Kernke v. The Menninger Clinic, Inc., Civil Action No. 00-2263-GTV.
| Decision Date | 05 November 2001 |
| Docket Number | Civil Action No. 00-2263-GTV. |
| Citation | 173 F.Supp.2d 1117 |
| Parties | Joseph Brian KERNKE, et al., Plaintiffs, v. THE MENNINGER CLINIC, INC. et al., Defendants. |
| Court | U.S. District Court — District of Kansas |
Stephen G. Dickerson, Kugler & Dickerson, Kansas City, KS, Murray E. Abowitz, Kayce L. Gisinger, Abowitz & Rhodes, P.C., Oklahoma City, OK, for Joseph Brian Kernke, Joseph C. Kernke, Jr.
Curtis J. Waugh, Goodell, Stratton, Edmonds & Palmer, Thomas E. Wright, Wright, Wright, Henson, Somers, Sebelius, Clark & Baker, LLP. Topeka, KS, for The Menninger Clinic, Incorporated.
Marta Fisher Lineberger, Wayne T. Stratton, Goodell, Stratton, Edmonds & Palmer, Topeka, KS, for The Menninger Clinic, Incorporated, Edward L. Eaton, M.D., Joyce E. Davidson, M.D., Patricia Solbach, Ph.D.
Harvey L. Kaplan, Karen A. Brady, Patricia Jean Castellano, John F. Kuckelman, Shook, Hardy & Bacon, LLP, Kansas City, MO, for Aventis Pharmaceutical Inc.
Plaintiffs bring this case alleging various claims against defendants Aventis Pharmaceuticals Inc. ("Aventis"), The Menninger Clinic, Inc., Edward Eaton, Joyce Davidson and Patricia Solbach ("Menninger defendants") arising from the death of Kenneth Kernke. Plaintiffs advance claims against Aventis for manufacturer's failure to warn products liability, breach of express warranty, negligence and wrongful death. The case is before the court on Aventis's motion for summary judgment (Doc. 144). For the reasons set forth below, Aventis's motion is granted.
The following facts are either uncontroverted or are based on the evidence submitted with the summary judgment papers and viewed in the light most favorable to the nonmoving party. Immaterial facts and facts not properly supported by the record are omitted.
Kenneth Kernke, the uncle of plaintiff Brian Kernke and the brother of plaintiff Joseph Kernke, lived with his parents in Oklahoma City, Oklahoma for most of his life. In 1988, Kenneth Kernke was diagnosed with schizophrenia. As a result of his mental illness, he often acted irrationally and was hospitalized several times in connection with attempts to commit suicide.
Kenneth Kernke's mother, who acted as his primary caretaker, died in April 1998. Following the mother's death, Brian Kernke assumed responsibility as Kenneth's primary caretaker. In June 1998, Brian Kernke, concerned that he was unable to effectively assist Kenneth with the necessities of daily living, called the Menninger Clinic in Topeka, Kansas to inquire about placing him in an assisted living program at the clinic. Shortly thereafter, Kenneth voluntarily admitted himself as an outpatient into Horizon House, the Menninger Clinic's supervised group living arrangement. Although his admission into Horizon House was voluntary, Kenneth repeatedly expressed to both Horizon House staff and Brian Kernke his desire to return home to Oklahoma City. At one point, he even packed his bags to leave Horizon House.
In August 1998, Kenneth Kernke voluntarily admitted himself as an inpatient into the Menninger Clinic's Hope Unit to take part in a clinical study of a new investigational drug for schizophrenia and schizoaffective disorders called M100907. Aventis's predecessor, Hoechst Marion Roussel, Inc. was the manufacturer of M100907.1 The primary purpose of the M100907 clinical study was to test the safety and efficacy of M100907 in comparison to placebo and haloperidol, a neuroleptic drug already approved by the Food and Drug Administration ("FDA").
Prior to the commencement of the M100907 clinical study, Aventis submitted required protocols to the FDA for its review. The FDA approved the protocols and permitted Aventis to proceed with the study. Pursuant to FDA regulations, Aventis provided the Menninger defendants, who were acting as one of numerous M100907 study investigators, with an Investigational Drug Brochure and updated drug safety reports. The Investigational Drug Brochure, which contained the chemical and pharmacological information known about the drug at the time the study commenced (including all safety and efficacy results) contained warnings that, among other things, previous study participants had experienced worsening of schizophrenic symptoms, depression, suicidal thoughts and that one previous participant had committed suicide while using the drug. The Menninger defendants in turn promised Aventis that they would obtain informed consent from all study participants, that they had read and understood the Investigational Drug Brochure and that they would at all times exercise their independent medical judgment as to the compatibility of a prospective study participant with the study protocol requirements.
After determining that Kenneth Kernke met the requirements for participation in the M100907/3001 ("Phase I") clinical study, the Menninger defendants obtained a signed Patient Information and Consent Form from him on August 10, 1998. Among other things, the informed consent form warned of the potential risks and hazards involved in participating in the study, including the worsening of schizophrenic symptoms, depression, suicidal thoughts and the fact that a previous participant had committed suicide. The informed consent form also warned Kenneth that because M100907 was an investigational drug, there might be risks involved in participating in the study that could not be predicted or anticipated.
During Phase I of the study, Kenneth Kernke received M100907, rather than the placebo or haloperidol. During the period of time that Kenneth participated in Phase I, he continued to inform Menninger staff members and Brian Kernke that he wanted to return home to Oklahoma City. Despite his desire to return home, Kenneth completed Phase I on October 9, 1998, and became eligible to participate in the M100907/3005 ("Phase II") clinical study, a two year continuation of the study in which all patients received M100907. After determining that Kenneth would benefit from participating in Phase II, the Menninger defendants obtained another signed informed consent form from him. The second informed consent form was identical in all relevant respects to the first form that he signed.
Three days after entering Phase II of the M100907 study, Kenneth Kernke walked away from the Menninger Clinic while on a return trip from the dining hall with a group of patients being escorted and supervised by a Menninger staff member. He was found dead in a wooded area near the Menninger Clinic three months later. The Shawnee County, Kansas coroner's report indicates that Kenneth probably died from exposure. He was 52 years old at the time of his death. Prior to Kenneth Kernke's death, Aventis did not have contact with either Kenneth Kernke, Brian Kernke or Joseph Kernke regarding Kenneth Kernke's care or treatment at the Menninger Clinic or his participation in the M100907 studies.
Summary judgment is appropriate "if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue of material fact and that the moving party is entitled to judgment as a matter of law." Fed. R.Civ.P. 56(c). The requirement of a "genuine" issue of fact means that the evidence is such that a reasonable jury could return a verdict for the nonmoving party. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). An issue of fact is "material" if it is essential to the proper disposition of the claim. Id. Essentially, the inquiry is "whether the evidence presents a sufficient disagreement to require submission to a jury or whether it is so one-sided that one party must prevail as a matter of law." Id. at 251-52, 106 S.Ct. 2505.
The moving party bears the initial burden of demonstrating the absence of a genuine issue of material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). This burden may be met by showing that there is a lack of evidence to support the nonmoving party's case. Id. at 325, 106 S.Ct. 2548. Once the moving party has properly supported its motion for summary judgment the burden shifts to the nonmoving party to show that there is a genuine issue of material fact left for trial. Anderson, 477 U.S. at 256, 106 S.Ct. 2505. "[A] party opposing a properly supported motion for summary judgment may not rest upon mere allegation or denials of his pleading, but must set forth specific facts showing that there is a genuine issue for trial." Id. The mere existence of some alleged factual dispute between the parties will not defeat an otherwise properly supported motion for summary judgment. Id. "Any evidence tending to show triable issues will be viewed in the light most favorable to the nonmoving party." Black Hills Aviation, Inc. v. United States, 34 F.3d 968, 972 (10th Cir.1994) (citation omitted).
Aventis argues that plaintiffs' failure to warn claim fails because Aventis is absolved of liability under the learned intermediary doctrine and because plaintiffs have failed to demonstrate a causal connection between Aventis's alleged failure to warn Kenneth Kernke of the risks involved in taking M100907 and Kenneth's death. The court agrees and grants summary judgment to Aventis on plaintiffs' failure to warn claim.
1. Learned Intermediary Doctrine Kansas law dictates that "[m]anufacturers of prescription drugs have a duty to warn of dangerous side effects and risks associated with use of such drugs." Humes v. Clinton, 246 Kan. 590, 792 P.2d 1032, 1039 (1990) (citations omitted). Under the learned intermediary doctrine, a drug manufacturer fulfills its legal duty to warn a patient of the risks associated with using a prescription drug if it adequately warns the patient's prescribing physician of the risks. Wright v. Abbott Labs., Inc., 259 F.3d...
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