New York Financial Regulator Sues UK Opioid Maker, Alleging It Downplayed Usage Risk
U.K.-based Mallinckrodt is the first company charged in a broader DFS investigation into the opioid crisis, according to the agency.
April 21, 2020 at 05:19 PM
3 minute read
The original version of this story was published on New York Law Journal
The New York State Department of Financial Services has charged the drug manufacturer Mallinckrodt with fraudulent insurance acts and intentional misrepresentation of facts, arguing that the company contributed to the opioid crisis in the United States by downplaying the risks and overstating the benefits of long-term opioid use.
U.K.-based Mallinckrodt is the first company charged in a broader DFS investigation into the opioid crisis, according to the agency.
In the past 10 years, New York health plans have incurred up to $1.8 billion in claims for unnecessary opioid prescriptions and the consequences of opioid abuse, DFS officials wrote in their statement of charges. According to a U.S. Drug Enforcement Administration database, Mallinckrodt manufactured 39% of the opioid pills in New York between 2006 and 2014, the DFS officials wrote.
Mallinckrodt promoted its opioid products in a way that minimized the risk of addiction and encouraged opioid prescriptions for long-term issues, including chronic pain, whereas opioids had traditionally been used for palliative care or for short-term recovery in hospitals, according to the statement of charges.
Mallinckrodt was the founding sponsor of www.pain-topics.org, a website launched in 2006 that claimed to provide information about the relative safety of opioid use, according to the statement of charges. DFS officials argued that the website actually promoted dangerous misconceptions, including the idea that opioid addiction isn't a particular risk for people without a history of other substance use issues.
DFS also accused Mallinckrodt of paying doctors who prescribed its pills, including $15,000 to $20,000 in honoraria for speaking engagements to one top prescriber.
A Mallinckrodt representative said the allegations were "without merit" in a statement Tuesday.
"In its Hobart, N.Y. facility, Mallinckrodt has and continues to manufacture necessary, legitimate opioid medications in amounts that are approved by the U.S. Drug Enforcement Administration, and does not promote these products to doctors," the statement said.
Mallinckrodt is charged with violating two New York insurance laws, which could each lead to $5,000 in civil penalties for every fraudulent prescription, according to the statement of charges, which was sent to Mallinckrodt Friday. A hearing is set for Aug. 24 in Manhattan.
In a statement Tuesday, Gov. Andrew Cuomo emphasized the human cost of the opioid crisis. "The worst frauds are those that go beyond individual harm to institutionalized systemic fraud—and the opioid scheme is no exception," Cuomo said. "The opioid manufacturers knew how addictive and dangerous their products were and they used it as a business model for their own financial gain at the cost of thousands of human lives and billions of dollars."
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