Medical Device

A medical device is a product used for a medical purpose that works physically or mechanically rather than as a drug. The category is huge: bandages and tongue depressors, insulin pumps, hip and knee implants, surgical mesh, pacemakers, catheters, and diagnostic software can all be devices.

The FDA regulates devices by risk. Class I devices face general controls, Class II devices face general and special controls, and Class III devices, the highest risk, require premarket approval (PMA); Class I and II devices that are not exempt generally need a 510(k) clearance to be marketed. A 510(k) clearance means the FDA found the device "substantially equivalent" to one already on the market. It is a lighter review than premarket approval, which requires evidence of reasonable assurance of safety and effectiveness.

That distinction matters a great deal in lawsuits. In Riegel v. Medtronic (2008), the U.S. Supreme Court held that federal law preempts many state-law injury claims against Class III devices that received FDA premarket approval. Claims involving 510(k) devices are generally not preempted in the same way, so people injured by cleared devices often have more room to sue. Plaintiffs in PMA device cases usually must show the manufacturer violated FDA requirements.

Device injury claims are usually individual cases, often grouped in multidistrict litigation. Keep your implant card and operative report, which identify the exact model and lot. See our pages on port catheter lawsuits, hernia mesh lawsuits, and spinal cord stimulator lawsuits.