Miller v. Pfizer Inc. (Roerig Division)

• Decision Date: 11 February 2002
• Docket Number: Civil Action No. 99-2326-KHV.
• Citation: 196 F.Supp.2d 1095
• Parties: Mark MILLER and Cheryl Miller, Individually and Mark Miller as Administrator of the Estate of Matthew Miller, Deceased, Plaintiffs, v. PFIZER INC (ROERIG DIVISION), Defendant.
• Court: U.S. District Court — District of Kansas

196 F.Supp.2d 1095

Mark MILLER and Cheryl Miller, Individually and Mark Miller as Administrator of the Estate of Matthew Miller, Deceased, Plaintiffs, v. PFIZER INC (ROERIG DIVISION), Defendant.

Civil Action No. 99-2326-KHV.

United States District Court, D. Kansas.

February 11, 2002.

COPYRIGHT MATERIAL OMITTED

Ruth M. Benien, Benien Law Offices, Chtd., Kansas City, KS, Richard W. Ewing, Paul F. Waldner, Vickery & Waldner, Houston, TX, Arnold Anderson Vickery, Arnold Anderson Vickery, P.C., Houston, TX, for plaintiffs.

Patrick Lysaught, Baker, Sterchi, Cowden & Rice, L.L.C., Kansas City, MO, Robert J.E. Edwards, Polsinelli, Shalton & Welte, P.C., Kansas City, MO, James E. Hooper, Malcolm E. Wheeler, Amy L. Padden, Michael L. O'Donnell, Craig R. May, Wheeler Trigg & Kennedy, P.C., Denver, CO, for defendant.

MEMORANDUM AND ORDER

VRATIL, District Judge.

Mark and Cheryl Miller claim that their 13-year-old son Matthew committed suicide because he took Zoloft—a prescription drug which Pfizer Inc. manufactured for treatment of depression. See Amended Complaint (Doc. # 92) filed December 16, 1999. The Millers seek to hold Pfizer liable for Matthew's wrongful death. Count I of their complaint alleges that Pfizer is strictly liable for marketing defects and misrepresentations about Zoloft. Count II alleges that Pfizer is liable under common law negligence theories for failing to test and warn about the dangers of drug-induced suicide. See Pretrial Order (Doc. # 171) filed March 6, 2000.

The matter comes before the Court on three motions for summary judgment: Defendant Pfizer Inc's Motion For Partial Summary Judgment On Plaintiffs' Claim Of Marketing Defect And Misrepresentation (Doc. # 505) and Defendant Pfizer Inc's Motion For Partial Summary Judgment On Plaintiffs' Failure To Warn Claim (Doc. # 504), both filed September 12, 2001, and Plaintiffs' Motion For Partial Summary Judgment (Doc. # 523) filed October 23, 2001. This matter also comes before the Court on Defendant Pfizer Inc.'s Motion In Limine No. 15 To Exclude References To Its Financial Condition And Announced Merger (Doc. # 276) filed April 28, 2000. The Court has carefully considered the parties' arguments and is now prepared to rule.

Summary Judgment Standard

Summary judgment is appropriate if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law. Fed.R.Civ.P. 56(c); accord Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986); Vitkus v. Beatrice Co., 11 F.3d 1535, 1538-39 (10th Cir.1993). A factual dispute is "material" only if it "might affect the outcome of the suit under the governing law." Anderson, 477 U.S. at 248, 106 S.Ct. 2505. A "genuine" factual dispute requires more than a mere scintilla of evidence. Id. at 252, 106 S.Ct. 2505.

The moving party bears the initial burden of showing the absence of any genuine issue of material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986); Hicks v. City of Watonga, 942 F.2d 737, 743 (10th Cir.1991). Once the moving party meets its burden, the burden shifts to the nonmoving party to demonstrate that genuine issues remain for trial "as to those dispositive matters for which it carries the burden of proof." Applied Genetics Int'l, Inc. v. First Affiliated Sec., Inc., 912 F.2d 1238, 1241 (10th Cir.1990); see also Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 586-87, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986); Bacchus Indus., Inc. v. Arvin Indus., Inc., 939 F.2d 887, 891 (10th Cir.1991). The nonmoving party may not rest on its pleadings but must set forth specific facts. Applied Genetics, 912 F.2d at 1241.

"[W]e must view the record in a light most favorable to the parties opposing the motion for summary judgment." Deepwater Invs., Ltd. v. Jackson Hole Ski Corp., 938 F.2d 1105, 1110 (10th Cir.1991). Summary judgment may be granted if the nonmoving party's evidence is merely colorable or is not significantly probative. See Anderson, 477 U.S. at 250-51, 106 S.Ct. 2505. "In a response to a motion for summary judgment, a party cannot rely on ignorance of facts, on speculation, or on suspicion, and may not escape summary judgment in the mere hope that something will turn up at trial." Conaway v. Smith, 853 F.2d 789, 794 (10th Cir.1988). Essentially, the inquiry is "whether the evidence presents a sufficient disagreement to require submission to the jury or whether it is so one-sided that one party must prevail as a matter of law." Anderson, 477 U.S. at 251-52, 106 S.Ct. 2505.

Statement Of Uncontroverted Facts

For purposes of summary judgment, the following facts are uncontroverted, deemed admitted, or, where disputed, viewed in the light most favorable to plaintiffs.¹

• Matthew Miller

In the spring of 1997, staff members at Harmony Middle School (including teachers, school counselors and the school psychologist) were concerned about Matthew Miller.² Matthew had expressed suicidal ideation to both Roxanna Rogers, his special education classroom teacher, and his friends (Abby Meckna, Hillary Burton and Chad Brownell).³ At least two students had told Ms. Rogers that Matthew had spoken of suicide. The staff therefore recommended that Matthew's parents seek professional evaluation and treatment for him, and that he see someone for counseling over the summer. Matthew's parents, Mark and Cheryl Miller, were also concerned. On June 30, 1997, they took Matthew to see Dr. Douglas Geenens, who was board certified in psychiatry by the American Board of Psychiatry and Neurology and board certified in child and adolescent psychiatry by the American Board of Psychiatry and Neurology. Dr. Geenens had done a residency in psychiatry at the Menninger Clinic and received further training in child psychiatry at Harvard Medical School. Eighty per cent of Dr. Geenens' practice involved the treatment of children and adolescents.

During Matthew's first visit, on June 30, 1997, Dr. Geenens diagnosed Matthew as suffering from "depression not otherwise specified."⁴ Three weeks later, on July 21, 1997, Dr. Greenens saw Matthew a second time. At that time, based upon additional tests and further psychiatric evaluation, he concluded that Matthew was significantly depressed and prescribed Zoloft 50 mg. once a day.⁵ At the time, Dr. Geenens warned Matthew and his parents that nausea and insomnia were common side effects of Zoloft, and told them to report any problems or anything unusual that happened while Matthew was taking Zoloft.⁶ In allowing Matthew to use Zoloft, plaintiffs relied solely on Dr. Geenens' advice. In prescribing Zoloft, Dr. Geenens relied solely on his education, training, review of medical and scientific literature, the Physician's Desk Reference and his own clinical experience.⁷ Dr Geenens testified that he does not review pharmaceutical marketing materials and, when he receives marketing, advertising or promotional materials from pharmaceutical representatives, he throws them away without reading them.⁸ He also testified that he did not read marketing, advertising or promotional materials about drugs in scientific and medical articles or journals.⁹ Finally, Dr. Geenens testified that Pfizer sales representatives have never encouraged him to prescribe Zoloft in conditions which the FDA has not approved, and that he knows more about Zoloft than Pfizer sales representatives. See id. at 59-60. In short, Dr. Geenens testified that Pfizer's marketing efforts had no effect on his decision to prescribe Zoloft for Matthew.¹⁰

At the time he prescribed Zoloft for Matthew, Dr. Geenens knew that published case reports and adverse event reports at the Food and Drug Administration ("FDA") had described instances in which patients who were undergoing treatment with antidepressants like Zoloft experienced suicidal ideation and committed suicide, or attempted to do so, while undergoing such treatment. In fact, Dr. Geenens was medically trained by Dr. Martin Teicher, the principal author of anecdotal case reports which involved suicidal ideation of patients on Prozac, an antidepressant drug which is similar to Zoloft. In his opinion, however, Zoloft was a safe and effective medication for the treatment of depression.¹¹ In retrospect, even in the face of plaintiff's evidence Dr. Geenens would have given the Millers the same warning he gave them before concerning Zoloft.¹²

Plaintiffs did not contact Dr. Geenens about any side effects and to his knowledge, Matthew did not experience any clinically-significant side effects while he was taking Zoloft. Nonetheless, about six days after his second visit with Dr. Geenens, during the late night of July 27 or the early morning of July 28, 1997, Matthew died from asphyxiation.¹³

• Regulatory Approval Process For Zoloft

The Federal Food Drug and Cosmetic Act ("FDCA") requires that prescription medicines be approved as safe and effective before they may be sold.¹⁴ The first step to obtain approval for a new prescription drug is to file an investigational new drug application ("IND").¹⁵ An IND is filed with the Food and Drug Administration after animal and laboratory studies have been completed.¹⁶ The IND describes in detail the product, the studies which have been performed, and a proposed plan for clinical trials with human volunteers.¹⁷ If the FDA approves the IND, clinical trials may proceed.¹⁸ If the clinical trials and other studies set forth in the IND are successfully completed, a new drug application ("NDA") may be filed with the FDA.¹⁹ The NDA provides detailed safety and efficacy information about the medicine to the FDA.²⁰

The FDA must reject a NDA for particular use if it "do[es] not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the...