Argued: April 26, 2018
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.
M. Lieberman, UNITED STATES DEPARTMENT OF JUSTICE,
Washington, D.C., for Appellant.
S. Bennett, HOGAN LOVELLS U.S. LLP, Washington, D.C., for
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
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.
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.
McKEAGUE, Circuit Judge.
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.
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
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
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.
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.
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.
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.
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.
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).
contends that these studies show that he could not have made
a false statement when ...