United States: Guest Post – Through The Dictionary, And What One Court Found There: Adventures In The BAAA

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?

This article is presented for informational purposes only and is not intended to constitute legal advice.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
In association with
Related Topics
 
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions