An Ad Hoc Inquiry Into the Feasibilities and Impracticalities Associated With Class Certification Of Blood Glucose Monitor Users


Recent developments in pre-emption law have outlined the requirements for bringing an action against a manufacturer of an FDA approved medical device. Specifically, devices that undergo the 510(k) approval process remain a viable target for state tort claims. In February, 2008 the Supreme Court handed down a crucial decision in Riegel v. Medtronic, Inc., involving medical devices regulated by the FDA. In Riegel, the Court reaffirmed the distinction between the exhaustive "federal requirements" of the PMA process and the looser scrutiny of 510(k) notification. This means that 510(k) devices—which vastly outnumber PMA devices—remain fully exposed to mass-tort liability. Medical devices are frequently the subject of class action cases, most of which are brought in federal court. The Supreme Court has handed down several decisions that make certifying a product liability class more difficult. Federal and state courts tend to tread lightly before certifying a class in a medical device product liability suit, noting the likelihood of attracting a great deal of publicity as well as claimants that may or may not have been able to pursue a traditional tort cause of action on their own. This article aims to examine the feasibility or bringing a class action case against the manufacturers of Blood Glucose Monitors, 510(k) devices, in light of the Riegel decision and class certification obstacles imposed by federal courts.

LOADING PDF: If there are any problems, click here to download the file.

Written by:

Published In:

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Kleyman & Associates, PC | Attorney Advertising

Don't miss a thing! Build a custom news brief:

Read fresh new writing on compliance, cybersecurity, Dodd-Frank, whistleblowers, social media, hiring & firing, patent reform, the NLRB, Obamacare, the SEC…

…or whatever matters the most to you. Follow authors, firms, and topics on JD Supra.

Create your news brief now - it's free and easy »


The Kleyman Law Firm is a premier multi-specialty law firm in New York. Our law offices are... View Profile »

Follow Kleyman & Associates, PC:

Reporters on Deadline

All the intelligence you need, in one easy email:

Great! Your first step to building an email digest of JD Supra authors and topics. Log in with LinkedIn so we can start sending your digest...

Sign up for your custom alerts now, using LinkedIn ›

* With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name.