CHICAGO (CN) - A woman who received radiosurgical treatments to her brain to relieve an painful neurological condition in her face has sued the manufacturers of the Novalis stereotactic system, saying the procedure left her nearly comatose, confined to a nursing home, and unable to care for her three young daughters. The complaint states, in essence, that the surgery, intended to be minimally invasive, did not precisely target the radiation beams it aimed, nor precisely target the dosage.
Marcia Faber and her husband claim that defendant BrainLab, Varian Medical Systems, North Shore University Health System, and Drs. Issam Awad and Ranjeev Nanda knew of defects with the Novalis system, but used it anyway, exposing her and others to "a serious risk of harm".
The New York Times reported this week that at least two other patients who received treatment with the device - which includes radiosurgical instruments, a linear radiation accelerator and related software - have been gravely injured by it.
"As a proximate result of one or more of the aforesaid, unreasonably dangerous conditions, Faber received an overdose of radiation to areas of the brain that were outside of the planned area of treatment," the Fabers say in their complaint in Cook County Court.
"As a result, she has been disfigured and disabled, has endured and will endure future pain and suffering, has incurred and will incur expenses for medical and rehabilitative care, has suffered loss of earnings and has been damaged in her capacity to earn a living," the complaint states.
Faber entered the treatment facility on March 20, 2009 to receive treatment for trigeminal neuralgia, a disorder characterized by episodes of intense pain emanating from one of the three trigeminal nerves in the face. Several medical websites describe it as one of the most painful conditions humans can suffer, and something of an enigma to the medical community.
The treatment Faber received, stereotactic radiosurgery, is a technology designed to target tiny tumors and other anomalies affecting the brain or spinal cord with intense beams of radiation, while minimizing damage to surrounding tissue.
But at the time of her treatment, the complaint states, the Novalis system was unreasonably dangerous in one or more of the following respects:
It was designed and manufactured in a manner that allowed excessive radiation to be administered; or
It was designed and manufactured in a manner that allowed radiation exposure outside of the planned area of treatment; or
It was designed and manufactured in a manner that allowed patients to receive overdoses of radiation;
It allowed imprecise target definition and localization;
It allowed imprecise dose volume and distribution;
It allowed peripheral dose administration;
It was otherwise defective and unreasonably dangerous.
During Faber's procedure, the system failed to detect the inaccuracies in the treatment plan and to limit and prevent administration of an overdose of radiation outside the planned area of treatment, the complaint states.
As a result, Faber's brain was exposed to far more radiation than is considered safe.
The couple seeks more than $50,000 in damages for each of 10 claims against the six defendants.
They are represented by Thomas G. Siracusa with Power Rogers & Smith and Gary Stone with Karchmar and Stone, all of Chicago.
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