What is Considered a Dangerous Drug?
A dangerous drug is a prescription drug that is put on the market without adequate clinical testing to understand its negative side effects. The quicker a drug is released onto the market, the more quickly a pharmaceutical company starts recouping its costs for the development of the drug and making money from it. That profit motive can lead some drug makers to take shortcuts in the clinical trial process to hurry drugs onto the market before they are fully tested.
A dangerous drug is one that causes unexpected adverse effects and interactions with other drugs. The harmful side effects of a drug may not be apparent to medical researchers or regulators until the drug is in wide distribution. Manufacturers are required to report to the FDA any adverse events reported by doctors or patients about a drug.
A dangerous drug is one that does not carry adequate warnings of potential side effects. Sometimes, clinical testing reveals that the drug has certain harmful effects and the manufacturer fails to warn adequately of the risks associated with the drug. Typically, neither the patient nor the patient’s doctor who prescribes the drug has been made aware of the dangers of the drug. The patient should not bear responsibility for the hidden dangers of a drug. The drugmaker should be held to account.
A drug may be dangerous because the drug company’s sales representatives are encouraging doctors to prescribe the drug for treatment purposes for which it has not been approved by the FDA.
A drug may be dangerous because it is contaminated during the manufacturing process. A pharmaceutical company may have failed to maintain environmental controls and allowed microbiological contamination of the manufacturing equipment or areas, leading to the release of contaminated drugs or defective drugs.
The U.S. Food and Drug Administration, which regulates the safety of drugs, may order follow-up studies after the approval of a drug to gather more information about the drug.
Each year, the FDA receives thousands of reports of side effects and injuries caused by drugs. The FDA may ask a pharmaceutical company to add additional warnings about a drug to the packaging. The FDA also may ask the manufacturer to recall a drug due to side effects that are potentially serious or deadly. But most dangerous prescription drugs are not part of FDA drug recalls and remain available to consumers. These products should always carry adequate warning labels about the risks of using the medication.
Most medications have some risks, but the risks should not outweigh the benefits of the drug. In all of the above situations, the drug manufacturer is legally liable and may be sued for damages, even if the manufacturer did not know the drug would cause a certain harmful effect.
Dangerous drug cases are complicated.
Dangerous Drug Cases We Handle
Our knowledgeable attorneys handle a wide range of injury claims involving dangerous prescription drugs.
Who is Liable for Prescription Drug Damages?
Drugmakers are required by law to manufacture and market drugs that are safe and effective when used as intended. They are required to use reasonable care in the design and manufacture of their products.
When drug makers do not adequately test drugs to ensure their safety, release products with manufacturing defects or fail to warn adequately of harmful side effects, they may be liable when consumers suffer preventable injuries.
Injuries sustained from dangerous drugs can have a catastrophic effect on your life, including long-term disability. A patient should not have to pay the hospital bills that accrue due to the adverse effects of a dangerous or defective drug. The drug manufacturer should bear those costs rather than the patient.
Dangerous drugs that have injured thousands of patients may be the subject of mass tort litigation involving hundreds or thousands of lawsuits.
Let the dangerous drug attorneys at Hardison & Cochran review your drug injury and determine whether you are entitled to seek compensation from the pharmaceutical company. By turning to an experienced Raleigh prescription drug lawsuit attorney for help, you will be in a better position to make informed decisions about pursuing compensation for mounting medical bills, lost time from work and pain and suffering.
When Does the FDA Recall a Dangerous Drug?
The U.S. Food and Drug Administration regulates the safety of both prescription medications and drugs sold over the counter. Consumers and doctors rely on the FDA’s safety review process.
When a medication is defective or potentially harmful, the FDA may issue a recall to remove it from the market and protect consumers. Among the FDA-regulated products that are subject to recall are human drugs, medical devices, vaccines, blood and blood products, and transplantable human tissue.
Recalls are typically voluntary. A drug maker may initiate a recall on its own before being asked by the FDA. A manufacturer may recall a drug after the FDA has notified it of concerns about the medication based on adverse event reports from doctors and patients. The FDA may ask the drug manufacturer to add warnings about the potential side effects or to recall the drug.
The FDA categorizes recalls by the seriousness of the hazard:
- Class I Recall—Class I recalls involve the most dangerous drugs and medical devices that could cause serious health problems or death due to safety defects.
- Class II Recall—Drugs that may pose a temporary health problem or a slight threat may be the subject of a Class II recall.
- Class III Recall—Products that violate the FDA’s labeling or manufacturing laws but are unlikely to cause adverse health effects may be the subject of a Class III recall.
The FDA may hold a press conference or issue a press release if regulators believe the public needs to be alerted about a drug’s harmful effects.
Unfortunately, many FDA drug recalls occur only after a dangerous drug has injured or led to the deaths of many people.
People who have been harmed by dangerous drugs do have legal rights to seek compensation for their injuries.
Call an Experienced Dangerous Drug Lawyer in North Carolina
If you suspect that you or your loved one was harmed by a dangerous drug, it is important to meet with a respected prescription drug lawsuit attorney as soon as possible and discuss the situation. You want to work with an established law firm that has the resources and determination to pursue these complicated cases against drug manufacturers.
Hardison & Cochran was founded to protect the rights of personal injury victims, including those harmed by dangerous drugs. Our Raleigh dangerous drug lawyers have a track record of success in both settlements and courtroom cases.
Our law firm has offices in Raleigh, Durham, Greensboro, Fayetteville, Dunn, Southern Pines and Wilmington.
We are available for a free consultation and we take pride in our responsiveness. If you contact us, we will respond within 24 hours.