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In re Smith & Nephew Birmingham HIP Resurfacing (BHR) HIP Implant Products Liability Litigation

United States District Court, D. Maryland

November 26, 2019





         Pending before the court is Smith & Nephew, Inc.'s ("Smith & Nephew") motion to amend and certify for interlocutory review the court's order addressing dismissal of claims in the THA track. The motion has been fully briefed and oral argument was held on October 23, 2019. For the reasons set forth below, the motion will be denied.


         Smith & Nephew seeks to appeal the court's decision granting in part and denying in part Smith & Nephew's motion to dismiss state law claims in two of the plaintiffs' Master Amended Consolidated Complaints. These claims concerned two medical device "hybrid" systems: first, the use of Smith & Nephew's Birmingham Hip Resurfacing ("BHR") cup with Smith & Nephew's cobalt-chrome modular femoral heads as part of total hip arthroplasties ("THA") (referred to as the "BHR-THA" system); and second, the use of Smith & Nephew's R3 metal liner in THA's with a metal modular femoral head and/or with the R3 acetabular shell (referred to as the "R3-THA" system)

         Smith & Nephew argued in its motion to dismiss that these claims were preempted by the Medical Device Amendments of 1976 (the "MDA"). The MDA contains an express preemption provision, which reads "no State .. . may establish or continue in effect with respect to a device . .. any requirement which is different from, or in addition to," any federal requirement that relates either "to the safety or effectiveness of the device" or "to any other matter" included in a federal requirement applicable to the device. 21 U.S.C. § 360k(a). The express preemption provision applies only to those devices approved through a rigorous pre-market approval ("PMA") process. The hybrid systems at issue, though, contained both PMA-approved components and components approved through § 510(k). Section 510(k) is a more lenient approval process, and § 510(k)-approved devices are not subject to the MDA's express preemption provision. The question, therefore, was whether state law claims directed at the hybrid systems as a whole would also be subject to the § 360k(a) preemption analysis.[1]

         After considering the MDA, Congressional intent, and case law, the court concluded, in part, that "§ 360k(a) preempts non-parallel state law claims that target premarket-approved components, but it does not govern state-law claims that target a hybrid system's § 510(k) components or the system as a whole." Mem. at 15, ECF 1714. Accordingly, the court denied Smith & Nephew's motion to dismiss certain of plaintiffs' state law claims targeting the hybrid system as a whole. Smith & Nephew seeks to appeal this decision.


         The Interlocutory Appeals Act of 1958, 28 U.S.C. § 1292(b), provides the district court with discretion to certify an interlocutory appeal of a decision not otherwise appealable. The certification of an interlocutory appeal under § 1292(b) is appropriate where a district court issues an order, and "(1) the order to be appealed involves a controlling question of law; (2) there is substantial ground for difference of opinion on that question of law; and (3) an immediate appeal from the order may materially advance the ultimate termination of the litigation." In re Microsoft Corp. Antitrust Litig, 274 F.Supp.2d 741, 741 (D. Md. 2003) (citing 28 U.S.C. § 1292(b)).[2] But interlocutory appeal under § 1292(b) is the exception, not the rule. Accordingly, it "should be used sparingly" and "its requirements must be strictly construed." Myles v. Laffitte, 881 F.2d 125, 127 (4th Cir. 1989). "Interlocutory appeal should not be sought to provide early review of difficult rulings in hard cases." Lynn v. Monarch Recovery Mgmt., Inc., 953 F.Supp.2d 612, 623 (D. Md. 2013) (internal quotations and citation omitted).


         Controlling question of law:

         A question of law for the purposes of § 1292(b) is "a question of the meaning of a statutory or constitutional provision, regulation, or common law doctrine." Id. (citation omitted). Therefore, § 1292(b) review may be appropriate where "the court of appeals can rule on a pure, controlling question of law" but is inappropriate where the question is one of "fact or [a] matter for the discretion of the trial court." United States ex rel. Michaels v. Agape Senior Comm., Inc., 848 F.3d 330, 341 (4th Cir. 2017) (quoting McFarlin v. Conseco Sen's., LLC, 381 F.3d 1251, 1258-59 (11th Cir. 2004)). Section 1292(b) was not intended for questions that would require the court of appeals "to delve beyond the surface of the record in order to determine the facts." McFarlin, 381 F.3d at 1259. "[Controlling means serious to the conduct of the litigation, either practically or legally." Johnson v. Burken, 930 F.2d 1202, 1206 (7th Cir. 1991) (internal quotation marks omitted) (quoting Katz v. Carte Blanche Corp., 496 F.2d 747, 755 (3d Cir. 1974)).

         Smith & Nephew presents the controlling question of law as "Whether Plaintiffs' claims j challenging the interaction of PMA-approved BHR components with non-PMA-approved components as part of a 'hybrid' THA or R3 system are exempt from express preemption analysis under 21 U.S.C. § 360k(a)." Smith & Nephew's Memo, in Supp. of Mot. to Amend and Certify for Interlocutory Review at 7, ECF 1722-1. As an initial matter, the court is not convinced this is a pure question of law. For example, the Third Circuit, in Shuker v. Smith & Nephew, looked at the specific nature of the claims made by the plaintiffs, as well as representations made at oral argument regarding how the hybrid systems were alleged to be defective, to determine whether "the heart of each of [the Shukers'] claims challenged the safety and effectiveness of the [PMA-approved] ¶ 3 metal liner." Shuker v. Smith & Nephew, PLC, 885 F.3d 760, 774-75 (3d Cir. 2018) (internal quotation marks omitted) (ruling on a motion for summary judgment). Likewise, in its amicus brief in Shuker, the Food and Drug Administration ("FDA") also emphasized the fact-specific nature of § 360k(a), stating that "§ 360k(a) requires a court to parse a plaintiffs claims to determine whether the state-law requirements that underlie them are indeed directed at the premarket-approved component." FDA, Amicus Br. at 10, Shuker, 885 F.3d 760. Therefore, the scope of § 360k(a) as to the plaintiffs' claims requires fact-specific inquiries.

         Further, even assuming this is a pure question of law, it is not controlling. Even if the Fourth Circuit were to hold that claims targeting the hybrid system are subject to § 360k(a) analysis, a number of the plaintiffs' claims targeting the hybrid systems, including the claims for negligent failure to warn (as to the FDA), negligent misrepresentation, fraud, fraudulent concealment, unfair & deceptive trade practice, and off-label promotion, would still go forward under the court's analysis.[3] The court found that these claims were not preempted as to the PMA-approved components because the state law claims ...

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