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But in McNellis v. Pfizer Inc., Simandle concluded that a state tort claim was not pre-emp

December 27 2007 at 10:25 PM

Response to Colacicco v. Apotex Inc.,

But in McNellis v. Pfizer Inc., Simandle concluded that a state tort claim was not pre-empted because the FDA's regulations "empower drug manufacturers to enhance the labeling warnings beyond the approved text when new risks emerge."

In nearly two hours of oral argument on Monday, the three-judge panel appeared inclined to rule in favor of the drug manufacturers on the grounds that the FDA has explicitly rejected the plaintiffs' proposed warnings for Paxil, Zoloft and Prozac -- antidepressant drugs known as "selective serotonin re-uptake inhibitors," or SSRIs.

Six lawyers presented arguments, including a Justice Department lawyer arguing for the FDA who urged the court to side with Baylson and hold that such claims are pre-empted.

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  1. Pharmalot: "White House Backs Preemption in Wyeth Case" - paula on Dec 28, 2007, 1:39 PM
    1. "...Wyeth case is 'the big one' as far as FDA labeling preempting concerned"... - paula on Dec 28, 2007, 1:47 PM
      1. "If FDA preemption is upheld there will be NO civil liability for failure to warn"... - paula on Dec 28, 2007, 2:05 PM
      2. we are talking Phenergan here !!! - Anonymous on Dec 28, 2007, 3:53 PM
        1. Phenegran; the stuff you give to infants ?? - Anonymous on Dec 28, 2007, 3:54 PM
          1. phenegran = antipsychotic - Anonymous on Dec 28, 2007, 4:01 PM
            1. phenergan inter arterial damage - Anonymous on Dec 28, 2007, 4:05 PM
              1. another pic of phenergan inter-arterial damage - Anonymous on Dec 28, 2007, 4:07 PM
    2. Drug&DeviceLaw Blog: "The Supreme Court's Preemption Trilogy"... - paula on Dec 28, 2007, 2:49 PM
      1. Wyeth - Levine case: Wyeth does 'NOT' challenge injury due to their 'failure to warn'... - paula on Dec 28, 2007, 3:06 PM
        1. Drug&DeviceLaw Blog - run by 2 lawyers. 1 from Dechert, the other from JonesDay... - paula on Dec 28, 2007, 3:32 PM
          1. Drug&DeviceLaw blog lawyers: 'Ho, Ho, & Ho!'...'2007 was fun, 2008 will be a blast'... - But NOT for people harmed by drugs, eh? on Dec 28, 2007, 4:32 PM

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