The deposition was taken over two days. It is reprinted in its entirety. Names of patients, witnesses, physicians and hospitals have been removed (see index, below). Attorneys’ names and that of Dr. Leavy remain. The following is a list of important sections that have been identified as containing remarkable statements relevant to the testimony. Commentary follows most items on the list. Efforts have been made to avoid the possibility of items being taken out of context. But to ensure accuracy, the reader is encouraged to look at the referenced parts of the deposition.
The testimony under review was given in July of 2005. The witness seems to frequently reference Rosen’s Emergency Medicine: Concepts and Clinical Practice. The 5th edition was published in 2002 and seems highly likely to be the one referred to by the witness (a 6th edition was published in 2006). In all cases, commentary comparing what is written in Rosen’s and the witness’s testimony refers, to the 5th edition.
Page 10 Line 5
The witness admits he did not read the entire article by Sanchez regarding heparin alone vs. heparin plus streptokinase.
Comment: In questioning, Dr. Leavy is asked to produce literature related to the case. He produces chapters from Tintinalli’s and Rosen’s and a sheaf of seven abstracts printed from PubMed related to pulmonary embolism (PE). The article by Sanchez is a key abstract as it is one of the few articles that claim the outcome of treatment with thrombolytics plus heparin (in this case, streptokinase) is superior to treatment with heparin alone in patients with submassive PE. (See “A brief discussion of submassive pulmonary embolism” elsewhere).
Comment: As an expert witness, what was Dr. Leavy’s responsibility regarding actually reading references he submits as supporting his position and what is his responsibility related to critical evaluation of those sources?
Page 31 Line 3
The witness states that pulmonary hypertension is listed by Rosen’s as an indication to give t-PA.
Comment: This is only partly correct. While Rosen’s does list thrombolytics as an appropriate therapy, it is for confirmed PE. Nowhere does Rosen’s, or any other source, suggest that thrombolytic therapy be given for suspected PE.
Page 36 Line 19
“Once the echo – once the echo was done and proved the patient had pulmonary hypertension, right heart strain, that’s when the t-PA should have been given”
Page 36 Line 24, into page 37
Witness agrees with statement that by failing to give t-PA is equivalent to “blowing the patient off.”
Comment: This is objectionable for two reasons. First, there were no studies confirming the presence of a PE. All studies of the use of thrombolytics in PE require confirmatory studies, not just an echocardiogram. Second, depositions and records show that numerous physicians were at the patient’s bedside trying to formulate a plan of care for them, thus hardly “blowing off” the patient.
Page 39 Line 7
This is the beginning of a series of questions in which Dr. Leavy puts forward the thesis that the presence of a pulmonary embolism was established by a high clinical suspicion and the echocardiogram results. At one point, he states that the patient “obviously” had a PE. He states “…it was really the only consideration.” Yet Rosen’s, the source most commonly cited during the deposition, says this about echo results:
Acute pulmonary hypertension causes both the right and left ventricle and pulmonary arteries to dilate, and the ratio of right-to-left ventricular end-diastolic diameters correlates well with angiographic indices of the severity of the obstruction. These indirect signs are of value in assessing the severity of proven VTE but should not be relied on for the primary diagnosis of PTE, because they are also seen in patients with right ventricular infarction and with other causes of pulmonary hypertension. The diagnosis of PTE cannot reliably be made on the basis of the transthoracic echocardiogram alone, unless thrombus actually is visible in the right side of the heart.
Comment: With regard to a PE being the only consideration, the echo also demonstrated right ventricular hypertrophy. This finding suggests chronic elevated pulmonary pressures, opening up a whole new list of possible disease processes. Dr. Leavy seems to ignore this.
Page 40 Line 11
Rosen’s book, the page that I copied or pages that I copied talking about the use of t-PA in people who are unstable from what’s thought to be a pulmonary embolism and people who are stable but have right heart strain, it was recommended to give the t-PA
Comment: This reviewer could find no recommendation in Rosen’s about giving t-PA in suspected PE without confirmation of the diagnosis.
Page 41 Line 8
Dr. Leavy is questioned about where, in the copy of Rosen’s provided, it says that treatment with t-PA should be initiated prior to confirmation of PE. This is his answer:
You know, it doesn’t mention how the diagnosis — or what is needed to make the diagnosis. It just said the people who are treated for pulmonary thromboembolism and the value of treating these people rapidly.
Further on the same page, Dr. Leavy discusses how the diagnosis could be made clinically.
Comment: This claim is not supported by the literature available to this reviewer.
Page 70 Line 14
Concerning the echo results, Dr. Leavy said this: “Immediately after the echo was read we have proof positive of the need for thrombolytic therapy.”
Comment: Again, this is not supported by available literature.
Page 123 Line 6
Dr. Leavy reads this statement from Rosen’s “Immediate fibrinolysis may also be indicated in (sic.) patients with acute right ventricular strain from thromboembolism (sic.), even in the absence of hemodynamic compromise.”
The examiner replies: “Okay. So that would be your support for the statement that it’s a — it is a standard to use t-PA in patients with these –”
Dr. Leavy Answers “Yes, ma’am.”
Comment: It seems a quantum leap to go from saying that a given therapy may be indicated to establishing it as a standard of care.
Page 123 Line 16
This states that the standard of treating PE with thrombolytic drugs applies to patients with either confirmed PE or highly suspected PE.
Comment: Again, this is not stated in Rosen’s, or supported by available literature.
Page 140 Line 17
Another question and answer in which Dr. Leavy states that an echo can confirm the diagnosis of PE.
Comment: At least he is consistent.
Under questioning, Dr. Leavy continues to assert the echo findings were diagnostic of PE, that nothing else could have caused these findings and that he would like to see a cardiologist state otherwise.
Comment: Again, the echo also showed right ventricular hypertrophy, a finding not typical for PE unless there had been a PE leading to chronic pulmonary hypertension. There are other things that could cause these results. Primary pulmonary hypertension and Eisenmenger’s Syndrome come to mind…
The witness quotes data from Rosen’s regarding survival benefit in patients treated with thrombolytics. He claims the data applies to patients with confirmed or suspected PE.
Comment: No, it does not.
Page 187 Page 10
He states that the patient should have got thrombolytics immediately after the echo results were available.
Comment: See previous comment about consistency.
Page 337 Line 15
He states that there is a consensus that thrombolytics should be given to patients with submassive PE.
Comment: What constitutes a consensus? The support for this treatment seems to be a few published opinions. The current literature states that this treatment is unsupported by available research. It is hard to call that a consensus.