Suboxone Film Lawsuit Filed by 46 Users Alleges Drug Makers Ignored Years of Mounting Dental Injury Reports

Complaint comes as 100 different Suboxone film lawsuits have been chosen to undergo case-specific discovery in preparation for early bellwether test trials.

A growing group of plaintiffs has filed a lawsuit alleging that Suboxone film strips, marketed to treat opioid addiction, caused severe tooth enamel damage resulting in dental injuries and tooth loss.

The joint complaint (PDF) was brought by 46 different plaintiffs in the U.S. District Court for the Northern District of Ohio on March 1. The lawsuit blames Indivior Inc., Indivior Solutions Inc. and Aquestive Therapeutics Inc., formerly known as MonoSol Rx LLC for injuries caused by the design of Suboxone film strips, which they say were defective and lacked proper warnings about the damage the strips could do to patients’ teeth.

Suboxone (buprenorphine and naloxone) is a prescription medication sold by Indivior Inc., which was approved by the U.S. Food and Drug Administration (FDA) in 2002, for the treatment of opioid use disorder. It is designed to help users avoid withdrawal symptoms while undergoing therapy to help them break their addiction.

While Suboxone was originally sold in tablet form, the drug makers later introduced Suboxone film strips, which users place beneath their tongue until they dissolve. However, after the design change, Indivior and the FDA began to receive tooth decay reports from patients, which ultimately led to a Suboxone dental side effects warning being added to the drug’s label in June 2022.

Since then, Indivior has faced thousands of Suboxone film lawsuits filed in federal courts nationwide, which claim the manufacturer failed to provide adequate warnings of the risks of Suboxone dental erosion, tooth damage and tooth loss.

Plaintiffs who signed on to this latest lawsuit are from across the United States, and all say they suffered damage to their teeth as a direct result of Suboxone film strip side effects.

Suboxone “Product-Hop” Allegations

According to the complaint, the shift from Suboxone tablets to film strips was not driven by improved safety or therapeutic benefit, but by an effort to block generic competition during a period of rising demand for opioid treatment medications. Plaintiffs allege the defendants engaged in a so-called “product hop,” introducing a bioequivalent film formulation that was not automatically substitutable for generic tablets, thereby preserving market exclusivity and higher-priced brand sales.

The lawsuit further alleges that the company discouraged physicians from prescribing the older tablet version by citing purported safety concerns before withdrawing the tablets from the market. Plaintiffs contend those actions were designed to delay generic entry and protect monopoly profits rather than improve patient safety.

The complaint alleges that FDA approval of the Suboxone film in August 2010 granted the company a three-year exclusivity period through 2013, and that subsequent patent litigation over the film formulation delayed generic competition until 2019. Plaintiffs contend this strategy effectively prolonged market protection and preserved monopoly profits beyond the original tablet’s exclusivity window.

Federal scrutiny later followed the company’s marketing of the film formulation. In 2020, former Indivior CEO Shaun Thaxter was sentenced to federal prison after pleading guilty to a misdemeanor misbranding charge tied to representations that the film strips were less susceptible to pediatric exposure, a claim federal prosecutors alleged was misleading.

Suboxone Failure To Test and Warn Allegations

Plaintiffs allege that in the push to preserve market exclusivity, defendants failed to adequately test, study or monitor the dental risks associated with the oral-dissolvable film formulation, even as adverse event reports and published research began linking prolonged sublingual exposure to enamel erosion and decay.

“Indivior Inc. sought FDA approval for the Suboxone film on October 20, 2008. In support of the application for the film, Defendants submitted safety and efficacy studies for the tablets. Defendants should have properly analyzed (and/or reanalyzed based on subsequent developments) the data from these studies for FDA as to dental injuries.”

– Brian Adkins et al. v. Indivior Inc. et al

According to the complaint, defendants had a continuing duty to conduct post-marketing surveillance and update the warning label once evidence of a causal link to serious dental injuries emerged. Plaintiffs argue that mounting adverse event data and established knowledge about the effects of acidic compounds on dental health should have prompted earlier action.

Instead, the lawsuit contends the company continued marketing Suboxone film for long-term maintenance use without strengthening its warnings through the FDA’s Changes Being Effected process. The complaint asserts claims of failure to warn, negligent failure to provide adequate warnings and instructions, and pre-approval defective design, seeking compensatory and punitive damages.

Suboxone Film Lawsuits

The complaint will be added to thousands of other claims currently consolidated before U.S. District Judge Philip Calabrese as part of a Suboxone film lawsuit MDL, or multidistrict litigation, in the Northern District of Ohio for coordinated discovery and pretrial proceedings.

Early in the litigation, Judge Calabrese announced that the Court would employ a bellwether trial process, which will prepare representative cases for early trial dates to help gauge how juries may respond to evidence and testimony likely to be repeated throughout the litigation. 

Last month, he announced the selection of 100 Suboxone film lawsuits that will form the core discovery pool, some of which will eventually be selected for bellwether trials.

While the outcome of these bellwether trials will not be binding on any remaining claims, the average payouts awarded by juries may have a significant impact on future Suboxone settlements. However, if no settlement or other resolution is achieved during the pretrial proceedings, Judge Calabrese is likely to remand the cases back to their originating federal districts for individual trial dates.

To stay up to date on this litigation, sign up to receive Suboxone lawsuit updates sent directly to your inbox.