Liability in Ordering and Prescribing Medication

By Joshua J. Moore, Franklin College, Franklin, IN; and Gregory P. Moore MD, JD, Attending Physician, Emergency Medicine Residency, Madigan Army Medical Center, Tacoma, WA

Administering medication in the emergency department (ED) or prescribing medication upon discharge exposes the ED physician to liability. When there are resultant complications, side effects, or injury as a result of a medication, lawsuits often are filed. This article will discuss the ED physician's duty to warn and will provide general guidelines on whether a pharmacist or a physician will assume liability in a given situation.

Duty to Warn

The confidential nature of the therapeutic relationship between physician and patient is an integral component of the practice of medicine. An expectation of confidentiality between physician and patient is an essential component of the therapeutic relationship. This duty to maintain confidentiality enables the transfer of potentially sensitive patient information to best serve the patient. The landmark case of Tarasoff v. Regents of University of California established a new duty for a physician to warn a third party regardless of this obligation of confidentiality, concluding that the "protective privilege ends where the public peril begins."1

In 1969, Prosenjit Poddar was detained by campus police on the request of his psychologist, Dr. Moore, after confiding his intention to kill Tatiana Tarasoff. Neither the victim nor her parents were warned before Poddar successfully carried out his deadly threat. In Tarasoff v. Regents of University of California, the parents of Tatiana Tarasoff argued to the California Supreme Court that their daughter's death occurred after Dr. Moore and others negligently failed to warn them.1 They alleged that the therapists predicted that Poddar would kill and that harm to a third party (Tatiana) was foreseeable. The court found that the therapists not only had a duty to the patient, but also had a duty to warn a third party of foreseeable violence.1

The Tarasoff opinion stated not only that "a hospital must exercise reasonable care to control the behavior of a patient which may endanger other persons" but also that a "doctor must also warn a patient if the patient's condition or medication renders certain conduct, such as driving a car, dangerous to others."1

Multiple cases in various states have legally addressed the Tarasoff opinion with regard to warning about medication. In a Hawaii case, the Tarasoff opinion was upheld. Three days after being prescribed prazosin hydrochloride (Prazosin) to treat hypertension, a patient fainted while driving and struck a pedestrian, Kathyrn McKenzie. The court allowed the injured pedestrian to sue the hospital/physician and ruled that a "physician owes a duty to non-patient third parties injured in an automobile accident caused by an adverse reaction to the medication prescribed...where the physician has negligently failed to warn the patient that the medication may impair driving ability and where the circumstances are such that the reasonable patient could not have been expected to be aware of the risk without the physician's warning."2

Two recent ED cases further illustrate the medico-legal importance of the "duty to warn." In the first, Rosemary Schmidt presented to the ED complaining of a headache. After her initial assessment, she was treated with an intravenous dose of 5 mg prochlorperazine (Compazine), a non- narcotic medication commonly used to treat nausea. Thirty-five minutes after receiving the medication and without alerting the staff, Schmidt spontaneously left the hospital's ED. Consequently, she failed to receive the appropriate discharge assessment and warnings with regard to her symptoms and prescribed treatment. Prochlorperazine is known to cause drowsiness, dizziness, and hypotension. Ten minutes after departure, the patient had a head-on collision, inflicting severe injuries on another party. The injured person sued the physician/hospital for "failing to warn" and was supported by the court. The doctor's defense was that there was no duty to the "general public." The court stated that a doctor can anticipate which drugs will impair driving and cause a danger to the public. The judge also announced anyone would find fault with someone who administers an impairing drug and doesn't warn of this, and it can be assumed that a reasonable person would not drive after being warned.3 It is likely that this patient had akasthisia as a side effect of compazine, which led her to leave prematurely. It is important to realize that this did not absolve the physician of liability. One should either prevent akasthisia with antihistamines or treat a patient who may develop it in an area of the ED from which the patient is unable to escape.

In a second case, a 52-year-old woman came to the ED with chronic migraines and was given nalbuphine (Nubain) and promethazine (Phenergen) in dosages that had been administered to the same patient 200 times before in the ED. No warning was given to the patient. One hour after discharge, she was found in a single-car motor vehicle accident, leaving her a quadriplegic. The patient recovered $1.3 million, despite the fact that she appeared alert at discharge.4

Many state courts do not support the Tarasoff decision. For example, a patient was prescribed fluphenazine (Prolixin) and chlorpromazine (Thorazine) and then consumed alcohol. He struck a tree while driving, injuring the car's passenger. The passenger sued the prescribing physician, but liability was not imposed on a physician when the court found that the physician had no duty to the passenger who was not a foreseeable victim.5

It is critical to realize that a physician may be responsible to warn patients or others when a patient has received medication that exposes the public or patient to danger of injury. This applies not only to narcotics but also to other sedating medications such as benzodiazepines, anti-emetics, or antihistamines. Not all states mandate a duty to warn the public. Physicians should know their state laws regarding duty to warn. However, it is easy to simply warn all patients and not worry about state law support. The warning should be clearly documented on the chart and should be given to a competent person. If the physician gives a warning to a patient who is already impaired or under the influence of medication, then it could be argued that the warning was given inadequately.

Who is Liable for Side Effects: The Physician or the Pharmacist?

Side effects and untoward reactions to medication are a known consequence. They may range from mild to severe and often result in litigation by patients. It is important to understand in a given situation if the pharmacist or the physician is responsible for educating and warning the patient, and thus is liable for bad outcomes. Case law provides general guidelines.

A 12-year-old boy was diagnosed with ADHD by his physician and it was decided to begin desipramine (Norpramin). The physician testified that she showed the patient's mother an entry for tricyclic antidepressants in the Physician's Desk Reference (PDR). The entry described common side effects associated with the group of antidepressants, such as dry eyes and mouth and increased pulse rate. The physician also explained that the child should be watched closely for rapid heartbeat. Two years later, after multiple medical visits to a variety of settings, for multiple complaints, the child died from hypereosinophilic syndrome, which is a rare but known complication of desipramine. The parents brought suit against Walmart alleging that it was negligent in the sale of desipramine "by failing to properly warn intended users of the hazards and harms associated with the use of the product." The court ruled that the pharmacist had no duty to warn the patient of side effects. The physician was held liable for $1.012 million.6

Thus, a pharmacist is not held to have a duty to warn a patient of side effects; this is considered the physician's responsibility. Multiple state courts have reached the same conclusion. Courts feel that "to impose a duty to warn on the pharmacist would be to place the pharmacist in the middle of the doctor-patient relationship, without the physician's knowledge of the patient."6

The ED physician erroneously may think the pharmacist will tell the patient things to watch for, and put labels on the bottles. Although this may happen, the courts do not feel this is the pharmacist's duty or obligation.

In another court case, a patient argued that once pharmacists put warning labels on bottles, they agree to be part of the warning process. The court said the pharmacist did not undertake the obligation to warn of all the potential dangers in taking a drug by placing a single warning sticker on the package. Requiring such a duty would discourage pharmacists from placing any warning labels on drug containers. The court said "consumers should principally look to their prescribing physicians to convey the appropriate warning regarding drugs, and it is the prescribing physician's duty to convey these warning to the patients."7

ED physicians will be held responsible and liable for all problems with medications that they dispense and prescribe. How can ED physicians take the time to warn of all side effects in the fast-paced and pressured environment in which they work? Common and anticipated side effects should be communicated clearly to patients. For rarer side effects and problems, general warning and transfer of some obligation to the patient can be accomplished by a discharge instruction of "read all medication package inserts and call me with questions."

Pharmacists can be held liable when a prescription is dispensed and an untoward patient outcome ensues. Courts have held that pharmacists owe purchasers of prescription medication "the highest practicable degree of prudence, thoughtfulness, and vigilance and the most exact and reliable safeguards consistent with the reasonable conduct of the business in order that human life may not constantly be exposed to the danger flowing from the substitution of deadly poisons for harmless medicines."8 A pharmacist who inaccurately fills a prescription therefore is liable to the customer for resulting harm. A pharmacist is bound to safely fill a medication.

For example, a physician prescribed a patient prednisone 80 mg QID, which amounted to 320 mg of prednisone daily. This is clearly an excessive dose. The pharmacist recognized this and called the physician to confirm the dosage. The physician stated that patient should take that dose, so the prescription was filled. Two days later the patient was seen in the ED for thrush. The medication error was recognized and corrected 10 days later. The patient, however, developed a nocardial lung infection and an aspergillosis infection of the brain. He required multiple hospital admissions and surgeries and was left with permanent kidney failure requiring dialysis. The court said, "A pharmacist must exercise his own judgment as to whether any dosage prescribed, even if confirmed by the prescriber, would be harmful to the patient. If he determines the dosage would be harmful, he has an obligation not to fill it." The patient was awarded $2.5 million.9

Liability in Prescribing: Learned Intermediary Doctrine

A prescribing physician may embrace the logic, "it's not my fault that the patient had the side effect; it is the drug company's product that caused the damage." Manufacturers often avoid liability via the Learned Intermediary Doctrine, which states that the manufacturer of a prescription drug has a duty to adequately warn the prescribing physician of the drug's dangers. The physician, relying on his medical training, experience, and knowledge of the individual patient, then chooses the type and quantity of drug to be prescribed.10 The physician assumes the duty to warn the patient of dangers associated with a particular prescribed drug. The drug manufacturers "warn" the prescribing physician by publishing the PDR, which alleges to make all prescribers aware of side effects and complications.

An example of the court's view of the relationship between drug manufacturer, pharmacist, and physician is illustrated in the following prominent legal case. A woman received prescriptions from her doctor for an appetite suppressant known as phendimetrazine (Plegine). The PDR entry for phendimetrazine notes that it is a potentially addictive amphetamine; therefore, its use should be discontinued within a few weeks to avoid addiction. Nevertheless, her doctor authorized refills of the drug for 10 years, and two pharmacists filled the prescriptions without warning her of the possible side effects of extended use. The patient sued the drug manufacturer, the prescribing physician, and the pharmacists for damages sustained as a result of her phendimetrazine addiction. She argued that her pharmacists were negligent in selling her phendimetrazine without warning of its adverse effects and for failing to provide the drug manufacturer's package insert. The Washington Supreme Court concluded that the learned intermediary doctrine, normally applied to the relationship among physician, patient, and manufacturer, applied with equal force to the relationship among physician, patient, and pharmacist. The court stated the physician was in the best position to "relate the propensities of the drug to the physical idiosyncrasies of the patient." The court held that the pharmacists did not have a duty to warn her of the dangerous propensities of phendimetrazine, nor were they legally obligated to give her the drug manufacturer's package insert containing such warnings.11

Conclusion

ED physicians are liable for drugs that are administered and prescribed from the ED. They may hold liability not only for their patients but also may be responsible for others injured by their patients. Pharmacists are required only to safely dispense a medication and they are not responsible to warn of side effects. Prescribers are solely responsible for patient side effects and complications of medications they utilize and prescribe. Prescribers assume this responsibility via the Learned Intermediary Doctrine and this concept allows drug manufacturers, in most cases, to abdicate their liability to prescribers by warning them of side effects with publication of the PDR. When confronted with the overwhelming responsibility of warning patients of all side effects and dangers, physicians should clearly warn and document that patients should not undertake dangerous activity/behavior and should read package inserts.

References

1. Tarasoff v. Regents of the Univ. of Cal., 17 Cal. 3d 425, 551 P.2d 334, 131 Cal. Rptr. 14, 1976.

2. McKenzie v. Hawaii Permanente Medical Group, Inc., No.23268, June 10, 2002.

3. Robinson v Heath Midwest Development Group, Missouri No. SC 83645, October 23, 2001?

4. West v Columbia Med. Center (Texas 5th Circuit Court No. cv00594 1997)

5. Kirk v. Michael Reese Hospital and Medical Center, 117 Ill. 2d 507, 513 N.E.2d 387, 1987

6. Morgan v. Wal-Mart Stores, Inc., No. 03-99-00700-CV (Tex.App. Dist.3 08/10/2000)

7. Frye v Walgreen 605 N.E.2d at 558

8. Dunlap v. Oak Cliff Pharmacy Co., 288 S.W. 236, 237 (Tex. Civ. App.-Austin 1926).

9. Brooks v Walmart Stores, No. COA 99-430, Aug. 29, 2000

10. Rolen v. Burroughs Wellcome Co., 856 S.W.2d 607, 609 (Tex. App.-Waco 1993, writ denied)

11. McKee v. American Home Products Corp., 782 P.2d (Wash. 1989)