The Food and Drug Administration (FDA) is the federal agency tasked with protecting Americans from contaminated food and unsafe drugs and medications. Too often, spoiled food and dangerous drugs end up on our shelves. Who is responsible for this? Can you sue the FDA if you or your family becomes sick? 

Unfortunately, like many other government agencies, the FDA is protected from personal injury lawsuits. A legal doctrine called sovereign immunity keeps citizens from suing this agency if they fail to do their job.

How Sovereign Immunity Prevents You From Suing the FDA

Sovereign immunity is an outgrowth of the Eleventh Amendment to the U.S. Constitution. This states, in part, that the judicial system of the United States cannot be used against “one of the United States by Citizens of another State.” The federal government has waived this immunity in specific cases, via the Federal Tort Claims Act and the Tucker Act. However, these waivers do not cover actions by government agencies.

As long as the FDA has provided adequate warnings, and its employees are not the direct cause of specific harm, the FDA cannot be sued under the Federal Tort Claims Act or any other waiver of sovereign immunity granted by the government.

Who Can Be Held Liable for Drug and Food Related Claims?

If you are injured by harmful drugs or contaminated food, who can you properly hold liable? The answer is the manufacturers themselves. The FDA is viewed as nothing more than a regulatory body or gatekeeper. Your complaint should be directed at the company that made the bad product to begin with.

Food Manufacturers

A food manufacturer is any business that grows, packages, processes, ships, or prepares food products for sale. A meat-packing plant is a food manufacturer; so is an organic tea shop that hand-wraps herbal tea bags; so is a donut franchise. All food manufacturers are responsible for ensuring their products are made according to FDA guidelines and packaged and sold with required labeling.

Drug Manufacturers

Drugs include everything from over-the-counter medications like Tylenol to the most obscure experimental medications being researched today. Drug manufacturers are required to use the formulae provided by the researchers or labs that created the drug. They must use best practices in compounding the medication and prevent contamination or adulteration of the product. Drugs must be clearly labeled and include clear warnings about side effects and possible allergic reactions.

If there are any concerns about the safety of a drug, it must immediately be removed from the market. The FDA is the agency tasked with drug recalls, but they can only act if the manufacturer warns them about potential hazards in a timely manner. 

This was the case with the painkilling drug Vioxx. Although the manufacturer was aware that the drug increased the risk of heart-related problems, it concealed this information from the FDA. As a result, the FDA did not demand a recall until after problems were uncovered by other whistleblowers.

What Constitutes Filing a Lawsuit?

A personal injury case against a food or drug manufacturer is basically a negligence lawsuit. The claimant (you) is alleging that the drug or food company owed you a duty of care which they breached by putting their contaminated product on the market, and this caused you illness and injury.

You should always consult a personal injury attorney before bringing any legal action against a business entity. These cases are complex and the companies involved often have entire legal departments on their side.

Strict Liability of a Drug Maker

Product manufacturers and drug manufacturers are held to a strict liability standard. This means that the manufacturer is automatically liable for any harm caused by their product. Their duty to the user is presumed by their manufacture and sale of the product.

What this means for you is that you do not have to show that the drug manufacturer was responsible for making their antacid in a clean factory and that they should have used the correct ingredients in the formula. Strict liability means that this is presumed. You need only show that they failed to do this.

Failure To Meet Standard of Care

Standard of care is an industry term for how things are done. A standard of care is not always the same thing as a guideline or a rule, but it can be both of those things. The standard of care is usually a baseline, the minimum acceptable level of how things should be done.

In the case of drug manufacturing, for instance, the standard of care would be the cleanliness of the factory, quality control, employee training, and so on. A standard of care might be that the lab floors are cleaned three times a day. Falling below the standard cleaning would mean the lab was not meeting even the minimum cleanliness of a good lab.

Inaccurate Marketing

Companies are required to market their products responsibly and without excessive embellishments or misleading claims. (“This new drug will cure all your ailments without a single side effect!”) They are required to list the most common side effects, possible common interactions, and the so-called black box warnings of who should not take the medication.

Advertising and other marketing are not required to list every single side effect and all known drug interactions, but the maker must disclose all potential hazards associated with the drug. If it relieves pain but increases the danger of heart attack, this has to be disclosed to the consumers.

Know Your Rights and Hold Responsible Parties Liable

Food and drug consumers, which is nearly all of us, have a right to eat and take our medications without worrying about whether we might be poisoned or sickened by what we put in our bodies. That has been the case since Teddy Roosevelt signed the Pure Food and Drug Act of 1906.

Today, skilled attorneys like those at Ratzan Weissman & Boldt want to help you recover the compensation you deserve if a food or drug manufacturer has not complied with the law. You can’t sue the FDA, but we can help you get the settlement you deserve if you or a loved one have been injured or died through the actions of a drug company.

Call us today if you believe you have been harmed by contaminated food or impure medications. We’re here to help you fight for your health and well-being.