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Package Inserts Can Play a Role in Malpractice Claims

October 28, 2018

ORLANDO, Fla.—There is nothing trivial about a prescription medication’s package insert, Sheldon H. Preskorn, MD, advised attendees at his session on pharmacology and malpractice at Psych Congress 2018.

Prescribers who dismiss a package insert as a document mainly written by lawyers to protect drug manufacturers are, at best, wrong, and may actually be skating on very thin ice, said Dr. Preskorn, a professor at the University of Kansas School of Medicine in Wichita who has served as an expert witness in multiple malpractice lawsuits.

    Sheldon H. Preskorn, MD

Practice inserts are jointly written by a team of clinical experts from the pharmaceutical manufacturer and the US Food and Drug Administration (FDA) as the last step of the drug approval process.

“It is one of the few places you will find where your federal government, the agency of the FDA, and the manufacturer have come together to write up what they think you should know about the prescription of a drug,” Dr. Preskorn said.

Package inserts can also figure significantly in medical malpractice cases. During his talk, Dr. Preskorn shared examples from actual cases where a package insert played a key role in the outcome of a medical malpractice lawsuit.


“Tommy” was a 55-pound 6-year-old diagnosed with attention-deficit/hyperactivity disorder (ADHD). When he failed to adequately improve with amphetamine and methylphenidate, the prescriber began imipramine at 50 mg/day, which was gradually titrated to 200 mg/day based on an assessment of response. One day at school, Tommy collapsed. Later, in the hospital, he experienced a bout of ventricular fibrillation and cardiac arrest and died.

The package insert for imipramine warned against exceeding 2.5 mg/kg in a child, the presenter explained. At the time of his collapse, Tommy was taking 8 mg/kg—an amount more than 3 times higher than the recommended dose.

The insert also recommended an electrocardiogram before starting the drug in a child and after each dose increase. None was ever done.

The case “ended poorly for the prescriber,” Dr. Preskorn said. “The failure to follow the package insert was a direct cause of the child’s death.”


“Michael” was an 18-year-old long-distance runner who was valedictorian of his senior class. Upset over the impending death of his grandmother, he saw three providers (two who practiced together in his hometown and a third in his grandmother’s town) for episodes of depression and anxiety and, finally, dehydration over 11 days. Among the medications prescribed over that time was quetiapine XR, which was switched to quetiapine IR at the insistence of Michael’s health insurer.

On day 11, Michael fell asleep in a recliner and, the next morning when his mother tried to wake him up, was unresponsive. He now lives in a vegetative state.

The package insert for quetiapine mentioned 5 times to avoid using the drug in patients with dehydration.

“You can see things going south, and that’s the reason why the (prescribers’ malpractice) insurance companies settled,” Dr. Preskorn said.


In addition to understanding the importance of package inserts, prescribers should keep pharmacology principles in mind when prescribing and take the time to document their decisions and the rationale behind them, the presenter advised.

“I believe these take-home points are good medicine, not just being defensive,” he said. “And that’s the reason why I presented them to you.”

—Jolynn Tumolo


“Malpractice and clinical pharmacology: lessons learned from real-life cases on how to improve care and avoid problems.” Psych Congress 2018: Orlando, FL; October 27, 2018.

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