Our lawyers are reviewing potential lawsuits for people who were injured by a radiation overdose after undergoing treatment with a Varian linear accelerator.
What is Radiation Therapy?
Radiation therapy uses high-energy radiation to kill cancer cells by damaging their DNA. When cells are damaged, they can’t grow and divide, and over time they die off. However, radiation therapy can damage normal cells as well as cancer cells, so treatment must be carefully planned to minimize potential side effects. The radiation used for cancer treatment may be injected into the bloodstream, come from radioactive material placed in the body near tumor cells, or from a machine outside the body, such as a linear accelerator.
What is a Linear Accelerator?
A linear accelerator, or LINAC, is an image-guided radiation therapy (IGRT) system used to treat complex cases of lung, breast, stomach and brain cancer. The instrument is designed to deliver high-energy x-rays to a patient’s tumor, destroying cancer cells while sparing the surrounding tissue.
While both good and bad cells can be damaged by radiation, healthy cells are able to regenerate themselves over time. Malignant cells do not have this ability, and thus do not survive, which is why radiation therapy is typically administered repeatedly rather than in a single massive dose.
What’s the Problem?
Some linear accelerators, which are commonly used for standard radiation therapy, were redesigned by Varian Medical Systems so they could also perform stereotactic radiosurgery (SRS), a procedure designed to target small tumors and other anomalies affecting the brain or spinal cord without damaging the surrounding tissue.
Because radiation from linear accelerators is so intense, accuracy of the instrument is extremely important. However, some medical facilities that use the devices have been found to lack critical safety features, including those that prevent radiation from missing its target.
Operator Error
From 2005 to 2010, SRS systems made by Varian and its German partner Brainlab were linked to “scores of errors and overdoses,” according to the New York Times [1]. In some cases, mistakes were caused by operator error. In Missouri, 76 patients were subjected to an overdose of radiation after a medical physicist failed to calibrate a linear accelerator correctly.
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‘Mix and Match’ SRS Systems Present Difficulties
Radiation safety experts say retrofitted linear accelerators made of different companies’ equipment are tricky to operate. Dr. Howard I. Amols, chief of clinical physics at Memorial Sloan-Kettering Cancer Center in New York, told the Times that some problems with the devices appeared to be “a combination of user error, coupled with neither the manufacturers nor the F.D.A. being able to anticipate a potential safety flaw in a ‘mix and match’ treatment delivery system.”
Medical Device Regulation Flaws
Despite their complexity, linear accelerators are less regulated than the simpler Gamma Knife, an instrument designed exclusively for stereotactic radiosurgery. Linear accelerators, which generate radiation without using radioactive material, are overseen by the U.S. Food & Drug Administration (FDA), while the Gamma Knife is regulated by the Nuclear Regulatory Commission (NRC) because it uses a radioactive isotope. The NRC wields greater power than the FDA in its ability to investigate and publicize problems with medical devices.
Linear Accelerators Approved Via FDA Loophole
The retrofitted linear accelerators were approved though the FDA’s controversial 510(k) process, which fast tracks devices that are “substantially equivalent” to products already on the market. And since there is no requirement that problems with linear accelerators be reported to the agency, determining how often SRS errors occur is difficult.
“Everybody says these are isolated incidents,” said Dr. William David Bloomer, chairman of radiation medicine at Evanston Hospital in Illinois. “Until you find out that maybe they are not so isolated.”
Radiation Poisoning Symptoms
Effects of radiation sickness vary according to the dose the patient is exposed to. In most cases, the higher the dose the sooner the effects appear -- and the worse the prognosis. Symptoms include:
- Nausea / vomiting
- Spontaneous bleeding from the nose, mouth, gums and/or rectum
- Red, blistered skin
- Hair loss
- Severe fatigue
- Ulcers in the mouth, esophagus, stomach and/or intestines
- Infections (bacterial, fungal, viral)
Radiation Overdose Lawsuit Settlement
In Sept. 2013, The family of Zacarias Chichioco Jr., who died of lung cancer in 2011, was awarded $15 million in compensation after settling a lawsuit against Varian Medical and doctors at the Pacific Cancer Institute (PCI) in Wailuku, Hawaii. The complaint was filed after Chichioco was exposed to 2.5 times the correct amount of radiation, which weakened and ultimately caused the death of the 45-year-old.
Chichioco was diagnosed with lung cancer in Feb. 2008. Dr. Daryl Makishi of PCI developed a radiation therapy plan using the Varian Eclipse System and linear accelerator. Soon after initiating treatment, Chichioco's health deteriorated and he began suffering from radiation symptoms including pain while swallowing, hallucinations, hearing loss, and paralysis on the left side of his face. As a result of these side effects, he was forced to undergo a number of skin graft operations.
Chichioco died of lung cancer in May 2011. A study conducted by PCI researchers determined that he had been administered more than double the prescribed dose of radiation during his first 21 treatments. A year before Chichioco was diagnosed, Varian discovered a problem with its medical device software. The company issued an update to PCI, but failed to provide any information about how to avoid the error.
According to the lawsuit, Chichioco was so weakened by the radiation overdose that he lost faith in conventional medicine and stopped seeking treatment, ultimately contributing to his death. Chichioco’s family was awarded $1 million from Dr. Bobby Baker, founder and president of PCI, and another $1 million from Dr. Makishi. Varian Medical was required to pay $13.25 million.
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Elekta Files Patent Infringement Lawsuit Against Varian
Swedish medical technology firm Elekta has announced that it is suing Varian over alleged patent infringement, according to Reuters [2]. Elekta contends that Varian's True Beam linear accelerator infringed patents owned by William Beaumont Hospital, which were exclusively licensed to Elekta.
The Swedish company also alleges patient infringements for its linear accelerator imaging system, which produces images of a tumor prior to treatment. The complaint was filed June 17 in the U.S. District Court for the Eastern District of Michigan.
Do I Have a Radiation Treatment Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in radiation therapy lawsuits. We are handling individual litigation nationwide and currently accepting new radiation overdose cases in all 50 states.
Again, if you or a loved one was injured by the side effects of radiation therapy, you should contact our law firm immediately. You may be entitled to compensation by filing a Radiation Therapy Suit and our lawyers can help.
