Suboxone maker Indivior in Trouble with the Law Again

Santa Clara, CASuboxone (buprenorphine and naloxone) was first introduced in 2002 for recovering opioid addicts. The dissolvable tablet was helping people on their road to recovery, but the problems began when a Suboxone film version was introduced in 2013, and it took the drugmakers almost a decade to warn consumers of its side effect: decayed teeth. Many people have experienced permanent damage and Suboxone lawsuits indicate that ruined teeth could have been avoided if the manufacturers warned them and the medical community from Suboxone film side effects. And yes, tooth decay is a legitimate injury that can have devastating effects, both physical and emotional. 

The manufacturers apparently knew that the drug is very acidic, and the Suboxone film version can be harmful to teeth because the sublingual film form of Suboxone, which is held under the tongue until it dissolves, reduces salivary flow and exposes the teeth to an unhealthy level of Buprenorphine. The original tablet was not as corrosive because it did not have prolonged contact with the user’s teeth and gums.

Indivior in Jail

The manufacturer Indivior Inc. (formerly known as Reckitt Benckiser Pharmaceuticals Inc.) cashed in on the opioid crisis. Since 2002, as an increasing demand for medical intervention was needed in the U.S., Indivior made sure it dominated the market. So much so that greed got in the way. In 2019, a federal grand jury indicted Indivior “for engaging in an illicit nationwide scheme to increase prescriptions of Suboxone Film, an opioid drug used in the treatment of opioid addiction”. According to the Department of Justice, Indivior made billions of dollars from Suboxone Film prescriptions by deceiving health care providers and health care benefit programs into believing that its medication was safer, less divertible, and less abusable than other opioid-addiction treatment drugs.

Even more insidiously, it allegedly boosted profits by using a “Here to Help” program to connect opioid-addicted patients to doctors the company knew were prescribing opioids at high rates and in a clinically unwarranted manner. Doesn’t that sound like Purdue Pharma and Oxycontin? The Sackler family avoided jail time for causing over 100,000 opioid deaths, but Shaun Thaxter, the former CEO of Indivior PLC, was sentenced in October 2020 to six months in federal prison. 

“Misleading information about relative product benefits undermines efforts to provide affordable treatment to those suffering from opioid addiction,” said Judy McMeekin, Pharm.D., Associate Commissioner for Regulatory Affairs, U.S. FDA. “We will continue to investigate and bring to justice those whose schemes jeopardize public health and put Americans at risk.”

Indivior must have known that an acidic substance like Buprenorphine would cause more harm the longer it was in contact with a user’s teeth. After all, it had sold the tablet version of Suboxone containing Buprenorphine for nearly a decade before marketing the sublingual film version of the drug. No wonder Suboxone lawsuits claim Indivior failed to warn the public about possible side effects.  Like all drug makers, it has a responsibility to thoroughly test its products and notify regulatory agencies as well as the public of the known side effects of their medications. Instead, it chose profit over people for two decades before the FDA slapped a warning label on Suboxone in January 2022.