Don’t Fax First and Ask Questions Later

By Josh Arkulary

Faxing unsolicited information about medical products or services, such as patient support programs, could violate the Telephone Consumer Protection Act (TCPA). A recent decision from the U.S. Court of Appeals for the Third Circuit is a pointed reminder that a communication intended as “help” or “support” can still trigger federal liability under the TCPA. In S.A.S.B. Corp. v. Johnson & Johnson Health Care Systems Inc., the court revived a class action over a two-page fax, holding that its promise of financial support promoted the affordability of the drug, that “help” and “support” read as promotional rather than neutral, and that the fax was a single unsolicited advertisement despite one page being purely informational.

What Is the TCPA?

The TCPA is enforced by the Federal Communications Commission (FCC) and regulates certain telemarketing phone calls, text messages, and faxes. In particular, the TCPA prohibits automatic telephone dialing systems, or “robodialing,” where an automated calling, texting, or faxing platform is capable of sending communications without a user actively and affirmatively manually handling the dialing and sending. To ensure TCPA compliance, companies should either avoid automated dialing or texting, instead having individuals manually make each call or affirmatively send each text message, or obtain express consent from individuals before calling, texting, or faxing. 

Most relevant here, the TCPA makes it unlawful to send an “unsolicited advertisement,” which is defined as “any material advertising the commercial availability or quality of any property, goods, or services,” to a fax machine without the recipient’s “prior express invitation or permission, in writing or otherwise.”

Advertisement or Information?

The Third Circuit applied an objective, two-part test: a fax is an advertisement if it (1) promotes goods or services to be bought or sold, and (2) has profit as an aim. 

The Court explained that the task of identifying an advertisement under the TCPA “is approached with a measure of common sense.” Purely informational communications, like genuine safety or clinical notices, generally fall outside the definition of an advertisement. However, the Court found that a promotional purpose cannot be avoided by an informational cover page.

Why Did the Court See a “Coupon,” Not Just Patient Support?

The fax, sent to a Florida pharmacy, promoted Janssen CarePath, a program helping patients afford the anticoagulant Xarelto, priced at roughly $400 a month, versus about $20 for the generic warfarin. Page one offered “help” by exploring options to lower out-of-pocket costs, while page two described Xarelto’s uses and side effects before urging readers to "explore" savings options. The district court dismissed the suit, finding the fax purely informational. The Third Circuit reversed, holding that a program narrowing that $380 price gap promoted the drug “similar to how a coupon promotes a product by offering the customer a discount.” Words like “help,” “support,” and “explore,” read in context rather than in isolation, plausibly encouraged purchase by emphasizing affordability. 

The court was explicit that a promotional first page cannot be negated by tacking on an informational second page, and that taken as a whole, the fax was one unsolicited advertisement. The court also pointed to the fax’s own voice: it spoke in the first person (“At Janssen, we don’t want cost to get in the way”) and displayed the Xarelto and CarePath trademarks, undercutting any claim that the sender’s promotional intent was unclear.

What Could This Cost?

TCPA exposure can be steep: $500 per violation, or up to $1,500 for willful conduct, with no cap or proof of actual harm required. Since each fax is its own violation, a single marketing campaign can generate significant damages.

Why Does This Matter? 

The takeaway: obtain proper prior express invitation or permission before faxing anything touching price, availability, quality, or that could be read, even if only in part, as an advertisement. Labeling a communication with “support,” “resources,” or “education” does not stop a court from reading it, in context, as promotional. In addition, companies should ensure TCPA and other marketing messaging compliance is incorporated into the legal review process for external communications regarding their products and services.

While this case concerns faxes, the TCPA also regulates many other types of communications, including phone calls and text messages. As with unsolicited fax-based advertisements, sending commercial text messages or making phone calls without prior express written consent from the recipient may implicate the TCPA, potentially exposing companies to significant liability.

How Gardner Law Can Help

Gardner Law advises FDA-regulated companies on state and federal privacy and health data laws such as the TCPA. Companies engaging in advertising communications about their products and services should incorporate legal review processes to mitigate TCPA and other risks. Gardner Law can help by advising on applicable legal standards and reviewing consent workflows and patient support communications.