Cleveland, OH – On December 16, 2024, Judge J. Philip Calabrese of the Northern District of Ohio heard oral arguments in Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation. The hearing concerned the defendant, Indivior PLC’s, motion to dismiss the Suboxone complaint under Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim on which relief can be granted. The arguments largely tracked briefs originally filed in July 2024, which the court required to be amended.
It’s a usual and ordinary step in a drug side effect lawsuit. For defendant’s counsel not to file a 12(b)(6) motion would be tantamount to professional malpractice. The betting money, however, says that it will fail.
But here is why it bears watching.
First, some facts, then some questions
In 2002, the FDA approved Suboxone, a buprenorphine-naloxone sublingual tablet, for the treatment of opioid use disorder. It approved the sublingual film form of the drug eight years later, in 2010. Indivior removed the tablet version from the market that same year. The change from tablet form to film method of delivery is significant here.
The film was thought to be less likely to be abused than the tablet form, but the chemical composition of the drug is highly acidic. Patients were encouraged to hold the film in their mouths to maximize absorption. This is now linked to a variety of dental injuries, including:
severe tooth decay;
cavities;
tooth loss;
oral infections;
gum injuries; and
tongue injuries.
The big question in this case is whether Indivior should have altered the warning label to reflect the greater risk of dental injury with the under-the-tongue film. The smaller question, and the entire focus of the hearing, was whether the plaintiffs had made even a minimally plausible case that the label should have been changed. This is a very low bar.
The plaintiff’s argument
The plaintiffs allege that the FDA-approved label for Suboxone film contained inadequate warnings about the risk of dental injuries from 2010 until 2022, when Indivior added some information to the label. Even after 2022, they claim, the warnings fell short. After 2022, reports of dental damage have continued to mount. The plaintiffs claim that the warning labels should have been amended to reflect the accumulating evidence. They anchor their argument in state products liability law.
Indivior’s preemption argument
Indivior’s first argument gets into esoteric issues of what to do when state and federal law conflict. In general, when the two bodies of law cover exactly the same territory, federal law wins. It “preempts” state law.
In this situation, Indivior argues that federal law, specifically the Federal Food, Drug, and Cosmetic Act (FDCA), preempts the plaintiffs' state law claims because FDCA gives the FDA exclusive authority to regulate the labeling of prescription drugs. In other words, Indivior argues that if the FDA has approved a drug label, then state law cannot impose additional labeling requirements.
Plaintiffs argue that the FDCA does not prohibit states from imposing additional labeling requirements, as long as those requirements do not conflict with federal law. Plaintiffs argue that their state law claims are not based on allegations of inadequate labeling, but rather on allegations of failure to warn.
Indivior’s second argument -- major or minor
Indivior also argues that it was not, in fact, permitted to make changes in the warning label without seeking new FDA approval of the drug because the changes requested do not fit within the FDA’s exception, known as the Changes Being Made (CMB) process. That process allows for certain minor changes to be made without prior FDA approval.
Indivior argues that the alteration of the warning about tooth damage was not minor because it raised new safety concerns. Therefore, they contend, it fell outside the scope of the CMB process. Plaintiffs disagree.
Standards for granting a 12(b)(6) motion
As a rule, federal courts will not grant a 12(b)(6) motion, unless there is no plausible way that the plaintiffs’ claims could support a lawsuit. Courts are deeply reluctant to decide the fate of a lawsuit without first hearing evidence.
Here, the evidence and arguments will relate to two substantive issues:
whether Indivior was required to obtain additional FDA approval to change the warning label on Suboxone; and
whether the plaintiffs' state law claims are preempted by federal law.
The court will need to consider these arguments carefully to determine whether the lawsuits should be dismissed.
Lurking beneath it all is the hot political issue of whether the FDA exceeded its statutory authority in preempting state law claims. For those disconnected from the challenges of opioid use disorder, but otherwise concerned with drug safety, this is why the Suboxone lawsuit bears watching.
If you or a loved one have suffered losses in this case, please click the link below and your complaint will be sent to a drugs & medical lawyer who may evaluate your Suboxone Tooth Decay claim at no cost or obligation.