In its simplest terms, pre-emption means that where the federal government has acted, the states may not. The concept has a very practical basis. For instance, we could not have 50 states imposing varying regulations upon airlines. Where the federal government has declared a product safe or its warnings adequate, the states may not act to the contrary. If Congress intends to pre-empt the area, the states may not enter it. Contrary or varying state legislation is thus prohibited.
The more problematic question arises in respect to jury trials which involve the common law of a state rather than its legislation. A number of current cases are being defended on the basis that FDA approval is an absolute defense, and that permitting juries to find approved products unsafe or approved warnings inadequate violates the principle of pre-emption---the theory being that a jury verdict is a form of state law that runs counter to federal law.
The subject has more than a passing interest to me, because I was confronted with the identical issue in the Cippolone case. The tobacco companies argued that the warning labels, mandated by Congress, prohibited a plaintiff from asserting that the warnings were inadequate; that permitting a jury to conclude that different warnings were required, in effect, would be tantamount to state action requiring a revision in the warnings in order to avoid future liability.
I struggled with the issue, but ultimately concluded that plaintiff's claims would not be pre-empted, if it was demonstrated that the defendant tobacco companies knew that the warnings were inadequate---that they knew that cigarette smoking was far more dangerous than it "may be hazardous to your health." I was also influenced by proffered evidence that the companies were engaged in a concerted campaign to neutralize the warnings through their advertising and public relations. I viewed government standards as a minimum requirement. If a builder knows that a construction standard is unsafe, he should not escape liability by asserting he followed the building code. If the FDA approves a product, the manufacturer, nonetheless, should be liable for injuries sustained, if it knows that the product is unsafe or the approved warnings inadequate.
Both the United States Court of Appeals for the Third Circuit and the Supreme Court reviewed my opinion. I will not attempt to summarize what they concluded. Justice Scalia indicated that it gave the courts complicated guidance for future cases, so I will let wiser minds unravel it. When Congress immunized gun manufacturers from liability, I then asked why it would single out an industry to protect that made a product that killed people rather than the drug industry which makes products to save lives. The latter would certainly make more sense. But now that it is on the table, I am not now certain that even the most beneficial industries should receive immunity under the pre-emption doctrine.
Considering that government agencies may be overworked, uninformed or even negligent, their approval should create a presumption of safety, but someone injured by the product should be permitted to rebut that presumption by establishing that the manufacturer knew the product was unsafe or its warnings inadequate. Government approval should be a factor, but not necessarily the dispositive one. A person injured by a dangerous, defective or unsafe product should not be barred from recovery merely because the product has received the government's stamp of approval. The manufacturer may have sought that approval, but it is the consumer who has relied upon it. The quest for uniformity should not supersede an individual's right to be compensated.