Suboxone Makers Back MDL for Dental Injury Lawsuits

Amidst a surge in lawsuits regarding dental injuries associated with Suboxone, manufacturers of the opioid dependency drug are expressing alignment with plaintiffs in advocating for the establishment of a multidistrict litigation (MDL) in federal courts.

The proposed MDL aims to consolidate all claims before a single judge for streamlined discovery and pretrial proceedings. Initially approved by the U.S. Food and Drug Administration (FDA) in 2002 for aiding recovering opioid addicts in managing withdrawal symptoms during therapy, Suboxone (buprenorphine and naloxone) was initially marketed as a tablet.

However, a Suboxone film was later introduced, meant to be placed beneath the tongue until dissolved. Disturbingly, users have reported severe dental injuries from the film, including tooth decay and loss. Consequently, an increasing number of former users are pursuing legal action against the drug manufacturer, alleging inadequate disclosure of risks to both users and the medical community.

The addition of Suboxone tooth loss warnings to the medication in early 2022 came after the FDA identified over 300 cases of dental problems reported to the agency. Plaintiffs argue that proper warnings and instructions to mitigate enamel erosion and tooth loss could have prevented permanent dental damage.

With numerous lawsuits across U.S. District Courts sharing common factual and legal aspects, plaintiffs moved on November 14 to centralize all Suboxone dental injury cases in the U.S. District Court for the Northern District of Ohio. Notably, both Indivior and Reckitt-Benckiser, the drug makers, submitted responses on December 6 endorsing the establishment of a Suboxone MDL. They not only acknowledge the necessity for centralization but also concur with plaintiffs that the Northern District of Ohio is the most suitable venue.

In their responses, the drug manufacturers state, "Defendants agree that there are issues of fact common to the cases identified in the Schedule of Actions accompanying Plaintiffs’ Brief. Defendants also agree that transfer of these and any subsequently filed ‘tag-along’ cases involving similar factual allegations or claims to the United States District Court for the Northern District of Ohio, for consolidated pretrial proceedings is appropriate."

In complex pharmaceutical litigation involving numerous claims stemming from the use of the same medication or medical product, centralizing the litigation through an MDL is a customary approach. This consolidation aims to streamline the legal process, prevent conflicting pretrial rulings, and enhance the efficiency of proceedings for all involved parties.


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