Taking the "Product" out of Product Liability: Litigation Risks and Business Implications of Innovator and Co-Promoter Liability

By Lasker, Eric G.; Klein, Stephen A. et al. | Defense Counsel Journal, July 2015 | Go to article overview

Taking the "Product" out of Product Liability: Litigation Risks and Business Implications of Innovator and Co-Promoter Liability


Lasker, Eric G., Klein, Stephen A., Barago, Tamara Fishman, Defense Counsel Journal


PLAINTIFF files a lawsuit claiming that her use of a prescription medication caused her to sustain injuries. Brand Pharmaceuticals did not manufacture the drug and therefore cannot be liable to Plaintiff, right? Not necessarily. Two emerging theories of liability, socalled "innovator liability" and "co-promoter liability," aim to hold a nonmanufacturer responsible for injuries caused by another company's pharmaceutical product. Under innovator liability, a pharmaceutical manufacturer may be liable for injuries caused by a competitor's generic version of its brand drug based on its supposed responsibility for the drug's prescribing information. Under co-promoter liability, a company that contracts to market another manufacturer's pharmaceutical product may be liable based solely on its marketing activities. This article explores the theories underlying these novel sources of liability and proposes business strategies to consider that could help mitigate these emerging risks.

I. Traditional Tort Doctrine Limits Product Liability to the Manufacturer of the Product.

By asserting innovator and co-promoter liability, plaintiffs are attempting to circumvent well-established tort law principles. It is axiomatic that "[a] fundamental principle of traditional products liability law is that the plaintiff must prove that the defendant supplied the product which caused the injury." A plaintiff suing for alleged injuries from a pharmaceutical product (or medical device) must identify the actual defendant that manufactured the product she alleges injured her.2

When advancing theories of innovator and co-promoter liability, plaintiffs target defendants they acknowledge played no role in manufacturing or supplying the drug that allegedly caused their injury. These theories require courts to suspend traditional tort law doctrines of causation and duty and have, for that reason, largely been rejected. However, as discussed below, a handful of jurisdictions have viewed these theories more favorably.

II. Innovator Liability Against Brand Manufacturers for Generic Drugs

A. Background: HatchWaxman Act, Wyeth v. Levine, and PLIVA v. Mensing

The roots of innovator liability can be found in the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the "HatchWaxman Act."3 Designed to facilitate the entrance of generic drugs into the pharmaceuticals market, the Hatch-Waxman Act relaxed the requirements for U.S. Food and Drug Administration (FDA) approval for those drugs. Instead of having to leap the same clinical hurdles as the original drug sponsor, generic manufacturers need only demonstrate that their product is "the same as" an existing brand drug, meaning that it is bioequivalent to its brand counterpart and has the same active ingredient(s), route of administration, dosage form, and strength.4 Other than routine information reflecting the different manufacturer or distributor, the generic drug also must have "the same" prescribing information, i.e. label, as the brand drug (i.e., the reference listed drug) on which its approval was based.5

This requirement of "sameness" is key to two recent U.S. Supreme Court decisions addressing federal preemption that appear to have reinvigorated innovator liability arguments. In Wyeth v. Levine, the Court held that FDA's approval of a brand drug's prescribing information did not preempt state-law failure-to-warn claims because the brand manufacturer had discretion under FDA's "changes being effected" (CBE) regulation to unilaterally strengthen a drug warning.6 Two years later, however, the Court held in PLIVA, Inc. v. Mensing, that failure to warn claims against generic manufacturers were preempted because - due to the HatchWaxman Act's sameness requirement - generic manufacturers cannot use the CBE process to unilaterally change their labels.7 In the post-Hatch-Waxman age, approximately 80% of prescriptions are filled with generic pharmaceuticals. …

The rest of this article is only available to active members of Questia

Already a member? Log in now.

Notes for this article

Add a new note
If you are trying to select text to create highlights or citations, remember that you must now click or tap on the first word, and then click or tap on the last word.
One moment ...
Default project is now your active project.
Project items
Notes
Cite this article

Cited article

Style
Citations are available only to our active members.
Buy instant access to cite pages or passages in MLA 8, MLA 7, APA and Chicago citation styles.

(Einhorn, 1992, p. 25)

(Einhorn 25)

(Einhorn 25)

1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

Note: primary sources have slightly different requirements for citation. Please see these guidelines for more information.

Cited article

Taking the "Product" out of Product Liability: Litigation Risks and Business Implications of Innovator and Co-Promoter Liability
Settings

Settings

Typeface
Text size Smaller Larger Reset View mode
Search within

Search within this article

Look up

Look up a word

  • Dictionary
  • Thesaurus
Please submit a word or phrase above.
Print this page

Print this page

Why can't I print more than one page at a time?

Help
Full screen
Items saved from this article
  • Highlights & Notes
  • Citations
Some of your highlights are legacy items.

Highlights saved before July 30, 2012 will not be displayed on their respective source pages.

You can easily re-create the highlights by opening the book page or article, selecting the text, and clicking “Highlight.”

matching results for page

    Questia reader help

    How to highlight and cite specific passages

    1. Click or tap the first word you want to select.
    2. Click or tap the last word you want to select, and you’ll see everything in between get selected.
    3. You’ll then get a menu of options like creating a highlight or a citation from that passage of text.

    OK, got it!

    Cited passage

    Style
    Citations are available only to our active members.
    Buy instant access to cite pages or passages in MLA 8, MLA 7, APA and Chicago citation styles.

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn, 1992, p. 25).

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn 25)

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn 25)

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences."1

    1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

    Cited passage

    Thanks for trying Questia!

    Please continue trying out our research tools, but please note, full functionality is available only to our active members.

    Your work will be lost once you leave this Web page.

    Buy instant access to save your work.

    Already a member? Log in now.

    Search by... Author
    Show... All Results Primary Sources Peer-reviewed

    Oops!

    An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.