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Wilson v. Ethicon, Inc.

United States District Court, E.D. Pennsylvania

December 16, 2019

ETHICON INC., et at. Defendants




         Plaintiff Cherie Wilson filed this product liability and negligence action claiming injuries allegedly caused by defects in a TVT pelvic mesh implant device that was either designed, manufactured, sold, or distributed by Defendants Ethicon, Inc., Johnson & Johnson, Secant Medical, Inc., and/or Secant Medical, LLC (the "Secant Defendants"). This action was filed as part of the Pelvic Mesh Litigation in the Philadelphia Court of Common Pleas and removed to federal court. The Secant Defendants have moved to dismiss the claims asserted against them pursuant to the Biomedical Access Assurance Act (the "BAAA" or "Act"), 21 U.S.C. § 1601-1606, which provides immunity for certain biomaterials suppliers. The issues raised by the parties have been fully briefed and are ripe for disposition. For the reasons set forth, the Secant Defendants' motion is granted and the claims against the Secant Defendants are dismissed with prejudice.


         The procedural and factual histories are known to the parties. Therefore, only the facts pertinent to the underlying motion will be discussed. These facts are taken primarily from the master long form complaint filed in the initial state court proceeding and the parties' briefs on the underlying motion. To the extent that any facts are disputed, such disputes will be noted and construed in Plaintiffs favor. As noted, the Secant Defendants seek dismissal of Plaintiff s claims pursuant to the immunity provisions of the BAAA.


         Generally, for a complaint to survive a motion to dismiss, it "must contain sufficient factual matter, accepted as true, to 'state a claim to relief that is plausible on its face.'" Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (citing Bell Atlantic Corp. v. Twombly, 550 U.S. 554, 570 (2007)). In determining the sufficiency of a complaint, the court must accept all well-pleaded factual allegations in the complaint as true and draw all inferences in favor of the non-moving party. Phillips v. Cnty. of Allegheny, 515 F.3d 224, 231 (3d Cir. 2008). However, "the tenet that a court must accept as true all of the allegations contained in a complaint is inapplicable to legal conclusions. Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice." Iqbal, 556 U.S. at 678.

         Under the BAAA, however, Congress has provided a modified standard for the dismissal of a complaint. See 21 U.S.C. §§ 1601-1606. 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." Id. § 1603(b)(1). It further 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" if the defendant: (1) is not "liable as a manufacturer;" (2) is not "liable as a seller;" and/or (3) is not "liable for furnishing raw materials or component parts for the implant that failed to meet applicable contractual requirements or specifications." Id. § 1605(a)(1)-(3).

         Under the BAAA's motion to dismiss procedures, when ruling on a motion to dismiss, the court must rely solely on the pleadings and any affidavits submitted under §§ 1605(c)(2)(A) and (B). See 21 U.S.C. § 1605(c)(3). Thus, the Act allows courts to dismiss biomaterials suppliers from lawsuits prior to discovery. Id. at § 1605(c)(2)(A)-(B). Further, under § 1605(e), dismissal must be with prejudice.


         In 1998, Congress enacted the BAAA with the aim of assuring "the continued supply of materials for lifesaving medical devices" through provisions insulating the suppliers of raw materials or component parts of medical devices from litigation. 21 U.S.C. § 1601 et seq. The BAAA protects parties who supply either raw materials or component parts for medical implants ("biomaterials suppliers") from the expenses of implant failure litigation by providing "expeditious procedures to dispose of unwarranted suits against the suppliers." 21 U.S.C. § 1601(15)(B). As noted above, one such procedure is a motion to dismiss, which a biomaterials supplier may file under 21 U.S.C. § 1605(a).

         To prevail on a BAAA motion to dismiss, the Secant Defendants must demonstrate that they: (1) are "biomaterials supplier[s];" (2) are not manufacturers of the failed implant; (3) are not sellers of the failed implant; and (4) did not provide raw materials or component parts that failed to meet applicable contractual requirements or specifications. Id. at § 1605(a)(1)-(3). Under these motion to dismiss procedures, the Secant Defendants may meet this burden through the submission of affidavits. Id. at § 1605(c)(2). This Court must grant the motion with prejudice, unless: (1) Plaintiff submits a valid affidavit demonstrating that the Secant Defendants are not biomaterials suppliers; (2) the Court determines, based solely on the pleadings and the parties' affidavits, that one of the three limited exceptions to the BAAA's general rue of immunity may apply; or (3) Plaintiff has not named the manufacturer as a party. Id. at § 1605(c)(3). Notably, Plaintiff has not submitted an affidavit but instead argues only that her pleading raises a question as to whether the Secant Defendants are biomaterials suppliers. The requirements noted above will be discussed separately.

         The Secant Defendants Are Biomaterials Suppliers

         The BAAA defines a "biomaterials supplier" as "an entity that directly or indirectly supplies a component part or raw material for use in the manufacture of an implant." 21 U.S.C. § 1602(1)(A). An "implant" is "a medical device that is intended by the manufacturer of the device to be placed into a surgically or naturally formed or existing cavity of the body for a period of at least 30 days." Id. at ยง 1602(5)(A)(i). A "component part" is "a manufactured piece of an implant," including a piece that: "(i) has significant non-implant applications; and (ii) alone, has no implant value or purpose, but ...

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