Stubbs and Copeland Discuss Litigation Implications of Biomaterials Access Assurance Act for Medical Device Manufacturers

Shook, Hardy & Bacon Partner Jennise Stubbs and Associate Kelsey Copeland have authored a September 14, 2016, article in Bloomberg BNA’s Medical Devices Law & Industry Report™ that explores how the Biomaterials Access Assurance Act (BAAA) can help both biomaterial suppliers and medical device manufacturers facing litigation brought by multiple plaintiffs. The article posits a scenario in which plaintiffs based in multiple states bring a lawsuit against an out-of-state medical device manufacturer while also suing an in-state component or materials supplier to prevent removal to federal court. According to the authors, “The BAAA is used by medical device suppliers as a shield for protection against product liability claims. And in doing so, medical device manufacturers may also use the Act as a sword in ultimately obtaining federal jurisdiction where it should have been appropriate from the outset of the case.”

In particular, the article describes how biomaterials suppliers can obtain dismissal and establish immunity under the BAAA by negating liability as a “manufacturer” or “seller” as well as negating liability for “failure to meet contractual requirements.”  Meanwhile, medical device manufacturers can use the BAAA to either (i) use a fraudulent joinder argument to remove the case to federal court before dismissal of the non-diverse biomaterial supplier, or (ii) remove after a finding of immunity.

“Though there may be obstacles on the route to federal court, the BAAA can provide medical device manufacturers with the necessary tools to get there,” conclude Stubbs and Copeland. “As more and more state and federal courts are asked to interpret the plain language and simple dismissal procedures of the BAAA, it will become even more obvious to practitioners that the Act can be used by both the biomaterials supplier defendant and the medical device manufacturer defendant. In addition, federal courts will be more willing to maintain jurisdiction based on a finding of fraudulent joinder (whether removing before or after the biomaterials supplier has been found immune). Thus, while biomaterials suppliers should continue using the BAAA to shield themselves from liability, medical device manufacturers can begin to pursue removal strategies by using the BAAA as their weapon.”