District Court Enters Permanent Injunction to Stop New Jersey and New York Companies and Executives From Distributing Unapproved and Misbranded Drugs
A federal court in New Jersey granted a motion for default judgment and entered an order of permanent injunction against S Hackett Marketing LLC d/b/a Just Enhance of Trenton, New Jersey; R Thomas Marketing LLC of Bronx, New York; Shawn Hackett, the President and owner of Just Enhance; and Roger Thomas, the President and founder of R Thomas Marketing LLC, the Department of Justice announced today. The injunction, entered by the U.S. District Court for the District of New Jersey, permanently enjoins the defendants from continuing to distribute unapproved new drugs and misbranded drugs in violation of the Federal Food, Drug, and Cosmetic Act (FDCA).
On July 5, 2017, the Department filed a complaint at the request of the U.S. Food and Drug Administration (FDA). The complaint alleged that Just Enhance and R Thomas Marketing LLC use over 100 websites to promote and distribute sexual enhancement products to U.S. consumers. The complaint further alleged that many of the products are unapproved drugs containing the undisclosed ingredient, sildenafil, which is the active pharmaceutical ingredient in the prescription drug, Viagra. According to the complaint, the labeling for defendants’ products claim—without FDA approval or clinical studies demonstrating safety and effectiveness—that the products can treat or prevent a variety of serious conditions, including erectile dysfunction, impotence, and prostatitis. In addition, the labeling does not reveal the potentially adverse consequences that may result from using a product containing sildenafil.
“Compliance with the Food, Drug, and Cosmetic Act is necessary to ensure that consumers have complete confidence in the safety and effectiveness of the drugs they use,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “The Department of Justice and FDA will continue to work together to enforce labeling requirements and protect consumers from the dangers of undisclosed ingredients in drugs.”
After the defendants failed to respond or even appear in the action, the government moved for a default judgment with a proposed order of permanent injunction. The permanent injunction entered today resolves the litigation and requires that the defendants cease the distribution of unapproved new drugs and misbranded drugs. It directs the defendants to cease distribution of all drugs until the companies implement specified remedial measures to ensure compliance with the FDCA.
The government is represented by Trial Attorney Jocelyn Hines of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Susan Pappy of the New Jersey U.S. Attorney’s Office Health Care and Government Fraud Unit, with the assistance of Associate Chief Counsel for Enforcement Laura Akowuah of the FDA, Office of General Counsel, Department of Health and Human Services.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the District of New Jersey, visit its website at www.justice.gov/usao-nj.