Suboxone Tooth Decay Lawsuits
As of August 2024, there are 673 Suboxone tooth decay lawsuits pending in multidistrict litigation (MDL) within the Northern District of Ohio. Attorneys predict this number to increase as people using Suboxone for the treatment of opioid use and suffering from tooth decay are discovering the link between the two.
Suboxone plaintiffs claim that Indivior failed to warn users of potential dental hygiene issues before adding a warning label in 2022. Lawsuits indicate that Indivior is responsible for failing to warn consumers about the dental risks of severe tooth decay and other oral health issues, including emotional issues.
On June 3, Judge J. Philip Calabrese heard arguments on the general causation issue and the discovery dispute. Calabrese denied Invidior’s motion. According to court documents,
"Defendants seek to sequence discovery by proceeding first with discovery related to general causation, limiting case-specific discovery and discovery relating to marketing, promotion, and other issues that generally apply to all cases in this MDL. Plaintiffs oppose this request, claiming it will unnecessarily prolong the MDL, poorly use the resources of the Court and the parties, and present difficult problems drawing lines between discovery relating to general causation and other issues. On June 3, 2024, the Court held oral argument on the dispute. For the reasons that follow, the Court DENIES Defendants’ motion."
Invidior's Arguments
At the beginning of August, Defendants filed a motion for partial dismissal of the lawsuits, mainly arguing that the plaintiffs' state law claims are barred (or “preempted”) by the federal laws governing prescription drug labeling and advertising.
Invidior attests that design defect and failure to warn claims are preempted by federal laws, which dictated what Indivior could put on the Suboxone label warnings. Because Invidior needed permission from the FDA before changing the label or the formulation of Suboxone, the company argues that it could not have changed the label – therefore it cannot be held liable for violating state design defect and failure to warn laws, as federal law should take precedence.
“Plaintiff claims that the Suboxone Film label was inadequate at the time the FDA approved it because it did not address the claimed risk of adverse dental events,” the motion states. “Federal law preempts this claim.”
The FDA determined the safety and efficacy of Suboxone when it approved the drug. Furthermore, after the FDA-mandated label change in June 2022, the defendants state that there has been no newly acquired information that would justify another label change under the FDA's "changes being effected" regulation. Therefore, any claims that the label remained inadequate are also preempted.
The defendants assert that federal law prohibits non-NDA (New Drug Application) holders from changing the drug label. Since only the NDA holder can change the label, claims against other defendants who do not hold the NDA are preempted.
READ MORE SUBOXONE TOOTH DECAY LEGAL NEWS
Canada Accepting Invidior Tooth Decay Claims
A class action was issued in May 2024 in the Supreme Court of British Columbia, alleging that Suboxone causes significant damage to patients’ teeth and associated dental issues and that defendants failed to warn patients and physicians of Suboxone’s material risk to their dental health. The plaintiff brings this action on behalf of himself and all Canadian residents who were prescribed Suboxone since 2007 and who developed dental issues, including but not limited to tooth decay, cavities, oral infections, tooth caries, gum disease, and loss of teeth.