Suboxone—a medication widely used to treat Opioid Use Disorder—has been linked to tooth decay by various medical studies and patient reports, leading to a slew of lawsuits. These lawsuits focus on the failure of Indivior, the maker of Suboxone, to warn patients about the severe dental damage that the medication can potentially cause.
These lawsuits claim that patients have suffered severe tooth decay, gum disease, infections, and, in some cases, total tooth loss. And, considering the medication has been on the market for 20 years, it is worth questioning why the manufacturer only added a warning about dental risks just two years ago.
What is Suboxone?
Suboxone is a sublingual film containing the active ingredients buprenorphine and naloxone, which help to decrease the effects of withdrawal symptoms caused by coming off opiate medications or illicit opiates.
The medication has been widely hailed as a revolutionary way for patients to get off damaging opiates and begin to rebuild their lives.
Buprenorphine is an opioid partial agonist that works by causing similar effects on the brain as opioids but without the “high” sensation. The “partial” element means that Suboxone partially fills the opiate receptors, allowing the brain to think they are filled and preventing other more harmful opiates from attaching.
By using buprenorphine, the body believes that it is at capacity with opioids. Therefore, users won’t crave further opioid use, and if they do use, the other opiates will just pass the brain and be processed out of the body.
Naloxone, however, is an opioid antagonist. It binds to opioid receptors and can reverse and block the effects of other opioids. It’s often used in larger amounts to treat overdoses. However, it’s added to Suboxone as a way to prevent users from abusing the medication by injecting it.
The listed side effects for Suboxone sublingual film include the following:
- Headache
- Nausea
- Vomiting
- Constipation
- Pain
- Increased sweating
- Insomnia
More severe symptoms include:
- Decreased blood pressure
- Liver problems
- Trouble breathing
In the Suboxone patient medication guide, Indivior also mentions that the films can cause severe tooth decay. However, that information was added in January 2022, a full 20 years after the medication was released in 2002.
Suboxone’s Role in Treating Opioid Use Disorder
Suboxone is frequently used in Medically Assisted Treatment (MAT). Doctors and inpatient/outpatient facilities offer these programs to help those with an addiction or dependency on opiates to withdraw safely and without experiencing painful and stressful side effects.
Since the relapse rate of opiate users is so high (91%) and it takes an average of 5 to 6 relapses before an opiate user can recover, Suboxone plays a significant role in preventing deaths and helping users stay off the more harmful versions of opiates.
This has been a big deal in the addiction recovery industry since, before Suboxone, there was no way to prevent cravings and relapses other than intensive in-patient talk therapy and perhaps Methadone treatment.
The Lawsuits Against Indivior
The lawsuits against Indivior have been gaining momentum as plaintiffs file suits that allege Suboxone directly contributed to their dental issues. These allegations are not just anecdotal; they are also backed by scientific studies and expert testimonies that show a potential link between Suboxone films and an increased risk of severe tooth decay.
In September 2023, David Sorensen filed the first lawsuit against Indivior and Reckitt Benckiser, claiming that sublingual Suboxone films had caused him to experience permanent damage to his teeth that required an extensive (and expensive) amount of dental work. Sorensen claimed he was never warned about the potential for dental damage despite the manufacturers being aware that the drug contains ingredients properties likely to cause tooth decay. Sorensen and his lawyers filed their lawsuit in the U.S. District Court for the Northern District of Ohio.
By February 2024, 15 more Suboxone tooth decay claims were filed, with hundreds or thousands more being vetted by lawyers nationwide.
As the number of similar cases reached 16, it was decided that they should be consolidated into a multi-district litigation (MDL) with Judge Philip Calabrese overseeing the case.
Consolidating into an MDL streamlines the litigation process and allows for consistent rulings on legal issues across the various claims. It saves a lot of time by preventing a dozen different courts from handling the pretrial elements of cases that are very similar. Once the pretrial proceedings are done and Judge Philip Calabrese clears the cases to move forward, they will all be tried (or settled) on their own merits and not as a whole.
All these lawsuits contain a common thread: that Suboxone sublingual films caused severe tooth decay, cavities, cracked teeth, and other dental issues and that they were never warned about these dangers. This is important because these lawsuits go beyond personal injury and into the area of law known as “failure to warn.”
Failure to warn is one of the three types of lawsuits one can file under product liability. Medication manufacturers have a legal obligation to create products that are safe for use and free from any dangers. If they fail to supply proper warning labels and consumers experience adverse effects (just like we’re seeing in the Suboxone cases), then the individual can sue because they were not given all the facts when they made the decision to take the medication.
It should be noted that Indivior stands firm on the drug’s safety, supported by its own array of scientific evidence and regulatory approvals.
FDA’s Response to Suboxone Causing Tooth Decay
In January 2022, the Federal Drug Administration (FDA) released a statement saying that they had received many reports of sublingual buprenorphine (Suboxone films) causing adverse dental events (basically dental injuries).
Because of the number of reports they received, the FDA forced Indivior to add a new warning to Suboxone to make patients and doctors aware of the serious concerns over tooth decay.
No warning existed prior to January 2022.
The Science Behind Suboxone and Tooth Decay
Scientific studies have shown that a multitude of Suboxone’s properties could be contributing to the drug’s tendency to decay teeth.
Tooth enamel, a layer of protection for one’s teeth, can dissolve when exposed to acid and bacteria, putting your teeth at a much higher risk of cavities and decay.
Here are the most common factors that may be contributing to Suboxone tooth decay. It is not yet known if it is one of these factors or a combination that is causing some people with no history of dental problems to lose all their teeth. Scientists are still working on it.
- Acids. When the teeth are exposed to acids, like orange juice or sodas, which have a similar pH as Suboxone, it can erode the enamel and cause tooth decay.
- Dry Mouth. Saliva creates a protective layer on the teeth and helps rinse away food particles. Since Suboxone causes dry mouth, the reduction in saliva could lead to decay.
- Sweeteners in Suboxone. Because Suboxone is taken sublingually, meaning under the tongue or in the cheek, for 30 minutes, the makers add sweeteners to make the medicine more palatable. The sweeteners are acidic and also help feed harmful bacteria.
- Prolonged Contact with the Teeth. Suboxone must stay in the patient’s mouth for 30 minutes. Compare this to a drug you just swallow immediately. Because the drug is in the mouth for so long—with its acidity, tendency to cause dry mouth and sweeteners—it has more time to cause problems.
- Streptococcus mutans Bacteria. The bacteria known as Streptococcus mutans is well known to cause tooth decay. It is thought that Suboxone may fuel the production of this harmful bacteria, but more research is needed.
Dental Health Problems Caused by Suboxone
The plaintiffs that are filing lawsuits against Suboxone have alleged a whole host of dental issues they suffered allegedly because of Suboxone. They include:
- Tooth Decay
- Gum Disease (Periodontitis)
- Tooth Erosion
- Mouth Sores
- Gingivitis
- Severe Cavities
- Rampant Cavities (many cavities at once)
- Fungal infections (thrush)
- Tooth Loss
- Infections
- Oral Abscesses
- Total tooth loss
These severe dental injuries have required the plaintiffs to undergo all kinds of treatments, including fillings, root canals, crowns, periodontal therapy, oral surgery, dentures, and many other expensive and painful treatments.
Conclusion
The lawsuit against Indivior over Suboxone’s alleged link to tooth decay is a multifaceted issue, combining scientific debates, legal challenges, and ethical considerations. As the Suboxone MDL continues, we will get more answers about what happened and what the resolution will be.
These lawsuits no doubt have to balance the undeniable benefits of Suboxone in treating opioid addiction with the need for drug manufacturers to warn about potential risks and do everything they can to mitigate them.
This legal battle is not just about compensation for the affected individuals (although that is important if Suboxone is found liable or decided to settle), but it also raises critical questions about the responsibilities of pharmaceutical companies to ensure the safety of their products. Previous cases have set various precedents in this regard, and the outcome of this lawsuit could have far-reaching implications for drug manufacturing and patient safety standards.
If you are on Suboxone and are worried about your dental health, make an appointment and speak to them about your medication and a plan for mitigating any risks. If you took Suboxone and think your dental injuries may be linked to the medication, reach out to a qualified lawyer who handles defective drug cases.
