Cisson v. C.R. Bard, Inc., Civil Action No. 2:11–cv–00195.

• Citation: 86 F.Supp.3d 510
• Decision Date: 20 January 2015
• Docket Number: Civil Action No. 2:11–cv–00195.
• Court: United States District Courts. 4th Circuit. Southern District of West Virginia
• Parties: Donna CISSON, et al., Plaintiffs, v. C.R. BARD, INC., Defendant.

86 F.Supp.3d 510

Donna CISSON, et al., Plaintiffs

v.C.R. BARD, INC., Defendant.

Civil Action No. 2:11–cv–00195.

United States District Court, S.D. West Virginia.

Signed Jan. 20, 2015.

Allison Overbay Van Laningham, Van Laningham Duncan, Greensboro, NC, Anthony J. Majestro, Powell & Majestro, Charleston, WV, Paul T. Farrell, Jr., Greene Ketchum Bailey Walker Farrell & Tweel, Huntington, WV, Andrew Judson Hill, III, Gary B. Blasingame, Henry G. Garrard, III, Josh B. Wages, Leanna Bankester Pittard, Blasingame Burch Garrard & Ashley, Athens, GA, for Plaintiffs.

Amanda Naes Shelton, Anita Wallace Thomas, Matthew B. Lerner, Taylor Tapley Daly, Richard B. North, Jr., Nelson Mullins Riley & Scarborough, Lori G. Cohen, Ronald Merrell, II, Greenberg Traurig, Atlanta, GA, Deborah A. Moeller, Shook Hardy Bacon, Kansas City, MO, Eric W. Swanis, Philip M. Hymanson, Greenberg Traurig, Las Vegas, NV, Jane T. Davis, Nelson Mullins Riley & Scarborough, Charleston, SC, Marc E. Williams, Melissa Foster Bird, Nelson Mullins Riley & Scarborough, Huntington, WV, Marilyn Ann Moberg, Reed Smith, Los Angeles, CA, Michael A. Nicodema, Greenberg Traurig, Florham Park, NJ, Daniel I.A. Smulian, Greenberg Traurig, New York, NY, for Defendant.

MEMORANDUM OPINION AND ORDER

(Motion for a New Trial)

JOSEPH R. GOODWIN, District Judge.

Pending before the court is Defendant C.R. Bard, Inc.'s Motion for a New Trial [Docket 450]; Defendant C.R. Bard, Inc.'s Request for Ruling, or Alternatively for Hearing, on Motion for New Trial [Docket 479]; and Defendant C.R. Bard, Inc.'s Second Request for Ruling, or Alternatively for Hearing, on Motion for New Trial and Motion to Remit Punitive Damages Award and Amend Judgment [Docket 482]. For the reasons discussed below, I DENY the defendant's Motion for a New Trial [Docket 450], and as a result, the defendant's Requests for Ruling [Docket 479 & 482] are DENIED as moot.¹

Also before the court is Plaintiffs' Motion to Strike Extraneous Materials Submitted With Bard's Motion for a New Trial (“Motion to Strike”) [Docket 458]. For the reasons discussed below, the Motion to Strike is DENIED as moot.

I. Background

This case was the first jury trial within the seven MDLs assigned to me by the Judicial Panel on Multidistrict Litigation concerning the use of transvaginal surgical mesh

to treat pelvic organ prolapse (“POP”) and stress urinary incontinence

(“SUI”). In the seven MDLs, there are more than 70,000 cases currently pending, approximately 10,000 of which are in the C.R. Bard, Inc. (“Bard”) MDL, MDL 2187. This particular case concerns Donna Cisson, who was implanted with transvaginal surgical mesh —specifically, the Avaulta Plus Posterior Biosynthetic Support System (“Avaulta Plus”) manufactured by Bard to treat POP—in May 2009, and after receiving the implant, she experienced “significant mental and physical pain and suffering.” (Compl. [Docket 1] ¶ 10). On March 10, 2011, she and her husband (collectively “the plaintiffs”) filed suit against Bard for various causes of action, (id. ), and trial began on July 29, 2013.² After fourteen days of trial, the plaintiffs ultimately presented three distinct claims to the jury: design defect, failure to warn, and loss of consortium.

On August 15, 2013, the jury returned a verdict in favor of Ms. Cisson on her design defect and failure to warn claims.³ In so doing, the jury awarded Ms. Cisson $250,000 in compensatory damages, (Verdict Form [Docket 404] ¶ 4), as well as $1,750,000 in punitive damages, (Verdict Form [Docket 406] ). After the trial, I considered and denied Bard's renewed motion for judgment as a matter of law, finding that the plaintiffs' claims had sufficient evidentiary basis such that the jury's verdict was reasonable under Federal Rule of Civil Procedure 50. (Mem. Op. & Order [Docket 448] ). Accordingly, I entered judgment in favor of the plaintiffs. (J. Order [Docket 449] ).

In a final attempt to absolve itself of the jury's verdict, Bard has moved for a new trial pursuant to Federal Rule of Civil Procedure 59(a)(1). (Mot. for a New Trial [Docket 450] ). Anxious to submit its case to the Fourth Circuit Court of Appeals, Bard recently requested a ruling on this motion. (Req. for Ruling, or Alternatively for Hr'g, on Mot. for New Trial [Docket 479] ¶ 4; Second Req. for Ruling, or Alternatively for Hr'g, on Mot. for New Trial and Mot. to Remit Punitive Damages Award and Amend J. [Docket 482] ). My ruling is set forth below.

II. Legal Standard

Rule 59 allows a court to grant a new trial “for any reason for which a new trial has heretofore been granted in an action at law in federal court.” Fed.R.Civ.P. 59(a)(1)(A). The Fourth Circuit has set forth a three-prong standard to govern Rule 59 motions:

[I]t is the duty of the judge to set aside the verdict and grant a new trial, if he is of the opinion that (1) the verdict is against the clear weight of the evidence, or (2) is based upon evidence which is false, or (3) will result in a miscarriage of justice, even though there may be substantial evidence which would prevent the direction of a verdict.

Atlas Food Sys. & Servs., Inc. v. Crane Nat'l Vendors, Inc., 99 F.3d 587, 594 (4th Cir.1996) (internal citations and brackets omitted). When considering a motion for a new trial, the “crucial inquiry,” particularly when employing the third prong, is “whether an error occurred in the conduct of the trial that was so grievous as to have rendered the trial unfair.”

Bristol Steel & Iron Works v. Bethlehem Steel Corp., 41 F.3d 182, 186 (4th Cir.1994) (emphasis added).

The decision to grant or deny a new trial “is within the sound discretion of the trial court.” Cline v. Wal–Mart Stores, Inc., 144 F.3d 294, 301 (4th Cir.1998). Moreover, the discretion bestowed under Rule 59 “should be exercised sparingly.” United States v. Arrington, 757 F.2d 1484, 1486 (4th Cir.1985) ; see also United States v. Perea, 458 F.2d 535, 536 (10th Cir.1972) (“A motion for a new trial is generally not regarded with favor, and is granted only with great caution. ”) (emphasis added). I FIND the defendant has fallen far short of clearing this high bar, and I DENY its Rule 59 motion.

III. Discussion

Bard asserts four grounds for a new trial:

(1) The Court deprived Bard of a fair trial by excluding evidence of Bard's compliance with the FDA's 510(k) process and other applicable federal regulations; (2) [t]he Court deprived Bard of a fair trial by admitting the Material Safety Data Sheet [“MSDS”] into evidence and by other evidentiary rulings; (3) [t]he Court's causation rulings deprived Bard of a fair trial; and (4) [t]he Court deprived Bard of a fair trial by allowing Plaintiffs to assert that Bard should have performed pre-market human clinical testing without competent expert testimony to support this claim.

(Mot. for a New Trial [Docket 450], at 1–2). I have addressed each of these concerns in previous orders during the course of this MDL. (See Order re: C.R. Bard, Inc.'s Mot. for Clarification & Reconsid. (“Clarification Order”) [Docket 309], at 2–4 (excluding evidence of the 510(k) process); Mem. Op. & Order re: Parties' Mots. in Limine (“Order Mots. in Limine ”) [Docket 302], at 5–6 (finding that evidence about the MSDS is admissible); Mem. Op. & Order [Docket 448], at 14–19 (concluding that the plaintiffs established causation); Mem. Op. & Order re: Failure to Test [Docket 356], at 4–9 (explaining the relevance of Bard's failure to test)). As such, the plaintiffs contend that Bard is improperly using a Rule 59 motion to “relitigate” old evidentiary issues. (Pls.' Resp. in Opp. to Bard's Mot. for New Trial (“Resp.”) [Docket 461], at 1–2 (quoting In re Miles, 453 B.R. 449, 450 (Bankr.N.D.Ga.2011) )). The Supreme Court has stated that “alleged substantial errors in admission or rejection of evidence” may warrant a new trial. Montgomery Ward & Co. v. Duncan, 311 U.S. 243, 251, 61 S.Ct. 189, 85 L.Ed. 147 (1940). Thus, this court will entertain the evidentiary challenges raised in Bard's Rule 59 motion. To succeed on this theory, however, Bard must demonstrate that the alleged evidentiary errors were “substantial. ” Id. (emphasis added); see also Creekmore v. Maryview Hosp., 662 F.3d 686, 693 (4th Cir.2011) (holding that the court will not set aside a judgment on this basis “unless justice so requires or a party's substantial rights are affected”). As explained below, none of Bard's arguments—taken individually or together—convey the substantial error required to secure a new trial.

A. Exclusion of Bard's Compliance with the FDA's 510(k) Process and “Other Applicable Federal Regulations”

Prior to trial and over Bard's objection, this court excluded evidence of Bard's compliance with the FDA's 510(k) process in marketing the Avaulta Plus on the basis of Federal Rules of Evidence 402 and 403. (See Order Mots. in Limine [Docket 302], at 3).⁴ The court's rationale focused on the Supreme Court's decision in Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) :

Under United States Supreme Court precedent, the FDA 510(k) process does not go to whether the product is safe and effective. Medtronic, Inc. v. Lohr, 518 U.S. 470, 478–79 [116 S.Ct. 2240, 135 L.Ed.2d 700] (1996) ; see also Riegel v. Medtronic, Inc., 552 U.S. 312, 323 [128 S.Ct. 999, 169 L.Ed.2d 892] (2008). There is ample case law discussing Lohr and finding that (1) the 510(k) process does not go to whether the product is safe and effective and (2) the 510(k) process does not impose any requirements on its own. See, e.g., Martin v. Am. Med. Sys., Inc., 116 F.3d 102, 104 (4th Cir.1997) ; Bass v. Stryker Corp., 669 F.3d 501, 507 (5th Cir.2012) ; Brooks v. Howmedica, Inc., 273 F.3d 785, 794 (8th Cir.2001) ; Soufflas v. Zimmer, Inc., 474 F.Supp.2d 737, 747 n. 6 (E.D.Pa.2007) ; Nicoll v. I–Flow, LLC, No. 12–1593, 2013 WL 2477032, at *3 (E.D.La. June 7, 2013) ; Mack v. Stryker Corp., 893 F.Supp.2d 976, 985 (D.Minn.2012). Because the FDA 510(k) process does not go to whether the Avaulta

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