Clinical trials harmed by lack of informed consent
September 1, 2002 9 minutes read
The mention of clinical trials often triggers a silence between physician and patient, usually because neither one knows much about the subject. Nearly 80% of physicians admit they would like to know more about clinical trials so they can help their patients make an informed decision before volunteering to participate.
"Most subjects enrolled in clinical studies have a meager understanding of what they have gotten into," says Alan Sugar, MD, chairman, New England Institutional Review Board and professor of medicine at Boston University School of Medicine. "Informed consent has largely focused around the signed form and has not practically become the continuous process that it needs to be. As a result, a subject’s misunderstandings largely go unchallenged."
Properly informing patients is not only ethically necessary, say clinical trials experts, but it also ensures better trials and data. Last year, more than 17 million people thought seriously about participating, but only a few million actually completed their trials. And even among them, many gave their consent without a thorough knowledge of the facts. Indeed, patients can be so daunted by questions and lack of information that they simply decide not to volunteer.
"There’s a simple ethical mandate that you don’t ordinarily do dangerous things to people without their knowledge and consent," says Dale E. Hammer-schmidt, MD, FACP, associate professor of medicine and director of Education in Human Subjects’ Protection for the University of Minnesota Medical School in Minneapolis. "From a more pragmatic perspective, a well-informed subject is likely to cooperate better with the trial and is more likely to report potential problems. The quality of the data and the safety of the trial are both enhanced when the subjects really know what’s going on."
A new resource, written for doctors and clinical trial participants, can help answer some of these tough questions. Boston-based CenterWatch, the leading publisher of clinical trial news and information, now offers Informed Consent, a guide to the risks and benefits of volunteering for clinical trials.
Informed Consent is a step-by-step guide that begins with a history of the clinical trials industry, explores the drug development process, and shows how a new drug makes its way to the marketplace. It also details why people decide to participate, how to find clinical trials, how to research clinical trials and evaluate their risks, how to ensure proper informed consent, what the vulnerable populations are, and what to do when things go wrong. Cost is $16.95, and can be ordered from CenterWatch at (800) 765-9647, or by faxing (617) 856-5901. It also can be ordered through www.centerwatch.com, www.amazon.com, and www.barnesandnoble.com.
Legal Review & Commentary: A failure to communicate leads to an $880,000 verdict
By Jan J. Gorrie, Esq., and Seema Patel
Buchanan Ingersoll Professional Corp.
Tampa, FL
News: The victim of an armed robbery was taken to a emergency department (ED) after receiving two gunshot wounds — one to the thigh and one to the chest. The chest wound resulted in a left hemothorax, which was treated by the on-call trauma surgeon. Damage to the patient’s lung required vascular surgery. The surgery became increasingly complex, so the patient was referred to a neurosurgeon for additional treatment. After surgery, and an unremarkable stay in the recovery room, the patient was placed in the intensive care unit (ICU), where he quickly deteriorated and died. The patient’s wife brought suit against several, but not all of the treating physicians, as well as the hospital. The jury found that the attending trauma surgeon and anesthesiologist met the standard of care, but held the hospital responsible for inadequate monitoring of the patient and awarded the plaintiff $880,000 in damages.
Background: The patient was shot twice, in the upper left chest and upper left thigh, during an armed robbery assault at his business. He was transported by ambulance to a hospital. The on-call trauma surgeon determined that his leg wound was not serious and focused on the chest wound. Decreased breath sounds and a chest X-ray revealed a lung injury and a left hemothorax. The trauma surgeon treated the hemothorax by inserting a chest tube. A moderate amount of blood was drained initially, but there was no subsequent bleeding. A follow-up chest X-ray showed resolution of the hemothorax and reinflation of the patient’s lung. The patient remained stable, alert, and oriented in the ED.
Further examination revealed possible vascular damage, so the trauma surgeon consulted with a vascular surgeon, who determined that the subclavian artery had been damaged and required immediate repair. The vascular surgeon took the patient into surgery, and the trauma surgeon continued to treat other patients in the ED.
During surgery, the vascular surgeon and his assistant took a vein from the patient’s leg to graft into the damaged subclavian artery. The repair was initially successful and there were no complications. However, during the procedure, the vascular surgeon discovered an injury to the brachial plexus nerve complex, which is close to the subclavian artery. Without consulting the trauma surgeon, the vascular surgeon called in a neurosurgeon to repair the damaged nerve.
The nerve repair extended the surgery for another hour or more, after which the vascular surgeon discovered that his vascular graft had clotted off. This required the reopening of the vessel, removal of the clot, and administration of a second dose of heparin, an anticoagulant, which was left unreversed. In addition, the vascular surgeon used a suction device to clear the surgical field during the operation. While suctioning blood, the vascular surgeon entered the pleural cavity, which negated the therapeutic effects of the chest tube that had been placed by the trauma surgeon. A large but underestimated amount of blood was removed.
The patient was then transferred to the recovery room with the heparin in full effect, meaning the patient’s blood could not clot. Before leaving for home, the vascular surgeon then instructed recovery room nurses to contact the trauma surgeon for any problems with the chest tube. Postoperatively, the trauma surgeon was to resume the primary care of the patient. The trauma surgeon did stop by the recovery room to examine the patient. At the time of the visit the patient was stable, with good vital signs, no significant drainage into the chest tube, and a new chest X-ray showed no further bleeding from his lung.
By all outward appearances, the patient was doing well. With no reports from the vascular surgeon, neurosurgeon or anesthesiologist regarding the extension of the original or subsequent surgeries, as well as the complications encountered in both procedures, the trauma surgeon felt that the patient’s condition was stable.
After the patient was transferred from the recovery room to the ICU, the trauma surgeon was called by the ICU nurse and told the patient’s blood pressure had fallen. The attending trauma surgeon ordered lab work and blood for a possible transfusion. Shortly thereafter, a second phone call informed the trauma surgeon that the patient was in cardiopulmonary arrest. The trauma surgeon ordered that the blood be hung for infusion STAT. In surgery he opened the patient’s chest to resuscitate him, but the patient remained unresponsive and died shortly thereafter. The trauma surgeon later learned that the patient had been fully anticoagulated in recovery and in the ICU, and he probably had lost more blood in surgery than the vascular surgeon had estimated. Those combined factors probably caused the patient’s condition to deteriorate until he was unable to compensate for the total blood loss.
The plaintiff, the patient’s wife, brought a wrongful-death action against the hospital, trauma surgeon, and anesthesiologist. Neither the vascular surgeon nor neurosurgeon were named in the suit. The plaintiff claimed the trauma surgeon failed to recognize the continuous bleeding from the patient’s lung injury and failed to perform surgery to repair his lung. The wife also claimed that the trauma surgeon should have taken the initiative to find out what happened in the surgeries rather than relying on the vascular surgeon, neurosurgeon, or anesthesiologist to approach him.
The plaintiff also claimed the hospital’s nurses failed to monitor the patient closely enough in the recovery room.
Conversely, the trauma surgeon and the hospital criticized the treating anesthesiologist for not informing anyone of the serious complications encountered during surgery. The trauma surgeon claimed that had he known about the nerve repair, the anticoagulant, and the large volume of blood suctioned from the patient’s chest, then his suspension for bleeding would have been higher and more blood would have been provided in the recovery room.
In his defense, the anesthesiologist testified that the standard of care requires discussion about the specifics of surgery take place surgeon-to-surgeon, not surgeon-to-anesthesiologist. The anesthesiologist countered that he had no direct duty to communicate any details to the trauma surgeon.
The court called the vascular surgeon as a witness, and both sides cross-examined him. He admitted seeing the trauma surgeon in the recovery room and that he failed to communicate the intraoperative events.
The jury found in favor of the two physicians, saying they had met the standard of care and were not liable. However, the jury held the hospital responsible for inadequate monitoring of the patient in the recovery room, and awarded the plaintiff damages for the value of the decedent’s life, which was set at $880,000.
What this means to you: Wrongful-death actions are rising due to an aggressive plaintiffs’ bar and generally litigious tendencies. Health care providers cry for tort reform at the national and state levels.
That makes this a very unusual case — a moderately high jury verdict against a hospital and no findings of fault for the physicians.
"Based upon the given facts of the case, I am first surprised that the jury did not find against the physicians but found that they had adhered to the standard of practice. Second, it is unclear why the plaintiff chose not to name the vascular surgeon given his admitted failure to communicate with the attending physician. And third, I am surprised that the jury only found against hospital on issue of inadequate monitoring of the patient in the recovery room," observes Stephen Trosty, JD, MA, director, risk management consulting, APAssurance, of East Lansing, MI. "Procedurally, the plaintiff’s attorney appears to have made a major error in not naming the vascular surgeon as a defendant. Given the vascular surgeon’s active involvement in the treatment of the patient and his testimony admitting his failure to confer with trauma surgeon or inform him of major occurrences/problems/ treatment issues related to patient, it is remarkable that he was not a party to this action. The vascular surgeon was directly involved in performing the graft to repair the damaged subclavian artery, removal of the clot from the vascular graft, administering second dose of heparin and leaving it unreversed, entering the pleural cavity while suctioning a large amount of blood, and negating the therapeutic effects of the chest tube inserted by the trauma surgeon.
"None of this information was shared with the trauma surgeon by the vascular surgeon. The large amount of blood loss experienced by the patient can be directly related to the actions of vascular surgeon and the fact that the patient’s blood would not clot. These events were directly related to the patient’s cause of death and the fact that this physician was not named is a mystery to me," he adds.
Communication among caregivers is critical to the delivery of quality care. Even if the physicians had chosen to not communicate directly with one another, the patient’s medical record should have been available and should have contained contemporaneous postoperative by all of the surgeons and the anesthesiologist.
"However, in this case there was a total lack of communication between the three surgeons and the anesthesiologist involved in the care of the patient. Important facts that should have been shared with the trauma surgeon as the patient’s attending physician, and should have very clearly conveyed to the recovery room and ICU staff. These facts include: 1) The patient was in surgery a long and extended period of time; 2) A second dose of heparin was given; 3) The patient’s blood would not be able to clot due to the fact that the second dose of heparin was left unreversed; 4) A large amount of blood was suctioned from patient during removal of the clot; and 5) The pleural cavity was entered, thereby negating the positive effects of the chest tube. This was all critical information for the trauma surgeon, as well as the recovery room and ICU hospital staff to have. This case required extremely close and constant monitoring of the patient, beyond what would normally occur if these problems’ had not occurred and the additional surgeries had not been required," adds Trosty.
"Finally, as for the finding against the hospital for inadequate monitoring, it seems that patient was monitored but that the actions of the physicians were not. In defending such actions, one can never underestimate the power of the jury and its tendency to go with the person, a/k/a physician, as opposed to the institution, a/k/a hospital. The outcome of this case exemplifies this phenomenon. At trial, facilities should always have a personal representative from the hospital and, when possible, have hospital personnel testify so that a face can be associated with the institution," concludes Trosty.
Reference
• Blanch Lee, et. al. v. Michael J. O’Reilly, MD, Christopher W. Stowell, MD, and Kennestone Hospital, Cobb County (GA) State Court, Case No. 96A-7013-2.
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