By Brian Craig, J.D.
In litigation involving a hip replacement implant system, the federal district court in Wisconsin has held that the Biomaterials Access Assurance Act (BAAA) (21 U.S.C. § 1601 et seq.) insulates a femoral neck component supplier as a biomaterials supplier from liability. In dismissing DiSanto Technology Inc (DiSanto), which transformed raw material into a component part of the hip replacement system, the court recognized that the BAAA broadly shields component suppliers from liability in implant cases (Daley v. Smith & Nephew Inc., June 21, 2018, Stadtmueller, J.).
Claims. Recipients of hip replacement implants filed an action against medical device manufactures alleging injuries. The hip replacement implants are known as the M-COR® Modular Hip System (M-COR). All of the claims are based on Wisconsin statute or common law. DiSanto machined the femoral neck component of the hip implants pursuant to a contract with MiPro U.S. Inc. DiSanto filed a motion to dismiss claiming that as a mere supplier of a component part used in the M-COR, the claims against it are preempted and barred by the BAAA.
Scope of the BAAA. The court first held that the BAAA governs claims involving devices governed by Section 510(k) of the federal Food, Drugs and Cosmetic Act (FDC Act) (21 U.S.C. §301 et seq), including the M-COR. Devices that fall under the exception to the premarket approval (PMA) rule from the FDA can get to market if they comply with the less onerous appraisal set forth in 21 U.S.C. § 360(k).
Biomaterials supplier. The court then turned to whether DiSanto, which machined the femoral neck component, is a biomaterials supplier protected by the BAAA. To prevail on a motion to dismiss under the BAAA, a company must prove: (1) it is a "biomaterials supplier;" (2) it is not a manufacturer of the failed implant; (3) it is not a seller of the failed implant; and (4) it did not provide raw materials or component parts that failed to meet applicable contractual requirements or specifications.
The court found that the femoral neck component supplier is a biomaterials supplier under the BAAA, as a biomaterials supplier is an entity that "directly or indirectly supplies a component part or raw material for use in the manufacture of an implant." The supplier used titanium as the base material to machine the femoral neck of the M-COR, which eventually became a component of the implant. Titanium has many uses other than medical device manufacturing. The supplier thus transformed raw material into a component part of the M-COR.
Exceptions. The court also held that none of the exceptions under the BAAA apply. The femoral neck component supplier is not a manufacturer or supplier of the failed implant. Furthermore, the femoral neck component supplier did not provide raw materials or component parts that failed to meet the applicable contractual requirements or specifications. The BAAA does not remove component suppliers from its protection even when they make design decisions that allegedly contributed to harm the patient. The court recognized that the purpose of the BAAA is to broadly shield component suppliers from liability in implant cases. The court observed it would be absurd for the "design deviation" exception to the BAAA to incorporate the functional equivalent of negligence liability. Otherwise, all state law negligence claims could survive the BAAA’s preemption clause. As such, the court dismissed the femoral neck component supplier as a biomaterials supplier protected under the BAAA.
The case is No. 17-CV-1315-JPS.
Attorneys: George E. McLaughlin (Warshauer McLaughlin Law Group PC) for Guy D. Daley and Starlynn Daley. J Ryan Maloney (Peterson, Johnson, & Murray, SC) for Smith & Nephew Inc. Tomislav Z. Kuzmanovic (Hinshaw & Culbertson LLP) for Maxx Health Inc. and Maxx Orthopedics Inc.
Companies: Smith & Nephew Inc.; Maxx Health Inc.; Maxx Orthopedics Inc.; MiPro U.S. Inc.; DiSanto Technology Inc.
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