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Smith v. Terumo Cardiovascular Systems Corp.

United States District Court, D. Utah

July 12, 2017

BUZZIE SMITH, individually and on behalf of the Heirs and Estate of Charles A. Smith, Deceased, Plaintiff,
v.
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; IHC HEALTH SERVICES, INC.; INTERMOUNTAIN MEDICAL CENTER; INTERMOUNTAIN HEALTH CARE, INC., Defendants.

          MEMORANDUM DECISION AND ORDER GRANTING [157] MOTION TO LIMIT TESTIMONY OF JOHN HEIDINGSFELDER, M.D.

          David Nuffer, District Judge

         The decedent Charles A. Smith (Mr. Smith), represented in this litigation by Buzzie Smith (Mrs. Smith), underwent surgery on his heart in September 2010. There were complications during the surgery. Eleven months later, Mr. Smith passed away. Mrs. Smith brings this action against the hospital and the manufacturer of a device used during the surgery (collectively “Defendants”).[1] Mrs. Smith offers Dr. John Heidingsfelder's expert opinion to help establish various aspects of her case. Defendants move (Motion) to limit parts of Dr.

         Heidingsfelder's expert opinion.[2] Mrs. Smith opposes (Opposition) the Motion.[3] Defendants reply in support of the Motion.[4]

         Table of Contents

         Background Facts ............................................................................................................................ 2

         Discussion ..................................................................................................................................... 11

         1. Dr. Heidingsfelder is not qualified to opine regarding the formation of plaque or progression of cardiomegaly. . ............................................................................... 13

         2. But even if Dr. Heidingsfelder were qualified, his opinion regarding plaque is not reliable ................................................................................................................... 15

         3. But even if Dr. Heidingsfelder were qualified, his opinion regarding cardiomegaly is not reliable. . ....................................................................................................... 17

         Order ........................................................................................................................................... 18

         BACKGROUND FACTS

         Defendants provide the background facts to the Motion in the manner of a fact section for a motion for summary judgment under DUCivR 56-1(b).[5] Mrs. Smith responds accordingly.[6]The facts will be reconciled as they would for a motion for summary judgment. For simplicity, the facts below will be drawn from the briefing instead of the supporting exhibits. If Mrs. Smith or the Defendants did not dispute the fact, the footnote citation will only be to the Motion or Opposition. If there is an alleged dispute, it will either be resolved or the fact will be omitted. The facts below do not represent a finding of undisputed facts for purposes of the pending motions for summary judgment. The following facts only relate to this motion.

         1. Mr. Smith underwent an aortic valve replacement surgery on September 13, 2010, at Intermountain Medical Center to Address severe aortic stenosis. The surgery was performed by Kent Jones, M.D. (Dr. Jones) and required that Mr. Smith be placed on heart bypass.[7]

         2. However, when Dr. Jones directed the perfusionist to initiate bypass and the perfusionist attempted to do so, the bypass machine failed to provide the forward flow of blood necessary for effective cardiopulmonary bypass.

         3. Although flow was later established, as a result of the initial problems, there was a lack of forward flow from the bypass machine for approximately 10 or 11 minutes out of 173 minutes of bypass during the five hour and thirty-five minute surgery. For part of the 11 or so minutes that the bypass machine failed to provide forward blood flow, Dr. Jones squeezed Mr. Smith's heart to “create any blood flow.” While he was massaging the heart, the anesthesiologist was giving crystalloid infusion, just to keep something circulating through Mr. Smith's body, but crystalloid does not have the ability to carry oxygen. Mr. Smith's heart had been drained of blood by that time, and for some of that time, Mr. Smith had no blood pressure; for other readings the systolic pressure was less than 20 millimeters of mercury, which is “very low blood pressure.” It took about 9 minutes before Dr. Jones could get any meaningful blood pressure. Dr. Jones could not say how effective squeezing the heart was, but it was “the only option you have.”[8]

         4. Following the surgery, Mr. Smith underwent cardiac rehabilitation, and was discharged from Intermountain Medical Center on December 10, 2010. Mr. Smith should have improved after the surgery because he no longer had aortic valve stenosis. But he did not. After “a prolonged hospitalization” in Utah, Mr. Smith was transferred to a rehabilitation facility in Missouri.[9]

         5. Mrs. Smith alleges that the failure of flow during the surgery injured Mr. Smith's heart and brain and about 11 months after the valve replacement surgery, on August 6, 2011, caused a heart attach which resulted in Mr. Smith's death.[10]

         6. Mrs. Smith seeks damages arising from Mr. Smith's death and damages for the harms and losses Mr. Smith suffered before his death as a result of the incident.[11]

         7. Following Mr. Smith's death, Mrs. Smith retained forensic pathologist John Heidingsfelder, M.D. to perform an autopsy on Mr. Smith.[12]

         8. Dr. Heidingsfelder performed the autopsy, consulted with pathologists specializing in cardiac pathology and neurologic pathology, and produced an autopsy report.[13]

         9. In determining the cause of death, Dr. Heidingsfelder relied on his medical knowledge, his knowledge of forensic pathology, and his knowledge of what to look for in natural disease deaths and other deaths.[14]

         10. Doctors reasonably rely on prior medical records to inform themselves about a patient's prior condition.[15]

         11. Dr. Raed Al-Dallow, Mr. Smith's treating interventional cardiologist in Illinois, testified:

In our area of experience as cardiologists treating those patients, there are certain factors that we consider when we care postoperatively. One of them is the length or the duration of surgery, and the tear had to be repaired, so this may have added time to the length of the surgical procedure, although this time is not stated.[16]

         12. During the surgery, Mr. Smith went some 10 minutes with no or very low blood pressure. A period of very low blood pressure can lead to a reduction in the function of the heart.[17]

         13. That damage can lead to further damage to the tissue of the heart itself over the next weeks and months.[18]

         14. That initial event can set in motion a biochemical process called cardiomyopathy that can be progressive.[19]

         15. When cardiomyopathy is severe, it can impair the patient's function and longevity.[20]

         16. Dr. Al-Dallow testified that if Mr. Smith had blood pressure of less than 20 mmHg for 9 minutes, then that could be why his cardiomyopathy worsened after his surgery.[21]

         17. Dr. Al-Dallow also testified that there may be other causes for why Mr. Smith's cardiomyopathy worsened.[22]

         18. Mr. Smith's left ventricle dysfunction could have been exacerbated or worsened by a period of very low blood pressure, such as occurred in Mr. Smith's September 2010 surgery.[23]

         19. Dr. Jones, the surgeon, noted that he had a difficult time weaning Mr. Smith from cardiopulmonary bypass “due to severe left ventricular dysfunction, presumably from lack of any coronary blood flow during the time of his hypotension.”[24]

         20. Dr. Jones also stated that in an echocardiogram performed after the surgery “[it] documented improvement in his left ventricular function, the ejection fraction now being 35-40%.”[25]

         21. A period of very low blood pressure can also lead to a problem with cerebral functioning.[26]

         22. Dr. Jones was “very concerned with [Mr. Smith's] cerebral function given the long period of absent blood pressure” and planned to treat him with hypothermia for 24 hours “in hopes of improving his brain function.”[27] Dr. Jones later reported: “Surprisingly, Mr. Smith awakened and showed no evidence of neurologic impairment.”[28]

         23. Dr. Al-Dallow stated that “[t]he cardiomyopathy process includes the enlargement of the heart, the hypokineses, the ejection fraction and the decreased systolic function. These are different aspects of the same process.”[29]

         24. When a person's heart is deprived of a sufficient flow of properly oxygenated blood for 9 minutes it can make a person more susceptible to an event that would terminate his life through the malfunctioning of the heart.[30]

         25. Mr. Smith's left ventricle was mildly enlarged in December 2008.[31]

         26. The autopsy of Mr. Smith's heart showed that it weighed 880 grams, which the cardiopathologist characterized as severe cardiomegaly.[32]

         27. The heart size for a normal, healthy individual is between 350 and 425 grams. Mr. Smith's heart was over twice the normal size.[33]

         28. The Surgical Pathology Report states that “[a]ll four chambers also show mild dilatation.”[34]

         29. The left ventricle is the chamber that pumps blood through the aorta to the rest of the body. The left ventricle ejection fraction is a measure of how well the left ventricle is functioning. For a normal, healthy 70-year-old, a normal ejection fraction is in the range of 55- 65%. From 2003 through 2005, Mr. Smith's left ventricle ejection fraction was 44-45%. In December 2008 his ejection fraction was 35%. Just before his September 2010 valve-replacement surgery, his ejection fraction was 30-35%, a moderate impairment. Instead of getting better or staying about the same after Mr. Smith's narrowed aortic valve was replaced, some four and a half months after the surgery his ejection fraction was down to 20%, a severe impairment.[35]

         30. Dr. Heidingsfelder's autopsy report included the report of a cardiac pathologist that stated that Mr. Smith's heart showed severe cardiomegaly (enlargement of the heart) and also a 60% to 70% narrowing of the right coronary artery by “calcific atherosclerosis, ” or ‘‘plaque, ” and 30% to 40% narrowing of the other three coronary arteries. (“Calcific atherosclerosis” is also referred to as “coronary artery disease” or in lay terms, “hardening of the arteries.”)[36]

         31. In his report Dr. Heidingsfelder states:

It is my opinion that the cause of death is fatal ventricular arrhythmia due to clinical acute myocardial infarct due to atherosclerotic cardiovascular disease. The manner of death is natural disease. Other significant conditions which may have contributed to the cause of death include aortic valve stenosis, aortic porcine valve replacement procedure, cardiomegaly with four chamber dilation and hypertrophy, COPD, and encephalopathy.[37]

         32. Dr. Heidingsfelder implied in his report that stress to Mr. Smith resulting from the events of the September 2010 surgery contributed to accelerated formation of coronary artery plaque (“atherogenesis”) in Mr. Smith and thereby caused the myocardial infarction which was the immediate cause of Mr. Smith's death.[38]

         33. Dr. Heidingsfelder also implied in his report that the events of the September 2010 surgery caused increased enlargement to Mr. Smith's heart.[39]

         34. In his deposition, Dr. Heidingsfelder answered the question of what he felt was the cause of Mr. Smith's death: “My opinion as to the cause of his death was that of a fatal ventricular arrythmia [sic] due to an acute myocardial infarct due to atherosclerotic cardiovascular disease.”[40]

         35. Dr. Heidingsfelder asserted in deposition that chronic stress from worsened health conditions resulting from the surgery in September 2010 caused accelerated formation of plaque in Mr. Smith's coronary arteries.[41]

         36. Dr. Heidingsfelder relied on medical records reporting that Mr. Smith had no significant coronary artery disease (“narrowing”) before the surgery; however, narrowing (“stenosis”) of coronary arteries is not considered a “significant” finding until it reaches 70%.[42]

         37. Mrs. Smith's expert cardiologist also stated that given Mr. Smith's prior history of atherosclerosis and the prior imaging studies, the findings upon autopsy were ‘‘not surprising” and were consistent with this history.[43]

         38. In his deposition, Dr. Heidingsfelder also suggested that the events of the surgery contributed to the severe degree of cardiomegaly found on autopsy.[44]

         39. Again, Dr. Heidingsfelder based his opinion that the events of the surgery caused a substantial increase in cardiomegaly on the difference between prior medical records referring to heart size and the findings on autopsy.[45]

         40. Dr. Heidingsfelder is trained in internal medicine and forensic pathology. He ...


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