Rx & The Law
by Don R. McGuire, Jr., R.Ph.,
Pharmacists Mutual Insurance Company
In the past, this series has examined a number of legal and claims issues. Think back to your pharmacy law class in college. How much do you remember about the elements of negligence? What does a plaintiff have to prove in order to win a negligence case? Time for Negligence 101 class to begin.
The more common types of claims involving pharmacists are negligence claims. Negligence is one category of cases in the area of the law known as Torts. Negligence is defined as “the failure to exercise that degree of care which a person of ordinary prudence would exercise under the same circumstances.” As you might have guessed, negligence and neglect derive from the same root word. Negligence does not include reckless behavior or intentional behavior.
To win a negligence case, the plaintiff must prove four elements. They are; duty, breach of that duty, proximate cause, and harm. We will examine each of these elements in turn as they apply to pharmacy practice.
Duty is the requirement to behave in a certain manner for the benefit of another. Pharmacists do have certain duties to their patients. There is a long line of cases that indicate that a pharmacist has a duty to fill a patient’s prescription correctly. Previous to changes in pharmacy practice, this was the pharmacist’s only duty to their patients. Today, we have additional duties, such as patient counseling and drug regimen reviews. The courts in the various states have been slow to recognize these additions to the pharmacists’ duties. This results in differing case law from state to state. However, the pharmacist’s duties to their patients are not unlimited. The pharmacist has to take only reasonable steps to prevent foreseeable harm. Therefore, it is not required to prevent all harm. If the plaintiff’s case involves a situation where the pharmacist did not have a duty to the plaintiff, then the case will fail.
The second element of a negligence case is whether a breach of the pharmacist’s duty to the patient has occurred. A duty can be breached in one of two ways. The required duty is not performed (nonfeasance) or the activity is performed, but it is incomplete or incorrectly done (malfeasance). This element most likely will require some proof of the standard of care. This involves the testimony of expert witnesses. The expert witness will draw on their own experience, laws and regulations, codes of ethics, and other such items to determine if the pharmacist performed their required duties adequately. In cases where a prescription has been misfilled, this element is not hard to prove. Case law is full of cases that state that a pharmacist must fill prescriptions correctly. If you don’t, that is a breach of duty. However, in cases where it is alleged that the pharmacist failed to perform DUR or provide patient counseling, it can be more difficult. Many times you will have opposing testimony from experts, as well as from opposing testimony from parties. It is usually not clear-cut what the judge or the jury will decide when they are given conflicting testimony.
The third element that the patient must prove in order to prevail is that they were injured or harmed. In many cases, this is not too difficult. The patient became dizzy and fell, their blood sugar dropped precipitously, their blood pressure increases or decreases, or they suffered an allergic reaction. Many states require a physical injury in order to make a claim for emotional injuries. The theory here is that claims for anxiety, stress, sleeplessness, etc. are more credible if they result from a bodily injury. Sometimes it is difficult to separate the symptoms complained of from the patient’s underlying pre-existing conditions. This leads us to the fourth element.
The injury that the patient suffered must have been proximately caused by the breach of duty. That is, if a prescription is misfilled, the injury suffered must be due to the misfill and not some other cause or underlying condition. For example, a person who experiences high blood pressure after taking an overdose of an antihypertensive drug would cause you to question if the misfill actually caused those symptoms. This element becomes very important in cases where it is not clear if the patient actually took the drug in question, or that the symptoms could be caused by some other factor. Again, this is an area where the use of expert witnesses is very important. There is also another concept under this element. It is called superceding or interceding cause. Suppose that a patient had been taking the wrong medication for a couple of days when she is involved in a car accident. The impact breaks her leg and requires surgery to repair the bone. Obviously, this injury is not the result of the misfill and would not be proximately caused by it. This injury would not be compensable under the misfill claim.
In summary, for a patient to prevail in a negligence claim against a pharmacist, the patient must prove the four elements of negligence. They are duty, breach of that duty, proximate cause, and harm. If they fail to prove even one of the elements, then there will be no monetary damages awarded to them. However, in cases involving the misfiling of potent medications, such as methotrexate or warfarin, this burden of proof is not a huge obstacle to overcome.