Patients who may have received high doses of radiation during routine brain scans filed a class action lawsuit, accusing the manufacturer, G.E. Healthcare, of poor safety features in the design of the scanner. The U.S. Food and Drug Administration recently found that CT perfusion scans, which are used to check for blockages and injuries in the brain, provided hundreds of patients with roughly eight times the recommended radiation levels.
The suit, which includes plaintiffs from Huntsville and Los Angeles, is limited to the manufacturer. The case argues that the manufacturer “carelessly researched the design and failed to adequately test” its products, and that the scanners lacked safety features to warn of overdoses. The class action suit asks G.E. Healthcare to set up a fund to cover future healthcare costs and payments, specifically providing regular monitoring for brain cancer in all affected patients. The manufacturer has responded with a statement which places the responsibility, as to radiation dose, back on the healthcare provider. Attorneys for the plaintiffs responded stating that there was no evidence of operator error in administering the scans.
The FDA, which has identified more than 250 cases of over-radiation, has urged hospitals across the country to review the patients who have received the scan, to check the dosage levels provided and to be careful in the future that “dosing protocols are followed every time.