Off-Label Prescription Drug Use and Injury

Thursday, October 1, 2015

Off-Label Prescription Drug Use and Injury

Written by Malman Law, reviewed by Steve J. Malman.

If you are prescribed a medication for a symptom or condition other than what the pharmaceutical manufacturer intended the drug to be used for, your physician is engaging in off-label drug prescribing. Off-label use, also known as non-approved use, is very common in the medical industry. Most physicians will prescribe a medication for uses other than what they were intended for to help their patients, and, in most cases, there are no issues or injuries that arise from this accepted practice.

Off-label Use Does Not Automatically Constitute Negligence

While a patient may file a lawsuit following an adverse event for off-label use, the fact that the prescription was used for an off-label purpose does not automatically mean the physician was acting negligently. The FDA and the American Medical Association both agree that physicians are free to prescribe FDA-approved medications for any scientifically supported use – even if that use is off-label.

Whether an off-label use meets the standard level of care will depend on the amount of evidence that supports the off-label use and how the physician gained access to that evidence or interpreted it. If there is an abundant amount of scientific research and data supporting the off-label use, and the physician can prove that they consulted that research before prescribing, then the off-label use may meet the standard care requirement and the physician will not be held not liable.

When a Drug Company Illegally Markets Off-Label Use

Sometimes drug companies or their office marketing consultants will promote a prescription medication to a physician or consumer for a use that is not approved by the FDA. No matter how effective the medication is for this off-label use, illegally marketing a prescription drug for off-label use can result in a lawsuit against the pharmaceutical manufacturer as well as their marketing professionals.

For example, a pharmaceutical representative presents an antacid to a physician, informing the physician that it can also be prescribed to pregnant women for morning sickness. The suggestion is off-label, as the company is offering multiple ways to use the medication, encouraging physicians to start prescribing it to their patients without any supporting research. This violates federal law and makes the company responsible liable for any injuries that result from their off-label marketing tactics.

Assessing the Standard of Care

A physician is not breaking the law when they prescribe a medication off-label. However, doing so can be considered a deviation from the standard of care. Standard of care refers to the legal obligation physicians have to administer an appropriate level of expertise and care towards a particular medical condition. This standard is assessed by experts in the same field to test if they would have acted the same way. If the majority of physicians would have also prescribed the same off-label use for the medication, then the physician did not deviate from the standard of care. If, however, the physician prescribed a medication that other physicians would not have prescribed in the same situation, and the patient suffered harm, the physician is liable.

Speak with a Medical Malpractice Attorney – Contact Malman Law

With more prescription medications flooding the industry, physicians are more apt to prescribe a drug off-label today than they were a few years ago. If you have suffered from a bad reaction or severe injury because of an off-label prescription, contact the attorneys at Malman Law. We can answer your questions and assess your case. You can contact us online or call 888-625-6265.