Since 1998, the Biomaterials Access Assurance Act (“BAAA”), 21 U.S.C. §1601, et seq., has protected certain manufacturers of medical implant components from liability in personal injury suits. Though significant in some cases, the BAAA has played a minor role in medical device litigation generally. This February, however, the Ninth Circuit Court of Appeals expansively construed the BAAA’s key term (“biomaterials supplier”) and immunized the manufacturer of a near-complete hip implant “component.” See Connell v. Lima Corporate, 988 F.3d 1089 (9th Cir. 2021). In doing so, the Ninth Circuit enshrined a controversial desire of Congress: that plaintiffs should center litigation on end-product manufacturers.

This article examines the significance of Lima and the BAAA to medical device litigation and to indemnity and contribution arrangements in the medical device industry. The authors are indebted to and continue the efforts of two helpful DRI predecessors: P.J. Cosgrove & Joshua A. Klarfeld, A Legislative Response to Shotgun Litigation, For The Defense 54 (Feb. 2014) “explor[ing] the bases of raising motions under the BAAA” and early caselaw), and James F. Murdica & Jenya Moshkovich, An Underused Tool Against Forum Shopping, For The Defense 20 (Sept. 2014) (providing overview of BAAA-based fraudulent joinder caselaw).