NEGLIGENCE, A REVIEW
OK, so let’s get this thing started.
The number one reason pharmacists and pharmacies are sued is mis-fills, a form of negligence. The second most reason is failure to counsel, also a type of negligence. The number one reason I get phone calls, e-mails, texts and FB posts is regarding negligent acts (the number two reason—questions regarding the proper filling and dispensing of controlled substances—used to run a far second but is closing the gap, a topic for the future). And looking back over ten years of Pharmacy Law Notes, my newsletter from years past, most scenarios there described negligent acts or cases.
So that takes care of that. This first blog will be a review of negligence. That way, it can be accessed later when I am writing about issues related to the topic.
Negligence is defined as performing an act that one should not have performed or failing to perform an act one should have performed. An example of an act one should not have performed would be mis-filling a prescription for penicillin with atenolol. An example of not performing an act one should have performed would be failing to include a common and clinically significant adverse effect in patient counseling.
In order for a plaintiff (one who is suing for harm or damages) to prevail in a negligence action, four criteria must be met: duty, breach of duty, causation, and damages.
A duty is an obligation to act or not to act on the behalf of another person in a manner that that person can not do for themselves. A primary duty of a pharmacist is to correctly and legally fill prescriptions. Patients can not fill their own prescriptions; thus, they must ask and trust another person to do this for them. By accepting their prescription to fill it, the pharmacist assumes the duty.
A breach of duty is a failure to live up to that obligation.
Causation is the link between the breach of duty and damages. In any negligence case with difficulty, this is almost always the issue. Proving the breach led to the damages incurred is the hardest part of a lot of negligence cases. In law school, it is sometimes called the “but for” test. Imagine, if you will, a [insert appropriate derogatory adjective or three] plaintiff’s attorney puffing before a jury, “BUT FOR the outrageous negligence of Jim Pharmacist in filling a prescription for my poor pitiful client, a drug to which she was allergic to, an allergy screen on his computer he ignored and bypassed, my poor pitiful client would not have had an anaphylactic reaction, had to stay in the hospital, miss time at work, and incur all kinds of unnecessary medical bills!!”
In my example right there, the link is easily established when the patient was given a drug she was allergic to, by a pharmacist who bypassed the allergy screen on his computer. This link is often more difficult to establish. For example, Pat Patient decides to take his atenolol intermittently rather than regularly, because he “knows” when his blood pressure is high. His use becomes more irregular and he suffers a stroke. Pat then sues the pharmacist for not stressing in his counseling that regular use of the drug was very important. Pharmacist claims he did make a statement about the need to take the atenolol regularly, but not stressing that point above and beyond any other point in his counseling. The link here is more tenuous—in two separate cases that match this fact scenario, one judge threw the case out for lack of causation while the other let the issue of causation be determined by the jury (which found for the pharmacist).
Finally, damages must exist and be established by the injured party. Damages must be compensable, which means that they must be measurable. As from the puffing lawyer above, health care costs (that are attributable to the negligence) and missed wages are two good examples of compensable damages. Replacement of lost property, measurable benefits from a known entity, cost of interrupted lifestyle (for example, the patient was hospitalized and missed a Final Four basketball game—the cost of the game tickets and any unrefundable portion for plane tickets or hotels) are also examples. Sentimental damages are not recoverable—too hard to ascertain. However, loss of companionship is something juries can be charged to measure.
Let me reiterate the point I made above. To win, a plaintiff must meet all four criteria. Three out of four will not even get you into a courtroom. All or nothing.
In most states, negligence and malpractice are interchangeable terms. Some states do define them differently but the differences are usually—you see this coming, don’t you?—negligible.
When I taught, I usually got good reviews from my students over my use of examples, so let’s go with a few.
Patient fills a prescription for trazodone and is counseled. Two weeks into therapy he experiences priapism. By the time he seeks medical care, surgery is required and he loses all sexual function. He sues the pharmacy over priapism not being included in the counseling. Will he prevail?
Patient gets prescription for penicillin despite being allergic to it and the pharmacy having this knowledge. Patient gets rash and itches a lot. Patient calls pharmacy; pharmacist recommends diphenhydramine. Patient recovers, discovers the error, and sues. Will Patient prevail?
Patient gets prescription for medication he is allergic to. No harm results. Patient sues pharmacy after discovering the error. Why won’t Patient prevail?
Pharmacist fails to counsel Patient on adverse effects of medication being dispensed. Patient drives after taking the drug, which causes drowsiness, and downs the pills with a beer. Big car wreck follows. The harm is not to the patient, but the car is totaled. It was Patient’s grandfather’s 1932 Duesenberg, which grandfather, son, and Patient all held dear to their hearts. Since the patient is unharmed, can Patient recover anything from the pharmacist?
No, I am not going to keep you hanging. The answers are below.
Two things worth mentioning in pharmacy these days, one good and one not so good.
First, pharmacy chains are moving away from long-held positions that were not always conducive to good practice. Here, following two of the Big Three chains getting fines for issues with the sales of PSE, the chains are telling their stores to hide these products again. Even better, the (subtle and denied) pressure placed on pharmacists to sell these products is in definite decline.
Along this same line, the chains that always took the line “we want every customer” are now supporting pharmacists who deny service to questionable patients. And the problem may not be the individual patient, but his or her prescriber. Beware of overdoing this, ladies and gentlemen. Step cautiously. Reasonable professional judgment and weighing issues in the best interests of the patient should always be your guideposts.
Now, if we can just get the chains to address the “we apologize for everything all the time even when it is not our fault” attitude, that will be real progress.
Second, I received two e-mails regarding this, followed by a third a few days later. Suboxone and pain treatment clinics are now handing out complaint forms to the Board of Pharmacy. If a pharmacy refuses to fill their (questionable prescriptions, the patients threaten to fill out the form and report the pharmacist and pharmacy to the Board.
My response to the pharmacists contacting me was “Let them.” At least currently, the Board is as interested in protecting your professional judgment as you are. The Board is required to investigate all complaints, so keep a documented record of whose prescription you refused and why: questionable patient, questionable prescriber, patient lives far away, prescriber practices far away, etc. With a ready response based on professional judgment, the Board will back you every time.
Trazodone. Since priapism is not a common and clinically significant adverse effect of trazodone, not counseling on that side effect was not a breach of duty. Pharmacy wins.
Penicillin allergy. If you want to sue somebody over the cost of a box of diphenhydramine, go ahead, but if you hire me to do so I am getting a big fat retainer check first. Damages here are pretty much non-existent. They do exist, maybe up to $5 total, but these are what lawyers call “nominal damages” and when they are this low there is no case.
No harm results. This one is more interesting than it looks. Two criteria are met: duty and breach of duty. But you actually get stuck at causation. While the “but for” test is essentially met, there are no damages to show for the mis-fill—the breach of duty does not extend to any damages. Lawyers are plagued with people who discover errors before harm occurs and who also want a million dollars just for finding the error. They want money for harm that could have been. As a pharmacist, I deplore the error and have compassion for the patient who escaped injury, but as an attorney it is plainly “no harm, no foul.”
Duesenberg. Of course damages can be collected. Just not what grandfather et al may think the worth of the car is. Naturally, a car in the same family for over 80 years is going to have sentimental value and they are going to want to zillion bucks for what they lost. What they can obtain is an appraiser’s value of the car in the current market.