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McNeil-Williams v. Depuy Orthopaedics, Inc.

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

May 20, 2019

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.



         This matter is before the court on defendants' motion for summary judgment (DE 28).[1] A l s o 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.


         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.[2] 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”).[3]

         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.


         As pertinent to the instant motion, the undisputed facts may be summarized as follows.[4] 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 Unidsputed 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).


         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 (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 (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 (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. 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; see United States v. Diebold, Inc., 369 U.S. ...

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