Can What The Supreme Court Said About Device Clearance In Lohr, A "Derelict On The Waters Of The Law," Finally Be Sunk?1

Published date13 December 2022
Subject MatterLitigation, Mediation & Arbitration, Food, Drugs, Healthcare, Life Sciences, Trials & Appeals & Compensation, Food and Drugs Law, Biotechnology & Nanotechnology
Law FirmButler Snow LLP
AuthorMr Luther Munford and Jin Yoshikawa

2 Even though they are still quoted, statements in Medtronic v. Lohr3, which question whether FDA (Food & Drug Administration) medical device clearance is a judgment about a device's safety, no longer accurately describe what the FDA does. To borrow from Perry Mason, today they are irrelevant, incompetent and immaterial because they describe a temporary process the FDA used in 1982 and say nothing about the permanent process used today to ensure the safety and effectiveness of devices.

A court decision undermined by subsequent events in caselaw has been called a "derelict on the waters of the law." 4 What Lohr says about safety fits that description. The statements are a "derelict" that need to sink and never surface again. Until they disappear, they will remain a trap for the unwary, a confuser of courts and a continuing mischief to manufacturers who have met FDA safety standards and want juries to know that.

Classification Matters

In 1976, Congress directed the FDA to use medical panels to classify medical device types according to the risk they present, and it specified procedures the FDA should use to provide reasonable assurance of the safety and effectiveness of each class of device. One example of a device type is surgical mesh. The medical panels, whose qualifications were dictated by Congress, published their proposed classifications in the Federal Register, along with citations to the medical studies on which they relied. After notice and comment, the FDA set the classification for each device type:

  • Class I contains the lowest risk devices and usually they can be sold without seeking FDA permission.
  • Class II contains devices that may need some regulation but do not "present a potential unreasonable risk of illness or injury."5 To sell a Class II device a manufacturer must file a 510(k) notice, which establishes that it is at least equivalent in safety and effectiveness to an existing Class II device.6 The manufacturer can only sell the device after the FDA reviews the 510(k) and grants a form of permission called "clearance."7 The FDA can impose special controls, such as a guidance, on Class II devices but is not required to do so.
  • Class III devices may, among other things "present a potential unreasonable risk" that requires the manufacturer to offer independent evidence of safety and effectiveness sufficient to satisfy an FDA process the statute calls "approval."8

The system is, in effect, a form of triage.9 It can be compared to a hospital emergency room. Patients who are not really sick get no treatment. Patients who have an illness that medicine will cure get sent home with medicine. Patients who are gravely ill go to the operating room for surgery. The ultimate goal for each category is to cure the illness.

No one would say that the patient who had surgery was healthier when all was said and done just because that patient went to the operating room. The goal for all patients is the same, i.e., to get well. Similarly, in the end, the FDA's reasonable assurance of safety and effectiveness is the same for all device types no matter which class they belong in or how much FDA scrutiny an individual device receives.

Two Different Uses of 510(k)

Congress established a permanent process for the clearance of Class II devices using '510(k). Pursuant to that process, a manufacturer submits a 510(k) notice to the FDA, which establishes that a new device is equivalent in safety and effectiveness to a predicate device with the same classification, i.e., Class II for a Class II device type. The FDA then takes into account the earlier medical panel classification process, the contents of the 510(k) and the regulatory record of the predicate device and other devices of the same type. It then decides whether to allow the device to be marketed.

This was not the process at issue in Lohr, which instead addressed a temporary FDA process. When the device regulations first took effect in 1976, Congress allowed previously unregulated devices to stay on the market until the FDA could get its regulatory program underway. To permit new devices to compete with those previously sold, it provided that manufacturers could sell new devices after filing a 510(k) that established the new device was equivalent in safety and effectiveness to one sold in 1976'all the manufacturer had to do before selling the device was file the notice and FDA permission was not required before marketing.10

The opportunity to market a new device based on equivalence to a 1976 device ended when the FDA either classified the device type as I or II or, in the case of a Class III device type, issued an order requiring manufacturers to submit the device for premarket approval. After that, either equivalence to a Class I or II device or premarket approval was required.

The Supreme Court's Lohr decision concerned a device marketed in 1982 pursuant to the transitional process. The question before the Court was whether the FDA...

To continue reading

Request your trial

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT