$7 Million Verdict: Improper Use of Balloon Device Leads to Death
By Damian D. Capozzola, Esq.
The Law Offices of Damian D. Capozzola
Jamie Terrence, RN
President and Founder, Healthcare Risk Services
Former Director of Risk Management Services
California Hospital Medical Center
Morgan Lynch, 2018 JD Candidate
Pepperdine University School of Law
News: A woman presented to a hospital to undergo treatment for an aneurism. The treating physician, a neuroradiologist, used a balloon catheter to increase the size of the artery and support a series of coils. As a result of his inexperience with the device, the physician overinflated the balloon and caused a laceration in the patient’s artery. This laceration led to a brain bleed, which was untreated and caused the patient’s death.
The patient’s two children initiated suit on her behalf, spurring a battle of the experts and a blame game between the neuroradiologist and the anesthesiologist. It became clear through the trial that the anesthesiologist’s position was well supported by the available evidence in the medical record. After a lengthy trial and deliberation, the jury returned a $7 million verdict in favor of the estate, but only against the neuroradiologist.
Background: On May 6, 2013, a 55-year-old woman underwent a neuroendovascular coiling procedure under general anesthesia at a hospital. The patient elected to undergo the procedure to treat a right middle cerebral artery bifurcation aneurysm using an inflated balloon catheter to hold a series of metal coils in place. The procedure was performed by a neuroradiologist from her employer-radiological consulting company, with the assistance of an anesthesiologist. During the procedure, it was determined that the patient suffered a laceration to the right middle cerebral artery, resulting in a brain bleed. She died three days later.
The patient’s two adult children, as administrators of their mother’s estate, sued the two physicians and their practices for medical malpractice which caused their mother’s wrongful death. The patient’s estate alleged that her fatal injury arose either from the failure to administer the proper amount of anesthesia or the negligent use of the balloon device.
The defendants collectively disputed liability, with the physicians pointing fingers and claiming the other was directly responsible for the brain bleed. The neuroradiologist alleged that the anesthesiologist used insufficient anesthesia, which caused the patient’s head to buck and jerk two to three times, with her head lifting at least six to eight inches off the table during the operation.
In response, the anesthesiologist denied the patient’s head moved during the procedure. He contended that the neuroradiologist did not know how to properly use the balloon device and fabricated the movement of the decedent’s head to circumvent liability. The anesthesiologist testified that the patient’s head could not have moved as it was taped to the table, and evidenced this with photographs.
The neuroradiology expert testified that the patient’s death was caused by overinflation of the balloon device. The anesthesiologist’s expert testified that it was scientifically implausible for the patient to have been insufficiently paralyzed from anesthesia given the conditions recorded.
The plaintiff’s neuroradiology expert testified that the neuroradiologist misused the balloon catheter, overinflating the device and allowing blood to enter it. He concluded that the contention that the patient’s head moved was unlikely.
The trial lasted seven days, and after six-hour deliberations, the jury found in favor of the plaintiff against the neuroradiologist and his associated consultancy. The estate was awarded approximately $7 million in damages, with each child receiving $3.37 million and the estate receiving $239,118.98 in medical expenses, along with $21,660.85 in funeral expenses, plus prejudgment interest. The award was capped at $2.05 million under applicable Virginia law. The anesthesiologist and related anesthesiology group were found not liable.
What this means to you: The operating table is not the place for experimentation or untested techniques. Of course, this limitation does not apply where informed consent is acquired. The neuroradiologist should have informed the patient of the risks associated with the balloon device and his lack of experience with the technique, as described by the anesthesiologist. When used properly, balloon catheters can enlarge narrow openings in the body, but in the hands of the inexperienced, the balloon can rupture blood vessels, as it did here.
The anesthesiologist in this case demonstrated an excellent knowledge of the procedure the patient underwent. While it is unclear whether he noted the exact amount of anesthetic administered, he did document other parts of the procedure. Perhaps noting the neuroradiologist’s lack of experience with the balloon catheter, the anesthesiologist was careful to create a robust medical record by photographing the steps he took, including taping down the patient’s head. Without this photographic evidence, it would be difficult to determine the cause of the patient’s death and could ultimately result in liability for the unwary or the lazy. The anesthesiologist could have demonstrated even further his conformity with the medical professional standard by noting the amount of anesthetic given to the patient throughout the procedure and any reactions she may have had.
The record also is unclear as to what steps were taken in the three-day period leading up to the patient’s death to alleviate her brain bleed. Patients with brain bleeds must be closely monitored, as a lack of oxygen to the brain has seriously deleterious effects. In a brain bleed situation, physicians should first focus on stabilization of the patient. While stabilization takes place, the patient may need to be placed on a ventilator to keep the oxygen saturation level high. Further, the patient’s blood oxygen level and pressure in the skull should be monitored carefully.
After stabilization, the physician must address the source of the bleed itself. One option is surgery, but whether to operate depends on the size and location of the hemorrhage. Medications are available to ease brain bleed treatment. Antihypertension agents may be used to lower blood pressure and prevent the exacerbation of the hemorrhage, while acetaminophen may be used to lower fever and relieve headaches. Anticonvulsants should be used in situations involving seizures. More and more data suggest that statins, a medication typically used to lower cholesterol levels in the blood, can have neuroprotective properties, but it appears that data more conclusively support the use of statins pre-hemorrhaging than it does during or post-hemorrhaging.
While it was found that the anesthesiologist in this case was not negligent in administering anesthetics and preparing the patient for her operation, a discussion of best practices in head surgery anesthetics is worthwhile. Before administering anesthetics, it is crucial that medical professionals ask their patients whether they are currently taking any medications or are allergic to any anesthetics. Comorbidities and other preoperative assessment factors also must be assessed to avoid complications. After conducting his or her preoperative inquiries, the physician should anticipate needed equipment and specialists, then ensure their availabilities to prepare for worst-case scenarios. Finally, before the operation begins, the patient should be placed in the most ergonomic position possible to avoid pressure sores, and, in the cases of head operations, should be secured to avoid cranial damage. At this point, anesthetics can be administered.
Note that every medical facility includes a physician chief of staff and a peer group of physicians that comprise the various medical and surgical committees that oversee the medical and surgical practices within the facility. Each medical and surgical committee includes a medical director. It is the role of each committee to determine what procedures can be performed in the facility and which physicians are credentialed to perform them. Credentialing is a critical process that requires proctoring of inexperienced physicians by those with expertise in the procedure in question. Experimental procedures undergo even further scrutiny by institutional review boards and must meet strict FDA guidelines to protect research subjects. Clearly, this physician was not or should not have been credentialed to perform the procedure. OR staff are trained and are responsible for reviewing the credentials of all surgeons performing procedures, and have the authority and responsibility to prevent the procedure if there are questions about a practitioner’s ability.
Decided on July 19, 2017, in the Virginia Circuit Court, Fairfax County; Case No. 2016-01808.
A physician's inexperience with a balloon device led to ruptured blood vessels and the patient's death.
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