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By PBN Staff
By PBN Staff
PROVIDENCE – Attorney General Peter F. Kilmartin announced Monday that Rhode Island will receive $213,126 as its share of a multistate and federal settlement with Endo Pharmaceuticals, a wholly owned subsidiary of pharmaceutical manufacturer Endo Health Solutions.
The settlement was made to resolve civil allegations of unlawful marketing practices to promote the sales of Endo’s drug Lidoderm to treat conditions not approved by the U.S. Food and Drug Administration.
Under the terms of the civil settlement, Endo will pay out more than $1.7 million to U.S. states and to the federal government, and will also pay a $20.8 million criminal fine. Rhode Island’s $213,126 share of the settlement will go toward the state’s Medicaid budget, according to a release from Kilmartin’s office.
“Pharmaceutical companies continually engage in off-label marketing, defrauding states’ Medicaid programs tens of millions of dollars each year,” said Kilmartin in a statement. “The FDA requires strict procedures to bring drugs to market for good reason – to protect the health and safety of patients. To skirt the FDA’s rules and regulation in exchange for profits is too big a lure for many companies. This practice is unethical, illegal and potentially dangerous.”
The whistleblower lawsuit against Endo alleged that between March 1999 and December 2007, Malvern, Pa.-based Endo knowingly promoted the sale and use of Lidoderm for use in connection with lower back and chronic pain, conditions not approved for Lidoderm treatment by the FDA and not covered by the state Medicaid program.
The FDA approved Lidoderm only for the treatment of pain associated with post-herpetic neuralgia, more commonly known as shingles, Kilmartin’s office said.