Driving Under the Influence of Medications: Are Physicians and Pharmacists Adequately Informing Their Patients of the Risks of Medication Use?
News and Views, American Academy of Forensic Sciences, Toxicology Section, May 2002
A man is discharged from a hospital-based alcohol detoxification program on 300mg of chlodiazepoxide (Librium), four times per day, to suppress alcohol withdrawal symptoms. His girlfriend picks him up at the hospital, and after months without driving, the patient tells the girlfriend that he wants to drive home. He promptly drove right into another car, causing injuries to himself, his girlfriend, and the occupants of the second car. The injured parties in the second car filed a civil suit against the driver and his physician. The plaintiffs alleged that the driver was impaired, and the physician shared liability because he failed to adequately warn the patient of the impairing effects of such a high dose of chlodiazepoxide and instruct him not to drive.
During the trial, the patient and girlfriend testified that the physician had given neither of them any warning or instruction about the dangers of sedation and impairment while driving. The physician testified that he had “done nothing wrong” and had acted “in the usual course of his professional practice.” The jury found that the driver had been impaired, but that the physician was not liable for any of the plaintiffs’ injuries.
As forensic toxicologists, many of us have seen similar tragedies occur and wondered aloud, “If only the doc (or pharmacist) had warned the patient, this case and its associated injuries could have been avoided.” However, up until a few years ago, neither the courts nor the juries have been supportive of this seemingly obvious duty to warn, and its causal relationship to a third party’s injury. Physicians generally have been found not to have been liable to third parties for a patient’s actions, while taking prescribed medications and in one old case, the trial court dismissed claims filed against the prescribing physician and HMO employer, [Kaiser v. Suburban Transportation System, 396 P.2d 14 (1965)].
However, in 1999, the Kentucky appellate court (Schrand v. Grant, 1999 Ky. App. LEXIS 76 (1999) reviewed a lower court case where the jury had found Dr. Schrand (and his associate Dr. Sander) to have been 50% responsible for injuries sustained by a woman and her son when a patient medicated with Demerol drove into their car. This case has been summarized by noted healthcare attorney Miles Zaremski in American Medical News, Feb. 7, 2000, p.11, and is paraphrased below.
Deborah Howard had been seeing Drs. Schrand and Sander since the 1980s due to migraine headaches. Migraines were treated with IM meperidine (Demerol). Ms. Howard later developed interstitial cystitis which was also treated with meperidine. Pain increased, and by July 1991, Dr. Sander prescribed meperidine by a self-administered, patient-controlled pump for Ms. Howard. On August 29, 1991, Ms. Howard was suspected of having overmedicated herself. A nurse was summoned who telephoned Dr. Schrand. Dr. Schrand told Ms. Howard to go to the hospital. Fearing problems at work, Ms. Howard refused to go to the hospital and Dr. Schrand allowed her to go home.
Arrangements were made for the nurse to drive Ms. Howard home, but in the parking lot the nurse allowed Howard to drive herself home. While driving home, Howard collided with a vehicle being driven by Ms. Grant and her son. Grant was seriously injured and her son was killed. Grant, her husband, and their son’s estate sued the doctors, the nurse, Howard, and others. At trial, the jury found the doctors to have been 50% responsible for the Grants’ injuries. The doctors appealed, arguing that they owed no legal duty to the Grants. The issue addressed by the Kentucky appellate court was whether the doctors should have reasonably foreseen that Howard might have had a car crash and caused injuries to other people due to the effects of meperidine.
The doctors argued that they did not have a duty to prevent injuries to the Grants because the Grants were not reasonably foreseeable victims of Howard’s actions. The appellate court ruled that defendants may not escape liability for negligence just because the identity of the victim could not be determined beforehand, and affirmed the findings of the lower court (Boone Circuit Court). (emphasis added by author)
In April 2000, a Texas woman received an unspecified drug for treatment of her migraine headache, left the hospital, and drove into another car nearby. Plaintiffs claimed that the standard of care required the hospital (nursing staff) to verify that sedated patients have someone to drive them home, (West v. Columbia BVM C, Tex., Brazos County 272d Jud. Dist. Ct., No. 48,274-272, Apr. 10, 2000).
Many prescription drugs can cause sedation, hypotension, or blackouts while driving. Drugs used for Benign Prostatic Hyperplasis (BPH) can cause postural hypotension and blackouts from coughing or other valsalva maneuvers (see Benjamin, Alpha Blockers and the Law, Abstract K15, February 1998 AAFS Syllabus). Tricyclic antidepressants also cause sedation and alpha blockade. Oral antidiabetic agents of the sulfonylurea class cause frequent hypoglycemic reactions and occasional “Antabuse” reactions which block ethanol metabolism.
In Kaiser, cited above, a Washington state bus driver asked his physician for something for his stuffy nose. The physician prescribed the antihistamine pyribenzamine, and the bus driver fell asleep behind the wheel. Neither the physician nor the pharmacist warned of drowsiness (pharmacists were not required to warn in 1965), and the pharmacist didn’t affix any warning labels to the medication container. Over-the-counter (OTC) drugs can also be sedating. A 50-mg OTC dose of diphenhydramine (Benadryl) significantly impaired driving performance and Benadryl was the largest selling OTC antihistamine in 1998 (Ann Intern Med. 2000;132:354-363).
The doctrine of informed consent derives, in part, from Justice Cardozzo’s decision in Schloendorff v. Society of NY Hospital, 211 NY 125, 129-30, 105 N.E. 92-933 (1914), where he stated that every adult had a “right to determine what shall be done with his own body . . .” This generally translates into a duty of the physician to supply information on what is material and foreseeable to the patient. Once the patient has been told what a reasonable person would need to know to accept or reject the proposed therapy (or procedure), the patient either assumes or rejects the risks and takes the medication or does not (informed refusal). With OTC medications like Benadryl, manufacturers have a duty to provide adequate warnings about dangers associated with driving, using dangerous machinery, and possibly the combination of their product with ethanol, a foreseeable, potentially catastrophic combination.
In 1990, congress passed the Omnibus Budget Reconciliation Act (OBRA ’90), which went into full effect on January 1, 1993. OBRA requires pharmacists to “offer to counsel” all Medicaid patients about their prescription medications. Each state must define the type of counseling required, and legal duty of the pharmacist to warn the patient has varied considerably from state to state. In one notable case, Johnson v. Walgreen, (No. 95-2807, 7/3/96), the Florida District court of Appeals, First District, held that a pharmacy had no duty to warn a customer of potential adverse drug interactions, and that its duty consisted only to filling prescriptions accurately. However, in a Massachusetts case Cafarelle, et al. v. Brockton Oaks CVS, Inc. (Lawyers Weekly No. 12-122-96), this defense failed to protect a pharmacy from a jury verdict when a 13-year-old girl died from overuse of her asthma medication (Proventil, albuterol), which the pharmacy had refilled more often than prescribed. In his opinion, superior court Judge Patrick Brady stated that a pharmacist owes a customer “a duty of ordinary care” and further noted that . . . “The [defendant’s] computer system alerted the [defendant] pharmacist that [the decedent] was getting the inhalers at improper intervals. . .The risk of her overuse of the medication was not only foreseeable, it was foreseen by the [defendant] pharmacists.” Once again, foreseeability was a pivotal factor in the legal analysis, as was the “reasonable man standard” which was stated by Judge Brady as “that degree of care that an ordinarily prudent pharmacist would have exercised under the same or similar circumstances . . . .”
In summary, driving a motor vehicle while under the influence of impairing medication is a common occurrence. Impaired drivers injure or kill themselves, their families, and other citizens who share the highways with them. They are then held accountable by our legal system and can face both criminal and civil penalties for their actions. Many of these “accidents” are foreseeable to physicians and pharmacists who prescribe, dispense, or sell medications, but in some cases, these healthcare professionals fail to adequately warn their patients about the dangers of driving or using dangerous equipment while using the dispensed medication. It is time for our legislators, public citizen groups, attorneys, and members of the forensic community to put greater pressure on physicians to meet their duty to patients, and to the rest of us who share the highways with their patients, and provide adequate warnings and instructions to patients being treated with medications known to impair cognitive abilities and psychomotor function, before they become another court date on our calendars.