In the United States, we trust that the over-the-counter and prescription drugs we take are safe and will work as intended. In fact, many of us rely on medication to treat serious or chronic illnesses daily. Unfortunately, despite a rigorous approval process that involves ongoing government oversight, defective drugs still make it into the hands of consumers. When that happens, serious illness or even death may occur.
If you or a loved on has been injured by defective medication, you may be able to hold the people responsible for defective drug accountable and obtain substantial compensation for your related medical expenses, pain, suffering and losses. The Casselberry defective drug attorneys at Warner & Warner want to help you obtain this justice. We have the experience and resources needed to fight for your rights and will work tirelessly to ensure that you are justly compensated for your physical and emotional injuries.
Who Regulates Prescription Drugs in the United States?
All prescription drugs in the U.S. must be approved by the Food and Drug Administration (FDA) before they are available to the public. According to the FDA, the purpose of that approval process is to assure that drugs available to the American people are safe, effective and secure.
To ensure drug safety, the FDA has a rigorous approval process overseen by the Center for Drug Evaluation and Research (CDER). To gain FDA approval, a new drug must go through lab testing followed by three phases of clinical trials involving humans. Phase I involves 100 carefully chosen volunteers. If Phase I is successful, the drug moves to Phase II, which involves 100-300 volunteers selected because they suffer from the condition targeted by the drug. Phase III is the final stage of approval and involves at least 1000 subjects. A drug must successfully make it through Phase III before being released to the public.
Despite this intensive approval process, defective drugs do make it into the U.S. market, often with very serious consequences. Defective medication can cause heart failure, cancer, blot clots and other life-threatening conditions.
The Problem with Defining “Safe” Drugs
When we hear that a prescription drug has been approved by the FDA most of us think that guarantees a drug is “safe.” The problem lies in the definition of the word “safe.” As commonly used, the word “safe” means “not dangerous” or “unlikely to cause or result in harm, injury, or damage.” The FDA, however, defines a “safe” drug as one in which the “benefits of the drug outweigh the risks for the population the drug is intended to treat and for its intended use.” Therefore, safe correlates to a risk-benefit analysis, meaning a safe drug is not necessarily a drug that is not dangerous.
Consider the following responses of 5,918 FDA scientists to a 38-question survey distributed by the Union of Concerned Scientists and Public Employees for Environmental Responsibility in 2006:
- Only 47 percent think that the “FDA routinely provides complete and accurate information to the public.”
- Just 49 percent agree that “FDA leadership is as committed to product safety as it is to bringing products to the market.”
- 1 in 5 say they “have been asked explicitly by FDA decision-makers to provide incomplete, inaccurate or misleading information to the public, regulated industry, media, or elected/senior government officials.”
- 26 percent feel that FDA decision-makers implicitly expect them to “provide incomplete, inaccurate, or misleading information.”
- Nearly 70 percent believe the FDA has insufficient resources to effectively perform its mission of “protecting public health and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.”
How Can a Casselberry Defective Drug Attorney Help?
If evidence suggests that an approved prescription drug is doing more harm than good, the FDA is supposed to recall the drug. Unfortunately, that recall may come too late to prevent serious harm or may not come at all. When that is the case, the drug may become the subject of litigation. For example, Avandia and Actos, both designed to help type 2 diabetes, also increased the risk for heart failure and certain types of cancer. The birth control pill Yaz (also known as Ocella) also increased the risk for blood clots, including a potentially deadly condition called deep vein thrombosis.
A drug may be defective in one of three ways, including:
- The drug was defectively manufactured (meaning it was tainted at the manufacturing. plant, during shipment, or improperly compounded at a pharmacy.
- The drug had dangerous side effects that weren’t clearly labeled.
- The drug was tested or marketed improperly.
Determining fault in a defective drug case can be a complex process because more than one party often shares responsibility. Responsibility could, for example, rest with one or more of the following parties:
- Pharmaceutical company
- Testing lab
- Pharmacy or pharmacist
- Hospital or clinic
- Pharmaceutical sales representative
The experienced Casselberry defective drug attorneys will investigate the circumstances surrounding your case and determine all of the parties who bear responsibility for your injuries. We will also work diligently to help you obtain maximum compensation for the injuries you have suffered.
What Kind of Compensation Can Victims of Defective Drugs Receive?
If you have been injured by defective medication, you may be able to obtain substantial compensation by taking legal action against those responsible for the medication and your resulting injuries. However, the exact amount of financial compensation available depends on the specific details of your case.
Florida law provides for both economic and non-economic damages for people injured due to others’ negligence. These potential damages include:
- Pain and suffering
- Emotional trauma
- Lost support and services
- Medical and other healthcare expenses, both current and future
- Lost wages
- Diminished earning capacity
- Other damages recoverable under Florida law
Get Experienced, Reliable Legal Help from Casselberry Defective Drug Attorneys
If you suffered physical injuries and/or emotional trauma because of a defective drug, you could be entitled to compensation for medical treatment and loss of income, as well as pain and suffering or emotional distress. Having an attorney on your side with the expertise and resources necessary to go up against the pharmaceutical legal team is the key to ensuring that your rights are protected throughout the litigation process.
The Casselberry defective drug attorneys at Warner & Warner are committed to holding pharmaceutical companies (and other parties) legally accountable when they allow defective drugs into the marketplace and to ensuring that victims are fully compensated for all their injuries.
Contact the Casselberry defective drugs attorneys at Warner & Warner today at 321-972-1889 or online to schedule a free case review.