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Advanced procedures can present the highest risks
It comes as no surprise that patients want to know when they’re about to undergo an exper imental procedure. You might be surprised to learn, however, that providers can get caught in sticky situations when they perform procedures that are advanced and risky but not necessarily experimental. Doctors may see such procedures as cutting-edge measures needed to help their patients, but some patients may think their doctors are simply experimenting on them without informed consent.
If so, a lawsuit is inevitable, and the potential loss is huge. That’s the situation facing Thomas Jefferson University Hospital in Philadelphia, where a patient has filed a lawsuit alleging that doctors subjected him to experimental treatment for a brain condition without his consent. The man was left incapacitated after the surgery.
The patient, George Phillips, was a 33-year-old auto mechanic when he sought treatment at the hospital in 1995 for bad headaches and numbness in his right arm. Tests revealed he had an arterio venous malformation (AVM) in his brain, a tangle of blood vessels that had been bleeding. The condition was life-threatening.
A lawsuit filed recently by Phillips’ wife, Nancy, contends that doctors used her husband as "a human guinea pig" for research that was not approved by the hospital and that did not meet federal standards for human research. The Phil adelphia Common Pleas Court allowed the couple to include punitive damages and allegations of civil conspiracy and fraud. That substantially ups the ante for the hospital, creating the possibility of a payout far beyond the typical malpractice case.
Doctors at the hospital deny the charges, contending that what they did was cutting-edge and daring, perhaps, but not experimental. A trial is scheduled for some time in 2000.
Phyllis Fisher, spokeswoman for Thomas Jefferson University Hospital, confirms that the university employs the physicians in question, therefore the university is handling the defense of all of the parties. While she was unable to comment on the defense of the case because the litigation is pending, she confirms a number of facts previously made public.
Phillips had a large AVM that was difficult to treat, partly because of its location in his brain. Surgeons ruled out surgery to remove the AVM or cut off its blood supply, according to court documents filed with the case. The surgeons then turned to another possibility, stereotactic radiosurgery, in which a beam of radiation is focused on the AVM to shrink it. The surgery is considered risky because the radiation can damage or destroy healthy brain tissue along with the AVM. One of the surgeons testified recently that he had used the technique on up to 40 patients before Phillips, but he had used a single dose of radiation on each of those patients.
In Nancy Phillips’ deposition, she said that the surgeons told her there would be only one dose of radiation and the likelihood of success was 80%. She says she learned later from a nurse that there would be multiple radiation sessions. Court papers show that the decision to switch to multiple sessions came after the case was discussed by senior surgeons at the hospital, who decided all such AVM patients should be treated with multiple doses of radiation because that would be more effective and safer than a single dose.
The Phillipses contend that the decision to use multiple doses of radiation pushed the treatment beyond aggressive to experimental, and that there was no informed consent process to obtain permission for experimental treatment. Phillips had six radiation sessions but was unable to return to work because of continuing problems, including new difficulties with seizures and speaking. In November 1995, Phillips had a stroke that left him unable to speak or do anything else. He now lives in a nursing home, and his wife says she does not know how much he comprehends.
According to court papers filed in response to the lawsuit and depositions by the accused, the surgeons were pursuing a course of therapy they knew to be aggressive, but they say the patient had little other choice. They deny that the multiple radiation treatments crossed the line into experimentation. The parties also disagree on how much information was given the Phillipses before the procedure. The plaintiffs contend they were assured that the risk was not exceptionally high, while the hospital contends that surgeons fully explained the unproven nature of the treatment and the high risk it entailed.
The outcome of the case will not be determined for some time unless there is a quick settlement. Nevertheless, the case raises some difficult questions for risk managers, says Steve Johnson, director of risk management for Wellstar Health System in Marietta, GA. Normally, any experimental treatment must be approved by the facility’s institutional review board (IRB), which can say yes or no to a request and will monitor any approved experimentation. The Phillipses’ lawsuit contends that one of the surgeons went to the IRB after the treatment, not before. Documents filed by the hospital contend that the surgeon went to the IRB at that point only to formalize a protocol so treatment results could be presented at a conference. (See p. 121 for more on surgeons’ suggestions regarding IRB approval and for advice on how to lower the liability risk.)
"If there is any doubt that the procedure is experimental, you usually take it before the IRB because it’s not standard practice," Johnson says. "There is an opportunity to be approved or disapproved on its merits. And, more importantly, the IRB ensures that the patient acknowledges through an informed consent process that this is considered experimental, outside the norm."
When the treatment clearly is experimental, the situation actually might be easier to handle, he says. The IRB must be involved, and certain protocols must be followed. But when the treatment is in more of a gray area, such as the radiation treatment for AVM, things are more dicey for the hospital. The surgeons may not pursue IRB approval because they sincerely think they don’t need to, but the patient or family may think otherwise. When the treatment involves something as complicated as brain surgery, there may be enough doubt to carry the case to a jury.
"The gray areas are dangerous because then you get providers pitted against one another, saying it is experimental or it isn’t," Johnson says.
The Philadelphia case is being reviewed by the U.S. Office of Protection from Research Risks in Washington, DC. The office is responsible for safeguarding the rights of people involved in medical experiments.
For more details, contact: Phyllis Fisher, Public Relations, Thomas Jefferson University Hospital, 1015 Chestnut St., Suite 810, Philadelphia, PA 19107-4302. Telephone: (215) 955-6300.
Steve Johnson, Risk Management, Well star Health Systems, 805 Sandy Plains Road, Marietta, GA 30066. Telephone: (770) 792-7536.