A class action lawsuit was filed Tuesday in Los Angeles Superior Court against Cedars-Sinai Medical Center in Los Angeles, GE Healthcare and GE Healthcare Technologies, on behalf of patients who received up to eight times the recommended radiation dose during their CT brain perfusion scans.
The plaintiff, Trevor Rees, is suing for medical malpractice against Cedars-Sinai, strict product liability against GE, negligence against GE, breach of express warranty against GE and breach of implied warranty against GE.
According to Los Angeles trial attorney William H. Newkirk, who filed the complaint, the suit represents all 206 individuals who received a CT brain perfusion scan at Cedars-Sinai from February 2008 through August 2009.
“It also includes anyone who received such a scan that utilized CT image machines manufactured by GE Healthcare and GE Healthcare Technologies at any medical facility during the two-year period preceding this suit,” Newkirk said in a statement.
Rees, who underwent two CT scans for a stroke in December 2008, learned about the problem from a television news report, the complaint said. He claims the doctor who called him about the radiation overexposure issue merely asked if he had experienced any hair loss.
In response to the suit, GE representatives said they are “aware of litigation regarding the incident at Cedars-Sinai,” but refused to comment further on the “ongoing litigation.”
GE said it continues to cooperate with FDA officials and is conducting an internal investigation. The company denies any malfunctions or defects with their equipment involved.
The “strict product liability” aspect of the suit alleges that GE’s CT scanners and their “component parts were defective and unreasonably dangerous in design and manufacture ....” The suit also alleges that the devices failed to have “adequate or proper warnings concerning the defective condition...[and possessed] inadequate post-marketing or instructions.”
However, the suit acknowledges that the patients were aware they were going to undergo a CT scan, and called the technology an “important tool in medical imaging.”
While the medical center also will not comment on the ongoing litigation, Thomas M. Priselac, president and CEO of Cedars-Sinai, issued a statement regarding the overexposure, noting that the provider conducts almost 6,000 CT scans of all types each month to diagnose numerous medical conditions and has taken steps to “fix the brain perfusion protocol before proceeding with further studies.”
“This isn’t just a Cedars-Sinai problem,” Newkirk said. “We believe that because of the way the machine is manufactured and explained to medical users, there is a very good chance that this same situation has been or is being played out in radiology departments across the country.”
As part of the ongoing FDA review, Cedars-Sinai recommended that the agency consider:
- Reviewing and revising the approach to manufacturer’s default settings: “The embedded default setting for image noise in the auto function in the 64-slice scanner, which was supplied by the manufacturer, did not match the manufacturer’s recommended settings,” according to Priselac. “The default applied by the machine in a CT brain perfusion scan is different from that applied during a regular CT brain scan. As a result of the default’s lower noise setting, the amount of radiation delivered was higher than expected.”
- Dose display: The dose displayed on the screen of the scanner could be enhanced to facilitate ease of use by the technologists. This is especially true for time-sensitive scans such as CT brain perfusion.
- Alerts and forced functions: Currently, there is no forced function on the equipment requiring technologists to proceed with the scan only after confirming they have reviewed the appropriate dose, Priselac said. Also, there could be more assertive audible or visual alerts on the scanners.
- Additional password protecting: Certain settings on the equipment should be password protected and only accessible for change by the manufacturer.
The suit asks for compensation for general damages for both past and future economic damage, including medical care, as well as loss of earnings during the trial and costs of the suit, including attorneys' fees.