Consumers have a right to expect that products that claimto diagnose serious medical conditions have been reviewed by the Food and Drug Administration (“FDA”) and approved for such marketing. Accordingly, when unscrupulous companies mislead consumers by marketing such products without having been approved the FDA, consumers have a right to hold that company to account in a court of law.
Recently, the FDA issued a warning letter to Health-Chem Diagnostics LLC stating that the company was marketingdiagnostic tests for the Zika virus– its One-Step Test for Zika Virus Antibody and One-Step Test for Zika Virus IgG/IgM Antibody tests — despite never seeking approval from the FDA.
When consumers purchase a regulated medical diagnostic productreasonably believing, because of deceptive and misleading product claims, that it has been approved by the FDA, when there is, in fact, no such approval, the company selling that producthas been unjustly enriched at consumers’ expense.The attorneys at Finkelstein, Blankinship, Frei-Pearson & Garber, LLP have successfully brought lawsuits on behalf of consumers aggrieved by such deceptive product claims. If you or someone you know haspurchased diagnostic tests for the Zika virus from Health-Chem Diagnostics LLC,please contact us today for a free consultation regarding your legal options.