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Brooks Schuelke
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Federal Preemption Part 2: Medical Devices As A Case Study of Express Preemption

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Last week we had our first post on federal preemption, and we talked about the general principles behind preemption. Today, we’ll use medical devices as a case study on how preemption might work in your lawsuit. Keep in mind that preemption issues are extremely detailed, and this is just an overview so that the reader gets a basic understanding of the application.

Many cases involving deaths from medical devices involve allegations that the devices were not designed properly. Almost all of these claims rely on state common law claims (such as negligence claims) or state statutory product liability claims.

At the same time, many types of medical devices have to be approved by the US Food and Drug Administration. The medical device act, which requires the approval of the devices, also states that a state shall not "establish or continue in effect with respect to a device intended for human use any requirement …(1) which is different from, or in addition to, any requirement applicable under [federal law] to the device, and …(2) which relates to the safety or effectiveness of the device or to nay other matter included in a requirement applicable to the device under" relevant federal law.

The above law was passed in 1976. At the time, it was recognized that the intent of Congress was to prevent states from putting up their own competing regulatory schemes that out manufactureres in the position of having to try and comply with two conflicting sets of rules. It was not intended as a preemption of state law claims. Thus, for the last twenty-plus years, the Food and Drug Administration and courts have taken the view that the state law tort systems work in conjunction with the federal regulations to provide safer products. Lawsuits were allowed, and recoveries were made, even if the products being sued about had received FDA approval.

However, recently, manufacturers have argued that by including the language in the statute, the statute expressly preempts any state law claims relating to the device. Thus, they argue, as long as the device meets the requirements and is approved by the FDA, then the product is okay, and they can never be liable for any problems relating to the design of the product.

Earlier this year, the US Supreme Court agreed with this argument. In Riegel v Medtronic, the Supreme Court held that the clause above constituted express preemption. They reasoned that Congress intended to create a federal oversight responsibility and, therefore, intended to limit the rights of those injured by medical devices. Allowing state law liability claims would create a conflict between federal and state law requirements, according to the Court. The preemption language, the Court held, "bars common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received premarket approval from the FDA."

The result is now that there is now a large group of medical devices where the manufacturers are immune. No matter how bad a person was injured as a result of the defect to the medical device, the manufacturer can’t be sued because the FDA made the fateful decision of approving the product.

So that’s generally how preemption works. We’ll take another look later in the week at additional forms of preemption, and their effects on consumers.