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What do California, Vermont and Alabama Have in Common? Innovator Liability for Brand-Name Prescription Drug Manufacturers

Introduction

Following a decidedly minority view, the Alabama Supreme Court joined California and Vermont in adopting the so-called “innovator liability doctrine.”1 In so doing, the Alabama Supreme Court became the first state supreme court in the country to recognize brand-name manufacturer liability for a generic drug sold by another manufacturer, departing from “the overwhelming majority of courts” that have rejected the innovator liability theory.2

Under Alabama law, brand-name manufacturers may be held liable for fraud or misrepresentation in a case involving ingestion of a generic drug.

In a case of first impression, the Alabama Supreme Court recently answered the following certified question:

May a brand-name drug manufacturer be held liable for fraud or misrepresentations in a case involving ingestion of a generic drug?

In Wyeth, Inc. v. Weeks,3 the Alabama Supreme Court answered “yes,” holding a plaintiff claiming personal injury from a generic product may maintain a misrepresentation claim against the brand manufacturer.4

Prior to certification by the Supreme Court, the Middle District of Alabama denied the brand-name manufacturer’s motion to dismiss, holding that plaintiffs had properly pleaded their claim that the brand-name defendants perpetuated a fraud on plaintiffs’ physician.5 The Middle District’s holding created an intrastate split in Alabama, thus warranting certification by the Alabama Supreme Court regarding the liability of a brand manufacturer for warnings provided to a physician by a generic manufacturer.6

Under Alabama’s learned intermediary doctrine, “[a] prescription drug manufacturer fulfills its duty to warn the ultimate users of the risks of its products by providing adequate warnings to the learned intermediaries who prescribe the drug.”7 Specifically, a plaintiff-patient must show that “the prescribing physician would not have prescribed the medication to his patient.”8 Plaintiffs Mr. and Mrs. Weeks brought suit against five brand and generic manufacturers of the pharmaceutical drug product Reglan alleging failure to adequately warn Mr. Weeks’ prescribing physician of Reglan’s risks which resulted in physical injury to Mr. Weeks.9

The court relied heavily on the United States Supreme Court’s holding in PLIVA, Inc. v. Mensing10 that “because the FDA prevented the generic-drug manufacturers from independently changing the safety label on their generic drugs, ‘it was impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal-law duty to keep the label the same.’”11 The Alabama Supreme Court noted that the PLIVA Court’s holding that state law failure-to-warn claims against a generic manufacturer are preempted by federal law was subsequent to the Alabama federal courts’ holdings in Mosley, Overton, and Simpson.12 Accordingly, the Alabama Supreme Court rationalized that these prior Alabama federal court holdings were now “questionable.”13

In further justification of its holding, the Alabama Supreme Court rationalized that “FDA regulations provide that a generic-drug manufacturer’s labeling for a prescription drug must be exactly the same as the brand-name-drug manufacturer’s labeling.”14 Although the court limited its holding to manufacturers and not distributors of prescription drugs, according to the Weeks court,

Under Alabama law, a brand-name drug company may be held liable for fraud or misrepresentation […] based on statements it made in connection with the manufacture of a brand-name prescription drug, by a plaintiff claiming physical injury caused by a generic drug manufactured by a different company.15

Furthermore, the court rationalized its holding as follows:

[I]t is not fundamentally unfair to hold the brand-name manufacturer liable for warnings in a product it did not produce because the manufacturing process is irrelevant to misrepresentation theories […] when those misrepresentations were drafted by the brand-name manufacturer and merely repeated by the generic manufacturer.16

On February 4, 2013, Justice Murdock issued his dissent in Weeks. Justice Murdock strongly disagreed with the court’s broad interpretation of the United States Supreme Court’s rationale in PLIVIA, stressing:

[T]he Supreme Court’s holding in PLIVA — that state-law claims against generic-drug manufacturers are preempted by the federal regulatory scheme — did nothing to undermine the essential rationale in the plethora of pre – and post-PLIVA decisions holding that brand-name manufacturers are not liable for injuries caused by deficient labeling of generic drugs they neither manufactured nor sold.17

The dissent further noted that the United States Supreme Court anticipated the arguably unfair scenario where a plaintiff who ingested a generic drug cannot seek compensation from the party who in fact manufactured the drug.18 Specifically, the Supreme Court acknowledged “the unfortunate hand that federal drug regulation has dealt Mensing, Demahy, and others similarly situated.”19 Justice Murdock agreed, holding that “[i]f it is unfair, however, it is an unfairness created by Congress and the Food and Drug Administration (“the FDA”) (in return for the perceived social benefit of less expensive prescription drugs), and by the follow-on application of the federal preemption doctrine by the Supreme Court in PLIVA.”20

Interestingly, since PLIVA was decided, eleven opinions applying the law of ten states have been issued.21 Each of these decisions reiterated the holding that brand-name manufacturers owe no duty to consumers who ingest generic drugs the manufacturers neither manufactured nor sold.22

According to Justice Murdock, “The answer, if there is to be one, lies at the federal level where the problem has been created.”23 The dissent stressed, however, that broadening the PLIVA holding to include the liability contemplated by the majority in Weeks “disrupt[s] the critical dynamic” of America’s free-market system.24

Conclusion

Based on the Weeks holding, brand-name drug manufacturers may now be held liable under Alabama law for misrepresentations in cases where plaintiff never ingested the brand-name drug product. While a certain victory for the plaintiffs’ bar, whether other states will follow and whether the “new” Alabama Supreme Court25 will reconsider its decision remain open questions.


[1] Wyeth, Inc. v. Weeks, 2013 Ala. LEXIS 2, *59 (Ala. January 17, 2013) (recognizing that only two other courts have adopted innovator liability); Kellogg v. Wyeth, 762 F.Supp.2d 694 (D. Vt. 2010); Conte v. Wyeth, Inc., 168 Cal. App. 4th 89, 95 (Cal. Ct. App. 2008).

[2] See PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011).

[3] Wyeth, Inc. v. Weeks, 2013 Ala. LEXIS 2, *59 (Ala. Jan. 17, 2013).

[4] Id. at 57.

[5] Weeks v. Wyeth, Inc., 2011 U.S. Dist. LEXIS 35137 (M.D. Ala. March 31, 2011).

[6] See Mosley v. Wyeth, Inc., 719 F.Supp.2d 1340 (S.D. Ala. 2010); see also Overton v. Wyeth, Inc., 2011 U.S. Dist. LEXIS 38290 (S.D. Ala. March 15, 2011); Simpson v. Wyeth, Inc., 2010 U.S. Dist. LEXIS 139246 (N.D. Ala. December 9, 2010) (all holding that plaintiffs who had only ingested the generic form of Reglan could not recover for alleged misrepresentations to plaintiffs’ physicians by the brand manufacturers).

[7] Weeks, 2013 Ala. LEXIS, *56-57.

[8] Weeks, 2013 Ala. LEXIS 2, *57.

[9] Weeks, 2013 Ala. LEXIS 2, *1-2.

[10] PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2578 (2011).

[11] Weeks, 2013 Ala. LEXIS 2, at *24-25 (citing PLIVA, 131 S. Ct. at 2578).

[12] Weeks, 2013 Ala. LEXIS 2, *34.

[13] Weeks, 2013 Ala. LEXIS 2, *34.

[14] Weeks, 2013 Ala. LEXIS 2, *58.

[15] Weeks, 2013 Ala. LEXIS 2, *57.

[16] Weeks, 2013 Ala. LEXIS 2, *59.

[17] Weeks, 2013 Ala. LEXIS 2, *63.

[18] Id. at 63, 96.

[19] Weeks, 2013 Ala. LEXIS 2, *96 (citing PLIVA, 180 L. Ed 2d at 596-597).

[20] Id. 63-64.

[21] Weeks, 2013 Ala. LEXIS 2, *97.

[22] Id. See Demahy v. Schwarz Pharma, Inc., 702 F.3d 177 (5th Cir. 2012); Smith v. Wyeth, Inc., 657 F.3d 420 (6th Cir. 2011); Mensing v. Wyeth, Inc., 658 F.3d 867 (8th Cir. 2011); Baymiller v. Ranbaxy Pharm., Inc., [No. 3:11-cv-858-RCJ-VPC, Sept. 6, 2012] 894 F.Supp.2d 1302, 2012 U.S. Dist. LEXIS 127285 (D. Nev. 2012); Strayhorn v. Wyeth Pharm., Inc., [No. 11-2058-STAcgc, Aug. 8, 2012] 887 F.Supp.2d 799, 2012 U.S. Dist. LEXIS 110806 (W.D. Tenn. 2012); Phelps v. Wyeth, Inc., 857 F.Supp.2d 1114 (D. Or. 2012); Metz v. Wyeth LLC, 830 F.Supp.2d 1291 (M.D. Fla. 2011); Lashley v. Pfizer, Inc., 877 F.Supp.2d 466 (S.D. Miss. 2012); Guarino v. Wyeth LLC, [No. 8:10-cv-2885-T-30GTW, Apr. 3, 2012] F.Supp.2d, 2012 U.S. Dist. LEXIS 55665 (M.D. Fla. 2012); Gross v. Pfizer, Inc., No. 10-CV-00110-AW, 2011 U.S. Dist. LEXIS 100346 (D. Md. Sept. 7, 2011) (not reported in F.Supp.2d); and Fullington v. PLIVA, Inc., [No. 4:10CV00236JLH, Dec. 12, 2011] F.Supp.2d, 2011 U.S. Dist. LEXIS 142931 (E.D. Ark. 2011). Some of these [*99] are cases in which a court that addressed the issue before PLIVA had an opportunity after PLIVA to revisit its previous ruling, only to reaffirm that previous ruling and implicitly or explicitly conclude that the Supreme Court’s holding in PLIVA did not alter the court’s pre-PLIVA analysis.

[23] Id. at 64.

[24] Id. at 117.

[25] Following the 2012 elections, two of the eight justices who signed the majority opinion in Weeks — Justice Tom Woodall and Chief Justice Charles Malone — are no longer on the court.

Finis

Citations

  1. Wyeth, Inc. v. Weeks, 2013 Ala. LEXIS 2, *59 (Ala. January 17, 2013) (recognizing that only two other courts have adopted innovator liability); Kellogg v. Wyeth, 762 F.Supp.2d 694 (D. Vt. 2010); Conte v. Wyeth, Inc., 168 Cal. App. 4th 89, 95 (Cal. Ct. App. 2008). Jump back to footnote 1 in the text
  2. See PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011). Jump back to footnote 2 in the text
  3. Wyeth, Inc. v. Weeks, 2013 Ala. LEXIS 2, *59 (Ala. Jan. 17, 2013). Jump back to footnote 3 in the text
  4. Id. at 57. Jump back to footnote 4 in the text
  5. Weeks v. Wyeth, Inc., 2011 U.S. Dist. LEXIS 35137 (M.D. Ala. March 31, 2011). Jump back to footnote 5 in the text
  6. See Mosley v. Wyeth, Inc., 719 F.Supp.2d 1340 (S.D. Ala. 2010); see also Overton v. Wyeth, Inc., 2011 U.S. Dist. LEXIS 38290 (S.D. Ala. March 15, 2011); Simpson v. Wyeth, Inc., 2010 U.S. Dist. LEXIS 139246 (N.D. Ala. December 9, 2010) (all holding that plaintiffs who had only ingested the generic form of Reglan could not recover for alleged misrepresentations to plaintiffs’ physicians by the brand manufacturers). Jump back to footnote 6 in the text
  7. Weeks, 2013 Ala. LEXIS, *56-57. Jump back to footnote 7 in the text
  8. Weeks, 2013 Ala. LEXIS 2, *57. Jump back to footnote 8 in the text
  9. Weeks, 2013 Ala. LEXIS 2, *1-2. Jump back to footnote 9 in the text
  10. PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2578 (2011). Jump back to footnote 10 in the text
  11. Weeks, 2013 Ala. LEXIS 2, at *24-25 (citing PLIVA, 131 S. Ct. at 2578). Jump back to footnote 11 in the text
  12. Weeks, 2013 Ala. LEXIS 2, *34. Jump back to footnote 12 in the text
  13. Weeks, 2013 Ala. LEXIS 2, *34. Jump back to footnote 13 in the text
  14. Weeks, 2013 Ala. LEXIS 2, *58. Jump back to footnote 14 in the text
  15. Weeks, 2013 Ala. LEXIS 2, *57. Jump back to footnote 15 in the text
  16. Weeks, 2013 Ala. LEXIS 2, *59. Jump back to footnote 16 in the text
  17. Weeks, 2013 Ala. LEXIS 2, *63. Jump back to footnote 17 in the text
  18. Id. at 63, 96. Jump back to footnote 18 in the text
  19. Weeks, 2013 Ala. LEXIS 2, *96 (citing PLIVA, 180 L. Ed 2d at 596-597). Jump back to footnote 19 in the text
  20. Id. 63-64. Jump back to footnote 20 in the text
  21. Weeks, 2013 Ala. LEXIS 2, *97. Jump back to footnote 21 in the text
  22. Id. See Demahy v. Schwarz Pharma, Inc., 702 F.3d 177 (5th Cir. 2012); Smith v. Wyeth, Inc., 657 F.3d 420 (6th Cir. 2011); Mensing v. Wyeth, Inc., 658 F.3d 867 (8th Cir. 2011); Baymiller v. Ranbaxy Pharm., Inc., [No. 3:11-cv-858-RCJ-VPC, Sept. 6, 2012] 894 F.Supp.2d 1302, 2012 U.S. Dist. LEXIS 127285 (D. Nev. 2012); Strayhorn v. Wyeth Pharm., Inc., [No. 11-2058-STAcgc, Aug. 8, 2012] 887 F.Supp.2d 799, 2012 U.S. Dist. LEXIS 110806 (W.D. Tenn. 2012); Phelps v. Wyeth, Inc., 857 F.Supp.2d 1114 (D. Or. 2012); Metz v. Wyeth LLC, 830 F.Supp.2d 1291 (M.D. Fla. 2011); Lashley v. Pfizer, Inc., 877 F.Supp.2d 466 (S.D. Miss. 2012); Guarino v. Wyeth LLC, [No. 8:10-cv-2885-T-30GTW, Apr. 3, 2012] F.Supp.2d, 2012 U.S. Dist. LEXIS 55665 (M.D. Fla. 2012); Gross v. Pfizer, Inc., No. 10-CV-00110-AW, 2011 U.S. Dist. LEXIS 100346 (D. Md. Sept. 7, 2011) (not reported in F.Supp.2d); and Fullington v. PLIVA, Inc., [No. 4:10CV00236JLH, Dec. 12, 2011] F.Supp.2d, 2011 U.S. Dist. LEXIS 142931 (E.D. Ark. 2011). Some of these [*99] are cases in which a court that addressed the issue before PLIVA had an opportunity after PLIVA to revisit its previous ruling, only to reaffirm that previous ruling and implicitly or explicitly conclude that the Supreme Court’s holding in PLIVA did not alter the court’s pre-PLIVA analysis. Jump back to footnote 22 in the text
  23. Id. at 64. Jump back to footnote 23 in the text
  24. Id. at 117. Jump back to footnote 24 in the text
  25. Following the 2012 elections, two of the eight justices who signed the majority opinion in Weeks — Justice Tom Woodall and Chief Justice Charles Malone — are no longer on the court. Jump back to footnote 25 in the text