Off-Label Drug Use vs. Off-Label Marketing: The Role of Deceptive Marketing in Antipsychotic Litigation

To reach the market, drugs must undergo an extensive approval process with the U.S. Food and Drug Administration. Drugs receive FDA approval for a specific use. But sometimes, doctors may prescribe drugs to treat a condition or disease that falls outside the specific use. 

This is known as prescribing “off-label.”

Off-label prescribing can be concerning because the drug may not have gone through the same rigorous testing for the unapproved use as opposed to what it was approved for. In some cases, drug companies have been known to market drugs for an unapproved, off-label use, known as “off-label marketing,” despite safety risks. When this occurs, it can result in litigation. 

What is Off-Label Drug Use?

When an FDA-approved drug is used for an unapproved use, it is called “off-label drug use.” In order to make it to market, drugs must go through an approval process with the FDA. When a drug is prescribed for its approved use, it generally means it has undergone pre-clinical testing, clinical trials, and a detailed evaluation. However, a prescriber may write a prescription for a drug for an unapproved use if they feel that it is medically appropriate. 

The off-label use of drugs is fairly common. According to the Mayo Clinic, one study found that as many as 1 in 5 prescriptions were written for off-label use. In some populations, the off-label use of drugs is even higher, such as with children who were discharged from a pediatric hospital.  

What Is Off-Label Marketing?

The FDA has authority over a drug’s approval and marketing, but is not tied to the drug’s use. Prescribers may write a prescription for an off-label use, but may not market it for that purpose. Off-label marketing is the promotion of a drug for an unapproved use. While it is legal for FDA-approved drugs to be used for off-label purposes, it is not legal for them to be marketed or promoted for unapproved use. Despite its illegality, “off-label marketing” still occurs. In some instances, off-label marketing can expose a broader market to dangerous drugs. 

Off-label marketing remains concerning because its unintended use did not go through the same scrutiny as its approved use. For example, atypical antipsychotics such as Risperdal, Zyprexa, and Invega were FDA-approved for the treatment of severe psychotic conditions, including schizophrenia. In order to broaden the market, manufacturers of these drugs reportedly marketed the off-label use of the drug for a number of additional conditions, including attention-deficit drugs for children and dementia drugs for the elderly. Over time, it was discovered that the drug may be linked with an increased risk of breast cancer. 

Attorneys with Wisner Baum have taken legal action against these drug companies, alleging they illegally promoted the off-label use of the drug, exposing new patients to significant dangers. 

Off-Label Marketing Allegations in Antipsychotics Lawsuits

In the 1990s, drug makers introduced second-generation atypical antipsychotic drugs, including Risperdal and Zyprexa, which were initially approved to treat schizophrenia. This particular diagnosis represented a narrow market for these particular drugs. To lessen this constraint on the market, drug manufacturers sought approval for other, milder psychiatric conditions in new patient populations. 

According to ongoing antipsychotics lawsuits, these drug companies illegally promoted the medications for off-label use. Off-label marketing of the drug allegedly included for the treatment of attention-deficit disorder in children, dementia treatment in the elderly, and as “mood stabilizers.” By widening the market for these second generation antipsychotics, the drug manufacturers turned narrow use medications into blockbusters. 

In 2025, our firm filed suit against the drug manufacturers alleging Risperdal, Invega, and Zyprexa may cause heightened levels of prolactin in a person’s body, thus increasing patients’ risk for developing breast cancer. By marketing the drugs for an off-label use, the drug companies allegedly exposed a significant number of new patients to the risk.

Examples of Off-Label Drug Use

Some of the most popular drugs on the market are prescribed off-label for unapproved uses. Anyone taking a drug for an off-label use should consult with their healthcare practitioner to ensure the benefits of taking it outweigh the risk of harm. 

Common drugs and their off-label uses:

• Ozempic: Ozempic is approved for the management of type 2 diabetes in adults, but it is frequently prescribed off-label for weight loss. 
• Provigil: Provigil is FDA-approved for narcolepsy and sleep apnea, but may be prescribed off-label for depression. 
• Beta blockers: Beta blockers are prescribed to treat cardiovascular conditions, including high blood pressure and arrhythmia, but may be prescribed off-label for anxiety. 
• Wellbutrin: Wellbutrin is FDA-approved for the treatment of major depressive disorder and seasonal affective disorder, but may be used off-label for ADHD. 
• Clomid: Clomid is approved for the treatment of female infertility, but may be prescribed off-label for male infertility. 

Examples of Off-Label Marketing

A drug company’s marketing and promotional activities must be limited to the uses prescribed under its FDA approval. While the drug may be used for off-label use when a doctor believes it is medically appropriate, it cannot be promoted for an unapproved use.

Drug companies can be held criminally and civilly liable for off-label marketing, as was the case with pharmaceutical giant GlaxoSmithKline. The company agreed to a $3 billion settlement for the unlawful promotion of certain prescription drugs, including Paxil, Wellbutrin, and Avandia. 

Pfizer also agreed to a multi-billion-dollar settlement for its off-label marketing of certain drugs. The $2.3 billion settlement resolved cases related to the fraudulent marketing of Bextra and other drugs. 

The Relationship Between Off-label Drug Use and Off-Label Marketing

There are several differences between off-label drug use and off-label marketing. A clinician engages in the prescription of off-label drug use when it is medically appropriate for their patient, while a pharmaceutical company engages in off-label marketing most often to enhance profits. 

It is legal for a clinician to prescribe a drug for an off-label use, while off-label marketing is illegal. The purpose of off-label drug use is generally for patient care, while off-label marketing is usually to expand the company’s product sales. The FDA has no direct control over the off-label use of a drug, while off-label marketing is directly prohibited by the regulator.

Off-label drug use requires a prescriber to use their professional judgment to determine whether the unapproved use is medically appropriate, while off-label marketing can endanger public safety and may lead to litigation.  

Public Health, Legal, and Ethical Implications Of These Practices

Off-label marketing is dangerous to the public because it involves unapproved uses, meaning the products have not undergone the rigorous testing required for their intended purposes. Off-label marketing can increase off-label drug use, which can have negative impacts. A study published in JAMA Internal Medicine found that off-label drug use was associated with a 44% increase in Adverse Drug Events (ADEs). 

Without formal testing, the safety of the off-label use of a drug is often unknown. Additionally, promoting the unapproved use of a drug may also disincentivize manufacturers from going through the timely and sometimes costly FDA approval process. Holding drug companies accountable for deceptive marketing practices is often critical to ensuring patient safety nationwide. 

The Role of Deceptive Marketing in Antipsychotic Litigation

Deceptive marketing, from illegal off-label marketing to aggressive campaigns promoting unproven safety claims, can expose new patients to significant dangers, as was the case in antipsychotic litigation championed by attorneys with Wisner Baum. 

Taking legal action against pharmaceutical companies, such as those that unlawfully market drugs for unapproved uses, can help to sway regulatory action and force compliance, saving countless patients from additional harm. 

Steps To Proving Deceptive Marketing in Court

There are several steps to prove deceptive marketing in court. Foremost, a patient affected by off-label marketing should consult with an attorney. An attorney well-versed in dangerous drug lawsuits can help determine eligibility in filing a claim and work to ensure that justice is served. 

Next, it is important to gather evidence to support the claim. Evidence can help to prove how a company’s false claims caused you damages. Evidence that may be necessary to secure includes:

• Internal marketing documents
• Sales training materials
• Medical records
• Proof of losses
• Internal communications regarding strategy
• Physician payment records and speaker programs
• Clinical data misrepresentation
• Studies on the safety or efficacy of the drug

The Impact Wisner Baum has had on Pharmaceutical Accountability

Wisner Baum has a long history of holding pharmaceutical companies accountable for deceptive practices. As a result of litigation, drug companies that engage in false or fraudulent marketing have faced multi-billion dollar settlements. Whistleblowers have helped to shine light on misrepresentations about the safety and efficacy of a drug and marketing strategies that help to promote inaccurate information. 

How Wisner Baum Can Help 

Individuals affected by the off-label marketing of a drug are encouraged to contact Wisner Baum to schedule a free, no-obligation consultation. Wisner Baum has been a leader in the industry for decades and continues to fight to hold Big Pharma accountable for its wrongdoing and deceptive practices.

Frequently Asked Questions 

Q: What is the difference between off-label use and misuse?

Off-label use occurs when a clinician prescribes a drug for an unapproved use. The clinician may do so when they feel that it is medically appropriate. The misuse of a drug involves using a drug for illegal or unintended purposes.

Q: Can you advertise off-label drugs?

It is unlawful to advertise or promote a drug for an off-label use. 

Q: Is off-label use ethical?

While the off-label use of a drug is legal, it may not always be ethical. The FDA approval process is stringent and requires preclinical testing, clinical trials, and evaluations. When a drug is used for an off-label purpose, it has not gone through the process of raising safety concerns.

Q: How common is off-label drug use?

Off-label drug use is common. It is estimated that 1 in 5 drugs may be used for an unapproved purpose and may be even more prevalent in specific populations.

Q: Does the FDA regulate drug advertising?

The FDA regulates drug advertising and prohibits the off-label marketing of a medication.