Suboxone Tooth Decay Lawsuits and Settlements
Suboxone lawsuits claim that people suffered dental issues after taking Suboxone sublingual film to treat their opioid addictions. Indivior, the company that makes the pain management drug, knew or should have known about the risk of tooth decay. However, the drug manufacturers did not warn users about tooth decay and other adverse effects.
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News Updates for Suboxone Tooth Decay Lawsuits
November 2023 Update
On November 27, 2023, plaintiffs’ legal counsel filed a petition with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate Suboxone lawsuits currently pending in federal courts around the country into a single multidistrict litigation (MDL). If successful, the MDL would also include “tag-along” cases, meaning any Suboxone film lawsuits subsequently filed involving similar facts or claims. The plaintiffs petitioned the JPML to transfer these cases to to the United States District Court for the Northern District of Ohio before the Honorable J. Philip Calabrese. See the Petition.
As of November 3, 2023, 14 new product liability lawsuits have been filed in federal courts against Indivior, makers of Suboxone. The lawsuits, eight of which were filed in the Northern District of Ohio, allege the sublingual opioid addiction treatment drug causes serious dental problems.
October 2023 Update
A federal judge denied Suboxone manufacturer Indivior's motion to dismiss a false claims act case against the company. Now, they will have to defend themselves against allegations of an illegal kickback scheme. Indivior added an additional $385 million to its settlement agreements in an antitrust lawsuit claiming the company suppressed generic competition.
Suboxone Lawsuit 2023
In 2022, the U.S. Food & Drug Administration (FDA) warned about the risk of dental problems linked to medications with active ingredient buprenorphine. Suboxone contains buprenorphine. Some individuals experience significant oral problems such as tooth decay, cavities, infections, and tooth loss. Reports how these issues have even occurred in people who have never had dental problems in the past.
According to the FDA, a growing body of medical research and adverse event data links sublingual film that dissolves in the mouth to dental problems.
As a result, the FDA required manufacturers to add a warning about these dental risks in prescribing information and the patient Medication Guide.
Do You Qualify for a Suboxone Lawsuit?
Your lawyer will consider several factors when determining if you can file a suboxone lawsuit for teeth injuries. For example, If your doctor gave you Suboxone before the label warned against tooth decay, you could not have known of the dangers. Even if you had regular dental care before using Suboxone, this drug raised your risk of dental problems.
You can pursue a Suboxone dental lawsuit if you had one or more of the following injuries:
- Tooth loss
- Tooth fractures
- Tooth decay
- Oral surgeries, like tooth extraction
- Tongue injuries
- Gum injuries
How Much Could You Get in a Suboxone Settlement?
When people file lawsuits against a pharmaceutical company like Indivior, the potential recovery amount varies. A jury award or settlement depends on the nature and extent of your teeth problems.
Personal injury cases like this often enable claimants to recover the following types of damages:
- Medical fees, past and future
- Costs of prescription medicines, past and future
- Lost income, past and future
- Pain and suffering
Timeline for Suboxone Tooth Decay Lawsuit 2023
- 2002: Suboxone is manufactured in pill form. The FDA grants it the agency's “Orphan Drug” approval. This orphan-drug exclusivity expired on October 8, 2009.
- Oct. 20, 2008: Defendants seek approval to change Suboxone’s form from pill to film. The request is based on safety and efficiency studies.
- Aug. 30, 2010: FDA approves the film version of Suboxone.
- July 2, 2013: The United States Patent and Trademark Office grants the patent for the film-based delivery of Suboxone.
- January 2022: FDA issues a drug safety communication about suboxone and dental problems.
- June 2022: Defendants begin to warn about dental adverse events.
What is Buprenorphine?
Buprenorphine is a medicine used to treat opioid addiction.
The FDA has approved the following buprenorphine products for the treatment of opioid use disorder (OUD):
- Generic Buprenorphine/naloxone sublingual tablets
- Buprenorphine sublingual tablets (Subutex)
- Buprenorphine/naloxone sublingual films (Suboxone)
- Buprenorphine/naloxone) sublingual tablets (Zubsolv)
- Buprenorphine/naloxone buccal film (Bunavail)
- Buprenorphine implants (Probuphine)
- Buprenorphine extended-release injection (Sublocade)
How Buprenorphine Works
Buprenorphine is an opioid partial agonist. Taking this drug can help reduce the physical dependency of opioids. However, the effects are weaker than those from powerful full agonists like methadone or heroin.
According to the Substance Abuse and Mental Health Services Administration (SAMHSA), Buprenorphine's distinctive characteristics help:
- Reduce the impacts of physical addiction to opioids, such as withdrawal symptoms and cravings
- Enhance safety during an overdose
- Decrease the likelihood of misuse
Side Effects of Buprenorphine
These partial agonists reduce the saliva production that is important for optimal oral health. Tooth decay is a common side effect of using these drugs, including Suboxone.
Research and Studies
Over a decade's worth of scientific evidence backs the Suboxone teeth lawsuits in 2023. Some of this research prompted the FDA's alert of the potential risk of tooth loss and decay from long-term use of sublingual buprenorphine.
2012: A study in The American Journal on Addictions discussed a patient with opioid addiction. This person was on buprenorphine/naloxone maintenance for their OUD and developed serious tooth decay. The patient had not changed her dental hygiene, nor had she increased her consumption of sugary foods and drinks. This raised the possibility that her regular use of sublingual buprenorphine/naloxone could have contributed to the dental problems.
2013 - The Primary Care Companion for CNS Disorders published another study (Sublingual Buprenorphine and Dental Problems: A Case Series). Scientists studied 11 patients with opioid addictions who had dental problems after taking buprenorphine. The researchers noted low salivary buffering capacity in 54.5% of the patients. Saliva helps prevent tooth decay, so the scientists said that the low buffering capacity may have caused dental issues.
Prolonged contact between patients' teeth and the dissolving buprenorphine could also have promoted the decay, according to the study.
2017 - In the article "Drug-Induced Dental Caries: A Disproportionality Analysis Using Data from VigiBase" (de Campaigno et al., 2017), researchers explored drugs thought to cause dental caries (pathological breakdown of the tooth). Scientists identified 88 drugs that showed a "significant positive disproportionality for dental caries." This included Buprenorphine/naloxone. The authors noted that drug-induced changes in salivary flow and composition were among the most frequently suspected cause of these dental problems.
2022 - The American Medical Association published a study, "Association Between Sublingual Buprenorphine Naloxone Exposure and Dental Disease." Authors used a health claims database to analyze reported dental adverse events linked to dissolving buprenorphine, like Suboxone.
They found an increase in the risk of dental issues with these drugs. To maximize absorption, patients are instructed to hold the tablet under their tongues for up to 10 minutes. According to the authors, this prolonged exposure could prompt tooth damage.
2023 - The research article "Dental Disorders Reported to the FDA Adverse Event Reporting System in Association with Buprenorphine: An Analysis by Ingredient Composition and Route of Administration" found significantly disproportionate reporting of dental disorders to the FDA Adverse Event Reporting System (FAERS) for patients treated with buprenorphine medications. The author said this suggests that for patients undergoing therapy with orally dissolving buprenorphine, dental hygiene and oral care should be emphasized.