Numerous lawsuits have been filed claiming gadolinium-based contrast agents cause wide-ranging adverse effects, known together as gadolinium deposition disease. And while some experts believe the problem is growing worse, authors of a new opinion piece see a more positive future.
The trio of experts, which includes two doctors and a lawyer, believe recent court rulings and evidence disputing GDD’s existence will make law firms “less likely” to represent patients claiming to suffer from the “disease.” They recommend radiologists follow imaging society guidance and take a patient-focused approach to administering GBCAs to mitigate what liability risk they may face, according to their comments published Friday in JACR.
“If experience has taught us anything, it is that the best legal defense always seems to rest on successfully demonstrating that, contemporaneously, you had the patient’s, not your own, best interests as the primary motivating factor for the patient care decisions you made,” wrote Emanuel Kanal, MD, with the University of Pittsburgh Medical Center’s Department of Radiology, and colleagues.
The authors’ comments were published in response to a JACR article released in November by a group that included H. Benjamin Harvey, MD, JD, with Massachusetts General Hospital. Those authors concluded that lawsuits regarding GDD are likely to increase, suggesting radiologists use gadoteridol (Prohance) and hold off on implementing an informed consent process, “given the lack of clear evidence of GDD.”
While that paper offers “important insights for radiologists,” Kanal et al. say the “very basis of the conclusions and recommendations of the paper by Harvey et al. must be called into question. What to them appears to be a grim and half-empty future to us appears quite the opposite—reassuring and significantly more than half full,” they continued.
Harvey, a neuroradiologist at MGH, also offered similar recommendations weeks after the JACR article, during a Dec. 3 session at the Radiological Society of North America annual meeting, encouraging rads to take a more data-driven approach to GBCAs.
Commenting on Harvey et al.'s article, Kanal and colleagues suggested that others try asking patients for consent prior to administering such contrast agents. Doing so would ensure that consumers are aware of their potential risks, they noted, adding that Harvey and colleagues' recommendation to avoid using an informed consent process—while at the same time recommending that radiologists lower their related liability risks—is "somewhat contradictory."
The doctors also believe radiologists should take a holistic view when using GBCA’s and refer to international radiologic society recommendations, including the International Society for Magnetic Resonance in Medicine, that suggest various GBCAs have different advantages and disadvantages depending on the clinical scenario.
“…we continue to feel—and recommend—that each patient’s needs continue to be assessed individually and that decisions regarding GBCA usage, agent selection, dosage, rate, and route be determined solely based on that which provides the optimal assessed benefit-risk ratio assessment for the specific patient at hand,” Kanal et al. noted.
“None of us knows for certain what will happen in the future. But observing the same facts as did Harvey et al, we arrive at entirely different conclusions and, most importantly, recommendations,” the authors wrote.