Tuesday, September 20, 2011

Generic Drug Preemption Scorecard

We’ve decided that, since PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), product liability preemption in the context of generic drugs has come into its own and should no longer be lumped in with the overall topic of drug/vaccine preemption.  Thus we’re bestowing a new scorecard on post-Mensing generic drug preemption decisions. We’ll start with Mensing itself and go from there:


  1. PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (U.S. June 23, 2011) (metoclopramide).  Hatch Waxman Act's requirement that generic drug labeling must stay the same as branded labeling preempts failure to warn claims against generic drug makers.  Generic drug manufacturers cannot change their labels without prior FDA approval.  Dear Doctor/DHCP letters cannot vary from generic drug labeling.  The bare chance that the FDA, if approached, might agree to change both the generic and branded labels simultaneously, is insufficient to prevent preemption.
  2. Sacks v. Endoscopy Center, 2011 WL 4915174 (Nev. Dist. July 28, 2011) (propofol).  Motion for summary judgment denied.   Claim that generic defendants should have sent a Dear Doctor/DHCP letter consistent with the drug’s labeling, and without any new or additional warnings, are not preempted.  Claim that generic defendants should have sent a Dear Doctor/DHCP letter consistent with the drug’s labeling, and without any new or additional warnings, are not preempted.  Design defect and implied warranty claims are not preempted.
  3. Brown v. Actavis Elizabeth LLC, 2011 WL 5826022, slip op. (E.D. La. Aug. 10, 2011) (metoclopramide).  Motion to dismiss granted. State law claims challenging the adequacy of generic drug labeling are preempted.  Minute order.
  4. Keck v. Endoscopy Center, 2011 WL 3921690, slip op. (Nev. Dist. Aug. 19, 2011) (propofol).  Granting partial summary judgment against preemption defense.  Claim that generic defendants should have sent a Dear Doctor/DHCP letter consistent with the drug’s labeling, and without any new or additional warnings, are not preempted.  Plaintiffs cannot argue that the label on the drug itself should be changed.  Refusing to defer to FDA view that generic manufacturers could not unilaterally send any such letters.  State law failure to warn claims are preempted.
  5. Demahy v. Actavis, Inc., 650 F.3d 1045 (5th Cir. Aug. 22, 2011) (metoclopramide).  Per curiam order on remand from the Supreme Court, vacating and remanding for entry of judgment in favor of defendant on grounds of preemption.
  6. Henderson v. Sun Pharmaceuticals Industries, Ltd, 809 F. Supp.2d 1373 (N.D. Ga. Aug. 22, 2011) (phenytoin and fosphenytoin).  Motion to amend denied; motion to dismiss granted.  Manufacturing-related warning letter sent to defendant did not relate to drug in question or to the plaintiff’s alleged injury.  None of the allegations plead causation.  State law failure to warn claims are preempted.
  7. Scott v. Baxter Healthcare Corp., 2011 WL 4007675 (S.D. Ala. Sept. 9, 2011) (phenergan). Unopposed summary judgment granted.  State law claims challenging the adequacy of generic drug labeling are preempted.
  8. Brasley-Thrash v. Teva Pharmaceuticals USA, Inc., 2011 WL 4025734 (S.D. Ala. Sept. 12, 2011) (metoclopramide).  Motion to amend granted in part and denied in part.  Claim that generic defendants should have sent a Dear Doctor/DHCP letter consistent with the drug’s labeling, and without any new or additional warnings, are not preempted.  At the time of the prescription, the FDA did not require pre-approval of such letters. State law claims challenging the adequacy of generic drug labeling are preempted.
  9. Beck v. Teva Pharmaceutical Industries Ltd., 2011 WL 4062219 (E.D. La. Sept. 13, 2011) (methotrexate).  Motion to dismiss granted.  State law claims challenging the adequacy of generic drug labeling are preempted.
  10. Hutchinson v. Endoscopy Center, 2011 WL 9378975 (Nev. Dist. Sept. 16, 2011) (propofol).  Motion in limine to exclude fake dear doctor letter denied.   State law claims challenging the adequacy of generic drug labeling are preempted. Claim that generic defendants should have sent a Dear Doctor/DHCP letter consistent with the drug’s labeling, and without any new or additional warnings, are not preempted.
  11. Smith v. Wyeth, Inc., 657 F.3d 420 (6th Cir. Sept. 22, 2011) (metoclopramide).  State law claims challenging the adequacy of generic drug labeling are preempted.  Cert. denied, 132 S.Ct. 2103 (2012).
  12. Schork v. Baxter Healthcare Corp., 2011 WL 4402602 (S.D. Ind. Sept. 22, 2011) (promethazine HCL).  State law claims challenging the adequacy of generic drug labeling are preempted.
  13. Fisher v. Pelstring, 817 F. Supp.2d 791 (D.S.C. Sept. 30, 2011) (metoclopramide), reconsideration denied, (Jan. 11, 2012) (see below).  Motion to dismiss on preemption grounds denied due to uncertainty whether generic drug labeling at the time of plaintiff's prescription timely included the most recent update to branded warnings.  Summary judgment on failure to warn, implied warranty, consumer fraud, and emotional distress denied because, inter alia, the defendant could have sent a "Dear Doctor" letter about the label changes it failed to include.  Express warranty, fraud, and misrepresentation claims preempted because they would have required a non-identical label change.  Plaintiff's claim for breach of a duty to keep current with scientific literature is preempted because without a non-identical label change, the duty could not be causal.
  14. LaBruyere v. Actavis, Inc., 2011 WL 5826018, slip op. (E.D. La. Oct. 4, 2011) (metoclopramide).  Unopposed motion to dismiss granted. State law claims challenging the adequacy of generic drug labeling are preempted.  Minute order.
  15. Stevens v. Community Health Care, Inc., 29 Mass. L. Rptr. 153, 2011 WL 6379298 (Mass. Super. Oct. 5, 2011)  (clarithromycin).  Summary judgment granted.  An distributor of a generic drug has no ability to change the warnings on generic drugs.
  16. Hutchinson v. Endoscopy Center, 2011 WL 6688744 (Nev. Dist. Oct. 5, 2011) (propofol).  Motion for summary judgment denied in part and granted in part.  State law claims challenging the adequacy of generic drug labeling are preempted.  Claim that generic defendants should have sent a Dear Doctor/DHCP letter consistent with the drug’s labeling, and without any new or additional warnings, are not preempted.  Claim that generic defendants should have sent a Dear Doctor/DHCP letter consistent with the drug’s labeling, and without any new or additional warnings, are not preempted.
  17. Guilbeau v. Wyeth, Inc., 2011 WL 4948996 (W.D. La. Oct. 14, 2011) (metoclopramide).  Motion for judgment on the pleadings granted.  State law claims challenging the adequacy of generic drug labeling are preempted.  No facts are pleaded to support any other claim.
  18. Phillips v. Wyeth, Inc., 2011 WL 5826035, slip op. (W.D. La. Oct. 14, 2011) (metoclopramide).  Unopposed motion for judgment on the pleadings granted on same grounds as Guilbeau.
  19. Morris v. Wyeth, Inc., 2011 WL 4973839, slip op. (W.D. La. Oct. 19, 2011) (metoclopramide).  Motion to dismiss granted. State law claims challenging the adequacy of generic drug labeling are preempted.  Express preemption cases do not control.  Claims based upon alleged failure to use other "FDA-recommended communication tools," such as "Dear Doctor" letters are preempted.  Plaintiff alleged no facts in support of any non-warning claim.  Motion to amend denied, 2012 WL 601455 (W.D. La. Feb. 21, 2012), plaintiff's failure-to-update claims claims that all pre-2009 labeling was defective, which is preempted; pre-Mensing cases recognizing less preemption are overruled.  Express warranty claims are preempted.  A reference listed drug designation does not convert the defendant into a branded manufacturer for purposes of preemption.  Affirmed, 713 F.3d 774 (5th Cir. Feb. 14 2013) (see below).
  20. Richardson v. Wyeth, Inc., 2011 WL 5402184, slip op. (W.D. La. Oct. 20, 2011), adopted, 2011 WL 5402396, slip op. (W.D. La. Nov. 6, 2011) (metoclopramide).  Unopposed motion to dismiss granted. State law claims challenging the adequacy of generic drug labeling are preempted.
  21. Metz v. Wyeth, LLC, 872 F. Supp.2d 1335 (M.D. Fla. Oct. 20, 2011) (metoclopramide).  Motion to dismiss granted.  All warning claims are preempted.  All non-warning claims are inadequately pleaded.  Causation must be pleaded in any non-preempted claim.  Claims that the defendant failed to monitor developments, or notify the FDA, relate to warnings and are preempted.  Design claims must allege that the generic defendant designed the product.  Warranty and fraud claims relate to information about the product and are preempted.  Negligence per se claims based on labeling are preempted.  Affirmed by unpublished order, No. 12-13321, slip op. (11th Cir. Aug. 1, 2013).
  22. Waguespack v. PLIVA USA, Inc., 2011 WL 5826015, slip op. (E.D. La. Nov. 3, 2011) (metoclopramide).  Motion for judgment on the pleadings granted.  State law claims challenging the adequacy of generic drug labeling are preempted.  Plaintiff did not plead an identical Dear Doctor letter claim.
  23. Sincoskie v. West Ward Pharmaceuticals, No. MEL-L-2643-10, transcript (N.J. Super. Law Div. Mercer Co. Nov. 4, 1022).  Motion to dismiss granted.  State law claims challenging the adequacy of generic drug labeling are preempted.  That the defendant's product has been designated a reference listed drug does not establish that it may unilaterally change its warnings. 
  24. Guarino v. Wyeth LLC, 823 F. Supp.2d 1289 (M.D. Fla. Nov. 7, 2011) (metoclopramide).  Motion to dismiss granted.  All warning claims are preempted.  Mensing does not include an exception for parallel violation claims.  "Failure to communicate" claims, based on Dear Doctor letters, are preempted. Reconsideration denied, 2012 WL 28810 (M.D. Fla. Jan. 5, 2012), second reconsideration denied, 2012 WL 1890516 (M.D. Fla. May 23, 2012).
  25. In re Accutane Products Liability Litigation, 2011 WL 6224546, slip op. (M.D. Fla. Nov. 9, 2011) (isotretinoin).  Judgment on the pleadings granted.  All warning claims are preempted.  (Unspecified) arguments that plaintiffs claims are not warning claims are "devoid of merit."  Warning-based claims against a pharmacist selling generic drugs are also preempted.
  26. Stevens v. PLIVA, Inc., 2011 WL 6224569, slip op. (Mag. W.D. La. Nov. 15, 2011) (metoclopramide). Unopposed motion to dismiss granted. State law claims challenging the adequacy of generic drug labeling are preempted.  Design defect claims are preempted. Adopted, 2011 WL 6224556 (W.D. La. Dec. 2, 2011).
  27. In re Reglan/Metoclopramide Litigation, 2011 WL 6259558, slip op. (Pa. C.P. Philadelphia Co. Nov. 18, 2011) (metoclopramide).  Master preliminary objections denied.  It is not shown with certainty that there can be no legal recovery in 2000 cases brought under the laws of numerous states.  Mensing "carve outs" must be decided on a state-by-state basis.  The same is true for claims involving the injectible form of the drug.
  28. In re Fosamax Litigation, 2011 WL 5903623 (D.N.J. Nov. 21, 2011) (alendronate sodium).  Judgment on the pleadings granted as to all generic defendants (some defendants' status as generic manufacturers was disputed and could not be resolved on the pleadings).  No factual allegations support any sort of manufacturing-related claim.  The design of a generic drug, like its warnings, must be the same as the branded reference drug.  Therefore design defect claims and negligent design claims are preempted.  State law claims challenging the adequacy of generic drug labeling are preempted.  Taking alleged increased risk evidence to the branded manufacturer rather than the FDA does not change the preemption analysis because any label change would still be dependent upon the act of an independent third party.  Nothing in the 2007 FDAAA changes the generic preemption analysis.  There is no evidence that generic labels were not updated promptly.  Negligence claims related to warnings are preempted.  Implied warranty claims are founded on changing the design of the drug, and are therefore preempted.  Express warranty, fraud, misrepresentation, and consumer protection claims all attack the drug's labeling and are therefore preempted.  Dependent claims are also dismissed.  Affirmed see below.
  29. Gross v. Pfizer, Inc., 825 F. Supp.2d 654 (D. Md. Nov. 22, 2011) (metoclopramide).  Judgment on the pleadings granted.  Negligence claims alleging that generic manufacturers had a duty to cease selling their product at all are preempted.  Such a claim, if it existed at all, would directly conflict with FDA authority to determine what drugs can be sold in interstate commerce.  Claims for concealing information are warning claims and are preempted.  Failure to test/inspect are warning claims and are preempted.  Claims alleging failure to update do not exist at state law, and in any event are preempted.  Reconsideration denied, 825 F. Supp. 2d 661 (D. Md. Jan. 27, 2012).  Plaintiffs have not pleaded that the allegedly unupdated warning was adequate, so that claim is also preempted.  Affirmed ___ F.3d ___, 2014 WL 292700 (4th Cir. Jan. 28, 2014) (see below under "Drager").
  30. Phelps v. Wyeth, Inc., 2011 WL 7629569 (Mag. D. Or. Nov. 30, 2011) (metoclopramide).  Motion to dismiss granted against all claims, including  post-marketing failure to monitor, with the exception of failure to update warnings after the branded label was changed.  Failure to update may be asserted as negligence per se.
  31. Whitener, v. PLIVA, Inc., 2011 WL 6056546 (E.D. La. Dec. 6, 2011) (metoclopramide).  Judgment on the pleadings granted in part and denied in part.  Nothing in the 2007 FDAAA affects the preemption rationale in Mensing.  Off-label use does not defeat preemption.  Any additional warning about an off-label would create a label that is not the same as the branded label.  If plaintiffs want to assert some claim based upon illegal off-label promotion, they must amend their complaint.  On reconsideration at, 2012 WL 3948797 (E.D. La. Sept. 10, 2012).  Conceivably illegal off-label promption could also violate state law so the claim will not be dismissed on the pleadings.  The 2007 FDAAA made no changes in generic labeling, thus nothing in FDAAA bars preemption of post-2007 claims.
  32. Schrock v. Wyeth Inc., 2011 WL 6130924 (W.D. Okla. Dec. 8, 2009) (metoclopramide).  Motion for leave to amend denied.  Express and implied warranty claims are preempted.  Affirmed see below.
  33. Fullington v. PLIVA, Inc., 2011 WL 6153608 (E.D. Ark. Dec. 12, 2011) (metoclopramide).  Motion to dismiss granted.  State law claims challenging the adequacy of generic drug labeling are preempted.  Non-warning claims not adequately pleaded.  Failure to update labeling claims not adequately pleaded.  Claims alleging that generic manufacturers had a duty to cease selling their product at all are preempted.  Amended complaint dismissed except for one count, 2012 WL 1893749 (E.D. Ark. May 23, 2012).  Alleged design defect claim alleging improper use of bulk packaging was actually a warning claim and was preempted.  Bartlett is distinguishable because it was pure risk-utility rather than involving only one use.  Failure to update claims are preempted to the extent that the updated label was allegedly still defective.  Other failure to update claims will be addressed on summary judgment.  Reconsideration denied, 2012 WL 2918711 (E.D. Ark. July 17, 2012), aff'd in part and vacated in part, 720 F.3d 739 (8th Cur, 2013) (see below).
  34. Del Valle v. PLIVA, Inc., 2011 WL 7168620, slip op. (Mag. S.D. Tex. Dec. 21, 2011) (metoclopramide).  Motion to dismiss granted.  State law claims challenging the adequacy of generic drug labeling are preempted.  Claims for failure to add label changes that plaintiffs claim were still defective do not state a claim, as there can be no causation for failing to add labeling that was still defective.  adopted 2012 WL 2899406 (S.D. Tex. June 22, 2012).  Affirmed ___ F. Appx. ___, Nos. 12-60861, 12-41148, slip op. (5th Cir. Feb. 21, 2014), see below.
  35. Grinage v. Mylan Pharmaceuticals, Inc., 840 F. Supp.2d 862 (D. Md. Dec. 30, 2011) (allopurinol).  Motion to dismiss granted.  State law claims challenging the adequacy of generic drug labeling are preempted.  All forms of communication between manufacturers and doctors, "Dear Doctor" letters, physician training, and professional publications, are labeling and preempted if different from branded labeling.  To the extent plaintiff argues for other communications bearing identical information, no causation is pleaded.  Taking alleged increased risk evidence to the branded manufacturer rather than the FDA does not change the preemption analysis because any label change would still be dependent upon the act of an independent third party.  Consumer expectation-based design defect claims are based on warning information and are preempted.  No alternative design or lack of utility is pleaded that could support a risk-utility design defect claim.  Implied warranty claims are either preempted or inadequately pleaded.  Fraud claims implicating the label are preempted, any others are inadequately pleaded.
  36. Yamane v. Wyeth, 2012 WL 1120367 (Haw. Cir. Jan. 3, 2012) (phenergan).  Summary Judgment granted.  All plaintiff's state law claims, including warranty, consumer fraud, and design defect, are really warning claims.  All warning claims involving a generic drug are preempted.  That no branded equivalent drug remains on the market does not affect preemption.  That the generic manufacturer purchased the brand name for the drug does not affect preemption.
  37. Moore v. Mylan, Inc., 840 F. Supp.2d 1337 (N.D. Ga. Jan. 5, 2012) (phenytoin).  Motion to dismiss granted.  State law claims challenging the adequacy of generic drug labeling are preempted.  That the defendant's product has been designated a reference listed drug does not establish that it may unilaterally change its warnings.  Negligence claims alleging that generic manufacturers had a duty to cease selling their product at all are preempted.  Such a claim, if it existed at all, would directly conflict with FDA authority to determine what drugs can be sold in interstate commerce.
  38. Fisher v. Pelstring, 817 F. Supp.2d 791 (D.S.C. Jan. 11, 2012) (metoclopramide).  Motion to dismiss denied with respect to preemption arguments.  An implied warranty claim not premised on warnings is not preempted.  Motion to dismiss denied on negligence, fraud, consumer fraud, and emotional distress claims relating to failure to update generic drug labeling to include FDA-approved changes. The changes relate to the plaintiff's claim.  A negligence action in which the standard of care is defined by statute is not necessarily the equivalent of private enforcement of the FDCA. Claim that generic defendants should have sent a Dear Doctor/DHCP letter consistent with the drug’s labeling, and without any new or additional warnings, are not preempted.
  39. Couick v. Wyeth, Inc., 2012 WL 79670 (W.D.N.C. Jan. 11, 2012) (metoclopramide). Motion to dismiss granted in part and denied in part. Without a showing establishing that the defendant's label actually mirrored the branded label, state law warning and express warranty claims may not be preempted. An implied warranty claim not premised on warnings is not preempted. No cause of action exists for failure to test. FDCA violation claims are preempted under Buckman.
  40. In re Fosamax Litigation, 2012 WL 181411 (D.N.J. Jan. 17, 2012) (alendronate sodium).  Motion for judgment on the pleadings granted.  An authorized distributor of a generic drug has no more ability to change warnings than any other generic drug manufacturer.
  41. Coney v. Mylan Pharmaceuticals, Inc., 2012 WL 170143, slip op. (S.D. Ga. Jan. 19, 2012) (phenytoin).  Motion for summary judgment granted.  State law claims, including fraud, challenging the adequacy of generic drug labeling are preempted.  Various warning theories were not pleaded.  Claims that generic manufacturers had a duty to cease selling their product at all are preempted.  Such claims  would directly conflict with FDA authority to determine what drugs can be sold in interstate commerce.  Generic preemption is not dependent on any way on conduct of branded manufacturers or other third parties.  Nonwarning claims are inadequately pleaded.
  42. In re Pamidronate Products Liability Litigation, 842 F. Supp.2d 479 (E.D.N.Y. Jan. 30, 2012) (pamindronate).  Motion to dismiss granted.  All state law claims are preempted.  State law claims challenging the adequacy of generic drug labeling are preempted.  Design defect claims are preempted because the same requirement of "sameness" applied to the design of generic drugs.  Negligent testing and breach of express warranty claims are warning claims in disguise and are preempted.  Implied warranty claims are design defect claims in disguise and are preempted.
  43. Kellogg v. Wyeth, 2012 WL 368658, slip op. (D. Vt. Feb. 3, 2012) (metoclopramide).  Motion for judgment on the pleadings granted.  All state law warning claims are preempted.  All claims alleging a duty to provide additional information are preempted, whether for promotional or educational purposes, and whether involving on or off-label use, as they would be different from the approved labeling.
  44. Lyman v. Pfizer, Inc., 2012 WL 368675, slip op. (D. Vt. Feb. 3, 2012) (metoclopramide).  Motion for judgment on the pleadings granted in part and denied in part.  All state law warning claims are preempted.  Design defect claims are preempted because the same requirement of "sameness" applied to the design of generic drugs.  Claims that generic manufacturers had a duty to cease selling their product at all are preempted.  Claims that generic manufacturers engaged in inadequate post-marketing surveillance are preempted.  Claims relating to failure to update generic drug labeling to include FDA-approved changes are not preempted but are inadequately pleaded.
  45. Moretti v. Mutual Pharmaceutical Co., 852 F. Supp.2d 1114 (D. Minn. Feb. 13, 2012) (metoclopramide).  Motion for judgment on the pleadings granted.  All state law warning claims are preempted.  Claims alleging inadequate post-marketing surveillance are warning-related claims and are preempted.   Claims that generic manufacturers had a duty to cease marketing their product at all are preempted.  Affirmed 2013 WL 3107472 (8th Cir. June 21, 2013), see below.
  46. Gaeta v. Perrigo Pharmaceuticals Co., 469 Fed. Appx. 556 (9th Cir. Feb. 27, 2012). Summary affirmance of pre-Mensing decision holding claims against generic manufacturer preempted. Follows remand from the Supreme Court.
  47. Bowman v. Wyeth, LLC, 2012 WL 684116 (D. Minn. March 2, 2012) (metoclopramide).  Motion for judgment on the pleadings granted.  Claims alleging false information, concealment, and knowingly marketing an unreasonably dangerous product are warning claims and are preempted.  Failure to update claims were not pleaded and fail to state a cause of action because plaintiff claims the later warnings are inadequate, and there is no duty to provide an inadequate warning.
  48. In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 718618, slip op.  (E.D. Ky. March 5, 2012) (propoxyphene).  Motion to dismiss granted.  Wrongful marketing claims that generic manufacturers had a duty to cease selling their product at all are preempted.  The sameness obligation applies to design as well as warning.  Both design and warning claims are preempted.  "Information and belief" pleading that the defendants did not update their warnings in a timely fashion is pure conjecture insufficient under TwIqbal to state a claim.  "Dear Doctor" letter-based warning claims are inadequately pleaded and would be preempted.  That a defendant's product has been designated a reference listed drug does not establish that it may unilaterally change its warnings.  Fraud, consumer fraud, and express warranty claims seek to change the label and are preempted.  Claims based on alleged violations of the FDCA are preempted as improper private rights of action.  Motion to amend denied 2012 WL 1478798 (E.D. Ky. April 27, 2012).
  49. Cooper v. Wyeth, Inc., 2012 WL 733846, slip op. (M.D. La. March 6, 2012) (metoclopramide).  Motion to dismiss granted in part and denied in part.  Claims that the defendant manufacturer failed to update its generic drug labeling to include FDA-approved changes are not preempted.  It is not impossible to comply with federal law.  Claims for failure to communicate strengthened labels via "Dear Doctor" letter following an FDA label change are not preempted.  These claims fit within existing tort causes of action and thus are not barred as private rights of action.  Claims of inadequate post-marketing pharmacovigilance are preempted.  Claims that generic manufacturers had a duty to cease selling their product at all seek repudiation of the FDA approved label and are preempted.  Claims of failure to use additional forms of communication to provide warnings are preempted.  That a defendant's product has been designated a reference listed drug does not establish that it may unilaterally change its warnings.  Express warranty claims based on labeling are preempted.
    Design defect claims are do not really challenge the design, only the warnings, and thus are preempted.  Manufacturing defect claims are inadequately pleaded.  Reconsideration granted 2013 WL 6502554 (M.D. La. Dec. 11, 2013), all remaining claims dismissed.  "Dear Doctor" letters are labeling which cannot be unilaterally altered.  A duty to update claim involves breach of a purely federal obligation.  There is no state law duty to give an inadequate warning.
  50. Blauvelt v. Teva Pharmaceuticals, USA, Inc., 2012 WL 4766950 (Pa. C.P. March 12, 2012) (cephalexin). Judgment on the pleadings granted. All of the plaintiffs' claims are effectively failure to warn claims and are preempted.
  51. Metz v. Wyeth, 872 F. Supp.2d 1335 (M.D. Fla. March 28, 2012) (metoclopramide).  Motion to dismiss granted in part and denied in part.  Summary judgment motion granted.  Negligence and warranty claims escape preemption to the extent they allege that the defendant should have taken additional steps to warn about information recently added to the FDA-approved label.  Claims that the drug should have been redesigned or removed from the market are preempted.  Inadequate testing and failure to report claims are preempted.  Summary judgment granted on grounds that the warnings were adequate as a matter of law.
  52. Phelps v. Wyeth, Inc., 857 F. Supp.2d 1114 (D. Or. April 24, 2012) (metoclopramide).  Summary judgment granted.  All warning claims preempted.  FDCA-based claims fail for lack of any private right of action.  Testing and monitoring claims cannot stand independently of a duty to warn.  Parallel claims cannot avoid implied preemption. 
  53. Eckhardt v. Qualitest Pharmaceuticals, Inc., 858 F. Supp.2d 792 (S.D. Tex. April 30, 2012) (metoclopramide).  Motion to dismiss granted.  Preemption is unaffected by the 2007 FDAAA amendments .  The fraud on the FDA exception to the Texas presumption of adequacy statute is preempted.  Failure to test or monitor is noncausal unless it results in a changed warning, and all warning claims are preempted.  Failure to update claims are preempted, to the extent pleaded, and not pleaded to the extend unpreempted.  Withdrawal from the market claims are a fortiori preempted.  Design defect and consumer fraud claims are preempted.  Defendant cannot be liable on theories Texas law has not recognized.  Affirmed, see below.
  54. Bartlett v. Mutual Pharmaceutical Co., 678 F.3d 30 (1st Cir. May 2, 2012) (suldinac).  Jury verdict for plaintiff affirmed.  A no-alternative design design defect claim is not preempted.  State law may impose liability on a generic drug manufacturer for not removing an FDA-approved drug from the market based on the jury's independent re-evaluation of the product's risks and benefits.  Second-guessing the FDA is permissible under Levine.
  55. In re Reglan Litigation, 2012 WL 1613329, slip op. (N.J. Super. Law Div. May 4, 2012) (metoclopramide).  Motion to dismiss granted in large part.   All plaintiffs' claims are warning-based and are preempted, except for failure to update labels when required by the FDA.  Nothing in the 2007 FDAAA changes the generic preemption analysis.  Claims of failure to use additional forms of communication to provide warnings are preempted.  Withdrawal from the market claims do not exist under state law and would be preempted if they did.
  56. In re Reglan Litigation,  2012 WL 1617417, slip op. (N.J. Super. Law Div. May 4, 2012) ("Reglan II") (metoclopramide).  Motion to dismiss granted.  That a defendant's product has been designated a reference listed drug does not establish that it may unilaterally change its warnings. 
  57. Brinkley v. Pfizer, Inc., 2012 WL 1865402 (W.D. Mo. May 22, 2012) (metoclopramide).  Motion for judgment on the pleadings granted.  All claims, including failure to communicate with doctors in other ways and failure to update, are merely back-door warning claims that are preempted.  On appeal at No. 13-3663.
  58. Johnson v. Teva Pharmaceuticals USA, Inc., 2012 WL 1866839 (W.D. La. May 21, 2012) (metoclopramide).  Judgment on the pleadings granted.   All warning claims preempted.  Claims of failure to use additional forms of communication to provide warnings are preempted.  Failure to update claims are not preempted, but fail to state a claim because plaintiff pleaded that even the updated warning would have been inadequate.  Express warranty and design defect claim asserting an alternative package design are really warning claims and are preempted.  Regular design defect claims are preempted because prior FDA approval is required.  A claim that the drug should have been removed from the market is preempted and does not state a claim under state law.  Affirmed see below
  59. Kriesmer v. Upsher-Smith Laboratories, Inc., 2012 WL 2003945 (Ohio C.P. May 24, 2012) (warfarin).  Motion to dismiss granted in part and denied in part.  All warning claims preempted.  Design/manufacturing defect claim that doses were subject to a recall because they contained more of the active ingredient than they were supposed to were not preempted.  Consumer fraud action survived because it did not have to be pleaded with specificity.
  60. Whalen v. Thompson, 2012 WL 9504373 (N.Y. Sup. May 29, 2012) (amiodorone).  Motion to dismiss granted.  Only warning claims are alleged, and all warning claims are preempted.
  61. Whitener, v. PLIVA, Inc., 2012 WL 1995795 (E.D. La. June 4, 2012) (metoclopramide).  Claims that the defendant passively knew its drug was being used off label are preempted.  Claims that the defendant actively promoted its drug for off-label use in violation of the FDCA might not be preempted and survive a motion to dismiss.
  62. In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 2457825, slip op. (E.D. Ky. June 22, 2012) (propoxyphene).  Motion to reconsider denied.  The Bartlett remove the product from the market theory is unpersuasive and is rejected.
  63. Lashley v. Pfizer, Inc.877 F. Supp.2d 466 (S.D. Miss. June 27, 2012) (metoclopramide).  Motion to dismiss granted.  All warning and design claims preempted.  Reconsideration denied (same citation).  Rejecting Bartlett and removal from the market claim, rejecting attempt to import parallel claim analysis into implied preemption.  Affirmed ___ F. Appx. ___, Nos. 12-60861, 12-41148, slip op. (5th Cir. Feb. 21, 2014), see below.
  64. Lyman v. Pfizer, Inc., 2012 WL 2970627 (D. Vt. July 20, 2012) (metoclopramide). Motion to dismiss granted. All warning claims preempted.  Claims of failure to use additional forms of communication to transmit later changed warnings are not preempted.  A failure to update claim is not preempted.  Claims that the product should have been packaged differently to discourage certain uses are preempted.  Design claim was preempted as a disguised attack on the product's warnings.
  65. Aucoin v. Amneal Pharmaceuticals, LLC, 2012 WL 2990697 (E.D. La. July 20, 2012) (tramadol). Motion to dismiss granted.  A claim that the drug should have been removed from the market is preempted as they necessarily repudiate the FDA approved label.  Design defect claims are preempted as generic designs are subject to the same "sameness" requirements as generic warnings. 
  66. In re Darvocet, Darvon & Propoxyphene Products Liability Litigation,  2012 WL 3109424 (E.D. Ky. July 31, 2012) (propoxyphene).  Judgment on the pleadings granted.  All claims against a contract manufacturer of generic drugs are either preempted by Mensing or barred by product identification.
  67. In re: Accutane (Isotretinoin) Products Liability Litigation, 2012 WL 3194952 (M.D. Fla. Aug. 7, 2012) (isotretinoin).  Judgment on the pleadings granted in part.  All warning claims preempted.  Design defect claims preempted under the statute's sameness requirement.  Plaintiff may replead a manufacturing defect claim.
  68. Strayhorn v. Wyeth Pharmaceuticals, Inc., 887 F. Supp.2d 799 (W.D. Tenn. Aug. 8, 2012) (metoclopramide).  Motions to dismiss granted in seven cases.  All warning claims preempted.  The Bartlett remove the product from the market theory is rejected.  Conte is unpersuasive and rejected.  Express preemption cases are irrelevant to implied preemption.  Dear Doctor letters are labeling so claims based on them are preempted.  Failure to conform claims are preempted as private attempts to enforce the FDCA.  Conspiracy claims are preempted.  Affirmed.
  69. Truddle v. Wyeth, LLC, 2012 WL 3338715 (N.D. Miss. Aug. 14, 2012) (metoclopramide).  Motion to dismiss granted.  All warning claims preempted, including consumer fraud.  A duty to test claim is a preempted warning claim because the test results would have to be communicated.  Fraud on the FDA claims are preempted.
  70. Wiley v. Jackson Medical Center, 2012 WL 6755096 (Ala. Cir. Aug 16, 2012) (promethazine).  Motion for summary judgment granted.  All warning claims preempted.  The branded drug's exit from the market did not allow the generic to change warnings unilaterally.  Even if the generic contractually obligated itself to update warnings, under the FDA regulations, it could not do so unilaterally. 
  71. Jacobsen v. Wyeth, LLC, 2012 WL 3575293 (E.D. La. Aug. 20, 2012) (metoclopramide).  Motion to dismiss granted.  To the extent a failure to monitor claim exists under Louisiana law, it is a warning claim and is preempted.  Monitoring must result in a label change to have any effect.  A "unit of use" design defect claim is really a warning claim and is preempted.  Design defect claims are also preempted by federal "sameness" requirements.  All warning claims, including Dear Doctor letters, are preempted.  Requiring a generic drug to be removed from the market is preempted as a repudiation of the label.  No failure to update claim was pleaded, and leave to amend is not sought.  An express warranty claim based on generic labeling is preempted, and no other warranty is alleged.
  72. Phares v. Actavis-Elizabeth LLC, 892 F. Supp.2d 835 (S.D. Tex. Aug. 30, 2012) (metoclopramide).  Motion to dismiss granted.  All warning claims preempted.  The fraud on the FDA exception to the Texas statutory presumption of adequacy is preempted, therefore the statutory presumption applied.  Fraud and suppression of evidence are inadequately pleaded.
  73. Madden v. Teva Pharmaceuticals USA, Inc.,  2012 WL 5129709 (Pa. C.P. Sept. 18, 2012) (zolpidem).  Judgment on the pleadings granted.  All warning claims preempted.
  74. Hogue v. Pfizer, Inc.893 F.Supp.2d 914 (S.D. Ohio Sept. 27, 2012) (metoclopramide).  Judgment on the pleadings granted.  All warning claims preempted, which includes express and implied warranty, misrepresentation, fraud, and misbranding-based negligence per se claims.  A reference listed drug designation does not convert the defendant into a branded manufacturer for purposes of preemption.  Dear Doctor letter, failure to update, and design defect claims preempted.
  75. Demahy v. Schwarz Pharma, Inc., 702 F.3d 177 (5th Cir. Oct. 25, 2012) (metoclopramide).  Motion to set aside judgment denied.  All warning claims preempted, and plaintiff did not assert anything else.  Equating design-related claims with failure to warn.
  76. Acree v. Watson Pharmaceuticals, Inc., 2012 WL 5306296 (N.D. Ill. Oct. 26, 2012) (fentamy patch).  Summary judgment denied.  Plaintiff's design defect claim was not preempted because evidence established a disputed issue of fact whether the FDA would have approved an ANDA using the alternative delivery design plaintiff advocated.  The evidence established that a competitor had such an ANDA approved.
  77. Pirello v. Qualitest Pharmaceuticals, Inc., 2012 WL 5363243 (M.D. La. Oct. 30, 2012) (metoclopramide). Judgment on the pleadings granted.  All warning claims preempted, and all means of communication with physicians are labeling, subject to sameness requirement. No express warranty claim survives because no advertisements beyond FDA-regulated labeling are alleged. Plaintiff failed to plead a design defect claim and Bartlett is not persuasive.
  78. Purvis v. Teva Pharmaceuticals, USA, Inc., 901 F. Supp.2d 716 (M.D. La. Oct. 30, 2012) (metoclopramide).  Judgment on the pleadings granted.  All warning claims preempted, and all means of communication with physicians are labeling, subject to sameness requirement.  No express warranty claim survives because no advertisements beyond FDA-regulated labeling are alleged.  Plaintiff failed to plead a design defect claim and Bartlett is not persuasive.
  79. Bowdrie v. Sun Pharmaceutical Industries Ltd., 909 F. Supp.2d 179 (E.D.N.Y. Nov. 9, 2012) (phenytoin).  Remand denied; motion to dismiss granted.  Where preemption has removed the usual common-law claims involving generic drugs, leaving only allegations that the defendant violated a federal "duty of sameness" and other FDCA-related claims, the causes of action have a substantial, disputed question of federal law as a necessary element, and the complaint is removable under federal question jurisdiction.  The failure to update claim is preempted because even updates to match branded label changes require approval by the FDA.  Strict liability, warranty, fraud, and negligence per se claims based on failure to update are likewise preempted.
  80. James C H v. Mylan Inc., 2012 WL 5504785 (E.D. Wis. Nov. 13, 2012) (fentamyl patch).  Partial motion to dismiss granted.  Marketing based claims, fraud, misrepresentation, and failure to warn claims are all labeling related and thus preempted.  All claims attacking the information provided the FDA are preempted by Buckman.
  81. Harris v. Pharmaceutical Associates, Inc., 2012 WL 6025954 (E.D. La. Dec. 4, 2012) (metoclopramide).  Motion to amend denied with prejudice.  All warning claims, including those involving Dear Doctor letters, "training programs" for doctors, and "specialized packaging" are preempted as involving labeling subject to the "sameness" requirement.
  82. Frazier v. Mylan, Inc., 911 F. Supp.2d 1285 (N.D. Ga. Dec. 18, 2012) (phentoyin).  Generic defendant's motion to dismiss granted.  All warning claims are preempted.  Any state-law duty to withdraw a product would be preempted by direct conflict with the FDA's power to determine what drugs can be sold in interstate commerce.  Design defect claims are preempted because generic designs are also subject to federal "sameness" requirements.  Bartlett is contrary to the logic of Mensing.
  83. White v. Mylan, Inc., 2012 WL 6951323 (W.D. Okla. Dec. 28, 2012) (fentamyl patch).  Motion to dismiss granted, primarily on TwIqbal grounds.  The complaint is too vague to find preemption, although several of the claims probably are.  Any request for judicial notice must comply with Rule 201.
  84. Abicht v. PLIVA, Inc., 2013 WL 141724 (D. Minn. Jan. 9, 2013) (metoclopramide).  Judgment on the pleadings granted.  All warning claims are preempted.  Failure to update claim is preempted because it seeks to enforce the FDCA.
  85. Gardley-Starks v. Pfizer, Inc., 917 F. Supp.2d 597 (N.D. Miss. Jan. 10, 2013) (metoclopramide).  Motion to dismiss granted.  All warning claims including "dear doctor" letters are preempted.  Failure to withdraw claim is preempted.  Failure to update claim dismissed as inadequately pleaded.  Design defect claim is preempted.  Reconsideration denied, 2013 WL 5423951 (N.D. Miss. Sept. 26, 2013).  Bartlett only reinforces preemption.  Mississippi follows risk/utility design defect.
  86. Arters v. Sandoz, Inc., 921 F. Supp.2d 813 (S.D. Ohio Jan. 25, 2013) (amiodarone).  Judgment on the pleadings granted in part and denied in part.  Applies presumption against presumption and pre-TwIqbal (Conley) standard of review.  All warning claims including "dear doctor" letters, are preempted.  Failure to withdraw/design defect claims involve a different duty and are not preempted.  Negligence, implied warranty, and fraud claims alleging off-label promotion are not preempted.
  87. Bryant v. Apotex, Inc., 2013 WL 394705 (E.D. Cal. Jan 30, 2013) (Gabapentin and Tramadol).  Judgment on the pleadings granted in part and denied in part.  Fraud claims are inadequately pleaded.  Overpromotion-type allegation that manufacturer told plaintiff's prison physicians to ignore its warnings and administer the drugs in a contraindicated fashion was not preempted.
  88. Morris v. PLIVA, Inc., 713 F.3d 774 (5th Cir. Feb. 14, 2013) (metoclopramide).  Judgment on the pleadings affirmed.  All warning claims, including those involving Dear Doctor letters are preempted.  Failure to update claim fails because plaintiffs alleged the updated warning was still defective.  Failure to update and test claims are preempted because they seek to enforce the FDCA.  A reference listed drug designation does not convert the defendant into a branded manufacturer for purposes of preemption.  Express warranty claim based on failure to remove from the market is preempted.
  89. Rojas v. Teva Pharmaceuticals USA, Inc., 920 F. Supp.2d 772 (S.D. Tex. Feb. 21, 2013) (metoclopramide).   Judgment on the pleadings granted.  All warning claims, including failure to test and off-label promotion, are preempted.  Manufacturing defect and fraud claims are not adequately pleaded.  Remove from the market claims are preempted, disagreeing with Bartlett.  Design defect claims are preempted by sameness requirement, and do not state a cause of action for lack of alternative design.  Failure to update claims fail to plead causation under the learned intermediary rule.
  90. Garza v. Wyeth LLC, 2013 WL 878586 (S.D. Tex. March 7, 2013) (metoclopramide).  Motion to dismiss granted in part and denied in part.  All warning claims are preempted except for failure to update in violation of FDA regulations.  State law does not recognize any claims other than warning in prescription drug cases.  Allegation of violation of FDA regulations precludes dismissal of warning claim under state presumption.  Fraud on the FDA statutory exception is preempted.  Second decision also allowing failure to update (but no other) claim - 2013 WL 3293956 (S.D. Tex. June 28, 2013).  Third decision granting summary judgment where warning was actually updated and rejecting Dear Doctor letter claim - 2013 WL 3293704 (S.D. Tex. June 28, 2013).
  91. Fulgenzi v. PLIVA, Inc.711 F.3d 578 (6th Cir. March 13, 2013) (metoclopramide).   Granting of motion to dismiss reversed in part.  A duty to update claim is not preempted.  It is not impossible to update warnings that the FDA has ordered changed, it is required.  Implied preemption is not supported by a general congressional purpose to encourage use of generic drugs.  Duty to update claims are not impliedly preempted as attempts to enforce an exclusively federal duty because such a duty may also exist under state law, separately from the FDCA.  Nothing in Ohio law prohibits assertion of a duty to give a warning that is nevertheless legally inadequate.  Because of the sameness requirement, plaintiff cannot suggest that any other warning, besides the FDA-approved update, should be given.  Reversing Fulgenzi v. PLIVA, Inc., 867 F. Supp.2d 966 (N.D. Ohio March 31, 2012).
  92. Chatman v. Pfizer, Inc., ___ F. Supp.2d ___, 2013 WL 1305506 (S.D. Miss. March 28, 2013) (metoclopramide).  Judgment on the pleadings granted.  Warning claims concededly preempted.  "Dear Doctor" letter claim is preempted.  Failure to update claims preempted.  Design defect, express warranty, fraud, and negligence claims are disguised warning claims.
  93. Phelps v. Wyeth Inc., 938 F. Supp.2d 1055 (D. Or. April 2, 2013) (metoclopramide).  Summary judgment denied on failure to update claims.  Impossibility rationale does not apply since FDCA required updating.  Mensing and some other appellate cases did not address updating violations.  Update claim based on state negligence is not disguised private enforcement of the FDCA.  Failure to update can inform state negligence duties.
  94. Krelic v. Mutual Pharmaceuticals Co., 2013 WL 1852473, slip op. (Pa. C.P. Allegheny Co. April 11, 2013)  (prednisone). Summary judgment granted.  All plaintiff's claims involve changes to the defendant's warnings and are preempted.  The "different manufacturers exception" to the sameness exception does not defeat preemption of warning claims. That exception does not permit different labeling as to safety and efficacy.  It does not apply to active ingrediants and other aspects where sameness is required, but only to inactive ingredients and other irrelevant aspects of generic drugs.  The FDA rejected comments advocating the equivalent of a CBE process for generic drugs.
  95. Teva Pharmaceuticals USA, Inc. v. Superior Court, 217 Cal. App.4th 96, 158 Cal. Rptr.3d 150
    (Cal. App. June 13, 2013) (alendronate).  Overruling of demurrer affirmed.  A duty to update claim is not preempted.  It is not impossible to update warnings that the FDA has ordered changed, it is required.  Following Fulgenzi.   A "Dear Doctor" letter claim is not preempted, to the extent that the communication followed FDA-approved updates in the labeling.
  96. Bell v. Pfizer, Inc., 716 F.3d 1087 (8th Cir. June 14, 2013) (metoclopramide).   Motion to dismiss affirmed as to all warning claims. All state law warning claims are preempted. Whether design defect and implied warranty claims are warning claims was not fully addressed by the district court, so dismissal of those claims is vacated and remanded.  Failure to update generic warning claims fail because the prescriber did not rely on the generic defendants' warnings, so preemption issues need not be addressed.  Affirming in part and vacating in part 845 F.Supp.2d 967.
  97. Moretti v. Mutual Pharmaceutical Co., ___ Fed. Appx. ___, 2013 WL 3107472 (8th Cir. June 21, 2013) (metoclopramide).  Judgment on the pleadings affirmed.  All of plaintiff's claims involved warnings.  All other arguments were waived.
  98. Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466, slip op. (U.S. June 24, 2013) (suldinac).  Jury verdict for plaintiff reversed.  Bartlett v. Mutual Pharmaceutical Co., (1st Cir. May 2, 2012) affirmed.   Generic drug companies cannot be liable for design defects.  The design of a generic drug must be the same as its reference drug.  Drugs composed of a single molecule cannot be redesigned, only labeled differently.  Mensing bars all warning-related claims.  Impossibilty preemption cannot be avoided by arguing that manufacturers have the option of removing their FDA-approved products from the market altogether.  That argument would eliminate implied preemption.  Reversing 678 F.3d 30.
  99. Guarino v. Wyeth, 719 F.3d 1245  (11th Cir. June 25, 2013) (metoclopramide).  Rule 12(b)(6) dismissal affirmed.  A "failure to communicate" claim based on Dear Doctor letters is a warning claim in disguise.  All state law warning claims are preempted.
  100. In re Isotretinoin Litigation, No. ATL-L-1321-09, 2013 WL 3483813 (N.J. Super. Law Div. June 28, 2013) (isotretinoin).  All claims dismissed.  The relevant warnings were at all times the same as the warnings required by the FDA for the branded product.   Nothing in the 2007 FDAAA changes the generic preemption analysis.  All state law warning claims, including implied warranty, common law fraud, fraudulent concealment, and negligent misrepresentation, are preempted, and warnings are the crux of all plaintiff's allegations.  Generic manufacturers cannot change the designs of their products, so design defect claims are preempted.  Where a manufacturer cannot change its design or label, risk/utility-based claim is preempted.  "Dear Doctor" letter claims are preempted.  Requesting a label change from the branded manufacturer would turn in the speculative actions of the branded manufactuere, and is therefore preempted by analogy to Mensing.  Wrongful marketing claims that generic manufacturers had a duty to cease selling their product at all do not exist under state law and are preempted.  Claims of inadequate post-marketing pharmacovigilance are preempted. 
  101. Ko v. Mutual Pharmaceutical Co., 2013 WL 3338596 (N.D. Cal. July 1, 2013) (suldinac).  Motion to dismiss granted.  All warning related claims are preempted.  Pro se plaintiff's complaint is vague as to what is alleged.  Leave to amend granted.
  102. Fullington v. PLIVA, Inc., 720 F.3d 739 (8th Cir. July 15, 2013) (metoclopramide).   Grant of motion to dismiss largely affirmed.   State law claims challenging the adequacy of generic drug labeling are preempted.   These are the vast majority of the claims.  Dismissal of possible non-warning claims vacated and remanded for probable re-dismissal in light of Bartlett.  The only possible distinction is between the risk/utility defect theory in Bartlett and Arkansas' following of a consumer protection design defect model.  Failure to update generic warning claims fail because the prescriber did not rely on the generic defendants' warnings, so preemption issues need not be addressed.  Affirming in part and vacating in part 2011 WL 6153608 (E.D. Ark. Dec. 12, 2011), reconsideration denied, 2012 WL 2918711 (E.D. Ark. July 17, 2012).
  103. Hassett v. Dafoe, ___ A.3d ___, 2013 WL 3874882 (Pa. Super. July 29, 2013) (metoclopramide).  Denial of preliminary objections affirmed in part and reversed in part in over 2000 cases involving claims from through out the country. Blanket preemption of state-law specific claims is premature. Absolute liability claims without regard to whether drugs can be redesigned is not a warning claim, nor are warning claims that subject distributors and retailers of defective products to strict liability even though they have no control over the design of the product. These might have vitality, but might be preempted under Bartlett as stop selling claims. Preemption depends on comparing the federal requirement against the particular state law at issue. Preemption of warning claims does not necessarily extend to marketing, negligent testing, or express and implied warranties. Warranty claims based on advertising and promotion not constituting FDA approved labeling would not be preempted, as only labeling is subject to a sameness requirement. Fraudulent advertising and promotion are not warning claims, but are based on a duty not to deceive. Disgorgement and civil conspiracy are not warning claims, but remedies for tortious business practices. Failure to communicate updated warning claims were not addressed by the Supreme Court and might survive preemption. Failure to update claims may be pursued as negligence per se and do not seek to enforce the FDCA. Without a thorough analysis preempting post-FDAAA warning claims is premature. Pre-FDAAA claims involving compliant generic labeling are preempted. Design claims may be preempted but is premature without a state-by-state analysis
  104. In re Reglan/Metoclopramide Litigation, ___ A.3d ___, 2013 WL 3874905, (Pa. Super. July 29, 2013) (metoclopramide).   Denial of preliminary objections affirmed in part and reversed in part in over 2000 cases involving claims from through out the country. Blanket preemption of state-law specific claims is premature. Absolute liability claims without regard to whether drugs can be redesigned is not a warning claim, nor are warning claims that subject distributors and retailers of defective products to strict liability even though they have no control over the design of the product. These might have vitality, but might be preempted under Bartlett as stop selling claims. Preemption depends on comparing the federal requirement against the particular state law at issue. Preemption of warning claims does not necessarily extend to marketing, negligent testing, or express and implied warranties. Warranty claims based on advertising and promotion not constituting FDA approved labeling would not be preempted, as only labeling is subject to a sameness requirement.  Fraudulent advertising and promotion are not warning claims, but are based on a duty not to deceive.  Disgorgement and civil conspiracy are not warning claims, but remedies for tortious business practices.   Failure to communicate updated warning claims were not addressed by the Supreme Court and might survive preemption. Failure to update claims may be pursued as negligence per se and do not seek to enforce the FDCA. Without a thorough analysis preempting post-FDAAA warning claims is premature. Pre-FDAAA claims involving compliant generic labeling are preempted.   Design claims may be preempted but is premature without a state-by-state analysis.
  105. In re Reglan/Metoclopramide Litigation, ___ A.3d ___, 2013 WL 3874931 (Pa. Super. July 29, 2013) (metoclopramide).   Denial of preliminary objections affirmed.  Whether the manufacturer of a generic drug, designated by the FDA as a reference listed drug after the withdrawal of the original innovator RLD from the market, acquires as a result of the FDA's designation the ability to change its label unilaterally through the CBE process is unclear under FDA administrative pronouncements.  Because the RLD defendant has the burden of proof, it has not established preemption.
  106. Neeley v. Wolters Kluwer Health, Inc., 2013 WL 3929059, slip op. (E.D. Mo. July 29, 2013) (metoclopramide).  Motion to dismiss granted in part and denied in part.  Duty to update claims are not preempted by sameness or Buckman.  It cannot be determined from the pleadings whether Kentucky law design defect claims are preempted.
  107. In re Fosamax Products Liability Litigation, 2013 WL 4306434, slip op. (S.D.N.Y. Aug. 15, 2013) (alendronate sodium).  Plaintiffs conceded most warning claims preempted.  Failure to update claims are not preempted.  Failure to communicate claims based on "Dear Doctor" letters are preempted.  Design defect claims are preempted since any change would have required FDA pre-approval.  Changes in design and warning are preempted, as is any claim to that the product should not have been marketed.  There is no other possible method of compliance, so design defect claims are preempted.
  108. Schrock v. Wyeth Inc., 727 F.3d 1273 (10th Cir. Aug. 28, 2013) (metoclopramide).  Denial of leave to amend to add express and implied warranty claims affirmed.  To the extent they are warning claims they are preempted.  To the extent they challenge the composition of the drug they are also preempted because design changes require prior FDA approval.  Stop selling claims are preempted.  Plaintiffs did not plead a misbranding claim.
  109. Parris v. Eli Lilly & Co., 2013 WL 5310167 (E.D. Tenn. Sept. 20, 2013) (fluoxetine).  Judgment on the pleadings granted.   All warning related claims are preempted, and plaintiff alleged nothing else.
  110. Ko v. Mutual Pharmaceutical Co., 2013 WL 5692375 (N.D. Cal. Oct. 18, 2013) (suldinac).  Motion to dismiss granted against all claims brought by pro se plaintiff.  All warning claims, including warranty and unfair competition are preempted.  A claim that preemption is unjust is beyond the power of a lower court to address.
  111. Tillman v. Woldenberg Village, Inc., 2013 WL 6198864, slip op. (E.D. La. Nov. 27, 2013) (phenytoin).  Motion to dismiss granted against all claims.  Design defect claims are preempted.  A trial court cannot ignore Supreme Court precedent as unfair.
  112. Strayhorn v. Wyeth Pharmaceuticals, 737 F.3d 378 (6th Cir. Dec. 2, 2013) (metoclopramide).   Grant of motion to dismiss against all claims affirmed under Tennessee law.  Warning claims, however styled, are preempted.  Warranty and fraud claims seek changes in labeling, and are preempted.  Express warranty claims also fail under TwIqbal.  Design defect claims are barred by Bartlett.  "Dear Doctor" letters are labeling and different labels are preempted.  Mensing and Bartlett control, not cases applying express preemption.  Failure to update claims fail under TwIqbal.  Conspiracy claims both failed TwIqbal and involved warnings.  Affirming 887 F. Supp.2d 799.
  113. Wilson v. Amneal Pharmaceuticals, L.L.C., 2013 WL 6909930 (D. Idaho Dec. 31, 2013) (generic Bactrim).  Motion for judgment on the pleadings granted against all claims.  Judicial notice of FDA documents and drug labeling allowed.  All warning and design claims preempted.  Plaintiff did not plead a failure to update claim.
  114. Drager v. PLIVA USA, Inc., ___ F.3d ___, 2014 WL 292700 (4th Cir. Jan. 28, 2014) (metoclopramide).  Judgment on the pleadings affirmed against all claims under Maryland law.  Plaintiff can't claim error in the denial of a motion to amend that was never made.  A generic manufacturer cannot be forced to change its label, change its design, stop selling its product or accept tort liability for not doing those things.  Claims based on marketing, testing, or post-market surveillance are all warning-related and preempted.  Whether a design defect claim is based on consumer expectations or risk/utility, it is preempted because it would require a design change without mandatory FDA pre-approval.  All express and implied warranty claims are preempted.  Fraud and negligent misrepresentation claims are preempted even if based on "promotional" materials because such claims are based on product information; it is "frivolous" to argue otherwise.
  115. Lashley & Del Valle v. Pfizer, Inc., ___ F.2d ___, 2014 WL 661058, slip op. (5th Cir. Feb. 21, 2014) (metoclopramide).  Grant of motions to dismiss against all claims affirmed under Mississippi and Texas law.  Failure to communicate/Dear Doctor letter claims are preempted.  There is no liability under state law for failure to include better warnings that are still inadequate.  Parallel claims analysis is unavailable in an implied preemption case.
  116. Dolin v. SmithKlineBeecham Corp., No. 12-6403, slip op. (N.D. Ill. Feb. 28 2014) (paroxetine).  Motion to dismiss granted against all claims.  Where there was no warning of a risk, and plaintiff claims that there should have been, there is no way a "Dear Doctor" letter claim could involve information that is the same as the label.
  117. Fullington v. Pfizer, Inc., No. 4:10CV00236 JLH, slip op. (E.D. Ark. Feb. 28, 2014) (metoclopramide).  Motion to dismiss remanded claims (see Fullington, 720 F.3d 739, above) granted.   Whether a design defect claim is based on consumer expectations or risk/utility, it is preempted because it would require a design change without mandatory FDA pre-approval.  Plaintiff could not identify anything that defendant could have done to comply with state law that did not violate federal law.  Plaintiff had no explanation how post-market surveillance fit as a recognized cause of action Arkansas law, and no explanation how post-market surveillance would have prevented the defendant from being liable.
  118. In re Yasmin & Yaz Drospirenone Marketing, Sales Practices & Products Liability Litigation, MDL No. 2100, 2014 U.S. Dist. Lexis 56862 (S.D. Ill. April 24, 2014) (drospirenone; ethinyl estradiol).  Judgment on the pleadings granted against all but one claim against authorized distributor of generic drug.  Distributors cannot unilaterally change FDA-approved labels.  Nothing in the 2007 FDAAA changes anything relevant to generic preemption.  Whether a design defect claim is based on consumer expectations or risk/utility, it is preempted because it would require a design change without mandatory FDA pre-approval.  A claim that the distributor participated in failing to report post-marketing risks that would have resulted in a misbranded product is not preempted outright, and raises factual issues that cannot be decided on the pleadings, and would escape preemption.
  119. In re Fosamax (Alendronate Sodium) Products Liability Litigation (No. II), ___ F.3d ___, 2104 WL 1687811, slip op. (3d Cir. April 30, 2014) (alendronate sodium).  Judgment on the pleadings affirmed against design defect claims (all other claims waived).  Any product liability claim that requires a generic drug manufacturer to change its warnings, change its design or remove its product from the market is preempted.  Neither Restatement (Second) §402A, comment k, nor Restatement (Third) §6(c) state unpreempted theories.
  120. Willis v. Hospira, Inc., 2014 WL 2795315 (Mag. E.D. Tex. May 5, 2014), adopted, same citation (E.D. Tex. June 3, 2014) (metoclopramide).  Motion to dismiss granted against all claims.  The only viable theory against a prescription drug in Texas is a warning claim, and all warning claims are preempted.  Fraud on FDA allegations preempted by Buckman.  Failure to commuincate/report claims are preempted.
  121. Eckhardt v. Qualitest Pharmaceuticals, Inc., ___ F.3d ___, 2014 WL 1908651 (5th Cir., May 13, 2004) (metoclopramide).  Granting of motion to dismiss affirmed against all claims.  All claims are product liability claims under the Texas statute.  All warning claims preempted by Mensing.  All design claims preempted by Bartlett.   An alternative design requirement is incompatible with FDA design approval.  Breach of warranty claims and consumer protection claims are warning-based and are preempted.  Affirming 858 F. Supp.2d 792.
  122. Dietrich v. Actavis, Inc., ___ So.3d___, 2014 WL 2101318 (Fla. App. May 21, 2014) (not stated).  Pleadings based preemption ruling affirmed.  Mensing preempts warning claims and is properly extended to failure to communicate claims based on Dear Doctor letters.
  123. Hendricks v. Pharmacia Corp., 2014 WL 2515478 (Mag. S.D. Ohio June 4, 2014) (phenytoin).  Motion to dismiss granted against all claims.  Warning claims, including implied warranty, and design claims are all preempted.  Pro se prisoner case.
  124. Moretti v. Wyeth, Inc., ___ F. Appx. ___, 2014 WL 2726886, slip op. (9th Cir. June 17, 2009) (metoclopramide).  Granting of motion to dismiss affirmed against all claims.  Claims based on failure to change a generic drug's warnings or composition are preempted.  Failure to report adverse events are preempted because any change to warnings remained dependent on the FDA's discretionary action.  Failure to withdraw claims are preempted.  Failure to update claim was non-causal because plaintiff had stopped taking the drug.
  125. In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, ___ F.3d ___, 2014 WL 2959271slip op. (6th Cir. June 27, 2014).  Granting of motion to dismiss affirmed against all claims.  "Parallel" misbranding claims, assuming they exist and could be an exception to preemption, are not pleaded without new information available to the generic defendants.  Information that the FDA already had is not sufficient.  Failure to update claims insufficiently pleaded.  "Dear Doctor" letter claims preempted.  Preemption applies equally to generic drugs designated as reference listed drugs by the FDA. All warranty, fraud, misrepresentation, and consumer fraud claims preempted.  Allegations that the defendants were negligent by violating the FDCA were impliedly preempted by Buckman.  All claims against an innovator who had sold its NDAs and thereafter manufactured on a contract basis for a generic ANDA holder are preempted because the innovator could not act without prior approval.
  126. Huck v. Wyeth, Inc., ___ N.W.2d ___, 2014 WL 3377071, slip op. (Iowa July 11, 2014) (metoclopramide).  Allows failure to update claims - the only claims appealed - to escape preemption.  Such claims can be brought without depending on the FDCA.  Reversing 2013 WL 1749774 and 2012 WL 553492 with respect to failure to update.
  127. Johnson v. Teva Pharmaceuticals USA, Inc., ___ F.3d ___, 2014 WL 3397786, slip op. (5th Cir. July 11, 2014) (metoclopramide).  Granting of motion to for judgment on the pleadings affirmed against all claims. All claims are product liability claims under the Louisiana statute. All warning claims including those based on Dear Doctor" letters, preempted by Mensing. Failure to update claims preempted as FDCA private enforcement.  No cause of action for failing to give a different, inadequate warning.  All design and stop-selling claims preempted by Bartlett.  Express warranty claims are warning-based and are preempted. Affirming 2012 WL 1866839.
  128. Wagner v. Pfizer, Inc., 2014 WL 3447476, slip op. (W.D. Wis. July 11, 2014) (synthetic progestins - hormone therapy).  Judgment on the pleadings granted.  All of plaintiff's claims, including infliction of emotional distress, would require changing either the generic drug's warnings or composition, which are preempted.  Failure to update claims are preempted as disguised FDCA enforcement.  There is no duty to give an inadequate warning.

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