Generic Drug Preemption Q and A

by Dechert LLP

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.

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