Twice in One Month

From Drug and Device Law
April 26, 2013 - 12:39pm

            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 liabil...


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