Lawsuit against HHS seeks overturn of restriction on refill reminder programs, cites Sorrell

I came across this press release from inVentiv Health and think it’s of interest because of the intersection of privacy and protected speech:

Adheris, Inc., an inVentiv Health company, filed suit today against the U.S. Department of Health and Human Services, asking a federal court to enjoin the government from implementing a new regulation that imposes unconstitutional restrictions on the speech of a company whose business is encouraging patients to properly take their medicine.

The motion for preliminary injunction, Adheris, Inc. v Kathleen Sebelius et al, was filed in the U.S. District Court for the District of Columbia seeking relief from sweeping new regulations that will otherwise take effectSeptember 23rd. The rule threatens to end refill reminder programs that serve millions of Americans with chronic diseases, including many elderly patients. The suit charges the federal government with attempting to restrain speech protected by the First Amendment.


Adheris strictly abides by all federal and state laws regarding the protection of patient privacy and has invested millions of dollars to develop technologies and processes to protect patient privacy. Since 1993, Adheris has sent hundreds of millions of communications to patients and handled billions of prescription records without ever having a known security breach.


The Motion for a Preliminary Injunction points out that Adheris’ speech in the form of communications to patients is constitutionally protected by the First Amendment’s role in furthering the “free flow of information.” In the recent Supreme Court ruling on Sorrell v IMS Health, Inc., the Court affirmed that “speech in aid of pharmaceutical marketing… is a form of expression protected by the Free Speech Clause of the First Amendment” and that the free flow of information “in the fields of medicine and public health… can save lives.”

The United States has a long history of placing special protections around free speech.  Attempts to restrict speech are subject to “heightened scrutiny” and must be shown to advance a substantial government interest. In this case, the new rule fails to pass such scrutiny and does not advance any government interest. On the contrary, the government’s interest is in improving public health while keeping down costs – and refill reminders further these interests.

The new regulation imposes restrictions on Adheris because its reminder communications are funded by pharmaceutical manufacturers. The same reminder funded by the government, non-profit organization or others is allowed without similar restrictions under the new rules.

“We are asking the court to stop HHS in its attempt to restrict communications to patients in a manner that is high-handed and inconsistent,” Sherbet said. “This rule addresses a non-existent problem with an unconstitutional regulation that is contrary to the best interest of patients and society.  We are hopeful that the court will agree.”

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