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:
  • "[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.

1 comment:

Soronel Haetir said...

Given your avowed pro-defense position I am somewhat surprised you linked in this order. There were a few plaintiff concessions, but what they got in would appear to be most of what they actually want. Certainly not a devastating order to their case.

Plus, admitting that an epidemiologist is actually qualified to render opinions in this area seems like a big deal.