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Medication-related liability.

Question: An 85-year-old woman with a hip fracture received a narcotic after open reduction and internal fixation. Over the first postop hour, she received two intravenous doses of 0.5 mg Dilaudid (hydromorphone), followed by an additional 2 mg in divided doses over the next 4 hours. She sustained a cardiorespiratory arrest shortly thereafter. Which of the following statements is correct?

A. This is a likely case of opiate-induced respiratory arrest.

B. The Dilaudid dose is relatively small and cannot be the cause of the arrest.

C. Monitoring of respiratory rate and pulse oximetry will always detect early opiate-induced respiratory depression.

D. This complication is unlikely to occur in previously healthy young adults.

E. Lawsuits over iatrogenic injuries are impossible to defend even if the doctor followed community standards regarding dosage, indication, and disclosure of risks.

Answer: A. Opiate-related complications typically occur in the first postop day, and some physicians are unaware of the updated guidelines on dosage reduction for Dilaudid.

For example, it has been recommended that the intravenous order for this drug be 0.2-0.6 mg every 2-3 hours for opiate-naive patients rather than the previous 1-2 mg every 2-4 hours. Respiratory depression is the feared complication; importantly, bradypnea and desaturation in those already on oxygen are late signs. Seemingly healthy young adults may succumb, especially where there is the concurrent use of alcohol or other CNS-modifying drugs.

Preventable adverse injuries from medication errors are a common phenomenon, estimated by the Institute of Medicine to occur in at least 1.5 million cases in this country each year. Not all medication-related adverse events are the result of an error. Some are unforeseen or unavoidable. An effective defense is to adhere to community standards and document all relevant patient discussions.

Under the law of negligence, medication-related claims against the doctor require the plaintiff to prove deviation from the standard ordinarily expected under the circumstances. The patient has to show proximate causation; that is, the medication at issue both factually and legally caused the injury.

Thus, in a lower-court case in which the plaintiff suffered a perforated bowel purportedly from the use of cholestyramine and codeine that resulted in severe constipation from huge fecaliths, the doctor defendant escaped liability because the patient fared to exclude a barium enema procedure as the cause of the perforation.

Disclosure of material treatment risks is always necessary, as well as documentation that such a discussion took place and that the patient understood and accepted the risks. The required level of disclosure may vary, but it is best to use the patient-centered standard, that is, what a reasonable person would want to know under the circumstances, rather than the physician-centered standard, which stands for what a reasonable doctor would disclose.

One class of drugs--opiates--bears highlighting. The therapeutic window for these drugs is narrow. Always consider accidental or deliberate overdosing, especially in the elderly, drug abusers, or those using alcohol or other drugs--especially antidepressants. In 2010, nearly 40,000 deaths resulted from drug overdoses--three-quarters of the overdoses being unintentional and 17% suicidal (JAMA 2013;309:657-9). Most were from prescription drugs.

The presence of comorbid states such as cardiorespiratory disease, hypothyroidism, and renal insufficiency can predispose to opiate-related respiratory depression.

Take a detailed drug history, especially in patients exhibiting drug-seeking behavior. Avoid all online prescriptions for controlled substances. Disciplinary actions and potential criminal sanctions may visit the professional who prescribes over the Internet without an established doctor-patient relationship.

Under the learned intermediary doctrine, the doctor, not the drug manufacturer, is liable for injuries arising out of prescription drug use. This doctrine was endorsed by the Supreme Court of Texas in Centocor Inc. v. Hamilton (372 S.W3d 140 [2012]), where a lupus-like syndrome resulted from the use of infliximab (Remicade) in a woman with Crohn's disease. All states have adopted this doctrine except West Virginia and New Jersey, which provide for manufacturer liability where there is direct marketing of a product to consumers.

So-called strict liability theories for "defective" products have been repeatedly held as inapplicable to doctors who, unlike manufacturers, are not usually considered to be sellers of the product. Strict liability is the basis for most product liability lawsuits, and all the plaintiff has to show is that the product is unreasonably dangerous. No proof of fault or negligence is necessary.

Avoid companies with negligent standards. In the recent steroid-preparation scandal that led to fatal fungal meningitis in some 45 patients nationwide, some of the prescribing doctors now face lawsuits, the compounding pharmacy at issue having declared bankruptcy in the interim.

BY S.Y. TAN, M.D., J.D.

Dr. Tan is emeritus professor of medicine and a former adjunct professor of law at the University of Hawaii. This article does not constitute medical, ethical or legal advice. It is adapted from the author's book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). Contact the author at Scan the QR code to read more of Dr. Tan's columns at
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Title Annotation:LAW & MEDICINE
Author:Tan, S.Y.
Publication:Family Practice News
Geographic Code:1USA
Date:Jun 1, 2013
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