§1604 Liability of Biomaterials Suppliers

Summary

Biomaterials suppliers are not automatically responsible if an implant hurts someone. They can only be held liable if they are treated as the implant’s manufacturer, treated as the seller, or if they supplied raw materials or parts that did not meet the contract or required specifications. A supplier can be treated as the manufacturer only if it registered with the FDA and listed the device under the rules in section 360 and 360(j), or if the FDA issues a declaration saying the supplier should have registered or listed but did not. A court can also treat a related company as the manufacturer if, based on sworn statements in a motion to dismiss, the company that met those requirements cannot pay a likely judgment. For seller liability, the supplier must have held title and sold the implant after the manufacturer’s first sale, or arranged transfer under contract after that first sale; a related-company rule like the manufacturer rule can apply. If someone asks the FDA for a declaration, the FDA must give notice, allow an informal hearing, docket the petition right away, and issue a final decision within 120 days. The statute of limitations is paused while the petition is pending, and courts must stay proceedings against that defendant until the FDA decides. A claimant can also win if they prove it is more likely than not that the supplier’s materials or parts did not match the contract or accepted specifications (including those published, provided to the buyer, in a master file, or in FDA premarket submissions under sections 360, 360c, 360e, or 360j) and that this failure caused the harm.