Admissibility Hurdles for 510(k) Evidence in Medical Device Litigation.

• Author: Simpson, Robert R.

AS a general rule, a product's compliance with applicable regulations is properly considered as evidence in determining whether that product is defective. In recent years, plaintiffs in medical device litigation have attempted to carve out an exception to this rule, specifically in the context of devices that are marketed pursuant to a regulatory process known as 510(k) clearance. This effort to exclude 510(k) evidence has gained traction in courts across the country, potentially resulting in juror confusion regarding device manufacturers' compliance with the governing regulatory framework. This article examines recent trends in admissibility of 510(k) evidence, including those courts that have continued to admit 510(k) evidence to speak to regulatory compliance. This article concludes by identifying the arguments that have been used by counsel to successfully admit 510(k) evidence.

1. Background

   1. The Medical Device Amendments of 1976

      In 1976, Congress amended the Federal Food, Drug and Cosmetic Act to provide for the safety and effectiveness of medical devices intended for human use. The resulting Medical Device Amendments (the "MDA" or the "Act") classifies medical devices into three categories based on the risk they pose to the public. A device that "does not present a potential unreasonable risk of illness or injury" is designated Class I and is subject to only minimal regulation in the form "general controls." 1 Devices that are potentially more harmful, and for which "the general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device," are designated Class II and must comply with federal performance regulations known as "special controls." (2) Finally, a device that either "presents a potential unreasonable risk of illness or injury," or that is "purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health," is designated Class III. (3)

   2. Process for Ensuring Device Safety and Effectiveness

      "Before a new Class III device may be introduced to the market, the manufacturer must provide the FDA with a 'reasonable assurance' that the device is both safe and effective." (4) The process of establishing this reasonable assurance, known as "premarket approval," or the "PMA" process, is rigorous. (5) Manufacturers must submit detailed information about the device to the FDA for review.

      However, not all Class III devices have received premarket approval "because of two important exceptions to the PMA requirement." (6) "First, Congress realized that existing medical devices could not be withdrawn from the market while the FDA completed its PMA analysis for those devices." (7) As a result, the statute includes a "'grandfathering' provision which allows pre-1976 devices to remain on the market without FDA approval until such time as the FDA initiates and completes the requisite PMA." (8) "Second, to prevent manufacturers of grandfathered devices from monopolizing the market while new devices clear the PMA hurdle, and to ensure that improvements to existing devices can be rapidly introduced into the market, the Act also permits devices that are 'substantially equivalent' to pre-existing devices to avoid the PMA process." (9)

      Although "substantially equivalent" Class III devices may avoid the rigors of PMA review, "such new devices, as well as all new Class I and Class II devices, are subject to the requirements of [section] 360(k)." (10) "That section imposes a limited form of review on every manufacturer intending to market a new device by requiring it to submit a 'premarket notification' to the FDA," a process which is also known as the "[section] 510(k) process," named after its section in the original Act. (11) "If the FDA concludes on the basis of the [section] 510(k) notification that the device is 'substantially equivalent' to a pre-existing device, it can be marketed without further regulatory analysis"--at least until the FDA begins the PMA process for the underlying pre-1976 device to which the new device is "substantially equivalent." (12)

   3. Medtronic, Inc. v. Lohr: Contrasting 510(k) and PMA

      The U.S. Supreme Court's 1996 opinion in Medtronic, Inc. v. Lohr, (13) rooted in an analysis of whether certain state law claims were preempted under 21 U.S.C. [section] 360k(a), quickly became the touchstone for any examination of the FDA's regulatory scheme for medical devices in federal court. In considering the FDA's processes for ensuring device safety and effectiveness, Lohr starkly contrasted the 510(k) process with the more rigorous PMA process. The Court explained: "The [section] 510(k) notification process is by no means comparable to the PMA process; in contrast to the 1,200 hours necessary to complete a PMA review, the [section] 510(k) review is completed in an average of only 20 hours. As one commentator noted: 'The attraction of substantial equivalence to manufacturers is clear. [Section] 510(k) notification requires little information, rarely elicits a negative response from the FDA, and gets processed very quickly.'" (14)

      Lohr further provided: "[T]he 510(k) process is focused on equivalence, not safety. As a result, substantial equivalence determinations provide little protection to the public. These determinations simply compare a post-1976 device to a pre-1976 device to ascertain whether the later device is no more dangerous and no less effective than the earlier device." (15)

2. Plaintiffs' Post-Lohr Admissibility Arguments

   Although the preemption analysis in Lohr had nothing to do with the admissibility of evidence, some plaintiffs have deliberately used the Lohr Court's 510(k)...