What Makes a Drug “Defective?”

If you or a loved one has been harmed by a defective drug, you may have grounds to file a lawsuit against the manufacturer. Successful lawsuits allow patients and their families to recover just compensation for their present and future losses—and this means that filing a successful lawsuit can be an important part of the recovery process.

But, this raises an important question: What makes a drug “defective”?

This is a complicated question to answer—and, as a patient or family member, it is not a question you will be able to answer on your own. Instead, you will need to hire an experienced defective drug lawyer to conduct an investigation and advise you of your legal rights.

Understanding the Concept of a “Drug Defect”

While understanding your legal rights requires a thorough assessment of your specific circumstances, there are some general principles that apply. For example, broadly speaking, both prescription and over-the-counter medications can be deemed defective based on any of the following:

1. The Drug is Defective Due to a Problem with Its Formulation or Ingredients

A prescription or over-the-counter drug can be deemed defective based on a problem with its formulation or one or more of its ingredients. This is referred to as a “design defect.” If there is an issue with the way that a drug was formulated or designed, then all lots and doses of the drug will present the same risks for patients.

For example, if a drug is formulated with an ingredient that causes cancer, this could give rise to a claim for a design defect. These types of drug defect claims are common, and if you have been harmed by a defective drug, seeking just compensation will most likely involve proving that the drug’s formulation is to blame.

2. The Drug is Defective Due to an Issue with Its Manufacturing, Shipment, or Storage

In some cases, prescription and over-the-counter drugs can also be deemed defective based on issues with their manufacturing, shipment, or storage. We’ve seen this in the lawsuits involving claims related to Valsartan and Zantac, among other drugs. In these particular cases, the drugs were allegedly contaminated with N-Nitrosodimethylamine (NDMA) during the manufacturing process. NDMA is classified as a known carcinogen.

Even if a drug is safe based on its formulation, it could still be classified as defective due to contamination or other issues. In these cases, drug defect lawsuits will often relate to specific lots of the drugs in question that were either sold at specific times or manufactured in specific facilities.

3. The Drug is Defective Because Its Warnings Are Inadequate

Along with issues with drugs themselves, issues with drug warnings can also give rise to defect claims. These “defective warning,” or “failure to warn,” claims are also common—and, in many cases, design defect and failure to warn claims will go hand-in-hand.

As a general rule, pharmaceutical companies have a legal duty to warn patients and healthcare providers of the health risks associated with their drugs. If a pharmaceutical company fails to provide an adequate warning about a risk—whether known or unknown—this can potentially provide clear grounds for patients or their families to seek just compensation.

Determining Whether a Prescription or Over-the-Counter Drug is Defective

Let’s say that you suspect a drug is defective. How do you prove it?

As we said above, this requires experienced legal representation. Proving that a drug is defective requires not only an understanding of the chemistry and medical benefits and risks behind the drug, but an understanding of the relevant product liability laws as well. The process of proving that a drug is defective generally involves:

• Testing the Drug – Proving that a drug is defective often involves testing the drug in a laboratory setting. What are its ingredients? Does the drug contain any contaminants? Based on its ingredients and any contaminants, what health risks does it present?
• Analyzing the Drug’s Packaging and Labeling – Assessing patients’ and families’ legal rights typically involves analyzing the drug’s packaging and labeling as well. Are the packaging and labeling accurate? Are they misleading? Do they omit any critical information?
• Applying the Relevant Product Liability Laws – After conducting these assessments, the next step is to apply the relevant product liability laws. Based on the testing and analysis conducted, does the drug qualify as “defective” under applicable law?

If a drug is defective, there are additional steps involved in assessing your legal rights as well. For example, to determine if you have grounds to file a defective drug lawsuit, it will also be necessary to assess factors such as:

• Can Your (or Your Loved One’s) Diagnosis Be Linked to the Drug? To have grounds to file a defective drug lawsuit, you must have medical records that prove that your (or your loved one’s) diagnosis is linked to the drug in question.
• Do You Have Documentation of Your Financial and Non-Financial Losses? Filing a defective drug lawsuit also requires documentation of your financial and non-financial losses (i.e., medical bills, lost earnings, pain and suffering, and loss of enjoyment of life).
• Do You Still Have Time to File? All defective drug claims are subject to statutes of limitations. As a result, before taking legal action, you need to make sure you still have time to file. This is one of many reasons why it is important to consult with a lawyer promptly.

While understanding your legal rights can be complicated, this is not something that you have to try to do on your own. You can hire a lawyer to help you—and you can do so at no out-of-pocket cost. At Searcy Denney, we have extensive experience representing clients in defective drug and other defective product lawsuits, and we have recovered billions of dollars in financial compensation for our clients.

Do You Have a Defective Drug Claim? Contact Us for a Free and Confidential Consultation

Do you have a defective drug claim? If you have questions about your legal rights, we invite you to get in touch. To schedule a free and confidential consultation at Searcy Denney, call 800-780-8607 or tell us how we can get in touch online today.