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Duty to Warn Fulfilled

Jesse C. Vivian, RPh, JD
Professor, Department of Pharmacy Practice
College of Pharmacy and Health Sciences
Wayne State University

Detroit, Michigan
 



12/17/2010

US Pharm. 2010;35(12):88-92. 

The number of cases raising the question of whether a pharmacy or a pharmacist has a legal duty to inform the patient or physician about potential dangers associated with the taking of a particular prescription drug in light of special circumstances, such as allergies or contraindications, have risen exponentially in the last two decades. The courts have yet to find one consistent standard or policy to address these and similar questions.1 Many jurisdictions have taken the position that pharmacists have no duty to warn based on a variety of judicial doctrines, while other courts have found that there are situations where a pharmacist does have a duty to warn. In a recent case, the issue was whether the pharmacy could be held liable to a patient who suffered injuries when the pharmacist warned the physician of a possible adverse interaction between two drugs but did not indicate the warnings to the patient.2 

Facts of the Case

The plaintiff's wife had been a patient of the physician for at least 10 years, during which time the physician prescribed lithium to treat her possible manic-depressive psychosis. On January 16, 2003, the physician prescribed atenolol to treat the patient's high blood pressure. She took the prescription to the same local chain drugstore she used to get her lithium prescriptions filled. The records indicate that the atenolol prescription was filled on January 20, 2003. However, as the pharmacist on duty began to enter the prescription information into the computer, a warning screen appeared indicating that there is a potential drug-drug interaction between lithium and atenolol that could lead to lithium toxicity. 

The pharmacist called and spoke with the prescriber. The prescriber told the pharmacist to fill the prescription and that the prescriber would monitor the patient for any problems. The pharmacist memorialized the conversation with the prescriber in a written note that was put in the patient's chart. The pharmacist did not say anything to the patient about the drug-drug interaction or toxicity warning. During the discovery phase of a lawsuit that would be filed later, the prescriber testified in deposition that he had no recall of the conversation with the pharmacist. 

On January 27, 2003, the prescriber issued another lithium prescription for the patient. She took it to the same pharmacy she had been using all along. While preparing to fill the new prescription, a second pharmacist saw the handwritten note in the patient's chart from the first pharmacist noting that the prescriber was going to be monitoring the patient after being informed of the drug-drug interaction. Based on that information, the second pharmacist filled the lithium prescription and dispensed it to the patient without giving her any additional warnings or precautions. The second pharmacist did not place a call to the prescriber because it appeared to him that the prescriber had already been notified and there was nothing else he needed to do. 

The patient became ill and was hospitalized on February 3, 2003. She died within a short time and the cause of death was allegedly lithium toxicity. 

Lawsuit

The estate filed a lawsuit against the prescriber and the pharmacy. The lawsuit claimed, in part, that the pharmacy failed to warn the patient of the drug-drug interaction either on January 20, 2003, when the atenolol prescription was initially filled, or on January 27, when a subsequent lithium prescription was dispensed. The trial court judge refused to dismiss the pharmacy from the lawsuit on a motion for summary judgment, ruling that it was a jury question whether the pharmacy had a duty to warn the patient. The case was docketed for a jury trial to begin on February 4, 2009. That same day, the pharmacy filed a motion with the court claiming it had no duty to warn either the physician or the patient of the interactions under the circumstances presented. The judge indicated he would take the motion under advisement. The next day, February 5, 2009, the lawsuit against the physician was dismissed because the physician and the estate for the patient had reached a settlement agreement. The details of that settlement agreement were not provided. 

Subsequently, on February 13, 2009, the trial court granted the pharmacy's motion to dismiss, finding that the pharmacy had no duty to warn the physician or the patient under the Illinois version of the “learned intermediary doctrine.” As part of his ruling, the judge determined that this case was distinguishable from another state lawsuit, Happel v. Wal-Mart Stores, where the Illinois Supreme Court held that a pharmacist could be held liable for failure to warn under the unique circumstances of that case.3 The estate for the patient appealed to the Illinois Court of Appeals. 

Ruling

Reviewing the pleading, the Court of Appeals noted that the plaintiff contends that the learned intermediary doctrine does not insulate the pharmacy from its legal duty to warn of a deadly drug interaction. The court went on to explain that the learned intermediary doctrine provides that manufacturers of prescription drugs have a duty to warn prescribing physicians of the drugs' known dangerous propensities, and that the physicians, in turn, using their medical judgment, have a duty to convey the warnings to their patients.4 The court noted that as a result, the doctrine prevents imposing a duty upon drug manufacturers to warn patients directly. However, the doctrine has also been applied to exempt pharmacies and pharmacists from giving warnings to patients.5 

The court found, based upon precedent from earlier state common law cases, that the pharmacy here also had no duty to warn. Here, reasoned the court, the patient's longtime physician prescribed atenolol to treat high blood pressure while she was already taking lithium for manic depression. The two drugs were known to have a negative interaction, and the computer indicated this when the atenolol prescription was being filled. The record indicates that the pharmacist called the physician prior to filling the prescription regarding the potential interaction, and the physician indicated that he would monitor the patient. Making a notation in the file, the pharmacist filled the prescription for the atenolol. When the lithium prescription was refilled, the pharmacist saw the note regarding notification to the physician about the interaction and that the physician would monitor the patient. 

According to the court, “We find that the pharmacist properly filled the prescriptions that the physician wrote, took notice of the warning in the system regarding a possible interaction between the two drugs, and notified the physician of the potential interaction prior to filling the prescription. The physician then indicated that he would monitor the usage, so the pharmacist filled the prescription and made a notation. Under these circumstances…we find that the pharmacist was under no duty to warn the customer of the possible interaction between the two drugs under the learned intermediary doctrine. To hold otherwise would impose a greater duty on the pharmacist than on the drug's manufacturer, as the duty of extending warnings to patients concerning prescription drugs belongs with physicians.”6 

As to the Happel case, which the plaintiff relied on to hold that pharmacists can have a legal duty imposed to warn patients of known drug allergies, the court found the facts to be distinguishable from the case at bar and therefore not the controlling law. 

In Happel, the Illinois Supreme Court framed the issue as “whether a pharmacy has a duty to warn about a known drug contraindication where the pharmacy is aware of a customer's drug allergies and knows that the medication prescribed by the customer's physician is contraindicated for a person with those allergies.”7 There, the plaintiff was allergic to aspirin, ibuprofen, and acetaminophen and experienced a severe reaction after taking Toradol (ketorolac), a pain reliever prescribed by her physician. Toradol should not be taken by persons who are allergic to aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs). The plaintiff's physician knew of her drug allergies, but was unaware of Toradol's contraindications for patients allergic to aspirin. Prior to having the prescription for Toradol filled, the plaintiff had gone to the Wal-Mart pharmacy approximately six times to have other prescriptions filled. Each time she went to the pharmacy, workers asked her if she had any drug allergies, and each time she told them she was allergic to aspirin, ibuprofen, and acetaminophen. The pharmacy manager testified that it was the pharmacy's policy to ask customers about their known allergies before dispensing medication to alert the pharmacist to any drug interactions or allergies, and that plaintiff's allergy information was in the computer and available when the Toradol prescription was filled. 

There was also testimony presented at trial that if the Toradol information was in the computer, a “drug interaction” warning would have flashed, requiring a call to the physician and a system override before the prescription could be filled. The pharmacist could not remember phoning the physician. When the prescription was picked up, the plaintiff was again asked about any drug allergies. The plaintiff became ill after taking the Toradol, and subsequently she and her husband filed suit against her physician and the pharmacy. 

The Illinois Supreme Court found a narrow duty to warn outside of the learned intermediary doctrine under the circumstances presented in the case because: 1) it was undisputed that the pharmacy was aware of both the patient's drug allergies and that the drug was contraindicated by persons such as plaintiff who were allergic to aspirin (superior knowledge); 2) the burden was minimal, as it required the pharmacist to phone the physician and notify him or her of the contraindication or notify the patient; and 3) there were no real consequences to Wal-Mart as it already had a practice of notifying physicians of a patient's drug allergies. 

According to the Court of Appeals, the same circumstances were not present. “Here, [the pharmacy] did in fact notify the physician of the potential drug interaction between [atenolol] and lithium prior to filling the prescription and made such a notation in her file, whereas the pharmacy in Happel did not. Even applying the holding of Happel to the instant case, [the pharmacy] acted within its duty by notifying [the patient's] physician of the potential drug interaction before filling the prescription because the Happel court indicated that the duty was discharged upon notification to the physician or the patient.”8 Therefore, the Court of Appeals ruled that the trial court did not commit error when it dismissed this case as being distinguishable from Happel

Analysis

This case should not be counted among those that hold pharmacists have no duty to warn about dangers associated with the use of a medication by a patient. The importance of this case is that the pharmacist did take the one necessary step to avoid liability--he notified the physician of the potential drug-drug interaction. After that, the physician assumed the role of managing the dangers. But note that the first pharmacist to fill the atenolol prescription did the one more thing that lawyers always tell their clients to do--document your actions. Or, in other words, if it's not written down, it didn't happen. This piece of evidentiary documentation was crucial to the court's decision. The physician stated that he did not remember having the conversation with the pharmacist about the lithium-atenolol interaction. The court completely ignored the putative oversight because there was written documentation that both pharmacists looked at and relied upon while serving this patient. The key is that the documentation actually was in the patient's chart. 

Let this be a lesson to all practicing pharmacists. Keep track of your conversations with patients and physicians and make written notes to document your actions. This will save you from the great potential of liability when your patients' outcomes are less than favorable. 

REFERENCES

1. Burns KA, Spies AR. A Pharmacist's Duty to Warn: Promoting the Acceptance of a Consistent Legal and Professional Standard. 47 Duq L Rev 1 (2009).
2. DiGiovanni v. Albertson's Inc., Slip No. 1-09-1297 (August 25, 2010), 2010 Ill App Lexis 891. www.chicago-personal-injury-
lawyer-blog.com/DiGiovanni% 20v%20Albertsons.pdf. Accessed November 21, 2010.
3. Happel v. Wal-Mart Stores, 199 Ill 2d 179, 766 NE2d 1118, 262 Ill Dec 815 (2002).
4. Kirk v. Michael Reese Hospital & Medical Center, 117 Ill 2d 507, 517, 513 N.E.2d 387, 111 Ill Dec 944 (1987); Fakhouri v. Taylor, 248 Ill App 3d 328, 330, 618 NE2d 518, 187 Ill Dec 927 (1993).
5. See Eldridge v. Eli Lilly & Co., 138 Ill App 3d 124, 485 NE2d 551, 92 Ill Dec 740 (1985); Leesley v. West, 165 Ill App 3d 135, 137-38, 518 NE2d 758, 116 Ill Dec 136 (1988); Fakhouri, 248 Ill App 3d at 332-333.
6. See Note 2, supra.
7. See Note 3, supra.
8. See Note 2, supra. 

To comment on this article, contact rdavidson@uspharmacist.com.

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