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 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
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.

Disclaimer

Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.

Registration

Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.

Cookies

A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.

Links

This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.

Mail-A-Friend

If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.

Security

This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.