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Discover the latest updates and insights on Suboxone lawsuits at federal-lawyer.com. Explore comprehensive legal resources and expert guidance regarding Suboxone litigation, designed to empower individuals seeking justice and compensation.

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Numerous lawsuits have been filed against the pharmaceutical companies responsible for making and marketing the drug Suboxone, which is used to treat opioid addiction and chronic pain. The lawsuits claim that prescription Suboxone film causes serious dental issues, including severe tooth decay, and that the manufacturer, Indivior, Inc., knew about the risk but did nothing to warn the doctors that prescribed Suboxone and their patients about it. Enough lawsuits have already been filed to create a multidistrict litigation, or MDL, which is similar to a class action.

The mass tort lawyers at Oberheiden P.C. are representing victims in these serious Suboxone product liability lawsuits.

Contact our Suboxone lawsuit attorneys at 866-611-7829 now for a free consultation.

Suboxone is a substance that contains a four-to-one ratio of buprenorphine hydrogen chloride to naloxone hydrogen chloride dehydrate. The buprenorphine is a partial opioid agonist, while the naloxone, which is also known as Narcan, is an opioid antagonist. When taken together, these drugs act as a useful way of combatting an opioid addiction, also known as opioid use disorder (OUD). The buprenorphine satisfies the brain's opioid receptors without actually activating them, while the naloxone further mutes the effects of the opioid. Together, these drugs satisfy the cravings that come with an opioid addiction and help reduce the feelings of an opioid withdrawal. Suboxone, therefore, is a common element in many opioid abuse treatments, along with:

Counseling

Drug use monitoring

Other lifestyle changes

It was first approved by the U.S. Food and Drug Administration (FDA) for this purpose in 2002. It is also approved to treat chronic pain.

Importantly, Suboxone is taken orally as a sublingual film. Patients put it in their mouths, often under their tongue or against the inside of their cheek. It typically dissolves within a few minutes. It comes in four different dosages, all of which stick to the four-to-one ratio:

2 milligrams (mg) of buprenorphine and 0.5 mg of naloxone

4 mg of buprenorphine and 1 mg of naloxone

8 mg of buprenorphine and 2 mg of naloxone

12 mg of buprenorphine and 3 mg of naloxone

Patients undergoing opioid use treatment would take one or more of these doses every day. The drug stays in the patient's system for several days, reducing the craving for other, more dangerous and addicting opioids like:

Because of the severity of the opioid epidemic in the United States, which killed nearly 645,000 people from 1999 to 2021 and increased the number of drug overdose deaths by 600 percent in that timeframe, Suboxone has become an extremely important and widely-prescribed medication.

Side Effects

Some common side effects of taking Suboxone are:

Pain in the back or stomach

Sweating

Headache

Difficulty sleeping

Swelling

Mouth redness or numbness

Tongue pain

Burning mouth

Nausea

Vomiting

These are more common in patients taking higher doses of Suboxone.

Additionally, patients may still suffer some of the symptoms of opioid withdrawal in spite of the Suboxone treatment.

Some severe side effects include:

Agitation

Facial swelling

Hallucinations

Breathing problems

Difficulty swallowing

Extreme fatigue

Fast heart rate

Loss of sexual desire or performance

Drinking alcohol or taking other medications can increase the likelihood of developing one of these severe side effects.

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Suboxone's Manufacturers

Suboxone is manufactured and marketed by the pharmaceutical company Indivior Inc., which spun off from the British consumer goods company Reckitt Benckiser in 2014. While Indivior is headquartered in Richmond, Virginia, it has close ties to the United Kingdom through its connection to Reckitt.

Indivior's main products are all opioid addiction treatments, including:

Sublocade, which is the drug buprenorphine without the accompanying naloxone, and is administered in the form of a monthly injection

Subutex, which is the oral version of just buprenorphine

Suboxone, the oral version of buprenorphine and naloxone

By using buprenorphine rather than the drug methadone, Indivior's products decrease the risk of patients getting addicted to the treatment drug or overdosing on it. The oral versions were also easier to administer than the drug's competitors.

Because of the need for opioid addiction treatment during the opioid crisis and in its aftermath, Indivior quickly became incredibly successful. According to the FDA, the estimated number of prescriptions for medication containing buprenorphine, which includes Suboxone, had increased from 11 million in 2014 to 16 million in 2020. Only three months after it became its own company, Indivior was capitalized at $3.1 billion. Before 2019 it was regularly earning over a billion dollars of revenue every year.

That success, however, was in part due to its manipulation of the drug market.

As mentioned earlier, Suboxone was first approved by the FDA in 2002. Back then, it came in the form of a dissolvable tablet, rather than a film. The FDA's approval gave Indivior, then still a part of Reckitt Benckiser, the exclusive right to sell the drug until October, 2009.

Rather than lose the market share to generic versions of Suboxone, though, Reckitt Benckiser came out with a new way of administering the drug - a thin film that would dissolve in the mouth, rather than a tablet. When the FDA approved this new way of administering the same drug, Reckitt Benckiser, and then its spinoff company, Indivior, got a new period of exclusivity for its sublingual film version of Suboxone. The company then pressured doctors to prescribe the new version, baselessly claiming that it was safer because the films posed less of a threat to children than the tablets because the films were individually packaged and this made access more difficult. The company then stopped making the tablet form of the drug to force the transition to its new, patent protected, film version.

These tactics to bolster profits from Suboxone led to Indivior, Reckitt Benckiser, and some of its executives facing civil and criminal charges for making false statements and for violating antitrust law. They also color the products liability lawsuits that have now been filed against Indivior for the links between Suboxone and tooth decay.

Contact our Suboxone lawsuit attorneys at 866-611-7829 now for a free consultation.

Suboxone Linked to Tooth Decay

Just the latest of these legal issues that Indivior is facing has to do with its drug Suboxone and its links to severe tooth decay. Numerous people who used the drug to overcome their opioid addiction suffered some horrendous and seemingly unprovoked dental problems, including severe tooth decay. Studies have long linked those teeth issues to Suboxone, but Indivior took no action to warn doctors who prescribed Suboxone and patients of these risks of dental injuries for over a decade.

The first of these studies came out as early as 2012, two years before Indivior had even become its own company. The study was a case report in The American Journal on Addictions that highlighted a patient who developed an addiction to Oxycodone and got treatment for it. That treatment consisted of an 8mg dose of Suboxone, twice a day, for 18 months. Despite having no prior dental problems and continuing her normal dental routines, her dentist told her that she had extensive tooth decay and that she would need root canals on four of her molars. The authors of the report speculated that the oral transmission route of the Suboxone may have caused the problems.

The lead author of the case study then published another article in 2013. It was another case report, this time of 11 patients, and was published in The Primary Care Companion for CNS Disorders. All 11 patients got opioid dependency treatment at Brigham and Women's Hospital between May and November, 2012. While not all developed dental problems, most had, with six of them saying that they had developed toothaches. Some fared far worse, though, as the study found that, among just these 11 patients, at least one of them had suffered:

24 cavities, requiring 30 fillings

3 root canals

4 tooth abscesses

5 cracked teeth

2 extractions

On average, the 11 patients had suffered:

6.6 cavities

1.1 root canals

1.2 abscesses

1.6 cracked teeth

0.8 extractions

A later study from 2022 was published in The Journal of the American Medical Association, or JAMA. This one used a database of patient information to find 21,404 patients who used Suboxone for opioid addiction treatment, and compared them to 5,385 people who used an injectable version of buprenorphine and another 6,616 who used an oral version of the drug naltrexone. Per 1,000 patients, adverse dental events occurred:

In 21.6 patients taking Suboxone

In 12.2 patients taking an injectable form of buprenorphine, like Sublocade

In 10.9 patients taking naltrexone

This suggested a significant correlation, though only after years of harm had already been done.

Indivior Likely Knew About the Risks

But Suboxone was approved by the FDA for opioid dependence treatment in 2002, a decade before these studies sounded the alarm about the risks of tooth decay. How could Indivior or, at that point, its original company Reckitt Benckiser know of the harm?

Because tooth decay and erosion tend to occur in acidic conditions. This is why people with relatively acidic saliva are at an increased risk of dental problems. The acidity erodes their teeth over time and causes decay, which can lead to cavities and the need for oral care like fillings or, if the problem is not addressed quickly enough, root canals or tooth extractions.

Acidity is measured using the pH scale, which goes from 0 to 14. A pH of 7 is neutral, pH levels over 7 are alkaline or basic, and pH levels under 7 are acidic. The pH level inside human mouths is generally between 6.7 and 7.3, or right about at neutrality.

Suboxone, however, has a pH level of about 3.4.

It also works by dissolving in the mouth. The sublingual film that Indivior developed as an alternative to an injection or tablet takes 5 to 10 minutes to dissolve, and sometimes even longer. Additionally, patients are often told to hold their saliva for as long as possible, up to 20 more minutes, in order to make the drug more effective.

Putting something that acidic into a patient's mouth for that long should have been a red flag for a pharmaceutical company. Teeth demineralize in acidic conditions under a pH level of 5.5. Demineralization is when the tooth enamel begins to dissolve. The healthcare professionals and chemists at Indivior should have conducted their own tests to see whether Suboxone would cause dental problems before making and marketing the drug that people would leave in their mouths for such long time periods, sometimes multiple times per day.

Apparently, they did not.

Suboxone's Warning Label Did Not Mention These Risks Until 2022

As a result, Suboxone hit the market with no warnings about the dental harm that it could cause. This prevented doctors and addiction professionals from informing their patients, who were desperately in need of help to break out of their debilitating opioid addiction, of the risks to their dental health. It also left those patients with no way to learn of the risks on their own. As a result, neither doctor nor patient could make an informed decision about whether to use Suboxone to treat opioid use disorder or an alternative, like methadone.

The studies from 2012 and 2013 linking Suboxone to tooth decay also failed to get Indivior to act. Instead, the warning label for the drug went unchanged year after year with regard to the dental risks of taking the drug.

It was not until January, 2022, that the FDA took action. The agency had discovered 305 cases of dental problems, including 131 serious ones and 113 that involved more than one tooth, in medical literature and in cases reported to them. In some cases, dental harm had occurred in the first two weeks of Suboxone treatment. 71 of the cases required tooth extraction. As a result of these findings, the FDA required Indivior to update the warning label on Suboxone to include:

The dental risks associated with taking the drug

Strategies to maintain or improve oral health while taking Suboxone

A recommendation that doctors prescribing Suboxone refer their patients to dental care services and encourage regular checkups there

A note to patients to inform their dentist that they are taking Suboxone

It is important to stress the fact that this was the FDA's doing, not Indivior. If the FDA did not require a warning about tooth decay to be included on the drug's label in 2022, it likely would still not have one and doctors and patients would still be unaware of the risks they face.

Contact our Suboxone lawsuit attorneys at 866-611-7829 now for a free consultation.

Products Liability and Defective Designs and Marketing

Products liability law exists precisely for these sorts of situations. Products, including complicated pharmaceutical concoctions and medications like Suboxone, can be defective in three different ways:

1. They can have a defective design

2. They can be manufactured defectively

3. They can be marketed defectively

The Suboxone lawsuits allege that the drug was defective both in how it was designed and in how it was marketed.

Design Defects

A defective design is fairly straightforward. When it comes to pharmaceuticals, a drug is defectively designed when it is either:

Not as safe as an ordinary consumer would expect when used as intended or in a reasonably foreseeable manner, or

The benefits of a particular design do not outweigh its inherent risks.

The lawsuits against Indivior claim that using a highly acidic, dissolvable film rather than a safer method of administration amounted to a defective design on both of these counts. Recall that this decision was made by Indivior in order to protect its patent for Suboxone and profit from its monopoly in the opioid addiction treatment industry for longer, rather than a legitimate safety reason.

Marketing Defects and the Failure to Warn Consumers

Marketing defects are not as easy to see or understand. They are harmful shortcomings in how the product is marketed to consumers, including the risks of using the product. These defects are especially common in the pharmaceutical industry, where drug makers stand to make substantially less in profit if all of the harmful side effects of their drug were disclosed. People simply would not use the drug as frequently. Therefore, pharmaceutical companies have a vested interest in only warning about the dangers that are absolutely required by regulators, such as the FDA. Due to this, marketing defects are often referred to as "failure to warn" cases.

However, products liability law puts a legal duty on pharmaceutical companies to warn doctors and patients about the risks of using their drug - even risks that are rare. This includes all known risks as well as the risks that the company should have known about. Failing to uphold this legal duty to warn people about the dangers of the drug exposes the pharmaceutical company to liability if it causes harm to the people who took it.

That is the legal theory supporting the marketing defects claims in the lawsuits against Indivior: The victims are claiming that they were harmed by the pharmaceutical company's decision to put them at risk of serious tooth decay by either:

1. Knowing of the risks, but intentionally not disclosing them in order to protect the company's profits, or

2. Failing to investigate the potential for tooth decay, even though the risks were reasonably likely due to the acidity of the drug.

If the latter is the case, evidence may reveal that Indivior was perfectly aware that the acidity of Suboxone posed a risk of dental decay, but deliberately chose not to investigate out of fear that they would confirm their suspicions and be forced to include it on the warning label.

Damages Plaintiffs Seek

The Suboxone tooth decay lawsuits filed against Indivior all demand compensatory damages to cover their losses from tooth decay. This includes financial compensation for their:

Medical bills

Lost income

Physical pain

Mental and emotional suffering

After all, they claim, they would not have suffered these losses were it not for the pharmaceutical company's failure to warn them of the risks of developing tooth decay. Therefore, these costs and losses should be borne by the company, not the victim.

Many of these federal Suboxone lawsuits are even demanding that punitive damages be assessed against Indivior for its behavior.

Medical Expenses

The plaintiffs in the Suboxone tooth decay lawsuits are all demanding financial reimbursement for their medical and dental bills. In some cases, these were quite substantial.

Root canal procedures frequently cost over a thousand dollars and, when the tooth is replaced by a crown, the crown can cost anywhere between $1,500 and $5,000. Many victims of the tooth decay caused by Suboxone needed serious dental work on multiple teeth.

Even just the costs of getting cavities filled can accumulate quickly. Each cavity can cost around $150 to fill, and one of the patients in the 2013 study needed 30 of them.

To make matters worse, many of the victims in these lawsuits were using Suboxone to overcome an opioid addiction - a costly and life-altering drug dependency. To face such substantial dental bills at that moment would have been financially crippling for many.

Lost Income

While unlikely, some of the victims in these cases may have lost some income if they had to miss time at work while they were at the dentist. In the worst cases, the tooth decay caused by Suboxone was substantial and required numerous procedures to treat, potentially causing the victim to lose multiple days at work.

Even if the lost income was not substantial, that does not mean that the victim should miss out on it. If Indivior's failure to warn the victim about the potential for tooth decay caused those lost wages, Indivior should pay for it.

It is also not impossible for some of the victims to have lost their ability to earn an income due to the tooth decay caused by Suboxone. For example, if the victim was a model and had to leave their career because of the dental work they needed, they should be compensated for the income that they would have earned, were it not for Indivior's failure to warn them of the potential consequences of using Suboxone.

Pain and Suffering

Perhaps the most substantial losses suffered in these cases was the physical pain and the emotional and mental suffering that the victims went through.

Serious dental work and oral surgeries are among the most painful procedures that you can go through. The pain associated with root canals and tooth extractions, even with anesthesia, can be excruciating. The aftermath of these oral surgeries can leave the victim too debilitated to function. Even just toothaches can inflict a constant pain that can be a distraction, make it difficult to focus on other tasks, and even make it difficult to fall asleep.

Victims are also likely to suffer mentally, particularly those who have never had problems with their teeth before. All of a sudden, and for seemingly no reason at all, their teeth are falling apart. Not knowing the cause or how to stop it from continuing can be agonizing.

The emotional distress that victims can feel can also be substantial, especially if the victim was not able to pay for a prosthetic or crown to replace a tooth that needed to be removed. Missing teeth are disfigurements that can lead to social stigmatization in a society that sees them as a sign of poverty and, particularly, drug use. It can be especially frustrating for people who were able to hide their opioid abuse from others only to lose their teeth to the treatment they chose.

All of these types of losses are difficult to state in a dollar amount. That does not mean that the victim did not suffer them, though. Because they only suffered in these ways because Indivior failed to uphold its legal duty to warn them of the risks of taking their drug, the victims deserve to be compensated appropriately.

Punitive Damages

Finally, some victims are demanding that punitive damages be imposed on Indivior.

Courts can impose this monetary penalty against a defendant in a civil lawsuit for products liability if the defendant's conduct was especially bad or problematic. If imposed, the result would be that the victims would be overcompensated, or recover more than they need in order to be made whole again. However, the court system sees this as justified if the defendant's behavior was bad enough to warrant it.

Punitive damages are rare in civil lawsuits, including those that are based on products liability. They are typically only assessed if the defendant's harmful conduct was intentional or extremely reckless. However, if the evidence reveals that Indivior actually knew about the risks for tooth decay but covered it up, we may see punitive damages get awarded. They may also get assessed due to Indivior's decision to pivot to dissolvable film in order to lengthen its patent and monopoly.

Since the word about the connection between Suboxone and severe tooth decay has gotten out, dozens of people have filed products liability lawsuits against Indivior in courts across the country. Because all of these Suboxone teeth lawsuits make the same allegations against the same defendants and involve the same sorts of dental injuries, they were ripe for consolidation into multidistrict litigation, or MDL. In November, 2023, the plaintiff attorneys in eight disparate actions filed a motion to create an MDL for their cases in the U.S. District Court for the Northern District of Ohio under Judge Calabrese. On February 5, 2024, the U.S. Judicial Panel on Multidistrict Litigation approved it.

Multidistrict litigation is a relatively new way of resolving situations where defendants have hurt a lot of different people in the same way, also known as a mass tort. MDLs are similar to class actions, but rather than gathering all of the plaintiffs into a single Suboxone tooth decay lawsuit, they are consolidated into a single court. There, one judge presides over all of the cases, which move forward through the pretrial motions together. This makes the Suboxone lawsuit process much more efficient. For example, important people only have to sit for a deposition once for the MDL, rather than once for each plaintiff's case. The evidence that is gathered is then used for all of the cases that have been gathered in the MDL.

In the past, MDLs have been used to consolidate as few as a dozen plaintiffs together, or as many as tens of thousands.

Defendants can offer the MDL a settlement and the MDL can accept it, though individual plaintiffs may choose to refuse it and pursue their case on their own, outside the MDL.

If the MDL does not settle, bellwether trials will be scheduled. A couple representative plaintiffs will be selected from the MDL. Their case will then go to trial. This is a real trial, with a jury, opening and closing arguments, evidence presentations, witness testimony, and a verdict. The bellwether trial ends the representative plaintiffs' claims against the defendant and they are removed from the MDL.

The outcome of the bellwether trials is then used to influence the settlement of the rest of the cases in the MDL. If the jury awards a big verdict for the plaintiffs in the bellwether trial, then the settlement value for the rest of the MDL will be massive as the bellwether trial will have shown what the defendant can expect if all the cases went to trial.

A Potential Obstacle: The Statute of Limitations

For people who have suffered dental harm after taking Suboxone and who have not yet filed a lawsuit over it, it is extremely important to act quickly. Any delay can lead to their case being dismissed as time barred by the statute of limitations.

The statute of limitations requires a lawsuit be filed within a certain period of time after the injuries were caused. For personal injury claims based on products liability, the statute of limitations can be as short as one year or as long as six, depending on the state.

Whether the statute of limitations has expired in a particular case is not always easy to tell. Nearly all states have discovery rules - the statute of limitations only starts to run once the victim reasonably should have discovered the harm. In cases like those related to Suboxone, where the connection between the harm and the drug were not clear, this can be controversial.

Reach Out to Oberheiden P.C. for Effective Legal Representation

If you took Suboxone to treat an opioid addiction or chronic pain and then found your dental health in disarray, you can demand financial compensation for what Indivior has put you through, with the help of Suboxone lawyers. By demanding compensation for what you have lost and the pain that you have suffered, you can hold the pharmaceutical company accountable for its egregious profit-seeking behavior.

Call the mass tort lawyers at Oberheiden P.C. on their national intake line at 866-611-7829 or contact them online to get the legal representation that you need to get the compensation that you deserve.

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The Suboxone lawsuits allege that the drug was defective both in how it was designed and in how it was marketed.