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Medication Approval Process
The U.S. Food and Drug Administration (FDA) requires drug manufacturers to test their products rigorously, and the results of those tests must be submitted to that government agency so professionals from many branches of science may review them. Testing processes include clinical trials, which determine absorption rates, optimal dosage, side effects, food and drug interactions and other important information.
A company may spend many years completing the testing and approval process, the FDA notes, and thousands of chemical compounds do not make it through the initial stages to be tested on humans in clinical trials. Even being introduced to the public is not necessarily the final phase of the process, since the FDA requires ongoing accounts of new information as it arises through channels such as reports of unfavorable reactions.
Dangerous Drug Risks
The Cornell University Law School’s Legal Information Institute notes that a company may be liable for the damages caused by a product if it contains a flaw in the way it is designed, if it sustained a defect while it was being produced, or if the information provided for safe use is incorrect.
When one of these three factors affects a medication, the potential for harm may be significant. For example, Natural News reports that the drug company, Hospira, has been the focus of FDA attention because of problems with their quality control processes. While the drug itself may not cause harm, the vials in which the medication was shipped contained particles of glass. The company warned that the production defect may cause patients to experience health problems such as chest pain, breathing issues, inflammation and rash.
Dangerous Drug Lawsuits Filed
A widely prescribed drug that causes injuries or fatalities may lead to hundreds of product liability claims against the manufacturer. For this reason, the U.S. Judicial Panel on Multidistrict Litigation explains that the federal court system may consolidate these lawsuits in a process known as Multidistrict Litigation (MDL). Since there is information common to all the cases, fewer resources are necessary to gather and present the evidence, and the rulings for the plaintiffs are consistent since a single judge makes the final decision.
Even though settlements against drug companies may cost them millions of dollars, Natural News states that the financial penalties are rarely a burden because they often represent a small fraction of the profit. Not only that, the ruling may not result in the recall of the medication in question, allowing the manufacturer to continue to reap financial gain in spite of the dangers acknowledged by the court system.
How an Arizona 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.
People 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.