Who Is Liable for a Defective Drug With FDA Approval Seal?

A defective drug refers to a medication that causes severe adverse side effects that far outweigh its benefits. Such drugs are defective because they don’t produce the desired results. Medications are supposed to help us regain good health. However, when they produce the opposite result and complicate our health problems, they become dangerous.

The FDA (Food and Drug Administration) exists to protect the public from dangerous drugs. One of the administration’s duties is to ensure the safety, efficacy, and security of medications. To do this, the FDA must evaluate new drugs and test them before they are open to the public. As such, many Americans trust the efficacy and safety of any drug that has the FDA seal of approval.

Unfortunately, the FDA has had to recall several drugs that were once approved. Also, many Americans have suffered long-term injuries due to FDA-approved drugs that turned out to be defective. Can you sue such companies through a mass tort attorney regardless of their FDA approval? Let’s find out.

Does the FDA Approve Defective Drugs?

The FDA will not intentionally approve defective drugs. However, it’s not a guarantee that every FDA-approved drug is defect-free, as many consumers think. That’s because the labeling system isn’t flawless and still has some loopholes. The only guarantee that FDA gives is that it has passed through the necessary process for approval.

There are many reasons why unsafe drugs can pass through the approval process to enter the market. One of the major ones is that the FDA doesn’t test drugs. Instead, they only carry out limited research and bank heavily on the manufacturer’s drug test results.

According to the FDA, these are the processes for an FDA approval:

  • The drug companies test the drug
  • FDA’s CDER (Center for Drug Evaluation and Research) receives evidence from the test result and assesses it.
  • CDER checks that the drug’s health benefits outweigh its adverse side effects based on the test result.
  • If the test result is satisfactory, the FDA approves it.

So, many times, when FDA-approved drugs turn out to be defective, the fault is from the manufacturers. Therefore, defective FDA-approved drugs can infiltrate the market because:

  • The manufacturers manipulated the test results.
  • The manufacturers failed to warn about the risks and dangers of the medication adequately.
  • Drugmakers discovered defects in the drug after releasing it and neglected to inform the FDA for a recall.
  • Intentional contamination of the drugs.
  • Failure to give clear instructions on drug administration
  • Tricking the FDA to believe that a drug is similar to an already approved one, etc.

What Happens When an FDA-Approved Drug Causes My Injuries?

Even with an FDA approval, you can hold a manufacturer liable for a defective drug. Your attorney will help you file a lawsuit and secure fair compensation for your injuries. However, you will only be eligible for compensation if you can prove the following:

  • The Manufacturer Owed You a Duty of Care 

Every drug manufacturer has a responsibility to ensure that their products are safe for the intended users. In legal terms, such responsibility is called the duty of care. Manufacturers exercise this duty by ensuring that they follow all industry standards in the production of their drugs. They must also warn users about the potential risks associated with using the drugs and lots more.

  • They Breached the Requisite Duty of Care By Producing Harmful Drugs 

Once you’ve established that the manufacturers owe you a duty of care, you must prove that they breached that duty. Many times, they breach their duty of care through defective manufacturing, improper marketing and dangerous side-effects. In addition, any action that shows that they were negligent in producing and marketing the drugs can count as a breach.

  • You Sustained Injuries Due to the Negligence

You must prove that you innocently used the defective drug, believing that it was safe as represented. Apart from using the drugs, they must have caused you some injury or worsened your health conditions. For example, you may have taken Truvada to prevent HIV/AIDS, and it caused you an acute renal failure.

Speak to a Defective Drug Attorney Today!

From Taxotere to Truvada, Round-up, and many more, defective products continue to complicate users’ health. If you’re one of such victims, you can get adequate compensation even if the drug is FDA-approved. To do that, however, you need the help of an experienced defective drug attorney like our team at Rueb Stoller Daniel.

At Rueb Stoller Daniel, we’ve successfully secured compensation for several clients like you over the years. We’ll love to do the same for you at no upfront cost. So, contact us for a free case review ASAP!