excerpt from forewarned i guess t … digest for professionals in radiation therapy and diagnostics...

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A digest for professionals in radiation therapy and diagnostics February 1994 Volurhe 2, No. 2 GUEST EDITORIAL EXCERPT FROM FOREWARNED IS FOREARMED... by David Wiedis, Donald E. Jose, and Timm O. Phoebe 1 Introduction Recent revelations concerning government experiments in which human subjects were exposed to radioactive materials (allegedly in some cases without their consent) have caused a heightened awareness of the perceived dangers related to radiation exposure.^ The general public has never been prop- erly educated that the effects of radiation exposure all depend on the dose. Consequently, the very mention of any "radiation" is enough to instill irrational fears of mutation and genetic disease in average members of society who base their beliefs on such contemporary cultural fixtures as the Teenage Mutant Ninja Turtles. Recent controversial epidemio- logical studies have not allayed these fears. Although a few new studies seem to show an appar- ent excess of some cancers at low doses, their observations are not presently accepted by the majority of radiation researchers as representing a valid radiation effect. 3 While the validity of these studies should be debated by scientists and epidemiologists, their primary effect may be to cast doubt upon the current oc- cupational dose standards within the minds of those whose occupation requires routine radiation exposure. The average annual exposure for medical staff personnel has been estimated to be about 150 millirem per year^ and certainly for some, such as nuclear medicine tech- nicians and physicians handling highly radioactive therapeutic sources, these doses can go signifi- cantly higher. 5 If then, there are some studies that show the appearance of excess cancers in those exposed to normal occupational doses, or perhaps more importantly, if there is a perception that radiation is more effective than previously believed in causing can- cer, then the questionmust be asked whether hospitals and health care facilities whose workers are using and being exposed to radiation ev- ery day have made preparations for the potential radiation injury claims that may be made by these employees. The Potential Scope of the Problem With the exception of the early pioneers in this field who used to calibrate their instruments by hold- ing their hands in the x-ray beam until their skin turned red and iso- lated accidents, the safety record in the industry has been admi- rable, due largely to quickly estab- lished and internationally accepted dose limits. However, even with a perfect track record, the fact re- mains that about 30 percent of all persons working in this field will develop cancer at some time in their lives!6 These cancers are .unrelated to their exposure to occupational radiation; the na- -continued on page 2 iso 1 OPICS is a digest for nuclear medicine professionals prepared by the technical staff of NUS, a division of Halliburton NUS Corporation. NUS has served the nuclear industry for over 30 years by monitoring, summarizing, and communicating consequences of NRC requirements, guidance, and technical information, in addition to offering technical services in health physics, radiation safety, and quality management. n!

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A digest for professionals in radiation therapy and diagnosticsFebruary 1994 Volurhe 2, No. 2

G U E S T E D I T O R I A LEXCERPT FROM FOREWARNED ISFOREARMED... by David Wiedis, Donald E. Jose, and Timm O. Phoebe1

IntroductionRecent revelations concerning government experiments inwhich human subjects were exposed to radioactive materials(allegedly in some cases without their consent) have caused aheightened awareness of the perceived dangers related toradiation exposure.^ The general public has never been prop-erly educated that the effects ofradiation exposure all depend onthe dose. Consequently, the verymention of any "radiation" isenough to instill irrational fearsof mutation and genetic diseasein average members of societywho base their beliefs on suchcontemporary cultural fixtures asthe Teenage Mutant NinjaTurtles.

Recent controversial epidemio-logical studies have not allayedthese fears. Although a few newstudies seem to show an appar-ent excess of some cancers atlow doses, their observations arenot presently accepted by themajority of radiation researchersas representing a valid radiationeffect. 3 While the validity ofthese studies should be debatedby scientists and epidemiologists,their primary effect may be tocast doubt upon the current oc-cupational dose standards withinthe minds of those whose occupation requiresroutine radiation exposure. The average annualexposure for medical staff personnel has beenestimated to be about 150 millirem per year^ andcertainly for some, such as nuclear medicine tech-nicians and physicians handling highly radioactivetherapeutic sources, these doses can go signifi-cantly higher.5 If then, there are some studies that

show the appearance of excess cancers in those exposed tonormal occupational doses, or perhaps more importantly, ifthere is a perception that radiation is more effective than

previously believed in causing can-cer, then the question must be askedwhether hospitals and health carefacilities whose workers are usingand being exposed to radiation ev-ery day have made preparationsfor the potential radiation injuryclaims that may be made by theseemployees.

The Potential Scope ofthe ProblemWith the exception of the earlypioneers in this field who used tocalibrate their instruments by hold-ing their hands in the x-ray beamuntil their skin turned red and iso-lated accidents, the safety recordin the industry has been admi-rable, due largely to quickly estab-lished and internationally accepteddose limits. However, even with aperfect track record, the fact re-mains that about 30 percent of allpersons working in this field willdevelop cancer at some time intheir lives!6 These cancers are.unrelated to their exposure tooccupational radiation; the na-

-continued on page 2

iso 1 OPICS is a digest for nuclear medicine professionals prepared by thetechnical staff of NUS, a division of Halliburton NUS Corporation. NUShas served the nuclear industry for over 30 years by monitoring, summarizing,and communicating consequences of NRC requirements, guidance, andtechnical information, in addition to offering technicalservices in health physics, radiation safety, andquality management.

n!

FOREWARNED (continued from page 1)

tional cancer incidence rate is about 30 percent. This meansthat about 30 percent of all those engaged in nuclear medicinewill develop cancer even if no excess cancers appear in thatgroup of people.

As the work force ages and natural cancers begin to appear, onecan expect that some significant percentage of those whodevelop cancer will sincerely believe that their employmentcontributed to their disease. Legal claims for compensationmost likely will be filed. These claims will be either tort(personal injury) claims filed in court or workers' compensa-tion claims filed with the state workers' compensation boards.The employment relationship between the plaintiff and defen-dant will determine where the claim must be filed.

In most states employees are barred from suing their directemployers because the workers' compensation system pro-vides the exclusive remedy for occupationally-injured em-ployees. In exchange for giving up their right to sue, employeesare theoretically granted the benefits of speedy compensationwithout the burden of proving the employer's negligence.Where, however, no employment relationship exists or wherethe state workers' compensation statute does not include aradiation-induced cancer, a lawsuit may be filed. In that case,the plaintiff must prove that the hospital acted negligently andcaused the plaintiff to suffer a legally compensable injury. Thebenefit for a plaintiff in a standard lawsuit versus the workers'compensation arena is that the potential awards from a juryverdict in a lawsuit are virtually unlimited whereas workers'compensation benefits are fixed by statue.

10CFR20.108 has been added to the regulations in an effort toensure that the radiation exposure of unborn children of occu-pationally-exposed mothers is appropriately curtailed. The

iso TOPICS is a monthly publication of NUS, 900 Trail Ridge Road, Aiken,SC 29803, telephone 800-368-5497. Send all inquiries, letters, andsubmissions to the above address. Subscription rate is $189 per year.

James S. Davis, Ph.D., CHP Technical Editor

Tish B. Morgan Editor

Dale T. Huls Contributing EditorMarilyn P. Heuer Contributing EditorKim O. Smith Layout and DesignRod Buckles Licensing Information

ServicesReproduction of this information by any means without the consent of NUS is prohibited. NeitherNUS nor any of its employees makes any warranty, express or implied, nor assumes any legalliabiHty or responsibility for the accuracy, completeness, suitability for use, or timeliness of theinformation. References to specific products and/or manufacturers in no way imply endorsement,preference, or disapproval by NUS or any of its employees.

<&> 1994, NUS

All rights reserved.i nis newsletter is pnntea onrecycled paper. SIM US

regulations mandate that women who declare themselvespregnant are limited to 500 millirem of radiation exposure forthe nine month period of their pregnancy. Notice here that thekeyword is "declared." It is not mandatory for women who arepregnant to declare themselves so. In addition, an employerwho merely believes an employee is pregnant, no matter howobvious it may be, may not unilaterally limit that employee'sexposure because such conduct would likely be ruled to be anact of sexual discrimination in violation of a woman's civilrights under Title VII of the Civil Rights Act of 1964.7 If,though, the fetus of a mother who did not declare herselfpregnant is harmed by radiation exposure, the employer maystill be liable to the injured child for the injuries sustained.Although this particular fact pattern has not yet arisen in anyknown court cases, the imposition of these new regulationsmakes such a scenario quite likely in the near future. Thus,employers must walk a fine line between the imposition of fetalprotection policies and their obligation to refrain from sex-based discrimination.

What should be done if radiation-induced cancers do appear inthe work force or when sincere employees who are part of the30 percent natural cancer incidence rate file claims for com-pensation? What should be done if employees file lawsuitssincerely believing that their child's birth defect was caused byradiation exposure? If they file a tort lawsuit, then it will bedefended on a number of grounds:

1. Because most states provide that workers may not suetheir employers directly but must sue under the state'sworkers' compensation system, most cases will firstbe analyzed as to whether or not coverage exists inthat forum.

2. Some of those cases that are tried in federal or statecourt may be established in the context of the nuclearindustry. For example, one legal defense to workerswho have sued utilities for injuries or emotionaldistress arising from radiation exposure that is withinfederal permissible dose limits is the O'Conner Doc-trine which states that the Federal Permissible DoseLimits as established by the U.S. Nuclear RegulatoryCommission in the Code of Federal Regulationsconstitutes the duty owed to workers and prevents aworker from successfully suing when his dose isbelow the permissible dose limits.8 If this precedentis applied in the context of injuries arising amonghospital workers, then it could severely limit thenumber of successful claims filed.

-continued on page 3

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FOREWARNED (continued from page 2)

3. Depending on the scientific validity of the plaintiff sexpert, the expert's causation or dose opinion may beexcluded from evidence as "junk science," the termused when someone who is supposedly an expert in acertain field seeks to testify in support of scientificproposition which is empirically and theoreticallyunfounded, causing the dismissal of the case. In theO'Conner case, the court employed this screeningdevice and excluded the plaintiff's expert's opinionas scientifically erroneous when he testified that hecould definitively discern a radiation-induced cata-ract from non-radiation-induced cataracts just bylooking at it.

4. The case may be terminated on some other issue ormay go to trial on the merits. However, even then theclaim is filed in court, a workers' compensation claimis also likely to be filed. This is especially true if thetort claim is defeated.

Presently, radiation claims which are defeated in court tend tothen be filed and paid as workers' compensation claims be-cause such settlements are cheaper in the short run than the costof defending such complex and emotional cases. For example,in the context of nuclear workers, two different tort suits wererecently defeated in court (one for emotional distress and theother for leukemia) only to be quickly filed and paid asworkers' compensations claims without any attempt evenbeing made to defend them on the merits. One case settled for$95,000 and the other for $120,000 for an average of $ 107,500.If this limited track record turns out to be meaningful, thenevery radiation technician who gets some form of cancer (or issimply fearful that he/she will) can expect to collect about$110,000 if he/she simply files a workers' compensationclaim. Moreover, this is a relatively modest average sum andcould easily be more than doubled over time. But not everyclaimant with cancer should automatically be awarded$110,000 simply because he/she happened to work in ahospital's nuclear medicine department. This problem ofhow to deal with occupationally-caused cancers, natural can-cers, and other conditions among radiation technicians shouldbe addressed before these cases are filed and the industry andworkers' compensation forums are swamped just attemptingto respond to them.

Some Possible AppjroaghgsWhat, if anything, should be done? Since the industry pres-ently has no uniform plan, each hospital will have to chart itsown course through these difficult waters. There are essen-tially three possible alternatives.

1. The present course can simply continue. That is, donothing and let the short-term economic forces resultin the payment of these claims as they are filed. Thisroute may be seemingly attractive but in the futuremay result in the hospitals and carriers paying forvirtually every natural cancer in its work force andpossibly for many other real or imagined conditions.

2. The hospitals can commit to paying only meritoriousclaims and defend those claims without merit. Mostwould agree that philosophically, meritorious claimsshould be paid and unmeritorius claims defended. Ifthis is the philosophical goal, then the hospital mustask itself how it proposes to identify and defend thosemeritless claims. Millions of dollars will likely needto be spent on the early cases which otherwise couldbe settled for hundreds of thousands of dollars. Thiscourse of action will appear to be many times morecostly in the short term. However, it is likely to bemore economical in the long term because fewerclaims will be filed against those hospitals that vigor-ously defend meritless claims than against hospitalsthat simply settle all claims which are filed.

3. Hospitals can decide that attempting to defend thesecases in the employees' compensation forum wouldbe a losing battle. In such a state, they can elect toaccept the fact that "the system" will inevitably forcethem to pay many of these claims, no matter howfrivolous. The only option then remaining is toattempt to structure better which claims they will beforced to pay and which ones they will not.

Perhaps the best way to restructure the system is to think ofcancer as an occupational disease among radiation technicians.Thus, the state Occupational Disease Act may need to beamended to include cancer for radiation technicians and tospecify certain essential requirements that must be met in orderfor those employees to collect. For example, some require-ments could be as follows: the type of cancer must be one ofthe types which is recognized by the latest BEIR Report asbeing radiogenic; the latency period must be more than 2 yearsfor leukemia and more than 10 years for a solid tumor; thelatency cannot be more than 10 years for leukemia or more than40 years for a solid tumor; the total organ dose to the worker forleukemia must be a bone marrow dose of greater than 10 rem;the organ dose for a solid tumor must be a dose of greater than50 rem; the Probability of Causation as calculated by the NIHmethod must exceed .30; etc. By taking the lead to propose andpass such legislation, the hospital can effectively establish the

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FOR E WARNED (continued from page 3)

parameters within which compensation decisions will be made.If done well, then a carefully drafted section in a state Occupa-tional Diseases Act can accurately and fairly select out thoseclaims that are more likely to bear a possible radiation genesisfrom those that are not.9

ConclusionFactors make it difficult to have a national policy and acoordinated effort. Some hospitals may weigh their optionsand come to dramatically different conclusions as to the bestcourse of action for them. The authors do not attempt here tosuggest for any hospital specifically what the right course ofaction is for them but certainly the time has come for eachhospital to face the issue and make some thoughtful decisionsbefore conclusions are established by the few cases now beingprocessed through the existing system. The only option thatseems to be clearly wrong is to not even think about this issueat all.

How will hospitals resolve those claims? If that decision willneed to be made in the future, then why not make it today andmaximize the opportunity to have an impact upon the cases assoon as they are filed, no matter how large or few the numberultimately turns out to be? We must not forget that precedenthas a great force in law. How the later claims will beadjudicated is largely determined by how the early claims arelitigated. The time to act, if one wants the best chance of havingapositive effect, is as soon as those early claims are filed beforeany precedent is established by them.

For a copy of the full text and citations of this article, pleasecall isoTOPICS at 800-368-5497.

REFERENCES:

* Mr. Wiedis, Mr. Jose, and Mr. Phoebe practice law atJose & Wiedis, West Chester, PA, where they special-ize in radiation litigation defense.

2At this writing the authors have noticed that the mediahas omitted dose. The central question for both thosewho have been unwittingly exposed and for those in thegovernment who are contemplating paying compensa-tion for these exposures must be what dose they re-ceived, whether there is any appreciable risk of harmposed by such doses, and whether the person's presentinjuries are even the type which radiation produces atthe dose received. The fact that the media has, in ouropinion, irresponsibly omitted this key fact simplyhighlights the public's irrational fear of anything radio-active and the incongruence of being unconcerned

about receiving 1-2 rem from a diagnostic procedurebut being deathly afraid of .00 1 millirem received froma nuclear reactor.

authors do not believe that the "excess" cancersobserved in the studies by Wing, Wilkinson, andGardner actually represent radiation-induced cancer atlow doses. They are not valid evidence that the currentscientific consensus on radiation risk is incorrect.

^National Council on Radiation Protection and Mea-surement, Report No. 101, Exposure of the U.S. Popu-lation from Occupational Radiation, June 1989 at 68.

^Physicians, for example, receive an average annualeffective dose equivalent of 192 millirem per yearwhile the figure for dentists stands at about 80 milliremper year. Id.

"American Cancer Society, Cancer Facts and Figures-1992, (1992), at page 1.

See, International Union v. Johnson Controls, Inc.,I l l S.Ct. 1196(1991).

^In a legal suit for negligence, the plaintiff mustdemonstrate that the defendant breached a "standard ofcare" or a "duty owed" to that plaintiff by the defen-dant. Usually, this standard or duty is defined under a"reasonable person standard," Le., the defendant actedor failed to act as would an ordinary prudent person inlike circumstances. Thus, the surgeon who operates onthe wrong limb or leaves a sponge inside the patientbreaches the duty owed to the patient because the"reasonably prudent surgeon" would not do so undersimilar circumstances. However, there are times whena different standard of care may be established by acourt. This most often occurs when a governmental orregulatory body has established specific regulationsregarding the safe conduct of some activity. If a courtbelieves that these specific regulations are more effec-tive and precise than the generalized standard of care,then the court may apply the regulations as the dutyowed by the defendant rather than the "reasonableperson" standard.

^In fairness, such a change in the state occupationaldiseases act should be drafted to include medical em-ployees, industrial employees, airline crews, and anyother persons who receive some radiation exposure aspart of their job. @