Charting the legal maze of off-label device use


Off-label use of a medical device can potentially result in medical malpractice litigation. To help physicians become familiar with the conditions under which the off-label use of a medical device is legally permissible and acceptable, O. William Brown, MD, JD, of the Oakland University William Beaumont School of Medicine, presented Legal Implications of Off-Label Device Use at the recent Northwestern Vascular Symposium.

The primary purpose of Food and Drug Administration regulation of medical devices is to provide protection for the public and to limit industry’s ability to promote the off-label use of their devices. Off-label use is defined as the use of a medical device for a purpose or manner not approved by the FDA.

Dr. O. William Brown

During his presentation, Dr. Brown stressed that it is not the intent of the FDA to limit the authority of a health care professional to utilize a legally marketed medical device. The court system has, on many occasions, supported the physician’s ability to use medical devices in an off-label manner.

“However, the courts have stressed that such uses must comply with the standard of care,” Dr. Brown said. “In addition, the courts have made it clear that physicians who choose to use devices off-label must have a thorough understanding and extensive experience with the use of the device on-label.”

The legal system has also emphasized the importance of obtaining true informed consent in the off-label use of the medical devices. In obtaining informed consent, the physician should provide the patient with the following:

  • a full diagnosis
  • the planned procedure
  • the risks and the benefits of that procedure
  • other treatment options
  • the natural history of the disease if left untreated.

Physicians who fail to provide such data, or provide inaccurate data regarding either experience with a device, or outcome results of previous procedures, will be held liable, according to Dr. Brown.

“Interestingly, as a result of the recent court case of the United States of America versus Alfred Caronia, the FDA’s ability to regulate industry’s promotion of off-label use has potentially been seriously impaired,” Dr. Brown said.

In that case, Mr. Caronia, a manufacturer’s representative, was charged with promoting the off-label use of a drug. He was found guilty but the U.S. Court of Appeals reversed the guilty verdict. The Appellate Court ruled that the promotion of off-label use was protected under the Free Speech Clause of the first amendment. It should be stressed that this ruling questions, but does not eliminate, the FDA’s ability to limit the promotion of off-label use.

“Present case law suggests that the physician, and not the manufacturer, will bear the brunt of liability if complications occur as a result of off-label use of a medical device,” Dr. Brown said.

“In general, lawsuits that have been filed against the manufacturer for the off-label use of a medical device have failed. Unfortunately, this leaves the physician in a very precarious position. If injured patients are unable to successfully obtain compensation from the manufacturer, they will be left with no choice but to turn their attention to the medical profession.”

Dr. Brown predicts that off-label use of medical devices will likely increase as technology tries to keep pace with the public’s desire to have all vascular problems treated with minimally invasive techniques.

“Physicians must understand the legal requirements and liabilities of off-label use if they wish to spend the majority of their time in the operating room and not in the court room,” Dr. Brown concluded.


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