How to Report Unsafe Drugs, Biologics, Medical Devices, Nutritional & Cosmetic Products
Generally speaking, consumers should report serious adverse events related to human medical products to the U.S. Food & Drug Administration (FDA). In addition, sometimes these reports are and can be made by an injured consumers legal counsel, i.e. their attorney or lawyer that is investigating the merits of a product liability lawsuit on behalf of the injured or killed individual.
Steps to Filing a Report with the FDA
The FDA has made reporting unsafe human medical products products very simple. You can use the online forms at the FDA website to report a serious adverse event.
Link to FDA Form: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
In addition, you may also report unsafe human medical products by phone 1-800-216-7331 or letter (Food and Drug Administration, 5600 Fishers Lane, Rockville, Maryland 20857).
Free Confidential Case Evaluation
The FDA receives a large number of serious adverse event reports every year. It is unfortunate that the FDA is underfunded and most likely cannot investigate every single consumer complaint related to a defective drug, medical device, etc. that is submitted to them. It is also unfortunate that if a consumer discovers a serious side effect of a drug or product design defect of a medical device that may have injured or killed a friend or loved one, their report may go unnoticed and without action. This is where a products liability law firm such as ours can help.
At Schmidt & Clark our sole focus is on helping individuals and families. We have built a reputation for success, and represent our clients in group and individual cases nationwide including product liability, mass torts (defective drug lawsuits), personal injury, environmental litigation, toxic exposure, transportation disasters, automotive crashworthiness, medical device failures and medical malpractice.
Although Schmidt & Clark is national in scope, we level the playing field for our clients by providing them with access to a level of professional legal representation previously available only to large corporations, while still providing personal attention to each client.
If you or a loved one have been injured by an unsafe drug or defective medical device, we urge you to contact us immediately. You may be entitled to legal compensation for your injuries and we can help. In addition, by investigating the merits of your potential product liability lawsuit, we (you and our firm) may be able to prevent similar injuries and/or deaths from occurring to others.
For a free confidential case evaluation, please feel free to contact us by using the form below or by calling toll free 24 hrs/day by dialing (866) 588-0600.



