Top Tips: Reducing the Risks and Managing the Consequences of Radiation Injury

While medical radiation produces many life-saving and life-sustaining therapies, it can also result in needless patient injuries, such as burns, hair loss and increased susceptibility to cancer. Such problems inevitably spur medical malpractice claims against physicians, and product liability claims against the manufacturers of radiology equipment.

As a barometer of the issue, one need only look to the Emergency Care Research Institute (ECRI) which, each year, releases a “top ten” list of health technology hazards. Its website offers a free download of a “Medical Technology Dangers Watch List.” At the end of 2010, ECRI ranked as the number one hazard the peril of overdose and dose errors during radiation therapy.

ECRI's spotlighting of radiology hazards is a matter of public knowledge that has not escaped the notice of the personal injury bar, whose members can be known to seek the “next big thing” in medical malpractice and product liability. Some law firms are actively soliciting clients through websites and television advertisements, hoping that patients claiming injuries from CT scans will retain them.

With radiation risks ranking as a number one problem, radiology professionals and companies manufacturing radiology equipment are sitting up and taking notice. What preventive measures should they be taking to minimize the risk of radiation errors and limit losses when errors do occur?

A Range of Adverse Outcomes

Radiology errors can happen for a number of reasons, including:

• Typographical errors;
• Misspellings;
• Machine/device related malfunctions; or
• Misreading of images, which produces false negatives or false positives.

Additional problems within clinical settings can heighten the possibility of adverse patient outcomes, including:

• Inadequate training or supervision of radiologists;
• High workloads that encourage practitioners to speed through readings; and
• Radiologist subjectivity, where different radiologists read the same results generated with comparable technology yet arrive at varying interpretations. Anecdotal evidence reveals the ubiquity of radiological errors.

The Food and Drug Administration (FDA) reported in October 2000 that at least 206 patients had been exposed to excessive radiation at Los Angeles's Cedars ' Sinai Medical Center. “LA's Cedars-Sinai Hospital Exposed 206 Patients to High Doses of Radiation During CT Scans,”StarTribune.com, Oct. 9, 2009. www.startribune.com/templates/Print_This_Story?sid=63906642. In 2010, The New York Times reported that a Philadelphia hospital administered incorrect radiation doses to over 90 prostate cancer patients. Bogdanich, “Well Blog: When Radiation Treatment Turns Deadly.” The New York Times (1/23/10).

Not all claims and actions involving radiation equipment are due to ionizing radiation. In March 2011, an Orange County, CA, woman sued the maker of a radiation delivery device, claiming that it riddled her breast with tungsten particles while she was receiving breast cancer treatment. She discovered the problem only later, after an MRI and mammogram revealed tungsten particles in her breast. She then learned that, over a six-month period, an electronic brachytherapy system had shed metallic flecks from a shielding accessory. The woman has sued the manufacturers of the device and the hospital where she received treatment, alleging that she may have to undergo a double mastectomy to keep flecks from spreading throughout her body. Doe v. Xoft Inc., No. 30-2011-00451816-CU-PL-CJC, summons filed (Cal. Super. Ct., Orange County Feb. 18, 2011).

When All Goes Well, But the Outcome Is Bad

A radiation oncologist at the University of Toledo, Dr. John Feldmeier, estimates that 5% of all patients will suffer radiation-related injuries. He is quick to add that most of these are “normal complications” from radiation, and not mistakes. However, discerning the difference between the two can be both a medical and legal challenge. In today's era of sophisticated patients with high expectations, anything less than a perfect outcome can carry the presumption of medical error.

Even if claims and lawsuits ultimately prove to be groundless and due to statistically expected complications, sizeable expense mounts from having to defend against claims. Further, to medical practitioners or radiology equipment makers who find themselves defendants in liability suits, there are the hidden (but still onerous) costs of professional/managerial time absorbed by dealing with litigation defense.

Medical professionals and medical product manufacturers should strive to make clinical settings as safe as possible and eschew an attitude of “No legal liability means we shrug it off,” because assuming that patients will forgo negligence or liability claims against radiology practitioners or equipment manufacturers just because outcomes flow from “normal” complications is a mistake.

Managing Radiology Risks

Radiology professionals may hear about risk management in the context of errors and adverse patient outcomes. There may only be a vague idea, though, of what the phrase means.

What exactly is risk management? We can view it as a process that involves:

• Identification ' identifying possible causes of loss;
• Developing options ' finding ways to address the causes of loss;
• Selection ' picking an appropriate technique to address the cause(s);
• Implementation ' putting the technique into action; and
• Monitoring ' observing the risk management program for results.

Radiology professionals can also view risk management as a “toolbox” of techniques. There are four classic risk management techniques, all of which apply in varying degrees to liability claims from radiology errors (real or alleged). They are: 1) Avoidance; 2) Control; 3) Retention; and 4) Transfer.

“Avoidance,” as the term implies, means forgoing an activity due to its potential for loss. It may involve
opting out of certain medical activities or deciding not to take part in other procedures due to the risk of loss. Avoidance is an extreme risk management technique, reserved largely for risks that a doctor deems uncontrollable or extremely threatening to his or her financial existence.

The “control” tool aims to reduce the frequency or severity of adverse patient outcomes. Loss control emphasizes continuing medical education, better communication and patient relations to keep adverse outcomes from occurring in the first place. Some loss control steps to take in a radiology context might include:

• Reviewing radiation dosing protocols to ensure that they are calibrated appropriately for each patient and for each treatment. Changes to default protocols by a facility quality control unit should be vetted for image quality.
• For each patient and each imaging session, adjusting the radiation dosage and calibration for each study.
• Adopting quality control measures to make sure that medical professionals administer only the planned amount of radiation.
• Making sure to document that radiology techs are trained on the specific equipment protocol that they are using.

The loss-control techniques will benefit radiology professionals in three ways. First, if preventive measures avert adverse patient outcomes, they save money and loss of life or limb. Second, insurance companies may offer lower premiums to doctors who show that they have well-conceived risk-management programs. Insurance companies may offer premium discounts to physicians who adopt loss control measures, like continuing medical education or attending risk management seminars. Finally, whatever the cost of loss control and safety measures, it is typically less than the cost of a single malpractice claim. If risk reduction measures avert one adverse patient outcome or one claim, those measures will pay for themselves many times over.

“Retention” is a conscious decision to self-fund losses without transferring risk to an insurer or another risk-bearing entity. In one's car or homeowners insurance policies, an example of retention is carrying a $500 deductible. While large companies have “self-insurance” programs, radiology professionals may lack the financial means to do this. However, wherever possible, such strategies can save practitioners money.

“Transfer” involves shifting the financial consequence of loss to another entity. The most obvious example of this is insurance. However, it should be remembered that while insurance is a common risk management technique, it works best and is most economical when blended with the avoidance, control and retention tools.

Asset Protection

There is nothing to keep injured or aggrieved patients from suing for sums in excess of a doctor's insurance coverage. Consequently, in some cases, malpractice claims may exceed the amount that a radiologist has in liability insurance. Add to this the fact that juries are often sympathetic toward victims of medical mishaps and want to make them whole, and you have a potential disaster for the medical practitioner. If a jury award or a settlement exceeds a radiologist's insurance limit, plaintiff's counsel may target personal assets as a source for funding an award or settlement.

Asset conservation, therefore, is an important goal not to be ignored. Left unchecked, liability from radiology errors can erode or wipe out assets, both financial (e.g., bank accounts and insurability) and non-financial (e.g., reputation and hospital privileges). Inattention to risk management can even cause a doctor to lose perhaps the most important asset of all ' his or her medical license and ability to practice medicine. Doctors who have not yet done so should consult with counsel about establishing their practices as corporations or limited liability partnerships.

When a Claim Is Made: Maintaining a United Front

Some radiation-related injuries occur due to medical malpractice; others because of an equipment defect or malfunction; and still others because of a combination of these. Also, as discussed above, adverse patient outcomes can occur even when no practitioner error or equipment problem is present. However, in many cases, the plaintiff attorney will allege both practitioner error and equipment malfunction, perhaps not being sure which is the case. Such “blended” claims involving medical malpractice and product liability can be touchy for defendants, and they pose special challenges.

The physician's and hospital's liability exposure is often defended and managed by a medical malpractice insurance company. The product liability exposure is often defended and managed by a product liability insurance carrier. The potential for finger pointing among and between defendants ' or their insurance companies ' is high. The physician or hospital may be tempted to impugn a malfunctioning piece of x-ray or imaging equipment, while its manufacturer blames the doctor. The laying of blame at the other defendant's doorstep usually benefits only the plaintiff, whom the defendants unwittingly assist in making a case for liability. Baffled jurors may not be sure where culpability lies, but they suspect that some error occurred and may believe that somebody (or multiple “somebodies “) must pay.

Therefore, one of the key risk management challenges of these types of claims is to defend both a professional and product liability claim without either defendant pointing the finger at the other.

Conclusion

Radiology professionals and firms that manufacture radiology equipment must anticipate the possibilities of tort claims, and plan ahead to limit the damage they can cause. By using sound risk-management strategies and working with counsel and co-defendants to minimize financial and other loses, they can arm themselves to survive and thrive despite the threat of liability from unfortunate medical outcomes.

Kevin M. Quinley, CPCU, ARM, is Vice President – Risk Management Resources, Berkley Life Sciences, Ewing, NJ, and a member of this newsletter's Board of Editors. He can be reached at [email protected]. Views expressed here do not constitute legal advice, are the author's own and do not necessarily reflect those of Berkley Life Sciences or its customers. Discussion of insurance policy language is descriptive only. Coverage afforded under any insurance policy issued is subject to individual policy terms and conditions.

While medical radiation produces many life-saving and life-sustaining therapies, it can also result in needless patient injuries, such as burns, hair loss and increased susceptibility to cancer. Such problems inevitably spur medical malpractice claims against physicians, and product liability claims against the manufacturers of radiology equipment.

As a barometer of the issue, one need only look to the Emergency Care Research Institute (ECRI) which, each year, releases a “top ten” list of health technology hazards. Its website offers a free download of a “Medical Technology Dangers Watch List.” At the end of 2010, ECRI ranked as the number one hazard the peril of overdose and dose errors during radiation therapy.

ECRI's spotlighting of radiology hazards is a matter of public knowledge that has not escaped the notice of the personal injury bar, whose members can be known to seek the “next big thing” in medical malpractice and product liability. Some law firms are actively soliciting clients through websites and television advertisements, hoping that patients claiming injuries from CT scans will retain them.

With radiation risks ranking as a number one problem, radiology professionals and companies manufacturing radiology equipment are sitting up and taking notice. What preventive measures should they be taking to minimize the risk of radiation errors and limit losses when errors do occur?

A Range of Adverse Outcomes

Radiology errors can happen for a number of reasons, including:

• Typographical errors;
• Misspellings;
• Machine/device related malfunctions; or
• Misreading of images, which produces false negatives or false positives.

Additional problems within clinical settings can heighten the possibility of adverse patient outcomes, including:

• Inadequate training or supervision of radiologists;
• High workloads that encourage practitioners to speed through readings; and
• Radiologist subjectivity, where different radiologists read the same results generated with comparable technology yet arrive at varying interpretations. Anecdotal evidence reveals the ubiquity of radiological errors.

The Food and Drug Administration (FDA) reported in October 2000 that at least 206 patients had been exposed to excessive radiation at Los Angeles's Cedars ' Sinai Medical Center. “LA's Cedars-Sinai Hospital Exposed 206 Patients to High Doses of Radiation During CT Scans,”StarTribune.com, Oct. 9, 2009. www.startribune.com/templates/Print_This_Story?sid=63906642. In 2010, The New York Times reported that a Philadelphia hospital administered incorrect radiation doses to over 90 prostate cancer patients. Bogdanich, “Well Blog: When Radiation Treatment Turns Deadly.” The New York Times (1/23/10).

Not all claims and actions involving radiation equipment are due to ionizing radiation. In March 2011, an Orange County, CA, woman sued the maker of a radiation delivery device, claiming that it riddled her breast with tungsten particles while she was receiving breast cancer treatment. She discovered the problem only later, after an MRI and mammogram revealed tungsten particles in her breast. She then learned that, over a six-month period, an electronic brachytherapy system had shed metallic flecks from a shielding accessory. The woman has sued the manufacturers of the device and the hospital where she received treatment, alleging that she may have to undergo a double mastectomy to keep flecks from spreading throughout her body. Doe v. Xoft Inc., No. 30-2011-00451816-CU-PL-CJC, summons filed (Cal. Super. Ct., Orange County Feb. 18, 2011).

When All Goes Well, But the Outcome Is Bad

A radiation oncologist at the University of Toledo, Dr. John Feldmeier, estimates that 5% of all patients will suffer radiation-related injuries. He is quick to add that most of these are “normal complications” from radiation, and not mistakes. However, discerning the difference between the two can be both a medical and legal challenge. In today's era of sophisticated patients with high expectations, anything less than a perfect outcome can carry the presumption of medical error.

Even if claims and lawsuits ultimately prove to be groundless and due to statistically expected complications, sizeable expense mounts from having to defend against claims. Further, to medical practitioners or radiology equipment makers who find themselves defendants in liability suits, there are the hidden (but still onerous) costs of professional/managerial time absorbed by dealing with litigation defense.

Medical professionals and medical product manufacturers should strive to make clinical settings as safe as possible and eschew an attitude of “No legal liability means we shrug it off,” because assuming that patients will forgo negligence or liability claims against radiology practitioners or equipment manufacturers just because outcomes flow from “normal” complications is a mistake.

Managing Radiology Risks

Radiology professionals may hear about risk management in the context of errors and adverse patient outcomes. There may only be a vague idea, though, of what the phrase means.

What exactly is risk management? We can view it as a process that involves:

• Identification ' identifying possible causes of loss;
• Developing options ' finding ways to address the causes of loss;
• Selection ' picking an appropriate technique to address the cause(s);
• Implementation ' putting the technique into action; and
• Monitoring ' observing the risk management program for results.

Radiology professionals can also view risk management as a “toolbox” of techniques. There are four classic risk management techniques, all of which apply in varying degrees to liability claims from radiology errors (real or alleged). They are: 1) Avoidance; 2) Control; 3) Retention; and 4) Transfer.

“Avoidance,” as the term implies, means forgoing an activity due to its potential for loss. It may involve
opting out of certain medical activities or deciding not to take part in other procedures due to the risk of loss. Avoidance is an extreme risk management technique, reserved largely for risks that a doctor deems uncontrollable or extremely threatening to his or her financial existence.

The “control” tool aims to reduce the frequency or severity of adverse patient outcomes. Loss control emphasizes continuing medical education, better communication and patient relations to keep adverse outcomes from occurring in the first place. Some loss control steps to take in a radiology context might include:

• Reviewing radiation dosing protocols to ensure that they are calibrated appropriately for each patient and for each treatment. Changes to default protocols by a facility quality control unit should be vetted for image quality.
• For each patient and each imaging session, adjusting the radiation dosage and calibration for each study.
• Adopting quality control measures to make sure that medical professionals administer only the planned amount of radiation.
• Making sure to document that radiology techs are trained on the specific equipment protocol that they are using.

The loss-control techniques will benefit radiology professionals in three ways. First, if preventive measures avert adverse patient outcomes, they save money and loss of life or limb. Second, insurance companies may offer lower premiums to doctors who show that they have well-conceived risk-management programs. Insurance companies may offer premium discounts to physicians who adopt loss control measures, like continuing medical education or attending risk management seminars. Finally, whatever the cost of loss control and safety measures, it is typically less than the cost of a single malpractice claim. If risk reduction measures avert one adverse patient outcome or one claim, those measures will pay for themselves many times over.

“Retention” is a conscious decision to self-fund losses without transferring risk to an insurer or another risk-bearing entity. In one's car or homeowners insurance policies, an example of retention is carrying a $500 deductible. While large companies have “self-insurance” programs, radiology professionals may lack the financial means to do this. However, wherever possible, such strategies can save practitioners money.

“Transfer” involves shifting the financial consequence of loss to another entity. The most obvious example of this is insurance. However, it should be remembered that while insurance is a common risk management technique, it works best and is most economical when blended with the avoidance, control and retention tools.

Asset Protection

There is nothing to keep injured or aggrieved patients from suing for sums in excess of a doctor's insurance coverage. Consequently, in some cases, malpractice claims may exceed the amount that a radiologist has in liability insurance. Add to this the fact that juries are often sympathetic toward victims of medical mishaps and want to make them whole, and you have a potential disaster for the medical practitioner. If a jury award or a settlement exceeds a radiologist's insurance limit, plaintiff's counsel may target personal assets as a source for funding an award or settlement.

Asset conservation, therefore, is an important goal not to be ignored. Left unchecked, liability from radiology errors can erode or wipe out assets, both financial (e.g., bank accounts and insurability) and non-financial (e.g., reputation and hospital privileges). Inattention to risk management can even cause a doctor to lose perhaps the most important asset of all ' his or her medical license and ability to practice medicine. Doctors who have not yet done so should consult with counsel about establishing their practices as corporations or limited liability partnerships.

When a Claim Is Made: Maintaining a United Front

Some radiation-related injuries occur due to medical malpractice; others because of an equipment defect or malfunction; and still others because of a combination of these. Also, as discussed above, adverse patient outcomes can occur even when no practitioner error or equipment problem is present. However, in many cases, the plaintiff attorney will allege both practitioner error and equipment malfunction, perhaps not being sure which is the case. Such “blended” claims involving medical malpractice and product liability can be touchy for defendants, and they pose special challenges.

The physician's and hospital's liability exposure is often defended and managed by a medical malpractice insurance company. The product liability exposure is often defended and managed by a product liability insurance carrier. The potential for finger pointing among and between defendants ' or their insurance companies ' is high. The physician or hospital may be tempted to impugn a malfunctioning piece of x-ray or imaging equipment, while its manufacturer blames the doctor. The laying of blame at the other defendant's doorstep usually benefits only the plaintiff, whom the defendants unwittingly assist in making a case for liability. Baffled jurors may not be sure where culpability lies, but they suspect that some error occurred and may believe that somebody (or multiple “somebodies “) must pay.

Therefore, one of the key risk management challenges of these types of claims is to defend both a professional and product liability claim without either defendant pointing the finger at the other.

Conclusion

Radiology professionals and firms that manufacture radiology equipment must anticipate the possibilities of tort claims, and plan ahead to limit the damage they can cause. By using sound risk-management strategies and working with counsel and co-defendants to minimize financial and other loses, they can arm themselves to survive and thrive despite the threat of liability from unfortunate medical outcomes.

Kevin M. Quinley, CPCU, ARM, is Vice President – Risk Management Resources, Berkley Life Sciences, Ewing, NJ, and a member of this newsletter's Board of Editors. He can be reached at [email protected]. Views expressed here do not constitute legal advice, are the author's own and do not necessarily reflect those of Berkley Life Sciences or its customers. Discussion of insurance policy language is descriptive only. Coverage afforded under any insurance policy issued is subject to individual policy terms and conditions.