Simply put, misbranding occurs if manufacturers place a label on their product that is misleading or confusing; or, if the label does not correspond to the proper product. Misbranding refers to the act of falsely branding something, such as an item or a product. The term also refers to brand something in an intentionally misleading way, as well as labeling in such a way that it violates any applicable statutory requirements.

Federal labeling laws have determined that medical device labels misbranded the product if:

  • The label is false or misleading in any way;
  • While in its packaging, the label does not contain the name and place of business for the packer, distributor, or manufacturer;
  • While in its packaging, the label does not contain an accurate statement regarding the quantity of the contents such as weight, measure, or numerical count;
  • The packaging or product fails to include prominently displayed required wording; and
  • The packaging or product fails to provide accurate instructions regarding the correct use of the device.

It is important to note that this is not an exhaustive list of how the Food and Drug Administration (FDA) defines a device’s label as being misbranded. These are some of the most common examples, but there may be other types and examples of misbranded products.

Injuries and other dangerous risks can result from a device, item, or product being misbranded. This generally happens because the consumer may be expecting one thing from the product, but instead may be receiving a different type of product. Some common examples of injuries associated with misbranding include, but are not limited to:

  • Exposure to food allergens;
  • Ingesting food that you are allergic to;
  • Taking a medication incorrectly, such as the wrong dosage, wrong timing, or taking medication for the wrong condition; and/or
  • Exposure to risk in terms of weight, age, or other such limitations that are associated with the product.

Who Can Be Held Liable For Injuries Resulting From Misbranding Issues?

There are several different parties that can be held liable for injuries caused by a misbranded product. The two most common include:

  • Manufacturers: This would specifically refer to the manufacturers of the product who have created the labels. Such manufacturers may be held liable under a warning label defect, which is a specific type of product defect claim. These claims will be further discussed below; and
  • Pharmacies or Pharmacists: Under specific circumstances, pharmacies are legally required to place labels or instructions on drugs and medical devices. As such, they can be held liable for some mislabeling incidents, such as failing to place a label or instructions on a device or drug they have dispensed to a consumer.

Similar to pharmacies or pharmacists, retailers may be held liable for injuries under specific circumstances. An example of this would be if they know or should have known of any products in their store that have been misbranded. Should they continue to sell the product, and fail to remove it from their shelves, they may be held liable for a violation.

As previously mentioned, liability for injuries resulting from misbranding issues are commonly associated with warning defect laws. A warning defect, or a warning label defect, is a specific legal theory which can be used as the basis of some defective products liability lawsuits. In terms of how manufacturers can be held legally liable for a warning defect:

  • The manufacturer failed to affix any sort of warning label;
  • The instructions provided by the warning label were unclear, vague, or contained mistakes;
  • The positioning of the warning label makes it impractical or impossible to read, such as small font, not being easily noticeable, or the color of the font is too light to read; or
  • The attached warning label is for an entirely different product.

In a larger sense, misbranding issues can be considered a type of product liability claim. Product liability refers to the manufacturer, retailer, and/or seller of a product being held liable for allowing a defective product to enter into the stream of commerce. This is regardless of the consumer’s own negligence.

Laws regarding product liability determine who is to be held responsible for defective or dangerous products. It is important to note that state laws regarding product liability claims vary, although there is a set of commercial statutes in each state that are modeled after the Uniform Commercial Code. They contain warranty rules which affect product liability.

Are There Any Legal Remedies For a Misbranding Injury Case?

Resolving a misbranding injury will most likely require filing a lawsuit against the liable party. For such lawsuits, the remedy will generally involve a monetary damages award similar to other personal injury claims. Personal injury claims involve a person who has suffered physical, mental, emotional injuries, and/or property damages. These losses result from some sort of accident.

When the injured party files a personal injury claim or lawsuit, they are likely requesting some form of financial compensation from the party that is responsible for causing their accident. These are also referred to as compensatory damages, because they are compensating the receiver for the injuries they suffered.

Compensatory damages can cover a wide range of costs and losses. Some examples of such compensation include:

  • Medical bills;
  • Hospital stay expenses;
  • Medication costs; and
  • Other related losses, such as lost wages from missing work.

In cases which involve severe negligence associated with the act of misbranding, punitive damages may also be issued. Punitive damages are intended to discourage the defendant from repeating their negligent actions in the future.

It is also common that misbranding will result in a product recall. This is done in order to avoid further injury to consumers. Product recalls are requests by manufacturers to have a product pulled from sales shelves and returned, generally for a refund or a similar product exchange. A product may be recalled when the manufacturer believes that the product poses a health or safety risk to consumers. By doing so, the manufacturer is attempting to avoid violations of product safety laws, while also decreasing potential legal action for products liability injuries.

Finally, class action lawsuits can be filed if several consumers are all injured by the same misbranding issue. A class action is a specific type of lawsuit that is usually brought by one or more persons on behalf of a group of others. Everyone involved in the lawsuit is required to share similar legal issues, and there must be enough individuals that it would not make sense to bring separate lawsuits.

Do I Need An Attorney For Misbranding Product Issues?

If you have been injured because of a misbranding product issue, you should consult with an experienced and local defective products lawyer. Because state laws vary in terms of liability and consumer law, an area attorney will be best suited to helping you understand how your state’s specific laws will affect your legal options.

Your attorney can also help determine your next best steps, or will assist you in joining any current class action lawsuits. Additionally, an experienced and local consumer lawyer will also be able to represent you in court, as needed. If you believe you have been affected by a misbranded product, you should contact a lawyer to help determine your legal rights, options, and next steps.