Court documents show that Allergan has finalized a settlement to end hundreds of testosterone lawsuits. The suits claimed the company’s Androderm testosterone replacement drug caused serious injuries. More than 500 people sued the company.
Actavis originally manufactured Androderm and is named in lawsuits over the product. Allergan acquired the company in 2015.
An Illinois federal court document dated July 26, 2018, revealed the agreement. The parties have not disclosed details of the settlement. A previous filing in June announced a tentative settlement was in the works.
The Androderm lawsuits are part of a multidistrict litigation (MDL). MDLs combine several similar lawsuits into a single action. They can move lawsuits through the legal process more efficiently. The testosterone therapy MDL includes several companies and their testosterone products.
Lawsuits claim people suffered serious testosterone therapy side effects. These include heart attack, stroke and death. The lawsuits accuse companies of marketing the drugs for off-label uses. Those are treatments the U.S. Food and Drug Administration has not approved a drug to treat.
The FDA approved testosterone replacement therapy to treat hypogonadism. That’s a condition in which the body fails to produce enough hormones. Lawsuits claim companies marketed the drugs to boost men’s sex drive or normal signs of aging.
In 2015, the FDA cautioned against using testosterone products to treat low testosterone due to aging. It also required manufacturers to add label warnings related to heart attack and stroke risks.
Allergan was supposed to face a trial in the MDL on August 6. The court canceled it after the settlement announcement this week.
The case was a bellwether trial. Bellwethers can test legal arguments for both sides. They can sometimes lead people to drop lawsuits. Or they can help shape settlements.
People have filed more than 25,000 testosterone lawsuits in recent years. Almost 6,000 were pending in the Illinois MDL as of July 16, 2018.
Six AndroGel lawsuits have gone to trial. Two trials resulted in verdicts of $140 million and $150 million. The court overturned both. A second trial reduced the second verdict to $3.2 million. AbbVie won the next four bellwether trials.
Eli Lilly announced it would settle about 400 Axiron lawsuits in December 2017.
In June 2018, Endo International announced a $200 million tentative settlement. That agreement affected 1,300 Testim lawsuits. Endo subsidiary Auxilium Pharmaceuticals manufactures Testim. GlaxoSmithKline co-promoted the drug in the U.S.
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