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What Is the Off-Label Use of Drugs and Can it Form the Basis of Product Liability Litigation?



Newly introduced pharmaceutical drugs receive labels from the U.S. Food and Drug Administration (FDA) after they have been tested in a clinical trial process using extensive research studies. Such tests must confirm a drug works to treat a given medical condition in the manner expected and is safe when used according to directions before the FDA will approve its use by the public. Once the FDA is satisfied a drug works and is safe for the public, it works with the pharmaceutical manufacturer to create the drug’s label. These labels set out specific uses and conditions for patients and consumers. They are not the paper stickers affixed to medicine bottles, but the reports of specific information and data about the drug. The FDA approves the report that comprises the drug’s label and makes it readily available to medical professionals who prescribe the drug to patients.

Admittedly, certain drugs have other uses—off-label uses—which differ from those depicted in the approved labels adopted by the FDA. These off-label uses include the treatment of different medical problems, a different manner of administrating the drug, different dosages, or a use not depicted in the FDA label report. In some instances, doctors and other treating professionals recommend to patients these types of off-label uses.

Why Are Doctors and Drug Companies Treated Differently Regarding Off-Label Drug Use?

The off-label use of drugs that have FDA approval is not regulated; such usage is legal in the U.S. and other countries. Doctors are not forbidden to make off-label use recommendations for pharmaceutical drugs and readily do so in the medical community and marketplace.

However, a pharmaceutical drug company is not allowed to take similar liberties. If a company recommends, markets, promotes, or otherwise directs doctors or patients to adopt an off-label drug usage, that company violates federal laws and regulations prohibiting such conduct. A doctor may legally use or prescribe drugs in off-label manners, but a pharmaceutical company cannot market a drug for usage that is off-label.

What Are Examples of Off-Label Drug Use?

Consider the common drug, aspirin. It was created and intended for the purpose depicted in its label—painkilling or pain treatment. However, aspirin is readily prescribed by doctors for other wide-scale, off-label uses such as fever reduction and reducing risks of heart attack and/or stroke due to its ability to thin blood.

Oral contraceptives are another example of common off-label drug use. Teen girls are prescribed oral contraceptives to regulate their menstrual cycles but not to prevent pregnancy, which is the documented label usage. Oral contraceptives are also prescribed to manage acne and to keep complexions clear in female teens and young adults, another off-label usage.

Can Off-Label Drug Use Fuel Product Liability Claims?

Off-label usage has proven to be fertile ground for a well-coordinated attempt by the plaintiffs' bar to seek the next front for large-scale, high-return litigation. Plaintiffs' counsel are organizing with state and federal governments to bring civil suits against life science, biomedical, and pharmaceutical companies, alleging promotion of off-label usage. One example of off-label, medical-device litigation involves the shoulder pain pump. Manufacturers of the device sought approval from the FDA to insert pumps directly into joints, but were denied approval for safety. The devices were used off-label anyway, resulting in chondrolysis, destruction of the shoulder joint cartilage from the introduction of toxic pain medication. In response, plaintiffs brought product liability suits alleging negligence, failure to warn, and fraud claims against medical device and drug manufacturers for off-label usage.