The opioid crisis has long been a contentious issue in the United States, and now, a new legal battle is unfolding as several plaintiffs have come forward with allegations against pharmaceutical companies responsible for Suboxone film. On December 11, 2025, Desiree Hawkins and other plaintiffs filed a complaint in the United States District Court for the Northern District of Ohio against Indivior Inc., Indivior Solutions, Inc., and Aquestive Therapeutics, Inc. The lawsuit claims that these companies’ negligence in the development and marketing of Suboxone film has led to severe dental damage among users.
According to the complaint, Suboxone film is marketed as a treatment for opioid use disorder. It combines buprenorphine and naloxone to help reduce withdrawal symptoms without causing the highs associated with opioid misuse. However, plaintiffs argue that its acidic formulation leads to significant dental erosion and decay. The lawsuit alleges that defendants were aware or should have been aware of these risks but failed to adequately warn patients or healthcare providers. The FDA’s Drug Safety Communication issued in early 2022 corroborates these claims by highlighting serious dental problems associated with buprenorphine-containing medications dissolved in the mouth.
The plaintiffs are seeking compensatory damages for their injuries caused by Suboxone film. They argue that despite changes made to prescribing information in June 2022, warnings about dental risks remain insufficient. The complaint also points out that while Canadian labels warned of potential dental harm from similar products, American labels did not include such warnings until mandated by the FDA. This omission forms part of their claim that defendants violated consumer protection laws by failing to disclose known dangers.
Represented by attorneys whose names are not specified in the document, plaintiffs demand judgment against defendants for statutory damages, punitive damages, attorneys’ fees, and costs incurred due to their use of Suboxone film. They assert jurisdiction under federal law due to diversity of citizenship between parties involved and an amount exceeding $75,000 at stake.
Judge J. Philip Calabrese presides over this case under Case No. 1:25-sf-66163-JPC alongside related multidistrict litigation concerning liability issues surrounding Suboxone products (Case No.: 1:24-md-03092-JPC). As this legal battle unfolds within Ohio’s Eastern Division courtrooms—spanning multiple jurisdictions across different states—it highlights ongoing concerns about accountability within America’s pharmaceutical industry amidst an enduring public health crisis exacerbated by opioids like those treated with drugs such as Suboxone.
Source: 125sf66163_Hawkins_v_Indivior_Inc_Complaint_Northern_District_Ohio.pdf
