For many years, Indivior Inc. has promoted Suboxone as a safe medication to treat opioid addiction and pain. However, the acidity in Suboxone strips has been linked to severe tooth enamel and dental issues, and patients throughout the U.S. are filing lawsuits. The claims urge that the defendant knew or should have known that the buprenorphine’s acidity in the film caused dental damage. Instead, they tried to monopolize the market by blocking generic alternatives to Suboxone and redeveloping tablets into sublingual films. You could be eligible for financial compensation if you used the medication and suffered tooth loss, tooth decay, gum injuries, tongue injuries, or fractured teeth. A seasoned mass tort attorney can evaluate your case circumstances to determine whether you are eligible.

An Overview of Indivior Suboxone Lawsuits

Indivior Inc., a Virginia-based subsidiary of Indivior PLC, a British drug manufacturer, manufactures suboxone.

Suboxone comprises two medications: naloxone and buprenorphine. Buprenorphine is acidic and an opioid agonist that stops receptors in the patient’s brain. It lowers withdrawal signs and the craving for opioids. It dissolves in the patient's mouth. On the other hand, naloxone reverses the hazardous signs of a drug overdose. Both medications make it challenging for patients recovering from opioid addiction to abuse this narcotic without causing the cycles of highs and lows related to opioid misuse.

After two decades of approval, the United States Food and Drug Administration warned that patients had reported dental health issues with drugs containing buprenorphine. These dental issues include tooth loss, tongue injuries, tooth fractures, oral infections, cavities, and tooth decay. Despite these issues, the FDA states that buprenorphine is a great treatment choice for opioid use disorder and pain, and these benefits outweigh the cons. 

Why Plaintiffs are Filing Lawsuits

According to the Federal Trade Commission 2020 complaint, Indivior is accused of participating in anticompetitive acts related to Suboxone to stop their future competitors.

In 2009, the manufacturer did not have regulatory or patent exclusivity and made annual sales worth $700 million. In 2010, many generic applicants applied with the FDA to obtain approval for their suboxone tablets, and that is when Indivior initiated an anti-competition approach to extend its market monopoly.

First, the manufacturer forced patients to replace their tablets with their films by fabricating a story that Suboxone film’s packaging was safer than their tablets and lowered the vulnerability of accidental pediatric exposure. No evidence supported the claim, and the FDA rejected it. Nevertheless, the manufacturer promoted the film's use and sale with false safety claims.

Additionally, Indivior forced patients and healthcare providers to switch to its film by raising the tablets’ cost. The Suboxone film was cheaper than the Suboxone tablet, although it was more costly to produce. In September 2013, it suspended Suboxone tablet production due to purported safety issues and notified doctors, urging them to switch to its film.

Second, in 2012, the defendant filed a citizen petition with the FDA requesting it to reject all generic Suboxone applications. By acting so, the manufacturer knew the move would delay approvals while the federal authorizing agency reviewed the petition. Later, the Food and Drug Administration rejected the petition based on insufficient supporting data.

The defendant willfully maintained monopoly power over Suboxone prescriptions using exclusionary and wrongful conduct. It led to consumer harm by denying users access to cheaper Suboxone alternatives.

Misleading Marketing Complaints

In 2019, misleading marketing claims were unlinked to the dental damage lawsuits. The manufacturer pleaded guilty to felony criminal charges and paid six hundred million dollars to resolve their civil and criminal liability. The defendant had deceived health plans and doctors into believing that Suboxone was less vulnerable to abuse and safer than identical medications.

The company also admitted to having persuaded MassHealth to increase Medicaid insurance for its film in Massachusetts. It sent MassHealth the wrong data, stating the film was less likely to cause accidental pediatric exposure. 

The Department of Justice settled with the defendant for $1.4 billion. And in 2018, the company compensated six states seven hundred million dollars for deceptive marketing.

Current Suboxone Lawsuits Updates

The status of the lawsuits is as follows:

  • In January 2023, the Food and Drug Administration announced that it received reports that medications with buprenorphine that dissolve in the mouth, like Suboxone, could result in dental issues.
  • In April 2023, the FTC announced that it paid $369,000 to plaintiffs in class-action claims but missed the deadline.
  • In August 2023, the defendant settled thirty million dollars with health care plans that had filed a federal antitrust claim against the company.
  • In September 2023, David Sorensen brought a dental health claim against the defendant after he used the medication, developed permanent teeth damage, and required significant dental work.
  • In October 2013, the defendant agreed to compensate wholesalers $385.

Tooth decay claims are in the initial stages, and lawyers still accept and analyze cases. There are no publicly announced, court-approved settlements and no scheduled trials.

Suboxone Lawsuit Qualifications

If you suffer from a dental issue after using prescription film, you can receive compensation. An experienced attorney can help you determine whether you can join a lawsuit.

You can be eligible for compensation if all the statements below are true:

  • Your doctor prescribed Suboxone Opioid for pain or addiction management.
  • You used the prescribed Suboxone for more than six (6) months before developing dental health conditions.
  • You suffer from either gum injuries, tooth fractures, tongue injuries, tooth loss, or cavities.
  • You have had your regular dental care before taking the medication.

Defining a Mass Tort

A mass tort allows victims harmed by the wrongful acts or negligence of the same defendant to take legal action to recover compensation.

Mass tort cases are settled through multi-district litigation (MDL). One judge oversees the cases, and the MDL streamlines the legal process. The judge appoints the plaintiffs’ steering committee (lawyers facilitating the litigation discovery process). During the discovery, witnesses are interviewed, and information is exchanged.

Next, bellwether cases are chosen to facilitate case compensation negotiations. It helps the involved parties understand how the case will unfold before the judge. It also allows the plaintiffs to assess the claims’ value.

After the defendant gives their settlement offer, plaintiffs in the MDL should determine whether to accept it or file their lawsuits.

Find an Experienced Mass Tort Attorney Near Me

Suboxone lawsuits claim that patients suffer from dental health conditions and permanent tooth damage after using sublingual film to treat opioid addictions. Indivior Inc., the manufacturer, knew or should have been aware of the tooth damage loss but failed to warn doctors and patients of the adverse effects. While no MDL exists for the lawsuits, courts throughout the U.S. are seeing a growing claim trend. The skilled attorneys at Consumer Alert Now are taking cases and are dedicated to holding the defendant accountable. We can listen to you, collect and analyze relevant evidence, build your case, and represent you in court to ensure you receive the compensation you deserve and need.

Please contact us at 800-511-0747 to schedule your free case review. We work on a contingency basis and will only charge after you recover your damages.