Guinn v. ASTRAZENECA PHARMACEUTICALS LP

602 F.3d 1245, 602 F. Supp. 3d 1245, 82 Fed. R. Serv. 325, 2010 U.S. App. LEXIS 7076, 2010 WL 1286947
CourtCourt of Appeals for the Eleventh Circuit
DecidedApril 6, 2010
Docket09-11104
StatusPublished
Cited by83 cases

This text of 602 F.3d 1245 (Guinn v. ASTRAZENECA PHARMACEUTICALS LP) is published on Counsel Stack Legal Research, covering Court of Appeals for the Eleventh Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Guinn v. ASTRAZENECA PHARMACEUTICALS LP, 602 F.3d 1245, 602 F. Supp. 3d 1245, 82 Fed. R. Serv. 325, 2010 U.S. App. LEXIS 7076, 2010 WL 1286947 (11th Cir. 2010).

Opinion

*1248 PER CURIAM:

Appellant Linda Guinn brought suit against Appellee AstraZeneca Pharmaceuticals LP (AstraZeneca), claiming her use of the prescription drug Seroquel caused her to develop diabetes. Prior to trial, AstraZeneca filed a Daubert motion for the exclusion of the expert testimony of Dr. Jennifer Marks and a motion for summary judgment. After conducting a Daubert hearing, the district court entered an order granting both motions. The court found that summary judgment in favor of AstraZeneca was appropriate because Guinn had failed to establish a genuine issue of material fact on the issue of causation. The court based its ruling on two alternative grounds. First, the court held that the testimony of Dr. Marks, Guinn’s only evidence on the issue of specific causation, did not satisfy the requirements of Rule 702 of the Federal Rules of Evidence and therefore should be excluded. Second, the district court held that even if Dr. Marks’ testimony were admissible, it did not support the conclusion that it was more likely than not that Seroquel substantially contributed to causing Guinn’s diabetes. We affirm the district court’s order granting both AstraZeneca’s Daubert and summary judgment motions.

I. BACKGROUND

A. Procedural Histoi“y

Guinn brought suit against AstraZeneca in the District of Massachusetts, claiming to have developed diabetes as a result of taking Seroquel. Guinn asserted claims against AstraZeneca for strict products liability, negligence, fraud, and civil conspiracy. Guinn contended that while her prescribers were unaware of any increased risk of hyperglycemia or diabetes associated with Seroquel, AstraZeneca knew Seroquel caused weight gain in approximately one-quarter to one-third of patients. According to Guinn, despite AstraZeneca’s knowledge of the relationship between Seroquel and weight gain, the company marketed Seroquel as having no effect on patients’ weight and failed to include adequate warnings on Seroquel’s labels as required by United States Food and Drug Administration (FDA) regulations. Guinn further contended Seroquel is no more effective than other antipsychotics which she claims pose less of a risk of weight gain.

The Judicial Panel on Multidistrict Litigation transferred Guinn’s case and 91 other actions involving Seroquel to the Middle District of Florida for coordinated pretrial proceedings in July 2006. At the time of the district court’s summary judgment order, the consolidated action had grown to include the claims of several thousand plaintiffs.

B. Facts

Seroquel, chemically known as quetiapine fumarate, is an antipsychotic medication manufactured and distributed by AstraZeneca. Seroquel has been approved by the FDA for use in the treatment of bipolar disorder and schizophrenia. Guinn was prescribed Seroquel from May 2002 through April 2007.

1. Dr. Marks’ Expert Report

Dr. Marks, Guinn’s expert witness on specific causation, first gave her opinion in an expert report submitted to the district court. 1 Dr. Marks began her discus *1249 sion of Guinn with a review of her medical records dating back to 1998. Dr. Marks noted that the first weight she had available for Guinn was 194 pounds in March 1999. According to Dr. Marks’ report, Guinn reached a peak weight of 205 pounds in January 2000 and thereafter her weight, though fluctuating, generally decreased until June 2002, when she reached her lowest weight of 155 pounds. It was at approximately this time that Guinn began taking Seroquel. Guinn then gained weight until she was diagnosed with diabetes with a weight of 198 pounds in February 2006. Dr. Marks summarized her review of Guinn’s medical records by stating she gained approximately forty pounds during her five years of taking Seroquel.

After reviewing Guinn’s weight history, Dr. Marks concluded, “based on reasonable medical probability[,] that Seroquel was a cause of [Guinn’s] diabetes.” Dr. Marks explained that “exposure to a medication which caused weight gain worsened her underlying insulin resistance and likely accelerated the onset of diabetes in such a predisposed individual.”

2. Dr. Marks’ Deposition and AstraZeneca’s Daubert Motion

In Dr. Marks’ deposition, AstraZeneca provided Dr. Marks with additional information regarding Guinn’s medical history and more fully examined Dr. Marks’ opinion on causation given this new information. The additional medical history discussed at the deposition revealed that Guinn had already had a number of risk factors for diabetes before she began taking Seroquel. Guinn had struggled with obesity, a significant risk factor for diabetes, and experienced dramatic weight fluctuations since her teenage years. In fact, Guinn’s weight fluctuated before, during, and after her use of Seroquel, with her highest recorded weight during each period being roughly equivalent. 2 Guinn also had a sedentary lifestyle, a poor diet, a significant family history of diabetes, hypertension, hyperlipidemia, schizophrenia, and prediabetes, all of which, in addition to her age of 61, put her at an increased risk for developing diabetes. Dr. Marks stated she was not aware of all of Guinn’s risk factors at the time she wrote her initial report because she had only reviewed medical records provided to her by Guinn’s attorneys dating back to 1998. 3

At the deposition, Dr. Marks expanded on her theory of causation. She reiterated her belief that Seroquel caused Guinn’s diabetes through the mechanism of weight gain. When asked what steps she had taken to determine whether Seroquel had caused Guinn’s weight gain, she replied that she had considered only the medical literature showing that Seroquel can cause weight gain and the temporal proximity of Guinn’s use of the medication. Dr. Marks stated she had made no attempt to quantify the amount of weight gain she attributed to Seroquel and had done nothing to rule out other factors as the sole cause of Guinn’s weight gain. Dr. Marks further acknowledged that Seroquel does not cause weight gain in approximately two-thirds of the patients who take the drug.

When asked what she had done to rule out Guinn’s other risk factors as the sole cause of Guinn’s diabetes, Dr. Marks stated she knew of no methodology for ruling out alternative causes and thus had not attempted to do so. In fact, Dr. Marks *1250 agreed Guinn’s other risk factors alone were sufficient to explain the onset of her diabetes. Dr. Marks stated, however, she had “no way of ruling out the Seroquel any more than [she] c[ould] rule out any other risk factors.”

Dr. Marks also stated she could not rule out the possibility that Guinn had diabetes before ever taking Seroquel. According to Dr.

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602 F.3d 1245, 602 F. Supp. 3d 1245, 82 Fed. R. Serv. 325, 2010 U.S. App. LEXIS 7076, 2010 WL 1286947, Counsel Stack Legal Research, https://law.counselstack.com/opinion/guinn-v-astrazeneca-pharmaceuticals-lp-ca11-2010.