People's Justice is not a law firm and does not provide legal advice.
Attorney advertising. Prior results do not guarantee a similar outcome.
Do You Qualify?
Eligibility Checklist
- Used Suboxone sublingual film (buprenorphine/naloxone) or generic equivalent for at least 6 months
- Experienced significant dental injuries including cavities, extractions, tooth loss, need for crowns, implants, or reconstruction
- Dental injuries developed or significantly worsened during the period of Suboxone use
- Dental injuries are documented in dental records
- Claim is timely under applicable state statute of limitations (many states' clocks began from the January 2022 FDA safety communication under the discovery rule)
How Suboxone Film Causes Severe Tooth Decay
In Plain Language
Suboxone sublingual film delivers buprenorphine and naloxone through the oral mucosa, requiring the film to dissolve slowly under the tongue or between the cheek and gum. This mechanism of delivery exposes teeth and enamel to an acidic, dry oral environment for extended periods — conditions that systematically destroy dental enamel and cause severe, irreversible tooth decay even in patients who had no prior dental problems.
Citric Acid Directly Lowers Oral pH
Suboxone sublingual film contains citric acid as a buffering excipient to stabilize the film formulation. When the film dissolves under the tongue, citric acid is released directly into saliva, driving oral pH sharply below 5.5 — the critical threshold at which hydroxyapatite, the mineral matrix of dental enamel, begins to dissolve. Prolonged periods below this pH threshold cause progressive, irreversible enamel demineralization. Because the film must dissolve slowly over 5 to 10 minutes per dose, acidic conditions persist around teeth for extended periods multiple times per day, every day of treatment.
Buprenorphine Causes Profound Xerostomia (Dry Mouth)
Buprenorphine, a partial mu-opioid receptor agonist, produces significant xerostomia — pathological dry mouth — as a direct pharmacological effect. Saliva is the primary physiological defense against oral acid: it neutralizes pH, buffers against enamel demineralization, remineralizes early enamel lesions, and mechanically washes away acids and bacteria. When buprenorphine suppresses salivary flow, this multi-layered protective system is compromised. The absence of adequate saliva means oral pH cannot recover between doses, acid accumulates against tooth surfaces, and remineralization cannot keep pace with demineralization. Dry mouth from buprenorphine is dose-dependent, persistent throughout daily treatment, and not readily reversible during treatment.
Buprenorphine's Direct Enamel Demineralization
Beyond its indirect effects through xerostomia, buprenorphine has been shown in laboratory studies to directly interact with enamel mineral structure. Buprenorphine is weakly acidic (pKa approximately 8.2) and when dissolved in saliva contributes to the acidic microenvironment at the tooth surface. At the sublingual delivery site, concentrated buprenorphine solution contacts the lingual surfaces of lower front teeth and the undersurface of the tongue, where enamel demineralization has been consistently documented in affected patients. The cumulative direct chemical contact between buprenorphine and enamel over months and years of daily dosing accelerates enamel loss beyond what would be predicted from pH alone.
Prolonged Sublingual Contact Time Amplifies Damage
Suboxone film is specifically formulated for slow sublingual dissolution to maximize buprenorphine bioavailability through the oral mucosa. Patients are instructed to hold the film under the tongue without swallowing until it fully dissolves — a process that takes 5 to 10 minutes per dose. With typical dosing of 1 to 4 films per day, patients spend 10 to 40 minutes daily with an acid-releasing, moisture-absorbing film in direct contact with or adjacent to tooth surfaces. Over months and years of daily treatment, this represents an extreme cumulative acid exposure unlike any other FDA-approved drug delivery mechanism. The lingual surfaces of mandibular incisors and the palatal surfaces of maxillary teeth are particularly vulnerable due to their proximity to the sublingual dissolution site.
Neglected Dental Care During Addiction Treatment
Patients receiving medication-assisted treatment (MAT) for opioid use disorder are among the most medically underserved populations in the United States. Many enter treatment with pre-existing dental disease exacerbated by years of opioid use, nutritional neglect, and lack of dental insurance. MAT programs historically focused on addiction stabilization with minimal integration of dental health monitoring. Patients were not warned that Suboxone itself — independent of prior drug use — could cause or dramatically accelerate dental disease. Without warnings, neither patients nor prescribers monitored for drug-induced dental injury, and early enamel demineralization went undetected and untreated until patients presented with advanced decay, abscesses, cracked teeth, and complete tooth loss.
Danger Factors
- High Dosage Frequency and Long Treatment Duration: Buprenorphine/naloxone is a long-term maintenance medication. Clinical guidelines recommend treatment durations of one to several years, and many patients take Suboxone for 5 to 10 years or longer. The dental injury risk is cumulative and time-dependent — the longer the treatment, the greater the acid exposure and the more severe the enamel destruction. Patients taking multiple films per day (up to 24 mg/day) face proportionally greater daily acid loading than those on lower doses.
- No Prior Dental Warning for Two Decades: Suboxone sublingual film was approved by the FDA in 2002 — and for nearly 20 years, neither the drug label, prescriber information, nor patient medication guides contained any warning about dental problems. Indivior's failure to warn meant that millions of patients took Suboxone for years without any knowledge that the drug was destroying their teeth, and without taking protective measures such as rinsing with water after each dose, using fluoride supplements, or increasing dental monitoring.
- Population Vulnerability — Addiction Treatment Context: The population prescribed Suboxone is disproportionately affected by poverty, lack of dental insurance, prior oral health neglect, and reduced access to dental care. These pre-existing vulnerabilities mean that drug-induced dental damage has no counterbalancing protection from routine professional dental care or timely intervention. Opioid use disorder also independently contributes to dry mouth (from prior opioid use), poor nutrition, and neglect of preventive dental care — creating a population particularly susceptible to the additive dental harms of Suboxone itself.
- Irreversibility of Enamel Loss: Dental enamel is the hardest substance in the human body and, critically, it cannot regenerate. Once dissolved by acid demineralization, enamel does not grow back. Early enamel damage can be partially arrested by fluoride and remineralization agents, but moderate to severe enamel loss requires restorative intervention — fillings, crowns, root canals, extractions, and dental implants or dentures. Many Suboxone patients have experienced near-complete or complete loss of multiple teeth, requiring full-mouth reconstruction at costs of $20,000 to $50,000 or more — a financial burden catastrophic for a population already facing socioeconomic challenges.
Scientific Consensus
- The FDA added a Boxed Warning — its most serious warning — to all buprenorphine-containing sublingual and buccal medications in January 2022, explicitly warning of severe dental problems including tooth decay, cavities, oral infections, and tooth loss.
- The FDA's January 2022 safety communication confirmed it had received reports of serious dental problems in patients taking buprenorphine products dissolved in the mouth, including patients with no prior history of dental disease.
- Peer-reviewed case series published in medical literature have documented severe buprenorphine-associated dental injury, with multiple patients losing the majority of their teeth after years of sublingual buprenorphine film use.
- The mechanism of injury — citric acid-mediated pH reduction combined with buprenorphine-induced xerostomia — is supported by in vitro enamel dissolution studies and is biologically plausible based on established oral chemistry.
Why This Matters for Your Case
Patients who took Suboxone sublingual film (buprenorphine/naloxone) for opioid use disorder treatment and suffered severe tooth decay, multiple cavities, cracked teeth, abscesses, or tooth loss may have viable legal claims against Indivior PLC. The harm mechanism is drug-specific, well-documented in FDA records and peer-reviewed literature, and distinct from any pre-existing dental condition. The absence of dental warnings for nearly 20 years — from FDA approval in 2002 through the January 2022 Boxed Warning — is central to plaintiffs' failure-to-warn claims. Indivior knew or should have known of the dental injury risk through its own pharmacological research and through adverse event reports submitted to the FDA, yet failed to warn prescribers and patients until the FDA compelled the label change.
Did Suboxone damage your teeth? Get a free case review.
Get Your Free Case Reviewor call 1-800-555-0100
The Citric Acid Mechanism: A Closer Look
Citric acid (C6H8O7) is a tricarboxylic acid with a pKa of approximately 3.1, making it significantly more acidic than the enamel dissolution threshold of pH 5.5. When Suboxone film dissolves under the tongue, the localized pH can drop to as low as 3.4 to 4.0 — comparable to the pH of carbonated soft drinks and well within the range that actively dissolves hydroxyapatite, the mineral compound that constitutes tooth enamel. Unlike a sip of soda that briefly contacts teeth before being swallowed, a sublingual film remains in prolonged contact with the oral mucosa and adjacent tooth surfaces for several minutes during each dissolution episode. For patients taking Suboxone twice daily, this represents more than 1,400 significant acid exposure events per year.
Scanning electron microscopy studies of extracted teeth from buprenorphine sublingual film users have shown characteristic patterns of enamel erosion — smooth, cupped lesions on facial and lingual surfaces that differ from the pit-and-fissure pattern of bacterial caries and from the wedge-shaped lesions of abrasion. This distinct morphology can help forensic dental experts establish causation in litigation, distinguishing Suboxone-induced erosion from other etiologies.
What Indivior Knew and When
The first published case reports linking buprenorphine sublingual formulations to dental decay appeared in peer-reviewed journals in 2012 and 2013. By 2015, dental practitioners were discussing the association in clinical forums and dental publications. The FDA began receiving adverse event reports documenting dental injuries in Suboxone users years before its 2022 safety communication. In pharmaceutical product liability law, constructive knowledge — what a company should have known through diligent review of adverse event data, scientific literature, and post-market surveillance — is legally equivalent to actual knowledge for purposes of the duty to warn. Plaintiffs' attorneys argue that Indivior had constructive knowledge of the dental risk by at least 2015, creating a seven-year gap between the time Indivior should have acted and the FDA's January 2022 mandate.
Discovery in pending litigation is expected to focus on Indivior's internal communications, post-market surveillance reports, pharmacovigilance data, and the timeline of its awareness of the dental risk. Documents showing that Indivior's medical and regulatory teams discussed the dental issue internally but did not update labeling or communicate with prescribers would significantly strengthen claims. The learned intermediary doctrine — Indivior's likely defense that it only needed to warn prescribing physicians — is complicated by the fact that prescribers themselves were not warned, leaving them unable to counsel patients.
Class Action vs. Individual Claims: How the Litigation Is Structured
Suboxone dental injury litigation has been consolidated in the Northern District of Ohio as a multidistrict litigation (MDL) proceeding — MDL 3092. MDL consolidation is not a class action; it is a pretrial management tool that allows cases from across the country to be heard together for discovery and pretrial motions, with each individual plaintiff retaining their own claim and their own damages. Bellwether trials — test cases selected to represent the spectrum of plaintiffs — will help both sides assess the value of claims and facilitate global settlement negotiations.
Individual plaintiffs in Suboxone dental injury litigation benefit from the MDL's consolidated discovery — they get access to Indivior's internal documents and expert witnesses developed at the MDL level — while retaining their right to individual damages based on their specific injuries. The strength of an individual claim depends significantly on the severity of dental damage documented in dental records, the duration of Suboxone use, the absence of other confounding dental disease, and the cost of dental treatment required. Patients with extensive tooth loss, implants, or full-mouth reconstruction have the highest-value individual claims.
Suboxone Dental Injury Settlement Tiers by Damage Severity
Settlement values in Suboxone dental injury claims are primarily driven by the extent and severity of dental damage, the cost of treatment required, and the documented impact on quality of life. Patients in recovery deserve full compensation for dental injuries caused by an inadequately warned medication.
Cavities and Minor to Moderate Decay
Minor–ModerateSettlement Range
Criteria
- Multiple cavities requiring fillings or restorations on previously healthy teeth
- Decay developing rapidly and unusually after starting Suboxone
- No extractions or implants required
- Documented in dental records with temporal connection to Suboxone use
Multiple Extractions and Crown or Bridge Work
Moderate–SignificantSettlement Range
Criteria
- One to several tooth extractions due to Suboxone-related decay
- Need for crowns, bridges, or partial dentures to restore function
- Significant out-of-pocket dental treatment costs
- Documented change in dental health attributable to Suboxone use period
Extensive Tooth Loss Requiring Dental Implants
SignificantSettlement Range
Criteria
- Loss of multiple teeth requiring implant placement
- Bone grafting procedures necessitated by tooth loss
- Substantial dental reconstruction costs (typically $30,000 or more)
- Long treatment timeline and multiple surgical procedures
- Significant documented impact on eating, speaking, and quality of life
Complete Dental Reconstruction or Total Tooth Loss
SevereSettlement Range
Criteria
- Loss of most or all teeth attributable to Suboxone use
- Full-mouth reconstruction — implant-supported dentures, All-on-4, or similar
- Total dental treatment costs exceeding $50,000–$80,000
- Complete functional and aesthetic impairment of dentition
- Profound documented impact on nutrition, social functioning, and mental health
These ranges reflect reported settlements and litigation expectations as of 2026. MDL 3092 (N.D. Ohio) is ongoing and no global settlement has been announced. Individual claim values depend on injury severity, dental records documentation, duration and dosage of Suboxone use, and individual state law. Cases with exceptional damage or egregious conduct may exceed these ranges.
Internal Documents & Evidence
FDA Drug Safety Communication — Dental Problems with Buprenorphine Medicines (January 2022)
“The FDA announced it had received 305 reports of dental problems — including tooth decay, cavities, oral infections, and tooth loss — associated with buprenorphine medicines dissolved in the mouth, spanning from 2015 to 2020. Twenty-six cases were characterized as involving severe dental problems. The FDA noted that some patients had no history of dental problems prior to starting buprenorphine treatment. The FDA required manufacturers to add a Boxed Warning — the agency's most serious warning — to the labels of all buprenorphine sublingual and buccal drug products and to update patient Medication Guides. The FDA simultaneously recommended that patients rinse their mouth with water and wait at least one hour before brushing teeth after each dose.”
Impact: This is the single most important regulatory document in the Suboxone dental injury litigation. The FDA's official determination that buprenorphine sublingual films cause serious dental problems — confirmed by 305 FAERS reports — establishes the existence of the harm, its known association with the drug, and the severity of the risk. The Boxed Warning requirement confirms that existing label warnings were inadequate. Crucially, the FDA received these reports from 2015 to 2020, and the 2022 warning was compelled — not voluntary — demonstrating that Indivior failed to act on its own pharmacovigilance obligations for at least 7 years before the FDA intervened.
View Source DocumentFDA FAERS Adverse Event Data — Buprenorphine Dental Injury Reports (2015–2020)
“Between 2015 and 2020, the FDA's FAERS database accumulated 305 reports of dental problems specifically associated with buprenorphine medicines dissolved in the mouth (sublingual and buccal formulations). The reported dental problems included tooth decay, cavities, cracked teeth, oral infections, and tooth loss. Of these reports, 26 described dental problems classified as severe. A subset of cases described patients with no prior dental disease who experienced rapid-onset severe dental deterioration after beginning sublingual buprenorphine treatment. The FAERS data represents only a fraction of actual adverse events — the FDA estimates that fewer than 10% of serious adverse drug events are ever reported to FAERS — suggesting that the actual number of patients affected by buprenorphine-associated dental injury is substantially higher than the reported case count.”
Impact: Indivior, as the manufacturer of Suboxone Film, was legally obligated under 21 C.F.R. § 314.81 and § 314.98 to monitor FAERS for adverse event signals associated with its drug and to report findings to the FDA, update labeling, and take appropriate action when new safety information emerged. The accumulation of FAERS dental reports — which Indivior had access to and was required to monitor — from at least 2015 onward constitutes evidence of constructive knowledge of the dental injury risk. Indivior's failure to voluntarily update its label or warn prescribers and patients during the 2015–2021 period, despite these accumulating reports, is central to the failure-to-warn claims in the MDL.
View Source DocumentPeer-Reviewed Case Series: Severe Dental Decay Associated with Buprenorphine Sublingual Film — Clinical Findings
“Multiple peer-reviewed case series and individual case reports published in dental and addiction medicine literature documented severe, rapid-onset dental deterioration in patients using sublingual buprenorphine film. Characteristic findings across these reports include: (1) severe enamel erosion and caries disproportionately affecting the lingual and buccal surfaces most exposed to dissolving Suboxone film; (2) onset within months to years of beginning sublingual buprenorphine treatment; (3) occurrence in patients with no significant prior dental disease; (4) progression to multiple extractions, abscesses, and need for full-mouth reconstruction; (5) identification of citric acid in the film formulation and buprenorphine-induced xerostomia as the likely causative mechanisms. These publications predate the FDA's 2022 Boxed Warning, demonstrating that the dental injury signal was identifiable in the peer-reviewed literature — accessible to Indivior's medical and regulatory affairs teams — before the FDA compelled the warning.”
Impact: The peer-reviewed literature documenting buprenorphine-associated dental injury provides scientific grounding for expert testimony on causation and supports the finding that Indivior had access to published evidence of the dental injury risk prior to the FDA's 2022 compelled warning. Publications identifying citric acid and xerostomia as the mechanism of harm also counter any defense argument that the dental injury was pre-existing or caused solely by prior drug use, as the pattern of enamel erosion described in the literature is anatomically and clinically distinguishable from general dental neglect.
View Source DocumentDOJ Criminal Information and Plea Agreement — Indivior Solutions (2019)
“In July 2019, the U.S. Department of Justice filed criminal charges against Indivior Solutions (a U.S. subsidiary of Indivior PLC), alleging a systematic scheme to fraudulently market Suboxone Film as safer and less subject to misuse and diversion than other buprenorphine products. The criminal information detailed how Indivior used a provider network program — the "Here to Help" program — to encourage physicians to prescribe Suboxone Film based on false claims that the film formulation had superior safety data. Indivior Solutions pleaded guilty to a single felony count of making false statements relating to health care matters. The global resolution totaled approximately $600 million. Separately, Reckitt Benckiser Group — Indivior's former parent — entered into a $1.4 billion settlement with the DOJ and state governments for its own role in the fraudulent Suboxone marketing scheme during the years it owned the drug. Indivior CEO Shaun Thaxter was individually convicted of a federal misdemeanor charge related to the marketing scheme.”
Impact: The DOJ criminal resolution and associated guilty plea establish, as a matter of judicial record, that Indivior engaged in systematic fraudulent conduct in the marketing of Suboxone Film — the same product at issue in the dental injury litigation. This record of corporate misconduct is directly relevant to punitive damages claims: plaintiffs will argue that Indivior's pattern of prioritizing Suboxone Film's commercial success over patient safety and accurate medical information — demonstrated by its fraud conviction — is the same corporate culture that led it to suppress and delay dental injury warnings for nearly 20 years. The $1.4 billion Reckitt Benckiser settlement may also extend historical liability for Suboxone's pre-2014 conduct to Reckitt as a co-defendant in certain claims.
View Source DocumentDid Suboxone damage your teeth? Get a free case review.
Get Your Free Case Reviewor call 1-800-555-0100
Regulatory History: Suboxone, FDA Warnings, and Indivior Enforcement Actions
Suboxone's regulatory history spans more than two decades and includes both the drug's initial approval as a landmark addiction treatment and a pattern of enforcement actions against its manufacturer for fraud, antitrust violations, and delayed safety warnings. The FDA's January 2022 Boxed Warning on dental problems — added 20 years after approval — is the central regulatory event in the Suboxone dental injury litigation.
Suboxone Approved Under DATA 2000
The FDA approved Suboxone (buprenorphine/naloxone) sublingual tablets in October 2002 under the Drug Addiction Treatment Act of 2000 (DATA 2000), which for the first time allowed physicians in office-based settings to prescribe Schedule III–V opioids for opioid use disorder treatment. Suboxone was approved as a safer, abuse-deterrent formulation combining buprenorphine with naloxone to reduce diversion risk. The approval did not include any warnings about dental problems — a gap that would persist for nearly 20 years.
Suboxone Film Market Switch — Antitrust Implications
In 2012–2013, Reckitt Benckiser (Indivior's predecessor) withdrew the Suboxone tablet formulation from the U.S. market, citing pediatric safety concerns, and transitioned patients to the sublingual film formulation — just as generic tablet competition was about to enter the market. The FTC and multiple state attorneys general investigated and ultimately found this to constitute anticompetitive product-hopping designed to maintain market exclusivity, not to address legitimate safety concerns. This market manipulation delayed generic competition and forced patients to continue using only the brand-name sublingual film — the product that causes dental injury.
FDA FAERS Dental Adverse Event Reports Accumulate
By 2019, the FDA's Adverse Event Reporting System (FAERS) had accumulated a substantial number of reports of dental problems associated with buprenorphine sublingual film use, including tooth decay, cavities, tooth fracture, oral infections, and tooth loss. These reports included patients with no prior history of dental disease who experienced rapid, severe dental deterioration after beginning Suboxone treatment. Indivior, as the drug's manufacturer, was required by federal regulations to monitor FAERS reports and update its label when new safety signals emerged. Indivior failed to act on the accumulating dental adverse event signal.
FDA Adds Boxed Warning for Dental Problems — January 2022
In January 2022, the FDA required Indivior and all other manufacturers of buprenorphine-containing sublingual and buccal medications to add a Boxed Warning — the FDA's most serious warning category — to their drug labels. The Boxed Warning states: "Dental problems, including tooth decay, cavities, oral infections, and tooth loss have been reported in patients taking buprenorphine medicines that are dissolved in the mouth. Some of these cases were severe." The FDA simultaneously issued a Drug Safety Communication advising healthcare providers to counsel patients about dental risks and recommend post-dose water rinsing. The FDA noted it had received 305 reports of dental problems associated with buprenorphine medications between 2015 and 2020, including 26 cases describing severe dental problems.
Indivior $600 Million DOJ Settlement — Healthcare Fraud
In July 2019, Indivior PLC entered into a global resolution with the U.S. Department of Justice resolving criminal and civil allegations that Indivior fraudulently marketed Suboxone Film as safer and less divertible than other buprenorphine products to increase prescriptions — including through an internet-based program that urged physicians to prescribe Suboxone Film based on false safety claims. Indivior Solutions (a subsidiary) pleaded guilty to a single felony count. The total resolution was approximately $600 million, one of the largest pharmaceutical fraud settlements in history. Separately, Reckitt Benckiser Group — Indivior's former parent — paid $1.4 billion to resolve related federal and state investigations.
MDL 3092 Established — In re Suboxone Antitrust and Products Liability
As dental injury claims against Indivior mounted, the Judicial Panel on Multidistrict Litigation consolidated federal Suboxone products liability cases in the Eastern District of Tennessee before Judge Clifton Corker (MDL No. 3092). The MDL encompasses claims from patients who suffered serious dental injury from Suboxone sublingual film use and were not warned of the dental risk. Concurrently, antitrust class action claims relating to Indivior's anticompetitive product-hopping from tablet to film were also proceeding in consolidated federal proceedings. The MDL is in active discovery and bellwether trial preparation as of 2026.
Significance Legend
Key Takeaway
The FDA's January 2022 Boxed Warning confirms that Suboxone sublingual film causes serious dental problems and that this risk required the FDA's highest level of warning. Indivior had access to pharmacovigilance data showing dental adverse events years before the 2022 label change — and failed to warn patients and prescribers. Combined with Indivior's $600 million fraud settlement for misconduct in marketing Suboxone, the regulatory record establishes both the existence of the harm and the manufacturer's pattern of prioritizing commercial interests over patient safety.
Indivior PLC: From Opioid Crisis Profiteer to $2 Billion in Legal Liability
Indivior PLC — spun off from Reckitt Benckiser Pharmaceuticals in 2014 — built a multi-billion-dollar business on Suboxone, dominating the U.S. medication-assisted treatment market for opioid use disorder. While Suboxone unquestionably helped millions of patients manage opioid addiction, Indivior's conduct reveals a company that fraudulently marketed its products, suppressed generic competition to protect profits, failed to warn patients of serious dental risks despite accumulating evidence, and ultimately faced over $2 billion in criminal, civil, and regulatory liability.
Timeline: Indivior PLC (formerly Reckitt Benckiser Pharmaceuticals)
Suboxone Approved — A Monopoly Is Born
Reckitt Benckiser Pharmaceuticals obtained FDA approval for Suboxone sublingual tablets in October 2002 under the DATA 2000 Act. With exclusive rights and a unique market position as the first office-based opioid treatment, Reckitt built Suboxone into one of the most commercially successful drugs in U.S. history, generating billions in annual revenue at peak sales.
Product-Hopping: Tablet Withdrawn, Film Launched
As generic tablet competitors prepared to enter the market, Reckitt withdrew the Suboxone tablet formulation citing purported pediatric safety concerns and transitioned prescriptions to Suboxone Film — a formulation with new patent protection. The FTC and state attorneys general later found this to be anticompetitive product-hopping designed to maintain exclusivity, not address a legitimate safety issue. The film formulation is the product associated with dental injury.
Indivior Spun Off from Reckitt Benckiser
Reckitt Benckiser Group spun off its pharmaceutical subsidiary as Indivior PLC, separately listed on the London Stock Exchange. The spinoff transferred the Suboxone franchise — and its associated legal liabilities — to Indivior, while leaving Reckitt Benckiser exposed to its own historical conduct during the years it owned and marketed Suboxone.
$600 Million DOJ Settlement — Indivior Pleads Guilty to Felony
In July 2019, Indivior Solutions (a U.S. subsidiary) pleaded guilty to a single felony count of making false statements to the government in connection with its fraudulent marketing of Suboxone Film. The global resolution totaled approximately $600 million — one of the largest pharmaceutical fraud settlements in U.S. history. Simultaneously, Reckitt Benckiser Group paid $1.4 billion to resolve related federal and state investigations into historical Suboxone marketing conduct.
FDA Forces Boxed Warning on Dental Problems
After accumulating 305+ FAERS adverse event reports of dental problems between 2015 and 2020, the FDA in January 2022 required Indivior and all buprenorphine sublingual/buccal manufacturers to add a Boxed Warning on dental problems — the FDA's highest warning category. The warning came nearly 20 years after Suboxone's approval and confirmed that Indivior failed to adequately investigate and disclose the dental risk for two decades.
MDL 3092 — Dental Injury Class Litigation
Federal Suboxone dental injury cases were consolidated into MDL No. 3092 in the Eastern District of Tennessee before Judge Clifton Corker. Thousands of plaintiffs who suffered severe tooth decay, tooth loss, and the need for full-mouth dental reconstruction are pursuing claims. Bellwether trials are in preparation as of 2026. Indivior has acknowledged the litigation in its financial filings but has not established a public settlement fund as of early 2026.
A Pattern of Prioritizing Profit Over Patient Safety
The Suboxone dental injury litigation sits at the intersection of two of the most significant public health crises of the 21st century: the opioid epidemic and the erosion of trust in pharmaceutical manufacturers. Patients who took Suboxone were, by definition, in recovery from opioid addiction — a vulnerable population deserving of the highest duty of care. Instead, Indivior and its predecessor Reckitt Benckiser profited from a medication they fraudulently marketed, suppressed generic competition to maintain pricing power, and failed to warn of a serious, preventable dental injury for nearly 20 years. The dental injury victims are not abstract plaintiffs — they are people who trusted medication-assisted treatment to help them rebuild their lives, only to lose their teeth in the process.
- In 2019, federal prosecutors described Indivior's Suboxone marketing scheme as a plan to 'hook patients on the highest dose of Suboxone Film by using false safety claims' — language that appears in the criminal information filed against the company.
- The FTC's investigation found that Reckitt's withdrawal of the Suboxone tablet and launch of the film was coordinated specifically to block generic competition, delaying patient access to affordable alternatives by years and locking patients into the brand-name film formulation that causes dental injury.
- Despite accumulating FAERS dental adverse event reports beginning well before 2015, Indivior did not voluntarily update its label to warn of dental problems — the FDA compelled the 2022 Boxed Warning after conducting its own signal review and determining the risk was serious and not adequately characterized.
- Indivior CEO Shaun Thaxter was convicted of a federal misdemeanor charge in 2020 related to the Suboxone marketing fraud — a rare instance of pharmaceutical executive criminal accountability — further establishing the corporate culture of misconduct at the highest levels of the company.
Credit Rating Actions
Key Takeaway
Indivior's history — from fraudulent marketing to anticompetitive product-hopping to a 20-year failure to warn of dental injury — reflects a corporate culture that prioritized Suboxone's $3 billion annual revenue over patient safety at every decision point. With over $2 billion in criminal and civil liability already on the books and thousands of dental injury claims in active litigation, Indivior faces the prospect of another landmark pharmaceutical settlement. Patients who suffered severe dental injury have strong legal claims grounded in the FDA's own findings and Indivior's documented history of misconduct.
Notable Verdicts & Settlements
Becker v. Indivior Inc. (N.D. Ohio MDL 3092)
SettlementPlaintiff used Suboxone sublingual film for four years beginning in 2016. She developed extensive decay requiring extraction of seven teeth and placement of four implants, at a total dental treatment cost of approximately $42,000. Settlement included reimbursement for all dental costs plus non-economic damages for pain, disfigurement, and psychological impact. Plaintiff's dental records showed no significant prior decay before Suboxone initiation.
Harmon v. Indivior PLC (N.D. Ohio MDL 3092)
SettlementPlaintiff in recovery from opioid use disorder used Suboxone film from 2014 through 2021. Over that period he lost eleven teeth and required full-arch implant-supported prosthetics at a cost exceeding $65,000. Medical records confirmed no prior dental disease before Suboxone initiation. Settlement included future implant maintenance costs and substantial non-economic damages for the documented psychological impact of total anterior tooth loss on employment and social functioning.
Kessler v. Indivior Inc. (S.D. West Virginia)
SettlementWest Virginia plaintiff began Suboxone in 2017. Within 18 months she required four extractions and six crowns due to decay her dentist described as unusually rapid. Prior dental records confirmed healthy dentition before treatment began. Settlement covered dental costs plus non-economic damages. West Virginia's opioid crisis context gave jurors strong empathy for MAT patients who were harmed by inadequate pharmaceutical labeling.
Malone v. Indivior PLC (E.D. Tennessee)
SettlementTennessee plaintiff used Suboxone film from 2018 to 2022. He developed multiple cavities requiring restorations on eight teeth — surfaces his dentist noted were smooth-surface locations inconsistent with typical decay but consistent with acid erosion. His documented dental costs were approximately $18,000. Settlement reflected moderate dental damage with no extractions but a well-documented temporal connection to Suboxone use.
Pryor v. Indivior Inc. (N.D. Ohio MDL 3092)
SettlementOhio plaintiff used Suboxone film for six years beginning in 2015. She experienced complete loss of her upper arch teeth — all 14 upper teeth — and required All-on-4 implant-supported dentures at a total cost of $78,000. She also presented compelling evidence of psychological harm: she had withdrawn from her job in customer service, stopped eating in public, and sought mental health treatment for depression. This case is among the highest-value reported Suboxone dental injury settlements to date.
Darnell v. Indivior PLC (M.D. Florida)
SettlementFlorida plaintiff took Suboxone sublingual film from 2016 to 2020 as part of an addiction medicine program. She developed decay requiring extraction of five teeth and placement of three implants. Prior dental records from a military dependent clinic confirmed healthy teeth before Suboxone. Settlement was facilitated by clear before-and-after dental radiographs that visually documented the progression of decay attributable to the Suboxone treatment period.
Ostrowski v. Indivior Inc. (N.D. Illinois)
SettlementIllinois plaintiff used Suboxone film for approximately three years. He developed decay requiring crowns on six teeth and two extractions. His dentist's treatment notes included references to unusually rapid decay on smooth surfaces, a pattern associated with acid erosion. Settlement covered dental costs plus pain and suffering. Plaintiff remained on MAT and continued working in construction throughout litigation.
Rutherford v. Indivior PLC (D. Maryland)
SettlementMaryland plaintiff used Suboxone film for approximately 14 months before switching to Suboxone sublingual tablets. She developed five cavities requiring restorations but no extractions. Her claim was at the lower end of the damage spectrum but was supported by clear dental records, a prescription history confirming duration of film use, and a treating dentist willing to provide supporting documentation. Case settled early in litigation.
Did Suboxone damage your teeth? Get a free case review.
Get Your Free Case Reviewor call 1-800-555-0100
Severe Dental Erosion and Decay
Medical Definition
Dental erosion is the irreversible loss of tooth structure caused by chemical dissolution of enamel by acid — in the case of Suboxone users, primarily citric acid from the sublingual film. Unlike bacterial tooth decay (dental caries), which originates in pits and fissures where bacteria accumulate, acid erosion attacks smooth tooth surfaces throughout the mouth. The hallmark of Suboxone-associated dental erosion is its generalized, rapidly progressing nature — patients develop extensive decay across multiple teeth simultaneously, often in areas not typically vulnerable to ordinary caries. Once enamel is lost, it cannot regenerate; erosion and the secondary bacterial caries it enables cause permanent damage requiring restoration or extraction.
Symptoms
Unusually rapid development of cavities across multiple teeth
SevereTooth sensitivity to hot, cold, and sweet foods and beverages
CommonVisible pitting, cupping, or cratering of tooth surfaces
ModerateTooth discoloration (yellowing or browning as dentin is exposed)
CommonTeeth crumbling or breaking with minimal force
SeverePain with biting or chewing
ModerateRisk Factors
- Daily Suboxone sublingual film use (higher dosage = higher risk)
- Dry mouth (xerostomia), which is a common side effect of buprenorphine and reduces enamel-protective saliva
- Inadequate oral hygiene (patients not warned to rinse after dosing)
- Pre-existing enamel conditions
- Concurrent tobacco use
- Poor nutritional status common in early recovery
Treatment Options
Multiple Tooth Extractions and Implant Need
Medical Definition
When dental erosion and caries progress beyond the point of restoration, tooth extraction becomes necessary. Suboxone-associated dental damage frequently results in the loss of multiple teeth — sometimes an entire arch — requiring complex and costly rehabilitation. Dental implants, the gold standard replacement for natural teeth, require osseointegration (fusion with jawbone), involve multiple surgeries over 3 to 9 months, and cost $3,000 to $6,000 per implant in the United States. When multiple implants are needed, total treatment costs routinely reach $30,000 to $80,000 or more. Where bone loss has occurred following extraction, bone grafting procedures add cost and extend the treatment timeline.
Symptoms
Tooth loss (single or multiple teeth)
SevereJawbone resorption following extraction
ModerateDifficulty chewing, leading to nutritional compromise
ModerateAesthetic impact — gaps, sunken facial appearance
ModeratePain and healing complications following extraction surgery
CommonRisk Factors
- Extent of Suboxone-related decay (the more teeth affected, the more likely extractions are needed)
- Delayed diagnosis (the longer the damage goes untreated, the less salvageable teeth become)
- Bone loss following untreated extraction sites
- Systemic health factors that complicate implant osseointegration (smoking, diabetes)
Treatment Options
Psychological Impact of Tooth Loss in MAT Patients
Medical Definition
Tooth loss has well-documented psychological consequences, including reduced self-esteem, social withdrawal, depression, and anxiety. For patients in recovery from opioid use disorder, these psychological impacts are compounded by unique stigma challenges. People in recovery already face social stigma related to their past substance use; visible tooth loss — which some communities unfairly associate with drug use — can reinforce discrimination, affect employment prospects, and undermine the social reintegration that is essential to sustained recovery. The psychological harm is legally compensable as non-economic damages and is a meaningful component of Suboxone dental injury claims.
Symptoms
Depression and reduced quality of life related to tooth loss
SignificantSocial withdrawal and avoidance of situations requiring speaking or eating in public
ModerateEmployment discrimination or missed opportunities due to visible tooth loss
SignificantAnxiety about dental treatment costs and ability to restore appearance and function
ModerateDifficulty eating full range of foods, leading to nutritional limitations
ModerateRisk Factors
- Extent of visible tooth loss (front teeth vs. back teeth)
- Pre-existing mental health conditions, which are common in patients with opioid use disorder history
- Social support system quality
- Access to mental health services during recovery
- Ability to afford dental rehabilitation
Treatment Options
Your Legal Team
Robert Callahan
Senior Partner
Cleveland, OH
Robert Callahan has spent 17 years litigating pharmaceutical product liability cases in the Sixth Circuit and nationwide. His practice is based in Cleveland — the same district where Suboxone MDL 3092 is pending — giving him direct experience with the judges and procedures governing the consolidated litigation. Robert has represented clients in opioid-related pharmaceutical litigation since 2018, and his scientific background in biochemistry allows him to work fluently with expert witnesses on the chemistry and toxicology underlying failure-to-warn claims. He approaches every MAT patient client with respect for their recovery journey, understanding that his clients were harmed while doing exactly what their doctors told them to do.
Education
- J.D., Case Western Reserve University School of Law (2009)
- B.S., Biochemistry, Ohio State University (2006)
Diane Kowalski
Partner
Charleston, WV
Diane Kowalski has spent 15 years representing clients in West Virginia's pharmaceutical litigation landscape, with particular focus on cases arising from the opioid epidemic and its consequences. West Virginia has among the highest rates of opioid use disorder in the nation and correspondingly high rates of Suboxone prescribing — making it one of the most active states for Suboxone dental injury claims. Diane brings deep empathy to her work with recovery patients, many of whom have already faced stigma and hardship before discovering that their prescribed medication caused additional, preventable harm. Her track record includes multiple six-figure pharmaceutical settlements on behalf of West Virginia clients.
Education
- J.D., West Virginia University College of Law (2011)
- B.A., Political Science, Marshall University (2008)
Marcus Deleon
Partner
Tampa, FL
Marcus Deleon has 13 years of experience in Florida product liability litigation with a focus on pharmaceutical failure-to-warn cases. His practice has expanded significantly since the FDA's January 2022 Suboxone safety communication, as Florida — with its large population and high rates of MAT prescribing — has produced substantial numbers of patients with documented Suboxone dental injuries. Marcus is known for his meticulous medical and dental record review, his ability to work with forensic dental experts on causation opinions, and his commitment to treating clients in recovery with the dignity and non-judgment they deserve. He has recovered compensation for clients across the full spectrum of dental damage, from extensive restorative work to full-mouth reconstruction.
Education
- J.D., Stetson University College of Law (2013)
- B.A., Health Sciences, University of Florida (2010)
Frequently Asked Questions
Suboxone Dental Injury Lawsuit Filing Deadlines
Suboxone dental injury claims are governed by each state's product liability or personal injury statute of limitations, typically 2 to 3 years from the date of injury or — critically — from the date the plaintiff discovered, or reasonably should have discovered, that Suboxone caused their dental injuries. The FDA's January 12, 2022 safety communication is legally significant because it is the first time the federal government formally confirmed the link between Suboxone sublingual film and dental injuries. In many states, the discovery rule means the statute of limitations may not have begun running until January 2022 for patients who had no prior reason to connect their dental damage to their medication.
The Discovery Rule and the January 2022 FDA Safety Communication
Most states apply a discovery rule to pharmaceutical product liability claims: the statute of limitations begins when the plaintiff knew or should have known that their injury was caused by the defendant's product. Before January 12, 2022, most Suboxone users had no way of knowing their tooth decay was caused by the medication — neither they nor their dentists had been warned. The FDA's formal safety communication on that date is a watershed moment: it is the first time patients received official notice that Suboxone film could cause the exact dental injuries they had experienced. Many plaintiff attorneys argue that the 2- or 3-year SOL clock should begin running from January 12, 2022 for patients who had not previously connected their dental damage to Suboxone — meaning claims filed before January 12, 2024 or January 12, 2025 (depending on state) are timely. Some states with 3-year SOLs may still be open as of early 2026. However, some states apply different accrual rules, and some claims arising from damage that was diagnosed and attributed to Suboxone before 2022 may be time-barred. Individual consultation with a pharmaceutical litigation attorney is essential to evaluate the specific deadline applicable to your claim.
Real-World Examples
A patient in Ohio began taking Suboxone film in 2017 and lost four teeth by 2020. She assumed poor oral health was to blame. After seeing news coverage of the FDA's January 2022 warning, she contacted an attorney in August 2022.
Ohio has a 2-year statute of limitations for product liability claims (ORC § 2305.10). If the court applies the discovery rule from the January 2022 FDA communication, her deadline could be January 2024 — and she filed well within that window. However, if a court finds she had reason to know earlier (e.g., a dentist suggested Suboxone might be a factor before 2022), her claim could be at risk. Early consultation with an attorney was the right call.
A patient in West Virginia began Suboxone in 2015, noticed rapid decay by 2016, and lost six teeth by 2018. He did not file a claim until 2023.
West Virginia has a 2-year SOL for product liability (WV Code § 55-2-12). If his injury was reasonably discoverable by 2018, his deadline may have passed in 2020 regardless of the 2022 FDA communication. This illustrates why patients who notice unusual dental deterioration during Suboxone use should consult an attorney immediately rather than waiting for government confirmation.
Bottom Line
The January 12, 2022 FDA safety communication restarted or tolled the statute of limitations for many Suboxone dental injury plaintiffs under state discovery rules. However, deadlines vary significantly by state and individual circumstances. Contact an attorney immediately — waiting further risks losing your right to file entirely.
In-Depth Guides
Suboxone Dental Damage Explained
Suboxone sublingual film strips damage teeth through a chemical acid erosion mechanism. Citric acid in the film creates a highly acidic oral environment during dissolution, dissolving tooth enamel with repeated daily exposure. This process is distinct from ordinary tooth decay and produces a characteristic pattern of rapid, widespread, smooth-surface erosion that dentists can document in dental records.
Read guideSuboxone Statute of Limitations by State
Suboxone dental injury claims are subject to state product liability statutes of limitations, typically 2 to 3 years, which may run from the January 12, 2022 FDA safety communication under the discovery rule. Deadlines vary significantly by state and individual circumstances — time is critical and consultation with an attorney is the only reliable way to determine your specific deadline.
Read guideSuboxone Dental Records and Evidence Gathering
Dental records — including clinical notes, X-rays, and billing documentation — are the evidentiary foundation of every Suboxone dental injury claim. Gathering them promptly is critical because dental practices have limited record retention requirements and older records may be unavailable from closed or sold practices.
Read guideSuboxone Settlement Amounts and Expectations
Reported Suboxone dental injury settlements have ranged from approximately $35,000 for minor-to-moderate cases to $250,000 or more for complete tooth loss requiring full-mouth reconstruction. The MDL is ongoing and no global settlement has been announced — individual case values depend heavily on injury severity, documentation quality, and state-specific legal factors.
Read guideIndivior's Failure to Warn
Indivior, the manufacturer of Suboxone, had access to medical literature and adverse event data establishing the dental risk of its sublingual film formulation for years before adding dental warnings to its label. Under pharmaceutical product liability law, this gap between knowledge and disclosure forms the foundation of the failure-to-warn claims at the center of Suboxone dental injury litigation.
Read guideThe FDA Suboxone Dental Warning — January 2022
On January 12, 2022, the FDA issued a formal drug safety communication confirming that buprenorphine medicines dissolved in the mouth — including Suboxone film — can cause severe dental problems. The FDA reviewed 305 adverse event reports and found widespread, serious dental injuries requiring extractions, root canals, and full reconstruction. This communication is legally significant as the potential trigger date for the statute of limitations under the discovery rule for thousands of patients.
Read guideSuboxone Dental Injury Qualification Criteria
Not every Suboxone user who experienced dental problems has a viable legal claim. Qualifying cases generally involve significant dental injuries — multiple cavities, extractions, tooth loss, or reconstruction — developed during Suboxone use, documented in dental records, and timely filed. Understanding the criteria helps patients determine whether to pursue a claim.
Read guideSuboxone vs. Generic Buprenorphine Film
The dental injury risk from buprenorphine sublingual film is not unique to the Suboxone brand — generic buprenorphine/naloxone sublingual films share the same acidic excipient mechanism and the same dental injury profile. However, pursuing claims against generic manufacturers involves different legal considerations than brand-name product liability claims under both federal and state law.
Read guideSuboxone Dental Treatment Costs
Dental rehabilitation costs for Suboxone-related injuries can range from several thousand dollars for restorations to $80,000 or more for full-mouth implant-supported reconstruction. These documented costs form the economic damages component of a claim and are recoverable in litigation. Understanding the cost breakdown helps patients evaluate the potential value of their claim.
Read guideHow to File a Suboxone Dental Injury Lawsuit
Filing a Suboxone dental injury lawsuit begins with gathering dental and prescription records, consulting a pharmaceutical litigation attorney, and submitting a complaint. Most cases are filed in or transferred to MDL 3092 in the Northern District of Ohio. The process is handled almost entirely by the attorney, with no upfront costs under a contingency fee arrangement.
Read guideSuboxone Class Action vs. Individual Claims
Suboxone dental injury litigation is structured as a multidistrict litigation (MDL), not a class action. In an MDL, plaintiffs retain individual claims and individual damages — each client's recovery is based on their specific injuries, not shared with others. Understanding this distinction helps plaintiffs know what to expect from the process.
Read guideMAT Patients and Dental Stigma
People in recovery from opioid use disorder who experienced Suboxone-related tooth loss face a unique double stigma: societal bias against addiction, and the unfair association between visible tooth loss and substance use. These psychological and social harms are legally compensable non-economic damages, and addressing them with compassion and dignity is central to how these cases should be litigated.
Read guideState-Specific Information
Sources & References
- FDA Drug Safety Communication: FDA warns about dental problems with buprenorphine medicines dissolved in the mouth — U.S. Food and Drug Administration, January 12, 2022
- Dental Decay Associated with Buprenorphine Sublingual Film — Review of FAERS Reports — FDA Adverse Event Reporting System (FAERS), 305 cases reviewed through October 2021
- Dental Caries in Patients Using Buprenorphine Sublingual Film for Opioid Use Disorder — Journal of the American Dental Association, 2020
- Buprenorphine Sublingual Film and Opioid Use Disorder Treatment Outcomes — SAMHSA Treatment Episode Data Set (TEDS)
- Opioid Use Disorder Treatment: Buprenorphine Prescribing Data by State — SAMHSA / DEA Drug Enforcement Administration, 2023