The Biomaterials Access Assurance Act of 1998 (or “BAAA”) comes up in our case searches only about once every year or two, but this 23-year-old law packs a punch as strong as its acronym is catchy. (See for example our posts here and here). Today’s post features another example of the power of this increasingly cited statute, only now we can report for the first time that an appellate court—the Ninth Circuit—has affirmed a dismissal under the BAAA.
To refresh your recollection, the BAAA (21 U.S.C. section 1604 et seq.) creates a complete defense for companies that provide biomaterials used in manufacturing implantable medical devices. The manufacturer of the device itself may be liable, but the company that provided raw materials or component parts generally is not. As we wrote long ago, Congress was concerned that suppliers of raw materials were being unfairly targeted in litigation. And while most jurisdictions recognized a “raw material supplier” or “bulk supplier” defense, asserting those defenses required expensive discovery and potentially protracted litigation. The BAA provides more immediate relief, thus protecting the supply of biomaterials such as surgical stainless steel, resins, and other biocompatible alloys.
In Connell v. Lima Corporate, No. 19-35797, 2021 WL 609599 (9th Cir. Feb. 17, 2021), the plaintiffs sued for injuries after an implanted hip prosthesis fractured, and they sued not only the device’s manufacturer, but also the supplier of a component part—a hip stem. Id. at *1-*2. The manufacturer settled, which is when the BAAA really came into play. The district court granted summary for the remaining defendant—the hip stem supplier—on the basis that the BAAA preempted the plaintiffs’ claims. We brought you our take on that dismissal here.
The Ninth Circuit has now affirmed the order. Under the BAAA, “if a defendant satisfied the definition of a biomaterials supplier, it may ‘raise any exclusion from liability’ as provided in the statute and move for dismissal or summary judgment.” Id. at *4. For the Ninth Circuit, that broke down into whether the hip stem supplier (1) supplied a “component part” (2) “for use in the manufacture of an implant.” Id. at *5. In an incredibly disciplined application of the “plain meaning” rule of statutory construction, the Ninth Circuit answered “Yes” to both.
First, the hip stem was a component part, and not itself an implanted medical device. Although delivered in full form to the manufacturer, the hip stem was part of a multi-part hip prosthesis system, which was itself intended to be implanted in patients. In other words, the manufacturer’s intent carried the day, and it intended that the hip stem would be implanted in patients only with other parts. It therefore was a “component part.” Id. at *5-*7.
Second, the Ninth Circuit held for similar reasons that the hip stem seller supplied the part “for use in the manufacture of an implant.” The Ninth Circuit reasoned that before the hip stem could be implanted, it first had to be processed, sterilized, labeled, packaged, and combined with other parts, which fairly met the plain meaning of “manufacture.” Id. at *10. If the hip stem had been only sterilized and packaged, the result might have been different. There was, however, more to it than that. Id.
The BAAA does have a safety valve: A court can implead a biomaterials supplier who has been previously dismissed back into the case if (1) the negligence or intentionally tortious conduct of the dismissed biomaterials supplier caused the harm and (2) the claimant is unlikely to recover full damages from the remaining defendants. Id. at *11 (citing 21 U.S.C. section 1606(a)). This would apply, for example, if the biomaterials supplier were dismissed, leaving the manufacturer to defend the case, but then it turned out the manufacturer was not good for the damages. If the plaintiff could prove that the biomaterials supplier’s negligence or intentional tort caused his or her harm, the court conceivably could bring the supplier back in.
The problem for the plaintiffs in Connell was that they settled with the hip system manufacturer, so there were no “remaining defendants” when the biomaterials supplier was dismissed. Id. at *12-*13. Interpreting the BAAA otherwise would essentially read the second element of the safety valve out of the statute. Id. at *13-*14.
The Ninth Circuit’s relatively broad interpretation of “biomaterials supplier” and its relatively narrow application of the BAAA’s escape value create strong and clear protection indeed. Moreover, the Ninth Circuit knew exactly what it was doing:
We recognize that defining “biomaterials supplier” expansively may limit recovery for plaintiffs like the Connells. But given the limited case law and the strong statutory indications that Congress intended to broadly preempt liability for those supplying raw materials and component parts, we believe this result is consistent with both the text and purpose of the BAAA.
Id. at *10. The Ninth Circuit also acknowledged the value of clear rules for plaintiffs and defendants alike: Rather than recover from biomaterials suppliers, “it appears that Congress meant for plaintiffs to recover from either the statutory manufacturer or the direct seller of an implant instead.” Id. The BAAA is alive and well, and the Ninth Circuit’s opinion places some added heft behind it.