As if Johnson & Johnson didn’t have enough legal woes already, with the mounting number of cases claiming a link between its talcum powder and ovarian cancer, the pharma giant now faces a fresh round of investigations into its marketing practices.
In a quarterly filing with the Securities and Exchange Commission, J&J disclosed new investigations by the U.S. Justice Department and the U.S. Attorney's Office in Massachusetts. The probes target arthritis drugs Remicade and Simponi, hepatitis C treatment Olysio and psoriasis drug Stelara.
Most recently, in April, J&J was subpoenaed by the Massachusetts district court, which is seeking documents related to copayment-support programs the company is offering for Olysio, Simponi and Stelara, according to the SEC filing. Investigators are seeking information about how J&J reports the prices of those products to the Centers for Medicare & Medicaid Services and how it discloses rebate payments to the state’s Medicaid agencies.
The company didn’t provide further details about the investigation, and a spokesperson didn’t immediately respond to a request for comment from FiercePharma.
But the first quarter had already gotten off to a rough start, with J&J’s Janssen unit receiving a “civil investigative demand” from the DOJ regarding the sales and marketing of Olysio. That was followed by a similar demand related to a False Claims Act investigation by the DOJ “concerning management and advisory services provided to rheumatology and gastroenterology practices that purchased Remicade or Simponi Aria,” the filing states.
J&J had previously been pulled into a separate Massachusetts investigation that involves several pharmaceutical companies. The district attorney’s office has been collecting information about ties between drug companies and nonprofits that help fund prescription purchases for Medicare patients. The office has been doling out subpoenas over the last two years, targeting Biogen, Celgene, Regeneron, Gilead and others.
In February, Pfizer disclosed in its annual SEC filing that it received two subpoenas seeking information about its relationship with Patient Access Network Foundation and other nonprofit groups that provide copay assistance to underinsured patients.
J&J hasn’t disclosed which charitable organizations the district attorney’s office asked about, but all such relationships have come under fire recently. That’s because it’s against the law for pharmaceutical companies to link their products with charitable organizations and to offer direct copay subsidies to patients covered by government-run insurance plans.
J&J’s latest legal disclosures come just days after the company suffered a bruising defeat in the ongoing talcum powder saga. The company was ordered to pay $110 million to a patient who alleged that her years of using talc caused her metastatic ovarian cancer. J&J is appealing the verdict, but it’s already lost three previous cases and is facing more than 3,000 additional suits just pertaining to talcum powder.