It’s no secret that non-medical device preemption arguments haven’t been as successful after Wyeth v. Levine as they were before.  Here at the Drug and Device Law Blog, we like to provide information, but we also follow a defense Hippocratic Oath not to do harm by doing the other side’s research for them.  Our “scorecards” cover all decisions on both sides of an issue – but for us to keep a scorecard, the good guys (our clients) have to be doing well enough that we’re not in effect helping the other side.  That’s why we also have “cheat sheets” that include only those cases where our side wins.

Levine changed the landscape.  Thus after thinking long and hard about it, we’ve decided to “demote” non-device preemption from a scorecard to a cheat sheet.  So here’s our Post/Levine drug/vaccine cheat sheet.  Maybe, if we prevail in Bruesewitz, the landscape changes again and we’ll separate out vaccines.  Fingers crossed.

  1. Smith v. Wyeth, 2009 WL 736208 (W.D. Ky. March 4, 2009), minute order reaffirming in light of Levine prior decision (2008 WL 4697002, reconsideration denied, 2009 WL 425032) (see pre-Levine scorecard) finding broad preemption of warning claims in case involving generic Reglan; entering final judgment (3/20/09) to permit immediate appellate review. An appeal (No. 09-5460) is pending in the Sixth Circuit.
  2. Morris v. Wyeth, 2009 WL 736200 (W.D. Ky. March 4, 2009), minute order reaffirming in light of Levine prior decision (582 F.Supp.2d 861, reconsideration denied, 642 F. Supp.2d 677) (see pre-Levine scorecard) finding broad preemption of warning claims in case involving generic Reglan; entering final judgment (3/20/09) to permit immediate appellate review. An appeal (No. 09-5509) is pending in the Sixth Circuit
  3. Wilson v. Wyeth, Inc., 2009 WL 736198 (W.D. Ky. March 5, 2009), minute order reaffirming in light of Levine prior decision (2008 WL 4696995, reconsideration denied, 2009 WL 425027) (see pre-Levine scorecard) finding broad preemption of warning claims in case involving generic Reglan; entering final judgment (3/20/09) to permit immediate appellate review. An appeal (No. 09-5466) is pending in the Sixth Circuit
  4. In re Aredia & Zometa Products Liability Litigation, 2009 WL 2497229 (M.D. Tenn. Aug. 13, 2009), finding preemption of fraud-on-the-FDA allegation made in opposition to Michigan tort reform statute presumption of non-defectiveness from regulatory compliance.
  5. In re: Aredia & Zometa Products Liability Litigation, 352 Fed. Appx. 994 (6th Cir. Nov. 24, 2009), affirming preemption (see pre-Levine scorecard) of fraud-on-the-FDA exception to Michigan tort reform statute. Preemption applies to all claims alleging fraud on the FDA, including post-approval fraud and fraud asserted against an affirmative defense.
  6. Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 682 F. Supp.2d 662, 678 (N.D. Tex. Jan. 27, 2010), dictum stating that “clear evidence” supporting preemption would exist if plaintiffs were claiming only that two technical disease terms should have been used in OTC labeling, in light of regulatory history rejecting these terms.  Finding, however, that plaintiff’s claims were broader than that.  Reconsideration denied, 2010 WL 2484505 (N.D. Tex. June 17, 2010).  Affirmed on other grounds, 672 F.3d 372 (5th Cir. 2012).
  7. Murphy v. Mylan, Inc., 2010 WL 2008797 (Utah Dist. Iron Co. May 10, 2010), finding Buckman preemption in case (specific drug not stated) involving statutory fraud-on-the-FDA exception to Utah statute barring punitive damages against manufacturers of FDA-approved drugs.
  8. Robinson v. McNeil Consumer Healthcare, 615 F.3d 861 (7th Cir. Aug. 11, 2010), finding failure to warn claim in in OTC Motrin case preempted with respect to failure to warn of SJS/TEN because the FDA rejected that warning in response to a petition. The FDA’s rejection was “clear evidence” under Levine that would not permit the warning plaintiff advocated. Possible preemption of claim that OTC drug should have been sold by prescription only.
  9. Goldsmith v. Allergan, Inc., 2011 WL 147714 (C.D. Cal. Jan. 13, 2011), finding consumer fraud claims preempted in Botox case where the allegations of illegal off-label promotion were nothing more than a private attempt to enforce the FDCA.
  10. Bruesewitz v. Wyeth LLC, 562 U.S. 223 (Feb. 22, 2011), Vaccine Act expressly preempts all design defect claims against vaccine manufacturers.  Any other reading would render “unavoidable” as used in the Act meaningless.  No mention of any presumption against preemption.  Affirming 561 F.3d 233 (3d Cir. March 27, 2009).
  11. Dobbs v. Wyeth Pharmaceuticals, 797 F. Supp.2d 1264 (W.D. Okla. June 13, 2011), regulatory history of Effexor was “clear evidence” that, had the defendant submitted a stronger warning about adult suicide to the FDA, the FDA would have rejected it.  Plaintiff’s failure to warn claim was preempted.
  12. Emerson v. Novartis Pharmaceuticals Corp., 446 Fed. Appx. 733 (6th Cir. Aug. 23, 2011), fraud on the FDA claims, made in pursuant to a statutory presumption of non-defectiveness by reason of FDA compliance, were preempted.
  13. In re Fosamax (Alendronate Sodium) Products Liability Litigation (No. II), 2012 WL 181411 (D.N.J. Jan. 17, 2012).  An authorized distributor of an innovator drug does not hold that drug’s New Drug Application and has no power to change that drug’s labeling.  Warning claims are preempted against those having no power to change the labeling unilaterally.
  14. Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372 (5th Cir. Feb. 22, 2012), fraud on the FDA claims, made in pursuant to a statutory presumption (Texas) of non-defectiveness by reason of FDA compliance, were preempted.  Garcia‘s reasoning is more persuasive than DesianoAffirming 682 F. Supp.2d 662  (N.D.Tex. Jan. 27, 2010).
  15. Romero v. Wyeth LLC, 2012 WL 12547105 (E.D. Tex. May 30, 2012), fraud on the FDA claims, made in pursuant to a statutory presumption (Texas) of non-defectiveness by reason of FDA compliance, were preempted.
  16. Marsh v. Genentech, Inc., 693 F.3d 546 (6th Cir. Sept. 6, 2012).  Reaffirming Garcia that Buckman preemption applies to fraud on the FDA statutory immunity exceptions and all other claims that attack the sufficiency of information submitted to the FDA.  “Compliance” refers to the aspects of the drug specified in the statute and not to fraud on the FDA-related non-compliance.  If “compliance” were broadly interpreted, then it would be preempted by Buckman for the same reasons as Garcia.  While Levine would preclude preemption of ordinary warning claims, the statute abolished those claims as a matter of state law.
  17. In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 1831632, slip op. (E.D. Ky. Oct. 10, 2012).  Mensing preemption bars warning-related claims in a branded drug case where the defendant had sold its NDA, and thus lost the ability to change warnings through the CBE process, before the plaintiff used its drug manufacture the product that the plaintiff ingested.  Affirmed, see below.
  18. In re Fosamax (Alendronate Sodium) Products Liability Litigation, 951 F. Supp.2d 695 (D.N.J. June 27, 2013).  The FDA’s rejection of a supplement submitted for pre-approval two days after the plaintiff suffered the injury that was the subject of the supplement was “clear evidence” that the FDA would have rejected a CBE submission concerning the same drug risk.  The substantive scientific standard for a warning was the same for both types of regulatory submissions.  The FDA had more information from more sources than any one manufacturer, and there was no evidence that any information was withheld.  Therefore, the plaintiff’s warning claim was impliedly preempted under Levine.
  19. Thompson v. Allergan USA, Inc., 993 F. Supp.2d 1007 (E.D. Mo. Jan. 28, 2014).  Any change in the dosage of a drug is a “major change” requiring prior FDA approval.  Therefore, plaintiffs’ class action consumer fraud claims based on “overfilling” are preempted because the dose in which the drug was marketed was approved by the FDA and was impossible to change immediately to comply with the plaintiffs’ claimed state-law obligation.
  20. In re Fosamax Alendronate Sodium Products Liability Litigation, 2014 WL 1266994 (D.N.J. March 26, 2014).  The previous implied preemption “clear evidence” ruling in Fosamax (see above) is extended to other, similarly situated cases in the Fosamax MDL.
  21. Amos v. Biogen Idec Inc., 28 F. Supp.3d 164 (W.D.N.Y. June 25, 2014).  Design defect claims against all prescription drugs are preempted as impossible under Bartlett.  Drug manufacturers cannot simultaneously comply with FDA requirements mandating the specific design of an approved drug and state law requirements mandating that the design be altered.
  22. In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. June 27, 2014).  Mensing preemption bars warning-related claims in a branded drug case after the defendant divested its NDA.  After divestiture a branded company has no power to change warnings and is no different than a generic manufacturer in that respect.
  23. DeBons v. Globus Medical, Inc., 2014 WL 12495351, slip op. (C.D. Cal. Aug. 8, 2014).  Buckman preempts all claims predicated on the defendant selling an “unapproved,” “not legal,” or not “safe and effective” medical device.  The claims are disguised FDCA enforcement and would not exist if the FDCA did not exist.  Incorporation of FDCA violations into California unfair practices statutes does not avoid Buckman and allow private FDCA enforcement in violation of federal law restricting enforcement to the government.  Affirmed, see below.
  24. Booker v. Johnson & Johnson, 54 F. Supp.3d 868 (N.D. Ohio Oct. 10, 2014).  Under Bartlett, state-law design defect claims that require manufacturers to render a non-generic drug safer by altering its composition are in conflict with federal laws that prohibit manufacturers from unilaterally altering drug composition.  Where state law demands an alternative design to avoid liability, that would require changing the composition of the drug, which is prohibited by federal law.  Therefore, the state-law claim is preempted.
  25. Yates v. Ortho-McNeil Pharmaceutical, Inc., 76 F. Supp.3d 680 (N.D. Ohio Jan. 5, 2015).  Under Bartlett, state-law design defect claims that require manufacturers to render a non-generic drug safer by altering its composition are in conflict with federal laws that prohibit manufacturers from unilaterally altering drug composition.  Following BookerAffirmed 808 F.3d 281 (see below).
  26. In re Celexa & Lexapro Marketing & Sales Practices Litigation, 779 F.3d 34 (1st Cir. Feb. 20, 2015).  A California consumer protection class action alleging misleading statements about the efficacy of an innovator/branded drug is entirely preempted under Levine/Mensing.  None of the efficacy-related label changes plaintiffs sought involved “new” information that the FDA had not already considered in its approval of the challenged indication, so they could have been accomplished through a CBE supplement.  Nor was the type of label change plaintiffs sought allowable through the CBE process.  The CBE process involves new safety-related information, and is not a way to second-guess FDA approval.  Because the CBE process is inapplicable, the label changes plaintiffs seek must be have FDA pre-approval, and are therefore preempted as impossible under Mensing.
  27. In re Depakote, 87 F. Supp.3d 916 (S.D. Ill. Feb. 20, 2015).  The defendant presented clear evidence that the FDA would not have included a developmental delay warning for Depakote at any time relevant to the plaintiff’s case.  Twice, after plaintiff’s use of the drug, the FDA refused attempts by the defendant to add such a warning, on the basis that the scientific support was insufficient.
  28. Shah v. Forest Laboratories, Inc., 2015 WL 3396813 (N.D. Ill. May 26, 2015).  Under Bartlett, state-law design defect claims against all prescription drugs are preempted.
  29. Rheinfrank v. Abbott Laboratories, Inc., 119 F. Supp.3d 749 (S.D. Ohio Aug. 10, 2015).  The defendant presented clear evidence that the FDA would not have included a developmental delay warning for Depakote at any time relevant to the plaintiff’s case.  Twice, after plaintiff’s use of the drug, the FDA refused attempts by the defendant to add such a warning, on the basis that the scientific support was insufficient.  Because fraud on the FDA claims are preempted, plaintiff cannot try to undercut this evidence with fraud on the FDA claims.  Buckman preempts statutory fraud on the FDA punitive damages exception.  Affirmed, ___ F. Appx. ___ (6th Cir. Feb. 21, 2017).
  30. Rheinfrank v. Abbott Laboratories, Inc., 137 F. Supp.3d 1035 (S.D. Ohio Oct. 2, 2015).  Under Bartlett, state-law design defect claims against all prescription drugs are preempted. Affirmed, ___ F. Appx. ___ (6th Cir. Feb. 21, 2017).
  31. In re Incretin-Based Therapies Products Liability Litigation, 142 F. Supp.3d 1108 (S.D. Cal. Nov. 9, 2015).  Because the FDA specifically considered pancreatic cancer risk, publicly confirmed the adequacy of the challenged labeling, and has maintained its position that scientific evidence of a causal association between the drugs in question and the risk is indeterminate, there is clear evidence under Levine that the FDA would have rejected the warnings that plaintiffs demand.  Timing does not suggest gaps in the FDA’s consideration.  Actual submission and FDA rejection of a warning are not required.  All warning claims are preempted.  Buckman preempts attempts at claiming misreporting and underreporting to the FDA.  What the FDA chooses to consider in its evaluation cannot be second-guessed by litigants.  On appeal at No. 15-56997 (9th Cir.)
  32. In re Byetta Cases, 2015 WL 7184655, slip op. (Cal. Super. Nov. 13, 2015).  Plaintiffs cannot oppose preemption by alleging fraud on the FDA, which is itself preempted.  Plaintiffs warning claims are preempted because of clear evidence that the FDA has concluded that there is insufficient scientific evidence to warrant a warning that incretin mimetics cause pancreatic cancer.  The FDA took account of the ADEs plaintiffs relied on.  Preemption is a legal, not a factual, question, which is inherently a judicial function.
  33. Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. Dec. 11, 2015).  Impossibility preemption under Bartlett applies where the alleged defect would have been a “major” change under FDA regulations, requiring FDA preapproval.  “Pre-approval” design claims are too speculative, since they require another design to have been approved, to have been used, and to have prevented injury.  Prior FDA approval of would have been necessary in any event.  A claim that a defendant should never have started selling its FDA-approved drug is preempted for the same reasons that stop-selling claims were preempted in BartlettAffirming 76 F. Supp.3d 680.
  34. Small v. Amgen, No. 2:12-476-Ftm29-CM, slip op. (Mag. M.D. Fla. Jan. 25, 2016).  Judgment on the pleadings denied for factual determination of whether the formulation of the defendant’s biologic was capable of being redesigned and thus preempted under Bartlett.  It is likely that under Yates even if the biologic is capable of redesign, that any claim that the defendants should have changed that design before seeking FDA approval would likewise be preempted.
  35. Batoh v. McNeil-PPC, Inc., 167 F. Supp.3d 296 (D. Conn. March 10, 2016).  Impossibility preemption under Bartlett applies to design defect claim involving OTC drug.  The change in composition that plaintiff claims is required would be a “major change” requiring FDA preapproval.  On appeal at No. 16-1288 (2d Cir.).
  36. Cerveny v. Aventis, Inc., 155 F. Supp.3d 1203 (D. Utah March 16, 2016).  FDA rejection, after plaintiff’s alleged injury, of citizen’s petition alleging same injury, was clear evidence that FDA would not allow the label change plaintiff demanded.  Further, the FDA continued to approve similar products with the labeling plaintiff challenged.  Pregnancy X label involving different risk was irrelevant.  Nonsensical to argue that any possible label strengthening, even if irrelevant to plaintiff’s case, precludes preemption.  On appeal at No. 16-4050 (10th Cir.).
  37. Barcal v. EMD Serono, Inc., 2016 WL 1086028 (N.D. Ala. March 21, 2016).  Impossibility preemption under Bartlett applies to design defect claim involving branded drug.  The design of any FDA approved drug cannot be changed without prior FDA approval, rendering compliance with both state and federal law impossible.
  38. In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, ___ F. Supp.3d ___, 2016 WL 2840215, slip op. (D.S.C. May 6, 2016).  Impossibility preemption barred all claims not based on new information not previously submitted to FDA because CBE label changes can only be based on newly acquired information.  Information solely related to efficacy, not safety, also cannot be changed by CBE.  All labeling, but not advertising, claims about this information are preempted, because advertising can be changed outside of the CBE process.
  39. Seufert v. Merck Sharp & Dohme Corp., 2016 WL 3369512 (S.D. Cal. May 11, 2016).  Clear evidence that FDA would not allow a warning change was established by FDA article in medical journal that alleged causal effect of branded drug was not supported by scientific evidence, and additional FDA actions.  FDA need not reject specific warning language before there can be preemption.  Lack of final FDA conclusion does not prevent preemption.  Buckman does not provide a basis for discovery of fraud on the FDA evidence in clear evidence cases.
  40. Fleming v. Janssen Pharmaceuticals, Inc., ___ F. Supp.3d ___, 2016 WL 3180299, slip op. (W.D. Tenn. June 6, 2016).  Impossibility preemption under Bartlett applies to design defect claim involving innovator drug.  A claim of design defect before approval is too attenuated and speculative as it depends on what the FDA might have done under different facts.
  41. Brazil v. Janssen Research & Development LLC, ___ F. Supp.3d ___, 2016 WL 3748771, slip op. (N.D. Ga. July 11, 2016).  Design defect claims against an innovator drug that would force changes in the drug’s composition are preempted because prior FDA approval would be required.  Preemption includes claims involving the pre-approval design.  Those are equivalent to stop-selling claims.  Warning claims against entities that do not hold the drug’s NDA are preempted because such entities have no power to change drug labeling.
  42. Gentile v. Biogen Idec, Inc., 2016 WL 4128159 (Mass. Super. July 25, 2016).  Warning claim against innovator drug preempted.  FDA rejection of label change regarding same risk for lack of sufficient scientific support occurring after plaintiff’s final treatment was clear evidence that warning change was impossible in plaintiff’s case.  Distributor has no power to change labeling, so warning claims against it are preempted under Mensing.
  43. Christison v. Biogen Idec Inc., ___ F. Supp.3d ___, 2016 WL 4223956, slip op. (D. Utah Aug. 5, 2016).  Warning claim against innovator drug preempted.  FDA rejection of label change regarding same risk for lack of sufficient scientific support occurring after plaintiff’s final treatment was clear evidence that warning change was impossible in plaintiff’s case.
  44. DeBons v. Globus Medical, Inc., ___ Fed. Appx. ___, 2016 WL 4363171 (9th Cir. Aug. 16, 2016).  Preemption of all plaintiffs’ claims but one under Buckman affirmed (see, above for district court decision).  Private litigants cannot sue to enforce the FDCA.  Only a contract claim based on an alleged express representation that the product was FDA approved could survive preemption, but that claim was inadequately pleaded.
  45. Estes v. Lanx, Inc., ___ Fed. Appx. ___, 2016 WL 4375644 (5th Cir. Aug. 16, 2016).  Fraudulent concealment claim based on manner in which the defendant submitted its 510(k) notifications to the FDA was preempted under Buckman.  Claims attacking the FDA clearance of a medical device are disguised FDCA enforcement.
  46. Elliott v. Sandoz, Inc., 2016 WL 4398407 (N.D. Ala. Aug. 18, 2016).  Buckman preempts claims that the defendant failed to warn by not maintaining an adequate supply of FDA-mandated medication guides for distribution by others directly to patients.  The claims is private enforcement of the FDCA, since otherwise there is no duty to distribute medication guides.
  47. In re Zoloft Litigation, 2016 WL 4529213, slip op. (W. Va. Cir. Aug. 30, 2016).  Fraud on the FDA provision of Michigan product liability statute is preempted by Buckman.  Desiano is unpersuasive.
  48. In re: Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, 2016 WL 7368203 (D.S.C. Nov. 1, 2016).  Warning claims against a pharmacy dispensing a branded drug are preempted under Mensing/Bartlett because pharmacies, like drug distributors, cannot change FDA-approved warnings.
  49. In re Lipitor (Atorvastatin Calcium) Marketing Sales Practices & Products Liability Litigation, 2016 WL 7335738 (D.S.C. Nov. 7, 2016).  Warning claims against a distributor of a branded drug are clearly preempted under Mensing/Bartlett because drug distributors cannot change FDA-approved warnings.  Other claims involving the distributor’s own advertising, may not be preempted.
  50. In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, 2016 WL 7644792 (D.S.C. Nov. 28, 2016).  Warning claims against a distributor of a branded drug are clearly preempted under Mensing/Bartlett because drug distributors cannot change FDA-approved warnings.  Other claims involving the distributor’s own advertising, may not be preempted.
  51. Utts v. Bristol-Myers Squibb Co., ___ F. Supp.3d ___, 2016 WL 7429449 (S.D.N.Y. Dec. 23, 2016).  Warning and design claims against branded drug manufacturer preempted.  At the time of FDA approval, a manufacturer cannot change its design or label.  Thereafter it can unilaterally change labels if meeting CBE requirements.  Warning claims attacking warnings as first marketed are preempted.  Warning claims attacking clinical trial results submitted to the FDA do not involve new information subject to CBE and are preempted.  Pre-approval design claim preempted as speculative, and as a stop-selling claim.  Design claims cannot posit counterfactual FDA conduct.  Claims premised on failure to provide data to the FDA are preempted.
  52. McDaniel v. Upsher-Smith Pharmaceuticals, Inc., ___ F. Supp.3d ___, 2017 WL 657778 (W.D. Tenn. Jan. 26, 2017).  Failure to warn claims involving:  (1)  alleged failure to supply a medication guide to the plaintiff, and (2) off-label promotion are barred by Buckman as private attempts to enforce the FDCA.
  53. Rheinfrank v. Abbott Laboratories, Inc., ___ F. Appx. ___, No. 16-3347; slip op. (6th Cir. Feb. 21, 2017).  Two FDA rejections, for lack of sufficient supporting data, of the defendant’s attempts to strengthen its label with respect to the risk in question after to the plaintiff’s use of the drug established clear evidence that that the FDA would have rejected an attempt to change the label unilaterally by CBE.  Since the FDA considered the data insufficient in 2008, it would also have rejected a similar warning in 2003, with even less data available.  A formal procedure for considering the label change was not necessary – that would change clear evidence test from “would have” rejected to “did” reject.  Arguments based on asserted failure to conduct research were too speculative to defeat preemption.