02/27/24 | Court Grants Final Approval to $385 Million Settlement with Indivior
A federal judge granted final approval to a $385 million settlement benefitting direct purchasers of the opioid treatment drug Suboxone, following a final fairness hearing on Feb. 27, 2024. In the final approval order, Judge Mitchell S. Goldberg wrote that the response to the settlement from the already certified class has been “overwhelmingly favorable,” with no objections from any class members. He favorably compared the direct purchasers’ settlement to the settlements Indivior has agreed to pay state attorneys general and end-payors regarding this same issue: “The Settlement here involves an immediate payout of $385 million, more than three times that of the States and more than ten times that of the EPPs.” The order also states that “Counsel has extensive experience handling complex class action litigation, particularly in the antitrust context.”
Hagens Berman is one of three co-lead counsel firms representing direct purchaser plaintiffs in this class-action lawsuit. The case alleges Reckitt Benckiser Pharmaceuticals (now Indivior Inc.) violated federal antitrust laws by delaying generic competition for its blockbuster opioid addiction medicine, Suboxone. The complaint alleges this scheme succeeded, and purchasers incurred substantial damages as a result.
This class-action lawsuit on behalf of direct purchaser plaintiffs of Suboxone alleges Reckitt Benckiser Pharmaceuticals violated federal antitrust laws by delaying generic competition for its blockbuster opioid addiction medicine, Suboxone. The lawsuit states that Reckitt’s scheme succeeded, and purchasers incurred substantial damages as a result.
RECKITT’S ALLEGED SUBOXONE SCHEME
The lawsuit alleges Reckitt’s scheme had many parts. First, Reckitt allegedly engaged in an anticompetitive “product switch,” introducing a new, patented formulation of Suboxone as a sublingual “film” so that generic versions of Suboxone tablets could not be substituted for the brand product at the pharmacy counter.
Next, Reckitt allegedly mounted a campaign to disparage the original tablet formulation, claiming without valid scientific basis that the tablets carried higher risk of accidental pediatric exposure, diversion and abuse. The lawsuit states that this was done to convert the market to the new film formulation. According to the complaint, Reckitt then advised physicians that the old formulation would be discontinued. As alleged, the purpose of the disparagement campaign was to impair the market for Suboxone tablets ahead of generic competition.
The complaint alleges that after stalling the FDA’s efforts to mandate a shared safety protocol between Reckitt and its prospective generic competitors, Reckitt filed a citizen petition with the FDA. This was done allegedly to block approval of the generics. Ultimately, the FDA denied the citizen petition and approved generic competitors in 2013, but, according to the complaint, the alleged scheme was successful in converting physicians and patients to the new “sublingual film” formulation before generic competition could begin, injuring competition as well as purchasers of Suboxone.
TOP PHARMA LAW FIRM
Hagens Berman is one of the most successful litigation law firms in the U.S. taking on pharmaceutical companies and has achieved more than $320 billion in settlements against Big Pharma largest sellers and manufacturers for antitrust schemes, pay-for-delay, IP shams and other forms of wrongdoing that drive up the costs of prescription drugs for consumers and others.
CASE TIMELINE
Judge Mitchell S. Goldberg of the Eastern District of Pennsylvania granted preliminary approval to a settlement benefitting direct purchasers in the In Re Suboxone (Buprenorphine Hydrochloride and Naloxone) Antitrust Litigation on Oct. 30, 2023. The $385 million settlement is on behalf of an already certified class consisting of all persons or entities in the United States and its territories who purchased branded Suboxone tablets directly from Reckitt Benckiser Pharmaceuticals Inc. from Jan. 1, 2012 through March 14, 2013. Judge Goldberg highlighted that the settlement, “was arrived at by arm’s-length negotiations by highly experienced counsel, after extensive mediation, more than a decade of litigation, and as a jury trial was imminent…”
A deadline to object to the settlement has been set for Jan. 12, 2024, and a fairness hearing on final approval will be held on Feb. 27, 2024. Read the judge’s order »
On August 8, 2022, Judge Goldberg issued an 87-page opinion and order denying Indivior’s motions for summary judgment in their entirety.
On July 28, 2020, the Third Circuit Court of Appeals affirmed Judge Goldberg’s order granting the motion for class certification.
On Sept. 27, 2019, the Court certified a class of direct-purchaser plaintiffs. Indivior was permitted to appeal the class certification ruling.
