The worker can report this violation to the FDA. The FDA website should have information on how to report a violation and what type of evidence is required. The worker may have a whistleblower claim against the employer if he or she is fired, demoted or treated differently at work because he or she reported a violation.
The information provided above is for general purposes only. It does not constitute legal advice or create an attorney-client relationship.
There may be what is called a Qui Tam lawsuit if any of the product is sold to the government or is paid for with medicare funds. If so, there is the possibility of a large reward to you for reporting the problem. You need to contact an attorney who handles cases for medical billing fraud.
I am a California attorney and cannot give legal advice in your state. My comments are information only, based on federal law and general legal principles. YOUR STATE MAY HAVE ITS OWN LAWS THAT OFFER SIMILAR OR GREATER PROTECTION. If I mention your state’s laws, it only means I did a quick Internet search and found something that looked relevant. You MUST check with an attorney licensed in your state to learn your rights.
Thank you for standing up for what is right. I know it's a very difficult position to be in. For more information about whistleblowers and their rights, please see my Avvo guide: http://www.avvo.com/legal-guides/ugc/whistleblowers-and-their-rights?published=true
*** All legal actions have time limits, called statutes of limitation. If you miss the deadline for filing your claim, you will lose the opportunity to pursue your case. Please consult with an experienced employment attorney as soon as possible to better preserve your rights. *** Marilynn Mika Spencer provides information on Avvo as a service to the public, primarily when general information may be of assistance. Avvo is not an appropriate forum for an in-depth response or a detailed analysis. These comments are for information only and should not be considered legal advice. Legal advice must pertain to specific, detailed facts. No attorney-client relationship is created based on this information exchange. *** Marilynn Mika Spencer is licensed to practice law before all state and federal courts in California, and can appear before administrative agencies throughout the country. She is eligible to represent clients in other states on a pro hac vice basis. ***