Physician's 'learned intermediary' status doesn't afford malpractice protection

October 21, 2005

Dr. Doe was responsible for choosing the laser treatment parameters for his patient under the learned intermediary doctrine. It is unlikely that a court will place liability on the rental laser company.

At the request of both his patients and staff, he decided to begin to perform some cosmetic procedures. It seemed most logical to start with laser hair removal. The procedure seemed fairly easy, rental companies were widely available and he had a large patient base to support the laser rental fees.

Relying on technician

Recently, Dr. Doe attended a local cosmetic surgery meeting where the very hair removal laser he used was being discussed. Apparently some of his peers anecdotally felt that they achieved even greater laser hair removal efficacy when more aggressive parameters were being used.

One month later, the laser technician once again brought the laser to Dr. Doe's office. He asked the technician for his thoughts on the more aggressive approach. The technician reported that several physicians had reported improved success with this method. However, he stated that the chosen laser parameters were more aggressive than were recommended in the supplied laser manual.

Turning up the heat

Dr. Doe said he would like to try this more aggressive approach, the technician agreed and dialed in the requested parameters.

The next treated patient was severely burned and sued Dr. Doe. Dr. Doe then sued the laser rental company for "allowing" him to use the more aggressive approach. After all, he contended, the laser technician had much more experience than he did and should not have allowed him to be so aggressive. The burned plaintiff also sued the laser rental company. What will happen to the laser rental company?

Plaintiff interaction

A recent Connecticut court case looked at the interaction between damaged plaintiff patients, sued doctors and medical device technicians.

In this 2005 case, an infant patient had been given a pacemaker soon after birth. The pacemaker manual provided a warning that when the battery voltage dropped below a certain level, the patient's physician must schedule a battery replacement. When the baby's pacemaker battery indicated that it had dropped below the recommended voltage level, her physician, believing that the child's mother would not consent to a pacemaker replacement procedure, consulted a technician from the pacemaker company. The technician discussed various programming options for the pacemaker without replacement, including reducing the pacemaker's rate so as to increase the battery's life expectancy.

However, the technician did indicate that replacement, as described in the pacemaker manual, was the safest option. The defendant doctor reduced the pacemaker rate. The child suffered cardiac arrest and permanent brain damage. The cardiologist was sued. Subsequently, the pacemaker device company was sued for providing the information to the doctor that allowed him to change the pacemaker parameters.

Doctrine applies

The Connecticut court ruled that the "learned intermediary doctrine" applied in this case. This doctrine provides that adequate warnings to doctors obviate the need for manufacturers of prescription-type products to warn the consumer directly. In the Connecticut case, the technician's oral advice was consistent with the manual and therefore the learned intermediary doctrine applied. The manual provided for safe pacemaker parameters. The medical decision-making liability rested with the physician.

Many courts have ruled that physicians act as a learned intermediary between their patients and drug/medical device manufacturers, not only because they are most capable of determining the needs of their patients, but also because it is essential for the physician-patient relationship to remain free of interference from outside influences.