What Does “Failure to Warn” Mean in a Product Liability Claim?

If you’ve read anything about personal injury lawsuits—or if you’ve been injured yourself—you may have heard the phrase, “failure to warn.” What does that mean, exactly, and why does it matter to you?

What is “Failure to Warn?”

“Failure to warn” is a principle of product liability that applies when a company or manufacturer fails to include proper warnings on a product label or within the product packaging. These warnings are meant to alert consumers, patients, doctors, and others to the potential dangers and risks associated with using the product.

Warnings are usually included as text or graphics on the product label, as text in the owner’s manual, as text in the prescription medication packet, or as an extra flyer, brochure, sticker, or single piece of paper somewhere else within the product packaging. Manufacturers are required to place clear and complete warnings on their products where a consumer can easily see them.

As to what these warnings are, it depends on the manufacturer’s research. They must study and test the product before it goes to market, and to warn the public about any potential risks detected through this process. Once the product is on the market, the manufacturers also must keep abreast of any problems reported and to provide additional warnings as needed.

When “Failure to Warn” Comes to Play in a Personal Injury Lawsuit

When a product comes onto the market, it typically contains one or more warnings on the label already. A medication, for instance, may warn about the risk of side effects like headaches, upset stomach, or fatigue. Other products have similar warnings depending on their unique risks. An e-scooter, for example, may warn of the importance of wearing a helmet while riding, and indicate that without a helmet a rider may be injured.

If you use a product and then suffer an injury, “failure to warn” becomes an important factor in your ability to recover damages from the manufacturer. If you used the e-scooter without wearing a helmet and you crashed and hurt your head, you would have a hard time providing a case of “failure to warn” against the company that sold you the scooter and included a warning to wear a helmet.

On the other hand, let’s say you took a certain medication for 15 years and then were diagnosed with cancer. There was nothing on the product label or within the packaging that warned you or even your doctor about the risk of cancer. You do some research and find out that the medication was contaminated with a cancer-causing compound. Yet the company failed to warn about this very serious risk.

This was what happened to many people who took Zantac (ranitidine) for years. On April 1, 2020, the U.S. Food and Drug Administration (FDA) requested the recall of all Zantac and generic ranitidine medications because studies showed unsafe levels of a cancer-causing agent could increase with time and exposure to heat. Yet the manufacturers never warned consumers or doctors about this problem.

Now, hundreds of people have filed personal injury lawsuits against those manufacturers, and one of their claims is that the companies “failed to warn” about the cancer risk.

Usually, the manufacturers are held liable in a case like this, but other parties may share in liability:

  • Another manufacturer involved in making parts for the product.
  • The product’s distributor.
  • The retailer that sold the product.
  • The product’s wholesaler.
  • The party that assembled or installed the product (if they did so incorrectly).

If you were injured by a product, talk to your personal injury attorney about a potential failure-to-warn claim. He or she can guide you in gathering the evidence you’ll need to prove it.