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Pharmaceutical Liability and Off Label Use

by | Dec 15, 2023 | Insurance Coverage Planning, Insurance Recovery |

Innovation can lead to great advances. In few industries do we see this more than the pharmaceutical industry. The advances that the industry has made with respect to the discovery of numerous medications to help heal and treat those who are ill or injured are staggering.  

Pharmaceutical companies work to help provide those medications for public distribution while also working to ensure compensation goes to the minds behind the innovation and their teams. But what happens when the government approves those innovations for one type of use and medical professionals use them for another?

This practice is known as off-label use and occurs when a medical professional uses the product for a different indication, dosage, or patient group. Although exact numbers are not available, off-label use is common. Such practices are common across many specialties. But those that tend to see it most frequently are pediatrics, oncology, infectious diseases, and psychiatry. 

Can Healthcare Professionals Use Products in This Way? 

It is important to note that the law generally does not allow pharmaceutical companies to promote their products for off-label uses. However, when such practices occur, manufacturers often respond to unsolicited questions from physicians and other medical practitioners about off-label use, though there are strict rules on who replies to the question and the need for proper documentation. 

Can Off Label Use Result in a Product Liability Claim? 

Sometimes off-label use may result in injury. A patient may attempt to hold the pharmaceutical company financially liable for the injury through a product liability lawsuit. Pharmaceutical companies can mitigate this risk with two important tools–warnings and insurance. Warnings provide medical professionals and patients alike with information about the potential negative implications of certain uses, while insurance provides a safety net in the event something goes wrong.  

The right insurance can provide support if someone is injured and attempts to hold the pharmaceutical company liable for the costs that result from the injury. It is important to complete proper due diligence and negotiations before signing off on an insurance provider to better ensure the policy meets your business’ needs. 

What Triggers Product Liability Insurance Coverage? 

Product liability claims can result from allegations that the product did not perform as marketed. The exact trigger is guided by the language of the policy. In addition to the policy language, the courts can also vary in their interpretation of the application of terms within these policies. This can be very complex. However, generally speaking, in these types of cases, the trigger could include claims of unclear or misleading marketing messages or issues with labeling. 

What Happens If an Insurance Provider Fails to Hold Up Their End of The Bargain? 

Denied insurance claims are common, but you don’t have to accept them. You can help to mitigate the risk of a denial by having clear and organized records to support that you took all actions necessary to align with the terms of the policy. It also helps to take action if the insurance provider fails to hold up their end of the bargain. You have the right to challenge denials and demand that your insurance provider fulfills the policy terms. Consult with our skilled attorneys to explore your options and act. Don’t let denied claims stand – reach out to our team today.