Suboxone is a prescription drug that is commonly used for the treatment of opioid addiction recovery. There is overwhelming evidence showing that Suboxone causes chronic dry mouth which can lead to acute tooth decay and tooth loss. The manufacturers of Suboxone were aware of this side effect for more than a decade but failed to include any warning about tooth decay on the drug product label.
Individuals who used Suboxone and suffered tooth decay are now bringing product liability lawsuits against the drug companies for negligently failing to warn about these risks. Plaintiffs are now seeking an MDL Suboxone class action lawsuit. The national product liability lawyers at Miller & Zois are now accepting Suboxone tooth decay lawsuits in all 50 states.
Suboxone Litigation News and Updates:
December 1, 2024: 38 new cases were added into the Suboxone tooth loss class action MDL during the month of November. That is a big upswing compared to the volume in October, when just 4 new cases were added. Overall, however, the volume of new cases coming into the MDL is way less than what we saw at the start of the year. There are currently 716 pending cases in the MDL.
November 24, 2024: A hearing on the defense motion to dismiss has been set for December 16, 2024. The MDL judge has instructed both sides to submit a joint report a few days prior to the hearing. The motion will most likely be denied.
September 2, 2024: Only 1 new case was added to the Suboxone class action MDL during the month of August, bringing the total number of pending cases in the MDL up to 674. The reason for the slowdown in the new filings is because a tolling agreement with the defendants is being worked out, which will allow plaintiffs to register their claims without having to file suit.
August 14, 2024: The plaintiffs have filed a response to the defense motion to dismiss. The defense motion argues that federal law preempts the plaintiffs’ claims, asserting that the FDA’s approval of Suboxone’s label and design shields them from state-law claims about inadequate warnings or design defects. They contend that since the FDA approved Suboxone’s film label and design, state-level challenges are invalid.
Plaintiffs counter that federal law does not bar claims based on the defendants’ failure to update the label with new information discovered after FDA approval. They emphasize the defendants’ ongoing duty to monitor and revise the label in light of emerging data, which is actionable under state law.
Regarding design-defect claims, the plaintiffs argue that preemption is inapplicable. They highlight the availability of a safer, FDA-approved alternative—Sublocade, an extended-release injectable buprenorphine—before Suboxone film’s release. This demonstrates that a safer design was feasible, and the defendants’ failure to adopt it supports the design defect claims under state law.
July 28, 2024: The defendants in the Suboxone litigation have filed a motion to dismiss based on the federal preemption doctrine. Motions to dismiss based on federal preemption are very common in mass torts involving regulated prescription drugs. They are rarely successful.
About Suboxone
Suboxone is a drug that is used to help people with chemical opioid dependency recover from their addiction. It is supposed to help ease the physical symptoms of withdrawal when someone stops using opioids.
Suboxone was first developed and released in the U.S. back in 2002, when the opioid epidemic was just beginning to explode. It was viewed as a groundbreaking medication because it was the only option for the treatment of opioid addiction that did not have to be administered in a clinical setting.
In 2009, when the original patent for the pill form of Suboxone was about to expire, the maker of Suboxone (Reckitt) released a new Suboxone sublingual film. The new sublingual version came in a small patch that was inserted under the tongue and dissolved in the mouth. At the same time, Reckitt attempted to claim that the old pill version of Suboxone was unsafe for children. The goal of all this was to ensure that Reckitt had a patent-protected Suboxone product. The Suboxone pills were no longer patent protected so anyone could start making them, but the sublingual film was under patent.
The FDA rejected Reckitt’s claim that the pills were unsafe. Reckitt was undeterred by this, however, began a scheme to pressure doctors authorized to prescribe Suboxone to create economic disincentives for doctors who did not transition their patients to the film from the tablet. Reckitt also discouraged physicians from continuing to prescribe the tablets under the pretext of alleged “safety” concerns with the tablet and publicly announced in 2012 it was pulling the tablet from the market due to “safety” issues. All of this was simply a scheme to suppress competition from generic pill versions of Suboxone.
Reckitt was eventually sued by the 41 states for antitrust violations in connection with this scheme.
Suboxone and Tooth Decay
Not long after the new sublingual version of Suboxone was released on the market, Reckitt and its corporate successors began to get a regular stream of reports indicating that the drug was causing very serious and rapid tooth decay. The reason that it causes tooth decay is because Suboxone causes chronic dry mouth, a condition where there is a lack of saliva in the mouth. Saliva protects teeth from bacteria and chronic dry mouth is a direct cause of acute tooth decay.
By late 2010 or early 2011, Reckitt was very much aware that Suboxone was causing major tooth decay issues. They had received a high number of adverse event reports stating that fact. There was also scientific evidence explaining how and why Suboxone was causing tooth decay. Despite having all of this information available, however, Reckitt and its successors refused to add a warning about tooth decay to the product label for Suboxone.
In January 2022, however, the Food and Drug Administration felt compelled to issue a public warning in the form of a drug safety communication informing the public about the risk of tooth decay from Suboxone. If was only after this point that the makers of Suboxone finally agreed to add a warning about tooth decay to the Suboxone product label. This is a clear example of negligently failing to warn.
Suboxone Teeth Lawsuits
The Suboxone Label Change in 2022 was effectively an admission of fault for their prior failure to add a warning label to the drug. As a result, this eventually led to a growing number of product liability lawsuits alleging that the makers of Suboxone were negligent for failing to warn about tooth decay for nearly a decade. The Suboxone tooth decay lawsuits are being brought by individuals who used Suboxone sublingual films for an extended time period and suffered tooth decay, cavities, tooth loss and related issues as a result.
So far, less than 100 Suboxone tooth decay lawsuits have been filed across the country. That number is increasing very rapidly, however, and hundreds or even thousands of Suboxone tooth lawsuits are expected to be filed over the next few years. Our law firm alone has signed hundreds of clients. The Suboxone lawsuits will soon be consolidated into a new class action MDL – probably in Ohio – which would likely result in a global settlement deal.
Suboxone Class Action Lawsuit
How do you join the Suboxone class action lawsuit? Well, right now there is no Suboxone class action lawsuit. But our lawyers expect an MDL-style class action by the end of the year. There has already been a filing with the JPML for an MDL. Our lawyers are now signing up clients who want to join the litigation.
How Do I Join the Suboxone Tooth Lawsuit?
Miller & Zois is currently accepting Suboxone tooth loss lawsuits from across the U.S. If you used Suboxone and suffered tooth decay or dental issues and want to sign up to bring a compensation claim, call us today at 800-553-8082 or contact us online for a free consultation.