SMITH v. PFIZER INC

CARLOS MURGUIA, United States District Judge

Plaintiff's husband, Daryl Dempsay, became violent in their home on March 13, 1996 and stabbed plaintiff, Ronda Smith, and each of the couple's two children. Plaintiff and the two children ran from the house, and Mr. Dempsay fatally shot himself in the head. Subsequently, plaintiff filed this product liability lawsuit alleging wrongful death and damages to plaintiff and her minor children caused by decedent's taking of the prescription drug Zoloft, manufactured by defendant, Pfizer Inc. Plaintiff asserts liability based upon failure to test and to warn, and marketing defects and misrepresentations.

This matter is presently before the court on numerous motions by plaintiff and defendant. Plaintiff made a motion (Doc. 156) for partial judgment on the pleadings and for partial summary judgment. Defendant filed motions: to strike (Doc. 170) certain portions of plaintiff's motion, for summary judgment (Doc. 169) that plaintiff's claims are preempted by federal law, for summary judgment (Doc. 175) that plaintiff has not and cannot present evidence to show plaintiff's damages were caused by defendant, and to exclude testimony of plaintiff's expert witness (Doc. 177). Defendant filed four motions (Docs. 308, 309, 323, 324) for leave to file supplemental authority concerning its motions regarding preemption, causation, and to exclude expert opinion. Those motions are granted as unopposed. On August 1, 2001, plaintiff filed supplemental authority regarding defendant's Daubert motion. The court considered the parties' supplemental authority in deciding the motions at issue. As explained hereinafter, defendant's motion to exclude testimony of plaintiff's expert witness is granted in part and defendant's motion for summary judgment regarding causation is denied.

The court has reviewed eleven separately bound volumes of defendant's exhibits in addition to two volumes of plaintiff's exhibits and numerous miscellaneous exhibits. Defendant provided no table of contents, appendix, or index to any volume from which the court could determine the contents of each exhibit without searching through defendant's memoranda for a citation or searching through the exhibits to find the subject of each. Furthermore, the court notes that defendant provided two multi-volume sets of exhibits relating to two different declarations of Lois Anne Gaul. Thankfully, one of the sets was labeled to identify it with defendant's Daubert and causation summary judgment motions.

Facts

All facts are uncontroverted unless otherwise stated. Both parties make much ado concerning allegations of fact by the other party. Neither party has entirely complied with D. Kan. R. 56.1 and has, therefore, greatly imposed upon the court's time to ascertain and compare "facts." The court finds that many of the "facts" alleged by each party are, in reality, argument, conclusory statements, or attempted statements of law as "fact" and are immaterial to the issues to be decided. Nonetheless, most of the facts material to the issues to be decided are not controverted by the parties. The court notes that counsel did not prepare a detailed, written stipulation of fact as suggested by the magistrate judge in the pretrial order.

Zoloft (sertraline hydrochloride) is one of a class of prescription drugs commonly referred to as "selective serotonin reuptake inhibitors" (hereinafter SSRIs). Some other SSRI's approved by the Food and Drug Administration (hereinafter FDA) are Prozac (fluoxetine), Paxil, Luvox, and Celexa. Serotonin is a neurotransmitter, a natural substance that serves as a chemical messenger between nerve cells, both in the brain and in other parts of the body. It carries signals across the spaces, called "synapses," between adjacent nerve cells. The amount of serotonin available to perform that function depends on the rate at which serotonin is produced and released, and the rate at which it is removed and taken back up into the neuron, a process called "reuptake."

Plaintiff argues that preemption is "a purely legal issue" and that defendant's "statement of facts" in its preemption motion should be stricken because "[t]he voluminous exhibits filed in support of Pfizer's motion provide the Court with ample documentation of the essential matters in dispute, without requiring a 46 item `request to admit.'" (Pl.'s Preemption Response (Doc.186), at 2). Plaintiff's argument ignores D. Kan. Rule 56.1 which requires a statement of material facts in addition to other factual material. The court recognizes that much of defendant's statement of facts is argument, conclusion, and alleged "factual" statement of the law, (Def.'s Preemption Mem. (Doc.173), at 4-18) and, therefore, does not accept such alleged "facts." Nonetheless, plaintiff is deemed to have admitted the facts stated above, which it has not controverted by citation with particularity to the record nor by stating "the number of movant's fact that is disputed." D. Kan. R 56.1 (a) (b)(1).

Abnormally low production and processing of serotonin is associated with depression, other mood disorders, and suicidal behavior. Zoloft and other SSRIs alleviate the symptoms by inhibiting the reuptake of serotonin and thereby promoting the signaling process. In doing so, SSRIs are "selective" for the serotonin reuptake mechanism, they have less or no effect on other neurotransmitters.

On April 13, 1988, defendant submitted a new drug application (hereinafter NDA), consisting of 117 volumes of safety and efficacy data, seeking approval from the FDA to market Zoloft for treatment of depression. The information in the NDA and in supplemental submissions included information about suicidality in patients given placebo, in patients given Zoloft, and in patients given other drugs during clinical studies of Zoloft. On November 19, 1990, the FDA convened a committee (Psychopharmacological Drugs Advisory Committee (hereinafter PDAC)) of nationally acclaimed experts to review the Zoloft NDA and to advise the FDA regarding the drug's safety and efficacy. The committee considered a presentation of safety data including data on suicide attempts in Zoloft, placebo, and active-control treated patients during the clinical studies of Zoloft and unanimously determined that the evidence showed that Zoloft is safe when used in the treatment of depression. On December 30, 1991 the FDA granted final approval of the Zoloft NDA. (Def.'s Preemption Mem., Brumfield Decl., Ex. 5). Subsequently, the FDA approved Zoloft for treatment of: adult obsessive-compulsive disorder (October 25, 1996), panic disorder (July 8, 1997), pediatric obsessive-compulsive disorder (October 10, 1997), and post-traumatic stress disorder (December 7, 1999). The decedent, Daryl Dempsay, had been abused as a child and had a long history of depression, drug abuse and alcohol abuse. In the fifteen years prior to his death, Mr. Dempsay had been incarcerated multiple times, often for matters related to alcohol and drugs, and had spent a total of five years behind bars. In January of 1996, Mr. Dempsay was admitted to a drug and alcohol rehabilitation center. Because of his depression and obsessive-compulsive thoughts, Mr. Dempsay was prescribed Zoloft. Mr. Dempsay was thereafter able to sleep and his depression was reduced.

After his discharge from the rehabilitation center, Mr. Dempsay saw his own physician, Dr. White, who refilled his Zoloft prescription and increased the dosage from 50 mg. to 100 mg. daily. On March 7, 1996, Mr. Dempsay called Dr. White and asked for something for anxiety attacks. Dr. White prescribed forty-eight tablets of Xanax, of which Mr. Dempsay picked up twenty-four tablets on March 9 and the remaining twenty-four tablets on March 13, the day of his attack on his family and subsequent suicide.

Summary Judgment Standard

Summary judgment is appropriate if the moving party demonstrates that there is "no genuine issue as to any material fact" and that it is "entitled to a judgment as a matter of law." Fed.R.Civ.P. 56(c). In applying this standard, the court views the evidence and all reasonable inferences therefrom in the light most favorable to the nonmoving party. Adler v. Wal-Mart Stores, Inc., 144 F.3d 664, 670 (10th Cir. 1998) (citing Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986)). A fact is "material" if, under the applicable substantive law, it is "essential to the proper disposition of the claim." Id. (citing Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986)). An issue of fact is "genuine" if "there is sufficient evidence on each side so that a rational trier of fact could resolve the issue either way." Id. (citing Anderson, 477 U.S. at 248).

The moving party bears the initial burden of demonstrating an absence of a genuine issue of material fact and entitlement to judgment as a matter of law. Id. at 670-71. In attempting to meet that standard, a movant that does not bear the ultimate burden of persuasion at trial need not negate the other party's claim; rather, the movant need simply point out to the court a lack of evidence for the other party on an essential element of that party's claim. Id. at 671 (citing Celotex Corp. v. Catrett, 477 U.S. 317, 325 (1986)). When the movant bears the burden of persuasion at trial, it must support its motion with evidence which would entitle it to a directed verdict if not controverted at trial. Celotex Corp. v Catrett, 477 U.S. 317, 331 (1986) (Brennan, J., dissenting); United States v. One 107.9 Acre Parcel of Land Located in Warren Township, 898 F.2d 396, 398 (3d Cir. 1990); see also Prince v. Farmers Ins. Co., No. 92-6126, 1992 WL 367887, at *1 (10th Cir. Nov. 30, 1992) (movant who asserts a right to summary judgment based upon an affirmative defense has the burden of persuasion at trial).

Justice Brennan agreed with the majority's analysis of Rule 56. He dissented, however, because he believed that the majority did not adequately explain what is required of the moving party who does not bear the burden of persuasion at trial. Celotex, 477 U.S. at 329-31.

Once the movant has met this initial burden, the burden shifts to the nonmoving party to "set forth specific facts showing that there is a genuine issue for trial." Anderson, 477 U.S. at 256; see Adler, 144 F.3d at 671 n. 1 (concerning shifting burdens on summary judgment). The nonmoving party may not simply rest upon its pleadings to satisfy its burden. Anderson, 477 U.S. at 256. Rather, the nonmoving party must "set forth specific facts that would be admissible in evidence in the event of trial from which a rational trier of fact could find for the nonmovant." Adler, 144 F.3d at 671. "To accomplish this, the facts must be identified by reference to affidavits, deposition transcripts, or specific exhibits incorporated therein." Id.

Finally, the court notes that summary judgment is not a "disfavored procedural shortcut," rather, it is an important procedure "designed to secure the just, speedy and inexpensive determination of every action." Celotex, 477 U.S. at 327 (quoting Fed.R.Civ.P. 1).

1. Duty of Prescription Drug Manufacturer to Warn of Dangerous Side Effects

[T]he manufacturer of an ethical [(prescription)] drug has a duty to warn the medical profession of dangerous side effects of its products of which it knows, has reason to know, or should know, based upon its position as an expert in the field, upon its research, upon cases reported to it, and upon scientific development, research and publications in the field. This duty is continuing.

Wooderson v. Ortho Pharm. Corp., 235 Kan. 387, 409, 681 P.2d 1038, 1057 (1984). In Wooderson, the Kansas Supreme Court was faced with an argument that the defendant had no duty to warn of side effects until "the drug maker is itself convinced that the drug causes or contributes to such problems." Id. at 400, 681 P.2d at 1049. The court concluded that such was not the law and established the standard quoted above. In reaching its conclusion, the court quoted extensively from decisions in other jurisdictions regarding the duty to warn and concluded, "We agree with the McEwen and Seley courts." Id. at 400-09, 681 P.2d at 1049-56 (citing McEwen v. Ortho Pharm. Corp., 528 P.2d 522 (Or. 1974); Seley v. G.D. Searle Co., 423 N.E.2d 831 (Ohio 1981)) (other citations omitted).

The Wooderson court, quoting McEwen, rejected the argument that it was unreasonable to impose upon a drug manufacture the duty to warn of dangers threatening only a statistically insignificant number of users. The court concluded:

The size of the class of endangered persons is one — albeit only one — of the factors to be considered in deciding whether the manufacturer's warnings were, in fact, reasonable.

The ethical drug manufacturer is, then, subject to a duty to warn the medical profession of untoward effects which the manufacturer knows, or has reason to know, are inherent in the use of its drug.

Wooderson, 235 Kan. at 401-02, 681 P.2d at 1051 (quoting McEwen, 528 P.2d at 530 (citations omitted)). The Wooderson court concluded, moreover, that:

A jury may find that a warning is inadequate and unreasonable even where the existence of a `risk,' i.e., a causal relationship between use of the product and resulting injury has not been definitely established. Thus, where scientific or medical evidence exists tending to show that a certain danger is associated with use of the drug, the manufacturer may not ignore or discount that information in drafting its warning solely because it finds it to be unconvincing.

Id. at 406, 681 P.2d at 1054 (quoting Seley, 423 N.E.2d at 837) (citations omitted).

Defendant's Motion to Exclude Testimony of Plaintiff's Expert (Doc. 177)

Defendant filed a motion pursuant to the Federal Rules of Evidence and the Supreme Court's opinion in Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993) and its progeny. Defendant requests that the court preclude testimony by plaintiff's expert, Dr. John T. Maltsberger, M.D., relating to general causation of suicide by defendant's drug, specific causation of the suicide of the decedent, and the appropriate warnings to include in defendant's labeling of its drug, Zoloft.

Standard for Admission of Expert Opinion

Federal Rule of Evidence 702 allows expert testimony, by opinion or otherwise, if the witness is "qualified as an expert by knowledge, skill, experience, training, or education" and his specialized knowledge "will assist the trier of fact to understand the evidence or to determine a fact in issue." Fed.R.Evid. 702. The court has a "gatekeeping" obligation to determine the admissibility of expert testimony. Kumho Tire Co. v. Carmichael, 526 U.S. 137, 141 (1999) (citing Daubert, 509 U.S. 579); see also, Fed.R.Evid. 104. The burden of proving admissibility of expert testimony is on the party proffering such testimony. Daubert, 509 U.S. at 592 n. 10. However, proponents need not show that their expert's conclusion is correct. In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 744 (3d Cir. 1994).

Expert testimony is admissible only if it is both relevant and reliable. Id. Rule 702 was amended in December 2000 in response to Daubert and its progeny, including Kumho Tire. Fed.R.Evid. 702, advisory committee notes (Dec. 1, 2000). The Rule now admits expert opinion testimony "if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case." Fed.R.Evid. 702 (Dec. 1, 2000).

The focus is on principles and methodology, not conclusions generated. Id. However, when an expert reaches conclusions "that other experts in the field would not reach, the trial court may fairly suspect that the principles and methods have not been faithfully applied." Id. (advisory committee notes) (citing Lust v. Merrell Dow Pharms., Inc., 89 F.3d 594, 598 (9th Cir. 1996)). Nonetheless, if the expert uses principles and methods used by a recognized minority of scientist in the field, his opinion may be admissible. Daubert v. Merrell Dow Pharms., Inc., 43 F.3d 1311, 1318 (9th Cir. 1995). Therefore, the court looks at principles and methods and how they have been applied to the facts. Id.

Reliability analysis applies to all aspects of the expert's testimony, including the facts underlying the opinion, the methodology, and the link between the facts and the conclusion drawn. See Heller v. Shaw Indus., Inc., 167 F.3d 146, 155 (3d Cir. 1999). Consequently, the court must make a practical, flexible analysis of the reliability of the testimony considering relevant factors in the circumstances of the case. Kumho Tire, 526 U.S. at 149-52; Heller, 167 F.3d at 155. The court has discretion how to approach the task of making reliability findings. Kumho Tire, 526 U.S. at 152; Goebel v. Denver and Rio Grande W. R.R., 215 F.3d 1083, 1087 (10th Cir. 2000); United States v. Velarde, 214 F.3d 1204, 1208-09 (10th Cir. 2000). It is essential, however, to make a determination on the record sufficient to allow a reviewing court to determine whether the trial court properly applied the relevant law. Goebel, 215 F.3d at 1087-88; Velarde, 214 F.3d at 1209.

In making its reliability determination, the court may use the Daubert factors: (1) has the theory or technique been tested (or can it be); (2) has it been subject to peer review and publication; (3) is there a known or potential high rate of error and are there standards controlling the technique's operation, and; (4) is the theory or technique generally accepted within the relevant community. Kumho Tire, 526 U.S. at 149. However, those factors are not exclusive, and may not apply in many cases. In determining whether the expert's specialized knowledge will assist the jurors, the court will "`scrutinize' whether the `principles and methods' employed by an expert `have been properly applied to the facts of the case.'" Id. at 157 (quoting Advisory Committee's Note on Proposed Fed. Rule Evid. 702, Preliminary Draft of Proposed Amendments to the Federal Rules of Civil Procedure and Evidence: Request for Comment 126 (1998)). "[N]othing . . . requires a district court to admit opinion evidence that is connected to existing data only by the ipse dixit of the expert." Id. (quoting Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997)).

An expert may offer an opinion even if it "embraces an ultimate issue to be determined by the trier of fact." Fed.R.Evid. 704. Even after Daubert, rejection of expert testimony has been the exception rather than the rule. Fed.R.Evid. 702 (Dec. 1, 2000) (advisory committee notes) "Vigorous cross-examination, presentation of contrary evidence and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence." Id. (quoting Daubert, 509 U.S. at 595). Nonetheless, an expert may not simply tell the jury what result it should reach. United States v. Simpson, 7 F.3d 186, 188 (10th Cir. 1993). Often, such expert testimony is excluded on the grounds of stating a legal conclusion, usurping the function of the jury in deciding facts, or interfering with the judge in instructing on the law. All of these rationale define evidence which is not helpful to the jury to understand the evidence or determine a fact in issue. Id. at 188-89.

Background

Plaintiff's expert is a medical doctor who received his M.D. from Harvard University in 1959 and, in 1970, was a graduate of the Boston Psychoanalytic Institute in psychoanalysis. Dr. Maltsberger is a general psychiatrist, psychoanalyst, and suicidologist. The doctor currently serves as an Associate Clinical Professor of Psychiatry at the Harvard Medical School, an Associate Attending Psychiatrist at McLean Hospital, Belmont, Mass., and a consultant to the Boston Veterans' Administration Outpatient Department, Boston, Mass. In arriving at his opinions, in addition to relying upon personal knowledge, skill, experience, training, or education, plaintiff's expert notes that he reviewed records relevant to the decedent supplied by plaintiff's counsel, had a telephone conversation with plaintiff, and read a number of books, journal articles, and other papers, of which three were supplied by plaintiff's counsel.

Dr. Maltsberger opined,

within a reasonable degree of medical certainty it is my opinion that Sertraline (Zoloft) constitutes a proximate cause of this patient's violent outburst on 13 March 1996. This compound is well known to have an activating effect, and it is well understood to precipitate hypomanic episodes in vulnerable individuals. A fairly common side effect is akathisia, and in view of the fact that the patient was already akathistic while in the Valley Hope facility, it should never have been prescribed for him. The association between akathisia and suicidality has been clearly established; akathisia is often accompanied by unendurable emotional pain, and patients destroy themselves in order to escape it.

(Pl.'s Response to Mot. to Exclude, Ex. L at 5 (emphasis added)). The expert eliminated alcoholism as a cause because the decedent "was known to have abstained from drinking and drugs from the end of December 1995." Id. During Dr. Maltsberger's deposition, he was asked his "opinion as to the warning that needs to be added to the Zoloft labeling and the labeling of other SSRIs in order to make them adequate." (Pl.'s Response to Mot. to Exclude, Ex. H (Maltsberger Depos.) at 42, ll. 1-3). Dr. Maltsberger wrote the following: "Warning: Zoloft and other SSRI drugs of its class are known in some instances to cause akathisia and excitement that can provoke assaultiveness and suicide in vulnerable individuals. Close supervision is indicated for all patients for whom it is prescribed." Id., ll. 7-11.

Parties' Arguments

Defendant argues that plaintiff's expert's opinions should be excluded because: (1) the expert is not qualified to testify as to causation or warnings in this case, (2) even if he were qualified, such opinions are unscientific and unreliable, (3) even if admitted, such opinions are of insufficient weight to establish causation by a preponderance of the evidence, and (4) the opinions are based upon data which are not of a type reasonably relied upon by experts in the field. Plaintiff responds that the industry has co-opted the field of potential experts with the expertise defendant alleges such experts must have, that in any case such specificity of expertise is not required, that plaintiff's expert's opinion is of the type normally made in the field of psychiatry, that behavioral scientists are given greater latitude under Rule 702 because predicting or explaining human behavior is difficult and there is no other science suitable to the task which is more exact, testable and repeatable, that the expert's opinion is based upon reliable procedures and methods, and that the Daubert analysis allows for more flexibility and discretion than asserted by defendant.

Defendant first claims that plaintiff's expert is not qualified to opine that Zoloft was the cause of the violence and suicide in this case because the expert is not a psychopharmacologist or epidemiologist and, therefore, has no expertise in the mechanisms of how drugs affect the human body or in designing or analyzing clinical trial and other epidemiological data to determine the probabilities of causation based upon the factors present in the studies. Plaintiff responds that her expert is well qualified to give opinion testimony regarding psychiatry and suicidology and that his opinion regarding general causation is supported by admissions of causation by defendant, by textbooks in the field, by scientific articles, and by Koch's postulates for inferring a causal relationship. Neither defendant's nor plaintiff's argument directly addresses the argument of the other.

To ultimately prevail at trial, plaintiff must prove it is more likely than not that defendant's conduct was a substantial factor in producing the harm to plaintiff. Roberson v. Counselman, 235 Kan. 1006, 1010-11, 686 P.2d 149, 152-53 (1984) (quoting Restatement (Second) Torts § 433B, cmt. a). Comment b to the Restatement explains that, "If . . . a particular act . . . might be expected to produce a particular result, and if that result has in fact followed, the conclusion may be justified that the causal relation exists." Id. at 1011, 686 P.2d at 153 (quoting Restatement (Second) Torts § 433B, cmt. b). Failure to adequately warn of the dangers of Zoloft could be expected to produce the result that the decedent would attack plaintiff and her children only if Zoloft was shown to cause such behavior in the decedent. Moreover, Zoloft could be expected to produce such behavior in the decedent only if Zoloft was shown or known to cause such behavior in some people (however small the number). Therefore, plaintiff must present evidence from which a rational trier of fact could find (1) the warning was inadequate, (2) general causation — Zoloft causes such behavior in some people, and (3) specific causation — Zoloft caused such behavior in the decedent.

Analysis

General Causation

Defendant's objection to Dr. Maltsberger's qualification applies to his testimony on general causation, while plaintiff's argument applies to his qualification to testify as to specific causation. As defendant asserts, and Dr. Maltsberger admits, the doctor is not a psychopharmacologist or epidemiologist. Therefore, the doctor is not qualified to testify as an expert regarding the ability of clinical trials, scientific studies, or case histories to establish an association or a causal relationship between Zoloft and akathisia, emergent suicidality, or violent behaviors.

Under Kansas law, a manufacturer has a duty to warn where scientific or medical evidence exists tending to show that a certain danger is associated with use of the drug. Dr. Maltsberger seeks to testify that Zoloft " is well known to have an activating effect" and that "[t]he association between akathisia and suicidality has been clearly established." Dr Maltsberger basis his opinion on epidemiological studies, textbooks, journal articles, other papers, and his clinical experience. Although Dr. Maltsberger, as a medical doctor, may make a diagnosis of specific causation based upon his interpretation of such information, his opinion as to the meaning of such information will not assist the jury in deciding whether general causation exists.

Whether scientific or medical evidence exists tending to show that akathisia or suicidality are associated with use of Zoloft is central to determination of adequate warning and of whether Zoloft causes such effect on some people is central to the jury's determination of causation. Dr. Maltsberger may tell the jury that he relied upon such information, but his reliance is not sufficient to establish association or general causation. Moreover, he is not qualified to explain to the jury the meaning and scientific weight or effect of such information. He has no expertise in either of the disciplines which might potentially explain to the jury (1) if the evidence establishes an association and the strength of the association (epidemiology) and (2) the mechanism whereby the drug affects the person (pharmacology). As such, the doctor's testimony would not help, and might tend to confuse, the jury.

Plaintiff's supplemental authority suggests that Dr. Maltsberger should be allowed to testify as to general causation. Estate of Tobin v. SmithKline Beecham Pharms., No. 00-CV-0025-Ben, slip op. at 13-19 (D.Wyo. May 3, 2001). In that case, plaintiffs presented both Dr. Healy, a Welsh neuro-pharmacologist, and Dr. Maltsberger as expert witnesses. That court's decision to allow expert testimony relating to general causation does not state unequivocally that Dr. Maltsberger will testify as to general causation, id. at 4, 17, 18, ("primarily . . . specific causation" and warnings), and was based primarily on: Dr. Healy's expertise as an academic neuro-pharmacologist, id. at 3, 14, Dr. Healy's methodology, id. at 27, and various works in the field of neuro-pharmacology, id. at 22-27. The court finds Tobin unpersuasive in these circumstances. Therefore, Dr. Maltsberger will not be allowed to testify as to his opinion regarding general causation.

Plaintiff's argument that general causation is supported by textbooks in the field, scientific articles, and Koch's postulates is not helpful either. Dr. Maltsberger is not qualified to explain the textbooks or scientific articles in the field or how Koch's postulates as applied in the field of epidemiology would lead an expert to infer an association or causation.

Plaintiff's remaining arguments are likewise unhelpful in relation to general causation. Although plaintiff implies defendant has co-opted the field of potential experts with the qualifications defendant suggests, she has not sought to depose defendant's experts under Rule 26(b)(4)(B) or to show why she cannot obtain qualified pharmacologists or epidemiologists. For plaintiff to argue that such specificity of expertise is not required is to argue that the jury does not need an explanation of the evidence from a qualified expert. In effect, plaintiff argues the jury may rely on a witness who has "relied upon" textbooks, scientific articles and "other papers" to reach his opinion, but who has no expertise to explain the basis for his opinion. Such a holding would defeat much of the purpose of Fed.R.Evid. 702 and the rule of Daubert and its progeny. Although the court would agree that expertise may be gained through experience in the applicable field, plaintiff's expert professes no expertise in the fields of epidemiology or pharmacology, but only "some familiarity" with psychopharmacology.

Specific Causation

The court must use a different analysis regarding specific causation. Physicians often make decisions regarding diagnoses of illness and specific causation of that illness. Reference Manual on Scientific Evidence 463, 468 (Federal Judicial Center, 2d ed. 2000). In reaching his opinion regarding external causation, the physician "must determine if the medical and research literature supports a determination of environmental causation." Id. at 473. Physicians must use a certain amount of judgment in determining causation of an illness. Id. at 470-71. In cases such as this, physicians often use differential diagnosis — eliminating other potential causes — to arrive at an opinion as to causation. See, e.g., Heller v. Shaw, 167 F.3d 146 (3d Cir. 1999); Zuchowicz v. United States, 140 F.3d 381 (2d Cir. 1998); Hall v. Babcock Wilcox, 69 F. Supp.2d 716 (W.D.Pa. 1999); Cavallo v. Star Enters., 892 F. Supp. 756 (E.D.Va. 1995), aff'd in part, rev'd in part, 100 F.3d 1150 (4th Cir. 1995).

In this case, Dr. Maltsberger considered the possible causes of the behavior at issue, decedent's medical history and treatment, the circumstances existing when the decedent attacked his wife and children and killed himself, the effect of the drugs based upon Dr. Maltsberger's clinical experience, decedent's history of alcohol abuse, and medical and research literature. Dr. Maltsberger eliminated alcoholism as a cause of the behavior and formulated his opinion that Zoloft was a cause of the behavior. This methodology is used time and again on a daily basis by medical doctors in diagnosing and determining the cause of illnesses in their patients, and the court finds that such methodology is a reliable basis for expert testimony regarding specific causation.

Defendant's claims that Dr. Maltsberger has failed to account for other potential causal factors goes to the weight and credibility of the opinion, not its admissibility. Defendant's arguments that the doctor's opinion does not meet the reliability factors of Daubert and its progeny and does not show sufficient relative risk relate only to the doctor's opinion on general causation, which has been excluded. Therefore, plaintiff's expert may testify as to specific causation.

Warnings

Defendant claims Dr. Maltsberger has no qualification, training, experience or familiarity with drug warnings or the FDA regulations concerning them and should not be allowed to opine on warnings. Plaintiff addresses this argument only in a footnote and argues that the doctor "demonstrated during his deposition that he is fully capable of drafting an appropriate warning." (Pl.'s Response to Mot. to Exclude at 8, n. 7). Plaintiff then argues that a similar challenge concerning testing was summarily rejected in Miller v. Pfizer, Inc. No. 99-2326-KHV, 2000 WL 968792 (D.Kan. June 26, 2000). Plaintiff fails to explain how the testing opinion challenged in Miller is similar to the warning opinion challenged here, and the court does not readily see the relationship. Plaintiff has failed to meet its burden to show Dr. Maltsberger's qualification to give expert opinion testimony on warnings. Therefore, such testimony will not be admitted.

Defendant's Motion for Summary Judgment Regarding Causation (Doc. 175)

Defendant seeks summary judgment on the grounds that plaintiff has not provided admissible evidence of medical causation and, even if she has, the undisputed evidence shows that decedent's treating physicians would have prescribed Zoloft for decedent even if presented with the warnings proposed by plaintiff. Plaintiff claims that defendant has admitted general causation, that the burden of proof of specific causation rests on defendant, and that, nonetheless, there is sufficient evidence from which a jury could find Zoloft was a cause of the decedent's behavior.

Medical Cause

Plaintiff first claims that defendant has admitted general causation in a report to the Irish Medicines Board and by admitting that Zoloft was the probable cause of a pediatric patient's attempted suicide. The court first addresses the pediatric patient. Defendant presents evidence that the FDA inquired whether Zoloft could be a plausible explanation for any clinical trial event involving suicidal behavior, and defendant answered that Zoloft might serve as a plausible explanation for the pediatric patient's attempted suicide. Further, defendant presents evidence that neither it nor the FDA determined that Zoloft was a probable cause of the pediatric patient's attempt. Plaintiff presents nothing to refute defendant's evidence. Therefore, the court finds defendant has not admitted causation in the case cited.

In connection with her response to defendant's motion, plaintiff filed a supplemental brief in which she referred to a report regarding sertraline suicidality that defendant provided to the Irish Medicines Board. Plaintiff asserts, based solely upon the language of the report, that the report constitutes an admission of general causation of suicidality in some people taking Zoloft. Defendant counters that the report constitutes no such admission and, in fact, shows that no "change in the suicide information contained in the product [labeling] is required." (Def.'s IMB Response (Doc197) at 4). Both parties present exhibits purporting to be the report, and, although the exhibits contain identical portions, it appears that plaintiff's exhibits include material which were source material for the report and/or notes made by the preparer of the report or added by plaintiff, her counsel or her consultants.

The court finds defendant's argument regarding the significance of the report compelling. Plaintiff takes certain statements and classifications used in the report and materials used in preparation of the report out of context and uses the statements and classifications to construct an "admission" of causation where none exists. Plaintiff relies upon her interpretation of 54 cases in which she argues that defendant or clinical investigators for defendant admitted that Zoloft was "causally related" to treatment emergent suicidality. Significantly, all 54 cases upon which plaintiff relies come from data gathered during defendant's clinical trials of the drug.

As defendant explains, in 25 of the cases, outside clinical investigators reported serious adverse events related to suicide. In the "Causality" block of the adverse event report, the investigators checked "Study Drug" as the most likely cause of the event. (Def.'s IMB Response, at 6, Ex. G, App. 2, p. 64). However, the clinical investigators are given instructions for completing the reports, and in the instructions are told: "Study drug should also be checked if `unknown' has been verified as the final determination of causality by the investigator. . . . If the investigator is unable to determine causality and is unable to rule out the study drug, check this block." (Id., Ex. G., App. 2, p. 67 (emphasis added)). Plaintiff presents no evidence to controvert these assertions.

Similarly, defendant explains that the remaining 29 cases involve situations in which Pfizer case evaluators (in the normal review process of newly-received adverse event reports) noted in the database that the suicide related event reported was "related" to the study drug. Case evaluators are required to enter into the database whether the adverse event was "related" or "not related" to the study drug, there are no other choices. (Id., Ex. H at 2-30, 2-32). In the materials governing the adverse event monitoring system used at Pfizer, a "related adverse event" is defined: "an event where there is a reasonable possibility that a causal relationship between a drug and an adverse event exists." (Id., Ex. H at T-7 (emphasis added)). While such evidence is potentially admissible to show an association, it cannot be understood as an admission of an association and certainly not as an admission of general causation. Moreover, plaintiff presents no evidence from which the court might infer a question regarding defendant's interpretation of its adverse event reporting system. Therefore, the court finds that defendant has not admitted general causation or an association between Zoloft and akathisia or suicidality.

As defendant argues, expert testimony will be necessary in this case to establish general causation or an association between Zoloft and akathisia or suicidality. Under Kansas law, when understanding of the facts is not within the common knowledge or experience of laymen, expert testimony is necessary. See Lewis v. Bd. of Sedgwick County Comm'rs, 140 F. Supp.2d 1125, 1140-41 (D.Kan. 2001) (excessive force under § 1983); Knowles v. Burlington N. R.R. Co., 18 Kan. App. 2d 608, 611, 856 P.2d 1352, 1355 (1993) (Federal Employer Liability Act). In this case, the relevance and significance of clinical trials and other scientific evidence which might establish an association or general causation is beyond the common knowledge and experience of the lay juror. Therefore, it will be necessary for an expert to explain such evidence to the jury.

The court determined above that plaintiff's expert is not qualified to testify as to his opinion of general causation. Furthermore, plaintiff points to no other expert in this case from whom she can elicit testimony to establish general causation.

Burden of Proof of Causation

Plaintiff also argues that defendant has the burden of proof on causation because Kansas law presumes causation in circumstances in which defendant has failed to adequately warn or test its prescription drug. The court assumes for purposes of summary judgment that plaintiff has correctly stated the law in Kansas. Nonetheless, plaintiff is not entitled to a presumption of causation here because she has not presented evidence admissible at trial to establish inadequate warning or inadequate testing. Without an expert qualified in epidemiology or pharmacology, plaintiff cannot show that akathisia or suicidality is associated with the use of defendant's drug.

To establish inadequate warning, plaintiff must present admissible evidence from which the jury could find that the danger of akathisia or suicidality is associated with use of the drug. Wooderson, 235 Kan. at 406, 681 P.2d at 1054. To establish a duty of additional testing, plaintiff must present admissible evidence that such testing would have been effective. Lindquist v. Ayerst Labs., Inc., 227 Kan. 308, 319-20, 607 P.2d 1339, 1349 (1980) (citing 1 Hursh and Bailey, Am. Law of Prod. Liab. 2d § 2:29, p. 217); compare 1 Timothy E. Travers, et al., Am. Law of Prod. Liab. 3d § 11:1 (1987). However, plaintiff has no expert qualified to present evidence as to the effectiveness of any potential additional testing which she argues should have been done, nor has she presented any expert to testify that such testing would show an association between akathisia or suicidality and use of the drug.

The court finds plaintiff cannot establish general causation, inadequate testing, or inadequate warning because she has no expert through whom to present evidence that a causal relationship or an association exists between akathisia or suicidality and the use of defendant's drug or that additional testing would be effective to show such a causal relationship or association. Plaintiff, therefore, cannot meet her burden on summary judgment to set forth admissible facts from which a rational fact-finder could decide in her favor. Consequently, defendant's motion for summary judgment regarding causation is granted.

Summary

The court determines that plaintiff's expert, Dr. Maltsberger, is not qualified as an expert on the issues of general causation or warnings. Therefore, he will not be allowed to testify as to his opinions on those issues.

Further, the court finds plaintiff cannot establish general causation, inadequate warning, or inadequate testing because plaintiff has presented no expert through whom to present testimony regarding those issues. Therefore, the court grants defendant's motion for summary judgment on the grounds of causation.

Because the court grants defendant's causation summary judgment motion, it need not address plaintiff's motions (Doc. 156) for partial judgment on the pleadings and partial summary judgment, or defendant's motions for summary judgment regarding preemption (Doc. 169) or to strike (Doc. 170).

Orders

IT IS THEREFORE ORDERED that defendant's motions for leave to file supplemental authority (Docs. 308, 309, 323, 324) are granted.

IT IS FURTHER ORDERED that defendant's motion to exclude opinion testimony of plaintiff's expert (Doc. 177) is granted in part as explained herein.

IT IS FURTHER ORDERED that defendant's motion for summary judgment regarding causation (Doc. 175) is granted and plaintiff's complaint is dismissed.

Dated this 14th day of August 2001, at Kansas City, Kansas.