Suboxone Lawsuit Filed Over Tooth Decay, Damage Caused By Opioid Addiction Drug

Lawsuit claims that the manufacturers knew about reports of Suboxone tooth decay long before the FDA required new label warnings in 2022.

Suboxone and Tooth Loss Lawsuit
Irvin Jackson

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The first of what could be many Suboxone tooth decay lawsuits to come was filed this week by an Ohio man, claiming that a version of the opioid addiction treatment designed to dissolve in the mouth causes tooth decay and permanent dental damage, due to its high acidity.

The complaint (PDF) was filed by David Sorensen this week in the U.S. District Court for the Northern District of Ohio, pursuing claims against Indivior, Inc., Aquestive Therapeutics, MonoSol Rx, Inc. and Beckitt Benckiser LLC as defendants.

Suboxone (buprenorphine and naloxone) is a drug first approved in 2002 to treat recovering opioid addicts; helping them avoid withdrawal symptoms while they undergo therapy to help them break their addiction.

In January 2022, the FDA warned there had been more than 300 cases of tooth decay and dental problems linked to Suboxone and buprenorphine drugs, most commonly involving users in their 40s. However, the tooth decay problems have also been seen among those as young as 18 years old, with some of the dental damage from Suboxone reported as soon as two weeks after beginning treatment.

Later that year, due to concerns about Suboxone and tooth decay side effects, the FDA mandated an update to the prescribing information for all buprenorphine products meant to dissolve in the mouth, including Suboxone films and tablets.

Suboxone Lawsuit

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Suboxone Lawsuits Over Tooth Decay and Tooth Loss
Suboxone Lawsuits Over Tooth Decay and Tooth Loss

Suboxone Lawsuit

Were you or a loved one prescribed Suboxone?

Lawsuits are being pursued by users of Suboxone who experienced tooth loss, broken teeth or required dental extractions. Settlement benefits may be available.

Learn More
SEE IF YOU QUALIFY FOR COMPENSATION

Suboxone Tooth Decay and Dental Damage

According to the Suboxone lawsuit, the manufacturer changed the prescribing information to add warnings about the risk of dental problem, but did not add it to the medication guide most commonly seen by patients.

Sorensen indicates he became addicted to opioids after using them for pain management treatment and was subsequently prescribed Suboxone to treat his addiction. As a result of his use of Suboxone, the lawsuit claims Sorensen now suffers from permanent tooth decay and has needed to undergo extensive dental work as a result.

The lawsuit indicates Indivior knew about the Suboxone tooth decay risks long before the FDA warning, but failed to adequately warn physicians or patients. By the end of 2010, the manufacturer had submitted at least 20 reports to the FDA of patients who suffered tooth decay after using Suboxone.

Case reports linking Suboxone tablets to dental health problems began to also be reported in medical literature in 2012. One case study by Harvard researchers identified 11 patients who suffered worsening dental health at Brigham and Women’s Hospital in Boston between just May and November 2012.

Patients reportedly suffered cracked teeth, an increased need for fillings, crown replacements, root canals and tooth extractions. Researchers blamed the decay on prolonged contact with Suboxone, which is acidic in nature and can damage tooth enamel.

As of June 2022, the manufacturers were aware of about 150 reports of Suboxone dental damage, but failed to add additional label warnings until required by the FDA, the lawsuit claims.

Did You Experience Tooth Decay from Suboxone?

If you or a loved one experienced problems with Suboxone tooth decay, share your story with the AboutLawsuits.com community.

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Suboxone Lawsuit Points to Deceptive Marketing Tactics

Originally designed as a dissolving pill, the drug manufacturer allegedly waited until its patent exclusivity expired, allowing generic versions of Suboxone to hit the market, before introducing a dissolving film version in 2009. The lawsuit claims the introduction of Suboxone film, which is placed under the tongue and rapidly introduced in the patient’s blood stream, was actually done to avoid generic competition and extend patent protections, not to benefit patients..

The FDA expressed concerns about the risk of pediatric exposure, however the agency approved the film version of Suboxone in August 2010. This gave the manufacturer another three years of exclusivity until August 2013. Just a month before that patent exclusivity expired, the manufacturer presented another version of the drug.

“Defendants executed a monopolistic strategy known as a product hop from sublingual Suboxone tablets to sublingual Suboxone film for the purpose of foreclosing generic competition,” Sorensen’s lawsuit states. “A product hop involves modest reformulations of a brand-name drug prior to expiration of its market exclusivity for the purpose of stymieing generic competition and preserving monopoly profits.”

But the lawsuit indicates the manufacturers did not stop there.

The states and federal government accused the manufacturer of submitting a fraudulent petition to the FDA in September 2012, which claimed the Suboxone Tablet had to be discontinued due to safety concerns. However, regulators determined that, in actuality, the manufacturer sought to control supply and improperly inflate Suboxone pricing, including what state Medicaid programs paid for it.

In 2019, Reckitt Benckiser Pharmaceuticals reached a $700 million settlement with the federal government and states over Suboxone Medicaid fraud allegations. Indivior spun off from the company shortly afterwards and reached a $600 million Suboxone settlement agreement with the Justice Department in 2020, to resolve claims of aggressive and deceptive marketing. Then, in 2021, the company agreed to pay another $300 million to settle similar claims filed by all 50 states and the District of Columbia.

Tags: Buprenorphine, Drug Abuse, Opioids, Suboxone, Tooth Damage, Tooth Decay
Image Credit: PureRadiancePhoto / Shutterstock.com

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71 Comments

  1. Daniel

    Shortly after beginning Suboxone treatment I began have issues with my teeth. I went from having no cavities at checkups to several severe cavities, toothaches and gums recessed. Since I have had 2 teeth removed, 1 root canal and 3 crowns, in addition to many filled cavities. I’m currently on track to have dentures before I’m 40.

  2. Misty

    Had I known that I would lose all of my teeth and gave full dentures by 45. I would have never taken a single Suboxone. I have looked into dental implants to be able to at least eat comfortably again.

  3. Alan

    I am 45 years old, had braces as a teen, and good dental care my whole life. Despite this, I have recently had allot of teeth pulled and I’m waiting to be fitted with dentures and a partial. I have been taking suboxone since 2009. If there was ever a case, I’ve got it. Please contact me with info on how to proceed.

  4. Mark

    It’s been about 15 years with this tooth problem all my front teeth are falling out cracking breaking rotting and it’s terrible and I’ve never had these problems before I don’t know what to say I heard about the Buford orphan and Suboxone use so I gave this so I’ll look at

  5. Jason

    Methadone/Methadose should be added as a lawsuit as well!!! I was taking the pill form of methadone for about 13 years, then the clinic stopped buying them and instead started using the liquid form of Methadose. Within a year my teeth were decaying and rotting away! I also have broken teeth. I was proud of my smile! I took and still take, great care of my teeth, as that was my best attribute! Now I have to cover my mouth, or keep my lips over my teeth when I smile!

  6. wayland

    i have cancer and was on percets but was in jail so they changed it to suxboxone pills and my teeth started getting rotten and cracking and falling out couldn’t furgure why till i seen this

  7. Joe

    I started suboxone approximately 14+ years ago. I was hooked on prescription drugs. I never took street drugs. Before I had all my teeth, I was always complemented how nice my smile was. However, after taking subs. When I would go to the dentist for cleanings the dentist would tell me I needed several extractions. I was to the point of dreading going to my dentist. I have had 8 teeth pulled. Just last week I went to a new dentist. She informed me that I needed 12 more teeth pulled plus a root canal and crown. She recommended an oral surgeon to do the extractions plus bone loss. Her estimate is $6k+. No telling what it would cost to have my teeth pulled. She said all of the decay was below the gum line. I looked up to see if there was anyone else with this problem. I choose a firm that has teamed up with others. After talking with the paralegal for 45 minutes. She called back after about a week. She informed me that the attorney had decided to take my case. Suboxone is a money racket. I have never had one doctor asked me I was ready to taper down. I wish everyone what they deserve! God Bless!

  8. Keith

    I had problems with my teeth after using suboxone for about a year a few years ago. Did not think too much about it really. About a year ago took suboxone again for about 6 months or so. Now again I am having problems with my teeth and actually going to have a couple extracted. If I had known about suboxone films causing problems with their clients teeth I would have used the pills or maybe rethought my using at all. Would have been nice to at least know that tooth decay was a side effect of use.

  9. Jason

    On Suboxone since 2009, no back. Horrible decay mostly below gum line . Always took great care of my teeth. Now I’m considering dentures at 37

  10. Luanne

    I’ve never taken Suboxin but take methadone for chronic pain. All my teeth except for two have died from the inside out. Broken teeth just break off while eating. It’s totally destroyed my life.

  11. Kimberly

    I’ve been on Suboxone since the year of we have power of 2019, I had perfect theeth were white they were straight I had no problems and now all my teeth of crumbled. I have no front teeth no bottom teeth hardly and when I brush my teeth the other day I had a whole tooth fall out. My teeth are crumbling from the inside out. My gums hurt there’s sore I can’t eat and this is all because it’s because of suboxone . Can you please help me I want to get my smile back.

  12. Heather

    I been took for over one year and noticed it took a huge decay started with my caps and then my teeth cracking.

  13. Georgette

    I agree with the other comments that Methadone should be added to this lawsuit because No doctor ive ever went to ever warned of tooth decay from taking Methadone. Ive been on methadone since 2010 and the clinic i go to has never warned about the amount of tooth decay that will happen. I barely have any teeth anymore and before i got on methadone I had pretty teeth. Now my mouth literally looks like a smoke Methamphetamine for a living. I work in retail and it’s extremely embarrassing to talk to people because of how bad my teeth are now. My problems with my teeth didn’t start til i began taking methadone and it started about 3-6 months after being on methadone. Its sad when your trying to better your life and all the sudden you start losing teeth like you’ve been cursed by a witch or something. I wont take pictures anymore its really depressing especially when you cant afford to even go to a dentist to get it fixed. Its extremely depressing. METHADONE should be added to the lawsuit!

  14. Leah

    This lawsuit should be for methadone as well not just a box suboxone. The clinics did not tell us that the methadone was gonna rot. Our teeth out really hope you guys choose to go on both. Not just the one you’ll benefit from it trust me.

  15. jessica

    Yes I definitely think methadone should be on here I’ve been on methadone for a long time at least 7 8 years and I’ve never heard of anything about your teeth going bad with methadone but every since I have been on it my teeth have fell out cracked broke rotten and it started once I started taking the methadone I used to do heroin and my teeth was never like this I think for sure methadone should be on here as well

  16. jessica

    Yes I definitely think methadone should be on here I’ve been on methadone for a long time at least 7 8 years and I’ve never heard of anything about your teeth going bad with methadone but every since I have been on it my teeth have fell out cracked broke rotten and it started once I started taking the methadone I used to do heroin and my teeth was never like this I think for sure methadone should be on here as well

  17. Bonnie

    I see many people saying methadone should be here as well. It’s different. Many medications can hurt your teeth after years of use methadone included. Suboxone was very different, though. I had beautiful teeth always went to dentist…started Suboxone around 2004/2005. Then the root canals started and teeth breaking….over a few years time the change was dramatic.. I complained to my Suboxone doctor they said it wasn’t Suboxone. I went off of it after 8 or 9 years. My teeth continued to suffer and I have had to undergo extensive, expensive dental work and denture….cannot afford the treatment I really need. Took a loan for part of it. Suboxone I always wondered if it was the culprit and when I saw this ad today I said. Right…I knew it all a long….wish I had been warned.

  18. Hayley

    I have endured everything and everyone’s review that they have said about the tooth decay to my teeth just falling apart. Well, look at my mouth and see what the Suboxone has done to it. It makes me sick to know that they would prescribe medication for recovering because the medication is here to help us but it did nothing but decrease the ability to smile because of what our teeth look like. The FDA of the FDA should’ve known better especially knowing people like us would think it was safe to take not knowing that it would ruin the best part of someone’s face smile. I’m writing a review because there’s more people out there that need help and someone needs to be an advocate because I’ve already filled this out once and got denied and I don’t understand why because I’ve been on the medication for 15 years and I need help, my sister is on methadone and she got Suboxone and I’m not able to get help so I’m hoping that I can be a advocate to anyone that’s on Suboxone or tax and the same thing is happening. It’s painful and when you go to the dentist, they look like you’re because you’re an attic and it’s not fair , especially when you’re sad thank you for letting me put a. I’ll be very grateful. Someone can get back with me. Thank you. Hope you have a great weekend and hope to hear back from someone soon. Sincerely Hayley Lowe.

  19. Lee

    I don’t care about any kind of compensation. I just want my teeth repaired or implants. I can’t eat or chew or anything.

  20. Diana

    some people say they don’t care about the Compensation I care about it. I would like to fix my teeth in the front and it looks very ugly and I get my fixed. If I get you by a lawyer, I’ll probably won’t even get enough of my teeth fixed on the 4 teeth that arr messed up!

  21. Christine

    My teeth have started decaying when I started talking the suboxene films my teeth are stained and still decaying also had about 4 teeth pulled

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