By Damian D. Capozzola, Esq.

The Law Offices of Damian D. Capozzola

Los Angeles

Jamie Terrence, RN

President and Founder, Healthcare Risk Services

Former Director of Risk Management Services (2004-2013)

California Hospital Medical Center

Los Angeles

Elena N. Sandell, JD

UCLA School of Law, 2018

News: A Texas appeals court ruled a trial court did not err in allowing the plaintiffs’ expert to amend his report to address certain deficiencies, and that, consequently, the hospital would have to face trial for the permanent injuries a patient sustained following brain surgery performed with a laser device recalled by the FDA. The device was recalled because it could unexpectedly heat and cause brain tissue damage. The patient was dismissed from the hospital a few days after surgery, but began experiencing dizziness, vomiting, and loss of consciousness. A few days later, she was admitted to a different hospital, where she was diagnosed with a ruptured pseudoaneurysm. The injury caused permanent brain damage. On appeal, the hospital challenged the plaintiff’s expert report, arguing it failed to provide sufficient facts regarding the connection between the alleged breach of proper care and the injury sustained. This appeal was rejected, and the court affirmed the trial court’s decision.

Background: The patient, a minor, had epilepsy, which required treatment by a minimally invasive brain surgery. In July 2018, a physician employed by the defendant hospital performed the surgery using a NeuroBlate system. The system, an MRI-guided laser device, had been recalled by the Food and Drug Administration (FDA) in October 2017 because the temperature measuring system in the device was potentially inaccurate and could cause unexpected heating and probe damage. This unanticipated heating could warm the surrounding brain tissue, leading to damage to the tip of the probe, causing CO2 cooling gas to leak into the brain. The FDA placed the system under a Class I recall, meaning device malfunction can cause death or serious injury. The physician who performed the surgery failed to disclose the device recall to the patient’s parents.

Two days after the procedure, the patient was discharged; however, shortly thereafter, she started experiencing symptoms, including dizziness, vomiting, and loss of consciousness. The patient was admitted to another hospital for further treatment, where CT imaging revealed a large acute right temporal intracerebral hematoma, intraventricular hemorrhage, and acute hydrocephalus. Another procedure was performed to reduce swelling in the patient’s brain. Additional scans revealed a pseudoaneurysm, which was treated at the hospital. Subsequently, the patient was transferred to a hospital in Tel Aviv for additional rehabilitation. According to the complaint, the patient suffered permanent brain damage.

The patient’s parents filed a lawsuit individually and on behalf of their daughter, alleging the hospital and the surgeon who performed the procedure were negligent in using the recalled device, and had failed to disclose material information to the parents, consequently depriving them of their right to make an informed decision on surgery. Defendants filed a motion to dismiss, arguing the plaintiffs’ expert failed to establish a causal nexus between the procedure and the injury sustained. The trial court ruled in favor of plaintiffs. On appeal, defendants argued the trial court erred in allowing the amended expert report. However, the court of appeals concluded the trial court had not abused its discretion and the plaintiffs’ expert report was sufficient.

What this means to you: As often is the case in medical malpractice cases, defendants made a concerted effort to dismiss the case based on the insufficiency of the plaintiff’s expert report. Here, however, the court of appeals began its analysis by specifying that based on the applicable standard of review, the purpose of the plaintiffs’ expert report is to demonstrate the plaintiff is not filing a frivolous lawsuit (i.e., that based on the opinion of a qualified medical expert, defendant’s conduct breached the standard of care).

State laws vary concerning whether and to what extent an expert must validate a malpractice case before they are even commenced. This is called the “certificate of merit” process, requiring a plaintiff to obtain a medical expert’s opinion that the facts give rise to medical malpractice before the case is even filed. Relatedly, states also vary as to what an expert must say to make the case stand up in court once it begins

Based on the applicable statute here, an expert report is sufficient when it identifies the applicable standard of care, identifies the manner(s) in which the physician’s care fell short of the standard, and establishes a relationship between the substandard care and the injury the plaintiff sustained. The report need not be indisputable; it must merely show the plaintiff made a good-faith effort in complying with the statutory requirements.

In this case, plaintiffs’ expert was a pediatric and adult neurosurgeon. The defendants noted the initial report submitted by the plaintiffs lacked certain information. The court allowed the expert to amend the report to address the deficiencies, which primarily related to why the FDA had recalled the NeuroBlate laser probe. The amended report explained the FDA’s recall strongly advised physicians to treat patients using alternative methods whenever available.

The expert also analyzed the physician’s report and noted the doctor had noticed an abnormal heating pattern during the surgery and later discovered a bleed in the patient’s brain. The bleed was located in the same region of the brain where the patient suffered a massive bleed 16 days after the surgery. Based on the FDA’s warnings, when the recalled laser probe excessively heated, the blood vessels in contact with the probe likely would be damaged, which could cause a pseudoaneurysm. A pseudoaneurysm occurs when the walls of a blood vessel are damaged, leading to blood leaking and collecting in the surrounding tissue. Based on the tests performed on the patient after the surgery, it was clear she had suffered from a pseudoaneurysm, which was one of the main risks the FDA indicated in its recall notice. Based on these facts, the court opined the expert’s report satisfied the necessary statutory requirements and the trial court did not abuse its discretion in denying defendant’s motion to dismiss.

It also should be noted that responsible healthcare facilities, including hospitals, surgery centers, and other settings where medical equipment is used, employ people responsible for monitoring the functionality of the biomedical equipment. Part of that responsibility includes monitoring for recalls of medical devices and reporting those recalls to areas in their facility that use the devices. Those departments are then required to remove the device or equipment from the shelves and return them to the manufacturer. These actions prevent the inadvertent use by a provider or staff member, and thus, the possibility of harm to the patient or the device user. Such arguments also could potentially bolster the plaintiff’s case, depending on what the facts reveal about these issues.

Although the outcome of a trial is never certain, in this case there are compelling arguments for defendants’ negligence. Given the detailed recall notice issued by the FDA eight months before the surgery, and the physician’s operative notes indicating excessive heating and a brain bleed during the surgery, it is likely that with a strong expert witness, plaintiffs will have a good chance of prevailing during trial.

REFERENCE

  • Decided Nov. 19, 2020, by the First Court of Appeals of Texas, Case No. 01-20-00146-cv.