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McDowell v. Eli Lilly & Co.

United States District Court, S.D. New York

November 7, 2014

JESSE MCDOWELL, Plaintiff,
v.
ELI LILLY AND COMPANY, Defendant

Decided November 6, 2014

Page 392

For Plaintiff: Harris L. Pogust, Esq., POGUST & BRASLOW, LLC, Conshohocken, PA.

For Defendant: Phyllis A. Jones, Esq., Michael X. Imbroscio, Esq., Brett c. Reynolds, Esq., COVINGTON & BURLING, Washington, DC; Laura M. Flahive Wu, Esq., COVINGTON & BURLIN, New York, NY.

OPINION

Page 393

Robert W. Sweet, United States District Judge.

Defendant Eli Lilly and Company (" Eli Lilly" or the " Defendant" ) has moved pursuant to Federal Rule of Civil Procedure 56 for summary judgment dismissing the failure-to-warn diversity action brought by the plaintiff Jesse McDowell (" McDowell" or the " Plaintiff" ). Based upon the facts and conclusions set forth below, the Defendant's motion is granted and the action is dismissed.

Prior Proceedings

The Plaintiff filed his complaint on June 4, 2013 alleging that the Defendant's labelling for its anti-depression drug Cymbalta failed to warn adequately about the risk of withdrawal upon continuance and that the Defendant designed the drug defectively, was negligent, breached an implied warranty, made a negligent misrepresentation, committed fraud, and violated state consumer fraud laws.

Discovery proceeded and the instant motion was heard and marked fully submitted on September 17, 2014.

The Facts

The facts have been set forth in the Defendant's Rule 56.1 Statement, the Plaintiff's Response to Defendant's Rule 56.1 Statement and Statement of Facts, and Defendant's Response to Plaintiff's Statement of Facts. The facts are not in dispute except as noted below.

Defendant's Rule 56.1 Statement

On August 3, 2004, the United States Food and Drug Administration (" FDA" ) approved Cymbalta (duloxetine), a serotonin norepinephrine reuptake inhibitor (" SNRI" ), for the treatment of major depressive disorder. At the same time, the FDA approved the contents of the U.S.

Page 394

Physician Package Insert, or label, for Cymbalta.

The Cymbalta Physician Package Insert in effect in September 2008 cited the risk of potential discontinuation-emergent adverse events in three sections of the label: Highlights of Prescribing Information, Dosage and Administration, and Warnings and Precautions.

The Cymbalta Physician Package Insert included the following language on the risk of potential discontinuation symptoms in the Highlights of Prescribing Information section:

HIGHLIGHTS OF PRESCRIBING INFORMATION
. . . .

DOSAGE AND ADMINISTRATION

. . . .

Discontinuing Cymbalta: A gradual dose reduction is recommended.

WARNINGS AND PRECAUTIONS

. . . .

Discontinuation: May result in symptoms, including dizziness, nausea, headache, fatigue, paresthesia, vomiting, irritability, nightmares, insomnia, diarrhea, anxiety, hyperhidrosis, and vertigo (5.6).

The Cymbalta Physician Package Insert included the following language on the risk of potential discontinuation symptoms in the Dosage and Administration section:

2 DOSAGE AND ADMINISTRATION
. . . .

2.4 Discontinuing Cymbalta

Symptoms associated with discontinuation of Cymbalta and other SSRIs and SNRIs have been reported. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible [see Warnings and Precautions (5.6)]

The Cymbalta Physician Package Insert included the following language in the Warnings and Precautions section:

5 WARNINGS AND PRECAUTIONS

5.1 Clinical Worsening and Suicide Risk

. . . .
All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
. . . .
If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is feasible, but with recognition that discontinuation can be associated with certain symptoms [see Dosage and Administration (2.4) and Warnings and Precautions (5.6) for descriptions of the risks of discontinuation of Cymbalta].

The Cymbalta Physician Package Insert included the following language in the Warnings and Precautions section:

5.6 Discontinuation of Treatment with Cymbalta
Discontinuation symptoms have been systematically evaluated in patients taking duloxetine. Following abrupt or tapered discontinuation in placebo-controlled clinical trials, the following symptoms occurred at a rate greater than or equal to 1% and at a significantly higher rate in duloxetine-treated patients compared to those discontinuing from placebo: dizziness, nausea, headache, fatigue, paresthesia, vomiting, irritability, nightmares, insomnia, diarrhea, anxiety, hyperhidrosis and vertigo.

Page 395

During marketing of other SSRIs and SNRIs (serotonin and norepinephrine reuptake inhibitors), there have been spontaneous reports of adverse events occurring upon discontinuation of these drugs, particularly when abrupt, including the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional instability, insomnia, hypomania, tinnitus, and seizures. Although these events are generally self-limiting, some have been reported to be severe. Patients should be monitored for these symptoms when discontinuing treatment with Cymbalta. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

According to the Plaintiff, the following language contained in Section 5.6 of the Package Insert is deliberately misleading and inaccurate: " Following abrupt or tapered discontinuation in placebo-controlled clinic trials, the following symptoms occurred at a rate greater than or equal to 1% and at a significantly higher rate in duloxetine-treated patients compared to those discontinuing from placebo . . . ." and Defendant has been aware since 2005 at the very latest that approximately 44% of patients who abruptly discontinued Cymbalta after having used the medication for 9 weeks or less experienced withdrawal symptoms, as well as 50% of patients who had used the medication for " longer term" trials.

The American Psychiatry Association's Practice Guidelines For the Treatment of Patients With Major Depressive Disorder (" APA Guidelines" ) state that " [a]s with the S[elective] S[erotonin] R[euptake] I[nhibitors]s, abrupt discontinuation of SNRIs should be avoided whenever possible." American Psychiatric Association, Practice Guideline for the Treatment of Patients With Major Depressive Disorder 40 (2010), available at http://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/mdd.pdf. According to the Plaintiff, it does not appear that these " guidelines" are tailored to Cymbalta or its specific risks and these guidelines were approved in May 2010 and published in October 2010 while Plaintiff began his Cymbalta treatment in September 2009.

The APA Guidelines further recommend that " [w]hen pharmacotherapy is being discontinued, it is best to taper the medication over the course of at least several weeks," and that discontinuation symptoms may occur. Practice Guideline for the Treatment of Patients With Major Depressive Disorder 20.

In 2005, an article entitled " Symptoms following abrupt discontinuation of duloxetine treatment in patients with major depressive disorder" was published in the Journal of Affective Disorders (" 2005 JAD Article" ). David G. Perahia et al., Symptoms Following Abrupt Discontinuation of Duloxetine Treatment In Patients with Major Depressive Disorder, 89 J. Affective Disorders 207 (2005). Two of the named authors David G. Perahia, and Durisala Desaiah, were employees of the Lilly Research Centre and Lilly Research Laboratories, respectively, at the time of the publication of the 2005 JAD Article.

According to the Plaintiff, there were three authors who contributed to the article who were Lilly employees: Daniel Kajdasz is also affiliated with the Lilly Research

Page 396

Laboratories. Further, the fourth author had been " paid by Eli Lilly" for lecturing and consultancy work. Additionally, the article was never circulated to Nurse Practitioner Joan Caruana (" Caruana" ) nor other prescribing practitioners, and the Defendant has produced no evidence that in 2008 the information contained in the 2005 article appeared anywhere other than the Journal of Affective Disorders.

The 2005 JAD Article reported data arising from nine clinical trials assessing the efficacy and safety of Cymbalta in the treatment of major depressive disorder. All of the studies in the article " were funded, designed and conducted by Eli Lilly and Company." The 2005 JAD Article noted that discontinuation symptoms are " common following antidepressant treatment." Perahia et al., supra, at 207.

The 2005 JAD Article reported that in the short-term placebo-controlled study " [s]ignificantly more duloxetine-treated patients (44.3%) reported at least 1 DEAE than placebo-treated patients (22.9%), with dizziness being the most common symptom." Perahia et al., supra, at 208.

The 2005 JAD Article reported that " [o]f the 510 events reported, 203 (39.8%) were mild, 258 (50.6%) were moderate and 49 (9.6%) were severe." Perahia et al., supra, at 208-09. According to the Plaintiff, the " 510 events reported" only account for the events reported in six of the nine studies and therefore do not represent the total number of events reported for the entirety of the studies.

The 2005 JAD Article reported that in the long-term placebo-controlled study " [s]ignificantly more duloxetine-treated patients reported at least one discontinuation-emergent adverse event (" DEAE" ) (9.1%) than did placebo-treated patients (2.0%) with dizziness being the most common symptoms." Perahia et al., supra, at 210. The 2005 JAD Article reported that " [o]f the 34 DEAEs reported, 24 (70.6%) were mild, 9 (26.5%) were moderate, and 1 (2.9%) was severe." Id. According to the Plaintiff, it is significant to point out that the " 34 DEAEs" referenced only reflect the reportable DEAEs for the two long-term trials.

The 2005 JAD Article reported that in the uncontrolled 52-week open-label study, " half of the patients reported at least one DEAE with dizziness being the most common symptom." Id.

The 2005 JAD Article reported that " [a]mong the 281 patients reporting at least one DEAE, there were a total of 793 DEAEs reported of which 290 (36.6%) were reported as being of mild severity, 367 (46.3%) moderate, and 136 (17.2%) severe." Id. According to the Plaintiff, the figures of " 281" patients and " 793 DEAEs" are only representative of the findings of one of the nine studies: the 52-week open-label study.

The Plaintiff began experiencing symptoms of depression and anxiety at the age of 18. At that time, he experienced a " lack of motivation or desire to really do anything" or " participate in any activities at all." (Pl.'s Dep. 106:21-107:25.) As a consequence of his depression, the Plaintiff would experience periods of one to two months where he " would feel really down." (Id. at 108:17-109:5.)

The Plaintiff also experienced periods in which he had trouble with his sleep, including both " times that I really slept too much, and then there were times that it was -- that I just didn't get a lot of sleep at all." (Id. at 109:23-110:20.) The Plaintiff denies that sleep issues began at age 18.

The Plaintiff also suffered migraines, which he reported in his October 30, 2008 visit to neurologist Dr. Josh Torgovnick. (Id. at 113:22-22; 171:5-7.)

Page 397

Handwritten notes drafted by the Plaintiff prior to his first visit with Caruana in September 2008 indicate that he had previously taken Remeron, Zoloft, Lexapro, Wellbutrin, Effexor, and Prozac, alone and in combination, in an effort to manage his depression. (Caruana Med. R. 4.) After treatment with those medications, the Plaintiff " had not yet been able to get [his] depression under control." (Pl.'s Dep. 140:15-18.)

The Plaintiff's handwritten notes of the antidepressants he had taken prior to commencing Cymbalta therapy indicate that he experienced side effects with all of those therapies, including insomnia, " feeling over-medicated," " tranquilized feeling[s]," " no energy," a " tight heavy feeling in [the] head," feeling " physically tired," feeling " down" even after increased dosages, and " feelings of paranoia." (Caruana Med. R. 4.)

Caruana first prescribed Cymbalta to the Plaintiff in September 2008. (Caruana Dep. 11:13-15; 18:22-24.)

Because the Plaintiff had tried various medications in the past, Caruana agreed that she had been " looking for perhaps a different option from something he had used before unsuccessfully," and that it was her " best medical judgment at the time that Cymbalta was the best ...


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