The M.D. Anderson-Orlando Cancer Research Institute has opened its new research facility in the University of Central Florida's Burnett School of Biomedical Sciences building, officially becoming a part of Lake Nona's "medical city." The 30,000-square-foot facility will triple the cancer research institute's wet lab space and provide thousands of additional square feet of work space.
One of the 206 patients who received a radiation overdose eight times normal during a CT scan at Cedars-Sinai Medical Center, has filed a class action lawsuit against both the hospital and the device manufacturer, GE Healthcare Technologies.
The lawsuit alleges that the plaintiff, Trevor Rees, was not only subjected to an overdose of radiation, but faces a higher risk of cancer, expense of longer term health monitoring of its effects, and suffers "severe and serious physical and emotional damage." Rees actually underwent two scans, and potentially received the overdose twice.
The lawsuit also maintains that hospital officials who contacted Rees nine months later asked about whether he had experienced side effects, but did not tell him he had been overexposed.
"There was no mention of radiation to me on the phone at all," Rees said in a statement issued by his Los Angeles attorney, William Newkirk. "I never thought anything more about it until I saw the news about five days later."
The 19-page complaint, filed on behalf of Rees and Does 1-100, seeks to represent "all individuals who received CT brain perfusion scans at CSMC from February, 2008 until August, 2009, or at any other medical or imaging facilities utilizing CT imaging machines manufactured by GEHC/GEHCT, during the two-year period preceding this action." It was filed in Los Angeles Superior Court.
Newkirk said yesterday in a statement, "This isn't just a Cedars-Sinai problem. 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. We have no idea how many people have been overdosed with radiation."
It is not known whether other hospitals or healthcare facilities using the same GE scanners, identified as 64-slice CT machines, experienced overdoses of radiation. But the U.S. Food and Drug Administration said that it was launching a safety investigation that extended beyond Cedars-Sinai.
"While this event involved a single kind of diagnostic test at one facility, the magnitude of these overdoses and their impact on the affected patients were significant," the FDA said Oct. 8 in an initial notification notice. "This situation may reflect more widespread problems with CT quality assurance programs and may not be isolated to this particular facility or this imaging procedure (CT brain perfusion)."
In a statement, a GE Healthcare spokesman yesterday said the company is "aware of litigation regarding the incident at Cedars-Sinai" but is unable to comment on specifics.
"We remain concerned for the health of patients who may have received excess medical radiation at Cedars-Sinai Medical Center. GE Healthcare continues to cooperate with the Food and Drug Administration officials on this matter. Although GE Healthcare continues its internal investigation, we confirm that there were no malfunctions or defects in any of the GE Healthcare equipment involved."
GE's statement adds: "GE Healthcare continues to offer dose-reducing technologies and expand key CT training initiatives to raise awareness of dose optimization and use of appropriate exam protocols.
"GE Healthcare CT products require that:
"1) Users carefully evaluate user-defined scanning protocols against the validated protocols that are provided on the scanners during installation, and
"2) Like dose recommendations for drugs, the recommended dose for a prescribed medical imaging scan is an important clinical decision that should be made by a licensed professional in the context of healthcare delivery.
"Patients and families should continue to have confidence in their doctor's recommendation for a CT scan."
According to Rees' lawsuit, he underwent a perfusion CT imaging procedure at the S. Mark Taper Foundation Imaging Center on Dec. 22, 2008 in order to diagnose and evaluate a suspected stroke.
Two days later, he was informed that there had been a technical problem with the scan and a second one was needed, according to the lawsuit.
"In the days and weeks immediately following the two CT scans at CSMC, plaintiff experienced significant hair and eyebrow loss, flaking of the scalp and facial skin, skin reddening or burns on his scalp and various other indications of excessive radiation exposure."
Nine months later, in late September, Rees says he was contacted by CSMC personnel to inquire about his CT scan experience and was questioned about whether he had experienced side-effects, but was not told why.
"Plaintiff was not advised of any radiation overexposure or other problem regarding the CT scans he had received, nor was he provided any further information by CSMC," the lawsuit claims.
In his statement, Rees said, "I certainly don't relish the chance of dying of tumors. I'm supposed to live stress free and this hasn't helped matters." A spokeswoman for his attorney said Rees is 65.
The lawsuit asks for general damages, past and future economic damages including cost of medical care, monitoring and treatment, loss of earnings, and for lawsuit costs and attorneys' fees.
Cedars-Sinai officials did not return requests for comment on the lawsuit. But last week hospital president and CEO Tom Priselac released a statement recommending to the FDA that CT scanner manufacturers make four adjustments, such as adjusting the settings of the "auto" function, to prevent such errors from occurring.
"We present this information not to shift responsibility, but to maximize patient safety by involving manufacturers in the process of continually improving processes and equipment," Priselac wrote.
Meanwhile throughout the Web, law firm advertisements are beginning to proliferate. One recent ad advised: "Did you get a radiation overdose at Cedars-Sinai MC? Free consultation."
After sitting on the question for the better part of the year, the Louisiana Supreme Court has handed the Louisiana State University System a legal victory and ruled that a lawsuit challenging the closing of Charity Hospital must be heard in East Baton Rouge Parish. The seven patients who filed the lawsuit want it tried in New Orleans, and a group of New Orleans lawyers originally filed the suit in January 2008 asking the Orleans Parish court to order the reopening of the giant hospital or mandate that the state replace it with equivalent services.
Because health insurance and employment go together, this year's devastating job losses have likely increased the ranks of the uninsured by four million people, including nearly 200,000 in Pennsylvania and New Jersey. The estimate is provided by Families USA, a Washington organization that focuses on consumer healthcare and supports improvements, the Philadelphia Inquirer reports.
Supporters of healthcare reform told senators that insurance exchanges are a critical part of proposed healthcare legislation for small businesses, which are cutting jobs and coverage to keep up with insurance costs. Legislation approved by the Senate Finance Committee would create insurance exchanges that supporters say would aid small businesses by spreading risk among a greater number of participants. The result, they said, would be lower premiums.
Alarmed by the spread of the H1N1 flu, hospitals throughout California restricted visitors, barring children and capping the number of visitors per patient. In Los Angeles, Cedars- Sinai Medical Center raised the minimum age for visitors from 12 to 18 and restricted the number of visitors for patients at greatest risk for H1N1, including those in labor and delivery, or in the pediatric and neonatal intensive care units.
With deep ties to Capitol Hill, President Obama's core healthcare reform team is designed for the inside game unfolding now in House and Senate offices. Their job includes gathering intelligence, assessing what lawmakers want, and devising compromises to win over balky members without alienating others, according to the Los Angeles Times. But their paramount goal remains to keep the process moving irrepressibly forward and on a practicable track.
Swine flu vaccine shipments to Massachusetts are running three weeks behind schedule, forcing the state to direct local health departments to cancel vaccine clinics scheduled for November. Shortages of the vaccine against seasonal flu strains are also being reported, as unusually high demand is outpacing the supply. The problems seen in Massachusetts reflect a nationwide shortage, as production facilities have been unable to churn out adequate amounts of either vaccine.
During the healthcare debate, the statistic that states the U.S. ranks 37th in the world in healthcare is often cited—but the ranking is dated and flawed, according to this article from the Wall Street Journal. The statistic is based on a report released nearly a decade ago by the World Health Organization and relies on statistics that are even older and incomplete, the article states, and has contributed to misconceptions about the quality of the U.S. medical system.
New data from the Centers for Disease Control and Prevention involving 4,958 hospitalizations from the H1N1 virus showed 53% of the cases were in people age 24 and younger. Another 39% were in people ages 25 to 64, and 7% in people age 65 and older. The hospitalizations were reported by 27 states from Aug. 30 through Oct. 10.