The Suboxone film lawsuits have taken a sharp turn with new claims revealing troubling allegations against its makers. One of the key accusations? The manufacturers—Indivior Inc., Indivior Solutions Inc., and Aquestive Therapeutics Inc.—allegedly knew as early as 2011 that the drug’s design didn’t match what was stated in its patent. Specifically, the average time for the Suboxone film to dissolve was between 5 and 6.6 minutes, much longer than the 3 minutes promised in its patent.
Why does this matter? The longer dissolution time, combined with the film’s acidic formulation, has been linked to severe dental damage, including tooth decay, erosion, and even tooth loss. Yet, the makers reportedly failed to warn patients or doctors about this risk for over a decade, even as complaints and safety concerns piled up.
If Suboxone film caused harm to you or someone you love, now is the time to take action. Speaking with an experienced Suboxone lawyer can help you understand your rights, explore your options, and pursue the compensation and accountability you deserve. Don’t wait—reach out today to get the help you need.
The New Allegations Against Suboxone Film Makers
The latest lawsuits against the makers of Suboxone film have brought some serious accusations to light. Plaintiffs claim that the manufacturers—Indivior Inc., Indivior Solutions Inc., and Aquestive Therapeutics Inc.—misled patients and doctors about the safety of Suboxone film while making choices that seemed more focused on profits than patient safety.
One major issue centers on how long the film takes to dissolve. According to the lawsuit, the makers knew as far back as 2011 that the average dissolution time was between 5 and 6.6 minutes, not the 3 minutes claimed in their patent. Why does it matter? Because the longer the acidic film sits in the mouth, the more likely it is to cause serious dental damage, including decay, erosion, and even tooth loss.
The plaintiffs also argue the manufacturers failed to properly warn patients and doctors about these risks. While users reported dental problems as early as 2012, the company didn’t update the label with a warning until 2022—more than a decade after the product hit the market. During that time, patients were left unaware of steps they could take to protect their teeth, like waiting an hour after the film dissolved before brushing.
Another big part of the case focuses on the film’s design. The lawsuit claims that the manufacturers could have stuck with the tablet version of Suboxone, which posed less dental health risk . Instead, they went with the film format—not to improve safety, but to block competition from cheaper generic tablets. This move allegedly created a monopoly and limited treatment options for patients while driving up costs.
These new allegations raise serious questions about how Suboxone was developed and marketed, making accountability for its harmful effects more important than ever.
The Dental Health Risks Linked to Suboxone Film
A major concern raised in the Suboxone film lawsuits is its link to serious dental damage. Patients using the drug have reported everything from cavities to severe tooth decay, gum disease, and even tooth loss.
The issue stems from the film’s acidic formulation, which dissolves under the tongue to release buprenorphine and naloxone. This process leaves the mouth acidic, which weakens enamel and makes teeth more vulnerable to decay and erosion. Compounding the problem, lawsuits allege the manufacturers knew film takes 5 to 6.6 minutes to dissolve—much longer than the 3 minutes claimed in its patent—prolonging exposure to harmful acidity.
Even patients with no prior dental issues have experienced significant problems, as confirmed by the FDA’s 2022 warning about buprenorphine-related dental damage. This included reports of cavities, oral infections, and tooth loss. Despite these risks, the manufacturers didn’t update the product’s label with dental health warnings until June 2022, leaving patients unaware of how to minimize damage, like avoiding brushing right after use.
For those who relied on Suboxone film, these dental risks have caused unexpected and lasting harm. The lawsuits aim to hold its manufacturers accountable for failing to warn patients and adequately address these dangers.
Design Defects and Anticompetitive Practices
The lawsuits against Suboxone’s makers bring up serious allegations that go beyond its dental health risks. Plaintiffs claim the manufacturers made decisions about the drug’s design and marketing that prioritized profits over patient safety and affordability. From switching to the film version to putting pressure on doctors, these actions are now being heavily questioned.
Tablets vs. Film: A Missed Opportunity for Safer Design
One of the central claims is that the manufacturers could have continued producing Suboxone tablets, which posed far less risk to dental health than the acidic film. The tablet version was already effective, but the lawsuit argues that the decision to focus on the film wasn’t about improving safety or effectiveness—it was about eliminating competition.
By introducing Suboxone film, the manufacturers created a product that couldn’t be directly substituted with cheaper generic tablets. This move, the lawsuit claims, secured their monopoly,
driving up prices and leaving patients with fewer affordable treatment options.
Pressure on Prescribers
The plaintiffs also allege that Suboxone’s makers put significant pressure on doctors to switch their patients from tablets to the film. According to the lawsuit, the company created financial disincentives for prescribers who didn’t comply, making it harder for doctors to continue prescribing tablets.
In 2012, the manufacturers announced they were pulling Suboxone tablets from the U.S. market, citing safety concerns. But the lawsuit argues that this was just an excuse to push the film version and discourage the use of cheaper generics. By doing so, the companies allegedly forced patients and providers to rely on the more expensive film.
These allegations suggest that the decisions around Suboxone weren’t made with patients’ best interests in mind. For those who relied on Suboxone, the lawsuits aim to hold its manufacturers accountable for their choices and the harm they caused.
Legal and Regulatory History of Suboxone Film
Suboxone film has been at the center of some serious legal and regulatory issues in recent years, raising big questions about the actions of its manufacturers. Back in 2016, Indivior paid $102.5 million to settle claims that it used unfair tactics to block generic versions of Suboxone, keeping prices high for consumers.
In 2019, things escalated when both Indivior and its former parent company, Reckitt Benckiser, were accused of misleading doctors and patients about the safety and effectiveness of Suboxone film. Reckitt ended up paying a massive $1.4 billion settlement—the largest of its kind for an opioid-related drug—over claims of fraudulent marketing that downplayed risks and exaggerated benefits.
More recently, a federal judge allowed lawsuits related to Suboxone’s design and lack of proper warnings to move forward. This decision opens the door for more evidence to be gathered, especially about whether the manufacturers knowingly withheld important safety information.
All of this paints a troubling picture of how Suboxone film has been handled. From legal battles to regulatory scrutiny, the ongoing issues only reiterate the need for accountability and transparency in the pharmaceutical industry, especially when it comes to medications tied to the opioid crisis.
What This Means for Plaintiffs in the Suboxone MDL
If Suboxone film has caused you harm, the ongoing multidistrict litigation (MDL) could be a chance to seek justice and hold the manufacturers accountable. Joining the MDL might sound complicated, but it’s a straightforward process, especially with the help of an experienced lawyer. Here’s how it works and what kind of compensation you could receive.
If you think you might have a case, here’s what you’ll need to do:
- Talk to a lawyer: Reach out to an attorney who specializes in MDL cases. They’ll listen to your story, look at your situation, and let you know if your case fits into the MDL.
- Collect your evidence: This includes medical records, proof that you used Suboxone, and any details showing how it caused harm. Your lawyer will help you pull together everything you need.
- File your case: Your attorney will handle the paperwork and make sure your claim is included in the MDL. They’ll guide you through the process, so you don’t have to figure it all out on your own.
By joining the MDL, you’ll benefit from shared resources, such as expert testimony and evidence, while still having your individual experience considered.
Why It’s Important to Act Now
If you’ve been harmed by Suboxone film, don’t wait to take the first step. Talking to a knowledgeable lawyer can help you figure out your options and get your claim moving. By filing a claim, you’re not just pursuing the compensation you deserve—you’re also standing up for accountability and helping to push for better safety standards in the future.
Potential Compensation
If you’re part of the MDL, you could be eligible for several types of compensation:
- Medical costs: This includes coverage for dental treatments, ongoing healthcare, and any other expenses related to Suboxone film’s side effects.
- Pain and suffering: Compensation may also cover the physical and emotional toll you’ve experienced, including how the harm has impacted your quality of life.
- Punitive damages: In cases where the manufacturers acted recklessly, additional damages may be awarded as a way to hold them accountable and send a strong message.
For plaintiffs, this case represents an opportunity to not only seek compensation but also push for accountability from Suboxone’s manufacturers. If you believe you’ve been affected, reaching out to a knowledgeable MDL attorney can help you understand your options and take the next steps toward justice.
Seeking Justice in the Suboxone Film Case
The claims brought by Gayle Ortega in the Suboxone film MDL highlight some serious concerns about patient safety and corporate accountability. From the drug’s acidic formulation leading to dental damage to allegations of blocking generic competition, these issues go beyond individual harm—they raise questions about the priorities of the manufacturers and their responsibility to patients. Ortega’s case adds significant weight to the ongoing litigation and shines a light on the need for greater transparency and oversight in the pharmaceutical industry.
If you or someone you care about has experienced dental damage, unexpected side effects, or other issues linked to Suboxone film, it’s important to know you’re not alone. You may have legal options to hold the manufacturers accountable and seek compensation for the harm caused.
Don’t hesitate to take action. Reach out to our Suboxone MDL attorneys who can help you understand your rights, review your case, and guide you through the process. Speaking with an experienced lawyer could be the first step toward getting the justice and compensation you deserve.