Prescription drugs and over-the-counter medications are supposed to help us stay healthy, but when those drugs don't work as intended, the consequences can be disastrous.
Taking a defective drug may cause serious long-term physical, emotional and psychological injuries. Someone who was injured by a defective drug may struggle financially due to the burden of medical expenses and missed work. He or she may also experience pain and suffering, mental anguish or loss of enjoyment of life. In the most extreme cases, taking a defective drug can even cause death.
If a defective drug resulted in injuries or loss of life, it may be possible to hold the drug manufacturer financially responsible via a product liability lawsuit.
What is a defective drug?
Most drugs have the potential to cause some sort of negative reaction or unintended side effect. Therefore, not all drug injuries are caused by a drug being defective.
A defective drug is a prescription or over-the-counter medication that:
- causes negative side effects; and
- has side effects that are severe enough to outweigh the drug's potential benefits.
Drug defects can occur when:
- A drug was inadequately tested and therefore has unexpected and dangerous side effects.
- A drug was manufactured incorrectly. Defective manufacturing can introduce dangerous contaminants (such as viruses, bacteria or hazardous chemicals) into a drug. Sometimes drugs are manufactured at the wrong strength or concentration, resulting in a dangerously high or dangerously low dose.
- A drug is not adequately labeled or doesn't include sufficient warnings about potential drug interactions, appropriate use or potential side effects.
Who decides a new drug is safe?
The Federal Drug Administration (FDA) regulates the sale of prescription and over-the-counter medication in the U.S. People sometimes believe that FDA approval automatically means a drug won't hurt them. But FDA approval does not necessarily mean a drug is safe.
Thousands of FDA-approved defective drugs have been recalled in recent years. Some defects were identified by the manufacturer who then voluntarily recalled a defective drug. Some drugs have been recalled due to reports from consumers who were injured by taking the defective drug.
So how does a defective drug end up being sold to consumers? First, it is important to understand that the FDA doesn't actually test new drugs. Instead, the agency generally relies on data submitted by drug manufacturers. To get a new drug approved, a drug company performs various tests, then submits its test results to the FDA.
Almost all drugs carry some risk of side effects. The goal of the FDA approval process is to determine whether the potential benefits of the drug outweigh the risks. If the benefits outweigh the risks, the drug may be approved for sale.
Unfortunately, pharmaceutical companies may be focused on making a profit, rather than on making safe and effective new drugs. In their quest for profit, pharmaceutical companies or drug manufacturers may take shortcuts when testing new products. The company may pressure the FDA to "fast-track" approval of a drug without adequate testing. Worse, a drug company might even hide negative results that could potentially prevent a drug from being approved by the FDA.
Holding a drug manufacturer responsible for defective drug injuries
There are a number of different ways to potentially recover compensation from a drug company for defective drug injuries. These include:
- Strict liability. Under Georgia law, product manufacturers can be held liable (financially responsible) for injuries caused by their defective products, even if the manufacturer did not know the product was defective. Because almost all drugs carry some risk of side effects, a drug manufacturer isn't necessarily strictly liable for all injuries that result from consuming its drugs. Generally, the danger of adverse side effects must be greater than the drug's potential benefits for the drug to be considered defective.
- Negligence. Drug manufacturers have a duty of care to produce a reasonably safe product. If the manufacturer was unreasonably careless in testing or manufacturing a drug, the company could potentially be found liable for injuries that occur due to its negligence. To prove negligence, the injured person generally must prove that a company knew about (or should have known about) a potential danger.
- Failure to warn. Drug manufacturers also have a duty to warn consumers of a drug's potential dangers. If a drug manufacturer does not provide adequate warnings, the company could potentially be found liable for injuries that occurred due to its failure to warn.
If it is proven that a defective drug caused a person's injuries, the injured person may be able to recover damages from the drug manufacturer. Damages include compensation for tangible things like medical expenses and lost wages, as well as intangible things such as pain and suffering, mental anguish and reduced quality of life.
In certain extreme cases, punitive damages may be awarded in defective drug cases. These are a special category of damages designed to punish a company and deter it and other companies from engaging in practices that endanger consumers in the future.
Proving a drug is defective
No one who has been injured by a defective drug should try to go up against a pharmaceutical company or drug manufacturer alone.
Defective drug cases require in-depth scientific knowledge of drug chemistry and the potential impact of a drug on the human body. They also require an understanding of drug testing, approval, and manufacturing processes to determine whether a drug company took dangerous shortcuts to get its products to market.
Pharmaceutical companies will work very hard to prove that a lucrative drug is not defective or that the drug did not actually cause a person's injuries. Because people who are taking drugs or prescription medication are often unwell to start, proving that a drug caused their injuries can be extremely complicated.
An experienced defective product attorney can stand up to the pharmaceutical company or drug manufacturer to help you get the fair compensation you are due for your injuries. If you or a loved one have been injured by a defective drug, contact the Hadden Law Firm as soon as possible.