Antitrust lawsuits and criminal indictments paint a picture of widespread damage
Cleveland, OHAs of September 2024, 674 lawsuits have been consolidated in the multidistrict Suboxone Film Productions liability litigation (MDL) in the Northern District of Ohio. These dangerous drug lawsuits allege that the sublingual film prescribed to treat opioid addiction also caused devastating tooth decay and long-term dental damage. For many patients, this led to costly treatments and a diminished quality of life.
But these 674 lawsuits are only a fraction of the roughly 11,000 lawsuits that have been filed. To fully appreciate the harm that Indivior, Suboxone’s manufacturer, has done, it can be helpful to look at the wider context of the dispute, including the antitrust and criminal complaints.
The MDL cases
Medication for opioid use disorder is essential for reducing cravings, withdrawal symptoms, and facilitating recovery. Suboxone was long a preferred treatment, at least in part because it contains both naloxone and buprenorphine. Research indicates that buprenorphine presents a lower risk of overdose and other side effects.
Prior to 2010, Suboxone was prescribed in tablet form. In 2010, the FDA approved Suboxone sublingual film. Indivior removed the tablet version from the market shortly thereafter. The under-the-tongue method of administration appeared to have advantages -- faster up take and a reduced risk of abuse.
But it also had disadvantages. The medication is highly acidic, and patients were encouraged to hold the film in their mouths for as long as possible to maximize absorption. This is now linked to a variety of dental injuries, including:
Severe tooth decay;
Tooth loss;
Oral infections; and
Gum and tongue injuries.
The lawsuits now consolidated in the MDL allege that Indivior knew or should have known of the risk of dental problems posed by the film, but it failed to warn patients until January 2022 when the FDA mandated the change.
The MDL is still in early stages. There have been no trials or settlements to date, but a great deal has occurred in surrounding litigation.
The antitrust lawsuit – why pull the pills off the market?
In 2019, a collection of pharmaceutical companies and organizations like Medicare that were forced to pay more for Suboxone brought another, different MDL antitrust lawsuit against Indivior and Reckitt Benckiser, Inc. (“RB Group”), its predecessor company. That antitrust lawsuit focuses on the 2010 corporate decision to pull Suboxone tablets off the market in connection with the introduction of the sublingual film.
Plaintiffs allege that this switch (the “product hop”) was done for the purpose of frustrating emerging competition from generic forms of the medication. It was, plaintiffs claim, accompanied by a campaign to disparage the tablet form through fabricated safety concerns. Without getting too deeply into the nuances of antitrust law, the bottom line was that, because of this move, consumers paid more money and lost the chance to choose a product that might have done them less harm.
The antitrust lawsuits had settled by early 2024, and the settlements were huge. In 2019, RB Group settled with the FTC and agreed to pay $50 million to consumers. In 2020, Indivior also settled and agreed to pay $10 million to consumers. In June 2023, Indivior paid a settlement to a group of states and then in August, paid $30 million in a class action brought by health plans. In November 2023, Indivior settled an antitrust suit, paying $385 million to 70 drug wholesalers.
None of the payouts came to individuals whose teeth were damaged by the switch to sublingual film. To the extent that these individuals saw a benefit, it is more abstract. The laws that protect competition are ultimately intended to protect consumers. More vigorous enforcement of antitrust laws may benefit patients in the future.
The criminal indictments
Indivior and RB Group also faced criminal and civil charges for allegedly engaging in deceptive marketing efforts. Charges were brought by the US Department of Justice (DOJ) and several states. Indivior and RB Group separately resolved the charges against them in 2019. Indivior agreed to pay $600 million, while RB Group agreed to pay $2.1 billion in resolution of DOJ and state charges.
Again, none of the payments came to individuals who were harmed by Suboxone or by Indivior’s deceptive marketing practices. Nonetheless, the criminal and civil charges, as well as the antitrust lawsuits demonstrate the range of harm that pharmaceutical opioid manufacturers like Purdue Pharma and Indivior have managed to do to the fabric of American life in the name of “medical treatment.” Many lay the blame directly on the Food and Drug Administration and a culture of lax oversight.
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