The Wall Street Journal ran a series of articles examining the ethical — and legal — problems associated with physician-owned medical device companies. At issue is the question of whether profit may have overridden medical ethics when it came to the choice of surgical procedures and implants, and whether patient lives were endangered by surgeries that may have been considered by some doctors to be unnecessary.
One story in the series looked at the case of surgeon-owners of a company called Spinal USA and the death of a patient from spinal fusion surgery. Two spine surgeons who reviewed the patient’s medical records after his death stated that he was a poor candidate for the complex procedure due to other serious medical problems. They say the surgery was ill-advised.
But the patient had significant back pain and a degenerative disk for which he wanted surgery? Wasn’t the patient’s request for the surgery and signed consent form enough?
A surgeon’s duty
A surgeon’s primary obligation is to put the patient’s best interest first in all medical decision making. When evaluating whether to perform a procedure, a surgeon should evaluate all available procedures to determine which are appropriate for that particular patient, paying attention to the degree of risk the patient will be exposed to if he or she undergoes the procedure.
All surgeries carry some degree of risk, including risk of infection and risk of anesthesia.
If a surgeon improperly informs a patient that he or she has a medical need that does not exist, or fails to accurately inform the patient of the benefits and risks associated with the procedure, or fails to explain other, less risky surgical or non-surgical alternatives, this is a violation of medical ethics and could be medical malpractice. The client cannot give informed consent because the patient has not been adequately informed.
When a doctor has a conflict of interest — the Wall Street Journal story alleges a financial interest not only in getting paid to perform a surgical procedure, but also getting a kickback for use of a specific product in which the surgeon had an ownership interest — there may be an incentive to provide less information in order to guide the patient to make a particular decision.
What constitutes unnecessary surgery?
Unnecessary surgery has gotten significant media exposure in recent years, including articles in the AARP newsletter and Consumer Reports. Consumer Reports identified angioplasty, cesarean section, hysterectomy and surgery for back pain as the most common unnecessary surgical procedures.
But what makes a surgery “unnecessary”? This is not a simple call to make. It depends upon the patient’s health, lifestyle and desire for treatment. For example, a vision problem may not affect the capabilities of a factory worker but could force a taxi driver off the job. However, if medical justification for surgery exists and appropriate informed consent is obtained, eye surgery for the factory worker would not be considered unnecessary.
One medical association has suggested that the term “unnecessary surgery” may apply when:
- The decision to perform surgery is beyond the range of reasonable judgment in light of the patient’s needs and is inconsistent with professional standards for determining the need for surgery, and/or
- There is a pattern of performing surgery in marginally justifiable cases.
In the case of Spinal USA, an examination of hospital records showed an increase in lumbar fusions at medical facilities after surgeons who worked in those facilities entered into a financial relationship with the company producing the medical device.
When unnecessary surgery leads to medical malpractice cases
Medical malpractice cases are not undertaken lightly. In order to bring a successful medical malpractice lawsuit, the surgical procedure must result in lasting injury or death of the patient. Temporary or reversible injury may not be sufficient for a patient to receive compensation, even if the surgery was unnecessary.
Injured surgical patients should discuss with an experienced medical malpractice attorney any concerns they have that they were not provided with full information regarding the risks and benefits of the procedure that caused injury.