In the United States, all products are required to include warning labels which inform consumers of any known and potential dangers associated with the product. In terms of drugs specifically, these requirements are especially stringent due to the risks associated with taking medicines whether prescription or over-the-counter.
According to federal law, if a product poses a danger that is not apparent or obvious to the average consumer, the manufacturer of the product must place a warning label on the product. However, the law does not require warning labels for every hypothetical danger the product could pose.
An example of this would be when the danger posed by a product is reasonably obvious, such as the danger posed by using a firearm. In such circumstances, the law does not impose a duty to warn. Federal law requires a duty to provide warning against dangers that any ordinary user could not predict.
The U.S. Food and Drug Administration (“FDA”) is the entity responsible for approving any labels accompanying drugs and medical products. Drug labels should contain the following information:
- Number of units per package;
- Safety concerns; and
- Other relevant information.
A consumer that is injured by an improperly labeled product may sue the product manufacturer or supplier for their injuries.
What Are Some Of The Dangers Associated With Drug Labels?
Generally speaking, the manufacturer’s duty to warn arises when:
- The product is dangerous in some way;
- The manufacturer knows, or should have known, of the danger;
- The danger exists when the product is used as directed; and
- The danger is not one that should be obvious to the average user.
An unsafe drug may be considered as such not only because of the contents of the drug, but also because of the way that it has been packaged. What exactly constitutes an unsafe drug will be discussed further below.
Some common examples of violations associated with a drug not being appropriately labeled include:
- Incorrect information included on the label;
- Errors or mistakes in terms of dosages and instructions;
- A complete failure to include any type of label; and
- Mislabeling of the product, such as if labels for two different products were accidentally switched.
What Are Off-Label Drugs?
Off-label refers to any use of a drug that has not yet been approved by the FDA. This can include:
- Differences in dosage;
- The type of patient; and/or
- The condition to be treated. An example of this would be using Avastin to treat macular degeneration when the drug is generally used as part of cancer treatment.
There are many different reasons why doctors prescribe drugs for off-label use. Some of these reasons include, but may not be 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 children and pregnant women are rarely approved, many of the treatments for these groups are off-label; and
- Diseases such as cancer and AIDS use off-label drugs in order to take advantage of new uses, without needing to wait for the long FDA approval process.
Prescribing off-label medication would be considered medical malpractice if doing so falls below the accepted standard of care. Off-label use is a fairly common practice; however, there must be a medical basis for the use. Off-label prescribing would be evidence of malpractice under specific circumstances. An example of this would be the existence of approved, safer drugs that could have been prescribed instead; or, a lack of sufficient medical evidence for the off-label use of the drug.
Generally speaking, the responsibility is on the prescribing doctor to ensure that the off-label use is medically reasonable. Drug manufacturers are not required to seek approval for all possible uses of their drugs. However, it is important to note that they cannot promote uses that are unapproved. Additionally, they are required to report known dangers and side effects, including those associated with unapproved use of the drug they are manufacturing.
Off-label drugs can still be sold. However, they too must present the appropriate labels that are needed. Additionally, if a doctor recommends such an off-label drug as an alternative, they must explain why it’s okay to do so. They must also explain any additional risks or concerns in doing so.
What Are Unsafe Drugs?
As previously mentioned, unsafe drugs are often associated with drug labeling lawsuits. A high alert drug or medication (“HAM”) is a medication that has an increased risk of causing significant harm when used in a way other than exactly as prescribed. Such medications are dangerous largely because small changes in the dose given, or in levels of the drug in a person’s blood, can lead to critical events.
Additionally, the adverse events caused by error in the administration of HAMs are persistent, life threatening, or sometimes permanent. They can lead to disability, hospitalization, or death.
The Institute for Safe Medication Practices has detailed three categories of high-risk medications. These are determined according to the settings in which they are used. The categories are as follows:
- Medications that are high alert medications in community and/or ambulatory care settings;
- Medications that are high alert medications in acute care settings; and
- Medications that are high alert medications in long-term care settings.
Some common examples of HAMs include:
- Anticoagulants: Blood thinners, such as warfarin and heparin, are used to treat blood clots. As too much of an anticoagulant can be life-threatening, it is important to take only as much as is prescribed, and on a strictly regular dosing schedule;
- Insulin: A prescribed treatment for diabetes;
- Opiates and Narcotics: OxyContin, hydrocodone, and methadone are opioids which carry a high risk of addiction. When taken in excess, they can result in death by overdose;
- Injectable Potassium Chloride or Phosphate Concentrate: For treatment of electrolyte imbalance, and require monitoring and careful supervision for administration; and/or
- Potassium and Other Electrolytes: Used to regulate electrolytes.
All of these medications have life-saving potential, when prescribed correctly and administered strictly as directed by a physician’s prescription. However, if used incorrectly and not as directed, their effects could be life-threatening.
What Else Should I Know About Warning Label Lawsuits?
If a manufacturer or supplier breaches their duty to warn by failing to provide an adequate label, a consumer may sue them for any resulting injuries. They must show that the failure to warn proximately (legally) caused injury resulting in damages.
According to federal law, a consumer may sue for inadequate warning when:
- There are expected risks of harm posed by using the product;
- The risks could have been lessened by providing the user with adequate warning;
- The failure to provide these warnings is what caused the product to be unsafe; and
- A consumer sustained an injury because of the failure to adequately warn.
Manufacturers do not have a duty to warn against uses that cannot be anticipated. However, the manufacturer of a product can be held liable for failure to provide adequate warning against uses that can be anticipated. A supplier or distributor can also be liable, if the supplier or distributor was in the “chain of sale.” This means that the supplier or distributor was an entity to which the product was transferred or sold. This also means that the supplier or distributor transferred or sold the product, in order to make it available for consumer purchase.
Manufacturers, distributors, and suppliers do not need to provide the same warning to everyone. A distributor or manufacturer must warn those whom it can anticipate are likely to use the product. They must also warn those whom it can anticipate are likely to be exposed to the danger of a product. An example of this would be family members who can access the product, but for whom the product is not intended.
Do I Need An Attorney For Drug Labeling Lawsuits?
If you or a loved one have been injured because of improper drug labeling, you should consult with an experienced and local personal injury lawyer.
An attorney can help you understand your rights and legal options according to your specific state, and will also be able to represent you in court, as needed, while working towards a suitable damages award. Additionally, a lawyer will also be aware of any class action lawsuits which you may join.