Monday, February 09, 2009

The Second Shoe Drops In Seroquel

On January 30, Judge Anne Conway granted summary judgment in favor of AstraZeneca in the first of two Seroquel test cases in the federal MDL.

At the end of last week -- on Friday, February 6 -- Judge Conway entered the order granting summary judgment in the second test case, Haller v. AstraZeneca Pharmaceuticals LP, No. 6:07-cv-15733-Orl-22DAB, slip op. (M.D. Fla. Feb. 6, 2009) (here's the obligatory link to the opinion).

Bexis's firm is still involved in these cases, so Bexis is still not participating in drafting posts about the cases. Herrmann alone is responsible for what follows.

And Herrmann's heading off to court in less than an hour. And this opinion weighed in at 68 pages. Forgive the brevity of what follows, but we're struggling to keep you abreast of the drug and device news while continuing to practice law in our spare time.

Haller is another Seroquel-diabetes case. The plaintiff, David Haller, is 47 years old. He had a troubled childhood, was in and out of juvenile detention centers and psychiatric hospitals in his teens, and completed formal education only through third grade. He "accumulated a lengthy criminal record" over time and was involuntarily committed to "psychiatric hospitals on at least seven separate occasions."

Haller suffered from several chronic non-psychiatric health conditions, including gastroesophageal reflux disease, high cholesterol, and high blood pressure, and he experienced significant weight fluctuations throughout his adult life. In addition, he has a history of alcohol abuse, smoking, and not exercising.

Haller was first prescribed Seroquel (presumably for bipolar disorder, with which he had been diagnosed in 1987) in October 2002, and continued taking the drug through at least July 2008. He was diagnosed with diabetes in August 2004.

Haller offered two expert witnesses to support specific causation in his case -- Dr. Brian Tulloch an endocrinologist, and Dr. I. Jack Abramson, a psychiatrist. The court found that neither expert's testimony was admissible under Daubert.

During his deposition, Dr. Tulloch admitted that he didn't physically examine Haller, speak to him, or review all of his medical records before Tulloch gave his expert opinions. Moreover, Tulloch's expert report was filled with errors and omissions. It gave the wrong date on which Haller had begun taking Seroquel. Tulloch didn't know what dose of Seroquel Haller had taken during certain time periods. Tulloch didn't know how much Haller weighed when he started taking Seroquel. And so on.

Tulloch also "could not rule out" sedentary lifestyle and psychosis "as the sole cause of Haller's weight gain when he was on Seroquel." Slip op. at 11. Tulloch agreed that the complications that Haller supposedly suffered from diabetes "may have been solely caused by pre-existing obesity, years of smoking, metabolic syndrome, and uncontrolled hypertension that preceded Haller's ingestion of Seroquel." Id. at 12. Tulloch also conceded (among many other things) that "Haller would have developed diabetes at some point even if he had never taken Seroquel." Id. at 13. Tulloch couldn't explain why Seroquel was responsible for weight gain when Haller had lost an equal amount of weight while taking Seroquel, and Tulloch couldn't isolate what contribution Haller's other medications might have made to his weight gain.

After AstraZeneca moved to exclude Tulloch's testimony and for summary judgment, Tulloch filed a declaration to try to repair the damage done by his deposition testimony. The opinion describes that declaration, and Tulloch's testimony at a later Daubert hearing, at some length. Id. at 20-45. Those 25 pages provide very little to help the plaintiff's side. The Court ultimately decided to exclude Tulloch's testimony under both the reliability and relevance prongs of Daubert, noting that "there are so many Daubert problems associated with Dr. Tulloch's opinions that it is difficult to know where to begin." Id. at 45. The court also made a point of saying that it had "not seen a clearer case of an expert being maneuvered by counsel to elicit an opinion with which he is not really comfortable." Id. at 50.

Dr. Abramson, the psychiatrist, fared no better. Abramson was unqualified to express a diabetes causation opinion because he had never diagnosed a patient with diabetes, doesn't treat patients for diabetes, and has no expertise in diagnosing the cause of diabetes in individuals. Id. at 56-57. Abramson's testimony also suffered from "many of the relevance and reliability concerns raised by Dr. Tulloch's testimony." Id. at 57.

As in the other test case of Guinn, the court concluded that plaintiffs had offered no evidence from which a reasonable jury could find causation under Florida law, and so granted summary judgment in favor of AstraZeneca. Id. at 67. As in Guinn, the court emphasized that its ruling applied only "to the specific facts" of this case, and that other cases may present distinguishable facts or arise under other states' laws and so might fare differently. Id.

The Haller decision, like Guinn, turns on specific causation, and so leaves open the possibility that plaintiffs might prevail in other cases in the Seroquel MDL. On the other hand, the huge collection of gaps in the expert witnesses' testimony suggests that many hurdles stand between the plaintiffs and recovery in these cases.

1 comment:

Anonymous said...

I've been on Seroquel for a few years. The physicians desk reference clearly lists weight gain as a side effect. My psychiatrist told me to watch my diet and excercise, and any weight gain would be temporary and and controlled with responsible behavior. Among every psychiatric patient I've met, all knew that atypical antipsychotics cause weight gain, however the benefits far outweighed the costs. (Older antipsychotics caused much worse side effects.)