Off-Label Drug Prescriptions Lawyers

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 What is a Prescription Drug?

Prescription drugs are medications that cannot legally be purchased without a prescription from an authorized medical professional, for example, a physician or a dentist. A prescription drug is not the same as an over-the-counter drug.

An over-the-counter drug may be purchased without a prescription. Prescription medications are typically stronger, or more effective, than over-the-counter medications.

In addition, they usually have more side effects than an over-the-counter drug.

What is Drug Labeling?

All products in the United States are required to include a warning label that informs a consumer of any known potential dangers that are associated with that product. In terms of medication, these requirements are more stringent because of the risks associated with taking medications, whether they are prescription or over-the-counter.

Pursuant to federal laws, if a product poses a danger that is not obvious or apparent to the average consumer, the manufacturer of that product is required to place a warning label on the product. The law, however, does not require a warning label for every hypothetical danger that a product may pose.

An example would include the danger that is posed by a product is reasonably obvious, such as the dangers associated with using a firearm. In these types of circumstances, the law does not impose a duty to warn.

Federal laws impose a duty to provide warnings against dangers that any ordinary user could not predict. The United States Food and Drug Administration (FDA) is the agency that is responsible for approving any labels accompanying drugs and medical products.

A drug label should contain the following information:

  • Ingredients;
  • Dosages;
  • Number of units per package;
  • Safety concerns; and
  • Any other relevant information.

A consumer who is injured by an improperly labeled product may sue the product manufacturer or the product supplier for their injuries.

What are Off-Label Drugs?

An off-label use is a use of a drug that has not been approved by the FDA. Off-label uses may include:

  • Differences in dosage;
  • The type of patient; or
  • The condition to be treated.

An example of an off-label use would be using Avastin to treat macular degeneration when the drug is typically used as part of cancer treatment. There are numerous different reasons why a doctor would prescribe a drug for off-label use, including, but not limited to:

  • New uses for the drug may be discovered after the initial FDA approval process, and the manufacturer does not want to go through the approval process once more;
  • As drug uses for pregnant women and children are rarely approved, many of the treatments for these groups of individuals are off-label; and
  • Diseases such as AIDS and cancer often use off-label drugs in order to take advantage of new uses without having to wait for the long FDA approval process.

Why Would a Doctor Prescribe a Drug for Unapproved Uses?

A doctor may prescribe the off-label use of a drug for several reasons, including:

  • New uses are sometimes discovered after the FDA approval process, and the manufacturer does not want to go through the process again;
  • Uses for children and pregnant women are rarely approved, so many of the treatments for these groups are off-label; and
  • Diseases such as cancer and AIDS use off-label drugs to take advantage of new uses without having to wait for the long approval process.

Is Prescribing Medication for Off-Label Use Malpractice?

Prescribing an off-label medication would be considered medical malpractice if doing so would fall below the accepted standard of care. Off-label uses of medications are fairly common practice.

There must, however, be a medical basis for their use. Examples of off-label medication use that may be considered malpractice include using a medication off-label when there is a safer medication that could have been subscribed or if there is a lack of sufficient medical evidence for the off-label use of the drug.

Does the Manufacturer have any Liability?

In general, the responsibility is on the prescribing physician to ensure that the off-label usage is medically reasonable. A drug manufacturer is not required to seek approval for all of the possible uses of their medications.

It is important to note, however, that a manufacturer cannot promote a use that is not approved. In addition, the manufacturer is required to report any known dangers and side effects, including those associated with unapproved use of the drug they are manufacturing.

An off-label drug can still be sold. However, the medication must also present the appropriate labels that are required. Additionally, if a physician recommends such an off-label drug as an alternative, they must explain why it is acceptable to do so.

The physician must also explain any additional risks or concerns associated with using the off-label medication.

What about Defective Prescription Drugs and a Failure to Warn?

The two main legal theories that drug manufacturers are sued under are defective product and failure to warn. Defective product claims allege that a manufacturer did not place a safe product on the market and it harmed the public.

A failure to warn claim alleges that a manufacturer was aware of the dangers associated with the drug and either sold the drug anyway or did not warn of its dangerous propensities. A manufacturer is required to conduct years of research on a drug before they can get FDA approval to sell the medication.

During the research period, a manufacturer will test whether the drug is safe. If the drug is determined to have some semi-unsafe side effects, a manufacturer is permitted to sell it so long as consumers are provided with adequate warnings regarding the side effects and the risks that the consumer will be taking.

Certain medical professionals, including pharmacists, doctors, and other professionals may be held liable for malpractice in connection with a prescription, as previously noted. For example, if a doctor prescribes the wrong dose of a drug, or if they knowingly prescribe a drug that has already been subject to a drug recall.

What are Prescription Drug Lawyers?

Today, millions of individuals rely on prescription medications to cure their ailments and even to save their lives. Although a prescription drug is typically intended to improve the individual’s quality of life, certain prescription drugs may be so poorly manufactured that they cause harm or even death to the user.

This applies especially in cases where the drug is a counterfeit drug. When a defective medication harms an individual, they may be able to file a lawsuit against the manufacturer to recover for the damages they suffered.

There are also other parties that may be held liable, depending on the situation and circumstances surrounding the use of the medication and the injury sustained.

Do I Need a Lawyer if I am Injured by Off-Label Drugs?

If you believe you have been injured by the use of an off-label medication, it is important to consult with a personal injury attorney. The standard of care for medical malpractice can be difficult to interpret and prove, especially with an unapproved drug use.

Your lawyer can review your case, determine if medical malpractice occurred, and assist you with filing a lawsuit to recover compensation for your injuries. Your attorney will represent you any time that you are required to appear in court.

In some cases, the opposing party may wish to settle the lawsuit outside of a courtroom. If this occurs, your lawyer will represent you during negotiations and help ensure that you receive a reasonable settlement amount that will cover your expenses.


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