Scaife v. Astrazeneca LP, C.A. NO. 06C-04-218 SER (Del. Super. 6/9/2009)

• Court: Delaware Superior Court
• Writing for the Court: Slights
• Decision Date: 09 June 2009
• Docket Number: C.A. NO. 06C-04-218 SER.
• Citation: Scaife v. Astrazeneca LP, C.A. NO. 06C-04-218 SER (Del. Super. 6/9/2009), C.A. NO. 06C-04-218 SER. (Del. Super. Jun 09, 2009)
• Parties: NINA SCAIFE, Plaintiff, v. ASTRAZENECA LP, ASTRAZENECA PHARMACEUTICALS LP and ZENECA, LP, Defendants.

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NINA SCAIFE, Plaintiff, v. ASTRAZENECA LP, ASTRAZENECA PHARMACEUTICALS LP and ZENECA, LP, Defendants.

C.A. NO. 06C-04-218 SER.

Superior Court of Delaware, New Castle County.

Submitted: March 27, 2009.

Decided: June 9, 2009.

Upon Consideration of Defendant AstraZeneca's Motion In Limine to Exclude Expert Testimony of Valerie Peck, M.D.

GRANTED.

Linda Richenderfer, Esquire and Jennifer Patone Cook, Esquire, KLEHR, HARRISON, HARVEY, BRANZBURG & ELLERS, LLP, Wilmington, Delaware; Lawrence J. Gornick, Esquire and Dennis J. Canty, Esquire, LEVIN, SIMES, KAISER & GORNICK, San Francisco, California; Paul J. Pennock, Esquire, WEITZ & LUXENBERG, New York, New York. Attorneys for Plaintiff.

Michael P. Kelly, Esquire and Noriss E. Cosgrove, Esquire, MCCARTER & ENGLISH, Wilmington, Delaware; Jane F. Thorpe, Esquire, ALSTON & BIRD, Atlanta, Georgia; Steven B. Weisburd, Esquire, DECHERT, LLP, Austin, Texas. Attorneys for Defendants.

MEMORANDUM OPINION.

SLIGHTS, J.

I.

In this opinion, the Court discharges its evidentiary "gate keeping" responsibility by reviewing the relevancy and reliability of proffered expert testimony on the question of whether Seroquel, an atypical antipsychotic medication manufactured by the defendants, Astrazeneca Pharmaceuticals, LP, Astrazeneca LP, and Zeneca, Inc. (collectively "AZ"), proximately caused the plaintiff, Nina Scaife, to develop Type II diabetes mellitus ("diabetes"). AZ has moved the Court to exclude the medical causation opinions of Ms. Scaife's expert witness, Valerie Peck M.D., on the ground that the opinions are not scientifically reliable. The Court's review has been guided by the settled directives of Daubert v. Merrell Dow Pharm., Inc.,¹ and its Delaware and federal progeny, that have led the Court down well-worn paths of inquiry into the methodologies employed by the expert to reach her medical causation opinions in this case. The Court has made every effort to follow the Daubert directives and to scrutinize the proffered expert testimony accordingly.

After carefully reviewing the expert's report, supplemental affidavit, deposition testimony, Daubert hearing testimony, and the extensive briefing submitted by the parties, the Court concludes that Dr. Peck's opinions do not satisfy the Daubert imperatives because, in reaching her differential diagnosis that plaintiff suffers from diabetes caused by Seroquel, she: (1) failed adequately to "rule out" other likely causes of the plaintiff's diabetes; (2) improperly relied upon the temporal proximity of the plaintiff's exposure to Seroquel and the onset of her diabetes in forming her opinion that Seroquel proximately caused the diabetes; and (3) failed to correlate the information she purportedly reviewed to support the diagnosis into a meaningful analytical framework from which to draw a scientific conclusion. Consequently, AZ's Motion In Limine To Exclude The Medical Causation Expert Testimony of Dr. Valerie Peck must be GRANTED. Because Ms. Scaife is unable to support her claims against AZ with competent expert testimony regarding specific causation, AZ's motion for summary judgment must also be GRANTED.

II.

A. Seroquel

AZ manufactures and sells a prescription drug known chemically as quetiapine fumarate and marketed as Seroquel.² The Food and Drug Administration approved Seroquel in 1997 for use in the United States. It is one of a class of medications known as "second-generation" or "atypical" antipsychotics, and it is prescribed to treat certain manifestations of psychotic disorders, as well as a number of "off-label" conditions.³

Over the past several years, reports have appeared in the medical literature and elsewhere suggesting a possible association between exposure to Seroquel and the development of diabetes and related metabolic disorders.⁴ Litigation followed in which patients who have been prescribed Seroquel allege that AZ failed adequately to warn them of the risk that Seroquel might cause them to develop diabetes, and further allege that Seroquel has, in fact, caused them to develop diabetes. These cases have been filed in state and federal courts throughout the country, including the approximately 700 such cases filed in this Court. The plaintiff here, Nina Scaife, is the first of the Delaware plaintiffs to have her claims reviewed on the merits through dispositive motion practice.

B. Nina Scaife

Ms. Scaife is a 46 year-old African American woman who lives in Kansas City, Kansas. She suffers from hypertension and degenerative joint and disk disease.⁵ Since the age of 16, she has undergone seven knee surgeries and a total knee replacement.⁶ Ms. Scaife's health problems generally have caused her to suffer from chronic pain and sleeplessness over many years.⁷ Her lower extremity injuries in particular have caused her to live a relatively sedentary lifestyle — she has experienced difficulty standing and walking long distances since the first of her several knee surgeries, and has required crutches, casts and canes at various points starting in the 1980's and continuing through the 1990's.⁸

Over the years, Ms. Scaife has been treated with a wide variety of medications to provide relief from her many ailments including, inter alia, painkillers, sleep aids, steroids, hormone therapies, anti-inflammatories, anti-depressants and anti-anxietals.⁹ She has smoked approximately a half a pack of cigarettes per day since the age of 23,¹⁰ and has never followed a regular exercise routine.¹¹ In addition, Ms. Scaife's medical records reveal a history of chronic obesity and difficulty maintaining a healthy body mass index ("BMI"), i.e., a healthy weight in proportion to height (Ms. Scaife is 5'4" tall).¹²

In addition to her many physical problems, Ms. Scaife has suffered from several mood disorders, as well. Her medical records reflect that she was diagnosed with affective disorder, which includes depression and anxiety disorder, in June 1999.¹³ Medical records from September 2001 indicate that Ms. Scaife continued to be treated for depression,¹⁴ and that she was treated for anxiety disorder in October 2001.¹⁵ Her significant pain caused her to develop a sleeping disorder.¹⁶ In May 2002, she sought treatment for sleep deprivation and fatigue at Olathe Medical Services.¹⁷ Her treating doctor noted that over the last couple of years Ms. Scaife's condition was marked by "crying, tearful, anxious, poor sleep, decreased energy, [and] mood swings."¹⁸ In the same month, Ms. Scaife also visited her primary care physician, who noted that her depression, anxiety and affective disorder were being exacerbated by menopausal symptoms.¹⁹

In May 2003, Ms. Scaife complained of headaches, as well as pain in her lower back, cervical area and left arm.²⁰ In addition, she told her doctor that she was "unable to be around people" and that she was "a walking ball of anxiety."²¹ She slept poorly. In response, her doctor prescribed Seroquel in August, 2003.²² She started taking the drug in low doses (25 milligrams once at night).²³ Two weeks later her doctor increased the dosage to 100 milligrams per night.²⁴ Ms. Scaife continued to take Seroquel at this dosage for five months, until early October 2003, when her doctor increased the dosage to 200 milligrams per night, instructing her that if she could not tolerate the higher dosage, she should return to taking 100 milligrams per night.²⁵ Subsequent pharmacy records beginning later that month indicate that Ms. Scaife continued to fill her prescription for sixty 100 milligram Seroquel tablets every other month, consistent with a 100 milligram per night dosage.²⁶

Ms. Scaife was diagnosed with diabetes in May 2004,²⁷ but continued to take Seroquel until September 2004.²⁸ Prior to this diagnosis, Ms. Scaife's diet consisted mainly of pasta, rice, doughnuts, slurpies, fish and fries from McDonalds and Burger King, chicken shrimp, and "[a] lot of Chinese food."²⁹ After stopping Seroquel in March 2005, Ms. Scaife reported that her pain level was interfering with her sleep more than ever, and she felt "like [she] had gone all the way backwards."³⁰

C. Diabetes

Diabetes is a disease with an extremely high background rate. According to Dr. Peck, 10% of the adult population in this country will develop diabetes.³¹ Data from the Centers for Disease Control ("CDC") estimates that approximately 1.6 million Americans are diagnosed with diabetes every year.³² The CDC has characterized the rapid increase in diabetes as an "epidemic."³³ Some data suggests that African American women with a BMI in the range of Ms. Scaife's (BMI > 33) are at a 54x increased risk of developing diabetes.³⁴ In addition, other data suggests that "98 percent of diagnoses of diabetes" in women with a BMI in the range of Ms. Scaife's "are attributable to obesity."³⁵ It is in this context that Dr. Peck attempted to formulate her specific causation opinion in this case.

D. Valerie Peck, M.D.

Ms. Scaife has designated Valerie Peck, M.D. as an expert witness who will opine at trial that Ms. Scaife's exposure to Seroquel caused her to develop diabetes. Dr. Peck's opinions in this case have been disclosed in many forms and have evolved substantially over time, particularly in response to AZ's Daubert arguments in this case and decisions from the court in the federal Multi-district Seroquel Litigation in which the court struck plaintiffs' specific causation experts on Daubert grounds.³⁶ A chronological summary of her opinions, as appears below, illustrates the point.

1. The Credentials

Before discussing her opinions, it is appropriate first to summarize Dr. Peck's credentials to serve as an expert. By any measure, they are impressive. She currently maintains a private endocrinology practice at New York University (NYU) Medical Center, where she also serves as a clinical associate professor of medicine.³⁷ After graduating from NYU's School of Medicine in 1974, Dr. Peck completed a residency in internal medicine and a fellowship...