- "[N]arrative history" of the defendant's "marketing and labeling practices." Slip op. at 7.
- "[S]tate of mind, intent, motives, or ethics of [defendant] or any of its employees." Slip op. at 8.
- "[F]oreign labeling regulations or foreign regulatory actions concerning [the drug]." Slip op. at 8.
- "[T]hat [defendant] defrauded the FDA in connection with [the drug's] NDA." Slip op. at 10-11.
- "[W]hether the format or contents of the NDA comply with FDA regulations." Slip op. at 11.
- "[W]hether physicians generally read and comprehend drug labels, or whether doctors generally understand the contents of the [drug's] label." Slip op. at 13.
- "[T]esti[mony] that, in general and without regard to any particular patient, [the drug] is unsafe or the drug's risks outweigh its benefits." Slip op. at 15.
Monday, July 20, 2009
Seroquel Expert Non-Causation Order
We can't say much about this, as Herrmann is on vacation and Bexis is involved in the Seroquel litigation. The MDL judge today ruled on the defendant's motion to exclude various "non-causation" opinions/testimony by the plaintiff's experts. Here is a brief summary of what Judge Conway excluded: