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So you saw the words "$2.36 billion," "settlement," and "Avandia" used in the same sentence and you think the litigation is over?
Well, the old gal's still kicking and nowhere was that more apparent that in GSK's Aug. 9 "overview memorandum" trying to kill off seven plaintiff general causation experts in the MDL in Philadelphia federal court.
What makes GSK's motion stand out is that in addition to attacking the plaintiff experts on the usual grounds, it attempts to leverage last month's FDA advisory committee vote as proof that Avandia doesn't cause heart attacks.
GSK seizes on one, brief event in the two-day hearing: when one committee member voiced concern over the way the FDA staff had written the question the committee members were being asked to vote on. The original question asked if data supported a finding that Avandia increased the risk of ischemic cardiovascular events.
The question was written over the lunch hour and by the time the committee got back, the question was changed to whether there was sufficient data about Avandia "to raise significant safety concerns for ischemic cardiovascular events in patients with type 2 diabetes." Not many observers picked up on the change. And after the committee voted, not many people listened to what its 33 members said in explaining their votes. Several alluded to how the change in the question changed how they voted; some indicated they would have voted differently if the question wasn't changed.
GSK picked up on the subtlety and in its overview to the MDL court, cites the committee vote as evidence that the data is unreliable to find Avandia has an increased risk of heart attack.
Trying to use an FDA advisory committee vote as evidence may be a bit of a legal Hail Mary. It's really a variation on the FDA Defense ("Because the FDA says so, that's why!"). Plus, FDA advisory committee votes are so ... advisory; the FDA takes the committee's votes and comments into account before the agency staff makes its own decision. And the FDA has already run counter to one advisory committee recommendation: when the committee voted to recommend continuation of the controversial TIDE study involving Avandia, the FDA turned around and ordered GSK to stop enrolling new patients. The study continues, but can't enroll new subjects.
GSK might also have to do more than wave the advisory committee vote before the court. The court might require GSK to have an expert testify about the committee vote. Taken to the extreme, a plaintiff might say that if the 32 advisory committee members are being held out as experts, let's depose them. The FDA has, in the past, objected to having advisors dragged into court as experts, saying it could chill future participation.
In the end, GSK's appeal to the authority of the FDA advisory committee might make good reading and, perhaps, good theater. Chances are, however, that the issue of which experts get admitted and what ones don't will probably come down to whether the named experts satisfy Rule 702 and Daubert.