Laboratory developed tests (LDTs) are diagnostic procedures that are often used to determine if a child suffers from a genetic disorder. Currently, these tests are overseen by the Centers for Medicaid and Medicare Services. Now though, the U.S. Food and Drug Administration (FDA) has proposed a set of new regulations for these procedures, claiming they have the authority to control these tests as if they were a medical product.
While many believe the new set of regulations can improve patient safety in the medical industry, others believe the new laws could implicate LDTs as a defective product.
An article released by The National Law Review highlights several recent cases in which parents of children suffering from genetic disorders successfully sued laboratories for failing to supply them with accurate test results. This has forced many labs to seek refuge under the Virginia Medical Malpractice Act, which places caps on the amount of damages that can be awarded in cases where a medical professional or facility’s mistake led to a patient suffering harm.
A decision on the new regulations is expected to be released in the near future. In the meantime, the Norfolk personal injury attorneys with Lowell Stanley Injury Lawyers are here to help if you’ve been harmed by a medical error that occurred through no fault of your own. Just give us a call at (757) 459-CASH to get started on your case today.