Suboxone Settlements Failed to Compensate Users Left With Tooth Decay or Tooth loss

In recent years, Indivior, Inc. and other drug manufacturers have agreed to pay more than $1 billion in Suboxone settlements to resolve antitrust claims brought by the federal government, states and third party payors, involving allegations that Suboxone film was introduced to block generic competition from entering the market and inflate drug prices for the opioid addiction treatment.

However, these Suboxone settlements have not resulted in financial compensation for users of the drug who have been left with permanent tooth decay and tooth loss, often resulting in disfiguring injuries and substantial dental costs.

While the efforts by the Department of Justice and other entities have uncovered clear evidence that the drug maker placed it’s desire for profits before the safety and health of users, individuals must now pursue their own Suboxone tooth decay lawsuit against the drug manufacturer to obtain justice.

In recent months, AboutLawsuits.com has covered stories that describe the allegations raised in a number of different product liability lawsuits brought throughout the federal court system, each seeking individual Suboxone tooth decay settlements.

These complaints include a lot of the same evidence presented by the government and third party payers. However, the plaintiffs claim that Indivior’s deceitful switch from a tablet to a sublingual film not only violated antitrust laws, but also created a substantial risk of tooth decay that was not disclosed to users until the FDA required a Suboxone tooth decay warning in 2022.

As a result of the manufactures failure to warn about Suboxone dental side effects, individuals with no previous history of dental issues indicate that they are now experiencing;

• Severe dental decay
• Tooth loss
• Tooth extractions
• Cracked/Chipped teeth
• Other serious tooth problems

In this featured post, we will explain why Suboxone settlements have been awarded to government entities and private payers, and outline how users seeking Suboxone settlements over dental side effects must now contact a lawyer and file an individual claim to pursue damages for tooth decay or tooth loss they experienced.

Suboxone Antitrust Lawsuit Overview

Suboxone (buprenorphine and naloxone) was initially approved in tablet form by the U.S. Food and Drug Administration (FDA) in 2002. This approval came during the height of the opioid epidemic, fueled by the over-prescription of opioid pain relievers and widespread illicit heroin use. As a result, Suboxone quickly became a blockbuster medication and generated billions in profits for the drug maker.

Although Suboxone dominated the market as the go-to opioid treatment drug throughout the early 2000’s, its original patent neared expiration in 2009, which would have allowed generic drug manufacturers to sell their own version of the buprenorphine and naloxone tablets at lower costs. As this deadline approached, Reckitt Benckiser and it’s Indivior subsidiary developed a sublingual film version of Suboxone, using the same active ingredients in the original tablets.

Shortly after Suboxone film was approved, Reckitt petitioned the FDA to remove the tablet forms of Suboxone from the market, claiming that the tablets posed child safety concerns and that the sublingual film was safer.

However, the U.S. government and other entities determined that the decision to remove Suboxone tablets from the market and replace it with Suboxone film was only done to extend patent protections, allowing the drug maker to control supply and inflate Suboxone pricing.

The controversial tactic culminated in a U.S. Department of Justice lawsuit being filed, accusing Reckitt Benckiser Group PLC of antitrust violations for hindering Suboxone market competition.

Suboxone Antitrust Settlement with DOJ

In July 2019, the Suboxone antitrust lawsuit reached a conclusion when Reckitt Benckiser consented to a $1.4 billion payment. This settlement was to address its likely criminal and civil liabilities stemming from a federal inquiry into its marketing practices for the opioid addiction treatment, Suboxone.

A significant portion of the settlement, amounting to $700 million, was civil settlements with the federal government and several states. This component was meant to compensate for the damages caused by the company’s actions to the healthcare systems operated by these entities.

An additional $50 million was allocated for an administrative resolution with the FTC, further addressing issues related to antitrust laws and unfair competition practices.

The settlement also included a forfeiture of proceeds totaling $647 million. This part was intended to strip the company of the profits it gained through its alleged anticompetitive and deceptive marketing practices.

2023 Suboxone Settlement with Wholesalers

In one of the latest Suboxone settlement agreements, Indivior agreed to pay $385 million to settle an antitrust lawsuit filed by about 70 direct purchasers, including wholesalers and clinics, who claimed Indivior illegally extended patent protections by introducing the film version of Suboxone to prevent cheaper generic alternatives.

The settlement was announced on October 23 just days before a trial was scheduled for October 30, 2023.

Suboxone Settlements Fail to Compensate for Tooth Decay

While the cumulative $1.8 billion in Suboxone settlements was among the largest in pharmaceutical history and highlights the ongoing legal and ethical issues surrounding the Suboxone manufacturer’s business practices, it is important to note that these settlements did not directly compensate individual users who suffered dental side effects.

Suboxone Tooth Loss Lawsuits Seek Settlement Benefits

Shortly after the film version was introduced, users and medical providers began to notice a concerning trend that linked Suboxone to serious dental side effects. These problems have been echoed in Suboxone user stories shared on this website and thoughout social media for years.

In February 2022, the FDA ultimately added new Suboxone tooth decay warnings to the medication’s label, after identifying more than 300 adverse event reports involving dental problems experienced by users, many of which were categorized as serious.

The new warnings now highlight the importance of regular dental checkups while taking Suboxone, as well as recommend that users rinse their teeth with water after Suboxone film has dissolved, and wait at least one hour before brushing their teeth to avoid long-term damage. However, this information came too late for many users, who are now pursuing lawsuits against the drug maker for failing to disclose these unexpected dental side effects earlier.

For those affected, the consequences of Suboxone-related tooth decay and other dental issues extend far beyond discomfort. Many individuals have reported severe tooth loss, significant pain, and a profound impact on their quality of life.

The financial burden is equally substantial, with the cost of dental procedures to address these side effects often running into thousands of dollars. These expenses, coupled with the emotional distress of dealing with unexpected dental health deterioration, have left many individuals with no choice other than to pursue a lawsuit.

Suboxone Dental Side Effect Lawsuits Could Be Consolidated

As awareness of the link between Suboxone and severe dental side effects grows, so too has the number of lawsuits filed by affected individuals.

As of late November 2023, at least 15 Suboxone tooth decay lawsuits have been brought forth in various federal district courts across the nation, each raising similar allegations that the manufacturer placed profits over patient safety, and that the manufacturer knew, or should have known that Suboxone films can cause users to experience devastating dental injuries, including decay, erosion and tooth loss.

Given the momentum behind the rising number of claims, several plaintiffs filed a motion to transfer (PDF) with the U.S. Judicial Panel on Multidistrict Litigation (JPML) on November 14, calling for all Suboxone lawsuits to be transferred to the U.S. District Court for the Northern District of Ohio for pretrial proceedings, as part of a multidistrict litigation (MDL).

The aim of this petition is to consolidate these individual Suboxone tooth decay lawsuits into a single Multidistrict Litigation (MDL). The rationale behind this move is clear and strategic. By combining these cases, plaintiffs can share collective resources, streamline the discovery process, and also ensure consistency in rulings and procedures, a crucial factor in complex pharmaceutical litigation.

Potential for Suboxone Tooth Decay Settlements

If the Suboxone MDL is granted, a judge would be assigned to handle pretrial proceedings and establish a series of Suboxone tooth decay bellwether trials, where small groups of representative claims will go through case-specific discovery and be prepared for early trial dates, to help the parties gauge how juries are likely to respond to certain evidence and testimony that would be repeated throughout the litigation.

The outcomes of such potential bellwether trials would have a significant impact on whether the manufacturer would be willing to negotiate a global Suboxone tooth decay settlement.

Have a Suboxone Lawyer Review Your Claim

If you have experienced dental side effects as a result of taking Suboxone, it’s important to understand that you are not alone, and you have options.

Drug manufacturers have a responsibility to adequately research and test drugs to ensure they are safe and free of defective designs, and to warn the public about the potential side effects.

Each individual seeking settlement benefits over the failure to warn about dental risks must now present their own claim, establishing that the tooth decay and tooth loss were caused by Suboxone. To help individuals determine whether they may be eligible for financial compensation, AboutLawsuits.com provides a free case evaluation service to allow your claim to be reviewed by a lawyer.

By completing the short form below, your claim will be evaluated by a law firm to determine if they can assist you with pursuing a settlement. Claim evaluations are free and all cases are handled by lawyers on a contingency fee basis, which means that there are no fees or expenses unless a recovery is obtained.