Indivior fails to escape class action lawsuit in Suboxone case
23 Aug 2022
Orphan Drug
Indivior isn’t getting out of its class action Suboxone lawsuit without a trial, a federal judge ruled on Monday.
Judge Mitchell Goldberg of Pennsylvania denied two motions by Indivior for a summary judgment in a case alleging the company committed a “product hop” scheme to prevent generic competition to its opioid addiction treatment Suboxone.
Suboxone, a combination of buprenorphine and naloxone, was approved in tablet form back in 2002 for the treatment of opioid dependence. Indivior, formerly a division of Reckitt Benckiser, developed the drug along with the United States National Institute on Drug Abuse, and received orphan drug exclusivity until October 2009.
At the time, Reckitt’s Subutex and Suboxone tablets were the only maintenance treatments on the market for opioid addiction that could be prescribed for at-home use, according to court documents.
By 2006, Reckitt execs had developed a “Generic Defense Strategy,” which included consideration of a new under-the-tongue film formulation developed by the company MonoSol. Plaintiffs accused the company of switching to the sublingual film and withdrawing Suboxone pills before losing exclusivity to keep generic competitors from the market, a process they called a “product hop.”
In justifying its decision to withdraw the tablets, Indivior asserted that there was a “high level of sensitivity at the moment to unintentional childhood exposure to buprenorphine,” and introduced individually wrapped child-proof packs for the film. The company also claimed that tablets could be abused by snorting, while film is more difficult to abuse.
Plaintiffs in the class action case, however, argued that the film could be “more easily converted to a liquid for inappropriate diversionary injections and is more difficult for children to spit out if accidental pediatric exposure occurs.”
The FDA noted in a March 2010 letter that “[W]e do not agree that the packaging for buprenorphine HCl and naloxone HCl [Suboxone] sublingual film provides meaningful incremental protection against pediatric exposure.”
In 2020, Indivior
pleaded guilty
to making false statements about the safety of Suboxone film around children to the Massachusetts Medicaid program.
While Indivior requested a summary judgment in the class action case, Goldberg noted in his opinion that both the company and plaintiffs have submitted hundreds of pages of responses, objections and facts, and that “any attempt to synthesize these submissions would essentially amount to a trial on the papers.”
In its argument for a summary judgment, Indivior admitted to anticompetitive conduct, but added that plaintiffs have failed to prove market-wide harm, or that consumers were unwilling to pay more for the film and its purported safety benefits.
The first companies to gain generic approval for sublingual film versions of Suboxone were Mylan Technologies and Dr. Reddy’s Laboratories, but not until 2018.
Goldberg noted in his opinion that “plaintiffs need only produce evidence that the challenged restraint had a substantial anticompetitive effect that harms consumers in the relevant market.’
“To that end, I conclude that Plaintiffs have produced evidence that, if accepted, could establish that Reckitt’s conduct harmed consumer welfare through the combined effects of Reckitt’s switch from tablet to film, increase in the price of the tablet, fabrication and marketing of a ‘safety story’ about the dangers of the tablet, and the subsequent withdrawal of the tablet prior to generic entry,” he wrote.
“Indivior is proud to be the global leader in developing medications to treat opioid use disorder. These evidence-based treatment options are a critical part of the solution to the global opioid crisis and we take our role as a responsible steward of these medications extremely seriously. We do not comment on ongoing litigation,” Indivior’s chief global impact officer Nina DeLorenzo said in a statement.
This article has been updated with a statement from Indivior.
Social image: (Photo by Kristoffer Tripplaar/Sipa USA)(Sipa via AP Images)
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