Reckitt Benckiser and Invidor, the manufacturers of Suboxone are back in the news.
The Justice Department in filings last week in federal court in Abingdon, Virginia, said it was intervening in four separate whistleblower lawsuits related to the Britain-based companies’ marketing of Suboxone and the related drug Subutex.
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Among the complaints unsealed on Aug. 2 was one filed by former Reckitt employee Ann Marie Williams.
Her 2013 lawsuit alleged the companies marketed unapproved dosages and uses of Suboxone and Subutex and claimed Reckitt made misleading claims to the U.S. Food and Drug Administration to obtain approval for a dissolvable film version of Suboxone.
You may recall that Reckitt’s rationale for switching to the film version was to protect children from accidental ingestion. This change occurred as Reckitt’s patent was about to expire. They also said that the film version would prevent misuse. They ended up getting a new patent for the film version and left a cloud of safety concerns over the new generic tablets coming to market.
One of the lawsuits alleges that the film actually poses an increased risk to children and is easier to misuse.