Consumers should report serious adverse events related to human medical products to the U.S. Food & Drug Administration (FDA). These reports can include side effects from dangerous drugs, over-the-counter medications, dietary supplements, and complications or injuries arising from defective medical devices.
Steps to Filing an Adverse Event Report with the FDA
The FDA has made reporting unsafe human medical products very simple. You can use the online forms at the FDA website to report a serious adverse event.
Can a lawyer file an FDA adverse event report?
Yes.
Sometimes these reports are and can be made by an injured consumer's legal counsel, i.e. their attorney or lawyer that is investigating the merits of a product liability lawsuit on behalf of the injured individual.
Information You Should Report to the FDA
- Unexpected side effects or adverse events can include everything from skin rashes to more serious complications.
- Product quality problems such as information if a product isn't working properly or if it has a defect.
- Product Use/Medication Errors that can be prevented. These can be caused by various issues, including choosing the wrong product because of labels or packaging that look alike or have a similar brand or generic names. Mistakes also can be caused by difficulty with a device due to hard-to-read controls or displays, which may cause you to record a test result that is not correct.
- Therapeutic failures. These problems can include when a medical product does not seem to work as well as when you switch from one generic to another.
Types of FDA Regulated Products You Can Report Through the MedWatch Reporting System
- Prescription and over-the-counter medicines including those administered in a hospital or outpatient infusion centers.
- Biologics such as blood components, blood/plasma derivatives, blood transfusions, gene therapies, and human cells and tissue transplants.
- Medical devices such as diabetes glucose-test kits, hearing aids, breast pumps, and many more products.
- Combination products such as prefilled drug syringes, auto-injectors, metered-dose inhalers, contact lens coated with a drug, and nasal-spray.
- Special nutritional products such as dietary supplements, medical foods, and infant formulas.
- Cosmetics such as moisturizers, makeup, shampoos, conditioners, hair dyes, and tattoos.
- Food such as beverages and ingredients added to foods.
Other Cases We Take On:
- Product Liability Lawsuits
- Dangerous Drug Lawsuits
- Defective Medical Device Lawsuits
- Toxic Tort Lawsuits
FAQs
Can I report an adverse event to the FDA anonymously?
Yes, you can choose to report an adverse event to the FDA anonymously. However, providing contact information allows the FDA to follow up if additional details are needed.
What types of adverse events should be reported to the FDA?
Report any serious adverse events, unexpected side effects, or problems that significantly impact the patient’s health. This includes life-threatening reactions, hospitalizations, disability, or death.
Can I report adverse events for over-the-counter products to the FDA?
Yes, adverse events related to over-the-counter products, dietary supplements, and cosmetics can also be reported to the FDA through the MedWatch program.
Contact a Product Liability Lawyer
The Product Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in dangerous drug lawsuits, defective medical device lawsuits, dietary supplement lawsuits, and food poisoning lawsuits. We handle these types of product liability lawsuits nationwide and are currently accepting new defective or dangerous product cases in all 50 states.
Free Confidential Case Evaluation: if you or a loved one have been injured by an unsafe product, you should contact our law firm immediately. You may be entitled to a settlement by filing a lawsuit and we can help.