Tardy v. Eli Lilly and Co.

Opinion

STATE OF MAINE SUPERIOR COURT CUMBERLAND, ss. CIVIL ACTION _ ._ '- r- f?C?CKET NO. CV-03-:p3~/

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DANNY TARDY and DIANE TARDY, Individually and as Personal Representatives of the ESTATE OF MICHAEL TARDY, Plaintiffs

ORDER ON ALL

v. PENDING MOTIONS

ELI LILLY AND COMPANY, Defendant

Before the Court is Defendant Eli Lilly and Company's Motion to Preclude the Expert Testimony of Dr. Michael J. Ferenc and Dr. Paul Fitzgerald and Motion for Summary Judgment.

BACKGROUND

Defendant Eli Lilly and Company ("Eli Lilly") manufactures and

distributes a drug known as Zyprexa, which is used to treat Attention Deficit/Hyperactivity Disorder ("ADHD"). Plaintiffs Danny Tardy and Diane Tardy ("Plaintiffs"), both individually and as the personal representatives of the Estate of Michael Tardy ("Michael"), sued Eli Lilly after Michael's death at the age of 27 in June 2002. The Plaintiffs' Complaint asserts counts of strict liability, negligence, breach of warranty and fraud against Eli Lilly due to Eli Lilly's alleged failure to disclose certain side effects of Zyprexa. The Plaintiffs claim that Michael's long-term use of Zyprexa caused a series of conditions that ultimately left Michael in a hyperosmotic, hyperglycemic, non-ketotic coma, which resulted in his death.

Eli Lilly now moves for summary judgment on the basis that the Plaintiffs cannot present sufficiently reliable evidence to show that Michael's injuries were caused by Zyprexa. Eli Lilly states that "the only potential sources of such evidence is [sic] Dr. Michael J. Ferenc and Dr. Paul Fitzgerald," Defendant's Motion for Summary Judgment, page 1, and their testimony is not admissible because it fails to conform to the Maine Rules of Evidence.

Eli Lilly states that Dr. Ferenc, a forensic pathologist, bases his opinion that Michael died as a result of taking Zyprexa solely on a postmortem urine dipstick test, which Eli Lilly states "both scientific literature and various courts have deemed unreliable." Eli Lilly states that the more "generally accepted" vitreous test should have been performed immediately postmortem and used by the Doctors in rendering their opinions. I Eli Lilly objects to Dr. Fitzgerald, an endocrinologist, on the basis that his opinions are derived solely from Dr. Ferenc's conclusions, which Eli Lilly believes are unreliable.

Eli Lilly further states that the facts do not support a conclusion that Michael suffered from a hyperglycemic condition prior to his death. Eli Lilly points to the medical notes of Dr. John Bell, Michael's psychiatrist, who recorded that Michael was "fit and healthy" and "playing a lot of basketball" nine days prior to Michael's death. Eli Lilly also points to the statement of Michael's mother that Michael appeared fine at a family dinner just days prior to this death. Finally, Eli Lilly states that Dr. Ferenc failed to take into account an empty vial of 60 Zyprexa pills found in Michael's bedroom. Eli Lilly argues that these facts do not support a finding that Michael was in a hyperglycemic crisis.

1 A vitreous test was performed about a year after Michael's death and showed a low level of glucose. The parties disagree as to the reliability of this test as the Plaintiffs argue that the sample was not properly preserved, thus rendering the test unreliable.

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In sum, Eli Lilly states that Dr. Ferenc's methodology and causation opinions are unreliable. Dr. Fitzgerald's opinions rely upon Dr. Ferenc's findings and therefore are likewise unreliable. As such, Eli Lilly argues, the Court should grant its Motion to Preclude the Expert Testimony of Drs. Ferenc and Fitzgerald. If the Court grants this Motion to Preclude, Eli Lilly argues, it must also grant the Motion for Summary Judgment because the Plaintiffs cannot prove causation, a necessary element of their claims.

STANDARD OF REVIEW

Summary judgment is proper where there exist no genuine Issues of material fact such that the moving party is entitled to judgment as a matter of law. M.R. Civ. P. 56(c); Arrow Fastener Co., Inc. v. Wrabacon, Inc., 2007 ME 34, err 15, 917 A.2d 123, 126. "A court may properly enter judgment in a case when the parties are not in dispute over the [material] facts, but differ only as to the legal conclusion to be drawn from these facts." Tondreau v. Sherwin-Williams Co., 638 A.2d 728, 730 (Me. 1994). A genuine issue of material fact exists "when the evidence requires a fact-finder to choose between competing versions of the truth." Farrington's Owners' Ass'n v. Conway Lake Resorts, Inc., 2005 ME 93 err 9, 878 A.2d 504, 507. An issue of fact is material if it "could potentially affect the outcome of the suit." Id. An issue is genuine if "there is sufficient evidence to require a fact-finder to choose between competing versions of the truth at trial." Lever v. Acadia Hasp. Corp., 2004 ME 35, err 2, 845 A.2d 1178, 1179. If ambiguities exist, they must be resolved in favor of the non-moving party. Beaulieu v. The Aube Corp., 2002 ME 79, err 2, 796 A.2d 683, 685.

In response to a defendant's motion for a summary judgment, a plaintiff having the burden of proof at trial must produce evidence that, if produced at

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trial, would be sufficient to resist a motion for judgment as a matter of law. Northeast Coating Technologies, Inc. v. Vacuum Metallurgical Co., Ltd., 684 A.2d 1322, 1324 (Me. 1996). This requires the plaintiff to establish a prima facie case for each element of the cause of action. Id.

DISCUSSION

In Eli Lilly's words, its Motion for Summary Judgment is "based entirely on the contention that plaintiffs are without admissible evidence that could support the conclusion that Zyprexa caused [Michael's] death" because Eli Lilly asserts that the expert testimony of Drs. Ferenc and Fitzgerald should be precluded. Maine Rule of Evidence 702 states, "If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise."

In a line of cases beginning with State v. Williams, 388 A.2d 500 (Me. 1978), the Law Court has held that in order to be admissible, expert testimony must be relevant pursuant to M.R. Evid. 401 and will assist the trier of fact in understanding the evidence or determining a fact in issue. Searles v. Fleetwood Homes of Pennsylvania, Inc., 2005 ME 94, en 21, 878 A.2d 509, 515-16. In order to meet this two-part standard for admissibility, expert testimony must also "meet a threshold level of reliability." In re Sarah c., 2004 ME 152, en 11, 864 A.2d 162, 165. This threshold does not require general acceptance. Searles, 2005 ME 94, en 22, 878 A.2d at 516 ("General acceptance is not a prerequisite for admission, however"). Rather, "requisite to the admissibility of proffered expert testimony is a showing of sufficient reliability to satisfy the evidentiary requirements of relevance and

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helpfulness, and of avoidance of prejudice to the defendant or confusion of the fact-finder." State v. Boutilier, 426 A.2d 876, 879 (Me. 1981) (emphasis in original).

In upholding the admission of various expert testimony, the Law Court has considered the following factors as relating to whether the testimony was sufficiently reliable: the expert's qualifications, whether the expert based his opinion on the facts of the particular case, and whether there is support in the relevant scientific community for the expert's opinion. Searles, 2005 ME 94, <[ 29, 878 A.2d at 518. The Law Court has also cited the "spirit" of the Maine Rules of Evidence as favoring admission of expert testimony. Williams, 388 A.2d at 503 ("We believe it would be at odds with the fundamental philosophy of our Rules of Evidence, as revealed more particularly in Rules 402 and 702, generally favoring the admissibility of expert testimony whenever it is relevant and can be of assistance to the trier of fact" [emphasis in original]).

When he performed his autopsy on Michael on July 1, 2002, Dr. Ferenc was a Deputy Medical Examiner for the Maine Medical Examiners Office performing the autopsy on behalf of the State of Maine. Eli Lilly argues that Dr. Ferenc's methods in conducting the autopsy and rendering his opinion on Michael's cause of death are not sufficiently reliable. First, Eli Lilly states that Dr. Ferenc performed an inadequate factual investigation, including not examining Michael's medical history and not ordering a test to see if overdose was a possible cause of Michael's death. Second, Eli Lilly argues that Dr. Ferenc's reliance on the urine dipstick test led to an unreliable conclusion, particularly because Dr. Ferenc did not save the dipsticks or take pictures of them. Eli Lilly cites various medical texts to support its argument that the urine dipstick test is not reliable. According to Eli Lilly, Dr. Ferenc should have employed the

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vitreous test for glucose. Finally, Eli Lilly argues that the condition that Dr. Ferenc claims caused Michael's death - hypersmolar, hyperglycemic, non- ketonic coma - did not exist because Dr. Ferenc did not find dehydration, which Eli Lilly states is "an essential characteristic of this condition."

The Plaintiffs contest many of Eli Lilly's factual assertions. First, they state that Dr. Ferenc did consider (and dismiss) overdose as the cause of Michael's death. They also assert that Dr. Ferenc spoke with Michael's family and spoke with Dr. Bell, the psychiatrist treating Michael at the time of his death, before finalizing his autopsy report. The Plaintiffs also contest Eli Lilly's assertion that urine dipstick tests are unreliable and point to various comments in which Eli Lilly's experts admit to using the test to screen for hyperglycemia. The Plaintiffs refute many of the medical text passages cited by Eli Lilly by arguing that the patients offered as examples in the medical texts differ significantly from Michael (most notably, because many of the patients in the texts were known diabetics, while Michael was not). In sum, the Plaintiffs argue, Eli Lilly has raised questions about the weight of Dr. Ferenc's testimony, not its admissibility, and, thus, summary judgment is inappropriate?

The Court agrees with the Plaintiffs. As an initial matter, the Court notes that Eli Lilly does not challenge the qualification of either Dr. Ferenc or Dr. Fitzgerald as a medical expert. Nor is there a question that the testimony of Dr. Ferenc and Dr. Fitzgerald, if admissible, is both relevant and would be helpful to the trier of fact. Thus, the sole issue before this Court is whether the testimony of the Doctors meets the threshold level of reliability. The Court finds that the

1 The Plaintiffs also argue that there is various evidence other than the testimony of Drs. Ferenc .and Fitzgerald that they can offer to show causation, including, inter alia, laboratory test results, medical literature, testimony of Michael's doctors, and the current labeling of Zyprexa.

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proffered testimony is sufficiently reliable and therefore denies Eli Lilly's Motion to Preclude the Expert Testimony and Motion for Summary Judgment.

The Court's decision is based on the facts that Dr. Ferenc is indisputably qualified to testify as an expert in forensic pathology; that Dr. Ferenc's opinion is based on the facts of this particular case and his work on Michael's autopsy; and that the parties do not disagree that urine dipstick tests are widely used by medical experts. Whether or not a urine dipstick test was proper in the particular instance of Michael's death and autopsy is a point of disagreement between the parties that goes to the weight the fact-finder should give Dr. Ferenc's testimony, but does not speak to the admissibility of that testimony in the first place. Likewise, the parties strongly disagree about the facts surrounding Dr. Ferenc's research and investigation prior and subsequent to his issuance of the autopsy report, including Dr. Ferenc's review of Michael's medical history and whether Dr. Ferenc spoke with Michael's family and doctors, which also renders summary judgment inappropriate. See, e.g., Lever, 2004 ME 35, <JI 2, 845 A.2d at 1179 (A motion for summary judgment must be denied if there "are competing versions of the truth" that involve genuine issues of material fact"); Arrow Fastener, 2007 ME 34, <JI 16, 917 A.2d at 126 (Though a court may believe that one party's offered proof is more persuasive, it is the responsibility of the trier of fact to weigh the evidence and render a decision).

The Court also rejects Eli Lilly's argument that Dr. Ferenc's failure to find dehydration, an "essential characteristic" of what Dr. Ferenc stated was Michael's cause of death, means his opinions are unsupported and thus should be precluded. Indeed, Dr. Ferenc did not state that Michael was not dehydrated; he stated that he did not find dehydration during the course of his testing

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because, as Dr. Ferenc explained, "in the postmortem state it's almost impossible for me to do much about that." Moreover, Dr. Ferenc did testify that dehydration "is slightly supported by the autopsy in the sense that [Michael's] urine was an amber color, which suggests concentration." While the Court offers no opinion about the merit of Dr. Ferenc's statements and findings, it holds that it is sufficient to defeat summary judgment.

In conclusion, the Court notes that its finding is in accord with what the Law Court has called the "spirit" of the Maine Rules of Evidence, which favors the admissibility of expert testimony when it is relevant and helpful, as it is in the instant case. As the Court declines to preclude the testimony of Dr. Ferenc, it likewise declines to preclude the testimony of Dr. Fitzgerald because the sole basis of Eli Lilly's objection to Dr. Fitzgerald's testimony is that it extrapolates from the work of Dr. Ferenc.

Therefore, the entry is:

Defendant Eli Lilly's Motion to Preclude the Expert Testimony of Dr. Michael J. Ferenc and Dr. Paul Fitzgerald is DENIED.

Defendant Eli Lilly's Motion for Summary Judgment is DENIED.

The clerk shall incorporate this Order into the docket by reference pursuant to M.R. Civ. P. 79(a).

Dated at Portland, Maine this ) t/',{ day of ------,7'-~--='-"'·+­ ~' 2008.

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