In the midst of America's ongoing battle with opioid addiction, Suboxone has emerged as a common prescription aimed at helping those hooked on opioids find their way to recovery. However, recent legal proceedings have shone a spotlight on a distressing side effect of the drug's sublingual film: severe tooth decay.
Suboxone is a combination medication containing buprenorphine and naloxone. This drug has been a critical component in the treatment of opioid addiction, helping to curb cravings and withdrawal symptoms. Approved by the FDA in 2002, Suboxone was initially available as a tablet and more recently as a sublingual film, designed to dissolve under the tongue.
Suboxone's sublingual film is currently under the legal microscope because of allegations that it may contribute to serious dental conditions. Patients have come forward with lawsuits against Indivior, Inc., the maker of Suboxone, claiming they weren't adequately warned about the product's high acidity—a factor that may lead to dental decay and even tooth loss.
To manage the growing number of lawsuits, the U.S. Judicial Panel on Multidistrict Litigation has decided to combine these cases into one multidistrict litigation (MDL) in the Northern District of Ohio. This move is intended to make the legal process more efficient by having one judge coordinate the discovery process and pre-trial procedures for the cases, which currently exceed twenty.
The plaintiffs allege that Indivior, Inc. was aware of the risks posed by the sublingual film and failed to adequately communicate these risks to patients and health care providers in a timely fashion. The lawsuits further allege that this failure deprived individuals of the chance to make well-informed decisions about their treatment, leading to unforeseen and significant health repercussions.
The MDL offers a streamlined approach to dealing with these claims, which share common factual questions, by litigating them together. This also places significant pressure on Indivior, Inc. to respond to the negligence and failure to warn claims, and it may result in a comprehensive settlement for those impacted. With the legal gears turning, the spotlight is now on the responsibility of drug manufacturers and the rights of patients to receive full and clear information about the drugs they are prescribed.
The MDL is presided over by Judge J. Phillip Calabrese, a decision that has been met with approval from those representing the plaintiffs. "Judge Calabrese is a well-respected and capable jurist," commented Trent B. Miracle, an experienced attorney in opioid-related cases. The initial status conference, set for March 7, 2024, aims to establish leadership roles within the plaintiff and defendant groups and to outline the progression of the case.
The allegations bring to light the impact of Suboxone’s dental side effects. One such patient, identified as D.S., shared with Drugwatch the emotional and physical suffering that came with severe tooth decay, a situation she says could have been prevented with proper warnings. The need for expensive dental repairs has placed an additional financial burden on individuals like D.S., who are already committed to the challenging path of recovery from addiction.
Mass tort litigation like the Suboxone case is about more than just the legal claims—it's about holding companies accountable and protecting public health. When a drug has side effects that aren't properly disclosed, it can betray the trust that patients and doctors place in treatment options. This litigation matters because it:
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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