"The generator has a limited shelf life, about 30 days," says Fulmer, "and after this time period there is a stability issue—for lack of a better scientific term." This means that the CardioGen-82 has the potential to cause radiation exposure.
"A cartridge in the generator is supposed to be replaced every month or so and patients who received their PET Scans after the cartridge had expired were allegedly overexposed to radiation," she says. The term is called strontium breakthrough, or over-radiation.
Those patients who were over radiated—including the international travelers who lit up Homeland Security's gamma radiation detector and subsequently set into motion the CardioGen recall—were apparently imaged after the shelf life of the generator had expired.
"In conducting an investigation on behalf of our clients, we have heard from some sources that there could have been a shortage of replacement cartridges and this was the reason why physicians were told by Bracco directly or the distributor's sales reps that it was OK to use the product beyond the expiration date," says Fulmer. The shortage likely occurred as a result of the Japanese earthquake and radiation scare from its nuclear facilities in March 2011. And because of the earthquake, Homeland Security began screening international travelers to detect any possible abnormal radiation levels.
CardioGen 82 Radiation Testing
"Obviously some patients have been undergoing evaluations but those details have not yet been published," says Fulmer, who currently represents six patients (including a few in Florida and a Nevada man) who had PET Scans from clinics nationwide. "These patients had no idea what happened until their doctors asked them to return to the clinics. Then they were told there was a potential excess dose of radiation." Most of the PET scans were performed in February and March of 2011.
Fulmer says that doctors knew about the expiration date problem after the terrorist alert triggered the recall, and they were able to identify patients who were potentially overexposed by reviewing their scheduling records and records relating to expiration dates on the CardioGen-82 generators. At first the FDA said they had to figure out how big the problem was, i.e., how many people could have been overexposed. They had to figure out whether something was wrong with the CardioGen-82 machine or whether it was the generator.
Bracco was involved in testing patients at their doctors' offices and various state health agencies; the FDA, and other federal authorities were also involved in the investigation. This problem has been taken very seriously.
Most of Fulmer's clients have gone through radiation testing. A few have only tested at local facilities such as their doctors' offices and local clinics, while others have gone to the Oak Ridge National Laboratory, which is a sophisticated facility to test radiation exposure and affiliated with the Department of Energy.
"Right now we are waiting for testing to be completed and in the meantime Bracco is putting its product back on the market," says Fulmer. "I expect that we will begin litigation before the end of this year unless Bracco and its physician customers decide to compensate those patients who were affected.
"Testing has indicated that some people could have minute levels of radiation (the FDA report says 375 patients from 43 different clinical sites had been tested, and that 54 of those patients required further testing due to abnormal initial screening results). Unfortunately, radiation poisoning can take 10-20 years before it manifests as cancer. Sadly, our legal system doesn't do a good job of protecting people who need long-term monitoring, and down the road, possibly long-term care."
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"I am hopeful that Bracco will step up to the plate and cover the costs of these evaluations and compensate these patients for the emotional toll that this over-radiation has exacted on them, as well as the risks that they face in the future due to this unfortunate overexposure," says Fulmer. "Because we don't have a crystal ball, our legal system doesn't have a good mechanism to cover future damages so we do the best we can to predict the future with our experts."