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Daley v. Smith & Nephew Inc.

United States District Court, E.D. Wisconsin

June 21, 2018



          J. P. Stadtmueller U.S. District Judge

         Plaintiffs bring this action under the Court's diversity jurisdiction to recover for injuries sustained as a result of failed hip replacement implants. All of their claims are premised on Wisconsin statute or common law. (Docket #36). Presently before the Court is a motion to dismiss by Defendant DiSanto Technology Inc. (“DiSanto”). (Docket #48). DiSanto machined the femoral neck component of Plaintiffs' hip implants pursuant to a contract with Defendant MiPro U.S. Inc. (“MiPro”). Those hip replacement implants are known as the M-COR Modular Hip System (the “M-COR”). DiSanto argues that, as a mere supplier of a component part used in the M-COR, the claims against it are preempted and barred by the Biomaterials Access Assurance Act (“BAAA”), 21 U.S.C. § 1601 et seq., which insulates biomaterials suppliers from liability in medical device failure litigation, subject to a few narrow exceptions. DiSanto's motion to dismiss pursuant to the BAAA is fully briefed and, for the reasons stated below, it will be granted.

         1. LEGAL STANDARD

         Federal Rule of Civil Procedure 12(b) normally governs motions to dismiss a complaint. Rule 12(b)(6) allows a party to move to dismiss a complaint on the ground that it fails to state a viable claim for relief. Fed.R.Civ.P. 12(b)(6). To state a claim, a complaint must provide “a short and plain statement of the claim showing that the pleader is entitled to relief.” Fed.R.Civ.P. 8(a)(2). In other words, the complaint must give “fair notice of what the. . .claim is and the grounds upon which it rests.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007). The allegations must “plausibly suggest that the plaintiff has a right to relief, raising that possibility above a speculative level[.]” Kubiak v. City of Chicago, 810 F.3d 476, 480 (7th Cir. 2016) (citation omitted). In reviewing the complaint, the Court is required to “accept as true all of the well-pleaded facts in the complaint and draw all reasonable inferences in favor of the plaintiff.” Id. at 480-81.

         For motions to dismiss brought pursuant to the BAAA, Congress has provided special protocols. See 21 U.S.C. § 1603(a)(2); Mattern v. Biomet, Inc., Civ. No. 12-4931 (ES), 2013 WL 1314695, at *1 (D.N.J. Mar. 28, 2013). The Act applies to “any civil action brought by a claimant, whether in a Federal or State court, on the basis of any legal theory, for harm allegedly caused, directly or indirectly, by an implant.” 21 U.S.C. § 1603(b)(1). It provides that “[a] defendant may, at any time during which a motion to dismiss may be filed under applicable law, move to dismiss an action against it on the grounds that the defendant is a biomaterials supplier, ” and if the defendant: (1) is not a manufacturer of the failed implant; (2) is not a seller of the failed implant; and (3) did not “furnis[h] raw materials or component parts for the implant that failed to meet applicable contractual requirements or specifications.” Id. § 1605(a)(1)-(3); see also Whaley v. Morgan Advanced Ceramics, Ltd., No. 07-cv-00912, 2008 WL 901523, at *2-3 (D. Colo. Mar. 31, 2008).

         When addressing a BAAA motion to dismiss, the Court must rule solely on the basis of the pleadings and any affidavits submitted under Sections 1605(c)(2)(A) and (B). 21 U.S.C. § 1605(c)(3). The submission of affidavits concerning the supplier's liability does not automatically convert a BAAA motion to dismiss into a motion for summary judgment, as would typically occur in any other civil litigation. See Fed. R. Civ. P. 12(d); Marshall v. Zimmer, No. 99-093-E, 1999 WL 34996711, at *3 (S.D. Cal. Nov. 4, 1999) (The Act “is quite clear that the suppliers can provide affidavits to demonstrate that they are not subject to litigation for their minimal contribution to a medical device ultimately designed, made, and sold by the manufacturer.”).[1] Thus, the Act allows trial courts to dismiss biomaterials suppliers from lawsuits prior to discovery. 21 U.S.C. § 1605(c)(2)(A)-(B). Further, under Section 1605(e), dismissal of a supplier must be made with prejudice. Id. § 1605(e).[2]

         2. ANALYSIS

         As will be explained below, the Court finds that DiSanto is protected as a biomaterials supplier under the BAAA. Consequently, the claims against it must be dismissed. First, however, the Court must address Plaintiffs' contention that the BAAA does not govern their claims at all.

         2.1 The BAAA Governs Claims Involving Section 510(k) Devices

         Plaintiffs first argue that the BAAA does not preempt their claims against DiSanto because the Act does not protect the types of devices at issue here. Plaintiffs distinguish between devices that have received pre-market approval (“PMA”) from the Food and Drug Administration and devices that have been authorized for sale under the “Section 510(k)” procedure. The M-COR falls within the latter category. Plaintiffs believe that the BAAA's protection extends only to claims involving PMA devices because only the rigorous PMA process results in meaningful assurances of device safety. No. such distinction can be found in the statutory text, and Plaintiffs cannot engraft ambiguity into the statute where none exists.

         Plaintiffs' premise is correct: the PMA process is far more meticulous as a safety assessment than the Section 510(k) process. Medtronic v. Lohr, 518 U.S. 470, 477 (1996). During the PMA process, “[m]anufacturers must submit detailed information regarding the safety and efficacy of their devices, which the FDA then reviews, spending an average of 1, 200 hours on each submission.” Id. Yet, not all devices subject to the PMA process actually undergo it. See Id. In many instances, devices can be released to the public without undergoing PMA review if they are “substantially equivalent” to approved devices that predate the creation of the PMA process in the Medical Device Amendments Act of 1976 (the “MDA”). See 21 U.S.C. § 360e(b)(1)(B).

         Devices that fall under this exception to the PMA rule can get to market if they comply with the less onerous appraisal set forth in 21 U.S.C. § 360(k). Lohr, 518 U.S. at 478. This is known as the “Section 510(k)” process, after the number of the section in the original act. Id. For a Section 510(k) examination, the manufacturer must submit a premarket notification showing that its device is substantially equivalent to a preexisting device. Id. If this is shown, no further regulatory analysis is done, at least until the PMA process is initiated for the pre-existing device to which the new device is substantially equivalent. Id. Section 510(k) review is minimal, requiring an average of only 20 hours' work. Id. at 479.

         While Plaintiffs' premise is correct, their conclusion concerning the reach of the BAAA is not. The Act draws no distinction between PMA and Section 510(k) devices. By its text, the BAAA applies to “any civil action brought by a claimant, whether in a Federal or State court, on the basis of any legal theory, for harm allegedly caused, directly or indirectly, by an implant.” Id. § 1603(b)(1). An “implant” includes “a medical device” intended by its manufacturer to be surgically placed in the human body for at least thirty days. Id. § 1602(5)(A)(i). “Medical device” is, in turn, defined by reference to 21 U.S.C. § 321(h) and includes implants that are intended to affect the structure or function of the human body. See 21 U.S.C. § 321(h). Under these broad definitions, the M-COR is undoubtedly an “implant, ” and Plaintiffs do not argue otherwise.

         Though the statute does not distinguish between the types of review imposed on implants, Plaintiffs nevertheless maintain that Congress could not have intended to preempt claims involving Section 510(k) devices because those devices do not have the same federal safety oversight that PMA devices do. Plaintiffs cite Congress' introductory findings in the BAAA, which include that “under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) manufacturers of medical devices are required to demonstrate that the medical devices are safe and effective, including demonstrating that the products are properly designed and have adequate warnings or instructions.” Id. ยง 1601(6). According to Plaintiffs, Congress was referring only to the PMA process here, as the Section 510(k) process does not require a determination that a device is safe and effective. (Docket #54 at 8-9). Thus, in Plaintiffs' ...

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