A California man has of has filed a class action lawsuit against Los Angeles’ Cedars-Sinai Hospital on behalf of himself and 206 other patients who were allegedly exposed to radiation overdoses during CT scans.
The radiation exposure lawsuit was filed this week in Los Angeles Superior Court in California on behalf of Trevor Rees, seeking class action status for all patients who were subjected to high levels of radiation due to incorrectly administered CT scans at the hospital over an 18 month period.
The complaint comes less than a month after the FDA issued a safety alert warning that some CT brain perfusion scans may be giving patients overexposure to radiation. According to the alert issued on October 8, more than 200 patients were exposed to eight times the normal amount of radiation while receiving CT brain perfusion scans for diagnosis and treatment of strokes.
The FDA did not specifically identify Cedars-Sinai Hospital, but the Los Angeles hospital has since admitted that patients were accidentally exposed to higher-than-normal radiation. The incident has raised concerns that there may be a more widespread problem with radiation overexposure associated with the CT scans at hospitals throughout the United States.
Rees is the only plaintiff named in the CT scan lawsuit, alleging that he suffered radiation exposure symptoms after being scanned at the hospital; including reddening of the skin, burns, hair loss, and flaking of the scalp.
Cedars-Sinai Hospital maintains that while the radiation exposure levels were higher than they are supposed to be, the exposure was similar to that experienced by patients undergoing other procedures, such as angioplasty. Investigators found that the CT scan machines had been manually manipulated to produce better pictures, inadvertently increasing the amount of radiation exposure.
The hospital says that it has put in place new procedures to prevent over-exposure in the future, including rules that stipulate any changes to the machine’s settings will have to go through the hospital’s head CT technician. The hospital is also providing more training for technicians working with the machine, and has said that the overexposure experienced by Cedars-Sinai patients was “unacceptable.”
The FDA is investigating whether similar incidents are happening at other facilities, and warns that such incidents may be going unrecognized and unreported, leading to long-term overexposure for patients. After gathering more data about the situation, the FDA indicates that a determination will be made about whether there are more widespread risks and the need for any actions.
In the interim, regulators are advising that all facilities performing CT scans should review their CT protocols and pay close attention to dose indices displayed on the machines’ control panels. Operators should “make sure the values displayed reasonably correspond to the doses normally associated with the protocol,” the warning stated. “Confirm this again after the patient has been scanned.”
The FDA is asking that any incidents of CT overexposure or other adverse CT events be reported to FDA’s MedWatch program.