Physician Legal Review & Commentary

$1.73 million was awarded against a defendant physician for the failure to properly perform a paraspinal injection

By Jonathan D. Rubin, Esq.
Partner
Kaufman Borgeest & Ryan
New York, NY

Sandra L. Brown, Esq.
Associate
Kaufman Borgeest & Ryan
New York, NY

Leanora Di Uglio, CPHRM, CPHQ
Corporate Director, Clinical Risk Management
Health Quest Systems
Lagrangeville, NY

News: A 24-year-old patient's estate was awarded $1.73 million against a physician for negligence in performing a paraspinal injection, medical malpractice, and wrongful death. The patient presented to the physician's family medicine practice for treatment of continuing pain in her neck and headaches following an automobile accident. The patient underwent a paraspinal injection in her neck, which was performed by the defendant physician, a part-time family practice osteopathic physician. The physician injected the patient's C4-C5 cervical nerve root with an anesthetic and steroid solution. Plaintiff's counsel contended that the patient died as a result of the injection.

Background: On March 17, 2005, the mother of the 24-year-old female patient accompanied her daughter to the practice of a part-time family practice osteopathic physician. The patient went for treatment of continuing pain in her neck and headaches following an automobile accident. The mother wanted to ask about the risks and potential side effects of the injection. According to the mother, the physician did not discuss any potentially harmful effects and, instead, assured the patient that he had performed the procedure many times with no adverse consequences.

The patient underwent a paraspinal injection in her neck, which was performed by the defendant physician. The physician injected the patient's C4-C5 cervical nerve root with an anesthetic and steroid solution.

Plaintiff's counsel contended that after the physician injected the patient's neck and walked out of the room, she lost consciousness and stopped breathing. The physician was summoned back to the room by the patient's mother. The physician found the patient unresponsive, which prompted him to call his nurse assistant to the room and direct his staff to call 911. The physician initiated CPR, but he could not establish a pulse or regular cardiac rhythm. Plaintiff's counsel also argued that the physician failed to properly monitor the patient's vital signs and did not have a crash cart available for the procedure.

After several minutes of CPR, medics arrived and determined the patient was in a state of cardiac arrest with no ascertainable blood pressure or pulse. Emergency resuscitative measures, including endotracheal intubation, were unsuccessful over the ensuing 30 to 45 minutes, prior to her arrival at the hospital. In the emergency department, providers determined that the patient was severely oxygen-deprived, and ventilation efforts were resumed, including reintubation of her trachea. Following reintubation, the patient's pulse spontaneously returned, followed by resumption of blood pressure. She then was placed on a ventilator with life support measures.

A neurological consultation later concluded that the patient had suffered a fatal loss of oxygen to her brain and remained neurologically unresponsive during the ensuing five days in the intensive care unit. Further tests confirmed the initial diagnosis, which prompted the hospital physicians to discontinue life support with agreement of the family. The patient was pronounced dead on March 22, 2005.

The patient's sister sued the physician on behalf of the deceased patient and alleged claims of medical malpractice and wrongful death. Plaintiff's counsel contended that the patient died as a result of the injection. Plaintiff's counsel argued that the physician's conduct was below the standard of care. Plaintiff's counsel also alleged the physician failed to obtain an informed consent from the patient. They also argued that the injection was performed in a "blind manner" as the physician failed to use guided fluoroscopy to ensure correct placement of the medication. Plaintiff's counsel further argued that the physician's placement of the injected solution pierced the spinal nerve root sleeve, where it intermixed with the cerebral spinal fluid and prompted an unintended paralysis of the patient's diaphragm and resulted in the patient's asphyxiating before artificial ventilation could be achieved.

Plaintiff's counsel contended that at the time of the injection, the patient was in good health other than having intermittent neck pain and headaches. Plaintiff contended that autopsy results later confirmed that the patient had suffered a fatal loss of oxygen to the brain as a consequence of complications arising from the defendant physician's nerve root injection. Ultimately, plaintiff argued, the physician lacked the proper training to perform the procedure and should have referred the patient to a specialist, such as a doctor in pain management.

Defense counsel argued that the injection was properly done and that the patient had an unexpected reaction to the injection. Defense counsel further argued that the paramedics were responsible for her death due to a problem with intubation.

The jury found the physician negligent and determined that damages totaled $1.73 million, apportioning $920,000 for the patient's sister and $810,000 for the patient's father.

What this means to you: It should be pointed out at the onset that patient safety protocols do not vanish when a procedure is being performed in an office-based setting. Instead, patient safety protocols should be consistent across the continuum of care regardless of the healthcare setting. In this case scenario, it is clear that the physician did not establish clinical or operational patient safety protocols and practices.

In a solo practitioner or group practice office setting, a review process should be in place to ensure there are appropriate clinical and operational policies and practices in effect that will support the safe performance of office-based procedures. In a single physician office setting. this process is particularly challenging. Absent any reimbursement constraints, solo practitioners are basically at liberty to determine what procedures can be done in their office setting. However, that liberty does not eliminate the solo practitioner's professional responsibility to establish clinical and operational policies and practices that support patient safety.

In the described scenario, the defendant physician did not provide evidence that he was competent to perform the paraspinal injection by background or training. When determining whether a procedure can be safely performed in an office-based setting, it is important to ensure that the provider performing the procedure has the required education, training, and competency to do so. For procedures being performed in an office setting, a retrospective review of clinical outcomes will provide information that can be used to identify and intervene in performance trends or system failures that might compromise patient safety. Although a retrospective review process is not ideal, it is a good strategy to use to monitor and mitigate performance issues, undesirable clinical outcomes, and unsafe conditions. For new procedures, a more thorough and rigorous review of peer-reviewed literature would help the physician determine the level of provider and staff training and competency needed to perform the procedure and to recognize and treat medical complications and emergencies.

In our case scenario, plaintiff's counsel contended that the paraspinal procedure was inappropriately performed using a blind method of injection and argued that the more appropriate method would be to perform the paraspinal injection using image-guided fluoroscopy. Obviously, the purchase of a fluoroscope for the physician would have a significant financial impact to his practice. However, this impact does not eliminate the physician's responsibility to use peer-reviewed literature to determine the safety and efficacy of performing the procedure in an office practice setting, while keeping in mind the financial and human resources available to the provider that might impact the purchase of necessary equipment or supplies, or staff training programs.

What is strikingly absent in the case scenario is the lack of nursing involvement before, during, and after the procedure. The physician failed to establish operational and nursing policies that support the provision of clinical care in a safe manner. There was no evidence of a nursing pre-procedure screening, which is important on an operational as well as clinical level. Operationally, during the pre-procedure screening, nursing staff will confirm the presence of required lab tests, screening forms, as well as the important signed informed consent form. In this particular case, a well-crafted informed consent form with the patient's signature would have shown that the patient was made aware of the risks associated with the paraspinal injection.

Significantly absent in the case description is documented evidence that the physician established protocols that outlined the scope of intra- or post-procedure monitoring. It appears that the physician performed the procedure without nursing staff's involvement to monitor the patient's vital signs and oxygen saturation and that he left the patient unattended at the completion of the procedure. Implementation of minimal patient safety protocols for intra- and post-procedure monitoring in the office setting, combined with a trained and competent nursing staff, might have been sufficient to change this patient's outcome.

In terms of the post-procedure emergency medical treatment, plaintiff's counsel contends that the physician's office was not appropriately equipped to handle the medical emergency. Although the assertion that the physician's office was not equipped with a crash cart might be valid, the presence of a crash cart in and of itself is not salient unless it can be demonstrated that the physician and staff possess the skills and competence in emergency resuscitation efforts. Based on the initial clinical assessment of the emergency medical personnel, it appears that the resuscitative efforts performed by the physician were ineffective.

The described case scenario brings to light clinical and operational opportunities for improvement in this physician's office-based practice. Clinical improvements range from determining which procedures can be safely performed in an office setting to ensuring training and competency of physician and nursing staff to establishing protocols for required pre-, intra- and post-procedure monitoring. Operational improvements range from acquisition of equipment and supplies needed to perform the procedure to establishing an informed consent policy. Had the physician given due diligence to the clinical and operational practices in his office practice, perhaps the clinical outcome would have been different.

Reference

No. 06-5309CI-21, Pinellas County Sixth Circuit, Florida (2011).