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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Understanding Federal Preemption

Posted in Preemption

What is federal preemption? It’s an easier concept to grasp than you might think.

Think back to when you were a kid, and you asked your mom if you could go to a party. She clearly said, “no.” You then went to ask your dad if you could go to the party, and he clearly said, “yes.” Since you were always taught that both parents ruled your actions, you figured as long as you had one parent’s approval to go the party, that was good enough, and you couldn’t get in trouble for going.

Wrong. That night, as you started to leave the house, your parents stopped you, forbidding you to go to the party after all. Angrily, they explained that since your mom had already determined that you could not go to the party, your dad’s permission was null and void. In other words, your mom’s rule wiped out or “preempted” your dad’s rule. Although you didn’t know it then, that night, you got your first lesson in the basic concept of federal preemption.

Federal preemption is a doctrine based on the Supremacy Clause of the United States Constitution, which states that federal law takes precedence over state law.

When state law and federal law conflict, federal law wipes out or “preempts,” state law, due to the Supremacy Clause of the Constitution. U.S. Const. art. VI., § 2. Specifically, the Supremacy Clause states, “the Laws of the United States …shall be the supreme law of the land …anything in the … laws of any state to the contrary notwithstanding.”

So, if federal law requires you to do something, and state law requires you do the opposite, which one wins? Due to federal preemption, federal law wins. For example, if, hypothetically, federal law requires you to paint your fence blue, and state law forbids you from painting your fence blue, federal law wins due to the Supremacy Clause of the Constitution. The federal law preempts the state law, and you would therefore be required to paint your fence blue.

In many recent cases involving prescription drugs, we have seen tension between federal law and state tort law. See, e.g., PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011). The general pattern among these recent cases is as follows: State law requires all drug manufacturers—whether it be a brand-name manufacturer or a generic drug manufacturer—to design medications safely, and to provide adequate warning labels on all of their medications. In turn, if a drug manufacturer fails to safely design a medication or fails to provide an adequate warning label, and someone in harmed as a result, that person can sue the manufacturer under state tort law.

By direct contrast, federal law only requires brand-name manufacturers to design medications safely, and to provide adequate warning labels on all of their medications. Under federal law, the generic drug’s design and warning label must be identical to that of the brand-name version of the drug, no matter how unsafe or inadequate.

Therefore, if you are harmed by a generic version of a brand-name drug, state law automatically permits you to sue the manufacturer of the generic version, while federal law automatically forbids you from suing the manufacturer. Which one wins? Due to federal preemption, federal law wins.

Most often, manufacturers successfully argue that they cannot be sued because federal law allowed them to sell the unsafe product and that preempts—and immunizes them from—the state laws that would hold them accountable. See http://publicjustice.net/blog/fighting-for-access-tp-justice-part-2#sthash.YBK8uZQ5.dpuf.

However, and fortunately, courts are finding creative ways around federal preemption, which allow plaintiffs to be compensated for their injuries. For examples, see our previous post entitled, Brand-Name Drug Manufacturer can be Liable for Harm Caused by its Generic Version.

Also, please check in soon for more upcoming articles on other specific, recent cases where courts have ruled in favor of plaintiffs despite federal preemption.