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Tuesday, February 23, 2010

Ind. Decisions - 7th Circuit decides drug preemption case today

In Mason v. SmithKline Beecham (CD Ill.), an 18-page opinion by a panel including "Philip P. Simon, United States District Court Judge for the Northern District of Indiana, sitting by designation," Judge Evans writes:

Twenty-three-year-old Tricia Mason committed suicide on March 2, 2003, two days after she started taking Paxil, a popular antidepressant. Her parents sued the manufacturer of the drug, the Smithkline Beecham Corporation, claiming it was negligent (among other things) for not warning that taking Paxil increases the risk of suicide, especially among young adults. The district court granted summary judgment for the company in 2008. The court concluded that the Masons’ claims were preempted under federal law because the warnings they say should have been included about Paxil conflicted with the FDAapproved warning labeling for the drug.

One year after the district court granted the defendant’s motion for summary judgment, the Supreme Court decided Wyeth v. Levine, 555 U.S. ___, 129 S. Ct. 1187 (2009), a case that represents a sea change in the way courts are to consider issues of federal preemption. Keeping the changed landscape in mind, we today consider the Masons’ appeal in light of Levine. * * *

Therefore, in light of the extensive showing required by Levine, we conclude that GSK did not meet its burden of demonstrating by clear evidence that the FDA would have rejected a label change warning about the risk of suicide by young adults before Tricia’s life came to an end at 23. Consequently, the plaintiffs’ claims are not preempted.

For these reasons, the judgment of the district court is REVERSED and the case REMANDED for further proceedings.

Also of note in this opinion is a discussion of the tenor of legal briefs, starting on page 2:
Before going further, however, we note that the district court, on the opening page of its opinion granting summary judgment, said:
The Court notes that the portions of the briefs addressing statements of undisputed and disputed fact that have been submitted by both Plaintiffs and Defendant are so replete with argumentative posturing that they are essentially useless both in determining the basic factual information underlying this case, as well as in resolving the pending motions. The inclusion of 13 and 11 pages of “Introduction” that is reminiscent of closing argument is also wholly inappropriate. Counsel should consider themselves on notice that future filings of this nature will be immediately stricken by the Court.
Any improvement in the tone and substance of the briefs on appeal is slight at best. They are still, as the district court observed, “replete with argumentative posturing.” That’s unfortunate. At this point in the proceeding, all that really needs to be said is that Tricia Mason committed suicide two days after taking Paxil. The briefs, however, go far beyond this statement. The plaintiffs paint a rather bright picture of Tricia. The defendant’s picture is much darker.

[The opinion continues with several pages of examples, before concluding this part of the opinion on p. 5.]

If this case ever gets to a jury, it will consider all the facts and circumstances surrounding Tricia’s life and suicide. We need not concern ourselves with how she should be viewed. In addition, a jury might well conclude that she committed suicide without any help from Paxil. These are not our concerns. Our issue is a legal one, and so we soldier on, mindful, however, that the parties have been extremely partisan in the way they have presented the case to us.

Posted by Marcia Oddi on February 23, 2010 12:40 PM
Posted to Ind. (7th Cir.) Decisions