For years, wrongdoers have tried to avoid responsibility for accidents they cause by arguing that, as long as they have complied with the applicable FAA regulations, they should be off the hook. Aircraft manufacturers, for example, argue that because the FAA certified their aircraft design before it went into production, a passenger injured in one of their airplanes should not be able to sue for design defects. Maintenance facilities argue that they should be immune from lawsuits for maintenance errors unless the injured passenger proves that the mechanic violated one of the federal aviation’s maintenance regulations.
These arguments are called the "pre-emption defense." The reasoning goes something like this: If it’s good enough for the FAA, it should be good enough for the court system. Courts shouldn’t be allowed to second guess the FAA. A court should not require more of a defendant than do the regulations.
Over the years, the pre-emption defense hasn’t worked all that well for defendants. After all, the FAA regulations themselves make clear that they are "minimum" standards only. Recently, however, the pre-emption defense has gained traction with some courts. For example, one federal appeals court recently ruled that airlines don’t have to warn passengers about the risks of airline-induced Deep Vein Thrombosis, even though the airlines knew that warnings would save passengers’ lives. The court’s reasoning was that the FAA regulations cover what warnings an airline must give to its passengers. The regulations require the airline to tell passengers how to unbuckle their seat belts, how to use the oxygen masks, and about placing their seat backs in the upright position before landing. The regulations don’t require the airline to tell passengers how to avoid DVT. So, according to the courts, that’s the end of the matter. The airlines are off the hook.
The US Supreme Court just put the brakes on the pre-emption defense with its decision in Wyeth v. Levine (pdf). Wyeth wasn’t an aviation case. It was a drug case. But the drug company in Wyeth made the same pre-emption argument that defendants make in aviation cases. And the Court rejected it. It ruled that the defendant drug company was properly found liable for failing to warn about a drug’s side effects. The fact that the drug company’s warnings complied with all the federal regulations was not a defense.
Wyeth is now the law of the land. A careless defendant can’t count on it’s having met the bare minimum of the regulations as a sure-fire way to to escape responsibility for the harm it causes. According to the Supreme Court, a defendant’s compliance with the regulations will be a complete defense only where holding the defendant to a higher "due care" standard would frustrate the purpose of the regulations, or make it impossible for the defendant to comply with the regulations.
The Supreme Court explained that one reason drug companies can be held to a higher standard than set forth in the regulations is because the Food and Drug Administration regulations were not intended to be the "final word" on drug safety. Defendants will likely seize on this part of the Wyeth opinion to argue that Wyeth shouldn’t apply in aviation cases. They will point to some federal appeals court opinions that have ruled that the FAA regulations, unlike the FDA regulations, were intended to "occupy the field."