Off-label use of a drug is any use that has not been approved by the FDA.  This can include differences in dosage, type of patient, or the condition to be treated, such as using Avastin to treat macular degeneration.  

Why Would A Doctor Prescribe a Drug for Unapproved Uses?

Doctors prescribe drugs for off-label use for several reasons:   

  • New uses are sometimes discovered after the FDA approval process, and the manufacturer does not want to go through the process again. 
  • Uses for children and pregnant women are rarely approved, so many of the treatments for these groups are off-label.  
  • Diseases such as cancer and AIDS use off-label drugs to take advantage of new uses without having to wait for the long approval process.

Is Prescribing Medication for Off-Label Use Malpractice?

Prescribing off-label medication is not itself medical malpractice unless doing so falls below the accepted standard of care.  Off-label use is actually quite common, but there must be a medical basis for the use.  Off-label prescribing can be evidence of malpractice in certain situations, such as the existence of approved, safer drugs or the lack of sufficient medical evidence for the use.

Does the Manufacturer have any Liability?

In most cases, the responsibility falls to the prescribing doctor to make sure that the off-label use is medically reasonable.  Drug manufacturers are not required to seek approval for all possible uses of their drugs, however they cannot promote uses that are unapproved.  They are also required to report known dangers and side effects, even from unapproved use.

Do I Need a Lawyer if I am Injured by Off-Labelled Drugs?

The standard of care for medical malpractice can be difficult to interpret and prove, especially with unapproved drug uses.  An experienced medical malpractice attorney can help you determine the appropriate standard of care.  A medical malpractice lawyer can also represent you in court.