Generic Drug Preemption Q and A

by Dechert LLP
Contact

There are now forty-eight post-Mensing generic drug preemption decisions on our scorecard, with more being decided on what seems like a weekly basis.  Thus, the scorecard gets a little unwieldy at times. Because of that, we thought we’d take a shot at organizing the cases we know about in a different fashion – by issue.

But that kind of post sure can get boring – having written more than a few, we know.  So to try to keep our readers’ attention a bit better, we’ve put this post together in a question and answer format.

But one thing we’re not going to do is list all the cases that bar warning claims – that would be all of them.  Preemption of warning claims is what Mensing was most directly and immediately about. But beyond that everything is fair game.

Where there’s been a pro-defense preemption decision of any sort, no matter what the product, the first response we always see from the other side (other than to run to the politicians to try to change the law) is concealment.  That is, that plaintiffs inevitably try to disguise preempted claims as something else.  That’s certainly happened in generic drug cases post-Mensing.  So what have they done, and how have they fared?

1. How have “fraud/misrepresentation” claims fared since Mensing?  Not very well, actually.  The following cases have held false-statement-based claims preempted:  Metz v. Wyeth LLC, ___ F. Supp.2d ___, 2012 WL 1058870, at *5 (M.D. Fla. March 28, 2012) (including fraudulent concealment); In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 718618, at *5 (E.D. Ky. March 5, 2012); Bowman v. Wyeth, LLC, 2012 WL 684116, at *6 (D. Minn. March 2, 2012); Bell v. PLIVA, Inc., ___ F. Supp.2d ___, 2012 WL 640742, at *3 (E.D. Ark. Feb. 16, 2012); Coney v. Mylan Pharmaceuticals, Inc., 2012 WL 170143, at *7 (S.D. Ga. Jan. 19, 2012); Fisher v. Pelstring, 817 F. Supp.2d 791, 822-23 (D.S.C. 2011) (including “constructive” fraud); Grinage v. Mylan Pharmaceuticals, Inc., ___ F. Supp.2d ___, 2011 WL 6951962, at *6-7 (D. Md. Dec. 30, 2011); Fullington v. PLIVA, Inc., 2011 WL 6153608, at *5 (E.D. Ark. Dec. 12, 2011) (including fraudulent concealment); In re Fosamax Litigation, 2011 WL 5903623, at *8-9 (D.N.J. Nov. 21, 2011); Metz v. Wyeth, LLC, 2011 WL 5024448, at *4 (M.D. Fla. Oct. 20, 2011); Del Valle v. PLIVA, Inc., 2011 WL 7168620, at *5 (Mag. S.D. Tex. Dec. 21, 2011) (adoption not yet decided); Huck v. Trimark Physicians Group, 2012 WL 553492 (Iowa Dist. Jan. 5, 2012) (including fraudulent concealment and constructive fraud).  Not a single post-Mensing case that we know of has let a plaintiff slap a “fraud” label on a warning claim and get away with it.

2. How have warranty claims fared since Mensing?  Plaintiffs have done a little better with “warranty” claims – at least those of the “implied” variety. A few courts, although certainly not the majority, have let implied warranty claims slide by Mensing, at least at the pleadings stage.  Metz, 2012 WL 1058870, at *5; Fisher, 817 F. Supp.2d at 832; Sacks v. Endoscopy Center, 2011 WL 4915174 (Nev. Dist. July 28, 2011), all holding implied warranty claims not preempted.  Still, that’s a distinct minority.  Every court to decide the issue has held express warranty claims preempted, and most have done the same with implied warranty claims.  Cooper v. Wyeth, Inc., 2012 WL 733846, at *9 (M.D. La. March 6, 2012) (express warranty); Darvocet, 2012 WL 718618, at *5 (express warranty); Bell, 2012 WL 640742, at *3 (express and implied warranty); Schrock v. Wyeth Inc., 2011 WL 6130924, at *2 (W.D. Okla. Dec. 8, 2011) (express and implied warranty); Morris v. Wyeth, Inc., 2012 WL 601455, at *5 (W.D. La. Feb. 23, 2012) (express warranty); In re Pamidronate Products Liability Litigation, ___ F. Supp.2d ___, 2012 WL 272889, at *4 (E.D.N.Y. Jan. 30, 2012) (express and implied warranty); Fisher, 817 F. Supp.2d at 819-820 (express warranty); Grinage, 2011 WL 6951962, at *6 (implied warranty); Fullington, 2011 WL 6153608, at *5 (implied warranty); Fosamax, 2011 WL 5903623, at *8 (express and implied warranty); Metz, 2011 WL 5024448, at *4 (express and implied warranty), Del Valle, 2011 WL 7168620, at *5 (implied warranty); Huck, 2012 WL 553492 (implied warranty).

3. How have consumer fraud/protection claims fared since Mensing?  Consumer fraud allegations, attacking the content of generic labeling, have also been tried, without success.  Such claims have been held preempted in:  Darvocet, 2012 WL 718618, at *5; Fosamax, 2011 WL 5903623, at *9; Del Valle, 2011 WL 7168620, at *5.

4. How have FDA-related claims fared since Mensing?  Plaintiffs have also tried hide their warning-related claims behind a curtain of FDA-related allegations – mostly involving allegedly inadequate pharmacovigilance (post-marketing surveillance and/or failure to report) after the generic drug was approved.  These claims have also been notably unsuccessful, being held preempted in the following cases:  Metz, 2012 WL 1058870, at *5; Cooper, 2012 WL 733846, at *5; Darvocet, 2012 WL 718618, at *5 (unspecified negligence per se); Moretti v. Mutual Pharmaceutical Co., 2012 WL 465867, at *4 (D. Minn. Feb. 13, 2012); Lyman v. Pfizer, Inc., 2012 WL 368675, at *4 (D. Vt. Feb. 3, 2012); Metz, 2011 WL 5024448, at *4 (unspecified negligence per se).

5. What other inventive warning-related theories have been preempted since Mensing?  The other side can be pretty darn creative when it has to.  Since Mensing they’ve put their thinking cap on and dreamed up various other supposed causes of action that in one way or another attack generic labeling.  It hasn’t helped them very much so far, however.  The following cases have preempted the following theories:  Darvocet, 2012 WL 718618, at *2 (wrongful marketing); Morris, 2012 WL 601455, at *4 (failure to test); Grinage, 2011 WL 6951962, at *5 (failing to warn the branded manufacturer); Gross v. Pfizer, Inc., ___ F. Supp.2d ___, 2011 WL 5865267, at *4 (D. Md. Nov. 22, 2011) (negligent concealment, failure to test); Metz, 2011 WL 5024448, at *3 (failure to test); Del Valle, 2011 WL 7168620, at *5 (suppression of evidence).

6. Has off-label use made a difference in Mensing preemption?  In a word, “no,” because off-label use inherently involves the scope of the label, which is – well – the label.  Labeling claims are preempted under MensingKellogg v. Wyeth, 2012 WL 368658, at *4-5 (D. Vt. Feb. 3, 2012); Whitener, v. PLIVA, Inc., 2011 WL 6056546, at *4 (E.D. La. Dec. 6, 2011).

7. OK, forget the labeling, what about some other means of communication, such as “Dear Doctor” letters?  Mensing recognized that “Dear Doctor” letters, although separate in time and place, are still labeling, so deviations in “Dear Doctor” letters would still yield preemption.  131 S. Ct. 2578-79.  Mensing didn’t address directly claims that a “Dear Doctor” letter doing nothing more than regurgitating existing warnings should have been sent – probably because the Mensing plaintiffs didn’t want to make such an intrinsically dumb argument (such a reminder isn’t likely to be causal, and the FDA doesn’t want warning letters to be used in this way) in the country's highest court.  Post-Mensing, plaintiffs haven’t been so selective, and some courts have held that purely repetitive Dear Doctor letter claims aren’t preempted.  Brasley-Thrash v. Teva Pharmaceuticals USA, Inc., 2011 WL 4025734, at *3 (S.D. Ala. Sept. 12, 2011); Hutchinson v. Endoscopy Center, 2011 WL 6688744 (Nev. Dist. Oct. 5, 2011); Keck v. Endoscopy Center, 2011 WL 3921690 (Nev. Dist. Aug. 19, 2011); Sacks, 2011 WL 4915174.  On the other hand, most courts have held that all generalized “Dear Doctor” letter-based claims are preempted.  Cooper, 2012 WL 733846, at *7; Darvocet, 2012 WL 718618, at *4 n.9; Kellogg, 2012 WL 368658, at *5; Grinage, 2011 WL 6951962, at *3-4; Fosamax, 2011 WL 5903623, at *8; Morris v. Wyeth, Inc., 2011 WL 4973839, at *2-3 (W.D. La. Oct. 19, 2011); Del Valle, 2011 WL 7168620, at *6.  Recently, however, one court has held that a more limited (and more plausible) “Dear Doctor” letter-based claim escapes preemption – that at the time of an FDA-approved label change, there could arise a duty, consistent with Mensing, to send a letter to doctors to apprise them of the new warning language.  Cooper, 2012 WL 733846, at *4.  Good try, but such a time-limited claim isn’t likely to do much good for very many plaintiffs.

8. Design defect claims don’t involve warnings, so how have they fared after Mensing?  At least as badly as warning claims.  That’s because, while it wasn’t before the Court in Mensing, the design of a generic drug is likewise subject to a statutory “sameness” requirement.  21 U.S.C. § 355(j)(2)(A)(ii).  Thus, design defect claims have, with only one exception, been held preempted.  Metz, 2012 WL 1058870, at *4; Cooper, 2012 WL 733846, at *9; Darvocet, 2012 WL 718618, at *3; Lyman, 2012 WL 368675, at *4; Pamidronate, 2012 WL 272889, at *3; Grinage, 2011 WL 6951962, at *6; Fosamax, 2011 WL 5903623, at *6; Stevens v. PLIVA, Inc., 2011 WL 6224569, at *2 (Mag. W.D. La. Nov. 15, 2011), adopted, 2011 WL 6224556 (W.D. La. Dec. 2, 2011).  The one contrary case, Sacks, 2011 WL 4915174, offers no reasoning for its result.

9. Well, if the generic manufacturer can’t give a warning that’s adequate under state law, shouldn’t it just stay out of the market altogether until it can?  Courts don’t even need to get to “sameness” to hold that kind of claim preempted.  Once the FDA has approved a generic drug for marketing, state law cannot demand that the drug not be marketed at all.  Metz, 2012 WL 1058870, at *4; Cooper, 2012 WL 733846, at *6; Darvocet, 2012 WL 718618, at *3; Bowman, 2012 WL 684116, at *6; Moretti, 2012 WL 465867, at *5; Lyman, 2012 WL 368675, at *4; Coney, 2012 WL 170143, at *5; Fullington, 2011 WL 6153608, at *6; Gross, 2011 WL 5865267, at *3.

10. Does the Food and Drug Administration Amendments Act of 2007, decided after the injury in Mensing, make any difference?  Plaintiffs have lost this argument because they haven’t pointed to a single relevant change made by the FDAAA.  Whitener, 2011 WL 6056546, at *3; Fosamax, 2011 WL 5903623, at *7.

11. Sometimes the FDA will designate a generic product as the “reference listed drug” once the branded drug leaves the market; does that designation affect Mensing preemption?  No. The FDA’s designation does not affect the statute’s “sameness” requirement or give the designated manufacturer any additional rights or responsibilities.  Cooper, 2012 WL 733846, at *7-9; Darvocet, 2012 WL 718618, at *5; Morris, 2012 WL 601455, at *5-6; Moore v. Mylan, Inc., 2012 WL 123986, at *6-7 (N.D. Ga. Jan. 5, 2012).

12. Can a generic plaintiff allege a “parallel” violation of the FDCA?  No.  The concept of “parallel violation” arises from specific statutory preemption language that is inapplicable to generic drugs.  It is an express preemption concept with no bearing on the implied preemption analysis in Mensing.  Henderson v. Sun Pharmaceuticals Industries, Ltd, 809 F. Supp.2d 1373, 1378-79 (N.D. Ga. 2011); Guarino v. Wyeth LLC, 2011 WL 5358709, at *3 (M.D. Fla. Nov. 7, 2011); Morris, 2011 WL 4973839, at *2; Del Valle, 2011 WL 7168620, at *6.

13. Is there any claim that post-Mensing courts have allowed plaintiffs to assert against generic manufacturers?  Most courts have held that, if the generic manufacturer does not maintain “sameness” by changing its label once the FDA has approved a corresponding change to the branded/reference label, then a claim based on that failure to update is not preempted.  Metz, 2012 WL 1058870, at *3; Cooper, 2012 WL 733846, at *3-4; Lyman, 2012 WL 368675, at *5-6; Couick v. Wyeth, Inc., 2012 WL 79670, at *3-5 (W.D.N.C. Jan. 11, 2012); Fisher, 817 F. Supp.2d at 805, 821, 823-26, 832-36; Del Valle, 2011 WL 7168620, at *7-8.  Some cases, however, disagree, finding failure to update claims preempted as attempts at improper FDCA enforcement, or for other reasons.  Bell, 2012 WL 640742, at*3-4; Gross, 2011 WL 5865267, at *4.

Also, Mensing preemption does not apply to a manufacturing defect claims unrelated to the product’s warning.  Fisher, 817 F. Supp.2d at 818.

14. Where else has Mensing preemption proved effective?  The critical question under Mensing “is whether the private party could independently do under federal law what state law requires of it.”  131 S. Ct. at 2579.  A party that does not hold either a branded NDA or a generic ANDA has no power even to ask the FDA to make a label change.  Thus, Mensing has been applied to preempt claims against distributors and contract manufacturers who are not the current application holders for the drugs at suit.  In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 767595, at *7 (E.D. Ky. March 7, 2012) (contract manufacturer); In re Fosamax Litigation, 2012 WL 181411, at *3-4 (D.N.J. Jan. 17, 2012) (distributors of both branded and generic drugs); Stevens v. Community Health Care, Inc., 2011 WL 6379298, at *1 (Mass. Super. Oct. 5, 2011) (generic distributor).

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.

© Dechert LLP | Attorney Advertising

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.