Maybe it was a recent couple of days spent in the Lancaster, Pennsylvania area, but when we saw a case about the BAAA – our first thoughts were along the lines of Old McDonald’s Farm. But today’s BAAA is significantly less known than either Dolly (the first cloned mammal) or Lamb Chop (the sock puppet) . Not too many other famous sheep, at least in the U.S.
So, what is the BAAA? The Biomaterials Access Assurance Act of 1998, 21 U.S.C. §§ 1601-1606. Need more? Well, we posted about this Act back in 2008. And it remained our only post under our biomaterials label – until today. In short, the BAAA creates immunity for companies that provide biomaterials that are used to manufacture implantable medical devices. The manufacturer of the device itself may be liable, of course, but the company that provided raw materials or component parts generally is not. When we posted about it over four years ago, we did so to alert biomaterial suppliers to its existence and potential usefulness in protecting them from products liability lawsuits. At that time, we noted that there was very little authority interpreting or applying the BAAA. And that hadn’t changed in the ensuing years. Until we found Mattern v. Biomet, Inc., 2013 U.S. Dist. LEXIS 44054 (D.N.J. Mar. 28, 2013).
Plaintiff alleged injury from hip replacement surgery involving a metal hip implant manufactured and sold by some of the defendants named in the suit. Plaintiff also named Biomet Fair Lawn, a casting manufacturer. Biomet Fair Lawn’s “sole role in the manufacturing process is to shape a raw piece of metal that will eventually become an implant.” Id. at *6. So, it moved to dismiss under the BAAA.
The BAAA creates a procedural device that allows a biomaterial supplier to file a motion to dismiss, which can be supported by affidavits (allowing for dismissal before discovery), showing that the supplier is not a “manufacturer” of the final implant, is not a “seller” of the final implant, and did not fail “to meet applicable contractual requirements” relating to the raw material. Id. at *3. The court reviewed the BAAA definitions of manufacturer and seller and found Biomet Fair Lawn was neither. Id. at *7-10. The court also acknowledged that “common ownership or control” may turn a supplier into a manufacturer or seller, but only if the actual manufacturer or seller “lacks sufficient financial resources to satisfy any [potential] judgment.” Id. at *10. Because finances weren’t an issue, this exception didn’t apply. Id. Finally, because Biomet Fair Lawn’s castings were made in accordance with specifications provided by the manufacturer of the final implant and the complaint did not allege any failure or defects in the castings, “there is no reason to believe that the [castings] failed to meet contractual requirements or specifications.” Id. at *11. Motion to dismiss granted.
While we haven’t done an exhaustive search for dismissals granted under the BAAA, given that Mattern cites only two cases – the same two we cited in our 2008 post (Whaley v. Morgan Advanced Ceramics, Ltd., 2008 WL 901523 (D. Colo. Mar. 31, 2008) and Marshall v. Zimmer, 1999 WL 34996711 (S.D. Cal. Nov. 4, 1999)) – we don’t think there is much more out there. So, if you represent a biomaterials supplier, keep these cases handy and don’t forget the BAAA, it’s not just for farms.