The Matrixx Zicam Verdict - Pharmaceutical Technology

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The Matrixx Zicam Verdict
The authors summarize the Matrixx Initiatives, Inc. v. Siracusano case's implications for industry.


Pharmaceutical Technology
Volume 35, Issue 10, pp. 118-122

References

1. D.G. Savage, Chic. Trib., Mar. 23, 2011; C. Bialik, Wall Street Jrnl. Apr. 1, 2011.

2. Matrixx Initiatives, Inc. v. Siracusano, 131 S. Ct. 1309 (2011) [hereinafter Matrixx].

3. Matrixx, 131 S. Ct. at 1313.

4. Id. at 1315. Zicam Cold Remedy Reportedly Accounted for Seventy Percent of Matrixx's sales. Id. at 1314.

5. Id.

6. Id. at 1317. "To prevail on their claim that Matrixx made material misrepresentations or omissions in violation of 10(b) and Rule 10b–5, respondents must prove '(1) a material misrepresentation or omission by the defendant; (2) scienter; (3) a connection between the misrepresentation or omission and the purchase or sale of a security; (4) reliance upon the misrepresentation or omission; (5) economic loss; and (6) loss causation.' " Id. at 1317 (quoting Stoneridge Investment Partners, LLC v. Scientific–Atlanta, Inc., 552 US 148, 157 [2008]).

7. 220 F.3d 36 (2d. Cir.1998).

8. Id.

9. Siracusano v. Matrixx Initiatives, Inc., No. CV 04 0886 PHX MHM, 2005 WL 3970117, *5 (D. Ariz., Dec 15, 2005).

10. Id. at *1.

11. Id.

12. Id. at *7.

13. Siracusano v. Matrixx Initiatives, Inc., 585 F.3d 1167, 1178 (9th Cir. 2009) [hereinafter Siracusano].

14. Basic Inc. v. Levinson, 485 U.S. 224, 236 (1988).

15. TSC Industries, Inc. v. Northway, Inc., 426 U.S. 438, 449, (1976).

16. Siracusano, 585 F.3d at 1178.

17. Id. at 1183.

18. Matrixx, 131 S. Ct. at 1313.

19. Id. at 1319.

20. Id.

21. Id.

22. Id. at 1321–22.

23. Id. at 1318.

24. Wyeth v. Levine, 129 S. Ct. 1187 (2009).

25. Levine v. Wyeth, 944 A.2d 179, 182 (Vt. 2006).

26. U.S. Const. art. VI.

27. Wyeth, 129 S. Ct. at 1193.

28. Id. at 1193-94.

29. FDA allows manufacturers to "add or strengthen a contraindication, warning, precaution or adverse reaction" in order to increase the safety of the product through use of a "changes being effected" (CBE) supplement. 21 CFR 314.70(c) (6) (iii) (A), (C).

30. Wyeth, 129 S. Ct. at 1197.

31. Id. at 1197–98.


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