Can I Sue for Side-Effect Injuries if I Took an FDA-Approved Drug for Off-Label Use?

October 9, 2020 Drug Injury

If you’ve had side-effect injuries after taking an FDA-approved drug for off-label use, you may be able to sue. Whether you can sue depends on the specifics of your unique case. But if it’s a case where a drug maker illegally promoted their product for off-label use and you were hurt, the manufacturer may be liable. Or if a doctor prescribed a drug for off-label use, you may be able to sue for your side-effect injuries if negligence was involved.

Drug injury cases are very complex. People who are considering suing for side effects from off-label use will benefit from getting the advice of experienced lawyers who handle drug injury cases. A lawyer who is experienced in handling drug injury and medical malpractice cases will look at all the individual factors of your case. They will counsel you about a potential claim and who might be held liable.

Understanding Off-Label Use of an FDA-Approved Drug and Who Can Be Sued

The FDA approves drugs to treat specific illnesses or conditions. In the approval process, the FDA uses tests and other data to understand the benefits and risks of the drugs. When a drug is approved, the illnesses and conditions that it can treat, the approved dosages and other information appears on the drug’s label.

Sometimes drugs are prescribed for treatment in ways that weren’t approved by the FDA. When this happens, it is called off-label use. The following are examples of off-label use:

  • A drug is prescribed to treat a non-approved illness or condition
  • A drug is prescribed at a different dosage than approved by the FDA
  • A drug is prescribed that isn’t in the approved form—such as intravenously instead of in a pill
  • A drug is prescribed for an age group it isn’t approved to treat.

How Pharmaceutical Companies Can Be Liable for Side-Effect Injuries from Off-Label Drug Use

Under the law, drug makers aren’t allowed to actively promote FDA-approved drugs for off-label use. However, some drug makers ignore these rules in order to get more profits. Sales reps from drug companies might promote drugs to doctors for uses for which they weren’t approved. Busy doctors might be confused and not even realize a medication they prescribe is off label because of the sometimes deceptive promotion tactics used by drug companies. When pharmaceutical companies market drugs for off-label use and patients have side-effect injuries as a result, they can be sued.

How Doctors May Be Negligent if They Prescribe Off-Label Drugs and Side-Effect Injuries Happen

Off-label prescribing by doctors is legal. It is also fairly common. Doctors know their patients’ healthcare histories and their illnesses and conditions. If they believe it’s in a patient’s best interests, they may prescribe off-label drugs. When would a doctor prescribe an off-label drug? A doctor might prescribe an off-label drug if other drugs that are approved for the illness aren’t working. If a doctor is careless, though, in prescribing an off-label drug and side-effect injuries happen, they may be held liable. They could also be accountable if they don’t clearly describe the potential risks of taking an off-label drug and injuries occur.

How Does a Suit for Off-Label Drug Injuries Work?

If your claim is against the drug manufacturer, your attorney will work to prove that your injuries were the direct result of illegal off-label marketing practices. Suing Big Pharma can be difficult because they have teams of high-priced lawyers. But with the help of a skilled Houston drug injury lawyer fighting for your rights, it can be done. Sometimes it makes the most sense to bring an individual lawsuit. In other cases, joining a class action might be advisable. Your attorney will counsel you about the most beneficial approach.

When suing a doctor for malpractice, your lawyer will work to prove that the doctor’s actions in prescribing an off-label drug were negligent. This means that they were outside the standard of care another competent doctor would have used.

Sometimes drug injury claims result in settlements with insurance companies and don’t go to court. In other cases, when a settlement can’t be reached, cases are decided by juries.

Damages for Off-Label Drug Injury Claims

Here are some of the typical damages that may be awarded in off-label drug injury claims:

  • Medical expenses
  • Lost income when you can’t work while you recover
  • Lost earning capacity if your ability to work is reduced
  • Physical pain and emotional suffering
  • Punitive damages, in cases of extreme negligence.

How much a claim asks for depends on the extent of damages. Speak with a Houston drug injury attorney about how much you may be able to ask for in your case.

Possible Side-Effect Injuries from Off-Label Drug Use

Some of the severe side effects from off-label drug use that can result in extensive damages can include:

  • Involuntary or uncontrollable movements, including eye blinking, lip pursing, lip smacking, tongue protruding, and cheek puffing
  • Tremors and muscle contractions
  • Seizures
  • Allergic reactions that including anaphylactic shock, a potentially life-threatening reaction that causes swelling in the throat and can affect breathing
  • Confusion, memory issues, and even hallucinations
  • Heart attacks, strokes, and other cardiovascular problems
  • Organ failure
  • Death.

If you were injured because of off-label drug use, speak with an attorney as soon as possible. You may be entitled to compensation. If a loved one died and you believe it was because of off- label drug use, you may be able to file a wrongful death claim.

Get Help from Experienced Houston Drug Injury Lawyers

Can you sue for side-effect injuries from a drug you took for off-label use? Our experienced lawyers at the accident and injury law office of Terry Bryant will advise you of your options after learning the details of your case. We have helped thousands of people injured by another party’s negligence get compensation for their injuries. If you had serious injuries after taking an FDA-approved drug for an off-label use, we will determine possible liability and then hold the party accountable. Call us today at (713) 973-8888 or toll-free 1 (800) 444-5000 to arrange a free consultation with one of our experienced Houston drug injury lawyers.

Attorney Terry Bryant

Attorney Terry BryantTerry Bryant is Board Certified in personal injury trial law, which means his extensive knowledge of the law has been recognized by the Texas Board of Legal Specialization, setting him apart from many other injury attorneys. The 22 years he spent as a Municipal Judge, Spring Valley Village, TX also provides him keen insight into the Texas court system. That experience also helps shape his perspective on personal injury cases and how they might resolve. This unique insight benefits his clients. [ Attorney Bio ]

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