Current Cases

U.S.A. v. Janssen Biotech, Inc.

Status Current Case

Practice area Whistleblower

Court U.S. District Court, District of Massachusetts

Case number 16-CV-12182-FDS


Cohen Milstein represents the plaintiff-relator in a whistleblower/qui tam lawsuit against Janssen Biotech (a subsidiary of Johnson & Johnson), alleging that the manufacturer of the rheumatoid arthritis drugs Remicade and Simponi ARIA violated federal law by engaging in a kickback scheme through which it provided physicians free practice management and infusion business consulting services over an extended period to induce the physicians to purchase Remicade and Simponi ARIA and administer the drugs to patients, including Medicare beneficiaries, via infusions performed in their offices.

In October 2020, the Court denied Janssen’s motion to dismiss the claims brought on behalf of the Medicare program. The case is currently in the discovery stage. On March 9, 2023, the Magistrate Judge ordered Janssen to comply with the court-ordered discovery. On February 15, 2024, the Court denied Janssen’s motion for judgment on the pleadings.

Case Background

Remicade has been one of the Medicare program’s biggest drug expenses. According to data from the Federal Government, Medicare paid over $6 billion for Remicade during the five-year period 2013 through 2017. Similarly, Simponi Aria is becoming one of the Medicare program’s largest drug expenses. During the four-year period 2014 through 2017, the government health care program spent over $600 million on the drug, according to data from the Federal Government.

The whistleblower lawsuit alleges that for more than a decade Janssen helped doctors at private practices establish “in-office infusion suites” and subsequently assisted these physicians maintain and grow their infusion businesses by having its team of Area Business Specialists, as well as outside health care consultants, provide ongoing practice management and infusion business advisory services free-of-charge. These services, the lawsuit asserts, led the physicians to buy and infuse more Remicade and Simponi ARIA.

The lawsuit alleges that the free services Janssen provided to the physicians constitute illegal remuneration under the Anti-Kickback Statute. Requests for payment that result from violations of the Anti-Kickback Statute are per se false claims under the False Claims Act.