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Oct 21, 2004 | Andrews Litigation Reporter Zehel-Miller v. AstraZeneca Pharms.

Arguing that the court made "conclusory findings" in rejecting their class certification request, the plaintiffs in a suit involving the popular anti-psychotic Seroquel have asked a federal judge in Florida to reconsider the motion.
Zehel-Miller et al. v. AstraZeneca Pharmaceuticals LP, No. 6L03CV1258 ORL 22JGG, 2004 WL 1987090 memo in support of reconsideration filed (M.D. Fla., Orlando Div. Sept. 9, 2004).

In a suit filed against Seroquel manufacturer AstraZeneca Pharmaceuticals in 2003, plaintiffs Susan Zehel-Miller and Rebajean Simmons said the drug, used in the treatment of schizophrenia and bipolar disorder, exposed users to a risk of developing diabetes that is "nearly 3.34 times higher" than older drugs, such as Haldol.

The women allege that Seroquel (quetiapine fumarate) "has been associated with diabetes and the serious complications stemming therefrom including seizures, coma, death, liver disease, kidney disease, blindness, and other serious side effects including rapid weight gain, pancreatitis, increased thirst, and hypoglycemia."
AstraZeneca, they say, should have warned patients about the risks and notified them of the heightened need for blood glucose monitoring.

In an Aug. 25 order, however, U.S. District Judge Anne C. Conway said the case is "clearly unsuited for class-action treatment."

The plaintiffs, the judge said, had not met their basic duty of identifying a thread of typicality that could run through the estimated 6.8 million people who have used Seroquel since it went on the market in 1997.

The judge added that Zehel-Miller and Simmons had not shown they could adequately represent all Seroquel users in the class proceeding they hope to launch.

Judge Conway said, "[I]ndividual issues of law and fact still overwhelm common questions" concerning the plaintiffs' plea for medical monitoring and the refund of money spent on Seroquel.

Although expressing little optimism for their success, the judge permitted the plaintiffs to amend their complaint to include only the medical monitoring request and their claim for injunctive relief. Other previous claims, including those for personal-injury damages and statutory damages, had to go, Judge Conway said.

The plaintiffs filed an amended complaint Sept. 7, the same day the judge issued a notice indicating that the parties are scheduled for a mediation conference in June 2005.

Zehel-Miller and Simmons filed a motion for reconsideration of the certification denial two days later. The plaintiffs say Judge Conway used the wrong legal standards in deciding the motion because they failed to apply the requirement of Federal Rule of Civil Procedure 23 that, "for the purposes of class certification, the court should generally accept the plaintiffs' substantive allegations as true."

The pair said the judge ignored their claim that, due to Seroquel's "pharmacologic properties individual medical factors of the potential class members have no bearing, whatsoever, on the need for exposed persons to undergo medical monitoring."

They also criticize the judge's references to the denial of national class certification for suits over Baycol, Rezulin and PPA. Those drugs, the plaintiffs maintain, are "of a different pharmacologic nature, and the facts surrounding the need for monitoring during and after cessation of the drugs are entirely different from the facts surrounding Seroquel."

Also ignored, they say, was their claim that, due to those same properties, for the relevant time period, "Seroquel's product labeling contained inadequate warning for all consumers, irrespective of any individualized plaintiff issues."

In their reconsideration motion, the plaintiffs assert that, because of pressure from both the Food and Drug Administration and their lawsuit, AstraZeneca revised the Seroquel label in January 2004 to address the shortcomings of which they complain.

The plaintiffs are represented by Bryan Aylstock, Douglass Kreis, Justin Witkin and Neil Overholtz of Aylstock, Witkin & Sassser in Gulf Breeze, Fla., and Herbert Waichman and Jerrold Parker of Parker & Waichman in Great Neck, N.Y.
Representing AstraZeneca are Edward Gerecke, Chris Coutroulis, David Barlow, Michael W. Davis and Steven Ellison of Carlton Fields in Tampa, Fla.
Judge: U.S. District Judge Anne C. Conway
Company: AstraZeneca Pharmaceuticals LP

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