Whistleblower Lawsuit Over Suboxone Kickback Scheme Allowed to Proceed by Judge

A federal judge has ruled that the makers of Suboxone must face a whistleblower lawsuit, claiming the company defrauded the government through a kickback scheme linked to sales of the opioid addiction drug.

The original lawsuit was filed by Rebecca Miller against Indivior in 2015, claiming the company conspired with Express Scripts, giving the pharmacy benefits managing company Suboxone rebates if Express Scripts recommended Suboxone coverage on commercial drug formulary lists.

This led to the company giving false price data to Medicare, which caused the government to pay more for the drug than it should have, Miller claims.

On October 17, Judge James P. Jones of the U.S. District Court for the Western District of Virgina issued an opinion (PDF) indicating that Miller, who has been joined in the lawsuit by the U.S. government, had adequately pled her case, and that the whistleblower’s claims could proceed.

Judge Jones rejected a motion by Indivior to dismiss the case, though he did dismiss some of Miller’s initial claims.

If the case ends in a settlement or a verdict against the defendants, Miller could receive a significant portion of any monetary damages under the qui tam provisions of the False Claims Act.

Suboxone Tooth Decay Lawsuits

The manufacturers of Suboxone have run into numerous legal problems with the sale and marketing of the opioid addiction drug.

Suboxone (buprenorphine and naloxone) was first approved in 2002 to treat recovering opioid addicts; helping them avoid withdrawal symptoms while they undergo therapy to help them break their addiction. Amid the nationwide opioid abuse and addiction epidemic in the United States, which has ravaged communities nationwide, Suboxone became a blockbuster drug, generating billions in profits for the manufacturers.

However, the U.S. Food and Drug Administration (FDA) required new Suboxone tooth decay warnings in early 2022, following hundreds of reports involving tooth decay and tooth loss linked to the medications. However, a number of former users are now pursuing product liability lawsuits against the drug maker, alleging that severe and costly dental work could have been avoided if earlier warnings and instructions had been provided with Suboxone.

The Suboxone tooth decay lawsuits focus on the use of a dissolvable film version of the drug, which they allege erodes the enamel on teeth, resulting in decay and the need tooth extractions.

Plaintiffs argue that drug maker placed its desire for profits before the dental health and safety of users, by introducing sublingual films as part of an effort to avoid competition from generic versions of an older tablet version, and failing to warn users about the long-term dental risks of Suboxone.

Previous Suboxone Deceptive Marketing Lawsuits

The whistleblower case and tooth decay lawsuits are not the only time Suboxone manufacturers have been hit over deceptive actions involving the marketing of the drug.

The federal government and various states previously pursued a lawsuit against Suboxone manufacturers, claiming that it illegally sought to control supply and inflate prices for the critical opioid addiction drug, including what state Medicaid programs paid for it.

In 2019, Reckitt Benckiser Pharmaceuticals reached a $700 million settlement with the federal government and states over Suboxone Medicaid fraud allegations. Indivior spun off from the company shortly afterwards and reached a $600 million Suboxone settlement agreement with the Justice Department in 2020, to resolve claims of aggressive and deceptive marketing. Then, in 2021, the company agreed to pay another $300 million to settle similar claims filed by all 50 states and the District of Columbia.

Earlier this month, Indivior announced another Suboxone settlement agreement, involving payments of $385 million to resolve claims brought by direct purchasers of the drug, such as wholesalers and clinics.