
The ongoing Suboxone tooth decay MDL has had a big win. Judge Calabrese denied the defendant's motions to dismiss claims related to design defects and the failure to warn patients. This decision is a huge development for plaintiffs seeking justice for the harm they suffered due to Suboxone’s acidic formulation that has caused major tooth decay.
Here's a breakdown of the ruling and its implications for the lawsuit.
Overview of the Suboxone Film MDL
Suboxone is a sublingual film medication that was approved in 2010 for the treatment of opioid use disorder. It contains buprenorphine, which reduces withdrawal symptoms, and naloxone, an opioid antagonist.
While Suboxone has been effective in treating opioid dependence, plaintiffs in the MDL argue that Suboxone’s acidic formulation leads to severe consequences, including dental issues, including tooth decay, tooth loss, and infections.
The case at the center of this motion involves plaintiff Ryan Bennett, who claims that long-term use of Suboxone film caused significant dental damage.
Bennett asserts that the defendants, Indivior, Indivior Solutions, and Aquestive Therapeutics, failed to adequately warn users of the risks and could have developed a safer alternative design.
Learn more about the lawsuit by reading our Suboxone FAQ page.
Design Defect Claim Survives Dismissal
In a recent ruling, Judge Calabrese of the U.S. District Court for the Northern District of Ohio declined to dismiss the plaintiff’s design defect claim. The judge’s decision is particularly notable as it touches on the hotly debated issue of preemption in pharmaceutical litigation.
What Is Preemption?
Preemption occurs when federal law supersedes state law. In this case, the defendants argued that federal law, specifically the Food, Drug, and Cosmetic Act (FDCA), preempts (aka prevents) design defect claims. They contended that once Suboxone film received FDA approval, which is at the federal level, state law claims challenging the drug’s design were no longer allowed. Remember the whole "federal law supersedes state law" thing?
However, Judge Calabrese ruled otherwise.
He determined that at the pleading stage, federal law does not preempt design defect claims involving pre-approval conduct. He cited precedents such as Tobin v. Astra Pharmaceutical Products, Inc. and Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., which allow for such claims under certain circumstances.
The court emphasized that the plaintiffs will have to show that a safer, feasible alternative design existed before FDA approval, which Bennett alleges with his reference to injectable alternatives like Sublocade.
The Role of Alternative Designs
The plaintiff highlighted Sublocade, an injectable buprenorphine product approved in 2017, as evidence that a safer alternative existed.
The judge found this argument persuasive enough to proceed with discovery, noting that further factual development is necessary to evaluate whether such an alternative was viable at the time Suboxone film was developed.
Failure-to-Warn Claim Moves Forward
The court also allowed Bennett’s failure-to-warn claim to move forward. This claim hinges on the allegation that the defendants failed to update Suboxone’s labeling to include warnings about dental risks, despite having “newly acquired information.”
Newly Acquired Information
Under FDA regulations, drug manufacturers must update their labels when they obtain new information that suggests significant risks associated with their products.
Bennett’s complaint cites multiple sources, including published case reports and adverse event data, to argue that the defendants were aware of the dental risks as early as 2011.
The judge ruled that further discovery is required to determine whether these studies and reports qualify as “newly acquired information” under the FDA’s Changes-Being-Effected (CBE) regulation.
This sets the stage for an in-depth examination of what the defendants knew, when they knew it, and whether they failed to act responsibly to protect patients.
Ruling's Implications for Plaintiffs
This ruling is a significant victory for the plaintiffs in the Suboxone MDL. By allowing the design defect and failure-to-warn claims to proceed, the court has opened the door for discovery, which could uncover crucial evidence about the development and marketing of Suboxone film.
Key questions that will likely be explored during discovery include:
- Whether the defendants had access to data indicating dental risks before Suboxone film’s approval.
- Why the initial label lacked warnings about dental issues.
- Whether safer alternative designs were feasible and could have been implemented.
If the plaintiffs can prove their claims, they could potentially recover damages for medical expenses, pain and suffering, and other losses related to their dental injuries.
Broader Implications for Pharmaceutical Litigation
The Suboxone MDL is also significant in the broader context of future pharmaceutical litigations involving dangerous drugs. Preemption arguments are a common defense strategy for drug manufacturers, and this ruling reinforces that courts may not automatically accept such defenses, particularly at the pleading stage.
The decision highlights the importance of thoroughly exploring the facts and circumstances surrounding a drug’s development, approval, and marketing.
Speak to a Suboxone Lawsuit Lawyer
As the litigation progresses, both sides will engage in extensive discovery to build their cases. For plaintiffs, this means gathering evidence to support their allegations of design defects and failure to warn. For the defendants, it involves mounting a robust defense to challenge these claims and potentially seeking summary judgment down the line.
The outcome of this MDL could have far-reaching implications for other cases involving Suboxone and similar medications. It also serves as a reminder that drug manufacturers must prioritize patient safety and transparency to avoid costly litigation and harm to their reputations.
If you or a loved one has experienced dental issues after using Suboxone film, you may be entitled to compensation. Contact our experienced partner firm to find out if you qualify for a Suboxone lawsuit claim today by filling out our simple form.