Making its presence felt as an early contender for a 2019 Top Ten DDL case, it’s In re: Genentech, Inc., Herceptin (Trastuzumab) Marketing and Sales Practices Litigation, 2019 WL 1284176 (N.D. Okla. Mar. 20, 2019).  The challengers came in swinging, but they were no match for federal preemption.  Down go plaintiffs!  (We hear that

We’ve written several times (here, for example) about the Biomaterials Access Assurance Act (BAAA), 21 U.S.C. section 1604 et seq., and how it issues a get-out-of-litigation-free card to suppliers of raw materials and components. Today’s case, Connell v. Lima Corp. et al., 2019 WL 403855 (D. Idaho Jan. 30, 2019), supplies another

We’ve blogged several times about the Biomaterials Access Assurance Act of 1998, 21 U.S.C. §§1601-06.  In a nutshell, the BAAA provides suppliers of “raw materials and component parts” used in the manufacture of medical devices with a “Get Out of Litigation Free” card in most situations.  It allows manufacturers of “biomaterials” – defined as “a

It’s August and several your valiant bloggers are on vacation, so the skeleton crew manning the fort is even more grateful for reinforcements than usual.  Here is another guest post, this time from Reed Smith‘s Court Chillingworth.  This is about a topic we’ve covered sporadically, the Biomaterials Access Assurance Act.  As always Court is entitled to full credit (and any blame) for everything appearing hereafter.  Except for this:  Edgar Allen Poe wrote on both.  Don’t worry, you’ll understand what it means by the end of Court’s post.

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When is a medical device an implant? When is it not? While far more drab than anything Lewis Carroll would have written, it is still a multi-layered riddle, and one that should be of particular curiosity – and possibly concern – to present-day medical device lawyers. It derives from the Biomaterials Access Assurance Act (“BAAA”), 21 U.S.C. §§ 1601 et seq., a statute that shields from liability in all state and federal courts the manufacturers of biomaterial and component parts that are supplied “for use in the manufacture of an implant.” Id., § 1601(1)(A) (emphasis added); see also id. § 1601(2), 1603(b)(1), 1604(a).  A Connecticut trial judge recently explored the question in Nolen-Hoeksema v. Maquet Cardiopulmonary AG, No. 146049888S, 2016 WL 4203030 (Conn. Super. New Haven Dist. July 11, 2016), and in particular, the question of whether one of the statute’s definitions of an “implant” – a device that is intended be “in contact with bodily fluids or internal human tissue through a surgically produced opening” [21 U.S.C. § 1602(5)(A)(ii) (emphasis added)] – would apply to a medical device that is used during surgery, but is not designed to be in direct contact with the patient.

Ultimately, the court found its answer from an otherwise simplistic source:  the Webster’s Dictionary and its definitions of the word “through.” But its analysis, which involved principles of statutory interpretation and federal preemption, was complex: which one of two Webster’s Dictionary definitions of the word “through” should be applied – one advocated by the defendant, meaning “by way of” in the abstract, or one advocated by the plaintiff, meaning “penetrating.” The court chose the latter, which effectively would require direct contact between the device and the patient for the BAAA to apply to component parts of the device under 21 U.S.C. § 1602(5)(A)(ii).


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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’ third-party complaint against Astro Seal had previously been dismissed for lack of personal jurisdiction).  Id. at *1.


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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) 

The Biomaterials Access Assurance Act of 1998?

Why the heck are we writing about that now?

Well, first, it’s our blog; if we entertain no one else, at least we can entertain ourselves.

And, second, one of us recently received a call from a sophisticated in-house lawyer at a sophisticated drug or device