News: A jury ruled against a Pennsylvania hospital and one of its neurosurgeons, finding the latter negligent for using an allegedly defective tool on a patient without securing proper consent. Jurors awarded the plaintiff $9.7 million.
In October 2015, a patient sought treatment from a neurosurgeon for a benign brain tumor. The neurosurgeon recommended laser interstitial thermal therapy (LITT), a minimally invasive procedure to destroy unhealthy tissue. However, the neurosurgeon failed to warn the patient the particular laser had not been used before for that kind of surgery, nor did he inform the patient he had never performed this procedure.
During the surgery, the outer tip of the probe broke off, releasing carbon dioxide in two eight-second blasts directly into the patient’s brain, apparently causing a spike in the patient’s intracranial pressure. The patient fell into a coma.
The subsequent lawsuit also alleged the neurosurgeon had only used the device in one other type of surgery, during which he had used a narrower, more fragile tip instead of a thicker one, and had ignored messages from the device’s software that should have prompted him to stop.
The jury found the neurosurgeon failed to obtain proper informed consent from the patient, and his omissions were material to the patient agreeing to the procedure. The jury also found the neurosurgeon and the hospital were negligent, and the defect in the device was a cause of the patient’s injuries. The neurosurgeon is liable for about $4.2 million of the verdict, and the hospital will pay about $1.5 million.
Background: On Oct. 16, 2015, a patient underwent LITT to treat a benign brain tumor. Previously, the patient underwent stereotactic radiosurgery for left frontal meningioma. The patient’s neurosurgeon recommended LITT as treatment for the ongoing edema and worsening symptoms. There has been no report in the medical literature of the use of LITT to treat meningioma or radiation necrosis in meningioma, nor had the neurosurgeon ever performed this procedure for meningioma. The neurosurgeon did not relay this information to the patient.
After the surgery, the patient experienced problems with his memory and speech. MRIs showed residual left frontal meningioma with central necrosis and edema.
The patient further alleged the neurosurgeon negligently chose the smaller 2.2 mm outer diameter probe for the LITT procedure instead of the more robust alternative with a 3.3 mm outer diameter probe. MRI images with contrast recorded during the procedure showed sequential development of hemorrhage and mass effect in the left frontal lobe.
On Oct. 21, 2015, the neurosurgeon informed the patient’s wife and son the fiber optic cable fractured during the procedure, and an approximately 2 mm piece of plastic coating was missing from the tip of the probe. Additionally, the neurosurgeon informed the patient’s family an eight-second infusion of carbon dioxide gas directly into the patient’s brain occurred twice during the procedure, producing a spike in the patient’s intracranial pressure. As a result, the patient fell into a coma.
The patient filed a malpractice lawsuit against the neurosurgeon and the hospital for medical negligence. He asserted a claim of battery for lack of informed consent before the procedure.
The patient also sued the manufacturer of the device used during the LITT procedure for counts of strict liability, failure to warn, malfunction, breach of implied warranty, and negligence. The patient’s wife asserted a final claim of loss of consortium and companionship as a result of the procedure.
The jury found the device manufacturer 42% at fault for the injury. The manufacturer had already settled with the patient for $12.5 million. The remaining fault was apportioned at 43% for the surgeon and 15% for the hospital. The jury awarded the patient and his wife $5 million for pain, suffering, and other noneconomic losses; $3.1 million for his future medical expenses; and $1.6 million for loss of companionship.
What this means to you: This case shows the importance of informed consent in medical negligence cases and defines how strictly a court upholds the standard of care when informing a patient of the asserted risks of a procedure outside the scope of a doctor’s expertise.
The main issue in this case concerns the level of informed consent. The patient was unaware of his neurosurgeon’s lack of experience with this procedure in treating the patient’s condition. As previously stated, there are no reports or precedents of the use of this specific device for LITT treatment of this condition. Additionally, the neurosurgeon had never performed this procedure for meningioma and did not relay this information to the patient. The patient stated he would not have undergone the procedure if he knew of its novelty as a treatment and the neurosurgeon’s inexperience.
Although the court ruled the medical device manufacturer is 42% at fault, they placed the largest percentage of blame on the surgeon at 43%.
It is important to provide patients full and comprehensive information on the procedure, including how common the practice is and the doctor’s experience level.
Responsibility also lies with the hospital’s medical staff to know physicians’ skill levels, awareness of medical devices, and to instruct physicians on proper usage of devices until they demonstrate proficiency. At that point, the physician must inform the patient about the upcoming procedures, including the physician’s knowledge of medical devices. Detailed documentation of the explanations and the patient’s understanding is the only reliable way to ensure fully informed consent.
Another key lesson is courts are likely to impose liability on a hospital or physician if they determine the patient did not feel adequately informed of the risks of injury following surgery. Regardless of what caused the injury, informing the patient of the commonality of the specific procedure and the physician’s personal experience with the procedure falls within the standard of care.
It is crucial to inform patients of all the attenuated risks of any procedure. It is evident from this case there are many risks in performing a procedure that is not standard and routine for treatment of a specific illness. There also is a high risk if a physician is performing a procedure for the first time. These were risks that were not related to the patient and were detrimental to the neurosurgeon’s case when assessing if the patient was adequately informed. Without informing the patient of these risks, the patient could not give informed consent.
REFERENCE
- Decided Nov. 12, 2021, in the Court of Common Pleas for Philadelphia, case number 160803335.
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