Drug manufacturers are legally responsible for marketing medications that are safe to use. More specifically, the Food and Drug Administration (“FDA”) is the federal agency that is responsible for assessing the safety and effectiveness of prescription drugs before they are sold to the public. However, even FDA approved drugs may still cause harmful side effects that are not identified during the approval process.
Harmful effects can also result from errors in the administration of medications, or if a person is taking more than one medication at a time, such as from the interaction of drugs in the body. If a person is injured because of a prescription medication, they may need to file a prescription drug lawsuit. This can help them obtain compensation from healthcare providers, or the pharmaceutical manufacturer of the drug.
A high alert drug or medication (“HAM”) is a medication associated with an increased risk of causing significant harm if it is used other than exactly as prescribed. They are dangerous because small changes in the dose given or in levels of the drug in a person’s blood can result in critical events. Additionally, the adverse events caused by error in the administration of HAMs are persistent, life threatening, or even permanent. They can lead to disability, hospitalization, or death.
The Institute for Safe Medication Practices has three categories of high-risk medications according to the settings in which they are used:
- 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 examples of HAMs include:
- Anticoagulants: Anticoagulants are blood thinners, such as warfarin and heparin, used to treat blood clots;
- Insulin: Insulin is a prescribed treatment for diabetes which must be taken as prescribed, as there are numerous risks associated with taking insulin;
- Opiates and narcotics: OxyContin, hydrocodone and methadone are opioids which carry a high risk of addiction, and when taken in excess, can result in death by overdose;
- Injectable Potassium Chloride or Phosphate Concentrate: For treatment of electrolyte imbalance, they require monitoring and careful supervision for administration; and
- Potassium and Other Electrolytes: These medications are used to regulate electrolytes, but can be dangerous if not used correctly and under supervision.
It is important to note that it is not only drugs on the HAMs list which can injure a person; all medications have the potential for undesirable side-effects, even when they are used properly. Additionally, interactions between different drugs can result in considerably serious health consequences.
What Is Daytrana?
Daytrana is a skin patch containing medication that is used to treat ADHD symptoms. The patch is placed on a person’s hip each day, allowing for the medication to be absorbed through the skin. One patch, which is left on the skin for up to nine hours, decreases restlessness and increases a person’s ability to focus.
In 2015, the U.S. Food and Drug Administration, or FDA, announced that it received approximately 51 cases of chemical leukoderma from people using Daytrana. Chemical leukoderma is the changing of skin color, which can begin from the first time that someone uses the patch. However, in some cases, it may take years for the skin color to change. An example of this would be how the 51 cases were reported over an 8-year period.
While the condition is not always immediately harmful or life-threatening, it can present various challenges and issues. An example of this would be how the condition may permanently disfigure a person because it changes the color of their skin. Other side effects of Daytrana can include:
- Dizziness and headaches;
- Mood swings and other emotional and/or psychological issues;
- Muscular or nerve-related tics; and/or
- Vomiting, stomach pain, nausea, weight loss, and/or loss of appetite.
Additionally, these patches should be carefully prescribed to those with a history of drug abuse, as there is a considerably high chance of dependence which can result in issues with mental health. As such, physicians that are aware of the patient’s history should carefully monitor and check in with the patient to ensure that the patch does not have any serious and negative impact.
What Is A Failure To Warn?
Failure to warn is a principle of product liability laws. When a product fails to provide an adequate warning of the dangers which are associated with the use of the product, it is considered to be a failure to warn.
Warning labels which can be found on the products themselves, as well as the owner’s manual which is included with the product, must be clearly and concisely written. Additionally, warning labels must explain all of the possible dangers and risks which may be associated with the use of the product.
Both manufacturers and suppliers are legally obligated to place clear and complete warnings on their products, which warn of any dangers that may not be immediately apparent to the average consumer. However, it is important to note that a supplier or a manufacturer does not have a duty to warn of any dangers that a reasonable user would anticipate. This would include putting a warning label on a knife which states that the knife is sharp.
It has been suggested that the manufacturer of Daytrana has failed to warn users of the patch about the potential of chemical leukoderma that is associated with the patch. If the manufacturer fails to adequately warn consumers about the potential harms that are associated with a product such as Daytrana, the injured consumer can file a product liability lawsuit or class action lawsuit against the manufacturer for the harm that was caused by not being properly warned.
Failure to warn lawsuits are part of a broader category of injury laws known as defective product laws. Defective product lawsuits generally result in a compensatory damages award for the injured party. In the case of a Daytrana lawsuit, damages may cover costs of medical treatment, damages for emotional distress, and various other monetary losses.
What Could Limit My Damages In A Lawsuit For Daytrana Side Effects?
Daytrana, similar to other medications, has specific directions and instructions. As such, if you ignore explicit warnings and are injured from doing so, you may have limited your ability to collect damages.
An example of this would be how Daytrana specifically states that:
- The user should not cut the patches;
- They should only place the patch on the hip area;
- They should not be reapplied if they fall off;
- The patch can fall off if exposed to water;
- Users should not expose it to heat sources, such as a hair dryer; and
- Users should only wear it for 9 hours.
Additionally, there are explicit instructions that the use of these patches should be supervised if the patient has a history of drug and/or alcohol dependence. This is why it is imperative that you are honest with your physician about any history of drug abuse, as you can be held contributorily negligent for any injury from the patch if you fail to adhere to Daytrana’s warnings.
Do I Need A Lawyer For Help With Daytrana Side Effects?
If you have experienced any injuries because of the Daytrana medication, you should speak with a class action attorney near you. Your lawyer can help you understand your legal rights and options, and will also be able to represent you in court, as needed.
Additionally, an experienced attorney may be aware of an ongoing class action lawsuit that you can join.
