Labeling Defects: When Can You Sue a Drug Company for “Failure to Warn”?

Drug companies are required to include warnings about known health risks on all prescription and over-the-counter medications. If you or a loved one has been harmed by a medication that did not include a necessary warning, you may have grounds to take legal action. In this scenario, a defective drug lawyer may be able to help you seek compensation for “failure to warn.”

As a patient, you have the right to know about the risks associated with taking any drug a pharmaceutical company promotes or a healthcare provider recommends. The law protects patients, and it entitles patients to hold pharmaceutical companies accountable when warranted.

One scenario in which pharmaceutical companies can be held accountable is when they sell drugs without adequate warnings.

“Failure to warn” is classified as a type of drug defect. If a prescription or over-the-counter medication suffers from a labeling defect, this can provide clear grounds for patients to take legal action. If you unknowingly made an uninformed decision due to a pharmaceutical company’s failure to warn, you may be entitled to just compensation, and it will be worth talking to a defective drug lawyer about taking legal action.

What Qualifies as a “Failure to Warn”?

Pursuing a defective drug claim based on a failure to warn requires evidence that the pharmaceutical company could (and should) have included a warning about the risk that led to your (or your loved one’s) diagnosis. This can be based on either of the following:

• The pharmaceutical company knew about the risk and failed to disclose it; or,
• The pharmaceutical company should have known about the risk but failed to identify it—either during clinical trials or during postmarket surveillance.

Ultimately, if the pharmaceutical company failed to include an adequate warning for any reason, this can justify a claim for just compensation. With that said, another key issue in “failure to warn” cases is being able to prove that the undisclosed risk is to blame for your (or your loved one’s) medical condition. This requires thorough medical documentation, and your lawyer will need to review your (or your loved one’s) medical records to determine if a claim is warranted.

How Do I Prove that the Pharmaceutical Company Knew (or Should Have Known) About the Risk?

One of the most challenging aspects of a “failure to warn” claim is proving that the pharmaceutical company knew (or should have known) about the risk it failed to disclose. Typically, this requires access to the pharmaceutical company’s internal records—and this requires filing a lawsuit in court.

Pharmaceutical companies (and other defendants) can be forced to disclose their internal records during the litigation process. As a general rule, litigants are required to disclose relevant records upon request, and they can face sanctions if they fail to do so. After filing a lawsuit on your behalf, your lawyer will be able to submit the necessary requests to the pharmaceutical company, and then your lawyer will be able to examine the pharmaceutical company’s internal records to determine what was known and when.

In many cases, pharmaceutical companies will try to avoid liability by arguing that the risk at issue was not reasonably foreseeable (in other words, there is no reason that they “should have known” about the risk). When pharmaceutical companies assert this defense, seeking to hold them accountable involves hiring an expert to explain how the risk could (and should) have been identified.

What Compensation Can Patients and Families Recover in “Failure to Warn” Cases?

The damages available to patients and families in “failure to warn” cases include compensation for all financial and non-financial losses resulting from the pharmaceutical company’s negligence or deceit. This includes compensation for medical bills and other out-of-pocket costs, lost earnings, pain and suffering, emotional trauma, loss of consortium and companionship, and loss of enjoyment of life.

If you have a claim, the compensation you are entitled to recover depends on your individual circumstances. An experienced defective drug lawyer will be able to comprehensively assess your losses and ensure that you are seeking the full compensation you deserve.

FAQs: Suing a Drug Company for “Failure to Warn”

Can I file a lawsuit if a pharmaceutical company failed to include a warning on a medication label?

If you or a loved one was harmed by a dangerous drug that did not include an adequate warning, you may have grounds to file a lawsuit against the pharmaceutical company. To find out if you have a claim, you should consult with an experienced defective drug lawyer promptly.

How hard is it to sue a pharmaceutical company?

Suing a pharmaceutical company is not easy. There are several steps in the process, and the pharmaceutical company will be fighting to liability by all means available. This makes it critical to have an experienced defective drug lawyer on your side.

How much does it cost to sue a pharmaceutical company?

For patients and families, it costs nothing out of pocket to sue a pharmaceutical company for selling a dangerous drug. Our law firm handles these cases “on contingency.” This means that we cover the costs of pursuing our clients’ claims while they are pending, and we only recover our costs and fees when our clients’ claims are successful.

What Our Law Firm Can Do to Help

If you have a “failure to warn” claim against a pharmaceutical company, our law firm can fight for just compensation on your behalf. We have extensive experience and a proven track record in these cases. We can help you make an informed decision about whether to take legal action; and, if you decide to take legal action, we can seek the maximum compensation available based on the circumstances of your case.

Discuss Your Legal Rights with a Defective Drug Lawyer at Searcy Law

To discuss your legal rights with an experienced defective drug lawyer at Searcy Law, contact us today. Call us at 800-780-8607 or tell us how we can get in touch online to arrange a free, no-obligation consultation.