Suboxone is a prescription medication used to treat opioid addiction. It works by combining buprenorphine (an opioid agonist), with naloxone (an opioid antagonist). The drug is used in combination with behavioral therapy to assist those battling opioid addiction. Buprenorphine was first approved in 2002. It is recognized as one of the most effective drugs to treat the postnatal opioid with drawl syndrome, NAS.

While Buprenorphine is efficient at binding to opioid receptors in the brain and acts to displace opioids from the receptors, Naxolone blocks the effects of the opioid. The use of the two in conjunction with each other is designed to reduce use and mitigate withdrawal symptoms.

The Side Effects

The components of the Suboxone sublingual films can cause tooth decay due to the inherent acidic properties and the resulting dry mouth. The acidic films are placed under the tongue to dissolve, exposing them to the enamel of the teeth, and potentially leading to erosion of the enamel and heightened susceptibility to decay. This can lead to a myriad of dental issues including tooth decay and loss, gum disease, and jawbone decay, which may require expensive and extensive oral surgery and tooth supplements to address.

The issue of potential tooth decay was not disclosed by the manufacturer and it was not until a January 2022 FDA Drug Safety Communication that a warning to patients regarding the correlation Buprenorphine films and said issues was illuminated.

Truvada All Over Again?

Suboxone, originally developed by Reckitt Benckiser (later Indivior), was approved by the FDA in 2002 to treat opioid dependence. As the opioid crisis worsened and the original patent neared expiration, Indivior developed a sublingual film version of Suboxone to extend its market exclusivity through a new patent, a practice known as “evergreening.” This move raised controversy, with lawsuits alleging the company removed the safer pill format for business reasons rather than the stated child safety concerns, a move akin to one of the accusations made against Gilead Sciences in the Truvada/tenofovir litigation.

DOJ Brings Suit

In April 2019, the US Department of Justice (DOJ) sued Reckitt Benckiser, the maker of Suboxone, for anti-competitive practices that allegedly inflated drug prices. The lawsuit was settled in July 2019, with Reckitt Benckiser agreeing to pay $1.4 billion without admitting wrongdoing. However, this settlement did not compensate individuals who experienced Suboxone side effects.

Current Status Of Litigation:

On February 2, 2024, the JPML panel agreed with plaintiffs’ motion for centralization and transferred the case to the Northern District of Ohio to be overseen by Judge J. Philip Calabrese for coordinated pretrial proceedings, forming MDL #3092. In March Judge Calabrese appointed a group of 20 plaintiffs’ lawyers to serve as leadership. As of April 2024, there were 44 pending lawsuits filed in the MDL.