Off-Label Prescription Injury: Who's Liable?

Off-label prescriptions are an unfortunate reality in today’s medical practice. Patients from Provo, Utah to the East Coast are prescribed medications for uses not initially intended by manufactures. Occasionally, off-label use of prescription medications can lead to drug injury or death. 

A study published in the Journal of the American Medical Association Internal Medicine found that 12 percent of all drugs prescribed by physicians are used for treatments they were not originally intended for or purposes not approved by the Federal Drug Administration. Other studies have found that up to 20 percent of all prescriptions in Provo and around the country are written for off-label use.  

Off-label prescriptions can result in a higher complication rate and increase rate of negative side effects. A JAMA study found that almost 80 percent of off-label prescriptions do not have support of scientific research and many doctors prescribe medications to patients with similar conditions based on how previous patients fared. 

In another JAMA study, researchers in Montreal and Quebec City studied 151,305 prescriptions for 46,021 patients over five years and found that 7.9 percent of patients suffered negative side effects from prescriptions taken for labeled purposes. Drug injury occurred 44 percent more often in patients who used prescriptions for off-label purposes. 

With such a high rate of inappropriate usage, the question becomes who is liable for off-label drug injury?

A drug injury lawyer in Provo would likely explain that there are two parties that are potentially liable: the manufacturer and the prescribing physician. In either case, a lawyer would be wont to explain that liability is not always cut and dry.

The courts have been split on manufacturer liability in the case of off-label drug injuries. In some cases, the courts have ruled that manufacturers bare no liability for off-label use. In other cases, the courts decided that a manufacturer must warn about off-label risks if the company is aware of off-label usage. Pharmaceutical companies, however, still frequently skirt advertising regulation laws to market drugs for unapproved purposes to boost sales. 

As for treating physicians, a Provo area lawyer would explain that off-label prescriptions are considered medical judgments. Depending on the case, a physician may be liable for medical malpractice for his or her off-label judgment call. 

If you have suffered a drug injury from a medication you are taking, contact a local personal injury lawyer immediately. He or she will be able to determine whether the medication was an off-label prescription and if you have cause for damages. 

Alex Kirkwood is a legal writer for Fusion 360, an SEO and content marketing agency. Information provided by Robert J Debry. Follow on Twitter.