Published 12/1/2008
Murray J. Goodman, MD

How far does your obligation go?

Can prescribing physicians be liable for their patients’ actions?

Driving while under the influence of narcotic pain relievers, sedatives, and psychotropic drugs is a recipe for disaster. And that’s just what happened in Massachusetts, when David Sacca—a 75-year-old man with metastatic lung cancer, chronic obstructive pulmonary disease, asbestosis, and hypertension—lost consciousness while driving and killed a 10-year-old child.

What sets­ this tragedy apart, however, is that the child’s parents sued both Mr. Sacca and his primary care physician Roland Florio, MD. Two years earlier, Dr. Florio had treated Mr. Sacca for lung cancer, giving him prescriptions for oxycodone, paroxetine (Paxil), oxazepam (Serax), prednisone, tamsulosin (Flomax), metolazone (Zaroxolyn), and furosemide. The doctor advised his patient that it was not safe for him to drive a car while he was being treated. Once the treatment was completed, Dr. Florio advised Mr. Sacca that he could safely resume driving. The accident occurred several months later.

The first judge to hear the case dismissed it, ruling that even if the plaintiff could prove everything alleged, the plaintiff would still lose. In the absence of a “special relationship,” he ruled, physicians have duties only to their patients, not to third parties. The parents appealed the case to the state Supreme Judicial Court (SJC).

No relationship, but an obligation
To determine whether the plaintiff could make a case, the SJC assumed that everything stated in the pleadings was true. The SJC just ruled on whether, in the absence of a physician-patient relationship, the physician had an obligation to the child. It did not make any decision as to the cause of the accident or any breach of obligation, only whether an obligation existed at all.

Testimony included a statement by the plaintiff’s expert witness that “the sedating effects of these drugs can be more severe in older patients, and that the standard of care for a primary care physician includes warning elderly or chronically ill patients about the potential side effects of these drugs and their effect on a patient’s ability to drive.” It was also noted that Dr. Florio did not discuss the side effects of the medication or warn Mr. Sacca about driving.

The SJC decided that the mother of the child had standing to bring suit against the prescribing physician and that the prescribing physician does have an obligation. Thus, the SJC ruling means that, in addition to having an obligation to the patient (the driver), the prescribing physician also has a duty to protect a third party who may be injured by the patient.

Among the six judges who heard the case, four ruled that a third-party obligation existed and two strongly dissented. The cause of the accident was never determined and Mr. Sacca died 5 months after the accident. The case was settled after his death, and no judgment has been entered against Dr. Florio.

Not malpractice, but negligence
The plurality opinion, representing three of the four justices, stated that this clearly was not a medical malpractice case because no doctor-patient relationship existed between the plaintiff and the defendant. Because the child was not Dr. Florio’s patient, the case was considered an ordinary negligence case and decided as such.

In Massachusetts, the plaintiff in an ordinary negligence case must show that the defendant owed a duty to the plaintiff and that the defendant violated that duty, causing harm to the plaintiff. The only legal issue under review was duty, and the real question posed was “did the physician owe an obligation to the people his patient could foreseeably injure or kill as a result of the treatment prescribed?”

Under the plurality opinion, “the risk of harm to another [must] be recognizable or foreseeable to the actor.” Physicians have a duty to inform their patients of a drug’s side effects that they determine “are necessary and relevant for patients to know in making an informed decision.” In this case, the justices wrote, the “warning serves to protect the patient from, for example, the foreseeable risk of an automobile accident [and] it is clear that the foreseeable risk of injury is not limited to the patient.”

The opinion cited the analogy of third-party liability, such as a bar owner who may be held responsible for car accidents caused by intoxicated patrons or a forklift owner who was held liable for leaving the keys in the machine’s ignition after a drunken seaman drove the forklift over a pedestrian’s foot. The opinion concluded that “a physician owes a duty of reasonable care to everyone foreseeably put at risk by his failure to warn of the side effects of his treatment of a patient.”

Intruding on the physician-patient relationship
The fourth judge took a narrower view, stating that comparing the physician’s prescription of medication to a bartender’s serving alcohol to “already inebriated persons” is “an immoderate and indefensible characterization of the medical profession” that “impermissibly intrudes on the traditional physician-patient relationship.”

Nevertheless, he agreed that the physician has an obligation to warn the patient of known potentially dangerous side effects of prescribed medication and would extend physician liability to others “foreseeably put at risk by an uninformed patient’s decision to drive.” He also emphasized that the physician cannot control the patient’s behavior but can only inform the patient about the potential effects of the drugs being prescribed.

Public policy considerations
The dissenting opinions focused primarily on public policy considerations that justices thought should have led the court to the opposite conclusion. The dissenting judges considered that the decision would have an immediate and injurious effect on the patient-physician relationship.

In her dissent, the Chief Justice wrote that the decision would effectively “dictate that a physician forbid a patient from engaging in any ‘hazardous activities,’ … regardless of whether, in the physician’s professional opinion, such a warning is necessary or wise in the individual patient’s circumstances.”

The other dissenting judge wrote that the ruling would distort “the highly personal, confidential physician-patient relationship…by introducing a new audience to which the physician must attend—everyone who might come in contact with the patient.” He was concerned that physicians would overreact in ways that may be harmful to patients, or that the decision would open the door to a flood of third-party litigation. He did agree, however, that the decision does not change the legal duty of the physician to provide the patient with sufficient information to make an informed decision.

What the decision means
In discussing this case, both the lay press and physicians have expressed concerns that physicians will not prescribe necessary levels of analgesic and psychotropic medications for fear of resulting liability. Another concern is that prescribing physicians will not consider individual patient needs and will issue blanket warnings about driving, holding grandchildren, or doing anything that involves interaction with another person.

Physicians have a duty to inform patients of potential side effects of prescribed medicines so that patients may make informed decisions about their ability to drive or engage in other activities that may be affected by the use of the drug. In Massachusetts, this obligation also extends to the protection of a third party from the harmful effects of the uninformed actions of the patient, and the third party has a right to recover against the physician under ordinary negligence laws. Other states that have cases directly addressing this issue agree with Massachusetts.

We have all seen pharmacy bottles with so many warning labels that we can barely read the name of the patient or the medication. Although one might assume that a pharmacist might have a duty to tell a customer about the side effects of a prescribed medication, the Massachusetts SJC has held that pharmacists have no such duty. Under the learned intermediary doctrine, both pharmacists and manufacturers are protected from a duty to warn ultimate consumers because that burden is placed on the prescribing doctor.

This case creates a vast new potential for the plaintiff bar by introducing a new deep pocket. Although automobile insurance policies often contain low liability limits, a physician’s resources are generally much greater. Medical liability policies might not cover cases involving simple negligence if the physician is not being charged with malpractice. The case against Dr. Florio is still to be decided, but Dr. Florio is being defended by his malpractice carrier. Similar cases are now appearing in other states, and the final chapter is not yet written.

Meeting our obligations
As physicians, we can meet our obligation of informed consent in several ways. We, or our assistants, can have a discussion with the patient when the prescription is written—and we must document that discussion in the medical record. We may also provide written material to the patient explaining the effects of the medicine we prescribe.

With electronic medical records and e-prescribing, we can program our computers to print out a statement on the prescription that says, “Do not drive or operate machinery while taking this medication.” For those still stuck in the paper world of prescription blanks, a rubber stamp can serve the same purpose. Whatever method you choose, be sure to have adequate documentation in the record to limit your liability.

Murray J. Goodman, MD, is a member of the AAOS Medical Liability Committee. He can be reached at mj-goodman@comcast.net

What do you think?
In Massachusetts, patients applying for a disabled parking placard or license plate are required to submit a form from their physician that responds to the following question:

In my professional opinion and to a reasonable degree of medical certainty: (Healthcare provider must check one)

A) The above condition or any other medical condition of which I am aware, WILL NOT IMPAIR the safe operation of a motor vehicle.

B) The person applying for this permit is NOT medically qualified to operate a motor vehicle safely.

C) The medical condition as stated above is of such severity as to require a COMPETENCY ROAD TEST.

One of your patients, a 74-year-old man with osteoarthritis of the right knee and multiple medical problems precluding total knee replacement, is requesting a disabled parking license plate.

Based on your understanding of the case discussed in this article, which option would you select? Your comments are also welcome.

Submit your response via email to feedback-orm@aaos.org. If sufficient responses are received, results will be published in a future issue of AAOS Now.