Law.com Subscribers SAVE 30%

Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.

Medical Malpractice Law & StrategyKickerFeaturesTopicsCommercial LawRegulationSectionsNewsLJN Newsletters

Off-Label Promotion of Drugs and Medical Devices

By Michael Kendall and Nicole Colby Longton

A spate of billion- and hundred-million-dollar settlements with the Department of Justice (DOJ) illustrates how the investigation of off-label promotions of drugs and devices has emerged as a predominant theory in pharmaceutical and medical-device prosecutions. Up to 60% of all prescription drug use in the United States is off-label, and the regulatory and medical issues are exceedingly complicated. The application of off-label regulations, therefore, has significant impact in these cases that generate enormous criminal and civil monetary penalties and can lead to misdemeanor convictions of corporate executives on a strict-liability theory.

Typically, prosecutors seek to punish off-label promotion with civil penalties under the False Claims Act predicated on billings to Medicare and Medicaid and criminal prosecution under the Food, Drug, and Cosmetic Act. Federal prosecutors have entered into criminal and civil settlements that included off-label allegations with Pfizer, Eli Lilly, Serono, Astra Zeneca, Cephalon, Bristol-Myers Squibb, and Schering Plough, among others. Several device manufacturers have entered into off-label settlements too. The DOJ has made off-label investigations a continuing priority, which means off-label cases will be among the largest cases the Department prosecutes over the next several years.

This premium content is locked for Entertainment Law & Finance subscribers only

  • Stay current on the latest information, rulings, regulations, and trends
  • Includes practical, must-have information on copyrights, royalties, AI, and more
  • Tap into expert guidance from top entertainment lawyers and experts

For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473

Read These Next
Bankruptcy Sales: Finding a Diamond In the Rough Image

There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.

Judge Rules Shaquille O'Neal Will Face Securities Lawsuit for Promotion, Sale of NFTs Image

A federal district court in Miami, FL, has ruled that former National Basketball Association star Shaquille O'Neal will have to face a lawsuit over his promotion of unregistered securities in the form of cryptocurrency tokens and that he was a "seller" of these unregistered securities.

Why So Many Great Lawyers Stink at Business Development and What Law Firms Are Doing About It Image

Why is it that those who are best skilled at advocating for others are ill-equipped at advocating for their own skills and what to do about it?

Blockchain Domains: New Developments for Brand Owners Image

Blockchain domain names offer decentralized alternatives to traditional DNS-based domain names, promising enhanced security, privacy and censorship resistance. However, these benefits come with significant challenges, particularly for brand owners seeking to protect their trademarks in these new digital spaces.

Coverage Issues Stemming from Dry Cleaner Contamination Suits Image

In recent years, there has been a growing number of dry cleaners claiming to be "organic," "green," or "eco-friendly." While that may be true with respect to some, many dry cleaners continue to use a cleaning method involving the use of a solvent called perchloroethylene, commonly known as perc. And, there seems to be an increasing number of lawsuits stemming from environmental problems associated with historic dry cleaning operations utilizing this chemical.