McNeil-Williams v. DePuy Orthopaedics, Inc.

• Decision Date: 28 May 2019
• Docket Number: No. 5:18-CV-220-FL,5:18-CV-220-FL
• Citation: 384 F.Supp.3d 570
• Parties: Annie MCNEIL-WILLIAMS, Plaintiff, v. DEPUY ORTHOPAEDICS, INC. n/k/a Medical Device Business Services, Inc. ; DePuy Synthes Products, Inc. ; Johnson & Johnson; Johnson & Johnson Services, Inc.; Johnson & Johnson Consumer Companies, Inc. n/k/a Johnson & Johnson Consumer, Inc.; Doe Defendants 1-100, Defendants.
• Court: U.S. District Court — Eastern District of North Carolina

384 F.Supp.3d 570

Annie MCNEIL-WILLIAMS, Plaintiff,

v.DEPUY ORTHOPAEDICS, INC. n/k/a Medical Device Business Services, Inc. ; DePuy Synthes Products, Inc. ; Johnson & Johnson; Johnson & Johnson Services, Inc.; Johnson & Johnson Consumer Companies, Inc. n/k/a Johnson & Johnson Consumer, Inc.; Doe Defendants 1-100, Defendants.

No. 5:18-CV-220-FL

United States District Court, E.D. North Carolina, Western Division.

Signed May 28, 2019

Filed May 29, 2019

Lawrence Wooden, Wooden Bowers, PLLC, 301 McCullough Drive, Suite 400, Charlotte, NC 28262, 704-326-2291, Fax: 704-973-9380, Email: lawrence.wooden@wobolaw.com, Margaret E. Cordner, Marc J. Bern & Partners LLP, 60 E. 42ns Street, Suite 950, New York, NY 10165, 212-702-5000, Fax: 212-818-0164, Email: mcordner@bernllp.com, LEAD ATTORNEY, ATTORNEY TO BE NOTICED, Katherine M. Kliebert, Kliebert Law, PLLC, 200 Providence Road, Suite 206, Charlotte, NC 28207, 704-940-5581, Fax: 704-940-5585, Email: kate@kliebertlaw.com, for Plaintiff.

Dixie Thomas Wells, Ellis & Winters LLP, Post Office Box 2752, Zip Code 27402, 300 N. Greene Street, Suite 800, Greensboro, NC 27401, 336-217-4193, Fax: 336-217-4198, Email: dixie.wells@elliswinters.com, ATTORNEY TO BE NOTICED, for Defendants.

AMENDED ORDER¹

LOUISE W. FLANAGAN, United States District Judge

This matter is before the court on defendants' motion for summary judgment (DE 28).² Also before the court are plaintiff's motion to vacate order staying discovery (DE 27) and motion for discovery (DE 43). These motions have been briefed fully. In this posture, the issues raised are ripe for ruling. For the following reasons, defendants' motion is granted and plaintiff's motions are denied.

STATEMENT OF THE CASE

Plaintiff commenced this products liability action in Harnett County Superior Court, on April 13, 2018, arising out of injuries she allegedly suffered as a result of insertion of a defective knee implant device (the "Product"). Plaintiff allegedly experienced severe pain and discomfort following the insertion of the Product and underwent a revision surgery due to the failure of the Product.

Plaintiff asserts negligence claims against defendants on the basis that they failed to exercise reasonable care in the design, research, manufacture, marketing, testing, advertisement, supply, promotion, packaging, sale, and distribution of the Product. She also asserts defendants failed to exercise due care in the labeling of the Product and failed to issue to consumers and healthcare providers adequate warnings of the risk of serious bodily injury resulting from its use.³ Plaintiff seeks compensatory and punitive damages, as well as lost wages, disgorgement of profits, restitution, attorneys' fees, interest, and costs.

Defendants removed the case on May 18, 2018, and answered on May 25, 2018. On August 31, 2018, following the parties' submission of individual reports and discovery plans pursuant to Federal Rule of Civil Procedure 26(f), and following a telephonic scheduling conference before a magistrate judge, the court entered case management order allowing defendants to file a summary judgment motion on the ground that all claims are preempted by federal law, and staying discovery pending entry of an order disposing of the motion.

On October 15, 2018, plaintiff filed the instant motion to vacate the court's August 31, 2018, order staying discovery. That same date, defendants filed the instant motion for summary judgment, relying upon a memorandum in support, statement of material facts, and a declaration of Kathy J. Brocato ("Brocato"), which incorporates and describes business records maintained by defendant DePuy Orthopaedics, Inc. ("DePuy"), including medical records of the Product that is the subject of the instant dispute, and the history of regulation and pre-market approval of the Product by the United States Food and Drug Administration ("FDA").⁴

Plaintiff filed the instant motion for discovery, as corrected, on December 3, 2018, relying upon a memorandum of law, which is identical in substance to her memorandum in opposition to summary judgment, filed separately on November 19, 2018. In support thereof, plaintiff relies upon a declaration by counsel for plaintiff, Margaret E. Cordner ("Cordner"), as well as proposed interrogatories and requests for production of documents. Defendants responded in opposition to the motion for discovery and replied in support of summary judgment.

On March 15, 2019, the court directed the parties to submit supplemental briefing, in light of the decision by the United States Court of Appeals for the Fourth Circuit in Burrell v. Bayer Corp., 918 F.3d 372 (4th Cir. 2019). The parties completed supplemental briefing April 8, 2019.

STATEMENT OF UNDISPUTED FACTS

As pertinent to the instant motion, the undisputed facts may be summarized as follows.⁵ In February 2000, defendant DePuy secured FDA approval of the Product, following defendant DePuy's submission to FDA of a PreMarket Approval Application. (Defs' Stmt. of Undisputed Material Facts ¶ 1; Brocato Decl. ¶¶ 18, 28). Following approval, defendant DePuy submitted to FDA several supplements to the Product, in February and May 2000, July 2007, and February and June 2009. (Defs' Stmt. of Undisputed Material Facts ¶ 2; Brocato Decl., ¶¶ 28-37). On or about April 25, 2013, plaintiff underwent total right knee replacement surgery, during which the Product was implanted. (Defs' Stmt. of Undisputed Material Facts ¶ 3; Brocato Decl., ¶9).

COURT'S DISCUSSION

A. Standard of Review

Summary judgment is appropriate where "the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(a). The party seeking summary judgment "bears the initial responsibility of informing the district court of the basis for its motion, and identifying those portions of [the record] which it believes demonstrate the absence of a genuine issue of material fact." Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). Once the moving party has met its burden, the non-moving party must then "come forward with specific facts showing that there is a genuine issue for trial." Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 586–87, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986) (internal quotation omitted).

Only disputes between the parties over facts that might affect the outcome of the case properly preclude entry of summary judgment. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247–48, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986) (holding that a factual dispute is "material" only if it might affect the outcome of the suit and "genuine" only if there is sufficient evidence for a reasonable jury to return a verdict for the non-moving party). "[A]t the summary judgment stage the [court's] function is not [itself] to weigh the evidence and determine the truth of the matter but to determine whether there is a genuine issue for trial." Id. at 249, 106 S.Ct. 2505. In determining whether there is a genuine issue for trial, "evidence of the non-movant is to be believed, and all justifiable inferences are to be drawn in [non-movant's] favor." Id. at 255, 106 S.Ct. 2505 ; see United States v. Diebold, Inc., 369 U.S. 654, 655, 82 S.Ct. 993, 8 L.Ed.2d 176 (1962) ("On summary judgment the inferences to be drawn from the underlying facts contained in [affidavits, attached exhibits, and depositions] must be viewed in the light most favorable to the party opposing the motion.").

Nevertheless, "permissible inferences must still be within the range of reasonable probability, ... and it is the duty of the court to withdraw the case from the [factfinder] when the necessary inference is so tenuous that it rests merely upon speculation and conjecture." Lovelace v. Sherwin–Williams Co., 681 F.2d 230, 241 (4th Cir. 1982) (quotations omitted). Thus, judgment as a matter of law is warranted where "the verdict in favor of the non-moving party would necessarily be based on speculation and conjecture." Myrick v. Prime Ins. Syndicate, Inc., 395 F.3d 485, 489 (4th Cir. 2005). By contrast, when "the evidence as a whole is susceptible of more than one reasonable inference, a [triable] issue is created," and judgment as a matter of law should be denied. Id. at 489–90.

B. Analysis

Defendants seek summary judgment on the basis that all of plaintiff's claims are preempted by federal law, where it is undisputed that the Product was approved by the FDA. To address the issue raised, the court first sets forth background on preemption law in the context of FDA-approved devices, and then applies that law to the claims plaintiff asserts in this case. Finally, the court addresses plaintiff's motions for discovery.

1. Preemption

The Medical Device Amendments of 1976 (the "MDA") to the Food, Drug, and Cosmetic Act "provides a rigorous, comprehensive, and exclusive framework that precludes state law tort claims that seek to impose different or higher standards upon federally approved devices." Walker v. Medtronic, Inc., 670 F.3d 569, 578 (4th Cir. 2012). Federally approved devices, for purposes of the instant case, include implantable medical devices that receive "premarket approval" by the FDA. Id. at 547 & 577.

"The premarket approval process includes review of the device's proposed labeling." Riegel v. Medtronic, Inc., 552 U.S. 312, 318, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). "Once a device has received premarket approval, the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness." Id. at 319, 128 S.Ct. 999. "If the applicant wishes to make such a change, it must submit, and the FDA must approve, an application for supplemental premarket approval, to be evaluated under largely the same criteria as an initial application." Id. "After premarket approval, the devices are subject to...