Issue of the Case:
A Louisiana court was asked, in this month?s case, whether a pharmacist was liable, along with the physician, for a home infusion therapy error when he dispensed an incorrect dose of a drug traditionally provided only within institutional settings.
Facts of the Case:
The plaintiff developed an infection that manifested itself through the development of boils all over her body. Over the course of 15 months, she saw various doctors, who would typically lance the boils, drain them, and prescribe antibiotics.
On 1 occasion, the plaintiff objected to the physician?s recommended course of oral antibiotics because it resulted in only limited success in the past. The doctor offered intravenous antibiotics as an alternative therapy. The plaintiff accepted the recommendation.
The next day she went to a hospital clinic, where 1 of the boils was drained. The pathology report revealed a staphylococcus infection. A subclavian catheter was inserted into her chest, and a dose of 240 mg of gentamicin was administered.
The plaintiff returned to the clinic the next day and received a second dose of gentamicin. She was then issued a prescription for 5040 mg of gentamicin to be self-administered 240 mg daily for 21 days. The physician also ordered weekly blood urea nitrogen and creatinine tests.
The prescription was taken to the defendant?s community pharmacy, but it did not have the drug in stock. The plaintiff was told to come back the next day. Upon her return, the pharmacist dispensed 8 g of gentamicin, nearly 3 g more than called for in the prescription. Additionally, the pharmacist allegedly failed to provide the plaintiff with any oral or written drug information.
The plaintiff self-administered the gentamicin for the next 21 days. Her laboratory results were normal. Although the treatment should have ended, she administered 7 additional doses, believing that she should continue therapy until it was gone. She began to experience dizziness. She called the clinic and was told to discontinue the drug and return in a month.
The plaintiff?s condition did not improve. She complained of dizziness, nausea, and feeling intoxicated. After being referred to a specialist, she was diagnosed with vestibular dysfunction as a result of the gentamicin?s ototoxicity. She filed a lawsuit against the physician, the clinic, the pharmacist, and the pharmacy.
The Court?s Ruling:
The resolution of the case is somewhat complex because Louisiana uses a Patient?s Compensation Fund in malpractice actions such as this. The bottom line: The jury awarded total damages of over $5.7 million and found the physician 85% at fault, the pharmacist 10% at fault, and the patient 5% at fault. The award was eventually reduced to $430,000 because of a legal limit on malpractice awards in Louisiana. On appeal, the award was upheld.
The Court?s Reasoning:
Experts testified that gentamicin is usually used with other drugs to treat life-threatening infections, whereas penicillin is more commonly used to treat infections such as the one that caused the plaintiff?s boils. Testimony also was given that gentamicin is generally not prescribed in a single bolus dose but instead should be taken every 8 hours to avoid high levels of the drug in the bloodstream. Finally, it was contended that, if gentamicin is to be used in long-term home therapy, it should be administered and monitored by a home health nurse.
The court concluded that the doctor was clearly at fault and should have appreciated the great risk caused by his conduct. However, the physician was not the only person whose conduct contributed to the harm. It was found that the pharmacist?s dispensing of additional doses of the drug clearly fell below the standard of care, and this allowed the plaintiff to take the drug for an excessive number of days.
In addition, the patient was found to have contributed to her own injury. She was aware that her prescription was for only 21 days, and yet she continued to self-administer the therapy. She also waited several days before calling the doctor, despite warnings by a family friend. The court could find no error in the jury?s allocation of fault.
Larry M. Simonsmeier is Emeritus Professor of Pharmacy Law at Washington State University College of Pharmacy.