In re Zyprexa Products Liability Litigation
| Decision Date | 31 July 2009 |
| Docket Number | No. 04-MD-1596 (JBW).,No. 06-CV-2592 (JBW).,04-MD-1596 (JBW).,06-CV-2592 (JBW). |
| Parties | In re ZYPREXA PRODUCTS LIABILITY LITIGATION. James Head, in Yolanda Chavez, et al., Plaintiffs, v. Eli Lilly & Company, Defendant. |
| Court | U.S. District Court — Eastern District of New York |
Samuel R. Bagenstos, Washington University Law School, St. Louis, MO, Allan Berger, Allan Berger & Associates, P.L.C., New Orleans, LA, Andrew S. Penn, Bazelon Center for Mental Health Law, Washington, DC, Eleanor L. Polimeni, Finkelstein & Partners, Newburgh, NY, Lawrence J. Gornick, Levin Simes Kaiser & Gornick LLP, San Francisco, CA, Marc Steven Albert, Seeger Weiss LLP, Samuel J. Abate, Jr., Pepper Hamilton LLP, New York, NY, for Zyprexa Products Liability Litigation.
Table of Contents
I. Introduction ........................................................... 20
II. History of Zyprexa Litigation .......................................... 21
III. Facts .................................................................. 24
A. Contents and Use of Zyprexa ......................................... 24
B. Labeling and Warnings to Patients and Medical Professionals ......... 24
1. FDA Labeling and "Dear Doctor Letter" ............................ 24
2. Consensus Statement of American Diabetes Association and Other
Learned Groups ................................................... 26
3. FDA March 2007 Letter ............................................ 27
4. Findings on Medical Community's Knowledge of Zyprexa's Risks ..... 27
C. Plaintiffs Medical History and Physicians' Knowledge of Zyprexa's
Effects .............................................................. 28
1. Psychiatric and Medical History ................................... 28
2. Prescribing Physicians' Knowledge of Zyprexa's Risks .............. 30
IV. Law ..................................................................... 30
A. Summary Judgment Standard ............................................ 30
B. Choice of Law ........................................................ 31
C. Learned Intermediary Doctrine ........................................ 31
V. Application of Law to Facts ............................................. 32
A. Expert Testimony of Dr. Stephen J. Hamburger ......................... 32
B. No Proximate Causation as to Prescription and Injury ................. 33
VI. Conclusion .............................................................. 33
I. Introduction
Defendant Eli Lilly & Company ("Lilly") moves for summary judgment against plaintiff James Head. Plaintiff commenced this action against Lilly in April 2006, in the United States District Court for the District of Arizona. The case was transferred to the Eastern District of New York pursuant to an order of the Judicial Panel on Multidistrict Litigation. Eight causes of action are asserted, all of which rest on the basic claim that Lilly failed to warn about the risks of Zyprexa. It is alleged by plaintiff that: (1) Zyprexa, a drug produced by Lilly, caused diabetes; (2) Lilly failed to warn of the risks of weight gain and other metabolic dangers of Zyprexa; and (3) Zyprexa would not have been prescribed, and diabetes would not have been suffered, if proper and full warnings had been given.
Lilly moves for summary judgment, contending that no further warning would have changed the decision to prescribe Zyprexa for Head. Lilly submits that operation of the learned intermediary doctrine prevents a finding of causation. Full briefing and, on July 31, 2009, oral argument has taken place.
For the reasons stated below, defendant's motion for summary judgment is granted.
II. History of Zyprexa Litigation
This massive and highly complex multidistrict litigation has included claims brought by individual Zyprexa users, states, third-party payors, and other entities alleging physical or financial injury. Some 30,000 cases have been brought against Lilly by individual plaintiffs suffering from serious psychiatric problems who were treated with the Lilly antipsychotic drug Zyprexa. They principally allege that Zyprexa caused deleterious side effects of 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 Zyprexa.
Litigation against Lilly for injuries allegedly caused by Zyprexa was initiated in this court in March 2004. See Benjamin v. Eli Lilly & Co., No. 04-CV-893. Thousands of cases were then transferred here from federal district courts throughout the United States pursuant to an order of the Judicial Panel on Multidistrict Litigation. See Letter from Multidistrict Litigation Panel to Clerk of the Eastern District of New York, No. 04-MD-1596, Docket Entry No. 1, Apr. 14, 2004. Similar cases have been litigated in state courts. See In re Zyprexa Prods. Liab. Litig., 239 F.R.D. 316 (E.D.N.Y.2007) ("Memorandum on Cooperation Between Federal and State Judges").
The individual Zyprexa user litigation has been administered as a quasi-class action. See In re Zyprexa Prods. Liab. Litig, 467 F.Supp.2d 256, 262 (E.D.N.Y.2006) (); In re Zyprexa Prods. Liab. Litig., 451 F.Supp.2d 458, 477 (E.D.N.Y.2006) () (citation omitted); In re Zyprexa Prods. Liab. Litig., 433 F.Supp.2d 268, 271 (E.D.N.Y.2006) (); In re Zyprexa Prods. Liab. Litig., 424 F.Supp.2d 488, 491 (E.D.N.Y. 2006) (same); In re Zyprexa Prods. Liab. Litig., 233 F.R.D. 122, 122 (E.D.N.Y.2006) (same).
Cooperation between federal and state courts has been encouraged at all stages of the Zyprexa litigation. See, e.g., In re Zyprexa Prods. Liab. Litig., 467 F.Supp.2d at 262 (); In re Zyprexa Prod. Liab. Litig., No. 04-MD-1596, 2006 WL 898105, at *1 (E.D.N.Y. Apr. 16, 2006) (); In re Zyprexa Prods. Liab. Litig., No. 04-M1596, 2006 WL 197151 (E.D.N.Y. Jan. 30, 2006) (); In re Zyprexa Prods. Liab. Litig., No. 04-MD-1596, 2004 WL 3520248, at *4 (E.D.N.Y. Aug. 18, 2004) ().
A national system for resolving Medicare and Medicaid liens was approved. See In re Zyprexa Prods. Liab. Litig., 451 F.Supp.2d 458 (E.D.N.Y.2006). All states and the federal government agreed to modify their lien demands to provide a national equitable system. See In re Zyprexa Prods. Liab. Litig., No. 04-M1596, 2006 WL 3501263, at *1 (E.D.N.Y. Dec. 4, 2006) () (citation omitted).
On April 16, 2004, a class action was filed on behalf of individuals claiming personal injury based on, among other claims, Lilly's failure to provide an adequate warning about the risks of Zyprexa. See Ortiz v. Eli Lilly & Company, No. 04-C1587 (E.D.N.Y.). A second and substantially similar class action was filed in this court on May 19, 2004. See Tringali v. Eli Lilly & Company, No. 04-CV-2104 (E.D.N.Y.). On September 15, 2004, Lilly and plaintiffs' counsel in the two putative class actions entered into an agreement to execute stipulations of dismissal of the class actions, with the effective date of dismissal to be November 1, 2004, or 167 days after the Ortiz action was filed. See Joint Memorandum of the Parties Regarding Stipulation of Voluntary Dismissal of Certain Claims, No. 04-MD-1596, Docket Entry No. 80, Attach. 2.
Discovery and negotiations were overseen in part by a court-appointed special discovery master and four special settlement masters. In November 2005, Lilly, without conceding liability, entered into a settlement covering some 8,000 individual plaintiffs. See In re Zyprexa Prods. Liab. Litig., No. 04-MD-1596, 2005 WL 3117302 (E.D.N.Y. Nov. 22, 2005). The settlement resolved virtually all cases then pending in the MDL, along with some state cases. See id.
An attorneys' fee structure for many cases was ordered, capping fees at 20% of recovery in smaller, lump-sum claims, and at 35% of recovery in other claims. See In re Zyprexa Prods. Liab. Litig., 424 F.Supp.2d 488 (E.D.N.Y.2006). Costs related to the individual cases and charged to individual settling plaintiffs were limited. See In re Zyprexa Prods. Liab. Litig., No. 04-MD-1596, 2006 WL 2443248 (E.D.N.Y. Aug. 24, 2006). Counsel for some 2,000 individual plaintiffs filed an appeal of an order capping fees, see In re Zyprexa Prods. Liab. Litig, No. 04-MD-1596, 2007 WL 2340789 (E.D.N.Y. Aug. 17, 2007), which is now pending before the Court of Appeals for the Second Circuit. The magistrate judge allocated funds from a first common benefit fund after reviewing the first Plaintiffs' Steering Committee's ("PSC I") applications. See In re Zyprexa Prods. Liab. Litig, No. 04-M1596, 2007 WL 805793 (E.D.N.Y. Mar. 15, 2007). Allocation of funds has been substantially completed for PSC I.
Following an influx of thousands of new cases, in January 2007 the parties announced another round of settlements,...
To continue reading
Request your trial
- Webb v. Zimmer, Inc., 2:14-cv-01106 (ADS)(GRB)
-
Patteson v. Astrazeneca, LP
...to initiate or maintain the prescription at issue. General claims of overpromotion are not sufficient.” In re Zyprexa Prods. Liab. Litig., 649 F.Supp.2d 18, 33 (E.D.N.Y.2009) (internal citations omitted). “In order to defeat a motion for summary judgment, an assertion of overpromotion must ......
- Plavix Mktg. v. Squibb
-
In re Zyprexa Prod. Liab. Litig. v. Lilly & Co.
...2485829 (E.D.N.Y. July 31, 2009) (applying California law and granting summary judgment on statute of limitations); Head v. Eli Lilly & Co., 649 F.Supp.2d 18 (E.D.N.Y. 2009) (applying Arizona law and granting summary judgment on learned intermediary doctrine), aff'd, No. 09-4455-cv (2d Cir.......
-
Unimpressed Learned Intermediaries Defeat Warning Causation
...regardless of [any] warning”). Such situations occurred repeatedly in the Zyprexa MDL. In In re Zyprexa Products Liability Litigation, 649 F. Supp.2d 18 (E.D.N.Y. 2009) (applying Arizona law): The factual record requires a finding that, given the serious psychiatric problems manifested by [......
-
Physician Conflicts of Interest in Court: Beyond the Independent Physician Litigation Heuristic
...on other grounds by Kaczkowski v. Bolubasz, 421 A.2d 1027 (Pa. 1980). 163. Head v. Eli Lilly & Co. (In re Zyprexa Prods. Liab. Litig.), 649 F. Supp. 2d 18, 33 (E.D.N.Y. 2009), aff'd, 394 F. App'x 819 (2d Cir. 2010).164. Id.165. See id.; see also Dean, 387 F. App'x at 30 ("Although the recor......