Orlando Defective Drug Attorneys
Millions of Americans turn to over-the-counter and prescription drugs when they don’t feel well. New drugs are constantly being developed to treat both emerging conditions and longtime illnesses. You can take medication for everything from arthritis and allergies, to high blood pressure and high cholesterol, to serious heart and lung problems.
When your medications work as prescribed, they may help you to feel better. But when a drug company makes a product that is defective, it can cause far more harm than good.
Pharmaceutical companies produce drugs that bring in billions of dollars per year, most of that from prescription drugs. Johnson & Johnson, the world’s largest pharmaceutical manufacturer, reported $40.81 billion in pharmaceutical sales during the second quarter of 2018. While prescription drugs can cure medical conditions and save lives, they can also cause harm. Defective drugs are known to cause severe adverse effects and death.
The FDA is tasked with the oversight of drugs. Their job is to ensure that a drug is thoroughly tested before being allowed to be prescribed to the general public. The Center for Drug Evaluation and Research (CDER), a branch of the Food and Drug Administration (FDA), is responsible for approving new drugs. The CDER says it has the mission to assure that “safe and effective drugs are available to the American people.”
Drugs are first tested in the lab, and then tested on humans. When human testing is involved it happens in three phases: I, II, II clinical trials.
Phase I involves 100 carefully chosen volunteers, if this trial is successful the trials move to Phase II, where 100-300 volunteers who have the condition the drug treats are tested. Phase III Is the final stage of approval. This final phase involves around 1000 subjects but can include more. Phase III normally takes 4-8 weeks but can last longer. If the FDA reviews the results of the Phase III clinical trial and determines that the drug is “safe”, then it is released to the public.
However, despite what is supposed a safe procedure to ensure the safety of the public, drugs sometime make it through the system only to find that there are issues in the future.
When most of us hear the word safe, we think of “not dangerous” or “unlikely to cause or result in harm, injury, or damage.” According to Janet Woodcock, M.D., director of the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER), safe has a different meaning to the Food and Drug Administration.
When it comes to any drug, “safe” means that the benefits of the drug outweigh the risks for the population the drug is intended to treat and for its intended use.
Safe does not mean harmless. The CDER has determined that the benefits of the drug outweigh the risks and that is why there are paragraphs of risk factors associated with the use of the drug. This may not be so bad, but how can you know if the benefits outweigh the risks if the test is done on a tiny percentage of the population, less than .001% of the population?
The CDER confirms this when it says, “So, the safety profile for new drugs that come on the market is never totally defined because new drugs are studied only in relatively small and homogeneous patient populations. The complete safety profile of a new drug will be defined only after it has been approved and is in use on the market.”
In 2006, the Union of Concerned Scientists and Public Employees for Environmental Responsibility distributed a 38-question survey to 5,918 FDA scientists in order to examine the state of science at the Food and Drug Administration. The results are distressing. The scientists who responded pointed to significant interference with the FDA’s scientific work which in turn led to problems with the FDA being able to fulfill its mission of protecting public health. Here are some of the results:
- Less than half (47 percent) think that the “FDA routinely provides complete and accurate information to the public.”
- Less than half (49 percent) agree that “FDA leadership is as committed to product safety as it is to bringing products to the market.”
- One-fifth (20 percent) 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.”
- In addition, more than a quarter (26 percent) feel that FDA decision makers implicitly expect them to “provide incomplete, inaccurate, or misleading information.”
- Two in five (40 percent) said they could not publicly express “concerns about public health without fear of retaliation.” More than a third (36 percent) did not feel they could do so even inside the confines of the agency.
- Nearly 70 percent do not believe the FDA has sufficient 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.”
Lawsuits Against Well-Known Drugs
Lawsuits have been filed against many well-known drugs in recent years. For example, two medications designed to help type 2 diabetes – Avandia and Actos – were found to also increase the risk for conditions such as heart failure and certain types of cancer. The birth control pill Yaz (also known as Ocella) was found to also increase the risk for blood clots, including a potentially deadly condition called deep vein thrombosis. Sometimes, dangerous drugs are recalled by the manufacturer or the Food & Drug Administration (FDA). Other times they are not.
When to Consult With an Orlando Defective Drug Attorney
If you’ve been injured by a prescription or over-the-counter medication, it’s in your best interest to talk with a lawyer who can fight for your rights. Pharmaceutical companies are often represented by teams of high-priced lawyers, so don’t go up against them on your own. The Orlando defective drug attorneys at Warner & Warner in Casselberry, Florida, offer free consultations for defective drug cases.
Florida has a four-year statute of limitations on defective drug cases, so if you think you have a case, it’s wise to talk with an attorney sooner than later. You may have a case if the drug you took was defectively manufactured (meaning it was tainted at the manufacturing plant, during shipment, or improperly compounded at a pharmacy); if the drug had dangerous side effects that weren’t clearly labeled; or if the drug was tested if marketed improperly.
In any of the above cases, several parties may be to blame, including the pharmaceutical company, its testing lab, the pharmacy or pharmacist, a doctor, hospital or clinic, or a pharmaceutical sales representative. If you can prove you were injured by a defective drug, you may be eligible for compensation for medical treatment, any loss of income, pain and suffering or emotional distress, from any of the responsible parties
If you’ve been harmed by a defective drug in Orlando, Maitland, Casselberry, Altamonte Springs, Sanford, Lake Mary, Winter Park, Oveido, Apopka or any Central Florida community, you have the right to seek compensation for your losses, because drug manufacturers are required to create products that are reasonably safe for consumers.
The Orlando medical malpractice lawyers at Warner & Warner have represented clients in defective drug cases. They can discuss your case, determine how strong a case you may have, identify the potential parties who are liable, and work hard to ensure you receive the compensation you deserve.