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United States v. Paulus

United States Court of Appeals, Sixth Circuit

June 25, 2018

United States of America, Plaintiff-Appellant,
v.
Richard E. Paulus, M.D., Defendant-Appellee. Witness (sample size) Trial Opinion Covered: Paulus's Conclusions Witness Conclusions

          Argued: April 26, 2018

          Appeal from the United States District Court for the Eastern District of Kentucky at Ashland. No. 0:15-cr-0015-1-David L. Bunning, District Judge.

         ARGUED:

          David M. Lieberman, UNITED STATES DEPARTMENT OF JUSTICE, Washington, D.C., for Appellant.

          Robert S. Bennett, HOGAN LOVELLS U.S. LLP, Washington, D.C., for Appellee.

         ON BRIEF:

          David M. Lieberman, UNITED STATES DEPARTMENT OF JUSTICE, Washington, D.C., Charles P. Wisdom, Jr., Kate K. Smith, UNITED STATES ATTORNEY'S OFFICE, Lexington, Kentucky, for Appellant.

          Robert S. Bennett, Michael P. Kelly, Hilary H. LoCicero, HOGAN LOVELLS U.S. LLP, Washington, D.C., C. David Mussetter, MUSSETTER LAW OFFICE, Catlettsburg, Kentucky, for Appellee.

          Andrew George, BAKER BOTTS L.L.P., Washington, D.C., Nicholas Bourtin, SULLIVAN & CROMWELL LLP, New York, New York, James F. Segroves, HOOPER, LUNDY & BOOKMAN, PC, Washington, D.C., for Amici Curiae.

          Before: BATCHELDER, McKEAGUE, and GRIFFIN, Circuit Judges.

          OPINION

          McKEAGUE, Circuit Judge.

         Mark Twain once quipped that "there are three kinds of falsehood: lies, damnable lies, and statistics." Dr. Paulus begs to differ and insists that certain statistical estimations cannot be false. As a cardiologist, Paulus interpreted hundreds of angiograms-specialized x-rays that approximate how severely a person's arteries are blocked. A federal jury convicted him of committing healthcare fraud and making false statements, on the theory that he exaggerated the extent of blockages (e.g., noting 80% blockage instead of 30%), so he could perform and bill for unnecessary procedures. The district court entered a judgment of acquittal and conditionally granted a new trial, reasoning that angiogram interpretations are not facts subject to proof or disproof. Because angiogram interpretations cannot be false, the reasoning goes, Paulus could not have lied. We disagree with this premise, and accordingly REVERSE the judgment of the district court and REMAND for further proceedings.

         I

         Heart diseases are a leading cause of death in the United States. One major contributor to these ailments is the narrowing of coronary arteries near the heart due to fatty plaque buildup. This case revolves around how doctors measure the severity of that blockage.

         A

         The arteries near a person's heart gradually narrow as a consequence of aging. An artery becomes narrower as fatty plaque and cholesterol accumulate on the inside of the artery wall. The medical term for this process is "stenosis." Stenosis itself is neither medically significant nor dangerous-many middle-aged people have some level of stenosis that does not impede the heart's ability to pump blood to the body. Problems arise when stenosis becomes more severe. If the artery becomes too narrow, it tends to restrict the amount of blood flowing back into the heart. This can trigger chest pain or pressure, which in turn should prompt a visit to the doctor. If ignored or left untreated, the plaque buildups can rupture and form a clot that completely blocks blood flow into the heart. The patient then experiences a heart attack, which can quickly be fatal.

         No one wants to risk a heart attack. But diagnosing the source of chest pain is complicated and difficult, even for seasoned doctors. There are plenty of other cardiac (and non-cardiac) conditions that can mimic the symptoms of severe stenosis. To promote accurate diagnosis and effective treatment, the medical field has developed a battery of tests, each with their own advantages and disadvantages. These include noninvasive Electrocardiograms (EKGs) and Echocardiograms (ECHOs), which use electrical signals and ultrasound waves to measure the heart's integrity. Invasive tests, such as Nuclear Stress Tests (NSTs), require injecting radioactive dye into the bloodstream and then using imaging software to observe blood flow through the cardiac system.

         When these tests indicate that the pain is coming from the heart, additional tests can be done to determine whether stenosis is the culprit. One of those tests is an invasive procedure called cardiac catheterization, which produces images known as angiograms. A doctor obtains an angiogram by threading a catheter up through a person's blood vessels and injecting contrast dye into the arteries near the heart. The doctor then takes an x-ray of the area, which permits a cardiologist to estimate how severe the blockage is. Catheterization is riskier than performing EKGs, ECHOs, or NSTs, due to the insertion of a foreign object (the catheter) into a blood vessel.

         If the angiogram shows at least 70% blockage, the accepted standard of medical care allows a doctor to insert a stent with no further testing. A stent is a small mesh cylinder that props the artery open to increase blood flow. Stents can improve blood flow and help prevent heart attacks, but they cannot cure stenosis or prevent its progression. Moreover, stents are permanent, and the procedure has been known to cause dangerous bleeding or blood clots in some cases. But when a patient's blood vessels are narrowed by 70% or more, the risk of a heart attack or stroke caused by the stenosis is more severe than any risks posed by the stenting procedure.

         Cardiologists also consider a blockage between 50% and 70% to be troubling. However, because angiograms are sometimes inconclusive in this range, the medical consensus appears to be that a stent is justified at these levels only if other testing (such as an intra-vascular ultrasound, or IVUS) confirms that the stenosis is dangerous to the patient. If the blockage is less than 50%, then the problem does not typically justify the risks involved in placing a stent.

         Part of the difficulty with angiograms is that they can be interpreted differently by different cardiologists. At trial, the government's experts acknowledged that the "inter-observer variability" between two cardiologists would generally be between 10% and 20%, meaning that one doctor might record 60% stenosis while the other observed 80% stenosis. Apparently, the variances are most pronounced in the "intermediate" stenosis range (between 50 and 70 percent). However, the government's experts reiterated that a cardiologist should rarely commit a larger error, such as recording a 40% blockage as a 70% blockage, due to the qualitative medical difference between mild, intermediate, and severe blockage.

         This relative confidence in angiogram interpretation has not gone unchallenged. Paulus and one of the amici in this case cite several studies where inter-observer variability was much larger. See Leonard M. Zir, et al., Interobserver Variability in Coronary Angiography, 53 Circulation 627, 627-29 (1976) (40 angiograms) (reporting 24 instances with inter-observer variability of 40% or greater and 10 instances where variability exceeded 90%); Miguel E. Sanmarco, et al., Reproducibility of a Consensus Panel in the Interpretation of Coronary Angiograms, 96 Am. Heart J. 430, 430-32 (1978) (14 angiograms) (reporting that, out of fourteen four-doctor panels who viewed the same angiogram seven months apart, six of them varied between 75% and 100% between the first and the second reading); Ernest N. Arnett, et al., Coronary Artery Narrowing in Coronary Heart Disease, 91 Annals of Internal Medicine 350, 354 (1984) (reporting variability of 40% and higher); Lucian L. Leape, et al., Effect of Variability in the Interpretation of Coronary Angiograms, 139 Am. Heart J., 106, 111 (2000) (reporting some instances where cardiologists disagreed by between 39% and 100% on the blockage shown by an angiogram).

         Paulus contends that these studies show that he could not have made a false statement when ...


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