Further review of off-label use of drugs and devices

| Jun 22, 2018 | Medical Product Liability

This blog has previously written about off-label use and marketing of drugs and other medical products.

What this means is that, even though federal authorities have approved a drug for a particular use, doctors prescribe, and pharmaceutical salespeople promote, the drug for other uses that are not necessarily vetted.

This practice can lead to serious problems for everyday residents of Georgia who use the drug off-label for a medical condition for which the drug was not designed. Take, for instance, the use of Zofran among pregnant women, which this blog has discussed.

Although originally designed as part of cancer treatment regimen, many women took the advice of their doctors and used it to treat severe morning sickness. This has led to serious allegations that this drug caused birth defects.

Still, off-label use of a drug remains legal. If a doctor has studied the drug and its possible effects, he or she is free, within his or her professional discretion, to prescribe the drug for any number of treatments, even those for which the drug is not marketed. Of course, if a doctor uses this discretion in a negligent manner, he or she may be held accountable in a medical malpractice lawsuit.

Moreover, pharmaceutical representatives recently scored an important victory regarding their ability to suggest to doctors and others that a drug or device might be good for an off-label use. While they cannot lie or mislead, one federal court recently held that these salespeople have a constitutional right to pitch a drug for an off-label use, even if the government has not approved that use.

What Georgia residents and others need to recognize is that using a drug off-label carries with it some significant risks, including the risk of serious medical complications. Depending on the circumstances, a victim of a drug promoted for its off-label benefits may be about to file a medical product liability case or even a medical malpractice case against the doctor who prescribed it.