Patients with opioid disorder who have been using Suboxone to treat the addiction are coming forward to allege the many dental issues like tooth decay, infections, tooth loss, cavities, and tooth breakages they are experiencing because of using the medication. These victims allege that the manufacturer of the drug, Indivior, was aware of the side effects but concealed them from the public or failed to warn them adequately. If you have suffered these side effects, you can pursue compensation through the Suboxone tooth decay lawsuit.

Overview of Suboxone

In the 1960s, Indivior developed a drug to numb pain and fight opioid addiction called Suboxone. The medication received FDA approval in 2002 as it brought hope in the middle of the opioid independence crisis. The primary ingredients of the drug were naloxone and buprenorphine, whose combination reduced the risk of misuse and, at the same time, reduced the withdrawal effects.

At the time of developing the drug, there was another drug that had entered the market called buprenorphine, also used to treat opioid addiction. These two were distinct drugs, with Suboxone comprising a combination of two ingredients designed to control opioid dependence. Conversely, buprenorphine was used to numb mild to severe pain and treat opioid addiction. 

In the 1970s, researchers started exploring the potential of buprenorphine as a remedy for controlling opioid use disorder (OUD). The drug drew the attention of researchers because it presented users with minimal overdose risk. Besides, the medication was user-friendly as it only required one to dissolve it below the tongue. How it was designed to be taken made it less probable to be abused.

In 1995, the FDA approved buprenorphine as a pain reliever. Later on, in 2002, buprenorphine products, including Suboxone, which is a combination of buprenorphine and naloxone, received approval to treat opioid disorders. Buprenorphine is a restricted opioid agonist, meaning it activates the same brain receptors opioids activate, but at a minimal level. The drug has fewer withdrawal symptoms and does not cause the intense high linked to complete opioid agonists like prescription pain relievers or heroin.

The other ingredient in Suboxone, naloxone, is an opioid antagonist, as it reverses opioid effects and precipitated withdrawal effects if misused. Suboxone is sold as tablets or sublingual film and is prescribed to complement treatment in programs like therapy.

While the drug has proved to be a game changer in managing OUD and helping recovering people with an addiction transition to sobriety, it has its downsides and adverse effects. It causes nausea, sweating, sleep disturbances, headaches, and constipation. Many doctors and patients ignore these side effects in favor of the drug's benefits. Many manageable and insufficient reasons exist to avoid using the medication but this does not stop its use. Also, the medication manufacturer sufficiently warns of the side effects so physicians and patients know them when purchasing.

Unfortunately, Suboxone has other adverse effects that the manufacturer seemed to have been aware of but withheld from the public. Although the drug's manufacturer knew the medication could lead to tooth decay and other oral health problems, they chose not to alert the public until 2022, when they included a warning on the label. However, prior to doing this, many patients were unaware of the medication's risks, which is why Indivior is the target of numerous lawsuits.

Newest Suboxone Lawsuits 

The lawyers investigating the Suboxone tooth decay lawsuit are in the initial stages of investigations and are accepting more victims who have sustained dental injuries from the drug. So far, there have been no arranged trials or court settlements for these suits, although there are ongoing lawsuits. Examples of these lawsuits are:

As of November 1, 2023, fourteen new Suboxone lawsuits have been brought against Indivior in various federal courts, although the Northern District of Ohio remains the venue with the most pending suits.

Indivior will be fighting two litigation battles based on the 30th of October, 2023, lawsuit updates. An individual who obtained tooth decay from the medication is suing the drug manufacturer for false claims. The victim is alleging the drug manufacturer defrauded the federal administration by participating in an unlawful kickback scheme involving Express Scripts. Indivior petitioned the court to dismiss the lawsuit, but a judge denied the motion, giving the case a nod.

Also, on October 25, 2023, Indivior agreed to an extra settlement of $385 million for a Suboxone lawsuit brought against them by wholesalers. The wholesalers accused the company of suppressing generic competition by developing Suboxone dissolving film after the lapse of their initial patent. The manufacturer has already settled $900 million in the lawsuit filed by the national government.

The latest lawsuit against Indivior was filed on October 16, 2023, by a Southern Ohio resident who was administered Suboxone sublingual films to treat OUD. The plaintiff alleges that after using the medication, they started experiencing tooth decay, leading to permanent multiple teeth loss. The accusation against the manufacturer is that they failed to warn drug users and physicians of these risks.

Studies Backing Up Suboxone Lawsuits

Suboxone tablets and sublingual films did not have a warning about the risk of dental injuries linked with the use of the medication on the label. Nevertheless, plaintiffs allege that the defendant knew of these risks but opted not to warn the physicians and their patients.

Several studies and research dated a decade ago support these lawsuits, and some are what encouraged the Food and Drug Administration (FDA) to warn the public about these risks in 2022.

A 2012 study by The American Journal on Addictions was one of these investigations. The study was conducted on a patient with OUD who was prescribed Suboxone, which contains the active ingredients buprenorphine and naloxone, and suffered extensive tooth decay. The patient had not adjusted their oral hygiene or increased sugar and carb consumption, attributing the medication to these dental problems.

Another study backing up the current lawsuits against Indivior was conducted by The Primary Care Companion for CNS Disorders in 2013. It involved eleven patients fighting opioid dependence and developing severe oral issues after using buprenorphine. The researchers discovered that these patients had minimal saliva buffering ability. The patients appeared to have a dry mouth, increasing the risk of tooth decay. Also, the study discovered that prolonged use of the dissolving drug could have contributed to tooth decay.

Suboxone Ph

Suboxone is a drug with a low pH, averaging 3.4 when run in water. The scale of acidity, or alkalinity, ranges from 0 to 14. Seven on the pH scale represents neutral. The numbers below seven show acidity, while those above seven show alkalinity. Typically, your mouth has a pH ranging from 6.2 to 7.0.

Your tooth enamel demineralizes when in contact with acids. When the mouth acidity rises to 5.5 or below, the enamel dissolves due to the high acidity that could stem from acidic substances, dry mouth, or bacteria. If the teeth are exposed to the acid for an extended period of time, they weaken the enamel, eventually causing decay. From this information, it is clear that Indivior did not require scientific studies to know that prolonged use of the drug increased the risk of dental injuries.

Dry Mouth

Also called xerostomia, dry mouth develops when your salivary glands do not produce sufficient saliva, causing a low pH level and increasing the risk of tooth decay.

Saliva is critical to maintaining a healthy mouth. It clears away food debris and harmful bacteria. Again, it neutralizes acids in the mouth, establishing a stable pH scale and keeping the mouth lubricated.

When saliva production levels in the mouth drop, the pH levels drop, increasing mouth acidity, which leads to oral problems like dental caries, gum infections, tooth decay, and eventually tooth loss.

Several reasons explain dry mouth or low saliva production, including Suboxone use and illnesses like diabetes, HIV, and Sjogren’s syndrome. Other factors that increase the risk of dry mouth are natural aging, tobacco use, chemotherapy, alcohol consumption, and neck or head radiation therapy.

Scientific studies have demonstrated that suboxone induced xerostomia. This is explained by the fact that low saliva production allows for bacteria accumulation in the mouth, contributing to dental health problems like infections, decay, and dental caries.

Failure to Issue Suboxone Warning

Despite sufficient evidence pointing to suboxone as the cause of tooth decay, the manufacturers of the drug did not take measures to warn users of the risks until 2022. All they needed to do was update their medication’s label to point out the dangers the drug posed to users’ oral health. Updating the tags would have averted the lawsuits the defendant faces today.

Unfortunately, Indivior chose to disregard any measures towards public safety. The current lawsuits against the company are because of their inaction, even when multiple studies showed that the drug was acidic and caused tooth decay. They acted negligently by disregarding their duty to consumers by not pointing out the possible injuries caused by the drug.

The manufacturers responsible for the drug and the ones the lawsuits refer to as the defendants ought to have taken the necessary measures to update their drug labels with growing proof linking the drug to oral problems. All they needed to do was warn patients and physicians that using the medicine increased the risk of dental injuries. Surprisingly, they chose not to take action.

Individuals recovering from opioid addiction pay little or no attention to their oral hygiene, making them vulnerable. Also, most dental work for these patients is not insured. Therefore, you have a vulnerable population that is trying to put their life back on track by fighting opioid dependence but is then administered Suboxone believing that it is safe and will enable them to fight the OUD, only to find themselves in more dental health complications.

These victims believed the medication would help them fight the disorder, and if any risks were linked with the medication, they would learn about them from the physician or drug label. However, the manufacturers did not take any measures to warn them, exposing them to severe oral illnesses.

FDA Warning

The FDA warned the public about the risks of oral issues associated with suboxone because of its buprenorphine ingredient. Some patients using the drug suffer severe oral problems like tooth caries, decay, tooth loss, and infections. These adverse side effects were reported even in patients without dental issues.

Extensive scientific research and evidence that the high acid content of the sublingual film that dissolves in the mouth contributes to tooth decay informed the FDA's decision to alert the public about the risks associated with Suboxone.

Because of this, the FDA advised the drug manufacturers, who are the defendants in the Suboxone lawsuit, to warn about the medication's potential for dental injuries on their product labels.

Is there extra proof that Suboxone causes dental problems? In January 2022, the drug manufacturer added a caution or warning on the drug label, specifying the oral issues the drug could cause. Notably, the sign mentions oral infections, cavities, tooth loss, and decay as the adverse effects of drug use.

Indivior, including the warning on the drug, shows that the party responsible for the safety of patients using Suboxone failed in their duty. They were unable to provide users and doctors with instructions or the requisite warnings on the dangers of the drug. The company’s negligence and disregard for public safety endangered the dental health of the patients prescribed the medication, denying them the opportunity to decide whether to use it.

Suboxone Tooth Decay Suits

Several product liability suits have been filed against Indivior throughout the country. The lawsuits accuse the drug manufacturer of participating in negligent and unlawful conduct regarding the crafting, design, testing, packing, labeling, promoting, marketing, advertising, distribution, and sale of the drug.

The lawsuit asserts that the drug manufacturer knew or should have known that the drug's active ingredient, buprenorphine acidity, caused serious dental injuries when taken as prescribed. The lawsuits state that the producer knew of these risks before marketing and selling it as safe.

Suboxone Lawsuit Defendants

Indivior, Inc. is the main defendant in Suboxone lawsuits. Indivior is a pharmaceutical firm focusing on producing and selling various drugs, including Suboxone. Previously a Reckitt Benckiser subsidiary, Indivior was spun off as a fresh and publicly traded firm by Reckitt in 2014 after Suboxone became a game changer in managing opioid dependence.

The primary defendants in the lawsuit are Indivior, Reckitt, and several other businesses operating in the United States. However, the direct liability of the suits will fall on Indivior, as it is a public entity listed on the London Stock Exchange and has the capital to compensate plaintiffs. The drug manufacturer has a tainted history, with the justice department indicting the firm for false publicizing and a system to refer patients to physicians likely to recommend Suboxone for their opioid disorder.

Another main defendant in the claims is Aquestive Therapeutics Inc., a pharmaceutical firm involved in the joint manufacture of Suboxone with Indivior, Inc.

Suboxone Class Action

With many individuals coming out to claim they have sustained dental injuries from Suboxone use, there are likely to be several lawsuits in federal court that could be consolidated to form a class action suit against the makers of the drug. Technically speaking, these lawsuits will not start a class action but a Multi-District litigation (MDL). The court uses MDL class actions when there are multiple civil suits with the same question of fact, as in the Suboxone lawsuits. Several plaintiffs have come out to sue suboxone manufacturers. It is worth understanding that MDLs are not clean class actions. Instead, they are mergers of lawsuits for a pretrial hearing to simplify the legal procedure and enhance efficiency.

With several suits with the same issue or injuries filed against common defendants in federal courts nationwide, plaintiffs can petition for an MDL for all cases to be consolidated and heard in one federal court. The appointed court handles the discovery hearings and pretrial motions for the lawsuits.

When it happens that the Suboxone lawsuits will be consolidated in one court and assigned to one federal judge, it will be beneficial to the victims because an MDL will give them a fair and equal settlement. What happens in MDLs is that Suboxone suit representatives are appointed to go to trial. The few cases selected to be representatives are deemed to be a more comprehensive representation of the plaintiffs in the MDL. You will benefit as a plaintiff from an MDL because you will not be going after the capitalized defendants alone, improving the chances of a fair settlement.

Possible Settlements for Suboxone Lawsuits

The estimated settlement for Suboxone lawsuits by lawyers investigating the case is approximately $50,000 to $150,000. This is the calculated settlement value. Therefore, if the opposing sides do not reach a settlement and the claim proceeds to trial, the court could award you $1 million, including punitive damages.

However, the prediction is premature because the lawsuits are only in the initial stages, and it is impossible to estimate the actual settlement at the end of the case. Suboxone lawsuits are likely successful because there is sufficient evidence that the defendants failed to warn users of the dental health risks.

Find Suboxone Lawsuit Assistance Near Me

If you have experienced tooth decay, oral infections, tooth loss, and decay after using Suboxone, Consumer Alert Now can help. We have the experts and resources prospective plaintiffs need to sue large pharmaceutical firms like Indivior, Inc. for producing and selling harmful drugs. Contact us today at 800-511-0747 for a no-obligation consultation with our legal experts. We will address all your questions and guide you to obtain maximum compensation by the close of the lawsuit.