Every drug on the market has to go through a rigorous process to be approved by the Food & Drug Administration (FDA), but that doesn’t mean that every drug is safe to use. In fact, it’s the pharmaceutical manufacturers that provide the research and data to the FDA for their evaluations, yet it’s those very companies that make the most money from the drugs’ being approved and sold. The companies are also responsible for testing and monitoring the drugs’ safety and efficacy on an ongoing basis once they are made available to patients.
However, sometimes drugs are released to the market before all of the drug side-effects are known, or before there is enough data to know if it is safe for its intended use. Also, things can go wrong in the manufacturing process, which means that even a safe drug could sometimes be defective and cause harm.
If you’ve taken medication that has been the subject of a drug recall, drug lawsuit or other action, you might be eligible to receive monetary damages. Some drug side-effects can be so severe that they cause permanent or life-threatening harm. At McIntyre Law, our priority is the well-being of our clients. That means that we will fight for you and do whatever it takes to win your drug lawsuit. We’ve been down this road plenty of times — we’ve handled cases that include Paxil birth defects, Topamax birth defects, defective medical devices and more. You don’t have to suffer alone.
Before a drug can be approved by the FDA, the pharmaceutical company that manufactures it must rigorously test it to make sure the drug does what it’s supposed to do. More importantly, it must be tested for safety. Drug labels must fully disclose all ingredients, intended uses, and must warn consumers about potential side effects. Labels must also warn against using the drug for any reason other than its intended purpose.
To ensure drugs are manufactured properly, the FDA enforces a set of regulations called Current Good Manufacturing Practices (cGMPs). These regulations are flexible to a degree since drugs are made from various ingredients, and for numerous purposes. If cGMPs are properly followed, they are meant to help prevent contamination, formula deviations, and other failures and errors that can occur during the drug manufacturing process. When a pharmaceutical company fails to follow cGMPs, and a drug is produced that does not meet quality standards for use and safety, the drug is defective.
The FDA does not have the authority to force a pharmaceutical company to initiate a drug recall. In fact, when the FDA determines that there are dangerous drug side-effects or a manufacturing defect, it will contact the pharmaceutical company for notification purposes. Generally, the Big Pharma company will then voluntarily issue the drug recall — but not always. When it doesn’t happen voluntarily, the FDA will instead warn the public about the drug dangers, and it could seize it from the market if necessary.
Pharmaceutical companies perform studies and clinical trials to determine whether a drug is safe and effective. As these tests are taking place, it will note the drug side-effects so that warnings can be included on the drug label. Unfortunately, some drug side-effects are not immediately discovered during. This happens for a few reasons, including, but not limited to:
People are different. The way a drug affects you might not be the same as the way it affects your mother, brother or friend. That means that you could take a drug and it could work as intended with no unpleasant side-effects. But, someone else could develop an allergy or other reaction that could be harmful or even life-threatening. That makes testing and reporting even harder because some of the drug side-effects might not become apparent until it has been out on the market and used by a large number of people.
However, even when a drug is properly tested, procedures followed and precautions taken, sometimes injuries occur. That means that the pharmaceutical companies must be held responsible — and that is where McIntyre Law comes in.
If you or someone you know has suffered severe drug side-effects, or if you know that you are taking or have taken a defective drug, you have options. Even if there isn’t a recall in place, you still might be eligible for a drug lawsuit. The McIntyre Law team is experienced in handling a drug lawsuit that can help you with damages associated with physical injury, suffering, pain, medical expenses and lost wages. If this is something that has affected you, contact us for a free consultation.