Suboxone Settlement Results in Indivior Agreement To Pay Another $385M To Resolve Antitrust Lawsuit

Settlement comes amid rising concerns about severe tooth decay from Suboxone film strips, which the antitrust lawsuit alleged were introduced to help the drug maker avoid generic competition, not to benefit patient health

The makers of Suboxone have agreed to pay $385 million to resolve an antitrust lawsuit filed by direct purchasers, who say the opioid addiction drug’s dissolving film tabs, which have been linked to severe tooth decay and damage, were marketed in an attempt to stifle generic competition.

Indivior announced the Suboxone settlement agreement in an October 23 press release, reaching a deal with about 70 direct purchasers of their drug, such as wholesalers and clinics.

The lawsuits were consolidated as part of a Suboxone antitrust multidistrict litigation (MDL) in the U.S. District Court for the Eastern District of Pennsylvania, since the claims each involved similar allegations that Indivior marketed, sold and formulated Suboxone film in a way that was designed to illegally prevent generic competition.

The settlement agreement led to the cancellation of an antitrust trial that was scheduled to begin on October 30, but it also comes as Indivior now faces a growing number of new Suboxone lawsuits that are being filed by former users who experienced severe tooth decay after using the film tab version of the medication.

Suboxone (buprenorphine and naloxone) was approved by the U.S. Food and Drug Administration (FDA) in 2002, for treatment of recovering opioid addicts; helping them avoid withdrawal symptoms while undergoing therapy to help them break their addiction. While originally sold as a tablet, the drug makers subsequently introduced Suboxone film in 2009, which users place beneath the tongue until it is dissolved.

According to allegations raised in lawsuits filed against Indivior by purchasers of the drug, including wholesalers and those who have experienced Suboxone tooth decay side effects, the film version of the drug was introduced for the sole purpose of prolonging patent protections and preventing competition from cheaper generic equivalents of the original tablet form of the drug.

In 2020 and 2021, Indivior paid about $900 million to states and the federal government to resolve claims that it deceived regulators and the medical community about the safety risks of its original Suboxone tablets. They claimed the manufacturer submitted a fraudulent petition to the FDA in September 2012, which claimed the Suboxone Tablet had to be discontinued due to safety concerns.

However, plaintiffs say that, in actuality, the manufacturer sought to prevent generic versions of the pill from coming to the market, as well as control supply and improperly inflate Suboxone pricing.

In June, Indivior agreed to pay $157 million to settle Suboxone antitrust lawsuits brought by various state entities. In this latest Suboxone settlement agreement, Indivior has agreed to pay an additional $228 million to direct purchasers who also brought antitrust lawsuits.

The company expects to make the payment next month, once the antitrust settlements are approved by the Court. However, the agreement does not resolve the mounting number of lawsuits being filed by former users left with long-term dental problems from the Suboxone filem.

Suboxone Tooth Decay Problems

Former users now pursuing Suboxone tooth decay lawsuits raise similar allegations that Indivior placed it’s desire for profits before patient safety and well being. However, rather than seeking to recoup damages caused by inflated drug prices, plaintiffs seek financial compensation for dental problems caused by use of the Suboxone filem.

Plaintiffs note the drug makers continued to market and promote the treatment as safe and effective years, despite an influx of adverse event reports and published case studies describing devastating tooth damage among Suboxone users. Medical literature began to be published as early as 2012, which included case reports of dental erosion linked to Suboxone use.

Despite that knowledge, the makers of Suboxone failed to provide adequate warning labels for patients or the medical community for years, according to allegations raised in the complaints.

It was not until early 2022 that Suboxone tooth damage warnings were added, after the FDA identified more than 300 cases of tooth decay and dental problems reported to the agency.