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New Drug/Vaccine Preemption Scorecard

By James M. Beck and Mark Herrmann

It was inevitable, we guess. Just as we ended up creating a new express preemption scorecard for medical devices after Riegel, we've decided to do the same with the drug/vaccine preemption after Wyeth v. Levine (yes, we know Levine doesn't address vaccines, but since we have to change one, we'll change them both).

It's basically the same as our other scorecards. It will be in chronological order after Levine, and we'll mention the drug, the basic result, pro or con, as well as the nature of the claims involved, to the extent they differ from Levine.

1. Smith v. Wyeth, No. 07-18 (W.D. Ky. March 5, 2009), minute order reaffirming in light of Levine prior decision (2008 WL 4697002, reconsideration denied, 2009 WL 425032) finding broad preemption of warning claims in case involving generic Reglan; entering final judgment (3/20/09) to permit immediate appellate review.
2. Morris v. Wyeth, No. 07-176 (W.D. Ky. March 5, 2009), minute order reaffirming in light of Levine prior decision (582 F.Supp.2d 861, reconsideration denied, 2009 WL 424590) finding broad preemption of warning claims in case involving generic Reglan; entering final judgment (3/20/09) to permit immediate appellate review.
3. Wilson v. Wyeth, Inc., No. 07-378 (W.D. Ky. March 5, 2009), minute order reaffirming in light of Levine prior decision (2008 WL 4696995, reconsideration denied, 2009 WL 425027) finding broad preemption of warning claims in case involving generic Reglan; entering final judgment (3/20/09) to permit immediate appellate review.
4. Schrock v. Wyeth Inc., ___ F. Supp.2d ___, 2009 WL 635415 (W.D. Okla. March 11, 2009), finding no preemption of warning claims in case involving generic Reglan. Considering defendant's arguments "similar, if not identical," to those rejected in Levine.
5. Stacel v. Teva Pharmaceuticals, USA, 2009 WL 703274 (N.D. Ill. March 16, 2009), finding no preemption of warning claims in case involving generic Minocin. While generics are distinguishable, the court rejects the FDA's position that generic manufacturers could not modify warnings via CBE process.
6. Longs v. Wyeth, 2009 WL 754524 (N.D. Ohio March 20, 2009) (slip op.), preemption recognized in fen-phen case of claim that the drug "was an ?unreasonably dangerous? drug for which no warning would have been adequate.

Full post as published by Drug and Device Law on March 26, 2009 (boomark / email).