After Diane Levine had her forearm amputated due to a botched intravenous (IV) push, the world was abuzz about a fairly basic concept in tort and personal liability law – a concept known as preemption. Levine, who suffered from migraines, took Demerol for pain and Phenergan for nausea. The Phenergan could be administered in one of two ways: it could either be injected into the buttocks, or it could be administered directly into a vein in the arm. This latter method, known as an IV push, carries with it the risk of gangrene, a condition that can lead to amputation. The medical professional in charge of administering the drug missed Levine’s vein and hit her artery, causing gangrene to set in.
Supreme Court Sides with Levine
When Levine learned of the risks after the fact, she sued the manufacturer, Wyeth, for failing to warn. As it turned out, the risks were listed on the drug’s label – a label approved by the FDA. The company appealed, taking the case to the Supreme Court. Eventually, the highest court agreed with the trial court that state law, in this case, was not preempted by federal regulations. The fact that the FDA’s standards were less strict than the state’s, did not relieve Wyeth from liability.
Definition
So what is preemption? As alluded to above, preemption refers to cases where state law conflicts with federal law. In such a circumstance, it can be said that federal law takes precedence and therefore preempts state law. To that end, defective device cases are often subject to the exigencies of preemption, meaning, in many cases, a company can’t be sued if it can be shown that they followed FDA guidelines – regardless of relevant state laws. However, as in the case of Diane Levine, the courts sometimes override preemption due to other relevant considerations.
Wyeth, the Supreme Court found, could have met state requirements without violating FDA procedures. Thus, there was no true conflict between Federal and State regulations.
Different Kinds
As noted by Sheila Scheuerman, a professor at the Charleston School of Law, there are two kinds of preemption: expressed and implied. Whereas expressed preemption is explicitly stated in the text of federal statutes, implied preemption does not exist in any textual format, but rather refers to a conflict between state law and the congressional intent behind federal statutes. This includes statutes written for the express purpose of authorizing certain federal agencies (such as the FDA) to make regulative decisions.
Dennis Quaid
According to former FDA Deputy Commissioner Randall Lutter, preemption prevents state courts from interfering with the policy-making prowess of the federal agency: “FDA believes that the important decisions it makes about the safety, efficacy and labeling of medical products should not be second-guessed by state courts,” he said in 2008, in relation to Dennis Quaid’s plea to Congress to weaken preemption.
Former Democratic Representative Henry Waxman opposed this interpretation, saying, “One of the most powerful incentives for safety — the threat of liability — would vanish.”
The Constitution
What is the source of preemption? As it turns out, this country’s founding document contains the foundations of preemption. In paragraph 2 of Article IV of the US Constitution, the so-called Supremacy Clause states that “This Constitution, and the laws of the United States which shall be made in pursuance thereof […] shall be the supreme law of the land; and the judges in every state shall be bound thereby.” In short, federal statutes are the law of the land, and no other laws shall overshadow them.
When It Comes to Drugs
This is the source of some legal turmoil. Take the emergence of legalized marijuana. This is highly contentious, as marijuana is still considered a controlled substance under federal law and is thus subject to federal prohibition, and yet it is deemed recreational in certain states. Earlier this year, a district court found that federal law does not preempt certain statutes concerning the firing of employees who use medically prescribed marijuana.
In the end, preemption does more to protect major manufacturers than it does to reduce confusion in the courts – though it may do some of that as well.
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