We hadn’t blogged about the Biomaterials Access Assurance Act (“BAAA”), 21 U.S.C. §§1601-1606, since 2008 (see post), and now we are posting about it for a second time this month. Maybe we should hashtag BAAA and see if we can start a Google trend. Maybe not.
Our prior posts focused on the BAAA’s procedural device that allows a biomaterial supplier to be dismissed upon a 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. 21 U.S.C. §1604(a). While this latest case, Sadler v. Advanced Bionics, LLC, 2013 U.S. Dist. LEXIS 54697 (W.D. Ken. Apr. 16, 2013), deals with that as well, it also addresses the preemptive effect of the BAAA. This is also a case where the claim against the biomaterial supplier was brought by the medical device manufacturer, the defendant, rather than the plaintiff -- which is why the court got the preemption issue.
It is important to the preemption discussion to know that Kentucky has adopted comparative fault/several liability for all tort actions, including products liability. Id. at *7-8. “In all tort actions, including products liability actions, involving fault of more than one (1) party . . . the court . . . shall instruct the jury to . . . indicat[e] . . . the percentage of the total fault of all the parties to each claim.” Ken. Rev. Stat. §411.182. So, in this case, defendant Advanced Bionics sought such an apportionment instruction that would direct the jury to consider the degree of fault of Astro Seal, its biomaterials supplier (Advanced Bionics’s third-party complaint against Astro Seal had previously been dismissed for lack of personal jurisdiction). Id. at *1.
The court found the BAAA blocked such an instruction on two grounds. First, under Kentucky law, an apportionment instruction involving a non-party (the “empty-chair” defendant) is permitted only where the active defendant can show that the empty-chair defendant is liable for plaintiff’s injuries. Id. at *2 (burden of proof shifts to the defendant who is seeking to transfer liability to a non-party). This Advanced Bionics could not do because it could not “overcome the shield from liability the BAAA confers upon Astro Seal.” Id. at *4. In other words, Advanced Bionics couldn’t demonstrate that Astro Seal fit within any of the above-identified exclusions. Id. at *4.
The court then moved on to preemption, noting that the BAAA contains an express preemption provision:
This Act supersedes any State law regarding recovery for harm caused by an implant and any rule of procedure applicable to a civil action to recover damages for such harm only to the extent that this Act establishes a rule of law applicable to the recovery of such damages. 21 U.S.C. §1603(c).
What is the BAAA’s rule of law regarding the recovery of damages? The answer leads us to another section of the BAAA we haven’t previously discussed -- the one that allows the device manufacturer to seek contribution from a supplier even if the supplier is dismissed from the case pursuant to the BAAA. In other words, the BAAA doesn’t provide total immunity to biomaterial suppliers. Where the BAAA applies (i.e. supplier isn’t the manufacturer or seller of the final device and met the contractual specifications for the component part), a plaintiff can't recover directly against the supplier, but the device manufacturer can (later)recover against the supplier if it can prove “negligence or intentionally tortious conduct of the dismissed supplier was an actual and proximate cause of the harm to the [plaintiff].” 21 U.S.C. §1606(a)(1)(A); (a)(2)(A). That contribution can be sought only “after entry of a final judgment in an action by the [plaintiff] against a manufacturer.” 21 U.S.C. §1606(a) (emphasis added).
Now, back to Sadler. Since the BAAA expressly preempts state law as to the plaintiff's recovery of damages and since the BAAA’s remedy provision is different than Kentucky’s comparative fault law, the latter is preempted:
The remedial scheme of the BAAA, which manifested a congressional decision to protect component part manufacturers from liability, is irreconcilable with Kentucky's adoption of several liability in all tort actions, including those actions against component part manufacturers. According to the express preemption provision of the BAAA, the BAAA's remedial scheme controls. Advanced Bionics' attempt to obtain an apportionment jury instruction under KRS § 411.182 is improper, because the operation of that statute is preempted in this case.
Id. at *8. We acknowledge that this is a fine point, and perhaps not one given to widespread use. But, it is enforcement of an express preemption clause in a statute that protects component part manufacturers. And, let’s face it – an obscure statute twice in one month. We couldn’t resist. We might not get another chance to mention the BAAA until 2018.