Suboxone Tooth Decay Lawsuits

As of March 1, 2024, the Suboxone tooth decay MDL contained 51 lawsuits, meaning dozens of additional cases have been filed in the short time since the litigation was consolidated a month prior.

On February 27, United States District Judge Mitchell S. Goldberg gave final approval to a $385 million Suboxone settlement with direct purchasers, ending more than decade-old antitrust litigation that alleged Indivior broke the law when it introduced the dissolvable strip version of the opioid addiction treatment just as the tablet form’s market exclusivity period was about to expire in 2009. 

According to court documents, the settlement covers in particular all individuals or entities in the U.S. and its territories who bought Suboxone tablets directly from Reckitt Benckiser Pharmaceuticals at any time between January 1, 2012 and March 14, 2013. 

“Ultimately, the Settlement provided the certainty of a $385 million immediate recovery without subjecting the [direct purchaser plaintiffs] to the rigors of a difficult trial,” Judge Goldberg wrote in a 33-page memo and opinion. 

With the $385 million Suboxone deal, the last part of the long-running antitrust “product hopping” litigation against Indivior is resolved. The company announced previously a $102 million settlement with several states and a $30 million settlement with insurers over allegations that unlawfully suppressed generic competition for Suboxone.

Suboxone lawyers from four law firms have petitioned a federal judge in Ohio to appoint them to co-lead the multidistrict litigation (MDL) over claims that the opioid addiction treatment can cause serious tooth decay and other dental problems. 

The attorneys filed a 10-page unopposed motion to appoint them as leaders in the Suboxone MDL on February 27, relaying to U.S. District Judge J. Philip Calabrese that the team “brings together attorneys from across the nation with a proven track record of successful MDL leadership” and who have worked together for months on all aspects of the Suboxone lawsuits. The lawyers added in the motion that none of the defendants in the Suboxone MDL oppose their proposal to co-lead the litigation.

On February 2, the United States Judicial Panel on Multidistrict Litigation (JPML) signed a transfer order to centralize 15 Suboxone tooth decay lawsuits pending across five districts, thus establishing new multidistrict litigation (MDL) to streamline the expanding litigation. 

The JPML is the legal body tasked with deciding whether civil lawsuits pending in more than one federal district should be consolidated and transferred before a single court, namely to converse resources, ensure similar case outcomes and conduct the overall litigation more efficiently. In its transfer order, the JPML reasoned that centralizing the Suboxone tooth decay lawsuits, specifically in the Northern District of Ohio before U.S. District Judge J. Philip Calabrese, was warranted given that the suits “share complex factual questions” stemming from the alleged propensity of the Suboxone film to damage teeth and cause other dental problems. 

“The same factual questions regarding general causation, including the mechanism of the alleged injury, are present in all cases,” the seven-member panel wrote. 

In the time since the plaintiffs requested in November 2023 that the JPML consolidate the Suboxone tooth decay lawsuits before one court, the panel was notified of 11 more lawsuits pending in nine districts, the transfer order states. 

The Suboxone tooth decay MDL is formally named In re: Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation.

On January 25, the United States Judicial Panel on Multidistrict Litigation (JPML) convened to discuss whether to consolidate all Suboxone tooth decay lawsuits filed in federal courts nationwide into multidistrict litigation (MDL). 

In particular, the JPML discussed centralizing 15 related Suboxone tooth decay cases, filed in five jurisdictions, in the Northern District of Ohio, the federal court in which 10 of the suits were filed. 

Notably, defendants Indivior and Reckitt Benckiser filed with the JPML motions in which they agreed with consolidating the Suboxone lawsuits before one court, indicating to some legal observers that an MDL was likely.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) announced that it would in fact hear arguments from the lawyers handling Suboxone tooth decay lawsuits on whether to consolidate the cases into multidistrict litigation (MDL) for the purposes of streamlining the litigation, particularly the discovery process and pretrial proceedings.

Attorneys for Suboxone users petitioned the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate related tooth decay lawsuits across the country before one federal court. At this time, legal observers suspected that the United States District Court for the Northern District of Ohio would be the ultimate venue for the potential Suboxone MDL.

On October 23, Suboxone maker Indivior agreed to pay a $385 million settlement to resolve antitrust allegations from drug wholesalers that claimed it illegally suppressed generic competition for the opioid addiction treatment. 

According to Reuters, a trial over the drug wholesalers’ claims against Indivior was slated for October 30 but had been called off as a result of the settlement. The publication reported that the wholesalers represented a class of roughly 70 Suboxone buyers, including other wholesalers and clinics, and alleged Indivior moved to an oral film version of the opioid addiction medication in order to extend its monopoly on the drug as generic makers were primed to begin selling their own Suboxone pills at a lower cost.

Toward the end of August 2023, Indivior announced that it had agreed to pay $30 million to settle a proposed class action lawsuit brought by health plans that alleged the company had illegally squashed generic competition for Suboxone.

A study of reports submitted to the FDA’s Adverse Event Reporting System (FAERS) between 2015 and 2022 uncovered a “significantly disproportionate” number of dental disorders among patients treated with buprenorphine-containing medications, including those issued sublingually, buccally or orally. 

The study, published in August 2023 in the Current Drug Safety journal, concluded that the findings were “consistent with prior data and suggest that regular oral care and proper dental hygiene be emphasized for patients undergoing therapy with orally dissolving buprenorphine.”

On June 2, 2023, Indivior announced that it had agreed to pay $102.5 million to settle a lawsuit in which 41 states and Washington, D.C., alleged the company had illegally suppressed generic competition for the opioid treatment. 

The states charged that Indivior switched from a tablet form to an oral film version of Suboxone as a means to extend its monopoly over the blockbuster medication as generic manufacturers were primed to begin selling their own, lower-cost tablets.

The Journal of the American Medical Association (JAMA) published in December 2022 a peer-reviewed study of tens of thousands of Suboxone patients between 2006 and 2020 that revealed an increased risk of adverse dental outcomes associated with sublingual buprenorphine/naloxone, in comparison to other forms of the medication.

In early January 2022, the Food and Drug Administration issued a Drug Safety Communication in which it warned that serious dental problems, including tooth decay, cavities, oral infections and loss of teeth, had been reported with buprenorphine-containing medicines that are dissolved in the mouth. The FDA noted that dental problems stemming from Suboxone use had been reported even in patients with no history of dental issues. 

The FDA said it would require a new warning about the risk of dental problems to be added to the prescribing information and patient medication guide for all buprenorphine-containing medicines that are dissolved in the mouth. 

Moreover, the FDA said that in the time since it approved buprenorphine, more than 300 cases of dental problems, with more than 130 considered serious, were reported to the agency via its adverse events reporting system.

In May 2021, the Federal Trade Commission (FTC) announced it would send out nearly 52,000 payments, totaling nearly $60 million, to individuals who allegedly overpaid for Suboxone tablets due to Reckitt Benckiser and Indivior having used their market position to “scare consumers away” from generic tablet versions of the medicine.

Per the FTC, the average payment amount was $1,139.

Months after Suboxone maker Indivior was indicted by a federal grand jury, the pharma company’s parent outfit, Reckitt Benckiser Group, agreed to pay the federal government a record $1.4 billion to end multiple criminal and civil investigations into its marketing of the opioid addiction treatment. 

The $1.4 billion marked the largest settlement related to the opioid crisis in U.S. history, authorities said at the time. 

As part of the settlement, Reckitt agreed to a non-prosecution agreement and to forfeit $647 million in proceeds it received from Indivior. It also agreed to abstain from making, marketing or selling Schedule I, II or III controlled substances in the United States for three years.

Further, Reckitt agreed to pay $700 million in civil settlements with the federal government and several states and a $50 million administrative resolution with the Federal Trade Commission.

In April 2019, a federal grand jury in Virginia indicted Indivior, a subsidiary of Reckitt Benckiser Group, over allegations that the company engaged in an illegal nationwide scheme to boost prescriptions of Suboxone film. 

Specifically, the indictment accused Indivior of reaping billions from Suboxone film prescriptions by deceiving healthcare providers and benefit programs into believing the medication was “safer, less divertible, and less abuseable” than other opioid addiction treatments. It was also alleged that Indivior had aimed to increase profits by way of its “Here to Help” program by connecting opioid-addicted patients to doctors the company “knew were prescribing opioids at high rates and in a clinically unwarranted manner.” 

A criminal trial against Indivior was scheduled for May 2020.

On June 14, 2018, the FDA approved the first generic versions of Suboxone sublingual film, which the agency said could expand access to treatment for opioid dependence. 

In its announcement, the FDA said it was “taking new steps to advance the development of improved treatments for opioid use disorder” and making sure that treatments were accessible to those who need them. 

“That includes promoting the development of better drugs, and also facilitating market entry of generic versions of approved drugs to help ensure broader access,” the agency added.

In July 2017, a study published in the Official Journal of the International Society of Pharmacovigilance found that buprenorphine/naloxone—Suboxone—was among 88 drugs that had a “significant positive disproportionality for dental caries,” or the pathological breakdown of teeth. 

In particular, the study confirmed a link between buprenorphine and dry mouth, a potential side effect of Suboxone. Dry mouth, known clinically as xerostomia, can cause elevated oral acidity, which can contribute to demineralization and tooth decay.

Between May and November 2012, a study was conducted of 11 patients with opioid dependence at Boston’s Brigham and Women’s Hospital, a teaching hospital of Harvard Medical School, who reported “worsening dental health” after initiating buprenorphine treatments via sublingual Suboxone tablets. The patients reported “a wide variety of dental problems requiring intervention,” including crown placements, tooth extractions, root canals, cracked teeth and fillings. 

“While dental problems are frequently reported in drug users, we previously described a patient who experienced a significant decline in dental health following initiation of treatment with buprenorphine,” the study’s authors wrote. “To better characterize this phenomena, we sought to describe patients on buprenorphine maintenance treatment reporting worsening dental health after treatment initiation.”

Ultimately, the Harvard Suboxone study found that the treatment’s low pH and the fact that taking buprenorphine/naloxone tablets requires prolonged contact with tooth surfaces—these patients took the medication three times daily, with each tablet taking roughly nine minutes to dissolve completely—could have been the root cause of the dental problems in the 11 subjects. 

The study, which was published in 2013, also noted that the 11 patients had low to moderate salivary buffering capacity. Given that saliva plays a critical role in preventing dental caries, which result from acid activity on tooth structure, low salivary buffering capacity “may be an additional contributor to dental problems in these patients,” the authors stated.

In August 2010, the FDA granted approval to Indivior’s new drug application for the sublingual film form of Suboxone to treat opioid dependence. The sublingual film version of Suboxone, which contains the same active ingredients as the tablet form of the medication, is to be placed under the tongue, close to the base on the left or right side, and kept there until the film is completely dissolved.

On October 20, 2008, Suboxone maker Indivior, a subsidiary of Reckitt Benckiser, submitted to the FDA a New Drug Application for a film version of Suboxone. 

Years later, the federal government would accuse Indivior of discontinuing the tablet form of Suboxone based on “invented” concerns regarding the risk of pediatric exposure to the tablets, when in fact company execs made the switch to film primarily to delay the FDA’s approval of generic tablet versions of the medication.

In 2002, Suboxone (buprenorphine/naloxone) tablets were approved for the treatment of opioid dependence, or opioid use disorder, in the United States by the Food and Drug Administration, an event described as a “regulatory milestone” after 36 years of research and development. 

Buprenorphine was discovered in 1966 by a chemist at a company called Reckitt and Colman amid an effort to develop painkillers. Years later, a federal and private industry partnership led to the creation of buprenorphine-based medications, and the drug went on to revolutionize treatment for opioid use disorder. 

A watershed moment for Suboxone came in 1994 when Reckitt and the United States reached a deal to co-fund the development of the medication for nationwide distribution in the treatment of opioid addiction. Suboxone received from the government “orphan drug” status, and FDA approval of Suboxone effectively gave Reckitt seven years of control over the market for the medication in the U.S., which expired in 2009.