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The Research and Approval Process
Drugs.com explains that drug companies must complete a lengthy process for any medication to be approved by the U.S. Food and Drug Administration (FDA). This includes an extensive laboratory testing phase, then three phases of clinical trials to ensure effectiveness and safety, and identify possible health risks.
According to the FDA, clinical trials must identify a drug’s effects and side effects, proper dosage, and how it reacts to other medications, and food or drink in the system. Testing must also show the way the body breaks down and retains the drug. The FDA does not actually perform any testing, but scientists at the agency’s Center for Drug Evaluation and Research review the records that the company submits with the application for approval.
Adverse Drug Reactions
The duty of manufacturers does not end upon receiving approval. They must continue to monitor the effects of their medications carefully and report all adverse reactions to the FDA. Doctors, pharmacists and patients are also encouraged to report adverse reactions.
The number of people included in the clinical trials and the length of time they are observed on the medication are rarely enough to get a complete picture of potential adverse reactions, the FDA reports. Hundreds or even thousands of people may still have serious or fatal reactions to a drug once it is approved and prescribed to millions of patients across the country. In fact, studies indicate that adverse drug reactions may be the fourth leading cause of death in the United States.
Failure to Warn and Product Liability
When a drug company fails to provide adequate warning of a potential side effect or otherwise violates marketing laws for medications, the FDA issues a warning letter to the company. According to Cornell University Law School’s Legal Information Institute, failure to warn is a factor in products liability, where manufacturers know or should know that there is a risk of harm from the product and do not provide that information to consumers.
Virginia Dangerous Drug Attorney
Many attorneys in Virginia and elsewhere in the United States have helped victims and family members file lawsuits against drug manufacturers in an attempt to hold the companies liable for the damages their products have allegedly caused. For example, one medication that has long been marketed to pregnant women for nausea has been the focus of many birth defect lawsuits. Families have alleged that the drug caused issues such as cleft lip and palate, as well as heart defects.
Similarly, a company that manufactures a blood pressure medication is facing hundreds of claims that the drug caused serious damage to the intestinal system. Because doctors were not warned of the potential for that side effect, many patients were not taken off the medication until some sustained permanent damage.
The U.S. Judicial Panel on Multidistrict Litigation explains that when many related civil actions have been filed in more than one federal district, they may be combined and tried in a single federal district court. This benefits the plaintiffs because it allows them to share their common evidence and eliminates inconsistencies in the rulings. Multidistrict litigation is often recommended for products liability cases against pharmaceutical companies. The process is typically resolved much more quickly than when the cases are tried individually.
Attorneys are alleging serious injuries and other complications in Virginia dangerous drug lawsuits being filed on behalf of affected patients.
Virginia Bad Drugs Attorney
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. A Virginia bad drugs 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.
How a Virginia Dangerous Drug Attorney Can Help
Drug makers have a duty to provide safe products. If there are risks of harm associated with their products, they also must provide adequate warnings. If a drug maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
Diego Cervo/iStock/ThinkstockPeople injured by bad drugs may be eligible to recover money for:
- Medical Expenses
- Lost Wages
- Pain and Suffering
The families of those who have died may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.