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.
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).
In Nolen-Hoeksema, the device at issue, an oxygenator, allegedly “fell apart” during the patient’s surgery, leading to the decedent’s death. Nolen-Hoeksema, 2016 WL 4203030, *1. His family sued the oxygenator’s manufacturer, as well as the manufacturer of the adhesive material used to keep the oxygenator assembled. Id. The adhesive manufacturer filed a motion to dismiss on BAAA grounds. As this blog has noted, component part manufacturers have applied the BAAA defense with virtually universal success. See, e.g., Sadler v. Advanced Bionics, LLC, 2013 WL 1636374 (W.D. Ky. April 16, 2013); Mattern v. Biomet, Inc., 2013 WL 1314695 (D.N.J. March 28, 2013); Whaley v. Morgan Advanced Ceramics, Ltd., 2008 WL 901523 (D. Colo. March 31, 2008); Marshall v. Zimmer, 1999 WL 34996711 (S.D. Cal. Nov. 4, 1999). The court in Nolen-Hoeksema acknowledged these cases, but drew a distinction – none of them involved the question of whether a medical device that is not in direct contact with the patient qualifies as an “implant” under the BAAA. Nolen-Hoeksema, 2016 WL 4203030, at *4 n.3.
To argue their points, both parties directed the court to the definitions of “through” in the Webster’s Dictionary (Webster’s Third International Dictionary (1993), to be exact). According to the plaintiff, “through a surgically produced opening” meant literally through, as in physical, functional “penetration of or passage within” the opening, as one of Webster’s definitions described the word. Id. at *3. But the defense countered that Webster’s also defined “through” “in the more general sense of ‘by means of’” [id.], as in, “the author made a poor attempt at levity in his article through strained allusions to Alice in Wonderland.”
Down the rabbit hole went the court to determine which definition would apply. The court’s first step was to decide what principle of statutory interpretation it should apply. Because the BAAA is a federal statute, it found that under Connecticut precedent, it had to apply the rule of construction utilized by the U.S. Second Circuit. Id. at *2. The Second Circuit “begin[s] with the text of the statute to determine whether the language at issue has a plain and unambiguous meaning. . . . [The court] attempt[s] to ascertain how a reasonable reader would understand the statutory text, considered as a whole.” Id. (quoting Louis Vitton Malletier S.A. v. LY U.S.A., Inc., 676 F.3d 83, 108 (2d Cir. 2012).
Given the BAAA’s explicit recognition that raw material and component suppliers “have ceased supplying certain raw materials and component parts for use in medical devices for a number of reasons, including concerns about the costs of such litigation” [21 U.S.C. § 1601(8)], a reasonable reader may agree with the defense interpretation of what is, after all, a remedial statute. One might argue that the defense’s broader interpretation is not just reasonable, but more appropriate than the alternative interpretation, in light of the BAAA’s goal to offset the discouraging effect litigation has on potential raw material and component suppliers. But while the court preliminarily cited this portion of the statute’s language [Nolen-Hoeksema, 2016 WL 4203030, at *1], it did not consider the language in its eventual analysis. Id. at *3-4. Instead, it looked outside the statute – indeed outside statutory interpretation altogether − to the “presumption against preemption.” That is, “where the text of a preemption clause,” which the BAAA is, since it bars any state law personal injury claims against medical implant component suppliers, “is ambiguous or open to more than one plausible reading, courts have a duty to accept the read that disfavors pre-emption.” Id. at *3 (citing New York State Restaurant Ass’n v. Board of Health, 556 F.3d 114, 123 (2d Cir. 2009)). Here, on the one hand, the defendant offered an interpretation of “through” that would “preempt state law in a greater number of cases,” while on the other, “the plaintiff construes it more narrowly.” Nolen-Hoeksema, 2016 WL 4203030, at *3. Given the two potential interpretations of the word “through,” the court sided with the interpretation that would have a lesser preemptive effect – thereby effectively ignoring what Congress intended to achieve through the BAAA.
With all that jabberwocky out of the way, the court finally got to what was probably its first gut reaction, which was to rely on what it understood to be the “ordinary meaning” of the word “implant.” Id. at *4. To this end, the court once again turned to the Webster’s Dictionary, which defined “implant” as “something that is ‘fix[ed] or set securely or deeply,’ ‘[especially] in tissue.’” Id. Since the undisputed evidence (That’s right, evidence. BAAA authorized submission of evidence in connection with a motion to dismiss, even in state court. See 21 U.S.C. §§ 1603(a)(2), (c)(1); see also Nolen-Hoeksema, 2016 WL 4203030, at *2 n.2 (BAAA procedure applies in state court)) showed that the oxygenator “is not inserted into the patient’s body,” it did not fit with the “common understanding” of the word “implant.” Id. Motion denied.
So, when is a medical device an implant under the BAAA? “Either [it] is, or [it] is not,” quoth the court. Id. at *4 n.4. According to the court’s reading of the dictionary, an oxygenator is not, and therefore its components do not qualify for the BAAA defense. Next question: Why is a raven like a writing desk?