Source: http://www.annalsofhealthlaw.com/annalsofhealthlaw/vol_22_issue_3?pg=95
Timestamp: 2019-04-18 21:15:57+00:00

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Despite Mensing’s apparently clear ruling regarding generic manufacturers’ lack of any duty to send Dear Doctor letters, some lower courts have already criticized the holding.69 Others have found that there are still situations in which generic manufacturers are required to send Dear Doctor letters.70 In Fisher v. Pelstring, for example, the Superior Court of Washington D. C. defied Mensing’s holding and ruled that the generic manufacturer should have “issue[d] a ‘Dear Doctor’ letter” alerting physicians of changes made in the branded drug’s label.”71 Similarly, in Brasley-Thrash v. Teva Pharmaceuticals, the District Court for the Southern District of Alabama held that the plaintiff’s effort to amend her complaint was not futile where she planned to allege that the defendant generic drug manufacturers were liable for failing to send a Dear Doctor letter advising her treating physician of a change in the label for a brand name drug.72 Thus, despite Mensing’s seeming preemption protection, generic manufacturers still have to consider whether a Dear Doctor mailer should be sent, and if so, work with the FDA to encourage either the FDA or the brand name manufacturer to send them out.
70. See, e.g., Bartlett v. Mut. Pharm. Co., 678 F.3d 30 (1st Cir. 2012); Couick v. Wyeth, Inc., Civ. A. No. 09-210, 2012 WL 79670 (W.D.N. C. Feb. 16, 2012); Brasley-Thrash v. Teva Pharms. USA, Inc., Civ. A. No. 10-31, 2011 U.S. Dist. LEXIS 102858, 2012 WL 4025734 (S.D. Ala. Sept. 12, 2011); Hassett v. Dafoe, No. 1551, 1997, 2012 WL 1512551 ( C. C.P. Phila. Mar. 22, 2012).
71. Fisher v. Pelstring, 817 F. Supp. 2d 791, 834-35 (D. C.S. C. 2012).
72. Brasley-Thrash v. Teva Pharms. USA, Inc., 2011 WL 4025734, at 4 (S.D. Ala. Sept. 12, 2011).
73. Patient Safety and Generic Labeling Improvement Act, S. 2295, 112th Cong. (2012); see generally James W. Huston, Erin M. Bosman & Julie Y. Park, Client Alert: Bill to Undo Mensing Decision and Allow Patients to Sue Generic Drug Makers for Failure to Warn, MORRISON & FOERSTER LLP (Apr. 19, 2012), available at http://www.mofo.com/files/ Uploads/Images/120419-Mensing-Decision.pdf.

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