Suboxone Sublingual Film Lawsuit

Lawsuits allege that the manufacturer of Suboxone sublingual film failed to provide satisfactory warnings about the risk of dental problems associated with the drug and that the company put profits ahead of patient safety.

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What is Suboxone?

Suboxone is primarily used to treat opioid addiction and for pain management. It contains a combination of both buprenorphine and naloxone, which helps to both manage withdrawal symptoms and reduce cravings for the drug. In 2002, Suboxone was originally approved to be sold as a tablet intended to be administered under the tongue. Then, in 2010, Suboxone was approved as a film positioned inside the cheek.   

Suboxone is more expensive than another treatment, Methadone, but it was marketed as having fewer side effects. Additionally, Suboxone can be acquired with a prescription instead of needing to visit a Methadone clinic. As a result, millions of Suboxone prescriptions are filled each year. 

Suboxone Use Linked to Dental Issues 

The sublingual film version of Suboxone has been linked to various dental complications, ranging from cavities and tooth decay to severe issues like tooth loss and oral infection. This is because the film exposes teeth and gums to acidic ingredients, which are harmful to dental health. These dental complications were not initially included on the warning label. 

FDA Warnings Regarding Suboxone 

On January 12, 2022, the FDA released a drug safety communication concerning Suboxone sublingual film. 

“The U.S. Food and Drug Administration (FDA) is warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth. The dental problems, including tooth decay, cavities, oral infections, and loss of teeth, can be serious and have been reported even in patients with no history of dental issues.” 

The FDA also reported that since Suboxone’s approval in 2002, 305 cases of dental problems associated with Suboxone medicines dissolved in the mouth were found. Of the 305 reported cases, 131 were classified as “serious dental issues” (meaning two or more teeth were impacted). Twenty-six cases had no history of dental problems before using Suboxone film. Dental problems occurred as soon as 2 weeks after starting Suboxone treatment. The FDA’s reports of dental problems caused by Suboxone use were only from adverse events reported directly to the FDA or those published in medical literature. For this reason, there are likely many more cases of which the FDA is currently unaware. 

The FDA provided an additional warning concerning Suboxone directed to healthcare professionals: 

“FDA is warning that cases of dental adverse events, some severe, have been reported following the use of transmucosal [Suboxone] medicines. Reported events include cavities/tooth decay, including rampant caries; dental abscesses/infection; tooth erosion; fillings falling out; and, in some cases, total tooth loss. Multiple cases were reported in patients with no prior history of dental problems. The most common treatment for the dental adverse events was tooth extraction/removal.” 

Dental Injuries Resulting from Suboxone Use 

Reported injuries linked to Suboxone use include: 

  • Cavities and tooth decay 
  • Cracked teeth or the need for crown or crown replacements 
  • Oral infection 
  • Loss of tooth enamel 
  • Need for root canal treatment 
  • Complete tooth loss 

Suboxone Lawsuits Timeline 

There have been multiple criminal and civil investigations regarding Suboxone and its manufacturers, including: 

July 2019: U.S. Department of Justice Obtains $1.4 Billion Suboxone Settlement
The United States Department of Justice obtained a $1.4 billion settlement from Rickitt Benckiser Group, the parent company of Indivior, the Suboxone manufacturer, in July 2019. The settlement was related to the marketing of Suboxone. The $1.4 billion Suboxone settlement was reported to be the largest opioid-related recovery for the United States at the time.

July 2020: Suboxone Manufacturer Pleads Guilty to Felony Charge & Agrees to Settle Criminal & Civil Investigations
The manufacturer of Suboxone agreed to an additional $600 million settlement with the Department of Justice in July of 2020. The manufacturer also admitted to one-count of felony criminal information charging false statements related to health care matters which came with additional terms.

October 2020: Suboxone Manufacturer Indivior’s Former CEO Sentenced to Prison
The former CEO of the manufacturer of Suboxone was sentenced to 6 months in federal prison with additional fines. He pleaded guilty to a misdemeanor for his role in causing the release of misbranded Suboxone sublingual film into interstate commerce.

November 2020: Suboxone Maker Sentenced to Pay $289 Million in Criminal Penalties
The maker of Suboxone was sentenced to pay $289 million in criminal penalties connected to the previous guilty plea for improperly marketing Suboxone.

April 2021: $300 Million Suboxone Settlement for Improper Marketing of Suboxone
Suboxone manufacturer Indivior agreed to settle claims with all 50 states, the District of Columbia, and Puerto Rico, regarding improper marketing of Suboxone that resulted in improper use of state Medicaid funds for $300 million.

October 2023: $385 Million Suboxone Settlement to Resolve Suboxone Antitrust Multi-District Litigation
The makers of Suboxone stated they had reached a $385 million Suboxone settlement to resolve claims brought in the In re Suboxone Antitrust Litigation multi-district litigation.

February 2024: Establishment of In Re: Suboxone Film Products Liability Litigation 
The United States Judicial Panel on Multidistrict Litigation (JPML) formed In Re: Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation (MDL 3092) in February of 2024. This consolidated all personal injury Suboxone lawsuits concerning dental injuries that had been filed in U.S. federal courts into the Northern District of Ohio. Plaintiffs in the litigation claim that the manufacturer designed Suboxone film to be acidic, which leads to dental erosion and decay when the film is dissolved in the mouth. Plaintiffs also allege that the makers knew, but failed to provide warning, that Suboxone film damages the teeth.  

Get Help from an Experienced Suboxone Lawyer 

If you or a loved one used Suboxone sublingual film and experienced: 

  • Cavities and tooth decay, 
  • Cracked teeth or the need for crown or crown replacements, 
  • Oral infection, 
  • Loss of tooth enamel, 
  • Need for root canal treatment, or 
  • Complete tooth loss 

Contact the Suboxone injury lawyers at Harding Mazzotti, LLP today for a free case evaluation. Click, Chat, or call 1800LAW1010 24/7 for a free consultation. 

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