Rimbert v. Eli Lilly and Co.
| Decision Date | 22 August 2008 |
| Docket Number | No. CIV 06-0874 JB/LFG.,CIV 06-0874 JB/LFG. |
| Citation | 577 F.Supp.2d 1174 |
| Parties | Mark Gilbert RIMBERT, individually, and as Personal Representative of the Estates of Gilbert John Rimbert, and Olivia Acosta Rimbert, deceased, Plaintiff, v. ELI LILLY AND COMPANY, Defendant. |
| Court | U.S. District Court — District of New Mexico |
Arnold Anderson (Andy) Vickery, Vickery, Waldner & Mallia, LLP, Houston, TX, for Plaintiff.
Thomas A. Outler, Rodey, Dickason, Sloan, Akin & Robb, P.A., Albuquerque, NM, and Andrew See, Katherine M. Hihath, Shook, Hardy & Bacon, LLP Kansas City, MO, for Defendant.
THIS MATTER comes before the Court on Defendant Eli Lilly and Company's Motion for Summary Judgment on All Claims, filed March 19, 2008 (Doc. 55)("Motion"). The Court held a hearing on May 16, 2008. The primary issues are: (i) whether the Court should certify to the Supreme Court of New Mexico the legal issue whether New Mexico law recognizes the learned-intermediary doctrine; (ii) whether the Supreme Court of New Mexico would adopt the learned-intermediary doctrine in prescription-drug cases; (iii) whether the 2003 Prozac warnings were inadequate as a matter of law; (iv) whether Defendant Eli Lilly and Company is entitled to summary judgment on Plaintiff Mark Rimbert's claim for strict liability; (v) whether Eli Lilly is entitled to summary judgment on Mark Rimbert's claim for negligence per se; (vi) whether Eli Lilly is entitled to summary judgment on Mark Rimbert's warranty claims; (vii) whether Eli Lilly is entitled to summary judgment on Mark Rimbert's claim for punitive damages. Because the Court does not believe that the Supreme Court of New Mexico would adopt the learned-intermediary doctrine, and because the Court cannot say that the warnings were adequate as a matter of law, the Court will grant in part and deny in part Eli Lilly's motion for summary judgment. The Court will grant Eli Lilly summary judgment on Mark Rimbert's warranty and negligence per se claims, and deny it summary judgment on Mark Rimbert's remaining claims.
Prozac, an FDA-approved prescription antidepressant that Eli Lilly manufactures, is a selective serotonin reuptake inhibitor ("SSRI"). At the time it was prescribed for Gilbert Rimbert, Prozac was a prescription antidepressant medication that the United States Food and Drug Administration ("FDA") had approved for use in the treatment of major depressive disorder. See Defendant Eli Lilly and Company's Memorandum in Support of its Motion for Summary Judgment on all Claims ¶ 2, at 5, filed March 19, 2008 (Doc. 56)("Memo. in Support"); Exhibit A to Memo. in Support, Declaration, of John M. Plewes, II. M.D. at 3 (taken March 11, 2008)("Plewes Aff."); Exhibit A to Memo. in Support, Package Insert for Prozac ("Prozac Insert"). Fluoxetine is the generic name for Prozac. See Exhibit C to Memo. in Support, Deposition of Barry Hochstadt, M.D. (taken August 15, 2007) at 23:6-10 ("Hochstadt Depo.").
Before 2003, Barry Hochstadt, M.D., Gilbert Rimbert's primary physician, had read literature regarding whether suicidality could be induced by the use of SSRI medications. See id. at 19:11-20:6.1 Dr. Hochstadt had been aware of the issue of suicidality in connection with SSRI medications for at least fifteen years. See id. at 19:11-20:6; id. at 53:4-9. Before August of 2003, Dr. Hochstadt had also read literature regarding whether violence could be induced by SSRI medications. See id. at 65:20-66:22. Dr. Hochstadt had been aware of the issue of violence in connection with SSRI medications, including Prozac, for at least fifteen years. See id. at 19:11-20:6; id. at 65:20-66:5.
Dr. Hochstadt does not warn patients about an alleged risk of violent activity from antidepressant use because he does not believe that there is any data to support the idea that SSRI medications cause increasing episodes of violence. See id. at 66:6-22. In 2003, if Eli Lilly had told him to do so, Dr. Hochstadt would have monitored patients beginning to use Prozac for suicidality. See id. at 105:15-20.
On August 18, 2003, Gilbert Rimbert went to see Dr. Hochstadt with increasing despondence and depression related to his wife's recent request for a divorce. See Hochstadt Depo. at 34:14-35:11. Dr. Hochstadt concluded that Gilbert Rimbert was not severely depressed using a Zung depression scale. See id. at 101:12-102:24. Dr. Hochstadt diagnosed Gilbert Rimbert with depression and prescribed a 20 milligram daily dose of fluoxetine. See id. at 40:2-41:4; id. at 54:16-21. At the time that Dr. Hochstadt prescribed Prozac for Gilbert Rimbert, a ten milligram dose of Prozac was available. See Prozac Insert at 1; Complaint ¶ 14, at 5. At the time Dr. Hochstadt prescribed Prozac for Gilbert Rimbert, Prozac Weekly, a weekly dose, was available. See Prozac Insert at 1; Complaint ¶ 15, at 15.
Dr. Hochstadt made the decision to prescribe Prozac based on his knowledge and training as a physician. See id. at 123:21-25. When Dr. Hochstadt prescribes any medication, he conducts a risk/benefit analysis. See id. at 23:21-24:2. Dr. Hochstadt relied on medical journals, conferences, textbooks, and the "ePocrates" computer program to education himself on prescription drugs. Id. at 27:12-28:5. Dr. Hochstadt does not recall Eli Lilly sales representatives calling on him regarding Prozac at the time he prescribed it for Gilbert Rimbert. See id. at 70:18-71:7.
Dr. Hochstadt discussed the risks and benefits of SSRI treatment with Gilbert Rimbert. See Exhibit C to Memo. in Support, Medical Clinic Note (dated August 18, 2003) at 2 ). Dr. Hochstadt testified that the implementation of blackbox warnings regarding suicide has changed since he treated Gilbert Rimbert, and he could not be sure what he told patients in 2003 about this issue. See id. at 47:17-49:15. Dr. Hochstadt recalled, however, telling Gilbert Rimbert to call his office if he experienced suicidality or worsening depression. See Hochstadt Depo. at 59:16-20; id. at 128:15-129:2.
Dr. Hochstadt testified:
Q. But you are confident that you would have told him in September of 2003, "If your depression gets worse or if you feel suicidal, you need to call me"?
A. I am confident I did that as a routine about that time in my practice career.
Hochstadt Depo. at 59:16-20. Dr. Hochstadt also testified:
Q. And just so that I understand, I thought that your testimony earlier was that in 2003, you would have also counseled patients taking an antidepressant about the risk of suicidality?
A. My understanding and recollection would be yes, even then.
Q. And, in fact, I think you have testified that you would have told Mr. Rimbert at both appointments that he came to see you when he was on Prozac—actually, the initial appointment in August and then the followup in September—that if he did develop suicidality, he should call you immediately?
A. That would be my recollection.
Id. at 128:15-129:2. Dr. Hochstadt further testified:
Q. ... You cautioned [patients] because of the concern that their depression could lead to suicide, right?
A. Not true. I only would caution, "If you start this medication, there is a potential increased risk for suicidality."
Q. Antidepressant-induced?
A. It could be because of medication, it could be because of their illness. I don't distinguish. I just say, "If you have increasing problems with, you know, depression, suicidal thinking, then call me immediately and stop the medication." I can't distinguish why they would feel that way.
Q. And you are saying you were saying that in August and September of '03?
A. My recollection is that's true. That's four years ago. So the answer is yes.
Id. at 135:21-136:11.
Mark Rimbert contends that Eli Lilly used the mass media to advertise Prozac. See Response ¶ 78, at 7 (citing www. prozac.com). There is no evidence that Gilbert Rimbert saw any advertisement for Prozac. See Memo. in Support, Exhibit D, Deposition of Tracy Rimbert Thiel at 36:3-9 (taken May 22, 2007)("Thiel Depo.").
Dr. Hochstadt did not dispense Prozac to Gilbert Rimbert. See id. at 10:25-11:8. Gilbert Rimbert did not ask for Prozac by name. See id. at 123:17-20. There is no evidence that Gilbert Rimbert had any Prozac prescription filled at a pharmacy. See Deposition of Grace E. Jackson, M.D. at 97:24-99:3 (taken December 13, 2007)("Jackson Depo.").
Dr. Hochstadt scheduled a follow-up appointment with Gilbert Rimbert, as it was Dr. Hochstadt's practice to schedule a three-to-four-week follow-up appointment with patients after he prescribed Prozac. See Hochstadt Depo. at 55:7-17. Gilbert Rimbert did not call Dr. Hochstadt's office between his August 18, 2003 and September 9, 2003 appointments to report worsening depression or suicidality. See id. at 58:20-59:20.
At the time that Dr. Hochstadt prescribed Prozac for Gilbert Rimbert, the Prozac package insert and the Physicians' Desk Reference ("PDR") contained the following statement in the "Precautions" section:
Suicide—The possibility of a suicide attempt is inherent in depression and may persist until significant remission occurs. Close supervision of high risk patients should accompany initial drug therapy. Prescriptions for Prozac should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose.
Prozac Insert at 2; Exhibit B to Memo. in Support, PDR at 5 (emphasis in original). Mark Rimbert objects that the reference to suicide in the "Precautions" section of the labeling in 2003 was in regard to suicide as a consequence of depression. Response at 3. The "Adverse Reactions" sections of the Prozac Insert and the PDR, however, also reference suicide attempt, akathisia, and...
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