Previously published in the Becker's Hospital Review
Exposure to excessive radiation has been a mainstay of popular
fiction for more than fifty years. The Incredible Hulk and Spider
Man obtained their super powers from genetic mutations caused by
radiation exposure, and film makers the world over have depicted
radiation producing all sorts of monsters from giant ants to
gargantuan lizards. Harmful health effects from high doses of
ionizing radiation, however, are not merely a convenient or
fantastical plot devise.
Because radiation is omnipresent, and because its use in medical
diagnosis and treatment is indispensible, federal and state
governments have published detailed standards intended to create a
safe work place for those whose occupations involve the use of
equipment that generates ionizing radiation. Those same regulations
also require that programs be established to keep occupational
exposure to radiation "As Low As Reasonably Achievable,"
a policy commonly referred to by the acronym ALARA.
In litigious 21st Century America, plaintiffs have brought
lawsuits claiming damages for personal injury, even when their
documented exposure is below regulatory dose limits, premised on
the argument that their doses could have been lower if only the
defendant had adhered to ALARA. The standard of care, these
plaintiffs argue, is not the detailed measurable dose limits set
out in occupational safety regulations, it is the more amorphous
concept of ALARA.
A federal court in New Orleans recently resolved this argument,
holding that an ambulatory surgery center that could have provided
a more rigorous ALARA program had no tort liability for personal
injuries claimed by a urologist who practiced at the center because
the surgeon's documented exposure was always below the
regulatory safety limits.
This article examines the court's decision, discusses issues
healthcare facilities may face in the courtroom, and offers some
guidance on ways healthcare providers can reduce the prospect of
being sued and increase the likelihood of a successful defense when
a lawsuit cannot be avoided.
Kidd vs. St. Luke's Surgery Center
Ralph Kidd, MD, is a board certified urologist with more than
thirty years of clinical experience who routinely performed
cystoscopy procedures with the aid of a fluoroscope, a piece of
diagnostic equipment that uses x-ray radiation to create a
real-time image of the internal organs of the body. For a three
year period ending in 2010, Dr. Kidd performed the vast majority of
his fluoroscopic cystoscopy procedures at St. Luke's, a
licensed ambulatory surgery center in Hammond, La., in which he was
also an investor.
In September, 2010, Dr. Kidd sued St. Luke's asserting a
number of claims premised upon various business disputes he had
with management of the center. Almost as an after-thought, Dr. Kidd
also claimed that he had suffered bodily injury from being exposed
to "excessive and unnecessary" x-ray radiation from the
fluoroscope. As the lawsuit progressed, the court entered a summary
judgment in favor of St. Luke's and dismissed all of Dr.
Kidd's business claims. His personal injury claim, however,
went to trial in the fall of 2011.
At trial, Dr. Kidd presented a medical physicist who testified as
an expert witness that although the measured dose readings from the
detection device that Dr. Kidd wore each time he used the
fluoroscope never equaled or exceeded the occupational dose limits
set by federal and state regulations, these readings were not
dispositive of the center's liability. This expert testified
that the measured dose readings did not accurately measure the
exposure to Kidd's eyes and hands because Kidd only wore a
single detection badge that was located in the area of his collar
bone, and the procedures he performed required his hands and eyes
to be much closer to the radiation beam than the detector badge. He
also testified that there were measures the center should have
implemented that would have reduced the exposure even further, that
the center was not compliant with ALARA, and that it therefore
failed to meet the standard of care.
The expert performed certain mathematical computations using data
compiled by universally recognized committees of radiation
scientists and concluded that Kidd had a .04 percent greater
likelihood of contracting a fatal cancer because of his exposure to
radiation at St. Luke's. Dr. Kidd complained that he suffered
various physical ailments attributable to radiation exposure, that
these ailments limited his ability to work and that his increased
mortality risk translated into an economic injury of millions of
dollars in lost future earnings.
In its defense, St. Luke's offered the testimony of a medical
physicist who testified that ALARA was not the standard of care,
but only an aspiration; the standard of care is the exposure limits
set by regulation. Testimony was also presented by a radiation
epidemiologist who rebutted the testimony of Dr. Kidd's expert
on the issues of causation and increased mortality risk. St.
Luke's further relied upon a number of previous court decisions
that rejected ALARA as the standard of care in favor of regulatory
dose limits.
The court observed that the state occupational safety regulations
were identical to counterpart federal regulations and held that,
consistent with federal jurisprudence adopting the dose limits as
the standard of care, the dose limits, not ALARA, was the proper
test under state law of whether St. Luke's was negligent. The
court also found that Dr. Kidd's evidence of causation was too
remote and that he had offered no competent medical evidence that
his physical problems were the result of radiation exposure.
Based on these conclusions, the court ruled in St. Luke's favor
and dismissed the complaint.
Courtroom hurdles
Every case involving bodily injury in a healthcare setting
carries with it the need to educate a judge or jury on arcane
concepts and terminology. Radiation exposure cases present their
own unique educational challenges that can be grouped into at least
three general categories:
1. Overcoming mythology. Most judges or jurors
will have personal experience with medical radiation and, despite
having never experienced any adverse effects, they will
nevertheless believe that medical radiation is inherently
dangerous. Consider the experience of a typical patient:
conspicuous warning signs declare the examination room to be a
hazard, a protective apron is draped upon the body and the
technician typically takes shelter before the device is
activated.
These experiences send the message that radiation, even diagnostic
radiation, is potentially deadly.
2. Understanding the science. Advocates trying lawsuits
have to help the fact finder understand the language of radiation
science so that they can understand the science itself.
Fact-finders will hear testimony about such things as "whole
body dose," "effective dose equivalent,"
"extremity dose," "individual dose limits," and
"linier no threshold hypothesis." The professional
literature even uses different forms of measurement for the same
things. For example, the international unit of effective dose
equivalent is the sievert (expressed as "Sv"). U.S.
regulatory agencies, however, express dose in terms of the rem.
(100 rem = 1 Sv).
Hand in hand with an understanding of the radiation science, the
judge or jury must understand the medicine of radiation exposure or
"radiation epidemiology." While it is true that acute and
chronic radiation exposure can produce measurable health effects,
not all populations are impacted the same way, and not all medical
conditions are caused or exacerbated by radiation exposure.
For example, there is a measurable difference in mortality rates
between men and women, and between various age cohorts in the same
populations. Likewise, there are certain conditions where radiation
is a known risk factor and others where it is not.
Underlying radiation epidemiology is the "Linier No Threshold
Hypothesis," which assumes that there are no safe levels of
exposure, even though no reliable study has ever been able to
detect adverse health effects with chronic exposure less than 10
rem. Some scientists suggest that there may even be beneficial
health effects to chronic low doses of radiation. The analogy they
use is the aspirin tablet. While many patients with heart disease
benefit from taking a single aspirin every day, those same patients
would probably suffer adverse effects if they took thirty tablets
one day a month.
3. Differentiating ALARA from the standard of
care. Juries and judges need to understand that ALARA is a
goal; an aspiration to pursue, not an objective standard by which a
duty of care can be measured. An ALARA program requires the
cooperation of everyone who works with radiation generating
equipment. What constitutes compliance at one facility may be
completely different at another. In its Position Statement 13-1,
originally adopted in March 2000, and revised as recently as July
2010, the Health Physics Society explains that "The
application of ALARA is founded in the professional judgment of
radiation-safety manager and personnel and is not, therefore, able
to be used as a measure of whether or not a particular
radiation-safety program is adequate in comparison with other
programs.""
Preventive Measures
The correct legal conclusion is that occupational dose limits,
not ALARA, provide the standard of care for radiation in the
healthcare setting. However, even though a court should not hold a
healthcare provider to an ALARA standard of care, providers should
take the philosophy of ALARA seriously. The most effective measure
that a healthcare provider can take to prevent a vexing lawsuit, is
to have a good radiation safety program.
Radiation workers should receive meaningful and periodic safety
training. Protective equipment such as lead aprons, protective
goggles, and exposure badges should be provided, and workers should
be required to use it. Exposure records should be kept current and
posted prominently so that each worker can know their own exposure.
Radiation generating equipment should be routinely inspected by a
qualified health physicist to make sure that it is functioning
within safe parameters. Equally important, this training,
equipping, monitoring and inspecting should be thoroughly
documented. Memories fade and employees come and go. Proof that a
provider's radiation safety program is effective should not be
left vulnerable to these realities of modern business.
Radiation exposure cases are challenging. But healthcare providers
can win them with good facts, skilled advocacy and the application
of the proper legal standard.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
