Shipley v. Forest Labs., Inc.

• Decision Date: 13 July 2015
• Docket Number: Case No. 1:06-cv-00048-TC
• Court: U.S. District Court — District of Utah
• Parties: ELAINE J. SHIPLEY, Plaintiff, v. FOREST LABORATORIES, INC., Defendant.

ELAINE J. SHIPLEY, Plaintiff, v. FOREST LABORATORIES, INC., Defendant.

Case No. 1:06-cv-00048-TC

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF UTAH NORTHERN DIVISION

July 13, 2015

ORDER AND MEMORANDUM DECISION

Plaintiff Elaine Shipley's husband, Kurt Shipley, took his own life on April 29, 2004, seventeen days after he began taking the antidepressant drug, Lexapro. Approximately two years after Mr. Shipley's death, Mrs. Shipley filed this wrongful death action against Defendant Forest Laboratories, Inc. (Forest), alleging that Forest failed to warn Mr. Shipley and his health care providers about the risks associated with Lexapro, particularly "the potential for [Lexapro] to induce its users to commit, or attempt to commit, suicide." (Compl. at 2-3, Dkt. No. 1.)

On June 14, 2006, this case was transferred to the Multi-District Litigation Panel in the Eastern District of Missouri, MDL No. 1736, In re: Celexa and Lexapro Products Liability Litigation. The case was remanded and reassigned to this court on August 27, 2013.

Forest has filed a motion to exclude the expert testimony of Dr. George Glass (Dkt. No. 78), along with two motions for summary judgment (Dkt. Nos. 79 and 80). On March 4, 2015, the court heard testimony from Dr. Glass to determine whether he qualifies as an expert under Rule 702 of the Federal Rules of Evidence and under Daubert v. Merrill Dow Pharmaceuticals,Inc., 509 U.S. 579 (1993). The court also heard oral argument on Forest's motions for summary judgment. For the reasons explained below, the court DENIES Forest's Motion to Exclude the Testimony of George S. Glass, M.D. (Dkt. No. 78); DENIES Forest's Motion for Summary Judgment Based on Federal Preemption (Dkt. No. 79); and GRANTS IN PART AND DENIES IN PART Forest's Motion for Summary Judgment (Dkt. No. 80).

FACTUAL BACKGROUND¹

I. Lexapro Labeling History

In August 2002, the United States Food and Drug Administration (FDA) approved the new drug application for Lexapro. Lexapro is manufactured by Forest Laboratories Ireland Limited. (Weinberger Decl. ¶ 4, Dkt. No. 80-66.) Forest Laboratories, Inc. (the Defendant in this case), is the U.S. sponsor for Lexapro. (Id. ¶ 5.) In addition, "[w]arnings for Lexapro are drafted by the regulatory affairs department of Forest Laboratories, Inc." (Id. ¶ 6.)

Lexapro is in a class of prescription antidepressant drugs known as "selective seratonin reuptake inhibitors" (SSRIs). The FDA and the scientific and medical communities commonly treat SSRIs as a class. In 2003, GlaxoSmithKline requested FDA approval for pediatric use of its SSRI, Paxil. In its review of the clinical trial data for the Paxil pediatric supplement, the FDA found that a number of adverse events involved suicidal behavior or ideation but had not been designated as such. The FDA requested clarification of the data, and GlaxoSmithKline'sreanalysis indicated an increase in suicidal thoughts and behaviors with the use of Paxil in pediatric clinical trials. To determine whether the increase in suicidality applied to other SSRIs, the FDA asked other drug sponsors, including Forest, to reanalyze their own pediatric data.

In February 2004, after receiving the results of the requested reanalysis, the FDA convened an advisory committee to discuss "the relationship, if any, between treatment of pediatric patients with antidepressant drugs and suicidal behavior." (Comm. Meeting Tr. 19, Feb. 2, 2004, Dkt. No. 94-3.) The FDA explained, "we do not believe that this data until now has been provided to us in a way that would permit us to interpret it fully." (Id. 24.)

Based on the committee's recommendations, the FDA issued a Public Health Advisory on March 22, 2004, indicating that it had asked sponsors of certain antidepressant drugs (including Lexapro) to update labels to include "a statement that recommends close observation of adult and pediatric patients treated with these agents for worsening depression or the emergence of suicidality." (FDA Public Health Advisory, Mar. 22, 2004, Dkt. No. 78-31.) The updated warning would advise health care providers to "carefully monitor patients receiving antidepressants for possible worsening of depression or suicidality, especially at the beginning of treatment" and to "instruct patients, their families and their caregivers to be alert" for emerging suicidality and to immediately report such symptoms. (Id.)

Three days before issuing the Public Health Advisory, the FDA wrote to Forest asking for updates to the Lexapro label to "caution practitioners and patients about the need for close observation of patients being treated with antidepressants," particularly for worsening depression, suicidality, and other symptoms that may precede suicidality. (Letter from FDA to Forest, Mar. 19, 2004, Dkt. No. 80-92.) The FDA requested the following relevant revisions:

Under WARNINGS, we are requesting the addition of a new subsection entitled Clinical Worsening and Suicide. Please note that the title of this new section should be bolded, as well as two statements embedded in this labeling language.

Warnings - Clinical Worsening and Suicide

Patients with major depressive disorder, both adult and pediatric, can experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs.

Although there has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients, a causal role for antidepressants in inducing such behaviors has not been established. Nevertheless, patients being treated with antidepressants should be observed closely for worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases. Consideration should be given to discontinuing the medication in patients whose depression is persistently worse or whose emergent suicidality is severe, abrupt in onset, or was not part of the patient's presenting symptoms.

. . .

Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications should be alerted about the need to monitor patients for the emergence of agitation, irritability, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. . . .

(Id.)

Responding to the letter, Forest suggested edits to the warning, and on April 19, 2004, the FDA responded with its own revisions, which became the final warning label. The edits added some language but did not substantively change the bolded sections. The FDA stated that the new labeling "should be implemented immediately, and submitted as a CBE supplement."² (See Email from Paul David to Andrew Friedman (Apr. 19, 2004), Dkt. No. 80-93.) On April 30,2004, Forest sent its final label to the FDA and indicated its intent to include the new label in Lexapro packages on May 31, 2004. The FDA approved the changes on May 20, 2004.

II. Kurt Shipley's Lexapro Use

Kurt Shipley first took Lexapro in June 2003, when Dr. Michael Kirkham gave Mr. Shipley some samples based on a diagnosis of "anxiety syndrome, panic disorder and depression, with physical symptoms of palpitations." (Kirkham Dep. at 49, Dkt. No. 78-42.) Lexapro appeared to help Mr. Shipley, and, according to Mr. Shipley's medical records, he took Lexapro from about June to October 2003. (Shipley Dep. at 116-17, Dkt. No. 78-44.)

Mr. Shipley did not begin taking Lexapro again until April 2004. At this time, the Lexapro label did not include the updated, bolded warning language related to suicide. The April 2004 label merely warned that "[t]he possibility of a suicide attempt is inherent in major depressive disorder and may persist until significant remission occurs. Close supervision of high risk patients should accompany initial drug therapy." (Lexapro Label at 7, Dkt. No. 80-73.)

On April 12, 2004, Mr. Shipley saw Nurse Practitioner Carl Christensen and reported having business problems and symptoms of anxiety, such as palpitations, insomnia, shortness of breath, sweating, and irritability. Nurse Christensen diagnosed "general anxiety disorder or mixed anxiety with depression" and prescribed Lexapro. (Christensen Dep. at 54, Dkt. No. 78-45.) At a follow-up visit with Nurse Christensen on April 14, 2004, Mr. Shipley reported that he was doing better and did not report any concerns about Lexapro.

On April 27, 2004, Mr. Shipley told his wife that he felt his condition was getting worse. So Mrs. Shipley made an appointment for Mr. Shipley to see Dr. Craig Julien that day. At his visit with Dr. Julien, Mr. Shipley reported concerns about fatigue, inability to get work done, andfinancial stress. Mr. Shipley also explained that he was having "horrendous thoughts," which "triggered the concern of suicidality" for Dr. Julien. (Julien Dep. at 47, Dkt. No. 78-48.) When Dr. Julien explicitly asked about suicide, Mr. Shipley "said that he had a good stout spirit and that he would never do that." (Id.) Dr. Julien did not pursue the issue further. Dr. Julien continued Mr. Shipley's prescription for Lexapro and added a prescription for Wellbutrin.

On April 29, 2004, Mr. Shipley committed suicide. Mrs. Shipley, personally and on behalf of Mr. Shipley's estate, now seeks to recover damages resulting from Mr. Shipley's death.

ANALYSIS

Forest filed three motions that the court will address in turn: a Motion to Exclude the Testimony of George S. Glass, M.D. (Dkt. No. 78); a Motion for Summary Judgment Based on Federal Preemption (Dkt. No. 79); and a Motion for Summary Judgment (Dkt. No. 80).

I. Motion to Exclude Dr. Glass

To succeed on her failure to warn claim,³ Mrs. Shipley must prove causation. House v. Armour of Am., Inc., 929 P.2d 340, 346 (Utah 1996). In prescription drug cas...