Greaves v. Eli Lilly & Co.

277 F.R.D. 243
CourtDistrict Court, E.D. New York
DecidedNovember 4, 2011
DocketNos. 04-MD-1596, 09-CV-4970
StatusPublished
Cited by4 cases

This text of 277 F.R.D. 243 (Greaves v. Eli Lilly & Co.) is published on Counsel Stack Legal Research, covering District Court, E.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Greaves v. Eli Lilly & Co., 277 F.R.D. 243 (E.D.N.Y. 2011).

Opinion

MEMORANDUM, ORDER, AND JUDGMENT

JACK B. WEINSTEIN, Senior District Judge:

Table of Contents

I. Introduction 244

[244]*244II. Facts.....................................................................244

A. Contents and Use of Zyprexa............................................244

B. Labeling and Warnings to Patients and Medical Professionals................245

1. FDA Labeling and the “Dear Doctor Letter”...........................245

2. Consensus Statement of American Diabetes Association and Other Learned Groups..................................................246

3. FDA March 2007 Letter.............................................247

4. Findings on Medical Community’s Knowledge of Zyprexa’s Risks.........247

C. Frederick Greaves’ Medical History and Treating Physicians’ Decision to Prescribe Zyprexa....................................................248

III. Law......................................................................249
A. Summary Judgment Standard...........................................249
B. Choice of Law.........................................................249
C. Rhode Island Law — Learned Intermediary Doctrine........................249

IV. Application of Law to Facts .................................................250

V. Conclusion ................................................................251
I. Introduction

Defendant Eli Lilly & Company (“Lilly”) moves for summary judgment against plaintiff Frederick Greaves. Plaintiff, then represented by counsel, commenced this action against Lilly in this court in November 2009.

The present action is essentially a negligence claim, based on a failure to warn. It seeks money damages for injuries, alleging that: (1) Zyprexa, a drug produced by Lilly, caused plaintiffs weight gain and diabetes; (2) Lilly failed to warn of the dangers of Zyprexa; and (3) Zyprexa would not have been prescribed, and plaintiffs injuries would not have been suffered, if proper warnings had been given.

For the reasons indicated below, defendant’s motion for summary judgment is granted. As indicated in Part III.C, infra, this ease presents a special problem of application of the learned intermediary doctrine under Rhode Island law, not yet clarified in that state.

II. Facts

The present ease is part of a massive and highly complex multidistrict litigation that has included claims by individual Zyprexa users, state attorneys general, third-party payors, and other entities alleging physical or financial injury. Some 30,000 eases have been brought against Lilly by individual plaintiffs suffering from serious psychiatric problems who were treated with Zyprexa. Like the present plaintiff, they principally allege that Zyprexa caused deleterious side effects, including excessive weight gain, hyperglycemia, and diabetes; that Lilly misled them and their physicians about the likelihood of these side effects; and that, had they or their attending physicians been aware of the risks, they would not have taken Zy-prexa. The court has previously detailed the procedural history and factual background of this multidistrict litigation. See, e.g., Mississippi v. Eli Lilly & Co. (In re Zyprexa Prods. Liab. Litig.), 671 F.Supp.2d 397 (E.D.N.Y.2009); Blume v. Eli Lilly & Co. (In re Zyprexa Prods. Liab. Litig.), Nos. 04-MD-1596, 06-CV-2782, 2009 WL 3596982 (E.D.N.Y. Oct. 20, 2009).

A. Contents and Use of Zyprexa

Zyprexa’s active ingredient is olanzapine, one of a class of medications known as “atypical” or “second generation” antipsychotics. It was approved for use in treating schizophrenia and acute manic episodes associated with bipolar disorder by the United States Food and Drug Administration (“FDA”) in 1996. In 2004, the FDA also approved Zy-prexa for the treatment of bipolar disorder generally.

[245]*245B. Labeling and Warnings to Patients and Medical Professionals 1. FDA Labeling and the “Dear Doctor Letter

The original 1996 Zyprexa package insert accompanying the drug disclosed information about possible side effects of administration of olanzapine based on clinical trials. The insert provided, in part, the following information:

Adverse Events Occurring at an Incidence of 1% or More Among Olanzapine-Treat-ed Patients in Shortr-Term, Placebo-Controlled Trials — Table 1 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred during acute therapy (up to 6 weeks) of schizophrenia in 1% or more of patients treated with olanzapine (doses > 2.5 mg/day) where the incidence in patients treated with olanzapine was greater than the incidence in placebo-treated patients.
The prescriber should be aware that the figures in the tables and tabulations cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence in the population studies.

Zyprexa Package Insert 11 (Oct. 1, 1996) (original emphasis).

Two tables in the insert provided the results of placebo-controlled clinical studies of olanzapine-treated patients. The data indicates that, over a six-week administration of Zyprexa, six percent of olanzapine-treated patients reported weight gain, while only one percent of the placebo-treated patients reported weight gain. Id. at 12-16.

For several years, this information on the insert remained substantially the same insofar as it provided physicians information on reported weight-gain-related adverse events. During this period, the results of longer-term studies and clinical experience with Zyprexa and competing drugs supporting weight gain, hyperglycemia, and diabetes became widely known. See Part II.B.4, infra.

In May 2000, the FDA undertook an analysis of the incidence of diabetes and hyperglycemia in patients using atypical antipsy-ehoties. The director of the FDA’s Division of Neuropharmacological Drug Products requested additional safety information about Zyprexa from Lilly. In its letter, the FDA cited post-marketing reports of diabetes-related adverse events associated with Zyprexa use. In response, Lilly provided the FDA with clinical studies, data analysis, and ease report reviews. See In re Zyprexa Prods. Liab. Litig., 253 F.R.D. 69, 119 (E.D.N.Y. 2008). There is disagreement about whether the information given by Lilly to the FDA was complete and accurate.

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