About Suboxone Lawsuits
- Suboxone film is used to treat opioid use disorder (OUD), but many people who take the medication have reported tooth loss, tooth decay, broken teeth, and other dental issues.
- Several Suboxone tooth decay lawsuits allege the manufacturer and other companies failed to warn patients, medical professionals, and the medical industry of the risks of dental problems.
- A Suboxone lawyer can help victims be compensated for a range of damages and hold companies responsible for their failure to warn and protect consumers.
Suboxone Lawsuits FAQs
What is Suboxone?
Suboxone is the brand name of a prescription film medication that contains buprenorphine and naloxone and is taken by placing it under the tongue. Suboxone produces some of the same effects as other opioids, but proper use of the drug reduces certain risks to patients.
What do people use Suboxone for?
Suboxone is used to treat opioid use disorder in combination with other treatments, including counseling. As the U.S. opioid crisis continues, medications like Suboxone are believed to be an essential part of treating opioid dependency and lowering addiction rates and overdoses nationwide.
Why are people filing Suboxone lawsuits?
For years, there have been an increasing number of serious dental problems reported to the U.S. Food and Drug Administration (FDA) by consumers who use Suboxone film. As a result, there’s been an influx of Suboxone lawsuits that allege the drug causes dental issues and that the manufacturer, Indivior, and its former parent company, Reckitt Benckiser, failed to warn consumers of potential oral side effects.
What dental problems does Suboxone cause?
Several dental issues have been reported by patients who take Suboxone. The common dental side effects reported by patients who took Suboxone film include tooth decay, cavities, cracked teeth, oral infections, and tooth loss.
Why does Suboxone cause dental problems?
Buprenorphine, one of two main ingredients in Suboxone, is acidic. It’s widely known that acid affects tooth health, which is why buprenorphine drugs like Suboxone cause dental problems.
Who can file a Suboxone lawsuit?
Patients who have experienced dental problems after or while taking Suboxone are filing lawsuits against Indivior. Tooth decay wasn’t added to the product’s warning label until 2022, and so far, the Suboxone lawsuits that have been filed are by patients who took it prior to the label change. However, anyone who took Suboxone and suffered dental problems should speak to a product liability attorney to see if they qualify to file a lawsuit.
Is there a class action Suboxone tooth decay lawsuit?
Currently, there is no class action lawsuit against Indivior for dental problems associated with Suboxone. However, with increasing tooth decay lawsuits filed against the company and others, the case may become a class action lawsuit or be moved to multidistrict litigation (MDL).
How does Suboxone help treat opioid dependency?
The ingredients in Suboxone help lower the risk of misuse and addiction by decreasing the physical side effects that other opioids cause. When used in combination with other supports, such as counseling, buprenorphine medications like Suboxone have shown to be an effective strategy to treat opioid dependency.
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Current Suboxone Tooth Decay Lawsuits
The first Suboxone tooth decay lawsuit was filed in September 2023, with many more quickly following. Lawsuits have been filed by victims who experienced severe dental problems from taking the drug.
The lawsuits against Indivior, Reckitt Benckiser, and others allege they knew or should have known of the damage Suboxone film could cause to teeth. There was no warning about the risks of dental problems on the drug’s prescribing information until 2022, and many Suboxone lawsuits claim the defendants were aware of the possible oral side effects but withheld this knowledge from doctors and patients.
Plaintiffs have suffered serious and, in many cases, permanent damage to their teeth from Suboxone. Some of them have paid for costly dental treatments or surgeries, like tooth extraction, due to side effects from taking the drug.
Suboxone lawsuits are seeking all or a combination of the following: compensatory damages (dental bills, lost wages, etc), statutory damages, punitive damages, attorneys’ fees, and costs. Currently, the U.S. District Court for the Northern District of Ohio has received the most lawsuits.
Suboxone tooth decay lawsuits are in the early stages. Many more Suboxone lawsuits are expected to be filed in the coming months, extending Indivior and Reckitt Benckiser’s legal troubles after years of criminal and civil cases.
If you suffered dental problems after taking Suboxone, it’s important to speak with an experienced product liability lawyer to see if you qualify for compensation.
The FDA and Suboxone
Suboxone tablets, a buprenorphine and naloxone-based medication first made by Reckitt Benckiser Pharmaceuticals Inc., were approved for the treatment of opioid dependence by the U.S. Food and Drug Administration (FDA) in 2002. The company held exclusive rights to sell the tablet form of Suboxone until 2009. In 2007, Reckitt Benckiser began working on a sublingual film version of Suboxone, which was approved by the FDA in August 2010.
The FDA says Suboxone should be just one part of a comprehensive treatment plan to address opioid dependence; counseling and psychosocial support should be used in combination with the drug.
After receiving more than 300 reports of tooth decay and other dental problems from patients who take buprenorphine medications that are dissolved in the mouth, the FDA issued a buprenorphine warning in January 2022. They warned that tooth decay, cavities, oral infections, and loss of teeth – all serious oral side effects – had been reported by patients, including those with no history of dental problems.
The FDA’s announcement also included new requirements for companies like Indivior that make buprenorphine medications that dissolve in the mouth. They’re required to add warnings of possible dental complications to both prescribing information and patient medication guides.
While Indivior updated Suboxone prescribing information, as of November 2023, there is still no warning about dental problems in the Suboxone patient medication guide. (The guide instructs consumers to tell their doctor and see a dentist if they experience problems with their teeth, but it is not listed under possible side effects).
It’s important to note that while Indivior has faced criminal and civil lawsuits in the past and is currently facing tooth decay lawsuits, the safety, efficacy, and continued use of Suboxone are not in question. The FDA still approves of the medication and says that at proper doses, drugs like Suboxone are effective at lowering addiction and making the misuse of buprenorphine less appealing because it decreases certain effects that other opioids cause.
The FDA’s standpoint is that the benefits of buprenorphine and naloxone medications outweigh the risks. And as a country that’s still experiencing widespread abuse of and overdoses from opioids, effective treatment of opioid use disorder is crucial to address the epidemic.
History of Suboxone Lawsuits
A growing number of product liability lawsuits allege Suboxone film causes dental issues and that consumers weren’t warned of the risks. Suboxone lawsuits have been filed against Indivior, Reckitt Benckiser, and other companies involved in the development, design, research, testing, licensing, manufacture, marketing, distribution, and/or sale of the drugs.
With Suboxone lawyers confident in the strength of the current product liability lawsuits, future settlements with injured consumers will likely be quite costly for the company. Over a two-week period this fall, an additional 14 tooth decay lawsuits were filed against Indivior, indicating many more may be on the horizon.
But Suboxone tooth decay lawsuits that allege failure to warn are far from the first time the drug manufacturer and its former parent company have faced legal troubles. In fact, Indivior and Reckitt Benckiser have settled criminal and civil lawsuits amounting to over $2 billion in recent years.
The history of lawsuits against the makers of Suboxone is lengthy. Below are details of the criminal and civil lawsuits and settlements with Indivior, Reckitt Benckiser, and others involved with everything from the creation to sales of Suboxone.
2019: In April 2019, Indivior pleaded guilty to false marketing of Suboxone after being indicted by a Federal Grand Jury. The Department of Justice (DOJ) had filed criminal and civil liability cases against the company, and a $1.4 billion resolution was reached. Ultimately, the defendants had to forfeit $647 million of proceeds, agreed to a $700 million civil settlement with the federal government, and reached $60 million in administrative settlements with the Federal Trade Commission (FTC).
The DOJ case claimed Indivior and Reckitt Benckiser violated antitrust laws because they misrepresented the film version of Suboxone when they marketed it to medical professionals and organizations, Medicaid, and others in the industry. It was promoted as a product that is less abusable and safer around children and communities than similar drugs, yet there was no evidence to their claim. The result of their deception ultimately prevented consumers from buying generic versions of the drug, causing them to overpay for treatment.
2020: In July 2020, Indivior reached a resolution with the U.S. Attorney’s Office for the Western District of Virginia for how they marketed Suboxone. Indivior and a subsidiary agreed to pay $600 million to resolve civil and criminal claims relating to improper conduct – specifically, the unlawful sales and promotion of Suboxone.
The Indivior subsidiary admitted to creating false statements around healthcare matters and agreed to pay nearly $300 million. Under the False Claims Act, Indivior agreed to a $300 million settlement.
Indivior also had to enter a Corporate Integrity Agreement (CIA) with the Office of the Inspector General of the U.S. Department of Health and Human Services. They had to implement compliance-related measures, such as additional training, reporting, and monitoring of practices.
2023: In October 2023, an agreement was reached with a class of around 70 Suboxone buyers (clinics, health plans, and wholesalers) that claimed Indivior switched from the tablet form of Suboxone to the film version to extend its monopoly on the product. Indivior agreed to pay $385 million to mark the end of the monopoly lawsuits they’d been facing for years. The class action lawsuit alleged the manufacturer illegally suppressed the competition, namely generic drug companies.
Earlier in 2023, a $30 million antitrust settlement for a class action lawsuit brought by health plans against Indivior was reached. Before that settlement in August, the company agreed to pay $102.5 million to resolve similar lawsuits filed by several states.
Side Effects of Suboxone
In addition to the Suboxone lawsuits that allege Indivior failed to warn of the risk of dental problems like tooth decay, cracked teeth, and cavities, there are several other possible adverse reactions patients may experience.
Common side effects of Suboxone include:
- Painful tongue
- Redness of the mouth
- Irregular heartbeat
- Blurred vision
- Back pain
- Drug withdrawal syndrome
As with any medication, anyone who experiences side effects from Suboxone should consult with their doctor. Many side effects do not pose a serious danger to patients, but some do. Keeping those involved in the treatment of opioid use disorder informed of any symptoms that develop after taking the drug is necessary to protect physical, emotional, and mental health – and ensure the benefits of Suboxone outweigh the risks.
About Opioid Use Disorder
Whether taken legally or illegally, the risk of addiction to opioids is high, especially when not monitored by a doctor. According to the U.S. National Institutes of Health, opioid use disorder affects an estimated two to three million people across the country. While effective in treating pain, opioid use and addiction have caused a nationwide crisis.
In just two decades, more than 800,000 Americans have died from drug overdoses, and in 2021, 80,411 overdose deaths involved opioids. These deaths accounted for 75.4% of all drug overdoses. So many people have died from overdoses that it’s affected life expectancy in the U.S.
Common symptoms of opioid use disorder include:
- Physical dependence* (stopping use causes withdrawal symptoms)
- Increasingly heavy, frequent, risky, or unhealthy use (inability to control use, even if it negatively impacts the user’s health, safety, financial security, or relationships)
- Cravings (physical and emotional cravings)
*While physical dependency is a symptom of OUD, it does not always mean that someone is addicted to opioids. For example, patients with illnesses and conditions that cause significant chronic pain regularly and safely use opioids as prescribed as part of their treatment plan. They may become physically dependent on them as a result, but it doesn’t mean they’re addicted.
In addition, OUD may cause other signs and symptoms over time, such as:
- Weight loss
- Flu-like symptoms
- Lack of hygiene
- Social isolation
- Changes to exercise habits
If you or someone you know is addicted to opioids or another substance, there is help available, even if you’re unsure whether or not it’s an addiction. Call the national helpline at 1-800-662-4357 or find opioid treatment programs near you by entering your address, city, zip code, or a facility’s name.