Suboxone Lawsuit (2024 Update) – Forbes Advisor – Forbes

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Suboxone is a drug made and distributed by Indivior to treat opioid addiction. Users of Suboxone have experienced oral health issues like dry mouth and tooth decay, and some have filed lawsuits claiming that Indivior failed to warn users of the oral health dangers of Suboxone use.

What Is Suboxone?

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Suboxone combines two drugs (buprenorphine and naloxone) for the purpose of decreasing opioid withdrawal symptoms and reducing opioid dependence.

Suboxone is commonly prescribed for treating addiction. It has been prescribed steadily since its introduction in the early 2000s as an alternative to methadone. Unlike methadone, it was believed to pose a lower risk for abuse and accidental overdose.

Suboxone is an oral medication. Patients are advised to take Suboxone by mouth and let it dissolve under the tongue. It can take between 15 and 30 minutes for Suboxone to fully dissolve.

Suboxone was created by Reckitt Benckiser Group (RB Group), and has been manufactured and distributed by Indivior. Until 2014, Indivior was a division of RB Group.

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Why Are Suboxone Lawsuits Filed?

Individual lawsuits have been filed after some patients experienced serious dental issues after using Suboxone. Patients reported developing dry mouth after taking Suboxone, making them more vulnerable to permanent tooth damage. These lawsuits claim that Indivior was either aware of the risk to dental health, or should have been aware, and failed to warn consumers and medical providers of that risk.

A limited clinical study published in 2013 first indicated a possible link between one of the drugs in Suboxone—buprenorphine—and dental problems. Then in 2017, researchers reviewing multiple medications potentially tied to dental caries (an infectious breakdown of the tooth) found that Suboxone had a high incidence of decreasing saliva production.

In January 2022, the Food and Drug Administration (FDA) issued a public warning that oral buprenorphine could be linked with developing dental problems. A few months following that warning, Suboxone’s FDA warning label was changed to include dental adverse events in its warnings and precautions. Prior versions of the FDA label did not include this warning. However, this warning is only included in the prescribing information used by physicians and is NOT included in the medication guide.

In October 2023, the National Institutes of Health initiated new comprehensive research into the ties between oral buprenorphine and the development of dental problems. Suboxone lawsuits rely heavily on research proving a link between Suboxone and dental complications, which makes new research in this area of particular interest.


History of Suboxone Lawsuits

The first lawsuit was filed on September 23, 2023 in the Northern District of Ohio. As of November 2023, over 100 lawsuits have been filed in federal courts in a variety of states alleging Suboxone caused damage. The majority of cases are in the Northern District of Ohio. No lawsuits alleging dental damage as a result of Suboxone treatment have been resolved to date.

The Joint Panel on Multidistrict Litigation met in January 2024 to discuss consolidation of all federal court Suboxone lawsuits. A consolidated multidistrict litigation (MDL) could make resolving the cases more efficient. No order has yet been issued with a decision on MDL consolidation.

Both Indivior and RB Group previously faced a class action antitrust lawsuit filed by the FTC. That lawsuit claimed consumers were forced to overpay for Suboxone when the defendants took strategic action preventing competition from lower priced generic drugs. In 2019, RB Group settled with the FTC and agreed to pay $50 million to consumers. Following in 2020, Indivior also settled and agreed to pay $10 million to consumers. In June 2023, Indivior paid a settlement to a group of states and then in August, paid $30 million in a class action brought by health plans. In November 2023, Indivior settled an antitrust suit, paying $385 million to 70 drug wholesalers.

Additionally, Indivior and RB Group faced criminal and civil charges for allegedly engaging in deceptive marketing efforts. Charges were brought by the US Department of Justice (DOJ) and several states. Indivior and RB Group separately resolved the charges against them in 2019. Indivior agreed to pay $600 million, while RB Group agreed to pay $2.1 billion in resolution of DOJ and state charges.


Suboxone Response

Neither Indivior nor RB Group have commented publicly on the allegations that they failed to provide notice of dental damage risks from Suboxone. An update was made to the FDA warning label on Suboxone only after the FDA issued a warning letter advising the public of a risk of dental damage from buprenorphine—one of the drugs in Suboxone.

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Recent Developments in Suboxone Lawsuits

The pending decision on whether to consolidate all federal Suboxone cases into an MDL is the most impactful recent development in these lawsuits. If an MDL is formed, it is possible that the consolidated cases will move more quickly toward resolution.

Meanwhile, a new Suboxone lawsuit filed in Kentucky on January 22, 2024 will test how courts view the statute of limitations as a bar to new lawsuits. Kentucky’s statute of limitations requires claims of personal injury, like those made in the Suboxone lawsuits, to be filed within one year from the date an injury is discovered or should have been discovered.

In the new case, the plaintiff was prescribed Suboxone in 2011, but states he discovered that the drug caused tooth decay in 2023. If that case is allowed to go forward, it may encourage others, who might otherwise believe their injury is too old, to file claims.


Can I Still File a Suboxone Lawsuit?

Lawsuits alleging dental injuries as a result of Suboxone treatment are still being filed. However, there are some timing obstacles to consider. Suboxone lawsuits are generally filed for patients who used Suboxone prior to 2022 and suffered dental issues as a result.

If you discovered your injury too long ago, you may be barred from filing a lawsuit now. This is because your claim may now be outside the personal injury statute of limitations in your state. Lawyers who take on new Suboxone lawsuits are more likely to be able to assist you if your state has a statute of limitations of two years or longer.

Lawsuits claiming recent dental injury from Suboxone can also be tricky. The FDA warning label for Suboxone was updated in June 2022 to include a specific warning about dental effects. This makes it difficult to claim you or your physician were unaware of the risk if you were prescribed Suboxone after that update.

It may be possible to file a lawsuit if you discovered your dental injuries more recently in spite of when you began taking Suboxone. For example, see our discussion of a recent Kentucky lawsuit above where the plaintiff was treated with Suboxone years ago but only recently discovered dental damage. Look for a personal injury lawyer familiar with these lawsuits to gain more insight and discuss your options.


Types of Suboxone Lawsuits and Claims

Indivior and RB Group previously faced civil and criminal charges for deceptive marketing tactics and a class action for antitrust actions. Those cases have been resolved and the last class action payments related to those claims were paid in 2023.

Numerous Suboxone lawsuits are ongoing that allege patients and physicians were not warned of the risk of dental damage from Suboxone. The types of dental damage allegedly caused by Suboxone include:

  • Tooth decay
  • Oral infections
  • Cavities
  • Tooth fractures (cracked teeth)
  • Root canals
  • Tooth loss
  • Tongue injuries
  • Gum injuries


How to File a Suboxone Lawsuit

Speaking with a personal injury lawyer in your area who has expertise in drug cases should be your first step. Some Suboxone claims may be blocked by a statute of limitations, but a lawyer can help evaluate your individual situation. Since Suboxone lawsuits may soon be joined into a MDL, finding a lawyer who is familiar with mass torts would also be helpful.

Evidence is needed to support your claims. Your lawyer can advise you on next steps, but will likely need you to gather:

  • Medical records documenting Suboxone treatment
  • Dental records documenting dental damage
  • Opinions from treating physicians and medical experts


Compensation for Suboxone

Substantial settlements have been paid out by Indivior and RB Group regarding Suboxone. However, these settlements were related to antitrust and deceptive marketing claims, not dental damage risks.

No lawsuits have been settled or resolved regarding dental damage from Suboxone. As a result, it is not yet possible to estimate the value of a Suboxone lawsuit.

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Has a Recall Been Issued for Suboxone?

There has never been a recall issued for Suboxone. The current lawsuits alleging dental damage from Suboxone focus on a lack of warning by the makers of Suboxone to medical providers and consumers. The drug’s effectiveness for its intended purpose, to aid in opioid addiction treatment, has not changed.


The Last Word on Suboxone Lawsuits

Numerous Suboxone lawsuits have been filed alleging patients were not warned of the risk of dental damage from Suboxone treatment. Many of these cases may be consolidated into a MDL in the near future. New lawsuits are also still being filed.

If you have experienced dental damage following Suboxone treatment, then consider discussing your situation with a personal injury lawyer in your area.

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Frequently Asked Questions (FAQs)

Has Suboxone been proven to be dangerous?

Suboxone continues to be used successfully for opioid addiction treatment. However, as with any drug, Suboxone comes with risks of unwanted side effects. Suboxone lawsuits do not claim that the drug is dangerous for all usage, but instead claim that patients were not made aware of all risks associated with its use.

Should I stop using Suboxone?

You should not alter your medication without speaking to your doctor. If you have concerns that Suboxone is causing problems, your doctor can help address your concerns and propose alternative treatments.

What is the Suboxone class action lawsuit about?

There is not an active Suboxone class action lawsuit. A previous class action antitrust lawsuit was filed against Indivior and RB Group, but that lawsuit has been resolved.

Current lawsuits against the makers of Suboxone allege that physicians and patients were not adequately warned of the risk of dental damage from Suboxone. These lawsuits are individual, but may be consolidated in the future into a MDL.

How to join the Suboxone class action lawsuit?

Current Suboxone lawsuits are not a class action. Multiple lawsuits may be consolidated into a single action, called a MDL, in a mass tort case. This type of consolidation is not the same as a class action.

There was previously a class action against the makers of Suboxone for antitrust allegations. That action has been resolved and all payments have now been made to the class members.

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