Indivior's Failure to Warn

The Legal Standard: What Pharmaceutical Companies Must Warn About

Pharmaceutical manufacturers have a continuing legal duty to monitor the safety of their products after FDA approval and to update their labeling when new safety information comes to light. This duty of post-market surveillance and label updating is codified in FDA regulations at 21 C.F.R. § 314.81(b)(2)(i), which requires manufacturers to report and disclose newly identified risks. Under product liability failure-to-warn doctrine, a manufacturer can be held liable for injuries caused by an undisclosed risk if it knew or reasonably should have known about that risk through the exercise of due diligence — including review of adverse event reports, published medical literature, and pharmacovigilance data.

The learned intermediary doctrine — a defense often invoked by pharmaceutical companies — holds that a drug manufacturer satisfies its duty to warn by providing adequate warnings to prescribing physicians, who then relay that information to patients. However, this doctrine has significant limitations in the Suboxone context: prescribers were themselves not warned about the dental risk, and therefore could not counsel patients to take protective measures such as rinsing after each dose, waiting before brushing, or scheduling more frequent dental evaluations.

The Timeline of Known Risk vs. Disclosed Risk

Suboxone sublingual film received FDA approval in 2010. Published case reports linking sublingual buprenorphine formulations to dental decay began appearing in peer-reviewed dental and addiction medicine journals in 2012 and 2013. Adverse event reports to the FDA's Adverse Event Reporting System (FAERS) describing dental injuries in buprenorphine sublingual users accumulated over the following years. By 2015 to 2016, the association was being discussed in dental professional forums and clinical publications. Through all of this period, Indivior's prescribing information and patient medication guides contained no meaningful dental safety warnings.

It was not until the FDA mandated new labeling on January 12, 2022 — more than a decade after Suboxone film's approval — that dental warnings were added to the product's labeling. Plaintiffs' attorneys argue that this twelve-year gap between the drug's approval and the addition of dental warnings, during which adverse event reports accumulated and medical literature documented the risk, constitutes a failure to fulfill the manufacturer's duty to warn that caused thousands of patients to sustain preventable dental injuries.

Indivior's Corporate History and Context

Indivior was spun off from Reckitt Benckiser in December 2014, inheriting the Suboxone product line and all associated regulatory and legal obligations. This is not the company's first encounter with product liability litigation: in 2019, Indivior pled guilty to a federal felony charge of making false statements to Medicaid about the relative safety of Suboxone film compared to generic alternatives, agreeing to pay $600 million in fines. This prior conduct is relevant background in Suboxone dental injury litigation, as it speaks to Indivior's approach to safety disclosures and its prioritization of market position over patient safety. Discovery in MDL 3092 is expected to probe Indivior's internal knowledge of the dental risk and the company's decision-making process regarding label updates.