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.
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.""
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.