of the supplemental report was not
a discovery violation at all.
Because Donalds failed to raise the Rule 26(e) argument before the district court,
she has forfeited review of it here. See Hicks v. Ferreyra, 965 F.3d 302, 310 (4th Cir.
2020) (“It is well established that this court does not consider issues raised for the first time
on appeal, absent exceptional circumstances.”) (cleaned up). But even if we were to
consider the belated argument, the district court did not abuse its discretion in refusing to
accept Dr. Luciani’s untimely affidavit.
Rule 26(e) permits a party to supplement an expert witness report “in a timely
manner if the party learns that in some material respect the disclosure or response is
incomplete or incorrect, and if the additional or corrective information has not otherwise
been made known to the other parties during the discovery process or in writing.” Fed. R.
Civ. P. 26(e)(1)(A); see also Fed. R. Civ. P. 37(c)(1) (“If a party fails to provide
information or identify a witness as required by Rule 26(a) or (e), the party is not allowed
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to use that information or witness to supply evidence on a motion, at a hearing, or at a trial,
unless the failure was substantially justified or is harmless.”).
Donalds’ submission of the supplemental affidavit was hardly made “in a timely
manner”—it was first offered three years after the close of discovery, to address the
deficiencies that Ethicon had pointed out in its motion for summary judgment. And
Donalds wholly failed to show that her failure to comply with the rules was justified or
harmless. See Southern States, 318 F.3d at 596. Rule 26(e) is not “a loophole to revise
[one’s] disclosures in light of [an opposing party’s] challenges to the analysis and
conclusions therein.” EEOC v. Freeman, 778 F.3d 463, 467 n.7 (4th Cir. 2015) (cleaned
up); see also Gallagher v. Southern Source Packaging, LLC, 568 F. Supp. 2d 624, 631
(E.D.N.C. 2008) (“Courts distinguish ‘true supplementation’ (e.g., correcting inadvertent
errors or omissions) from gamesmanship, and have therefore repeatedly rejected attempts
to avert summary judgment by ‘supplementing’ an expert report with a ‘new and improved’
expert report.”).
For these reasons, we hold that the district court did not abuse its discretion in
refusing to consider the supplemental affidavit, nor was it required to sua sponte consider
the affidavit as a Rule 26(e) submission or create reasons why it should be considered
despite Rule 37(c)(1).
III.
Finally, Donalds argues that the grant of summary judgment was erroneous because,
even if the district court properly excluded Dr. Luciani’s opinions, Dr. Ellerkmann could
have provided expert testimony on causation. Donalds raised this argument for the first
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time in her motion for reconsideration under Federal Rule of Civil Procedure 59(e). The
district court denied the motion because Donalds could have but failed to raise this
argument in opposition to the motion for summary judgment and, in the alternative,
because she had also failed to meet the disclosure requirements for a hybrid expert witness.
“[A]n issue presented for the first time in a motion pursuant to Federal Rule of Civil
Procedure 59(e) generally is not timely raised; accordingly, such an issue is not preserved
for appellate review unless the district court exercises its discretion to excuse the party’s
lack of timeliness and consider the issue.” Holland v. Big River Minerals Corp., 181 F.3d
597, 605 (4th Cir. 1999); see also Pacific Ins. Co. v. American Nat. Fire Ins. Co., 148 F.3d
396, 403 (4th Cir. 1998) (“Rule 59(e) motions may not be used . . . to raise arguments
which could have been raised prior to the issuance of the judgment, nor may they be used
to argue a case under a novel legal theory that the party had the ability to address in the
first instance.”). The district court did not excuse Donalds’ failure to raise the issue in this
case and, therefore, Donalds has not preserved this argument for appellate review.
Even if we were to entertain the issue, however, the district court did not abuse its
discretion in denying the motion because Donalds also failed to meet the disclosure
requirements for Dr. Ellerkmann. See United States ex rel. Carter v. Halliburton Co., 866
F.3d 199, 206 (4th Cir. 2017) (explaining that the denial of a motion for reconsideration is
reviewed only for an abuse of discretion). A Rule 59(e) motion for reconsideration “may
only be granted in three situations: (1) to accommodate an intervening change in
controlling law; (2) to account for new evidence not available at trial; or (3) to correct a
clear error of law or prevent manifest injustice.” Mayfield v. Nat’l Ass’n for Stock Car
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Auto Racing, Inc., 674 F.3d 369, 378 (4th Cir. 2012) (cleaned up). “It is an extraordinary
remedy that should be applied sparingly.” Id.Dr. Ellerkmann was designated in his capacity as a treating physician, not a retained
expert. Nevertheless, Rule 26(a)(2)(C) required Donalds to disclose “(i) the subject matter
on which the witness is expected to present evidence under Federal Rule of Evidence 702,
703, or 705; and (ii) a summary of the facts and opinions to which the witness is expected
to testify.” Fed. R. Civ. P. 26(a)(2)(C). Dr. Ellerkmann was designated as a non-retained
expert witness who “is expected to provide testimony . . . as it relates to his care and
treatment of the Plaintiff.” J.A. 1195. Dr. Ellerkmann was never designated to offer
testimony on the issue of causation. Thus, even if Dr. Ellerkmann could have offered
expert opinions as to causation, which alone is doubtful, Donalds failed to comply with the
disclosure requirements necessary to do so under Rule 26(a)(2)(C). Accordingly, the
district court was well within its discretion to also deny Donalds’ motion for
reconsideration on this basis.
IV.
Having reviewed the record on appeal as well as the parties’ briefs, and for the
reasons summarized above, we find no abuse of discretion or reversible error and affirm
on the reasoning of the district court. We dispense with oral argument because the facts
and legal contentions are adequately presented in the materials before this court and
argument would not aid the decisional process.
AFFIRMED
13