This will certainly change the events of current and potential lawsuits...who do you trust...can the FDA do the job? BD
The majority of Class III devices submitted for F.D.A. consideration — hundreds each year — are variants on products like standard pacemakers that were already in the market when the main law covering devices was passed by Congress in 1976. While companies must notify the F.D.A. when introducing such products, the agency does not require extensive safety and effectiveness testing before allowing them to be sold. As things stand now, lawyers expect injury lawsuits to leave design questions behind and focus on whether patients were harmed because a company did not make or handle the product according to the safety processes laid out in the documents approved by the F.D.A.
Hours after the decision in the case, Riegel v. Medtronic, was announced, lawyers involved in a group of Florida state court cases related to Johnson & Johnson’s drug-coated Cypher heart stent received an e-mail message from Judge Mary Barzee Flores asking for briefs on whether the lawsuits should be allowed to continue.