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What is Preemption?
The doctrine of federal preemption is based on the precept that the U.S. Federal constitution is the supreme law of the land, and that federal law supersedes inconsistent state law. Federal preemption doctrine is based on the premise that federal laws will occasionally conflict with laws passed by states. Preemption doctrine is all about conflicting state and federal authorities, and which set of standards one should apply in any given area of the law. There are typically two types of preemption that may bar a claim's standing - express preemption and implied preemption.
Express preemption of claims takes place when the Congress bars a particular claim with the words, 'we hereby preempt' in a statute or other similar context, precluding state products liability laws from taking precedence over federal law in this area. Implied preemption is a more complex issue, and attaches when both federal law and state law address the same issue and render it impossible to comply with both federal and state laws. This normally occurs in the form of a regulatory scheme devised by Congress. In this instance, federal law is said to have 'occupied the field', and it trumps state law.
The Unites States Federal System
In the greater context of the preemption discussion, it is vital to underscore that the United States Government is a federal system of government, divided into three branches: the Executive Branch
(the President), the Legislative Branch
), and the Judicial Branch
(the Supreme Court
and the Federal Judiciary
). The Federal Government of the United States is distinguished by its separation of powers
with checks and balances
placed on each branch of government. Historically, this system was envisioned by the Framers of the Constitution
such that one branch of government would rein in another branch if power became too concentrated in any one branch. Any powers of government not explicitly granted to the Federal Government by the Constitution are reserved to the several states
Source of Controversy
The federal doctrine of preemption has had particular importance to the consumer in recent years. Products liability cases have emerged in which state tort laws protecting consumers from unsafe drugs and medical devices approved by the FDA have differed from federal policy or regulation. Under the Bush Administration, the FDA reversed its previous stance, from allowing claims to proceed against pharmaceutical companies for drug injuries to joining pharmaceutical companies in the effort to obtain "corporate immunity" for private enterprise.
Pharmaceutical companies contend that once the FDA approves a drug for a particular purpose, that drug is legally deemed safe for that indication. The notion of FDA approval presupposes that the FDA has completely evaluated a drug for efficacy and has discovered any potential damaging side effects. Unfortunately, the FDA has not always been completely thorough in evaluating prescription drugs and medical devices, and has neither the time nor resources to ensure the complete safety of a medical device or drug, nor sufficient power to enforce decisions regarding certain products.
Preemption Case Law
Riegel v. Medtronic
In February 2008, the U.S. Supreme Court reviewed the issue of federal preemption of plaintiffs' lawsuits against medical device manufacturers. The Court held in Riegel v. Medtronic
that FDA agency evaluation and pre-market approval (the PMA process
) was sufficient to gird medical device manufacturers against potential lawsuits from injured plaintiffs. As a result of the Riegel decision
, injured plaintiffs can no longer sue a medical device manufacturer under state products liability law for an injury sustained from an FDA-approved medical device.