Antitrust Lawsuits and Criminal Indictments Paint a Picture of Widespread Damage

As of September 2024, 674 lawsuits have been consolidated in the multidistrict litigation (MDL) related to Suboxone Film Products in the Northern District of Ohio. These lawsuits target Indivior, the manufacturer of Suboxone. They allege that the sublingual film used to treat opioid addiction caused severe tooth decay and long-term dental damage. This harm has forces many patients to undergo expensive dental treatments and has drastically diminished their quality of life.

However, these 674 lawsuits are just the tip of the iceberg. In total, approximately 11,000 lawsuits have been filed against Indivior. To grasp the full extent of the damage caused by the company, it is essential to consider the wider context. This includes not only the product liability claims but also antitrust lawsuits and criminal indictments. These cases shed light on a disturbing pattern of corporate misconduct that has left a trail of harm in its wake.

Suboxone’s Shift to Sublingual Film

Medications for opioid use disorder, such as Suboxone Film Products, play a critical role in helping patients reduce cravings and withdrawal symptoms, facilitating recovery from opioid addiction. Suboxone, a combination of buprenorphine and naloxone, was a widely prescribed treatment due to buprenorphine’s lower risk of overdose and other side effects. Initially, Suboxone was available in tablet form, but in 2010, the FDA approved a new version—Suboxone sublingual film.

Shortly after this approval, Indivior removed the tablet form of Suboxone from the market. The sublingual film dissolves under the tongue. It appears to offer several benefits, including faster absorption and a reduced potential for abuse. However, this method also introduces significant risks. The film’s high acidity, combined with the recommendation to hold it in the mouth as long as possible, has now been linked to various dental injuries, including:

• Severe tooth decay
• Tooth loss
• Oral infections
• Gum and tongue injuries

Patients allege that Indivior was aware of these risks but failed to provide adequate warnings until January 2022, when the FDA mandated a label change. As the MDL progresses, no trials or settlements have occurred yet, but the surrounding legal battles offer important insight into the company’s questionable practices.

The “Product Hop” and Its Consequences

While the MDL focuses on product liability, Indivior has also faced antitrust lawsuits related to the 2010 decision to pull Suboxone tablets from the market. These lawsuits accuse Indivior and its predecessor, Reckitt Benckiser Group (RB Group), of engaging in anti-competitive practices. Plaintiffs, which include pharmaceutical companies, health organizations, and Medicare, argue that the removal of the tablet form constituted a “product hop,” a strategy designed to stifle emerging competition from generic drug manufacturers.

According to the plaintiffs, Indivior’s decision to switch from tablets to sublingual film was not driven by patient safety or improved efficacy. Rather it was pushed by a desire to maintain market dominance. To further this goal, the company allegedly launched a smear campaign against its own tablet form. It was exaggerating safety concerns to discourage its use and thwart generic competitors. By doing so, the company was able to inflate the price of Suboxone Film Products. They were able to limit consumer choice, forcing patients and insurers to pay more for the film.

Financial Impact

The financial impact of this anti-competitive behavior has been substantial. In 2019, RB Group reached a $50 million settlement with the Federal Trade Commission (FTC). This settlement would compensate consumers for the inflated costs. Indivior followed with its own settlement, agreeing to pay $10 million to consumers in 2020. Additional settlements continued into 2023. The company agreed to pay $30 million in a class action lawsuit brought by health plans. The company paid $385 million to 70 drug wholesalers as well in November 2023.

Despite these large payouts, none of the settlement money has gone directly to individuals who suffered dental damage from Suboxone. For these patients, the antitrust lawsuits may seem distant and abstract. However, antitrust laws are ultimately designed to protect consumers, and vigorous enforcement could help prevent similar corporate misconduct in the future.

Suboxone Film Products Deceptive Marketing Practices

Indivior and RB Group have not only faced civil lawsuits; they have also been the subject of criminal investigations and charges related to their marketing practices. The U.S. Department of Justice (DOJ) and several states brought criminal and civil charges against both companies for engaging in deceptive marketing efforts.

In 2019, Indivior agreed to pay $600 million to resolve these charges. However, RB Group reached a much larger settlement of $2.1 billion. These charges stemmed from allegations that both companies misled healthcare providers and the public about the safety and efficacy of Suboxone. Prosecutors accused Indivior of marketing Suboxone Film Products as safer and less addictive than it truly was. Additionally, they contributed to the broader opioid crisis that has ravaged communities across the United States.

Once again, however, the individuals harmed by Suboxone’s dental side effects saw no direct compensation from these settlements. While the payments addressed some of the broader damage caused by the opioid epidemic, they did not provide restitution for the personal injuries. Dental costs incurred by thousands of patients.

Suboxone Film Products and Other Pharmaceutical Companies Prioritize Profits Over Patients

The Suboxone Film Product cases are just one example of how pharmaceutical companies have prioritized profits over patients, leaving behind a trail of harm. Indivior’s actions—whether in manipulating the market, deceiving consumers, or failing to warn patients about the risks of Suboxone film—mirror the misconduct of other companies, such as Purdue Pharma, whose marketing of OxyContin fueled the opioid epidemic.

Many critics point to the Food and Drug Administration (FDA) and a culture of lax oversight as key contributors to this crisis. The FDA’s delayed action in requiring Suboxone’s warning label change in 2022 illustrates the gaps in the regulatory system meant to protect patients. As legal battles continue to unfold, it remains clear that without stronger oversight and enforcement, the pharmaceutical industry’s unchecked practices will continue to harm consumers.

The lawsuits against Indivior demonstrate the broad-reaching consequences of corporate malfeasance, from inflated drug prices to devastating personal injuries. In the end, while the legal system may hold companies financially accountable, it often leaves individual patients to bear the brunt of the damage.

KBA Can Help

KBA Attorneys is committed to holding pharmaceutical companies accountable for the harm they cause. We offer invaluable support to individuals affected by Suboxone-related dental damage. With extensive experience in mass tort litigation and pharmaceutical lawsuits, KBA can help guide victims through the complex legal process. We will help to ensure client claims are properly represented in the multi-district litigation (MDL). Our legal expertise can secure compensation for costly dental treatments, pain, and suffering caused by Suboxone’s side effects. We are committed in advocating for justice against corporate negligence. KBA Attorneys can provide personalized assistance, standing by those affected from consultation to resolution. Contact us to learn more.