A New Jersey federal judge has given preliminary approval to a settlement with the attorneys general of all 50 states ensuring that thousands of consumers who paid high prescription prices for the antidepressant drug Remeron will get their money back.
The manufacturer of the drug, Organon USA Inc. of New Jersey, and its Dutch parent company, Akzo Nobel N.V., agreed to settle for $36 million after engaging in a scheme to mislead the U.S. Food and Drug Administration and manipulate the patent process.
This orchestrated practice unlawfully kept cheaper generic equivalents of Remeron off the market, extended the company's monopoly over the drug and wrongly generated millions of dollars in profits, the states charged.
"The company abused the system by preventing Texas consumers from having access to more affordable, generic versions of this drug," said Texas Attorney General Abbott. "My antitrust team led the way in getting justified relief for the end-users of the medication here in Texas and nationwide, and the overall result is lower drug prices."
Consumers, as well as state purchasers such as Medicaid programs, will be among those who may submit claims for reimbursement. The court approval allows attorneys general to implement a claims administration process for consumers who purchased Remeron or a generic equivalent between June 15, 2001, and the present.
Consumers will be notified via advertising in major newspapers and magazines, as well as by direct mail and radio public service announcements from pharmacies and psychiatrists. Beginning in March, the claims administrator will introduce a Web site, www.remeronsettlement.com, and toll-free number for information about filing claims.
Generic equivalents are included for consideration in refunds because Organon's actions delayed their entry into the marketplace, which adversely influenced how quickly the prices might have fallen for Remeron and its generic substitutes.
Organon USA also agreed to an injunction that will require it to make timely listings of patents and prohibits it from submitting false or misleading information to the FDA.
The settlement must receive final court approval before the money will be distributed.
