Weekly Mass Torts Bulletin 2023-October-30

Indivior Settles Last Suboxone Monopoly Case for $385M

Indivior Inc., a pharmaceutical company, has announced a $385 million settlement in an antitrust lawsuit related to its opioid addiction treatment Suboxone.

This settlement, which needs approval from a Pennsylvania federal court, has averted a trial in the multidistrict litigation that was scheduled to commence on October 30.

Previously, Indivior reached a $102 million settlement with various states and a $30 million agreement with end-payor insurers over allegations that the company employed tactics to extend its monopoly over the market for Suboxone. The accusations involved Indivior introducing a new dissolvable-strip version of Suboxone to the market just as its exclusive rights over the tablet form were expiring in 2009. The company was accused of misrepresenting to the U.S. Food and Drug Administration that the tablets posed a risk to children, thereby encouraging a switch from tablets to strips.

Indivior's CEO expressed satisfaction with the settlement, stating that it brings closure to a decade-old antitrust lawsuit, providing more certainty for the company and enabling them to concentrate on their work in treating patients with opioid use disorder and mental health issues.

The specific terms of the settlement have not yet been made public, but Indivior has disclosed that the $385 million will be paid in November and will be funded from the company's existing cash reserves.

Previously, a coalition of 42 states and end-payors settled their claims, and the case was divided into different groups, including end payors (customers and insurers) and direct purchasers (health care providers and wholesalers) in 2019.

Indivior, which was separated from Reckitt Benckiser Group PLC in 2014, introduced Suboxone tablets in 2002 for treating opioid addiction, and the FDA granted the company seven years of exclusivity, which ended in October 2009.

As the exclusivity period neared its end, the company worked to introduce a patent-protected dissolvable film version of Suboxone, allegedly to hinder generic versions from claiming equivalence. To promote their new product and hinder competition from generic tablets, Indivior increased tablet prices and raised concerns about tablet safety, particularly in relation to accidental pediatric overdoses.

Direct purchasers who remained in the case attempted to streamline the issues they needed to prove at trial by seeking summary judgment on the definition of the "product market" for Suboxone. However, in late August, a U.S. District Judge ruled that there were still unanswered questions about whether consumers could switch to other opioid dependency treatments as the price of Suboxone increased, so the determination of the market's "cross-elasticity" in response to price hikes would be left to a jury.

CPAP Linked to More Eye Bleeding in Diabetic Patients

A recent study has revealed that while the use of CPAP (Continuous Positive Airway Pressure) devices can be beneficial for certain eye issues in diabetic patients, it can also lead to minor bleeding events in the eyes.

According to a report, CPAP devices can effectively slow down the advancement of diabetic retinopathy, a condition that can potentially lead to blindness. However, researchers from Spain have issued a warning, stating that the use of these machines also elevates the risk of microhemorrhages, which can result in vision disturbances such as streaks, a reddish tint, or other vision problems.

Diabetic retinopathy is a complication associated with diabetes, affecting the blood vessels in the retina. It can cause symptoms like blurred vision, dark spots, floaters, difficulty in perceiving colors, and ultimately, it can lead to vision loss and complete blindness if diabetes is not properly managed.

In this latest study, scientists examined the impact of CPAP therapy on patients suffering from obstructive sleep apnea and mild to moderate non-proliferative diabetic retinopathy (NPDR). They conducted a controlled trial at a university hospital in Spain, involving 83 patients between October 2016 and February 2020. Among these patients, 43 received CPAP treatment, while 40 were part of a control group and did not receive CPAP devices.

The findings indicated that the use of CPAP reduced the occurrence of hard exudates in the eyes by nearly 50%. Exudates are cells and fluids that leak from blood vessels, typically due to inflammation, and serve as a marker for diabetic retinopathy.

However, the study also revealed that diabetic patients using CPAP devices were six times more likely to experience retinal microhemorrhages, and these occurrences were directly associated with the prescribed pressure levels of the CPAP device. Although these small bleeds often do not present noticeable symptoms, they can lead to vision issues like streaks, floaters, or a reddish tint in the vision.

The researchers concluded that "In patients with obstructive sleep apnea and non-proliferative diabetic retinopathy, extended CPAP treatment, in addition to standard care, may result in a slower progression of retinal disease. However, it could also lead to an increase in retinal microhemorrhages."