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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.

  1. 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.
  2. In re: Aredia & Zometa Products Liability Litigation, 352 F. 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.
  3. 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).
  4. 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.
  5. 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.
  6. 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.
  7. 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).
  8. 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.
  9. 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.
  10. Stevens v. Community Health Care, Inc., 2011 WL 6379298 (Mass. Super. Oct. 5, 2011), motion to dismiss granted.  An authorized distributor of a generic drug has no power to change that drug’s labeling.  All claims are preempted.
  11. 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.
  12. 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).
  13. 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.
  14. 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.
  15. 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.
  16. 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.
  17. 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.  Subsequent ruling, see below.
  18. 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.
  19. 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.
  20. 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.
  21. 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).
  22. 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 “newly acquired” 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.
  23. 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.
  24. 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.
  25. 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, 680 F. Appx. 369 (6th Cir. Feb. 21, 2017).
  26. 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.
  27. 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.  Note:  Buckman aspects were reversed without the appellate court reaching the Levine grounds:  In re Incretin-Based Therapies Products Liability Litigation, 2017 WL 6030735 (9th Cir. Dec. 6, 2017).
  28. 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.
  29. Small v. Amgen, 2016 WL 4942078, slip op. (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.
  30. 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.
  31. 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.  Affirmed in part and reversed in part, see 855 F.3d 1091 below.
  32. 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.
  33. In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, 185 F. Supp.3d 761 (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.
  34. Seufert v. Merck Sharp & Dohme Corp., 187 F. Supp. 3d 1163 (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.
  35. Fleming v. Janssen Pharmaceuticals, Inc., 186 F. Supp.3d 826 (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.
  36. Brazil v. Janssen Research & Development LLC, 196 F. Supp.3d 1351 (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.
  37. 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.
  38. Christison v. Biogen Idec, Inc., 199 F. Supp.3d 1315 (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.
  39. DeBons v. Globus Medical, Inc., 668 F. Appx. 258 (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.
  40. Estes v. Lanx, Inc., 660 F. Appx. 260 (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.
  41. 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.
  42. 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.
  43. 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.
  44. 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.
  45. 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.
  46. Utts v. Bristol-Myers Squibb Co., 226 F. Supp.3d 166 (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.  Affirmed, 2019 WL 1339013, below.
  47. Rheinfrank v. Abbott Laboratories, Inc., 680 F. Appx. 369 (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.
  48. Risperdal & Invega Product Liability Cases, 2017 WL 4100102 (Cal. Super. March 16, 2017).  Preemption is a legal question.  CBE changes require “newly acquired evidence,” and cannot be based on evidence the FDA has already reviewed.  Denial of citizen’s petition is evidence of clear evidence the FDA would not allow label change.  Reconsideration denied, 2017 WL 4479317 (Cal. Super. July 24, 2017).
  49. Caltagirone v. Cephalon, Inc., 2017 WL 1135576 (Pa. C.P. March 23, 2017).  Preliminary objections sustained. A cause of action for off-label promotion cannot exist in the absence of the FDCA.  It is not a state law cause of action, but only a private attempt to enforce the FDCA barred by BuckmanAffirmed, 2018 WL 2750560, below.
  50. Aston v. Johnson & Johnson, 248 F. Supp.3d 43 (D.D.C. March 31, 2017).  Design defect claims against branded drugs are preempted by Bartlett.  Bartlett is not limited to generic drugs, and its preemption holding applies to all prescription drugs.
  51. Amos v. Biogen Idec, Inc., 249 F. Supp.3d 690 (W.D.N.Y. April 10, 2017).  Warning defect claims are preempted, both under Mensing/Bartlett and Levine “clear evidence.”  Only the FDA can order a change to a black box warning.  The FDA believed until after plaintiff’s injury that there was insufficient scientific evidence to justify the other warning plaintiff advocated.  Two “smoking gun” FDA rejections establish clear evidence.  Warning claims against a distributor that does not hold the New Drug Application for a drug are preempted, since such entities have no power to change labels under the FDCA.
  52. Cerveny v. Aventis, Inc., 855 F.3d 1091 (10th Cir. May 2, 2017).  FDA denial of citizen’s petition for lack of evidence of the same risk of which plaintiff complains was clear evidence as a matter of law as to that risk.  FDA denial of citizen’s petitions applies the same scientific standard used for manufacturer submissions.  Denial of one is clear evidence as to the other.  We will not presume that the FDA violates its own regulations to treat citizen’s petitions more harshly.  Risk of taking the drug during pregnancy, which plaintiff did not do, is not preempted since the FDA proposed a different warning.  Whether state law bars warning claims based on risks the plaintiff did not encounter was waived.  Preemption of fraud, misrepresentation, and warranty claims must be considered independently on remand.  Affirming in part and reversing in part 155 F. Supp.3d 1203, above.
  53. Utts v. Bristol-Myers Squibb Co., 251 F. Supp.3d 644 (S.D.N.Y. May 8, 2017). All warning claims preempted where none of the information plaintiff relied upon was “newly acquired” so that the CBE exception to FDA warning pre-approval would apply.  Information is “newly acquired” when it was not submitted to the FDA during the approval process and revealed reveal risks the are of a “different type or greater severity or frequency” than information the FDA already had.  Federal law preempts all pre-FDA approval failure to warn and design defect claims for branded prescription medication.  Post-approval warning claims are preempted under Mensing/Bartlett if they require FDA pre-approval.  Defendant not required to give warning precluded by FDA.  Speculation is not newly acquired information.  Evidence consistent with existing labeling cannot be newly acquired information.  Whether information is “newly acquired” is a legal question amenable to a motion to dismiss.  Without any newly acquired information, plaintiffs never get to Levine‘s clear evidence standard.  Addition of a boxed warning would require FDA pre-approval.  Warranty claims that attack a manufacturer’s right to advertise an FDA approved drug are preempted.  An alleged breach of warranty that a drug is safe for its indicated use seeks to challenge the FDA’s decision to that effect and is preempted.  Fraud claims implicating disclosures to the FDA are preempted by BuckmanAffirmed, 2019 WL 1339013, below.
  54. Trejo v. Johnson & Johnson, 13 Cal. App.5th 110, 220 Cal. Rptr.3d 127 (Cal. App. June 30, 2017).  OTC drug design defect and negligent design claims preempted under Bartlett.  Claims that the defendant should have sold a different compound than what the FDA approved are preempted.  The savings clause in §379r does not apply to implied preemption.  Plaintiff’s alternative design would have required FDA pre-approval to execute.  All stop selling claims are preempted.  Review denied (Cal. Oct. 11, 2017).
  55. In re Risperdal & Invega Product Liability Cases, 2017 WL 4479317 (Cal. Super. July 24, 2017).  Denying reconsideration of  2017 WL 4100102, above.  Fosamax was wrongly decided.  Preemption is a question of law for the court to decide.
  56. Fortner v. Bristol-Myers Squibb Co., 2017 WL 3193928 (S.D.N.Y. July 26, 2017).  Design and warning defect claims dismissed as preempted under Utts decisions.  Cannot avoid Utts by failing to plead the information examined in that case.  The absence of information only underscores lack of any newly acquired evidence that would allow resort to CBE exception.  Consumer protection claims preempted as involving same information as warning claims.  Affirmed, 2019 WL 1339013, below.
  57. Franco v. Janssen Pharmaceuticals, 2017 WL 11673894 (Cal. Super. Aug. 4, 2017), Pletcher v. Janssen Pharmaceuticals, 2017 WL 11674852 (Cal. Super. Aug. 4, 2017), and Dumas v. Janssen Pharmaceuticals, 2017 WL 11674853 (Cal. Super. Aug. 4, 2017).  Three essentially identical opinions.  Pre-approval design claim dismissed as preempted. Mensing/Bartlett preemption is not limited to generic drugs.  All claims that a drug manufacturer should have submitted an different design, whether before or after initial FDA approval, are preempted because the alternative would require prior FDA approval.
  58. Warren v. Boehringer Ingelheim Pharmaceuticals, Inc., 2017 WL 3970666 (S.D. Ind. Sept. 8, 2017).  Mensing/Bartlett preemption is not limited to generic drugs.  Not every design defect claim necessarily involves a change that requires FDA pre-approval.  Preemption precludes any non-holder of the relevant new drug application from being liable for defects that it lacks the power to change.
  59. Cleary v. Biogen Inc., 2017 WL 4126240, slip op. (Mass. Super. Sept. 13, 2017).   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.
  60. Markland v. Insys Therapeutics, Inc., 270 F. Supp.3d 1318 (M.D. Fla. Sept. 15, 2017).  Negligent marketing claim asserting off-label promotion preempted under Buckman as private FDCA enforcement.  Off-label preemption is a federal concept, and is a critical element of the claim.  No equivalent state-law cause of action exists.  Affirmed 2018 WL 6666385, below.
  61. Gustavsen v. Alcon Laboratories, Inc., 272 F. Supp.3d 241 (D. Mass. Sept. 29, 2017).  Consumer fraud Class action dismissed because changing dosage of eye drops would be a major change requiring FDA pre-approval.  Pre-approval design claim preempted as never start selling theory.  That defendants could have submitted different designs to FDA is irrelevant.  Affirmed 903 F.3d 1 below.
  62. Swanson v. Abbott Laboratories, 2017 WL 5903362 (S.D. Ohio Nov. 28, 2017).  Summary judgment granted on preemption.  The FDA’s four rejections of subsequent attempts to strength the drug label in the manner plaintiff sought, for reasons of inadequate supporting data, constituted clear evidence that the FDA would not have approved that change to the label at an even earlier time.  Defendant does not have a First Amendment right to add warnings rejected by the FDA.
  63. Willis v. Abbott Laboratories, 2017 WL 5988215 (W.D. Ky. Dec. 1, 2017).  Partial summary judgment granted on preemption.  FDA rejection of proposed label changes are clear evidence supporting preemption.  Fraud and misrepresentation preempted to same extent as warnings.  Defendant does not have a First Amendment right to add warnings rejected by the FDA.  No question of fact for jury on this record.  Arguments based on asserted failure to conduct research were too speculative to defeat preemption.  Design defect claim preempted as requiring prior FDA review.  Contraindications to not implicate alternative design.
  64. Ideus v. Teva Pharmaceuticals USA, Inc., 2017 WL 6389630, slip op. (D. Neb. Dec. 12, 2017).  Motion to dismiss granted.  Plaintiff failed to plead that any information relevant to her warning claim was “newly acquired” after the product’s approval, so that it would qualify for the CBE exception to preemption.
  65. Chambers v. Boehringer Ingelheim Pharmaceuticals, Inc., 2018 WL 849081 (M.D. Ga. Jan. 2, 2018).  Summary judgment granted against warning and design claims involving a dosage of the drug that the FDA refused to approve on several occasions.  A design defect claim that the drug should not have been sold until an antidote was also FDA approved is preempted as a stop-selling claim.
  66. Boone v. Boehringer Ingelheim Pharmaceuticals, Inc., 2018 WL 5807938 (Conn. Super. Jan. 24, 2018).  Summary judgment granted in part.  Design defect claim involving failure to obtain earlier approval of a different drug preempted as requiring prior FDA review.
  67. In re Bard IVC Filters Products Liability Litigation, 2018 WL 1256768 (D. Ariz. March 12, 2018).  Yes, it’s really a 510(k) device case, but it’s very good on holding that FDCA-based negligence per se is preempted under Buckman as private FDCA enforcement.
  68. McGee v. Boehringer Ingelheim Pharmaceuticals, Inc., 2018 WL 1399237 (N.D. Ala. March 20, 2018).  Allegations of pre-approval failure to communicate risk information to the FDA are fraud on the FDA claims preempted by Buckman.  As to post-approval claims, plaintiff failed to plead any newly acquired evidence that would bring the CBE exception into play, so that claim is dismissed without prejudice.
  69. Nelson v. Biogen Idec, Inc., 2018 WL 1960441 (D.N.J. April 26, 2018).  Summary judgment granted.  Warning defect claims are preempted by “clear evidence” satisfying Levine standard, even after Fosamax.  The FDA believed until after plaintiff’s injury that there was insufficient scientific evidence to justify the other warning plaintiff advocated.  Warning claims against a distributor that does not hold the New Drug Application for a drug are preempted, since such entities have no power to change labels under the FDCA.
  70. Patton v. Forest Laboratories, LLC, 2018 WL 5270476 (C.D. Cal. May 10, 2018).  Partial motion to dismiss granted.  Any claim that the warnings in a drug’s “highlights” section is preempted.  FDA regulations do not permit changes to highlights without prior FDA approval, requiring preemption.
  71. Caltagirone v. Cephalon, Inc., 190 A.3d 596 (Pa. Super. June 8, 2018).  Grant of preliminary objections affirmed.  All claims for negligence, misrepresentation, fraud, and consumer protection violations were explicitly premised on violation or disregard of the FDCA and FDA regulations, which cannot be privately enforced.  All claims preempted under Buckman.
  72. Dolin v. GlaxoSmithKline LLC, 901 F.3d 803 (7th Cir. Aug. 22, 2018).  Denial of summary judgment reversed.  Warning claims were preempted as a matter of law.  Clear evidence, in the form of four prior FDA rejections of the same proposed warning, existed.  FDA rejection not based on position in label.  Preemption cannot be defeated by a claim that the defendant should have met further with the FDA.  That is a “take steps” argument barred by Mensing.   Between the FDA’s last rejection and plaintiff’s use of the drug, no newly acquired information existed to prevent preemption.  The FDA was aware of claimed shortcomings in submitted data.
  73. Plavix Products Liability Litigation, 2018 WL 4005859 (N.Y. Sup. Aug. 22, 2018).  Summary judgment granted.  No evidence that plaintiffs’ warning claims involve any newly acquired evidence.  Expert “design” opinion that drug’s risks outweigh its benefits and that it should not be sold preempted as a “stop selling” claim.
  74. Robinson v. Eli Lilly & Co., 2018 WL 4039703 (E.D. Ky. Aug. 23, 2018).  Motion to dismiss granted in part.  While preemption did not preclude a warning claim against a branded drug, design defect claims were preempted because it would be impossible to change the drug’s design without prior FDA approval.  Allegations of pre-approval design defect were also preempted.
  75. Gustavsen v. Alcon Laboratories, Inc., 903 F.3d 1 (1st Cir. Aug. 27, 2018).  Grant of motion to dismiss affirmed.  Alternation of drug dosage is a “major change” requiring prior FDA approval.  Impossibility preemption bars demands for changes that require prior FDA approval.  All changes described in 21 C.F.R. §314.70(b)(2)(i-viii) are “major” changes.   Affirming 272 F.Supp.3d 241, above.
  76. Patton v. Forest Laboratories, Inc., 2018 WL 5269239 (C.D. Cal. Sept. 19, 2018).  Motion to dismiss granted.  Plaintiff failed to plead any newly acquired evidence that would support an unpreempted claim seeking a label change.
  77. Byrd v. Janssen Pharmaceuticals, Inc., 333 F. Supp.3d 111 (N.D.N.Y. Sept. 21, 2018).  Motion for judgment as a matter of law granted.  Plaintiff’s claim that the defendant should have changed its warnings about an off-label use is preempted because prior FDA approval is required before such warnings can be added or changed.  Clear evidence is also present, since the FDA previously rejected warnings about pediatric use as promotional.  Nor was the risk of gynecomastia new information that would have supported a CBE-based label change.  Plaintiff’s expert’s opinion that unilateral off-label warning changes were allowed was ipse dixit and contrary to the plain language of the FDA’s regulations.  CBE-based unilateral warnings must also involve a “serious” hazard, which was not the FDA’s assessment of gynecomastia.  Serious risks, at the time in question, required either hospitalization or surgery to avoid hospitalization.  Preemption is decided as a matter of law.  Fraud on the FDA arguments are preempted.
  78. Markland v. Insys Therapeutics, Inc., 758 Fed. Appx. 777 (11th Cir. Dec. 19, 2018).  Negligent marketing claim based on allegations of illegal off-label promotion is preempted under Buckman as an improper private attempt to enforce the FDCA.  Without the FDCA, there could be no such thing as off-label promotion.  Affirming 270 F. Supp.3d 1318, above.
  79. McCallister v. Sanofi S.A., 2019 Cal. Super. Lexis 61761 (Cal. Super. Feb. 6, 2019).  Demurrer granted as to all claims.  Preemption extends to drug distributors.  It is impossible for a distributor to change drug warnings.
  80. Marroquin v. Pfizer, Inc., 367 F. Supp.3d 1152 (E.D. Cal. Feb. 14, 2019).  Motion to dismiss granted as to all claims.  Preemption extends to drug distributors, whether branded or generic.  The risk of confusion or being misled by differing labels would be even greater if a mere distributor could add additional warnings that it deems necessary or advisable.
  81. Maze v. Bayer Healthcare Pharmaceuticals Inc., 2019 WL 1062387 (E.D. Tenn. March 6, 2019).  Motion to dismiss granted as to all claims.  Preemption of warning claims after Levine requires some allegation of “new” information existing after a drug’s initial FDA approval.  Information available to FDA at the time of approval cannot defeat preemption.  Where the defendant in fact warned of the risk at issue, plaintiff must allege some new information that could render the existing warning both inadequate under state law and falling within the CBE regulation to permit an immediate label change under federal law.  Plaintiff’s complaint contains no such allegations and is therefore preempted.
  82. Paulsen v. Abbott Laboratories, 368 F. Supp.3d 1152 (N.D. Ill. March 19, 2019).  Motion to dismiss granted as to some claims.  Design defect claims were preempted because it would be impossible to change the drug’s formulation without prior FDA approval.  Warning claims, and “design” claims that amount to warning claims, are not preempted.  Any warning claim against a non-holder of the New Drug Application that cannot change labeling would be preempted.
  83. Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699 (2d Cir. March 26, 2019).  Affirming grant of motion to dismiss as to all claims.  To escape implied preemption under Levine, a plaintiff must plead the existence of “newly acquired evidence” that would allow unilateral warning changes under the FDA’s changes being effected regulation.  Despite amendment, plaintiffs’ pleading of such evidence was only conclusory and vague, justifying dismissal.  Affirming 226 F. Supp.3d 166, 251 F. Supp.3d 644, and 2017 WL 3193928, above.
  84. State v. Purdue Pharma, Inc., 2019 WL 2245743, slip op. (N.D. Dist. May 10, 2019).  Granting summary judgment.  Clear evidence, FDA rejection of a Citizen’s Petition raising the same issues, preempted plaintiff’s claims, and no newly acquired evidence suggested any different result.
  85. Merck Sharp & Dohme Corp. v. Albrecht, ___ U.S. ___, 139 S. Ct. 1668 (U.S. May 20, 2019).  Reversing reversal of grant of summary judgment.  Preemption is an issue of law for courts to decide, including any subsidiary factual issues that may arise.  Standards of proof are irrelevant.  The judge simply decides which argument is correct.  “Clear evidence” for purposes of impossibility preemption in cases “like” Levine, means that the FDA informed the drug manufacturer, after being fully informed of the justifications of a particular warning, that it would not approve that warning.
  86. Pierik  v. GE Healthcare, Inc., 2019 WL 4686551 (N.D. Ill. June 18, 2019).  Granting motion to dismiss.  A distributor has no power to change an FDA-approved label, therefore all warning-related claims against the distributor defendant are preempted.
  87. McGrath v. Bayer Healthcare Pharmaceuticals Inc., 393 F. Supp.3d 161 (E.D.N.Y. June 24, 2019).  Granting motion to dismiss.  Plaintiff failed to allege any newly acquired evidence of a causal association with claimed risks.  The FDA intended that its CBE regulation be used “sparingly” for label changes.  Insufficient evidence of any actual risk from exposure.  “Unknown” risk cannot be “reasonable evidence.”  Newly acquired evidence must precede the plaintiff’s injury.
  88. McCallister v. Sanofi SA, 2019 Cal. Super. Lexis 30943 (Cal. Super. May 7, 2019).  Demurrer granted.  All claims preempted against drug distributor because it does not own the new drug application and thus cannot change the labeling or design of the drug.
  89. State v. Purdue Pharma L.P., 2019 WL 3776653, slip op. (N.D. Dist. July 22, 2019).  Denying reconsideration of dismissal.  Limitation of preemption to manufacturer-initiated actions was nonsensical since citizen petitions involve identical standards.  Albrecht expressly declined to reach questions of methods of FDA disapproval of proposed warning changes.
  90. Cerveny v. Aventis, Inc., 783 F. Appx. 804 (10th Cir. Aug. 9, 2019).  Affirming grant of motion to dismiss.  Dictum in footnote that Albrecht did not change the preemptive effect of FDA denials of citizen petitions because such cases were not “like” Levine.
  91. Ridings v. Maurice, 2019 WL 4888910 (W.D. Mo. Aug. 12, 2019).  Motion for partial summary judgment granted.  Claims based on failure to obtain FDA approval of a separate drug depend on FDA action and are impossibility preempted.  Caution:  There is also a less important adverse preemption ruling regarding warnings.
  92. Klein v. Bayer Healthcare Pharmaceuticals Inc., 2019 WL 3945652 (D. Nev. Aug. 21, 2019).  Granting motion to dismiss.  Plaintiff failed to plead facts establishing that defendant had newly acquired information permitting it to unilaterally add her desired warning under the CBE regulation.
  93. Smith v. GE Healthcare, Inc., 2019 WL 4565246 (Mag. W.D. La. Sept. 4, 2019).  Granting in part and denying in part motion to dismiss.  A distributor has no power to change an FDA-approved label, therefore all warning-related claims against the distributor defendant are preempted.  Redhibition not preempted.  Adopted 2019 WL 4551622 (W.D. La. Sept. 19, 2019) (plaintiff voluntarily dismissed the preempted claims, so motion technically denied as moot).
  94. Roberto v. Boehringer Ingelheim Pharmaceuticals, Inc., 2019 WL 4806271, slip op. (Conn. Super. Sept. 11, 2019).  Deciding preemption post-trial as a question of law after Albrecht was decided three days after trial.  Preemption after Albrecht is a two-pronged test, first that the prerequisites to the CBE regulation, such as “newly acquired information” are satisfied, and second if a CBE label change is permissible, was there “clear evidence” that the FDA would have rejected the warning in question.  Both prongs are questions of law.  Plaintiff bears the burden of proof on the first prong, and the defendant on the second.  Whether a presumption against preemption applies post-Albrecht is unclear since the FDA did not intend wide use of CBE label changes.  Label changes based on information the FDA already has are preempted.  Caution:  There is also a less important adverse preemption ruling.
  95. Goodell v. Bayer Healthcare Pharmaceuticals, Inc., 2019 WL 4771136 (D. Mass. Sept. 30, 2019).  Granting motion to dismiss.  Plaintiff failed to plead facts establishing that defendant had newly acquired information permitting it to unilaterally add her desired warning under the CBE regulation.
  96. Essure Product Cases, 2019 WL 5873725 (Cal. Super. Oct. 2, 2019).  Granting and denying motions to dismiss.  Where state law does not recognize failure to report or negligent risk management claims, Buckman preempts such claims as private FDCA enforcement.
  97. Pradaxa Cases, 2019 WL 6043513 (Cal. Super. Nov. 8, 2019).  Summary judgment granted.  All of plaintiffs’ warning claims are preempted because none of them are based on newly acquired evidence that could have supported a change to FDA-approved labeling.  Purported newly acquired evidence that post-dated a plaintiff’s injury is irrelevant.
  98. Parchim v. Biogen, Inc., 2019 WL 9654875 (W.D. Tex. Dec. 5, 2019).  Granting motion to dismiss.  All plaintiff’s claims were warning related and subject to the Texas presumption of adequacy for FDA-approved warnings.  Fraud on the FDA exception is preempted.  Failure to test claim is a warning claim in sheep’s clothing.
  99. Mahnke v. Bayer Corp., 2019 WL 8621437 (C.D. Cal. Dec. 10, 2019).  Motion to dismiss granted in large part and denied in part.  Plaintiff has burden of coming forward with evidence that defendant could have used CBE process to change labeling, but did not.  No newly acquired information and no link to a serious condition.  Bartlett precludes design claim.  Label-based warranty claims preempted.  Caution:  There is also a less important adverse preemption ruling.  Subsequent decision, 2020 WL 2048622, below.
  100. Drescher v. Bracco Diagnostics, Inc., 2020 WL 699878 (Mag. D. Ariz. Jan. 31, 2020).  Granting motion to dismiss.  Since FDA has found that claimed condition causes no present injury, defendant could not have used CBE to change label, since no “reasonable evidence” to support a label change exists.  Later FDA-allowed label change refutes plaintiff’s claims.  No newly acquired information and no link to a serious condition because FDA stated that clinical consequences “have not been established.”  Design defect claim preempted for demanding a major product change requiring prior FDA approval.  Adopted  2020 WL 1466296, below.
  101. Dennis v. Bayer Healthcare Pharmaceuticals, Inc., 2020 WL 534307 (W.D.N.C. Feb. 3, 2020).  Summary judgment granted to one of several defendants.  A distributor has no power to change an FDA-approved label, therefore all warning-related claims against the distributor defendant are preempted.  Caution:  There is also an adverse preemption ruling regarding a different defendant and newly acquired information.
  102. Smith v. Teva Pharmaceuticals United States, 437 F. Supp. 3d 1159 (S.D. Fla. Feb. 4, 2020).  Granting motion to dismiss.  Abundant precedent establishes that only NDA holders can change drug warnings.  Warning claims against mere distributors are preempted.  That a parent corporation plaintiff did not sue held the relevant NDA does not avoid preemption.  FDA regulations specify that only NDA holders, not their subsidiaries, can change drug labeling.
  103. Sabol v. Bayer Healthcare Pharmaceuticals, Inc., 2020 WL 705170 (S.D.N.Y. Feb. 12, 2020).  Granting motion to dismiss.  No basis for a CBE warning change exists.  At the time of plaintiff’s use, no “newly acquired information” existed that could serve as “reasonable evidence of a causal relationship” to a “clinically significant adverse reaction.”  Retention of the product has not been shown to cause any serious risk.
  104. Thomas v. Bracco Diagnostics, Inc., 2020 WL 1016273 (Mag. W.D. La. Feb. 27, 2020).  Granting motion to dismiss.  Plaintiff’s design defect claim involves an alternative design that would require prior FDA approval as a major change, and is therefore impossibility preempted.  Warning claim preempted for two reasons:  no newly acquired evidence of any causal link to a significant adverse event, and clear evidence that FDA would not have allowed plaintiff’s change since it approved a label change only a month earlier stating that no such causal link existed.  Adopted 2020 WL 1243389 (W.D. La. March 13, 2020).
  105. Kumaritakis v. AstraZeneca Pharmaceuticals, LP, 2020 WL 1024933 (Del. Super. March 2, 2020).  Granting motion to dismiss.  Plaintiff’s design defect claim involves an alternative design that would require prior FDA approval as a major change, and is therefore impossibility preempted.
  106. Mahnke v. Bayer Corp., 2020 WL 2048622 (C.D. Cal. March 10, 2020).  Granting in part and denying in part motion to dismiss.  The CBE regulation cannot be used without newly acquired information.  The material plaintiff asserted did not qualify, because it either did not find a risk at all or was too tentative.  Caution:  minor adverse preemption ruling.  Prior ruling, 2019 WL 8621437, above.
  107. Adkins v. Boehringer Ingelheim Pharmaceuticals, Inc., slip op., 2020 WL 1704646 (Conn. Super. March 13, 2020).  Granting motion to dismiss.  Albrecht did not abolish grounds for preemption other than clear evidence.  Plaintiff must establish that the prerequisites to application of the CBE regulation exist.  The CBE regulation cannot be used without newly acquired information.  The material plaintiff asserted did not qualify.  A pending patent application, later withdrawn, is too tentative.  Medical commentary without new data or analysis beyond recommending further study is not newly acquired information.  Articles published after the plaintiff’s injury cannot be newly acquired information.
  108. Lewis v. GE Healthcare, Inc., 2020 WL 1243397 (W.D. La. March 13, 2020).  Granting motion to dismiss.  A distributor has no ability to change the design or warnings of an FDA-approved drug.  Redhibition alone survives preemption.
  109. Ridings v. Maurice, 444 F. Supp.3d 973 (W.D. Mo. March 16, 2020).  Granting motion to dismiss.    To determine preemption, plaintiff must identify what information should have been included in a revised warning and must establish that newly acquired information existed to support a unilateral warning change.  Only then must defendant provide clear evidence that the FDA would reject the warning.  The newly acquired evidence standard prevents overwarning.  A variety of material was considered and held not to be newly acquired.  The FDA already had most of it.  Information already submitted to the FDA cannot be newly acquired.  Such evidence must show an association with a serious hazard.  Theoretical hazards are insufficient.  Studies concluding that the association remains unknown or requires further study are insufficient.  Material post-dating a plaintiff’s injury cannot be newly acquired.  Foreign warnings are not themselves newly acquired evidence.  Foreign labeling is a product of different regulatory standards.  Withdrawn patents are too tentative to be newly acquired evidence, and this one was an idea that did not pan out in clinical practice.  An article finding no single preferable dosage fails to establish any worse risk.  Preliminary discussions in preparing medical literature are too tentative to be newly acquired evidence.  Continued FDA inaction in response to submitted material can be clear evidence that a warning would be rejected in light of known issues and ongoing FDA interactions.  On appeal 20-1824 (8th Cir.)
  110. Drescher v. Bracco Diagnostics, Inc., 2020 WL 1466296 (D. Ariz. March 26, 2020).  Adopting magistrate’s recommendation (2020 WL 699878, above) to dismiss all claims.  Warning claim barred by lack of reasonable association to a serious risk, as established by FDA-mandated label changes.  Defendant could not materially change its design without prior FDA approval.  Plaintiff’s claim that defendant should have sold a different type of product was a preempted stop-selling theory.
  111. Smith v. GE Healthcare, Inc., 2020 WL 1880787 (Mag. W.D. La. March 31, 2020). Preemption can be decided on pleadings although it is an affirmative defense.  Major drug design changes cannot be made unilaterally so impossibility preemption applies. CBE unilateral changes must be based on newly acquired information of greater product risks.  FDA has concluded that no increased risk exists and has revised the warnings to so state.  Not only does that mean no newly acquired information is present, but it is also clear evidence that plaintiff’s stronger warning would be, and has been, rejected.  Adopted 2020 WL 1875644 (W.D.La. April 15, 2020).
  112. Gayle v. Pfizer, Inc., 452 F. Supp.3d 78 (S.D.N.Y. April 7, 2020).  Granting motion to dismiss.  All claims impliedly preempted under Albrecht.  Defendant supplied FDA with all information that met “reasonable association” standard.  While FDA required a labeling change, it did not require the disease-specific labeling change plaintiffs were demanding.  No newly acquired evidence.  Reference to 6000 adverse event reports with no analysis could not be newly acquired evidence.  The raw data had been reported and no analysis qualified as newly acquired information.  Affirmed mem., 847 F. Appx. 79 (2d Cir. May 12, 2021).
  113. Burgess v. Pfizer, Inc., 2020 WL 1812010 (E.D.N.C. April 9, 2020).  Granting motion to dismiss.  Plaintiff only brought a warning claim, which, in the absence of any pleading of newly acquired information that could bring the case within the CBE regulation, meant it was preempted under the Mensing independence principle.
  114. Boone v. Boehringer Ingelheim Pharmaceuticals, Inc., 239 A.3d 1175 (Conn. May 4, 2020).  Affirming grant of partial summary judgment.  Claims that defendant should not have sold its drug until a second, related drug was also FDA approved necessarily depended on prior FDA action.  Any claim demanding an action that the defendant could not have taken independently of the FDA is preempted.  The logic of Mensing and Bartlett extends to branded drugs.  Albrecht does not limit preemption to “clear evidence” situations.  Clear evidence is necessary only when a defendant argues preemption despite being able to change its label unilaterally.  That FDA approval of another drug was technologically feasible does not change that claim’s dependency on FDA action.
  115. Javens v. GE Healthcare Inc., 2020 WL 2783581 (Mag. D. Del. May 29, 2020).  Recommending grant of judgment on the pleadings.  Preemption can be decided on pleadings although it is an affirmative defense.  Albrecht does not limit preemption to “clear evidence” situations.  Warning claim barred by lack of reasonable association to a serious risk, as established by FDA-mandated label changes.  Defendant could not materially change its design without prior FDA approval.  Plaintiff’s claim that defendant should have sold a different type of product was a preempted stop-selling theory.  Adopted 2020 WL 7051642 (D. Del. June 18, 2020).
  116. Vardouniotis v. Pfizer, Inc., 2020 WL 3890928 (N.Y. Sup. July 7, 2020).  Granting partial motion to dismiss.  Plaintiff pleaded no facts that any newly acquired information existed that would have allowed a unilateral CBE label change.
  117. Epstein v. Gilead Sciences, Inc., 2020 WL 4333011 (S.D. Fla. July 27, 2020).  Granting motion to dismiss.  Design defect claim preempted because to change an active ingredient would require prior FDA review and approval,  Other claims dismissed on non-preemption grounds.
  118. Estep v. Boehringer Ingelheim Pharmaceuticals, Inc., slip op., 2020 WL 5290777 (Conn. Super. Aug. 25, 2020).  Granting summary judgment.  Albrecht did not abolish grounds for preemption other than clear evidence.  Plaintiff must establish that the prerequisites to application of the CBE regulation exist.  The CBE regulation cannot be used without newly acquired information of a greater or different risk.  European submissions could show a greater risk but were not new.  “Newness” requires only what the regulation states, no prior submission to the FDA.  Information need not have been submitted as part of a label change, nor need the FDA have responded specifically to the information.
  119. Evans v. Gilead Sciences, Inc., 2020 WL 5189995 (D. Haw. Aug. 31, 2020).  Motion to dismiss granted.  All design defect claims, whether characterized as pre- or post-approval are preempted.  The FDA has to approve any drug design before it could be marketed.  Stop-selling claims, however, presented, are preempted.  Warning claims are not preempted at this point because there is no obligation to plead newly acquired information, as preemption is an affirmative defense.  However, plaintiff failed to adequately plead any information-based claim.
  120. Miller v. Corcept Therapeutics, Inc., 2020 WL 12991878 (Cal. Super. Sept. 4, 2020).  Partial demurrer granted.  All warning-based claims are preempted because plaintiff failed to identify any newly acquired information that could have supported a unilateral label change.
  121. Castle v. Boehringer Ingelheim Pharmaceuticals, Inc., 2020 WL 6712428 (Conn. Super. Sept. 11, 2020).  Motion to strike granted.  No non-NDA holder, even one closely affiliated with the actual NDA holder, has the ability to change drug labeling.  Therefore, warning-related claims are barred by impossibility preemption.  Nor may a non-NDA holder legally distribute information contrary to the drug’s labeling.
  122. Exela Pharma Sciences, LLC v. Sandoz, Inc., 486 F. Supp.3d 1001 (W.D.N.C. Sept. 15, 2020).  Motion to dismiss granted.  Implied preemption precludes plaintiff from second-guessing FDA decision to allow importation of unapproved product.  Consumer fraud claims preempted that would force defendant to stop selling a product FDA permitted be sold.  Plaintiff cannot challenge FDA prosecutorial discretion.  Preemption of claim that defendant should have sent Dear Doctor letter that FDA did not require.  FDA letter was not official action and could not create a legal standard that could support a violation claim.
  123. Ignacuinos v. Boehringer Ingelheim Pharmaceuticals, Inc., 490 F. Supp.3d 533 (D. Conn. Sept. 23, 2020).  Motion to dismiss granted.  No “newly acquired information” to allow use of CBE regulation to change complained-of dosage amount.  Newly acquired information must be scientific in nature and contain analysis.  Neither a plaintiff’s own counts of doses per container nor online customer reviews were scientific.  A change to the dosage of a drug is a major change requiring FDA pre-approval.  Affirmed 8 F.4th 98, below.
  124. Lyons v. Boehringer Ingelheim Pharmaceuticals, Inc., 491 F. Supp.3d 1350 (N.D. Ga. Sept. 29, 2020).  Summary judgment granted.  Everything plaintiff claimed was newly acquired information had already been shared with FDA. FDA’s repeated rejection of particular warnings was clear evidence that FDA would also have rejected warnings plaintiff demanded.  Existence of newly acquired information is a question of law.  Preliminary analyses are not not final enough to be newly acquired information.  Differing foreign labeling was not new, since FDA had same information, but reached different conclusions. Articles based on same information FDA had cannot be newly acquired information.  Same for inconclusive articles.
  125. Silverstein v. Boehringer Ingelheim Pharmaceuticals, Inc., 2020 WL 6110909 (Mag. S.D. Fla. Oct. 7, 2020).  Summary judgment granted.  Plaintiffs must identify what they claim is newly acquired information.  Then defendant has the burden of proving preemption.  Plaintiffs identified no newly acquired information to justify a CBE warning change.  To prevent overwarning, CBE evidence must be scientifically reliable.  Uncorroborated, unpeer-reviewed and unreplicated sources are not sufficiently scientifically reliable to be newly acquired information.  That information is in the label is conclusive that it was submitted to FDA.
  126. In re Zantac Ranitidine Products Liability Litigation, 512 F. Supp.3d 1278 (S.D. Fla. Jan. 8, 2020).  Partial motion to dismiss granted.  Design defect claims that attack the formulation of a product would be “major” changes requiring prior FDA approval and are therefore preempted.  Allegations that a brand-name drug’s FDA-approved formulation renders the drug misbranded are preempted because the drug’s manufacturer cannot independently change a drug formulation that the FDA has approved.  Claims to recover economic losses for damages allegedly from over-the-counter are expressly preempted by 21 U.S.C. §379r and not saved by the “product liability” savings clause.  Preemption of “design” claim actually based on warnings and pre-approval design defect claim not reached.  Appeal pending No. 21-10335 (11th Cir.).
  127. In re Incretin-Based Therapies Products Liability Litigation, 524 F. Supp.3d 1007 (S.D. Cal. March 9, 2021).  Summary judgment granted against all claims against four different drugs.  Clear evidence that FDA, which has closely monitored pancreatic cancer risk for over a decade, would not have approved a warning.  Label changes can only be  based on reasonable evidence.  FDA never found sufficient evidence of causal association.  Preemption not limited to when manufacturers submit labeling changes to FDA.  Citizen petition denial is clear evidence that FDA would reject, and is sufficiently formal.  Medical journal article was also sufficiently formal evidence of FDA rejection.  No newly acquired information.  FDA reviewed adverse events.  Foreign regulatory action not insufficient and foreign regulatory ultimately reached same conclusion as FDA.  Studies not sent to FDA were inconclusive, poorly constructed, and/or concerned different drugs.  Unpublished, litigation-driven animal study insufficient.  Attacks on validity of what was submitted to FDA are not newly acquired anything.  Such information must be limited to avoid overwarning.  Continuous FDA monitoring for new data does not make all prior FDA decisions insufficiently final to support preemption.  FDA inaction combined with its vigorous monitoring can be clear evidence supporting preemption.  Appeal pending No. 21-55342 (9th Cir.).
  128. In re Byetta Cases, 2021 WL 2462800, slip op. (Cal. Super. April 6, 2021).  Summary judgment granted against all claims against multiple drugs.  Similar to Incretin.  Plaintiffs must present evidence of newly acquired evidence, and why it would have made a difference.  Foreign regulatory action not insufficient and foreign regulatory ultimately reached same conclusion as FDA.  Outdated, unreliable, and/or speculative data cannot be newly acquired evidence.  Information already available to the FDA cannot be “newly acquired.”  Various nit-picks of  information submitted to FDA were either untrue or were of no significance to the FDA.  Unpublished, litigation-created materials were not scientific information the FDA would have considered.  Information published on clinicaltrials.gov was necessarily known to the FDA.  Studies about different, similar drugs were not relevant.  Plaintiffs failed to show that any of the challenged information would have made a difference to the FDA’s evaluation of the products.  There was also clear evidence that the FDA would not have allowed the warning plaintiffs seek.  Medical journal article was only an informal communication, but explains the FDA’s consistent behavior in it exercise of labeling authority, which was official agency action.  A CBE to add the warning plaintiffs sought would have been rejected.
  129. Center for Environmental Health v. Perrigo Co., 2021 WL 1960333, slip op. (Cal. Super. May 7, 2021).  Demurrers granted.  Preemption bars any attempt to apply California Proposition 65 warnings to over the counter drugs.  Prop. 65 warnings are “labeling” under the FDCA, and OTC labeling must be the identical to what the FDA approved.  As for branded drugs, a Prop 65 warning can only escape preemption if that information also could be added under the requirements of the CBE regulation, which plaintiffs have failed to plead.
  130. Zamfirova v. AMAG Pharmaceuticals, Inc., 2021 WL 2103287 (D.N.J. May 25, 2021).  Summary judgment granted against all claims.  Preemption bars consumer fraud claims that challenge FDA-approved labels.  The CBE regulation requires newly acquired information.  A study that the FDA considered in approving the drug cannot be “new.”  Plaintiffs’ class period includes considerable time before the only subsequent study, thus including preempted claims.  Since none of the plaintiffs plead use of the product during a non-preempted period, all labeling-related claims are dismissed.
  131. Silver v. Bayer Healthcare Pharmaceuticals, Inc., 2021 WL 8362387 (D.S.C. May 28, 2021).  Motion to dismiss granted against all claims.  A distributor does not hold a drug NDA and cannot change the warnings, design, or manufacture of a drug.  Therefore all claims are subject to impossibility preemption.
  132. In re Zofran (Ondansetron) Products Liability Litigation, 541 F. Supp.3d 164 (D. Mass. June 1, 2021).  Summary judgment granted against all claims in multidistrict litigation.  FDA already requested data about common off-label use and concluded data did not support label change.  FDA response to two post-litigation submissions confirmed insufficient proof of actual risk.  To prevent overwarning, FDA does not put “possibilities” or hypothetical “mechanisms of action” on labels.  Plaintiffs’ junk science thus falls to preemption.  FDA has a duty to require label changes based on any evidence it learns of and declined to do so, despite having plaintiffs’ expert reports.  Clear evidence under Albrecht established that FDA rejected plaintiff’s’ claimed risk.  Only CBE availability defeats preemption.  Preemption is an affirmative defense.  Clear evidence established by citizens petition denials and submission by denial of label change requested by defendant’s successor in interest.  These were final agency action.  Post-litigation submissions eliminated issues over completeness of prior submissions.   Since FDA obligated to consider all information, preemption not limited to portions of label containing rejected changes.  FDA review not “narrow and myopic.”  Preemption does not require rejection of the exact warning the plaintiffs seek.  To ignore later FDA actions involving the same drug simply because a new company owned the NDA would be illogical and poor policy.  Any FDA “insufficient data” rejection necessarily covers all prior periods, since less data is necessarily available at an earlier time.  Affirmed, 2023 WL 128570, below.
  133. Ignacuinos v. Boehringer Ingelheim Pharmaceuticals, Inc., 8 F.4th 98 (2d Cir. Aug. 6, 2021).  Grant of motion to dismiss affirmed.  All product liability claims demanding something that the FDA considers a “major change” necessarily require prior FDA approval of the change and are therefore preempted.  Affirming 490 F.Supp.3d 533, above.
  134. Paulsen v. Abbott Laboratories, 563 F. Supp.3d 787 (N.D. Ill. Sept. 28, 2021).  Motion to dismiss granted.  Only the holder of a new drug application can change the warnings on a prescription drug.  Whatever else the defendant did, it did not have the NDA.  Therefore, failure to warn claims are preempted.  Appeal pending, No. 21-2877 (7th Cir.)
  135. Hernandez v. Aurobindo Pharma USA, Inc., 2022 WL 204401 (M.D. Fla. Jan. 24, 2022).  Judgment on the pleadings granted.  Pharmacy selling generic drug could not be liable for inadequate warnings.  The pharmacy did not posses the drug NDA and thus could not have changed the warnings.
  136. In re Fosamax (Alendronate Sodium) Products Liability Litigation, 593 F. Supp.3d 96 (D.N.J. March 23, 2022).  Summary judgment granted.  Warning changes limited to prevent overwarning.  FDA would not have rejected a warning based on language if it thought scientific data required one, given its obligation to require label changes based on information received from any source.  A drug manufacturer may prove preemption where it did not actually attempt an unsuccessful label change.  A complete response letter is formal, preemptive FDA action.  Internal FDA communications are not preemptive, but useful to interpret formal FDA actions.  Requiring futile CBE supplements to preserve preemption would burden the FDA.  On appeal (#22-3412).
  137. Vesoulis v. Reshape Lifesciences, Inc.,  2022 WL 989465 (5th Cir. April 1, 2022).  Summary judgment affirmed.  FDCA-based negligence per se claim was based solely on a claimed FDCA violation and therefore preempted under Buckman.
  138. Pfaff v. Merck & Co., 627 F. Supp.3d 1346 (E.D.N.Y. Sept. 9, 2022). Partial summary judgment granted.  Clear evidence establishes that one of plaintiffs’ warning claims is preempted because the FDA reviewed the defendant’s CBE supplement and rejected the additional warning plaintiff demanded.  That the FDA did not inform the defendant of the rejection does not defeat preemption.  The FDA restated the rejection publicly in rejecting a later citizen petition.  Plaintiff failed to identify any newly acquired information to support another claim.  Animal studies cannot be newly acquired information.  Unanalyzed adverse event reports are not newly acquired information.  Information that only came into being after the relevant drug use cannot be newly acquired information.
  139. Amiodarone Cases, 300 Cal. Rptr.3d 881 (Cal. App. Nov. 3, 2022).  Demurrer affirmed.  Because the learned intermediary rule precluded any state-law duty to provide medication guides directly to a patient, plaintiffs’ warning claims were disguised private FDCA enforcement and barred by Buckman.
  140. Holcomb v. Pfizer, Inc., 2022 WL 17670003 (E.D. Cal. Dec. 14, 2022).  Motion to dismiss granted.  Plaintiff failed to plead the existence of any newly acquired information that could create independent ability to change a warning.  A “high rate of unexplained failures” is insufficient, as it does not pertain to the injury plaintiff claims.  Federal law necessarily preempts, as a major change requiring FDA pre-approval, any claim that a drug’s chemical composition should be different.
  141. Chennault v. Bayer Corp., 2022 WL 17814626 (S.D. Tex. Nov. 28, 2022).  Motion to dismiss granted.   Plaintiff failed to plead any newly acquired information.  Information published before FDA approval is not “new.”
  142. Barnes v. Merck & Co., 648 F. Supp.3d 283 (D. Mass. Jan. 4, 2023).  Partial motion to dismiss granted.  Design defect claims are preempted because they are major changes requiring prior FDA review and approval.
  143. Ortega v. Merck & Co., 648 F. Supp.3d 293 (D. Mass. Jan. 4, 2023).  Partial motion to dismiss granted.  Design defect claims are preempted because they are major changes requiring prior FDA review and approval.
  144. In re Zofran (Ondansetron) Products Liability Litigation, 57 F.4th 327 (1st Cir. Jan. 9, 2023).  Affirming grant of motion to dismiss.  Certain studies did not constitute newly acquired information because they did not show any statistically significant risk increase, and in any event did not involve greater or different risks.  Plaintiffs could second guess the FDA’s standard for such information.  A case where the defendant disputes the existence of newly acquired information is not a case fitting the Albrecht description of being “like Wyeth.”  Multiple FDA decisions over the past decade constitute clear evidence that the FDA would have rejected the label change plaintiffs demand.  The FDA being fully informed does not require all of the information to come from the defendant manufacturer.  Verbatim identity is not necessary to preemption.  When the FDA formally approves a statement that data reveals no effects, it necessarily rejects the contention that the data does reveal effects.  Affirming 541 F. Supp.3d 164, above.
  145. Roshkovan v. Bristol-Myers Squibb Co., 2023 WL 2626371 (C.D. Cal. Jan. 13, 2023).  Motion to dismiss granted.  All of the risk information plaintiff pleaded in the complaint had already been reported to the FDA, so there was no newly acquired evidence that would allow a unilateral warning change of the type plaintiff was demanding.
  146. Licht v. Merck & Co., 2023 WL 1111275 (D. Mass. Jan. 30, 2023).  Partial motion to dismiss granted.  Design defect claims are preempted because they are major changes requiring prior FDA review and approval.
  147. Beaver v. Pfizer, Inc., 2023 WL 2386776 (W.D.N.C. March 6, 2023).  Motion to dismiss granted.  A failure-to-recall claim against a branded drug was a stop-selling claim preempted by Bartlett.
  148. Polson v. AstraZeneca Limited Partnership, 2023 WL 2770687 (D. Conn. April 4, 2023).  Motion to dismiss granted.  A consumer expectation design defect is incompatible with the FDA’s standards for prescription drug approval and any design change affecting whether a drug is “unreasonably dangerous” requires prior FDA approval, making simultaneous compliance with state and federal law impossible.
  149. In re Acetaminophen – ASD-ADHD Products Liability Litigation, 2023 WL 3045802 (S.D.N.Y. April 21, 2023).  A state consumer protection claim is not a “product liability” claim and is therefore preempted against the manufacturer of an over-the-counter product by the express preemption clause of 21 U.S.C. §379r(a).
  150. Brashear v. Pacira Pharmaceuticals, Inc., 2023 WL 3075403 (S.D. Ohio April 25, 2023).  Motion to dismiss granted.  Design defect claims preempted because any reformulation would be a major change requiring prior FDA approval.  The same is true of any claimed pre-approval design defect.  FDA approval also required and no facts pleaded to establish that FDA would have approved a different formulation.  Warning claim preempted because it would have required a change to “highlights” section, and that cannot occur without prior FDA approval.  Plaintiff failed to plead any newly acquired information that could have justified a CBE label change, had that even been possible.  FDA approval creates a presumption of an adequate label that can only be overcome with specifically pleaded facts.
  151. Neto v. Bristol-Myers Squibb, 2023 WL 3689533 (D. Conn. May 26, 2023).  Motion to dismiss granted.  Plaintiff failed to plead the existence of any newly acquired evidence of clinical significance that would allow a unilateral warning change.
  152. Bossetti v. Allergan Sales, LLC, 2023 WL 4030681 (S.D. Ohio June 15, 2023).  Partial motion to dismiss granted.  Design defect claims, whether before or after FDA approval are preempted.  Pre-approval design defect claims are preempted stop selling claims.  Punitive damages claims based on statutory fraud on the FDA exceptions are impliedly preempted.
  153. Telebrands Corp. v. Luminas International LLC, 2023 WL 6370902 (S.D. Cal. July 12, 2023).  Judgment on the pleadings granted.  All of plaintiff’s state-law claims would require the court to decide whether the defendant’s product violated the FDCA.  The FDCA’s enforcement clause impliedly preempts attempts at private enforcement.
  154. In Re Gardasil Products Liability Litigation, 2024 WL 1197919 (W.D.N.C. March 20, 2024).  Judgment on the pleadings granted against most claims.  However  captioned, all claims that attack common vaccine attributes are functionally design claims and expressly preempted.  All claims attacking the information provided to patients, parents, or the general public are preempted.  Tortured statutory construction concerning DTC warnings rejected.  Only concealment claims are not preempted at the pleading state.
  155. Hickey v. Hospira, Inc., ___ F.4th ___, 2024 WL 2513487 (5th Cir. May 24, 2024).  Denial of summary judgment reversed as to most claims.  Implied preemption applies to §355(b)(2) “paper NDA” drugs in the same fashion as with other prescription drugs.  The FDA’s CBE requirement must apply to avoid preemption of warning claims.  The CBE regulation requires “newly acquired information” as a prerequisite.  Newly acquired information must not only be “new,” but must also “reveal risks of a different type or greater severity or frequency” than previously submitted data.  All but one item of information advanced by plaintiffs failed the different/greater test, and the one remaining item was doubtful.
  156. In re Chantix (Varenicline) Marketing, Sales Practices & Products Liability Litigation, 2024 WL 2784234 (S.D.N.Y. May 28, 2024).  Motion to dismiss granted in large part.  “Warranty” claim that product contamination violates “therapeutic equivalence” as not being the “same” Buckman preempted as a private FDCA enforcement.  No equivalent state-law claim involving “therapeutic equivalence” exists.  FDA determines therapeutic equivalence.  FDA does not treat bioequivalence as absolute identity and has never found a “new and unapproved” drug due to contamination.  Labeling related claims preempted because no newly acquired information supporting a unilateral CBE label change.  FDA’s prophylactic standard of  in 100,000 cancer over a 70-year lifetime exposure was not a significant risk that permits a CBE change.  FDA found no such risk and advised continued drug usage.  Nor was contamination known prior to the recall.  Issues with other drugs are not newly acquired information.  Manufacturing defect claims on pleadings as potentially parallel claims Related misrepresentation claims (about CGMP compliance) survive preemption.
  157. Brashear v. Pacira Pharmaceuticals, Inc., 2024 WL 3860465 (S.D. Ohio Aug. 19, 2024).  Second motion to dismiss granted.  Claim that the defendant had a duty to submit a supplemental application to FDA to change its warnings was Buckman preempted, since the asserted duty arose solely by virtue of the FDCA, not state law.  Nor could a CBE-based claim survive, since plaintiff did not plead newly acquired information.  A single-person case study is not sufficient.  Misrepresentation claims attacking the drug’s FDA-approved label are preempted.  Negligence claim that the drug was not safe is preempted as a stop-selling claim.