Suboxone Tooth Decay Lawsuits

Suboxone is prescribed to treat opioid use disorder in conjunction with other treatments. Patients, however, have experienced dental problems during or after taking the drug and they are filing lawsuits against Indivior, the manufacturer. Indivior has profited from the opioid crisis but by doing so it created medical, financial and emotional problems for Suboxone patients.  To date, lawsuits have been filed by patients who took the Suboxone sublingual film version – rather than the original oral tablet-- before Indivior included a warning in January 2022 of Suboxone potential tooth decay. That warning came 20 years after the drug was approved. Indivior’s failure to inform users of the risks associated with using Suboxone sublingual film breaches a duty of care to users, meaning that the drug manufacturer may be liable for the damages that plaintiffs have incurred as a result of their dental injuries caused by Suboxone.
 

Suboxone Dental Disease

The opioid Buprenorphine is the active ingredient in Suboxone. It is acidic and it’s commonly known that acid affects tooth health. The tablet form of Suboxone was approved in 2002 to treat opioid use disorder, acute and chronic pain. As a pill, the drug’s corrosive potential was not an issue because it did not have prolonged contact with the user’s teeth. 

Indivior held exclusive rights to sell the treatment in tablet form until 2009. According to Reuters, a lawsuit filed by health plans and drug wholesalers claimed Indivior switched from the tablet to an oral film version of Suboxone to extend its monopoly, just as generic manufacturers were poised to sell their own lower-cost pills. 
 

Suboxone and FDA Warning

In January 2022, the FDA warned that the dental problems associated with buprenorphine medicines can be serious and have been reported even in patients with no history of dental issues. Although Indivior updated Suboxone prescribing information, as of November 2023, there was still no warning about dental problems in the Suboxone patient medication guide.  (The guide just advises consumers to tell their doctor and see a dentist if they experience problems with their teeth, but dental problems are not listed under possible side effects).

In 2010, Suboxone was approved as a film to be placed inside the cheek or dissolved under the tongue. But a study by JAMA found that this sublingual film form of Suboxone reduces salivary flow and exposes the teeth to an unhealthy level of the acidic Buprenorphine.  This acidic exposure can lead to the erosion of enamel and generally weaken teeth, especially when Suboxone is taken long-term. The sublingual film version of Suboxone has been linked to:

• Severe tooth decay and loss
• Cavities 
• Tooth extractions
• Broken teeth
• Jaw bone injuries
• Other serious dental injuries

 

Suboxone Lawsuits

Suboxone tablets were first made by Reckitt Benckiser and FDA-approved in 2002. The company began working on a sublingual film version of Suboxone in 2007, which was approved by the FDA in August 2010. 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.

Suboxone lawsuits claim that Indivior should have known – and it should have informed patients and the medical community-- that an acidic substance like Buprenorphine has the potential to cause dental problems by eroding enamel and generally weakening teeth, and that the medication would cause more harm the longer it was in contact with a user’s teeth.

January 2023: In a lawsuit filed on her behalf, an Ohio woman claims that the Suboxone manufacturer was aware of serious dental injuries but chose not to include any warning about possible tooth decay on the drug's warning label or in the drug's medication pamphlet given to patients. As well, the lawsuit claims her physician was also not aware of the dangers of Suboxone when it comes to tooth decay and other dental problems. She says that, having conquered her addiction and the tribulations that go along with it, she then had to undergo extensive dental work to repair the damage caused by Indivior's negligence and is seeking compensation for her present and future medical bills along with pain and suffering.

September 2023:   David Sorensen filed a lawsuit in the Northern District of Ohio, alleging the sublingual film form of Suboxone led to permanent tooth decay and he incurred significant expenses in treating with multiple medical providers for dental care. According to court documents, plaintiff’s lawyers will argue that Invidior was fearful their patent on Suboxone tablets was about to expire, so it introduced the sublingual film version which arguably was rushed to market and in doing so, Invidior avoided dealing with generic versions of their medication designed to treat drug addicts during the opioid crisis.

November 2023: Fourteen new Suboxone lawsuits were filed against Indivior in federal courts.

January 12th, 2024:  Lindsay Haddad filed a lawsuit with the U.S. District Court of Western Pennsylvania, alleging extensive tooth decay as a result of using the defective drug. Haddad was prescribed sublingual film version of Suboxone in 2013, when it was not labeled with any warnings concerning potential tooth decay. Haddad argues that Indivior:

• Should be liable for her damages based on the flawed design of sublingual Suboxone,
• Failed to warn her or her providers that using Suboxone could cause irreparable damage to her teeth.
• Failed to rigorously test the sublingual film form of the drug and used a defective design.

There is no class action lawsuit against Indivior for dental problems associated with Suboxone-- yet. However, with increasing public awareness, there may be a class action lawsuit or cases moved to multidistrict litigation (MDL). On January 27, 2024 the Joint Panel on Multidistrict Litigation discussed consolidation of all Suboxone lawsuits filed in Federal Courts throughout the U.S.

This isn’t the first time that Indivior and Reckitt Benckiser have faced Suboxone legal problems. The Department of Justice filed criminal and civil liability cases against Indivior and in April 2019, the company pleaded guilty to false marketing of Suboxone.  A $1.4 billion resolution was reached but the defendants had to forfeit $647 million of proceeds, agreed to a $700 million civil settlement with the federal government, and in May 2021, the Federal Trade Commission reached a $60 million agreement  to resolve false marketing claims. (The FTC sent about 51,875 class-action settlement payments to consumers who allegedly overpaid for Suboxone because of a “deceptive scheme by Reckitt Benckiser Group and Indivior, Inc. to thwart lower-proved generic competition with the branded drug Suboxone.”)
 
To file a Suboxone complaint and qualify for compensation, the following must apply:

• You used Suboxone sublingual films as prescribed to treat your opioid dependence before 2022
• You experienced severe dental issues beyond a normal rate of decay
• You sustained damages as a result of your Suboxone dental injuries

 

SUBOXONE TOOTH DECAY Legal Help

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Last updated on Feb-15-24