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1.7.2.3 Generic Medications

In 2011, in PLIVA, Inc. v. Mensing,255 the Supreme Court held that the Federal Food, Drug and Cosmetic Act preempts failure to warn claims regarding a generic medication. The Court reiterated that similar claims would not have been preempted if they had been asserted against a name-brand manufacturer,256 but based its ruling on differences in the statutory schemes. The critical distinction is that, for name-brand drugs, the manufacturer has the unilateral right to strengthen a medication’s warning label. Advance approval by the FDA is not required, although the FDA can rescind the manufacturer’s change. By contrast, the statute requires a generic drug to have the same label as the name-brand medication. The manufacturer of a generic drug has no ability to change the label, but can only ask the FDA to work with the name-brand manufacturer to change the name-brand label.

The Court concluded that these federal restrictions made it impossible for the generic medication manufacturer to comply with the state law tort duty to change its label, and therefore the state law was preempted. The Court did not, however, address whether 2007 amendments to the Federal Food, Drug, and Cosmetic Act would change its analysis.257 In 2013, the FDA proposed a rule that would effectively overrule Mensing by granting both brand and generic manufacturers the ability to improve labeling unilaterally and then seek approval from the FDA.258 However, in 2018 it withdrew the proposed rule.259

In 2013, in Mutual Pharmaceutical Co. v. Bartlett,260 the Court held that design defect claims against manufacturers of generic drugs are also preempted, on the theory that the only way the manufacturer could avoid liability would be to strengthen the warning label, which federal law prohibited. The Court rejected the argument that the manufacturer could have chosen to stop manufacturing the product and thus there was no conflict with federal law. However, the Court left open the possibility that a statute that imposed absolute liability without regard to breach of any duties might not be preempted.261 It also left open the possibility that a generic drug manufacturer might be liable for failing to pull a drug from the market when new information showed that it was dangerous even when used in accord with the label.262 Like Mensing, the case arose before the 2007 statutory amendments.

Lower courts have still found that some claims against manufacturers of generic drugs are not preempted.263 For example, a claim that a generic manufacturer should have sent letters to doctors reiterating the information on the label may not be preempted.264 A claim is not preempted if the generic manufacturer failed to conform its label to that approved for the name-brand version.265 Nor does federal law preempt a failure to update claim—that is, a claim that a generic drug manufacturer did not promptly change its labels to reflect new warnings added by the non-generic manufacturer.266 Claims based on marketing materials other than the label may also survive.267 However, the Sixth Circuit has held that express warranty claims are preempted268 and that an implied warranty claim is at core a design defect claim that is also preempted.269

Because the brand-name manufacturer controls the labeling for the generic drug, the question arises whether it can be held responsible for injuries that consumers suffer because of the generic drug’s label. The highest court in Massachusetts held that a consumer who took the generic version of a drug could assert a common law claim of recklessness against a brand-name manufacturer that intentionally failed to update the label, knowing or having reason to know of an unreasonable risk of death or grave bodily injury associated with its use, but could not assert a negligence or UDAP claim.270

Footnotes

  • 255 {238} PLIVA, Inc. v. Mensing, 564 U.S. 604, 131 S. Ct. 2567, 180 L. Ed. 2d 580 (2011). Accord Strayhorn v. Wyeth Pharmaceuticals, Inc., 737 F.3d 378, 397–398 (6th Cir. 2013) (finding most of plaintiffs’ claims against generic drug manufacturers to be, at core, failure to warn claims and therefore preempted). See also Schrock v. Wyeth, Inc., 727 F.3d 1273 (10th Cir. 2013) (applying Mensing to hold that warranty claims based on the label are also preempted).

  • 256 {239} PLIVA, Inc. v. Mensing, 564 U.S. 604, 625, 131 S. Ct. 2567, 180 L. Ed. 2d 580 (2011) (“Had [plaintiffs] taken . . . the brand-name drug prescribed by their doctors, Wyeth would control and their lawsuits would not be pre-empted.”).

  • 257 {240} Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110-85, 121 Stat. 823 (Sept. 27, 2007). See PLIVA, Inc. v. Mensing, 564 U.S. 604, 131 S. Ct. 2567, 2574 n.1, 180 L. Ed. 2d 580 (2011) (noting that decision expresses no view on effect of 2007 amendments). See also Hassett v. Dafoe, 74 A.3d 202, 217 (Pa. Super. Ct. 2013) (declining to address effect of 2007 amendments).

  • 258 {241} 78 Fed. Reg. 67,985 (Nov. 13, 2013). See also 80 Fed. Reg. 8577 (Feb. 18, 2015) (scheduling public forum on proposal and reopening comment period).

  • 259 83 Fed. Reg. 64,299 (Dec. 14, 2018).

  • 260 {242} Mut. Pharm. Co. v. Bartlett, 570 U.S. 472, 133 S. Ct. 2466, 186 L. Ed. 2d 607 (2013).

  • 261 {243} Id., 570 U.S. at 480–483 (contrasting New Hampshire’s strict liability law with an “absolute” liability law). See Hassett v. Dafoe, 74 A.3d 202, 213 (Pa. Super. Ct. 2013) (noting that Bartlett left open the question whether strict products liability design defect claims would be preempted). But see In re Fosamax (Alendronate Sodium) Products Liab. Litig. (No. II), 751 F.3d 150 (6th Cir. 2014) (strict liability design defect claims are preempted). But cf. Drager v. PLIVA USA, Inc., 741 F.3d 470 (4th Cir. 2014) (claims against generic drug manufacturer under Maryland’s strict liability law are preempted even though statute uses consumer expectations test rather than risk-utility test).

  • 262 {244} Mut. Pharm. Co. v. Bartlett, 570 U.S. 472, 487 n.4, 133 S. Ct. 2466, 186 L. Ed. 2d 607 (2013). See In re Darvocet, Darvon, & Propoxyphene Products Liab. Litig., 756 F.3d 917, 928–933 (6th Cir. 2014) (describing this theory but finding it unnecessary to address it).

  • 263 {245} See, e.g., Hassett v. Dafoe, 74 A.3d 202, 217 (Pa. Super. Ct. 2013) (trial court erred in dismissing claims other than pre-2007 failure to warn claims).

  • 264 {246} Brasley-Thrash v. Teva Pharmaceuticals USA, Inc., 2011 WL 4025734 (S.D. Ala. Sept. 12, 2011). But see In re Darvocet, Darvon, & Propoxyphene Products Liab. Litig., 756 F.3d 917, 932–933 (6th Cir. 2014) (claim that generic manufacturer should have sent letters to doctors is preempted); Strayhorn v. Wyeth Pharmaceuticals, Inc., 737 F.3d 378, 397–398 (6th Cir. 2013) (claim that manufacturer should have sent letters to doctors with additional warnings is preempted).

  • 265 {247} Fisher v. Pelstring, 817 F. Supp. 2d 791, 803–805, 818–822 (D.S.C. 2011) (allowing implied warranty of merchantability claim to proceed); Huck v. Wyeth, Inc., 850 N.W.2d 353 (Iowa 2014) (allowing consumer to proceed with failure-to-warn, negligence, implied warranty, and fraud claims).

  • 266 {248} Fulgenzi v. PLIVA, Inc., 711 F.3d 578 (6th Cir. 2013); Huck v. Wyeth, Inc., 850 N.W.2d 353 (Iowa 2014); In re Reglan/Metoclopramide Litig., 81 A.3d 80, 95 (Pa. Super. Ct. 2013). See also In re Darvocet, Darvon, & Propoxyphene Products Liab. Litig., 756 F.3d 917 (6th Cir. 2014) (recognizing this theory but finding it insufficiently pleaded). But cf. In re Fosamax Products Liab. Litig., 965 F. Supp. 2d 413 (S.D.N.Y. 2013) (claim that generic drug manufacturer should have sent letters to physicians with new warning information is preempted).

  • 267 {249} See, e.g., In re Reglan/Metoclopramide Litig., 81 A.3d 80, 93 (Pa. Super. Ct. 2013). But see Strayhorn v. Wyeth Pharmaceuticals, Inc., 737 F.3d 378, 393–394 (6th Cir. 2013).

  • 268 {250} In re Darvocet, Darvon, & Propoxyphene Products Liab. Litig., 756 F.3d 917, 934–935 (6th Cir. 2014).

  • 269 {251} Id. at 935.

  • 270 Rafferty v. Merck & Co., 92 N.E.3d 1205 (Mass. 2018).