Opinion ID: 2341867
Heading Depth: 1
Heading Rank: 5

Heading: sufficiency of causation evidence

Text: Dr. Armstrong argues that Appellants were entitled to a directed verdict because Appellees did not present sufficient reliable evidence that Parlodel caused Mary Gunderson's alleged seizure. In ruling on a directed verdict motion, the trial court should draw all inferences in favor of the nonmoving party, and a verdict should not be directed unless the evidence is insufficient to sustain the verdict. Kroger Co. v. Willgruber, 920 S.W.2d 61, 64 (Ky.1996) (citing Spivey v. Sheeler, 514 S.W.2d 667, 673 (Ky.1974)). Questions as to the weight and credibility to be given to the evidence are reserved for the jury. Commonwealth v. Benham, 816 S.W.2d 186, 187 (Ky.1991). Medical causation must be proved to a reasonable medical probability. Brown-Forman Corp. v. Upchurch, 127 S.W.3d 615, 621 (Ky.2004); Turner v. Commonwealth, 5 S.W.3d 119, 122 (Ky. 1999). As to general causation, Dr. Kulig and Dr. Petro testified that Parlodel causes late postpartum seizures, based on their review of case reports, ADRs, animal studies, the ERI study, toxicology knowledge about ergot drugs, clinical trial results and observations. Dr. Kulig testified that he also considered other factors medical textbooks and publications, Sandoz's reports and causation analyses on Parlodel, FDA evaluations of Parlodel, his knowledge of pharmacokinetics, and his observations of and experience with patients taking Parlodel. We agree with the trial court's assessment that although the individual pieces of evidence may not conclusively prove general causation, together they tend to show that Parlodel can cause postpartum seizures in women taking the drug for PPLS. As the court stated in Brasher, 160 F.Supp.2d at 1296, Although it is true that none of these bits of evidence establish conclusively that Parlodel can cause vasoconstriction and vasospasm, taken together they present a compelling picture, one which can support a reasonable scientific inference. Additionally, as noted earlier, Dr. Kulig and Dr. Petro both testified that the ERI study actually supported their opinion because, contrary to Rothman's analysis of the data, they viewed the data as showing that women taking Parlodel for PPLS had a 2.86% greater risk of having a seizure than postpartum women not taking Parlodel. Even the internal Sandoz memos from 1982 acknowledged a connection between Parlodel and postpartum hypertension and seizures. The next question is whether the Gundersons presented sufficient evidence of specific causationthat Mary Gunderson's death was actually caused by a seizure due to her ingestion of Parlodel. All of the Gundersons' causation experts employed a methodology called differential diagnosis in determining Mrs. Gunderson's cause of death to be a Parlodel-induced seizure. Differential diagnosis is a well-recognized and widely-used technique in the medical community to identify and isolate causes of disease and death. Globetti, 111 F.Supp.2d at 1177. The differential diagnosis calls for the physician to list the known possible causes of a disease or condition, usually from most likely to least likely. Then, utilizing diagnostic tests, the physician attempts to eliminate causes from the list until he is left with the most likely cause. Id. Differential diagnosis has been accepted by many courts as a reliable method of ascertaining medical causation. Kennedy v. Collagen Corp., 161 F.3d 1226 (9th Cir.1998); Glaser v. Thompson Med. Co., Inc., 32 F.3d 969 (6th Cir.1994); Perkins v. Origin Medsystems, Inc., 299 F.Supp.2d 45 (D.Conn.2004). Even in Dr. Armstrong's appellate brief, he acknowledges that differential diagnosis is an accepted methodology in choosing among known causes of a disease in an individual. Dr. George Nichols, a physician, board-certified in forensic pathology with twenty years' experience as Chief of the Kentucky Medical Examiner's Office, looked at the following in reaching his conclusion that Mrs. Gunderson died as a result of a seizure caused by taking Parlodel: thorough examination of the body during the autopsy, including microscopic studies of the lung, heart, and brain tissues; the police report and photos of how the body was found; Mrs. Gunderson's medical history; medical records from her pregnancy; the toxicology report; dozens of depositions taken in the case; and reports by the family about Gunderson's behavior and condition the night of her death. Dr. Nichols also relied on much of the same evidence that Drs. Petro and Kulig did regarding general causationthe ERI study, 73 case reports of women taking Parlodel for PPLS having seizures, animal studies, and the vast amount of scientific literature on Parlodel. Dr. Nichols estimated that he had conducted more than 10,000 autopsies in his career as a pathologist and stated that he had spent more time investigating the death of Mary Gunderson than any other case in his career. Upon examination of Mrs. Gunderson's body, Dr. Nichols and Dr. McCloud, another pathologist from the Medical Examiner's Office who conducted the first examination of the body, could not find any anatomic cause of death. Dr. Nichols testified that from the autopsy, he was able to eliminate all possible causes of death (e.g., pulmonary embolism, stroke, heart attack) except some form of sudden death syndrome. The toxicology report revealed a normal therapeutic amount of acetaminophen in the body, which was consistent with the prescription for the pain medication Percocet (a combination of acetaminophen and oxycodone) that Mrs. Gunderson was given upon her release from the hospital. Dr. Nichols rejected an overdose of Percocet as a possible cause of death because she was not acting intoxicated prior to going to bed, the therapeutic levels of acetaminophen in her system, and the number of pills left in her prescription suggested she was taking the medication according to the prescription. In reviewing the photos of Mrs. Gunderson's body and the way her arms were flexed up around her head and her hands were clenched, Dr. Nichols testified that it was apparent that her muscles had contracted for a long enough amount of time to develop rigor mortis. Dr. Nichols posited that only three things could account for such a position at deathelectrocution, military combat, or a seizure. After eliminating electrocution and military combat as possible causes of death, Dr. Nichols concluded that Mrs. Gunderson died from a seizure. According to Dr. Nichols, the fact that Mrs. Gunderson had voided from her bladder was also consistent with a seizure. Mrs. Gunderson's medical history indicated that she was generally healthy, although she smoked and was somewhat overweight. She had no history of seizures. Dr. Nichols rejected Sandoz's assertions that she had an enlarged heart at the time of death, explaining that Mrs. Gunderson's heart was at the upper limit of normal, which is normal for a postpartum woman and not significant. Dr. Jay Patrick Lavery testified that in his opinion, Mrs. Gunderson had gestational hypertension during her delivery in 1993 and immediately after the birth. However, Dr. Lavery opined that the gestational hypertension was not the cause of Mrs. Gunderson's death because her blood pressure was steadily improving after the delivery. The medical records from Mrs. Gunderson's pregnancy four years earlier indicated that she took Parlodel for PPLS and suffered no ill effects. However, Dr. Nichols testified that it is not uncommon for a patient to not have an adverse reaction to a drug the first time they take it, and then suffer an adverse or paradoxical reaction upon the second or subsequent administration of the drug. Dr. Nichols also testified that the evidence that Mrs. Gunderson had a severe headache prior to her death was indicative of an adverse reaction to Parlodel. Both Dr. Nichols and Dr. Petro noted that in many of the case reports for women taking Parlodel for PPLS who suffered a stroke or seizure, the women reported a severe crescendo headache prior to the adverse event. Dr. Nichols and Dr. Petro further stated that the pain that Mrs. Gunderson was experiencing between her shoulder blades on the day she died was consistent with an adverse brain event. The Gundersons also presented the testimony of Dr. Michael Balco, a forensic neuropathologist, who viewed the slides of Mary Gunderson's autopsy. Dr. Balco testified that the slides of Mary Gunderson's brain showed evidence of damage to her brain consistent with a seizure. Dr. Petro and Dr. Kulig relied on much of the same facts and information as Dr. Nichols in forming their opinions that Mrs. Gunderson died from a seizure caused by taking Parlodel. Dr. Petro agreed that the symmetric, flexed, gravity-defying position of Mrs. Gunderson's arms was proof that she died of a seizure. Dr. Petro also noted that seizures are more common at night. The Gundersons' causation experts all agreed that the fact the Mrs. Gunderson's death occurred seven days after the birth was a significant factor in attributing the seizure to Parlodel because the data from the ERI study and the case reports revealed that the postpartum seizures suffered after the ingestion of Parlodel for PPLS were more likely to occur late in the postpartum periodmore than 72 hours after delivery. Dr. Kulig and Dr. Petro acknowledged the studies showing that the postpartum period itself is associated with seizures, strokes and heart attacks. However, they opined that the seizure suffered by Mrs. Gunderson was Parlodel-induced because postpartum seizures attributable to the postpartum status alone rarely occur late in the postpartum period and are much more likely to occur soon after delivery. In reviewing the record, we believe there was sufficient reliable and relevant evidence that Mrs. Gunderson died as a result of a Parlodel-induced seizure to submit the issue before the jury in this case. Hence, the trial court properly denied Appellants' motions for directed verdict.