Chapter 4. Medical Device Litigation: Theories of Liability and Common Defenses

• Pages: 53-70
• Author: Samuel L. Felker and Sarah Murray

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4

MEDICAL DEVICE LITIGATION:

THEORIES OF LIABILITY AND

COMMON DEFENSES

Samuel L. Felker and Sarah Murray

Medical device litigation is a specialized area of products liability law. While many

of the guiding principles are common to both medical device litigation and more

generalized products liability litigation, the heavy overlay of federal regulation

creates liability theories and defenses that are unique to medical device litigation.

To be effective, the medical device litigator must understand the basic federal

framework for approval, labeling, and monitoring of medical devices. Although a

detailed discussion of the federal regulations governing medical devices is outside

the scope of this chapter, a brief overview of the regulatory system will provide

context for the exploration of issues related to medical device litigation. Following

this overview, this chapter will address liability theories, defenses, and damages

common to medical device cases.

Overview of Federal Regulation of Medical Devices

The U.S. Food and Drug Administration (FDA) regulates companies that manu-

facture medical devices sold in the United States. A medical device is “any instru-

ment, apparatus, implement, machine, contrivance, implant, in vitro reagent or

similar article . . . intended for use in the diagnosis, cure, mitigation, treatment or

prevention of disease . . . which does not achieve its intended purpose by chemical

action and need not be metabolized for achieving its purpose.”1 Medical devices

are regulated by the Food, Drug, and Cosmetic Act (FDCA).2 When the Medical

Device Amendments (MDA) were enacted in 1976, the FDCA was amended and

“swept back some state obligations and imposed a regime of detailed federal over-

sight” for medical devices.3

The FDCA established three classes of medical devices, with regulatory con-

trol increasing with each classification. Devices labeled Class I are devices that are

1. 21 C.F.R. § 312.1(a).

2. 21 U.S.C. §§ 301–399.

3. Riegel v. Medtronic, Inc., 552 U.S. 312, 316 (2008).

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An Introduction to Tort-Based Healthcare Litigation

54

not of substantial importance to health and that do not present an unreasonable

risk of injury or illness. Examples of Class I devices include enema kits and elastic

bandages. Class II devices are devices that necessitate performance standards to

ensure they are safely and effectively used. Examples of Class II devices are pow-

ered wheelchairs and some pregnancy kits. Class III devices are devices to be used

in supporting or sustaining human life, devices that are of substantial importance

in preventing impairment of human health, or devices that present a potential risk

of illness or injury. Examples of Class III devices are implantable pacemakers and

breast implants. Most Class II and all Class III devices must receive regulatory

clearance by the FDA before they can be marketed in the United States.

There are two types of FDA regulatory clearance: the 510(k) process for

clearance of devices that were on the market when the MDA passed or that are

substantially equivalent to approved devices on the market; and the more exten-

sive Premarket Approval process, which involves scientific and regulatory review

to evaluate the safety and effectiveness of Class III medical devices. The vast

majority of devices are cleared by the FDA under the streamlined 510(k) process

whereby the manufacturer submits to the FDA a Premarket Notification contain-

ing detailed information about the device. The 510(k) filing must demonstrate

that the device is substantially equivalent to one legally sold in the United States

before May 28, 1976, or to a device that the FDA has authorized to be on the mar-

ket. A product is substantially equivalent to another device when it has the same

intended use and the same technological characteristics, or when it has the same

intended use and different technological characteristics but does not raise new

questions of safety and effectiveness and is at least as safe as the products already

on the market. A manufacturer cannot commercially distribute a device until the

FDA provides a letter of substantial equivalence.

Unlike the 510(k) process, the Premarket Approval process requires the man-

ufacturer to submit scientific evidence demonstrating reasonable assurance of

safety and effectiveness for the device’s intended use. Approval for a Premarket

Approval application (PMA) requires a determination by the FDA that the appli-

cation contains enough scientific evidence to assure that the device is safe and

effective for its intended use. While the FDA regulations provide a 180-day period

for review, the review period is normally longer. Before approving or denying a

PMA, the appropriate FDA advisory committee may review the PMA at a public

meeting and provide the FDA with the committee’s recommendation on whether

the FDA should approve the submission. After the FDA notifies the applicant

that the PMA has been approved or denied, a notice is published on the Internet

(1) announcing the data on which the decision is based and (2) providing inter-

ested persons an opportunity to petition FDA within 30 days for reconsideration

of the decision. A Class III device that fails to meet PMA requirements is consid-

ered to be adulterated under section 501(f) of the FD CA and cannot be marketed.

The FDA allows investigational device exemptions under which a device can

be used in a clinical study so that the manufacturer can collect the data on the

safety and effectiveness of the device that the manufacturer will need to submit

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