/publications/issue/2003/2003-06/2003-06-7239

Pharmacist and Physician Contribute to Alleged Ibuprofen Reaction

Author: Larry M. Simonsmeier, JD, RPh

Issue of the Case:
After finding that a pharmacist and a physician both erred in writing and dispensing an ibuprofen prescription, a federal court was asked to determine whether these acts were the actual and legal cause of the patient?s internal bleeding.

Facts of the Case:
The plaintiff served in the US Army in Vietnam and Cambodia. He received an honorable discharge, but on his return to civilian life he began experiencing psychiatric problems. In the early 1980s, he was diagnosed with posttraumatic stress disorder.

The plaintiff?s tours of duty and subsequent psychiatric problems seem to have exacerbated an earlier struggle with alcoholism. Although sober now, he drank heavily for more than 20 years. Since losing an eye and suffering a skull fracture in a car accident, the plaintiff also has shot heroin intravenously, sometimes sharing needles. In 1994, the plaintiff was admitted to a VA hospital because he was vomiting blood. An endoscopy revealed dilated veins at the bottom of the esophagus and the top of the stomach. It was determined that this condition was caused by increased pressure in the veins passing through his cirrhotic liver. The plaintiff was given a scarring agent that toughens the veins in an attempt to prevent bleeding. He was discharged with specific instructions not to take over-the-counter Motrin (ibuprofen). Two weeks later, the plaintiff was admitted to a different VA hospital because he was experiencing flashbacks and nightmares. Despite knowing that the plaintiff had been told not to take Motrin, the VA physician at this location prescribed 600 mg of ibuprofen. The VA pharmacist who dispensed the prescription incorrectly gave him 800-mg tablets. He began bleeding again after taking 1 tablet and was readmitted to the hospital.

The plaintiff brought this lawsuit against the VA physician and pharmacist for negligently prescribing and dispensing the ibuprofen, alleging that their malpractice caused his internal bleeding.

The Court?s Ruling:
The court found that the VA doctor and pharmacist had breached their duty of care. It did not award damages, however, because the plaintiff?s expert failed to establish by a preponderance of the evidence that the ibuprofen caused the bleeding. The appellate court agreed.

The Court?s Reasoning:
Under federal law, the United States is liable for government employees? negligent acts to the same extent that a private person would be under the law of the state where the cause of action arose. The alleged malpractice occurred in Illinois, which requires a showing that the injury was proximately or directly caused by the defendants? lack of skill or care.

The plaintiff?s expert witness testified that the 800 mg of ibuprofen irritated the wall of the esophagus, precipitating the bleed. He based this conclusion partially on the analysis of the earlier hospitalization. The government countered with its own expert testimony from a gastroen-terologist, who did not believe that a breach in the standard of care had occurred. He argued that the medical records from the earlier hospitalization did not mention ibuprofen as a potential cause but instead focused on the dilated veins in the esophagus. He further indicated that the medical histories were likely the product of medical personnel recording what the plaintiff told them, not actual diagnoses.

The government expert also noted that the plaintiff was taking Tagamet (cimetidine), which should have acted as a prophylactic against the effects of the ibuprofen. He further stated that a single dose of the drug should not cause the bleeding, claiming that the damaging effects are more noticeable in patients who have taken it continuously for extended periods.

In short, the trial court made a credibility finding, accepting the government expert?s version that the ibupro-fen was not the cause of the bleeding. The plaintiff did not produce any evidence undermining that finding and, as a result, lost the case.


Larry M. Simonsmeier, JD, RPhLarry M. Simonsmeier is Emeritus Professor of Pharmacy Law at Washington State University College of Pharmacy.