McDowell v. Eli Lilly & Co.

• Decision Date: 06 November 2014
• Docket Number: No. 13 Civ. 3786.,13 Civ. 3786.
• Citation: 58 F.Supp.3d 391
• Parties: Jesse McDOWELL, Plaintiff, v. ELI LILLY AND COMPANY, Defendant.
• Court: U.S. District Court — Southern District of New York

58 F.Supp.3d 391

Jesse McDOWELL, Plaintiff

v.ELI LILLY AND COMPANY, Defendant.

No. 13 Civ. 3786.

United States District Court, S.D. New York.

Signed Nov. 6, 2014.

Filed Nov. 7, 2014.

Pogust & Braslow, LLC, by: Harris L. Pogust Esq., Conshohocken, PA, for Plaintiff.

Covington & Burling, by: Phyllis A. Jones, Esq., Michael X. Imbroscio, Esq., Brett C. Reynolds, Esq., Washington, DC, Covington & Burling, by: Laura M. Flahive Wu, Esq., New York, NY, for Defendant.

OPINION

SWEET, 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. 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.

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 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 (...