Court Opinion

ID: 9378668
Source: CourtListenerOpinion
Date Created: 2023-03-11 21:00:21.601367+00
Date Added: 2024-06-11T17:15:37.130559
License: Public Domain

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                                            UNPUBLISHED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        Affirmed by unpublished per curiam opinion.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        Unpublished opinions are not binding precedent in this circuit.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
                                                      12
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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

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