Chapter 3. Pharmaceutical Product Liability Litigation

• Pages: 35-52
• Author: Tamar Kelber and Daniel Kennedy

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3

PHARMACEUTICAL PRODUCT

LIABILITY LITIGATION

Tamar Kelber and Daniel Kennedy

The primary differences between pharmaceutical product liability litigation and

traditional products litigation arise from the federal Food and Drug Administra-

tion (FDA) regulation of pharmaceuticals and the learned intermediary doctrine.

Although there are important differences in applicable regulations, the FDA reg-

ulates both pharmaceuticals and medical devices, and the learned intermediary

doctrine has a similar application in both contexts. As such, there are many simi-

larities between pharmaceutical and medical device litigation.

This chapter provides an overview of FDA regulation of pharmaceuticals, dis-

cusses the claims most commonly asserted in pharmaceutical product liability liti-

gation, and concludes with a discussion of other issues seen in the pharmaceutical

context. The next chapter focuses on medical devices and the specific issues that

arise in device cases.

Background: The FDA Approval Process

The FDA sits within the Department of Health and Human Services and regulates

food, drugs, tobacco, medical devices, and biologics. The FDA’s Center for Drug

Evaluation and Research (CDER) regulates over-the-counter and prescription

drugs. The FDA’s Center for Devices and Radiologic Health (CDRH) regulates

medical devices. Finally, the FDA’s Center for Biologics Evaluation and Research

regulates therapeutic substances derived from animal products or other biologic

sources, such as vaccines, blood components, gene therapy, and recombinant

products. Some therapeutics are “combination products,” which fall under the

purview of two review divisions; for those therapeutics, regulatory authority is

shared by the two divisions. For example, a product that is a combination drug

with delivery device would be regulated jointly by CDER and CDRH as a com-

bination product.1 The FDA’s Office of Combination Products coordinates and

oversees this regulation.

1. W hile it is beyond the purview of this chapter, litigation regarding biologics raises many similar

issues to litigation regarding pharmaceuticals. The regulations governing biologics can be found at 21

C.F.R. § 600 et seq.

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An Introduction to Tort-Based Healthcare Litigation

36

Regulations governing pharmaceuticals are found in subchapters C (Drugs:

General) and D (Drugs for Human Use) of Title 21 of the Code of Federal Reg-

ulations. The FDA periodically issues “Guidance for Industry” documents that

provide helpful information regarding its interpretation and application of the

regulations. Guidance can be found on the FDA’s website at http://www.fda.gov

/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.2

Development and marketing of a pharmaceutical product is a long, multilay-

ered process. It is important for a lawyer handling pharmaceutical product liabil-

ity cases to have a working understanding of that process. Once a compound is

developed, the “sponsor” tests the compound for toxicity on multiple species of

animals and develops a plan for testing it on human subjects. The sponsor submits

the results of the animal testing and plans for human testing to the FDA in an

Investigational New Drug Application (IND). There are three phases of testing

on human subjects. Phase 1 evaluates the drug’s side effects and how the drug is

metabolized. Phase 2 tests the drug’s efficacy in patients with the condition or

disease that the drug is intended to treat. Thereafter, the sponsor meets with the

FDA and develops a plan for Phase 3. In Phase 3, the drug is tested in thousands of

human subjects who receive the drug in different dosages.

Next, the sponsor submits a New Drug Application (NDA). The NDA

includes summary information regarding the prior phase of testing, manufactur-

ing information, and the company’s proposed labeling. In the NDA, the sponsor

must demonstrate that the drug is safe and effective, that the benefits outweigh

the risks, and that there are adequate manufacturing methods and controls. If the

FDA accepts the NDA for filing, it assigns a review team to evaluate the submis-

sion. The FDA also reviews the proposed labeling and inspects the sponsor’s pro-

posed manufacturing facility. Thereafter, the FDA issues either an approval letter

or a response letter to the sponsor. The response letter may direct the sponsor to

perform additional testing. After approval, the drug’s sponsor must submit peri-

odic safety updates to the FDA. The FDA also receives and reviews Adverse Event

Reports (AERs) directly from physicians and consumers through its MedWatch

system.

While the FDA does not regulate the practice of medicine, it does approve

drugs for particular indications. The NDA must demonstrate the drug’s safety and

efficacy for the indications for which the sponsor seeks approval. Once approved,

the sponsor may only promote the drug for the approved indication. Use for any-

thing other than an approved indication is deemed “off-label.” To obtain the FDA’s

approval for a new indication or dose, a sponsor submits a Supplemental New

Drug Application (sNDA). A generic drug manufacturer submits an Abbreviated

New Drug Application (ANDA) for a generic version of an approved drug.

2. The FDA website is an invaluable resource for pharmaceutical product liability litigation. For

example, approval histories, labeling, and FDA correspondence are all available on the Drugs@FDA

page of the website. See D@FDA, http://www.accessdata.fda.gov/scripts/cder/drugsatfda

/index.cfm.

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