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Dangerous Drug Recall Process
In order to be permitted to enter the market, prescription drugs must be rigorously tested and analyzed. According to the U.S. Food and Drug Administration (FDA), when a drug maker wants to produce a medication, they must first submit a new drug application to the Center for Drug Evaluation and Research (CDER). While a team of physicians, chemists, pharmacologists and other professionals from the CDER will review the medication, it is up to the drug company to thoroughly test the drug and provide evidence that it is safe and effective for use.
When a drug poses a health risk, the FDA or the manufacturer of the medication may issue a recall. Also, if it is discovered that a medication causes problems when it is taken in combination with a particular type of vitamin, certain foods or another drug, a recall may be issued. Additionally, a drug might be recalled if an error occurred during the manufacturing process that makes the medication unsafe to use.
The Cleveland Clinic states that drug recalls can be divided into three different categories, which include the following:
- Class I Recall—when a Class I Recall is issued, a medication is pulled from the market after it is discovered that using it will result in serious health consequences or death.
- Class II Recall—a drug may undergo a Class II Recall if it is determined that the medication may cause temporary health problems. This type of recall may also occur if a medication can cause adverse health consequences, but the possibility of this occurring is unlikely.
- Class III Recall—this type of recall is the least serious, and occurs when the use of a drug is not likely to cause problematic health issues.
According to ABC News, in a study conducted at the Brigham and Women’s Hospital in Boston, researchers discovered that Class I recalls, and drug recalls in general, are extremely common. After reviewing FDA records of medication recalls that occurred between 2004 and 2011, the researchers found that of the 1,743 recalls that happened, 91 were categorized as Class I.
Bad Drug Risks
There are other situations where a drug might cause dangerous side effects. In order to remain on the market, drug makers that manufacture drugs that may cause side effects must disclose this information so that it is readily available to consumers. Patients, in conjunction with their medical provider, can then weigh the benefits of taking the medication over the side effects it might cause.
Additionally, in some cases, a drug may be marketed for “off-label” use. According to the National Center for Biotechnology Information, off-label use refers to situations where a drug is taken for a different purpose than it’s intended for, or a dosage or dosage form is used that has not yet been cleared by the FDA. Although off-label use occurs in all specialties of medicine, it is most likely to occur in situations where certain groups of patients are not included in clinical trials.
Attorneys are alleging serious injuries and other complications in Ohio dangerous drug lawsuits being filed on behalf of affected patients.
How An Ohio Dangerous Drug Attorney Can Help
Holding a pharmaceutical company liable for dangerous drugs is a difficult task. These are large corporations, with both the financial and legal resources to fight back against any claims made against them. Yet you needn’t go through this process alone. An Ohio dangerous drug attorney can provide assistance to you throughout the entirety of your case. He or she could be a valuable resource in helping to determine the extent of harm you were forced to endure, to assess how much is needed to compensate for your injuries, to negotiate with the drug company in an attempt to settle your claim, and to represent your interests at trial if necessary.
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 an Ohio dangerous drug attorney to learn more about their rights and remedies.