Rosen Quoted on Product Safety Evaluation

Foley Partner David Rosen discusses product safety evaluation following the Food and Drug Administration’s (FDA) warning of fines and sanctions to Johnson & Johnson for selling faulty insulin pumps and delaying disclosures of injuries to diabetics using two of the company’s pumps. He says that proper safety evaluation of a product is continuously conducted throughout its life span, adding that companies can institute safety infrastructures to process, review and classify complaints that may indicate larger issues with a product.