321 F. Supp. 3d 891
E.D. Wis.2018Background
- Plaintiffs sued under Wisconsin law for injuries from failed M-COR modular hip implants; DiSanto machined the femoral neck component under contract with MiPro.
- DiSanto moved to dismiss under the Biomaterials Access Assurance Act (BAAA), 21 U.S.C. § 1601 et seq., which shields biomaterials suppliers from liability for implant failures except in narrow circumstances.
- DiSanto submitted affidavits showing it was a contract manufacturer that machined titanium stock into femoral necks per MiPro specifications; Plaintiffs alleged DiSanto made independent design choices and violated ISO 13485-based specifications.
- The BAAA permits courts to decide such motions on pleadings plus affidavits and requires dismissal with prejudice if the supplier qualifies for immunity.
- The court analyzed whether the BAAA covers Section 510(k) devices (the M-COR) and whether DiSanto fits any statutory exceptions (manufacturer, seller, or failure to meet contractual requirements).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Does the BAAA apply to Section 510(k) devices? | BAAA should not protect suppliers of 510(k) devices because 510(k) lacks PMA's rigorous safety review. | BAAA text applies to any "implant" without distinguishing PMA vs. 510(k). | BAAA governs 510(k) implants; statute's plain language controls. |
| Is DiSanto a "biomaterials supplier" under the BAAA? | DiSanto acted as more than a mere supplier by incorporating design inputs. | DiSanto supplied/ma-chined a component part from titanium stock per contract and fits the statutory definition. | DiSanto is a biomaterials supplier despite any design inputs. |
| Do statutory exceptions apply (manufacturer/seller or failure to meet specs)? | Plaintiffs: DiSanto deviated from MiPro/ISO 13485 specs (material/process choices) and failed to validate design, causing failures. | DiSanto: not a manufacturer or seller; any design choices were within permissive specs and not specific contractual deviations; ISO provision cited applies to device designers not component contract manufacturers. | No exception applies; Plaintiffs proved only negligence-type allegations, not the specific contractual/specification breach required by BAAA. |
| Should discovery be allowed under 21 U.S.C. § 1605(c)(1)(B)(i)? | Plaintiffs requested targeted discovery to prove specification deviations. | DiSanto argued pleadings and affidavits suffice; no specific deviation alleged that discovery would cure. | Denied: Plaintiffs failed to identify a plausible specification deviation that additional discovery could establish. |
Key Cases Cited
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (pleading standard requires plausible claim)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (discusses differences between PMA and 510(k) processes)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (PMA-based preemption analysis)
- Lamie v. United States Trustee, 540 U.S. 526 (plain-text statutory interpretation)
- Engine Mfrs. Ass'n v. S. Coast Air Quality Mgmt. Dist., 541 U.S. 246 (courts enforce plain statutory text)
- Kubiak v. City of Chicago, 810 F.3d 476 (Seventh Circuit on pleading/ inference standard)