Product Safety and the FDA
The Food and Drug Administration (FDA) evaluates all new drugs, vaccines, and medical devices. The FDA does not test the drugs itself, but requires manufacturers to conduct clinical trials of the new product and send the results to the FDA. Approval by the FDA does not guarantee that a drug, vaccine, blood product, biologic, or medical device is entirely safe. Many drugs, products, and devices are known to carry serious risks. In approving a product FDA weighs the available clinical evidence and makes a determination as to whether the benefits outweigh the known risks.
To minimize the risks to patients, FDA approvals are narrowly limited to specific uses, circumstances, and populations (e.g. a drug may be approved to treat schizophrenia in adults may not be approved to treat attention-deficit-disorder in children). Additionally, FDA has strict warning requirements which companies must follow in labeling and marketing their products (e.g. if a product is associated with a higher risk of stroke, product labels and marketing materials must adequately warn of that risk). Any use not specifically approved by the FDA is called an "off-label use". Although off-label uses are not illegal, patients may not be able to recover against a company if they were injured by an off-label use unless that company improperly marketed the product for the "off-label" use. Every year millions of people are injured and thousands are killed by the side effects and complications of prescription drugs, contaminated blood or biologic products, and defective medical devices. In many cases, public awareness of a product defect starts with the FDA event reporting database, MedWatch, which collects voluntary reports by patients and healthcare providers of any adverse events for drugs, biologics, medical devices, special nutritional products, cosmetics, and food/beverages. (To voluntarily report an adverse effect to the FDA fill out the form on MedWarn's Get Help page.) If there are serious or unusually large numbers of adverse events associated with a product, the FDA may take action to protect the public by issuing a warning letter to the company, requiring additional studies, strengthening the warning labels on a product, announcing a recall of a product and/or seizing the product. Read More About: If you have any questions about any potential claims your family may have or are interested in finding out about the existence of litigation pending for a particular drug, medical device, or other product, contact us and we will connect you with a qualified professional. |
If you have experienced adverse events or side effects from a defective drug, blood product, biologic or medical device find help here.
Statutes of Limitations limit the time period that plaintiffs have to file a legal claim. These time limits vary from state to state, but generally range from 2-6 years. In product liability cases, the statute of limitations usually begins when the injury occurs, but in some cases may not start until the affected person discovers, or should have discovered, that the product caused their injury.
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