The FDA & Medical Devices -- When Dangerous Products Are on the Market

The United States Federal Food and Drug Administration (FDA) is the federal agency that is tasked with protecting and promoting the public’s health and safety by regulating food and drug products that are available to American consumers. Ideally, all products under the purview of the FDA that receive approval will have been thoroughly vetted and be safe for their intended use. Unfortunately, however, this is not always the case, and dangerous products may occasionally become available to the public.

If a person is injured by a defectively designed, manufactured, or marketed product, he or she may be able to recover through an Indiana products liability lawsuit. These claims can be very complicated, and can implicate many different parties as responsible for the injuries caused. As a result, it is important for anyone who believes that they may have a products liability claim to consult with an experienced Indianapolis personal injury attorney. An attorney can help you determine whether you have a claim, and if so, who the legally responsible parties may be.

Unsafe Medical Products

One category of product that the FDA is responsible for regulating is medical devices. Medical devices are tools that are used by or implanted in a patient for the purpose of diagnosing, preventing, or treating a disease or other condition, and does not achieve its desired result through chemical action. Medical devices could be:

• Crutches
• Pacemakers
• Hearing aids
• Prosthetic limbs
• Replacement joints

Under the Federal Food, Drug, and Cosmetic Act, the FDA is required to subject all medical devices to an approval process. The level of scrutiny the agency uses depends on the classification of the device, and ranges from devices like dental floss that do not require approval or clearance to a stringent Premarket Approval process.

Sometimes, even the most thorough analysis of a product cannot detect all potential flaws, and dangerous products make it to the market and into patients. Other times, the product is not given enough scrutiny to begin with. In these cases, an injured person may have a right to legal recovery. If you have been injured by a medical device, you should contact an experienced products liability attorney for a free consultation. Simply because a device has received FDA approval does not necessarily mean that it is safe and it may not be fit for medical use.

Products liability cases involving defective medical devices can raise complicated legal and scientific issues, and it is important to hire an Indiana personal injury attorney who understands how to effectively handle these cases and has the resources to carry it through. Often, once a test case has established liability, the responsible parties are much more willing to settle out of court in order to predict and manage legal liability.