Putting It All Together

by Dechert LLP
Contact

Our first reaction upon reading Metz v. Wyeth, 2012 U.S. Dist. Lexis 42432 (M.D. Fla. March 28, 2012), is boy, this case has a little of everything!  After it was over, the plaintiffs must have felt a little like the French after they went to war against the Prussians in 1870.

FirstMetz has a little Conte (for the uninitiated, that’s shorthand for the branded liability in generic cases controversy), although only a little – the court notes (at *2 n.1) that it previously dismissed the claims against the non-manufacturing branded drugmaker.  See Metz v. Wyeth, Inc., ___ F. Supp.2d ___, 2011 WL 5826005, at *1-3 (M.D. Fla. Nov. 18, 2011).  That moves Metz onto our list of one-two punch cases that combine product identification with Mensing preemption.  It’s the seventh suit to achieve this distinction that we know of.

Second, as you might have guessed, Metz has Mensing/generic drug preemption issues all over it.  The court held that most of the plaintiff’s claims against the manufacturer of the generic drugs she took were preempted.  Those were:  (1) negligence claims, except for (possibly, the court used “may” and never definitively decided the point) allegations that the defendant could have “take[n] additional steps to warn doctors and/or consumers of information already appearing in, or recently added to, the label.”  Metz, 2012 U.S. Dist. Lexis 42432, at *8; (2) the defendant’s failure to “inform itself” of alleged risks, id. at *10; (3) all strict liability claims, including design defect and failure to withdraw the drug from the market, id. at *11-13; (4) warranty claims (unless based on the “additional steps” theory), id. at *13-15; and (5) misrepresentation/fraud.  Id. at *15-17.

In addition to Mensing-based preemption, the court invoked Buckman Co. v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001), in holding that claims “that [defendant] failed to supply relevant information to the FDA” were also preempted.  2012 U.S. Dist. Lexis 42432, at *17 n.6.

Third, the court addressed another of our pet peeves, negligence per se claims based on alleged allegations of Food, Drug and Cosmetic Act (“FDCA”) violations.  As a matter of state law, Metz held that Florida did not recognize such an animal.  Only statutes that the legislature (Congress, in the case of the FDCA) intended be privately enforced could give rise to negligence per se.  Id. at *17-19. Furthermore, “failure to comply with administrative regulations rather than substantive regulations establishing a specific standard of care” also cannot be the basis of an negligence per se claim.  Id. at 19 n.8.  These are two of the grounds covered in our comprehensive negligence per se post on state-law defenses.

Fourth, the court noted the plaintiff’s improperly vague pleading at two points in the first half of the Metz opinion.  No facts concerning manufacturing defect were pleaded, leading to a dismissal under TwIqbal. 2012 U.S. Dist. Lexis 42432, at *11 n.4 . Plaintiff’s misrepresentation claims – mostly concerning post-marketing pharmacovigilance – failed the particularity requirements of Rule 9(b).  Id. at *16.

Fifth, all non-preempted claims failed on summary judgment under the learned intermediary rule because the labeling, specifically warning against long-term use, was adequate as a matter of law:

"[T]he product label . . . contained the accurate, clear, and unambiguous warning that “[t]herapy should not exceed 12 weeks in duration.”  This warning, which was available both in the package insert and on the internet . . .. satisfied [defendant’s] duty to provide Plaintiff’s treating physician with adequate information about the risks associated with [the drug’s] use (including the FDA indicated prohibition on long term use)."
Metz, 2012 U.S. Dist. Lexis 42432, at *23 (footnote omitted).

The warning discussion in Metz also accepted a couple other noteworthy propositions.  (1) Once an adequate warning is given, “[w]hether the physician in fact reads the warning, or passes its contents along to the recipient of the drug is irrelevant.”  Id. at *22.  “This is true even if [defendant] knew or should have known that the medical profession was not warning patients of allegedly known harmful side effects.”  Id. at *23 n.12.  Also, (2) “there is no duty to communicate an inadequate warning,” so the plaintiff cannot claim liability for not changing to a warning that they still allege is inadequate.  Id. at 23 n.11.  It would a good idea to save these quotes somewhere.  Both of these points are worth remembering for future cases.

Thus, the Metz case featured Conte, preemption, negligence per se, TwIqbal, and the learned intermediary rule – and the defendant won on all of them.  That’s what we call putting it all together.

Written by:

Dechert LLP
Contact
more
less

Dechert LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Privacy Policy (Updated: October 8, 2015):
hide

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.

Security

JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*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. Or, sign up using your email address.