In re Zyprexa Products Liability Litigation

• Decision Date: 11 June 2007
• Docket Number: No. 04-MD-1596.,No. 06-CV-1729.,04-MD-1596.,06-CV-1729.
• Citation: 489 F.Supp.2d 230
• Court: U.S. District Court — Eastern District of New York
• Parties: In re ZYPREXA PRODUCTS LIABILITY LITIGATION. Monty Souther, Robert Cusella, Judith New, Beverly Pearson, Donna Worthington, Plaintiffs, v. Eli Lilly & Company, Defendant.

489 F.Supp.2d 230

In re ZYPREXA PRODUCTS LIABILITY LITIGATION.

Monty Souther, Robert Cusella, Judith New, Beverly Pearson, Donna Worthington, Plaintiffs, v. Eli Lilly & Company, Defendant.

No. 04-MD-1596.

No. 06-CV-1729.

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

June 11, 2007.

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J. Christopher Ide, Michael J. Joseph Miller, Miller & Associates, Alexandria, NY, for Plaintiffs.

Lawrence J. Myers, Smith Moore, Atlanta, GA, Samuel J. Abate, Jr., Pepper Hamilton LLP, New York, NY, for Defendant.

MEMORANDUM, ORDER, & JUDGMENT

WEINSTEIN, Senior District Judge.

TABLE OF CONTENTS I. Introduction .....................................................................236 A. History of Litigation ........................................................236 B. Some General Considerations ..................................................238 1. Preemption ...............................................................240 2. Benefits and Roles of Others Reducing Damages ............................241 3. Protections Available to Plaintiffs Through Sources Such as Available Experts' Information and Treating Physicians ...........................244 4. Appropriate Recoveries and Payments ......................................245 C. Motions for Summary Judgment .................................................247 II. Facts ............................................................................248 A. Nature of Zyprexa ............................................................248 B. FDA Labeling .................................................................248 1. September 2003 Label Change ..............................................248 2. Consensus Statement of American Diabetes Association and Other Learned Groups .........................................................249 3. FDA March 2007 Letter ....................................................250

                      C.  International Zyprexa Labeling ...............................................250
                          1.  Japan ....................................................................250
                          2.  European Union, Australia, and Canada.....................................250
                      D.  Lilly's Promotion of Zyprexa..................................................250
                          1.  Pre-September 2003 Label..................................................250
                          2.  Post-September 2003 Label.................................................251
                      E.  Plaintiffs ...................................................................253
                          1.  Robert Cusella ...........................................................253
                              a)  Patient History ......................................................253
                              b)  Prescribing Physician's State of Knowledge ...........................253
                              c)  Representations Made by Lilly Salespeople ............................255
                          2.  Judith New ...............................................................256
                              a)  Patient History ......................................................256
                              b)  Prescribing Physician's State of Knowledge ...........................256
                              c)  Representations Made by Lilly Salespeople ............................257
                          3.  Monty Souther ............................................................259
                              a)  Patient History ......................................................259
                              b)  Prescribing Physicians' State of Knowledge ...........................259
                              c)  Representations Made by Lilly Salespeople ............................261
                          4.  Donna Worthington ........................................................261
                              a)  Patient History ......................................................261
                              b)  Prescribing Physician's State of Knowledge ...........................261
                              c)  Representations Made by Lilly Salespeople ............................262
                III.  Summary Judgment .................................................................262
                      A.  Law ..........................................................................262
                          1.  Summary Judgment Standard ................................................262
                              a)  Generally ............................................................262
                              b)  Right to a jury ......................................................263
                          2.  Choice of Law ............................................................264
                              a)  Substance ............................................................264
                              b)  Statute of Limitations ...............................................264
                          3.  Florida Law ..............................................................265
                              a)  The Learned Intermediary Doctrine ....................................265
                              b)  Adequacy of Warning ..................................................266
                              c)  Statute of Limitations ...............................................266
                          4.  Pennsylvania Law .........................................................267
                              a)  The Learned Intermediary Doctrine ....................................267
                              b)  Adequacy of Warning ..................................................268
                              c)  Statute of Limitations ...............................................268
                          5.  North Carolina Law .......................................................269
                              a)  The Learned Intermediary Doctrine ....................................269
                              b)  Adequacy of Warning ..................................................269
                              c)  Statute of Limitations ...............................................269
                          6.  Application of Federal Law ...............................................270
                              a)  Preemption ...........................................................270
                                    i)  FDA Preamble ...................................................270
                                   ii)  FDA Regulation of Prescription Drug Warning Labels .............271
                                  iii)  Deference Due FDA's Interpretation .............................272
                                   iv)  FDCA Preemption of State Law Causes of Action ..................272
                              b)  Preemption of State Failure to Warn Claims ...........................273
                                    i)  The Preamble Does Not Control the Question of Preemption .......273
                                   ii) State Law Failure to Warn Claims are Not Preempted ..............275
                          7.  Damages Issues ...........................................................278
                      B.  Application of Law to Facts ..................................................278
                          1.  Robert Cusella ...........................................................278
                              a)  Choice of Law ........................................................278
                              b)  Statute of Limitations ...............................................278
                              c)  Adequacy of Warning Post-September 2003 Label Change .................278
                

                              d)  Deposition of Treating Physician .....................................279
                              e)  Summary Judgment Decision ............................................279
                          2.  Judith New ...............................................................279
                              a)  Choice of Law ........................................................279
                              b)  Statute of Limitations ...............................................279
                              c)  Adequacy of Warning Post-September 2003 Label Change .................279
                              d)  Deposition of Treating Physician .....................................279
                              e)  Summary Judgment Decision ............................................279
                          3.  Monty Souther ............................................................279
                              a)  Choice of Law ........................................................279
                              b)  Statute of Limitations ...............................................279
                              c)  Adequacy of Warning Post-September 2003 Label Change .................279
                              d)  Deposition of Treating Physician .....................................279
                              e)  Summary Judgment Decision ............................................279
                          4.  Donna Worthington ........................................................280
                              a)  Choice of Law ........................................................280
                              b)  Statute of Limitations ...............................................280
                              c)  Adequacy of Warning Post-September 2003 Label Change .................280
                              d)  Deposition of Treating Physician .....................................280
                              e)  Summary Judgment Decision ............................................280
                          5.  Adequacy of September 2003 Warning Label .................................280
                 IV.  Admissibility of Expert Opinions at Trial ........................................281
                      A.  Motions Regarding Admissibility of Expert Reports ............................281
                      B.  Rules 702 and 703 of the Federal Rules of Evidence ...........................281
                      C.  Qualifications of Expert Witnesses ...........................................282
                      D.  Helpfulness and Relevance ....................................................282
                      E.  Reliability ..................................................................283
                      F.  Individual Experts' Reports ..................................................285
                          1.  Challenges to Plaintiffs' Experts ........................................285

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