A settlement agreement was recently reached between Endo International, makers of Androgel, and the 1300 plaintiffs who sued the company after using its product.
The settlement will resolve “all known cases,” and allow plaintiffs to draw from a settlement fund, but did not result in Endo admitting any wrongdoing.
According to plaintiffs, Endo and other drug makers marketed their testosterone or Low T products as safe and effective, and ignored the safety risks that had arisen in tests and after the product was on the market.
Issues related to Androgel use include:
- Increased prostate enlargement symptoms, including the need to urinate more frequently
- Potential prostate cancer risk increase
- Blood clots in the legs or lungs and associated symptoms
- Reduced sperm count for users taking Androgel in large quantities
- Sleep apnea
- Swelling in the ankles, feet, or body, exacerbating problems for those already suffering from heart, kidney, or liver disease
- Possible increased risk of heart attack or stroke
It’s this last complication that is one of the most serious and is included in the claims of many of the lawsuits against Endo and other testosterone product manufacturers.
There is increasing scientific evidence showing the link between heart health issues and the use of testosterone products. The concern was great enough that the FDA issued a safety announcement in 2014, warning users of the results from two studies that showed a significant increase in the risk for heart attack, stroke, and death among Androgel users.
One study that was conducted in 2010 demonstrated that testosterone supplements users had a 10 times higher risk for suffering a heart attack.
Despite these risks coming to light nearly a decade ago, Endo and other testosterone product manufacturers have done very little to warn the public of any danger.
Verdicts in Testosterone Lawsuit Cases Mixed
In 2017, Endo won the first bellwether trial related to its testosterone product. The lawsuit had been filed by a Tennessee man claiming his use of the Endo drug Testim had caused him to have a heart attack.
Following the verdict in that case, Endo and plaintiffs’ attorneys agreed to try to work out a deal regarding the remaining lawsuits.
Endo recently told the SEC it believes it has estimated the probable amount of losses correctly, but litigation costs could soar to more than $200 million. Endo’s chief legal officer Matthew J. Maletta issued a statement that he hopes the settlement agreement will help those impacted move forward and enable the company to focus on its core business.
Other Drug Makers Face Lawsuits Related to Testosterone Products
Endo is not the only drug manufacturer facing legal action stemming from use of a testosterone product.
AbbVie is dealing with more than 4600 lawsuits that are currently in multidistrict litigation and Eli Lilly is facing about 500 of its own. The latter is in the midst of trying to work out a settlement deal, as Endo did. There have already been verdicts in some of the AbbView lawsuits, including one requiring the company to pay $150 million in damages. However, that original verdict was overturned by a judge and the company was later ordered to pay just $3 million. Since that original verdict, the company has won one case and lost another.
There are nearly 8000 multidistrict litigation cases pending in courts regarding complications related to testosterone products.