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Many people throughout the U.S. take prescription or over-the-counter medications to treat certain health conditions and symptoms. While many drugs are designed to provide recognizable health benefits, some patients experience adverse side effects after taking medication. When a drug causes harm, drug makers can be held legally responsible for the resulting damages—even if the drug has been previously approved for use by the U.S. Food and Drug Administration (FDA). Patients who have been injured by dangerous drugs are filing lawsuits against the drug makers with the assistance of a North Carolina dangerous drug attorney.
The Drug Approval Process
Before a new prescription drug can enter the marketplace and be prescribed to patients by a medical professional, it must undergo a rigorous testing and evaluation process. According to the FDA, the first step a drug manufacturer must take is to receive approval to perform animal tests to determine if the medication will be safe enough for humans to use. After animal testing is performed, the manufacturer can then perform clinical trials, which are monitored by the FDA, and submit a New Drug Application to the FDA’s Center for Drug Evaluation and Research (CRER) if the trials are successful.
Once it is determined by the CRER that the new drug has more benefits than risks, it can then enter the health care marketplace. However, just because a drug enters the marketplace does not mean that the FDA discontinues its monitoring of the medication. After a drug is permitted to enter the marketplace and be sold, the FDA uses a number of strategies to monitor the safety and effectiveness of the medication.
Why Drug Approval Data is Limited
Despite the FDA’s comprehensive testing and approval process for new drugs, the safety data they collect during these processes is still limited for a number of reasons, including:
- When drug manufacturers performs clinical trials, they are only able to test a group of people that is substantially smaller than the total number of people who will eventually take the drug. As a result, it can be difficult for companies to determine if rare side effects will occur.
- While the data from a drug’s clinic trials are assessed by a team of professionals, it is extremely difficult to determine exactly which bad reactions can occur when the drug is used.
- Many prescription drugs are taken by sick people who take a number of medications, making it hard to tell how every individual will react to a certain medication.
Additionally, since adverse drug-related events are reported on a voluntary basis, many serious drug reactions go unreported to the FDA, allowing some harmful medications to remain in circulation.
How a North Carolina Dangerous Drug Attorney Can Help
When patients experience emotional, psychological or physical injury from taking a prescription drug, the medication may be pulled from the market after the recall process is initiated. Although drugs are most often recalled if they are a health hazard to those who take them, there are other situations which may result in a drug being recalled. For instance, according to WebMD, the FDA may issue a drug recall if the medication is labelled or packaged poorly, or if the drug was contaminated with either a harmful or non-harmful substance. A drug may also be recalled if what exists inside the medication’s packaging is not correct or if a manufacturing defect harms a drug’s potency, purity or overall quality.
Proving that a drug is defective or that a drug maker breached its duties to the public and patients can be a highly complex undertaking. An experienced North Carolina dangerous drug attorney will know how to fight the drug companies and pursue maximum compensation for their clients. Even if a drug company appears to take responsibility for a bad drug and seeks to resolve claims with an injured patient directly, it is almost always advisable to seek the counsel of a dangerous drug lawyer before dealing with a pharmaceutical company.
Injured Patients May Be Entitled to Compensation
Drug manufacturers have a duty to ensure their products are accompanied by full and accurate instructions and warnings to guide prescribing doctors and other health care providers in making treatment decisions. If a drug maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
Patients who have been injured by dangerous drugs may be entitled to compensation for damages, including:
- Medical expenses
- Pain, suffering, and mental anguish
- Loss of income or ability to work
If a patient dies from complications after taking a dangerous drug, his or her family members may be able to pursue claims for their loved one’s wrongful death. Compensation may include:
- Pain, suffering, and mental anguish from the loss of a loved one
- Loss of financial support of a loved one
- Funeral expenses
Affected patients are encouraged to speak with a North Carolina dangerous drug attorney to learn more about their rights and remedies.