Mushrooming lawsuits and settlements point to widespread harm
New York, NY On July 26, New York Attorney General, Letitia James announced that Suboxone manufacturer Indivior had agreed in principle to pay $86 million to settle Suboxone lawsuits brought by the attorneys general of New York, Illinois, Tennessee, Utah and Virginia. The settlement was reached in coordination with 11 other states. Their dangerous drug lawsuits alleged that Indivior produced and then marketed buprenorphine-based products to dangerous prescribers who, under the guise of “medical treatment,” triggered further harm.
The pervasive damage done by opioid manufacturers like Indivior can be seen in the sheer number and variety of recent settlements and pending lawsuits against the company. Indivior has harmed patients, their families and states, in sometimes unanticipated ways.
In addition to the $86 million settlement, 42 states have also recently negotiated a $102.5 million settlement over anticompetitive business practices. Not just a business law matter, these practices may have deprived patients of less expensive and potentially less harmful generic treatment options. But the most significant legal development may be the multidistrict litigation (MDL) in the Northern District of Ohio which, as of August, consolidates 673 Suboxone tooth decay lawsuits.
Targeting doctor-run “pill mills”
Indivior produced buprenorphine-based products to treat opioid use disorder. These were marketed under a variety of names. Suboxone is a combination of buprenorphine and naloxone. Subutex Sublingual Tablets contains only buprenorphine. Both are opioids, but were thought to be appropriate treatment alternatives because they were less addictive.
As the multistate coalition of attorneys general allege, Indivior inappropriately targeted its sales to dangerous prescribers – including doctors running pill mills. The company also failed to monitor suspicious orders, causing its products to be inappropriately prescribed and used to fuel, rather than treat, addictions. For a price, often paid in cash, unethical doctors were willing to sell prescriptions to addicts and drug dealers far in excess of medically approved limits.
“The greed and exploitation that fueled the opioid crisis has now spread even to those companies which purported to help solve the problem by treating those addictions,” said Attorney General Labrador of Illinois. “These settlements will never put those lost lives back together, but hopefully we can avoid the wreckage of future addiction with wisely targeted investments in prevention and treatment.”
"When companies like Indivior exploit those in the thralls of addiction for profit, their behavior must be stopped," New York AG James said. "As a result of our work to hold Indivior accountable, they will end their destructive practices and provide new resources to invest in opioid addiction treatment, prevention, and education that will help save lives in New York."
The settlement will provide $86 million over five years. The funds will be used for opioid addiction treatment, recovery, and prevention programs in the five plaintiff states. But this is not the end of the damage caused by Indivior.
No warning of potential dental injuries
The FDA approved Suboxone sublingual film on August 30, 2010, and Indivior removed the tablet version from the market that same year. The film was thought to be less likely to be abused than the tablet form, but the chemical composition of the drug is highly acidic. Patients are encouraged to hold the film in their mouths to maximize absorption. This is now linked to a variety of dental injuries, including:
Severe tooth decay;
Cavities and tooth loss;
Oral infections;
Gum injuries;
Tongue injuries; and
Other dental issues.
The personal injury lawsuits consolidated in the MDL allege that Indivior knew or should have known of the risk of dental problems with the under-the-tongue method of administration. Nonetheless, the company failed to warn patients of the potential harm for over a decade.
In early 2022, the FDA issued a Drug Safety Communication, which warned that dental problems had been reported with medicines containing buprenorphine that are dissolved in the mouth. Thereafter, Indivior updated its Suboxone film prescribing information to warn of the risk of dental problems.
But the damage had already been done for patients like Billy Henley of West Virginia. Already struggling to overcome opioid addiction, he then had to deal with the effects of tooth loss, tooth decay and broken teeth. In addition to the pain, these injuries can be disfiguring and may deepen the social isolation of patients already struggling to leave addiction behind.
Suboxone, for all its initial promise, seems to have become an evil gift that keeps on giving. The lawsuits and settlements that have mushroomed, especially since 2023, may not undo all the damage done, but they do point in the direction of accountability and may prevent future harm.
If you or a loved one have suffered losses in this case, please click the link below and your complaint will be sent to a drugs & medical lawyer who may evaluate your Suboxone Tooth Decay claim at no cost or obligation.