Tuesday, February 03, 2009

Seroquel MDL Summary Judgment Order

Shoot!

We reported last week that Judge Anne Conway had orally granted summary judgment in the first two test cases in the Seroquel MDL, and that a written order would be forthcoming.

We checked the MDL docket last night and didn't see an order, so we told you this morning that the promised written order had not yet been entered.

We lied.

Judge Conway docketed the order in the individual case, Guinn v. AstraZeneca, No. 6:07-cv-10291-Orl-22DAB, slip op. (M.D. Fla. Jan. 30, 2009), rather than in the general MDL docket, so we missed it. (Those judges can be awfully sneaky.)

Anyway, the court entered the order granting summary judgment on Friday; here's a link to the 15-page decision.

Since Bexis has recused himself from writing about the Seroquel MDL, this report again is written by Herrmann alone.

AstraZeneca faces about 9000 lawsuits involving 15,000 plaintiffs generally pleading that patients' ingestion of the atypical antipsychotic Seroquel caused the plaintiffs to develop diabetes and related disorders.

The MDL transferee court selected several test cases to be presented at bellwether trials. As of last week, two of those cases remained pending. The MDL court then granted AstraZeneca's motion for summary judgment in both cases.

The Guinn opinion involves the case of Linda Guinn, a 61-year-old former legal secretary who had been unemployed for roughly 20 years as a result of medical ailments including schizophrenia, bipolar disorder, depression, epilepsy, and a bunch of others. Slip op. at 2. Most recently, she began to suffer from diabetes. Id. Guinn has had dramatic fluctuations in her weight during her life (ranging from 111 pounds in 1988 to 200 pounds in 1994) and was a lifelong heavy smoker. Id.

The court recited the usual description of the burden of proving causation in a medical product liability case: The plaintiff must prove both general causation -- that the drug is capable of causing an injury in the abstract -- and specific causation -- that the drug caused this particular plaintiff's ailment. Id. at 5. The "big win" for a defendant would be on the ground of general causation, because that would mean that no plaintiff could prevail. The smaller win is on the ground of specific causation, which means that this particular plaintiff loses, but some other plaintiff might theoretically still be able to prove a case.

Judge Conway decided the Guinn decision on the ground of specific causation. Id. at 6-7.

Guinn's medical expert witness, Dr. Marks, testified that Seroquel was a "substantial factor" in Guinn's weight gain and diabetes. But Marks was "unable to identify any mechanism by which Seroquel causes weight gain and, further, could not articulate even an average amount of weight gain that could be attributed to Seroquel." Id. at 12.

Marks also conceded that Guinn had "numerous pre-existing health conditions that could equally have contributed to her weight gain during the time she was on Seroquel, and that Guinn had numerous risk factors for diabetes." Id. at 13. Marks didn't try to quantify the relative contribution of those other factors to Guinn's injury because "'it is not possible or practical' to do so." Id. Marks conceded that "Guinn's pre-existing health conditions alone could have caused her to develop diabetes and that it was more likely than not, to a reasonable degree of medical probability, that Guinn would have developed diabetes whether or not she ever took Seroquel." Id. at 14.

(We don't know who did the cross-examination of that witness, but it was plainly a job well done.)

On that record, the court naturally granted summary judgment in favor of AstraZeneca, although the court went on to stress "that its ruling herein is strictly confined to the application of Florida law to the specific facts of Ms. Guinn's case. Other cases . . . may fare differently." Id. at 15.

That's a huge win for AstraZeneca, and kudos go to Steve Weisburd (who argued the motion) and his team at Dechert for a job well done.

It remains to be seen whether experts in future Seroquel cases will be able to provide the scientific evidence of causation that was missing from Guinn's case.

And Judge Conway's decision notes that AstraZeneca presented "numerous [other] grounds for summary judgment in its motion," which the court didn't reach because of its decision on specific causation. Id. at 1 n.2. That suggests that AstraZeneca still has a bunch of unused arrows in its quiver.

When those arrows get shot, we'll be here to tell you where they land.

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