Off-Label Use

Off-label drug use involves prescribing, distributing or consuming a drug for reasons outside of the purpose for which the U.S. Food & Drug Administration has approved it.

The practice is legal. In fact, it is estimated that 40 to 60 percent of total U.S. drug use is off-label. However, off-label use can be risky. The FDA, which regulates the sale, manufacture and labeling of drugs, doesn’t regulate the practice of medicine. So it can’t mandate physicians take certain precautions in prescribing drugs for off-label uses, but it does recommend doctors:

  • Be well-informed about the product;
  • Base its use on firm science rationale and sound medical evidence;
  • Maintain records of the product’s use and effects.

At Jeffrey Glassman Injury Lawyers, our Boston dangerous drugs attorneys, we recognize that while there are some benefits to off-label uses, too many pharmaceutical companies heavily and irresponsibly market drugs for uses that haven’t been tried and tested.

There have been many instances in which patients have suffered ill effects as a result of consuming drugs that haven’t been proven safe for all patients. In some cases, companies push these drugs onto consumers even knowing there is great potential for harm. Some lawsuits have revealed there are drug firms that actively conceal this information, depriving doctors and patients of making an informed choice.

When patients are injured as a result of off-label use of prescription drugs, all avenues for compensation should be explored with an experienced injury attorney. Claims against doctors may be predicated on a theory of medical malpractice, while claims against drug manufacturers will be based on theories of product liability.

Our injury law team firmly believes this type of litigation serves not only to compensate those impacted by careless marketing and negligent medical practices, it has the potential to improve drug safety and health care for all consumers.

Benefits of Off-Label use

It’s important not to overlook the benefits of off-label use (sometimes referred to as “unapproved” or “non-approved” use) to understand why it’s legal in the first place.

As the FDA notes, approved drugs aren’t always available for treatment of serious illnesses. Even when they are, not all patients respond to those drugs that are approved. That could mean patients might want to explore off-label uses. This could mean the drug is:

  • Used for a different medical condition or disease;
  • Given in a different way;
  • Provided in a different dose.

An example might be a chemotherapy medication that is approved for treating one type of cancer, but may be prescribed by a doctor to treat another type of cancer.

Risks of Off-Label Use

The risk of off-label uses is that they expose patients to drugs or treatments that may at best be ineffective and at worst may be harmful.

An example of how an approved drug used for off-label purposes can be extremely harmful is that of “Fen-Phen.” Initially, the FDA granted approval for phentermine hydrochloride and fenfluramine hydrochloride – but only individually and just for short-term treatment of obesity. However, after one medical journal article detailed stunning weight loss by prescribing the two together, that’s what doctors started doing. Unfortunately, the end result was that many patients ended up with serious heart damage. Some even died. The FDA pulled Fen-Phen from the market in 1997 and the manufacturer settled some 9,000 lawsuits for $3.75 billion. Thousands rejected this offer or weren’t included in the class action, and proceeded with private action.


FDA policy allows that once a pharmaceutical product is approved for marketing, doctors are free to prescribe it for uses or treatments of patient populations that aren’t approved in the labeling. However, those physicians do so at their own risk because if they fail to adhere to acceptable medical standards, which involves basing the decision to prescribe on sound evidence of benefit, the doctor is vulnerable to a medical malpractice action if there is an adverse effect.

This “practice of medicine exemption” when it comes to off-label use is spelled out in the 1938 Food, Drug and Cosmetic Act (FDCA). The passage of the 1997 Food and Drug Administration Modernization Act (FDAMA) includes additional prescriber protections.

However, if a drug manufacturer promotes a product for uses not approved by the FDA, the drug will be deemed “misbranded.” If a manufacturer wants to promote new uses for the drug, it has to resubmit it for additional testing and approval. However, the FDAMA’s “Mack Frist provision” does allow proactive dissemination of peer-reviewed articles, reference books and medical journals regarding clinical trials of off-label drug use.


Some drug companies evade liability for promotion of off-label uses via the Mack-Frist provision and the “learned intermediary doctrine.” If drug or device manufacturers have provided sufficient warning to prescribing physicians about the potential risks of that drug, they are generally protected from liability. This can be true in cases of off-label uses, but it can be tougher to prove, as the warnings aren’t directly on the labels as they would be for an approved use.

Patients who are harmed by off-label drug use have the right to hold manufacturers responsible for failure to adequately warn of the risks.

In cases where a patient is bringing action against a physician for allegedly improper off-label use of a drug, most likely it will allege failure to obtain informed consent or negligence.

Contact the Boston personal injury lawyers at Jeffrey Glassman Injury Lawyers by calling (617) 777-7777.

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