June 17, 2024, looms large for many who relied on Suboxone, a medication designed to help people overcome opioid dependence. This date marks the two-year anniversary of the FDA requiring Suboxone labels to warn about a potential side effect: severe tooth decay.
Now, a race against time is on for thousands who believe the drug's maker failed to adequately warn them about this risk, leaving them with permanent dental damage.
Suboxone, launched in 2002 as a dissolvable tablet, offered hope for many battling addiction. However, a new film version introduced a decade later came with a devastating consequence, according to lawsuits filed by thousands.
These lawsuits allege the film significantly increased the risk of serious dental problems. Plaintiffs claim the manufacturer prioritized profits by introducing the film to prevent generic competition, pushing consumer safety aside. They argue that earlier warnings about potential tooth damage could have prevented their suffering.
In June 2022, after receiving reports of over 300 cases of dental damage linked to Suboxone, the FDA required the medication's label to include warnings about tooth decay. This prompted a surge in lawsuits from people who believe they suffered because of a lack of earlier warnings.
To streamline the legal process, all federal Suboxone lawsuits were consolidated in February 2024 before a single judge in Ohio. The number of claims skyrocketed from 20 to over 200 in just two months. However, June 17th, 2024, poses a potential challenge. The manufacturer may argue this date triggers the statute of limitations, a deadline for filing some claims.
With the deadline approaching, the recent Case Management Conference on April 29th focused on how the lawsuits will proceed. A key point of contention is the order of discovery, the process of exchanging information between parties. The manufacturer, Indivior, wants to first focus on "general causation" – can Suboxone cause tooth decay?
This seems like a basic question, but there's a twist. Indivior already added a warning about tooth decay to the Suboxone label in 2022, without a legal fight. Plaintiffs argue this is an admission of a link between Suboxone and dental problems. They believe the focus should be on whether the drug caused their specific injuries, not a general question about Suboxone's potential harm.
The judge will decide how discovery will proceed. Plaintiffs argue that addressing both general and specific causation simultaneously is the most efficient way to move the cases forward, ensuring a faster resolution for those facing the June 17th deadline and struggling with dental problems they believe Suboxone caused.
One thing is certain: thousands who fought addiction now face a new battle – a fight for justice and the chance to restore their smiles.
The Suboxone MDL is In Re: Suboxone (Buprenorphine/Naloxone) Film Marketing, Sales Practices, and Products Liability Litigation, MDL No. 3092, in the U.S. District Court for the Northern District of Ohio.
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