In 2022, the FDA released a safety communication about serious dental problems such as tooth decay, oral infections, cavities and loss of teeth occurring in people who used buprenorphine medications such as Suboxone Sublingual Film. Plaintiffs harmed by Suboxone have since begun filing lawsuits against the drug’s maker, Indivior.

Suboxone Sublingual Film is a brand-name prescription medication used to treat opiate addiction. Suboxone contains the active ingredients buprenorphine and naloxone.

In this Q&A, mass torts and product liability attorney Trent B. Miracle of the award-winning law firm Flint Cooper, LLC, explains why people are filing Suboxone lawsuits, the status of Suboxone litigation and who qualifies to file a claim.

Q: What is Suboxone, and why are people filing Suboxone lawsuits?

Suboxone is a drug that’s actually an opiate, and it’s used to reduce withdrawal symptoms for people trying to break from opioid addiction. The reason people are filing lawsuits related to this is very specific to the delivery system that the manufacturer of Suboxone started putting out in 2013. It’s a film that you put between your cheek and your gum, kind of like a Listerine breath strip that you might put in your mouth to freshen up your breath.

Unfortunately, that delivery system has a very high acidic content. And when you use it — which is typically three times a day — you’ve got to keep it in your mouth for about 10 minutes each time to get the full benefit of the dosage. Studies are reflecting that that amount of acidic content that many times a day is resulting in tooth breakage, tooth loss, tooth decay and all sorts of serious dental issues. And that’s the underlying reason for the lawsuits.

Q: So Suboxone lawsuits are claiming that the drug is poorly designed and Invidior, the manufacturer, didn’t properly warn the public about the risk? 

Absolutely. So, if it got approved back around 2013 and hit the market not too long after that, until 2022 there was no warning associated with decay and dental issues. So, for the better part of over a half decade, people were using this without the benefit of a warning. Physicians who were prescribing it couldn’t use the warning to help patients make an informed decision about whether to take Suboxone because the manufacturer kept that risk to themselves.

Q: What are the injuries people are claiming in Suboxone lawsuits? 

The injuries that we’re seeing so far, and I think the injuries that you’re going to see moving forward, have to do with permanent damage to people’s teeth. So, you’ll be seeing people with lost teeth, broken teeth, chronic cavities and loss of tooth enamel, which eventually is going to lead to tooth loss and tooth decay.

Many of these people are losing their teeth. That becomes another medical issue they’re having to deal with (on top of their addiction treatment) and whether or not they’re going to need to get replacement procedures done. Those procedures aren’t inexpensive. But, at the end of the day, these people are trying to help themselves. They were trying to raise themselves out of a really terrible situation: opiate addiction. And as a thank you for that from the drug companies, they ended up with their teeth falling out of their head.

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Q: You talked about the financial costs, but is there also a heavy emotional cost associated with these injuries as well?

Well, 100%. There’s already the stigma attached to the fact that somebody is struggling with addiction issues. So that is crushing. Someone’s self-confidence and self-worth are obviously affected. Then just add to that this condition with serious dental issues and it makes it exponentially worse than it already was.

Q: What does the science say about Suboxone’s connection to dental problems?

There have been a few case studies since around 2012 that kind of highlight the dental issues that go along with the usage of Suboxone. But I think even more illuminating are the adverse event reports the FDA has been receiving for the last 10 years. They’ve been receiving reports from the manufacturer and from the general public.

The company is and has been aware that there are complaints related to their product — in this particular case, tooth decay or dental issues. They’re supposed to report that to the FDA, then the FDA can track these adverse events and try to make an educated determination on whether a new warning is warranted, whether the drug should be taken off the market or whether the drug’s use needs to be more limited.

There’s been a consistent wave of complaints and adverse events reported to the FDA going back about 10 years. So the FDA was aware, but more importantly, the manufacturer Indivior was aware that these issues were out there. They could have taken it upon themselves to approach the FDA and say, “Hey, we need to make a change to the label.” But they didn’t do that. They waited until 2022 when the FDA finally realized this was an issue and directed them to make the label change and include the warning on the product.

That’s why we decided to bring these lawsuits and are 100% invested in helping people affected by Suboxone.

Q: What’s the current status of the litigation and how much bigger do you think this litigation is going to get?

The current status of litigation is that there are cases filed in various federal courts around the country. There are around 14 of those. Recently, there was a petition filed with the judicial panel for multidistrict litigation, seeking to have these cases consolidated before a single court. We filed a notice of appearance in front of the panel, and we backed up that application. We’re associated with the firm that filed a petition originally, and we are part of a coalition of firms that will be working together moving forward on these cases.

I can’t give you a specific number of how many cases I think will be filed at the end of the day, but I can tell you that we are going to be representing thousands of individuals in this litigation, and we’re not going to be alone in that effort. So I could see a scenario where this litigation balloons to 5,000 or 10,000 individuals in the MDL, maybe more. We’re hopeful that, as the suit progresses, it’s really going to shine a light on the issues with Suboxone so more people become aware of what happened and whether it’s happening to them specifically.

The big reason we wanted to get involved in this case and are helping lead the charge on it is because you have this demographic of people who traditionally have been stigmatized. This problem was ignited by the manufacturers of these opiates over the last 10 or 20 years and that in turn created the opioid epidemic. So people were injured using Suboxone through no fault of their own because they weren’t warned of the risk, and all they were trying to do in this situation was make themselves better. We’re here to help anybody in that situation.

Q: If people believe they were injured by Suboxone, how do they know if they qualify for a lawsuit?

I’d say first find out if you qualify for a lawsuit by contacting a firm that is handling these types of cases. They can walk you through the vetting criteria and the process for whether or not you’re going to qualify.

But in broad strokes, if you were suffering from addiction to opioids and a physician prescribed Suboxone in this delivery system, and as a result of using Suboxone you have suffered from tooth decay, tooth loss, broken teeth or any other serious dental condition, you could qualify for this lawsuit.

Q: What is the process of filing a Suboxone lawsuit after you find an attorney?  

After going through that process, you find a firm willing to represent you, and if you’re comfortable with signing the contracts, that firm will start to gather up your medical records They will collect your pharmaceutical records so they can prove that you were using this specific type of Suboxone. They’re going to gather up your dental records to show the issues that you suffered as a result of the use of that particular type of Suboxone and possibly gather a more comprehensive group of your medical treatment records.

In a situation where there are thousands of lawsuits, typically, there’s only going to be a handful of individual cases that actually get to the point where they are tried. This is so both sides — the defendants and the plaintiffs — see what the value of these cases is within the context of a jury trial. If your case is one that will be tried in what we call a bellwether trial, obviously it’ll be a more comprehensive work up. You’ll probably have to give depositions, we’ll be gathering all of your medical and pharmaceutical records, and it’ll be a much deeper dive.

However, for 99.9% of the people involved in litigation, you’re going to deal with your attorneys, you’re going to give them authorizations to get records of various types, and then you may not have to do a whole lot for the next couple of years.

It could potentially be three or four years before the first trial. Sometimes it’s sooner, but three or four years is typically the rule of thumb. Then once you have that trial, sometimes it’s constructive enough to be able to lead to a resolution sooner than later.

Fortunately for us, public sentiment for this particular issue, as it relates to opioid addiction and the national epidemic, is timely. So hopefully, that type of timeliness and that type of public sentiment will bring enough pressure to bear on the defendants here to resolve their cases sooner rather than later.

Q: What tips do you have for people looking for an attorney?

I think it’s important that you find a firm that not only has involvement in this particular litigation but also has experience in dealing with multidistrict litigation and what’s commonly referred to as mass torts. Especially cases involving pharmaceuticals. These cases are highly specialized, incredibly complex, and involve armies of experts and experience brought to bear over past litigations.

It’s imperative to find an attorney who meets those qualifications. You shouldn’t just walk into an injury lawyer’s office and say, “Hey, I got this case, can you represent me?” Because nine times out of 10, while they might take your case, they’re just going to send it on to somebody else anyway and then you have no control over who your lawyer is at that point.

Q: What experience does Flint Cooper, LLC, have in this type of litigation?

Flint Cooper is made up of lawyers who have been doing this type of litigation for quite a while.

I have been doing these types of cases for about 25 years now. And I’ve been co-lead counsel on several multidistrict litigations involving pharmaceuticals. As I said before, I was involved in litigation against Purdue Pharma regarding OxyContin in the early 2000’s and it was very gratifying to be able to represent people before any of this really broke seven or eight years later.

This firm has the ability to back these types of cases with the experienced and experienced staff, as well as the financial resources necessary to pursue these claims. And aside from that, our relationships — and specifically my relationships — with other firms that we coordinate with and co-counsel with during the course of these litigations are very valuable. We work together both in the leadership structure of the litigation and tactical planning, as well as decisions made about how the litigation is going to move forward. There are only so many firms in the country that can do that, and we just happen to be fortunate enough to be one of those.