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We’ve written several times (here, for example) about the Biomaterials Access Assurance Act (BAAA), 21 U.S.C. section 1604 et seq., and how it issues a get-out-of-litigation-free card to suppliers of raw materials and components. Today’s case, Connell v. Lima Corp. et al., 2019 WL 403855 (D. Idaho Jan. 30, 2019), supplies another illustration of the BAAA’s power. The plaintiffs sued for injuries after a hip prosthesis fractured. The defendants initially included the manufacturer and a supplier of component parts. The plaintiffs settled with the manufacturer and then directed their fire at the supplier. Big mistake. The remaining defendant moved for summary judgment, arguing that because all it had done was supply the stem and neck parts of the manufacturer’s hip system, all claims against it were preempted by the BAAA.

The plaintiff attempted to evade this rather clear preemption by recharacterizing the parts supplier as the actual manufacturer, and the (now-settled-out) manufacturer as a mere distributor. But, as John Adams said, facts are stubborn things. The actual, settled-out manufacturer had submitted the 510(k) application to the FDA, listing itself as the manufacturer of the “hip system,” which was made up of component parts. Moreover, the settled-out manufacturer – not the component parts supplier – had its name on the front of the IFU and the surgical technique brochure. The Supply Agreement between the manufacturer and the parts supplier also shed light on who was what. Importantly, when the settled-out manufacturer had received the component parts from the defendant supplier, those parts were not yet ready for implantation into a human being.

The plaintiffs’ product liability claims would not have been pre-empted by the BAAA if the remaining defendant acted (1) as manufacturer of the implant; (2) as seller of the implant; or (3) furnished raw materials or component parts for the implant that failed to meet applicable contractual requirements or specifications. But the answer was No, No, and No. The court considered whether there might be some basis to treat the parts supplier as a manufacturer of the implant. Under the BAAA, this exclusion applies only in three situations: first, if the parts supplier registered or was required to register with the Secretary of Health and Human Services and included or was required to include the implant on a list of devices filed with the Secretary; second, if the parts supplier was subject to a declaration issued by the Secretary that stated the company was required to so register and list the implant but filed to do so; and third, if the supplier was related by common ownership or control to the manufacturer. Again, three strikes and the plaintiffs were out. and that meant that the supplier defendant was out of the case. BAAA preemption applied and the parts supplier was dismissed.