At the height of the testosterone litigation, more than 25,000 lawsuits
had been filed against AbbVie Inc., Eli Lilly & Co., Pfizer Inc.,
Endo International and other manufactures. Cases involved popular
products such as AndroGel and Depo-Testosterone.Testosterone powder
They claimed men who used the drugs experienced side effects such as
heart attacks, strokes or blood clots called pulmonary embolism and deep
vein thrombosis. Most of the injuries, with the exception of death, had
to occur within 90 days of using the product for a person to be able to
sue.
Because of the large number of manufacturers and cases, the U.S.
Judicial Panel on Multidistrict Litigation created a testosterone
multidistrict litigation, or MDL, in June 2014. U.S. District Judge
Matthew F. Kennelly oversees the MDL, formally called MDL-2545 IN RE:
Testosterone Replacement Therapy Products Liability Litigation.
Of the 206 MDLs across the U.S., the testosterone MDL is especially
complicated, with the ninth most pending actions, according to the U.S.
Judicial Panel on Multidistrict Litigation’s April 2019, MDL statistics
report.
More than a half-dozen cases have gone to trial with mixed results, and
AbbVie, Eli Lilly, Endo International, Auxilium Pharmaceuticals,
GlaxoSmithKline and Allergan have tentatively reached confidential,
global settlements for thousands of cases.
Lawsuits filed in federal court all made the same allegation:
Manufacturers of testosterone products put healthy men in danger by
marketing the hormone to treat sexual dysfunction, age-related fatigue
and other symptoms that go beyond the use approved by the U.S. Food
& Drug Administration.
The FDA approved these drugs for use in the treatment of a medical
condition known as hypogonadism, but drugmakers widely marketed the
products for off-label use for a condition they allegedly invented and
call “Low T.”
Lawsuits accused makers of testosterone products of marketing the
products as safe and effective for this off-label use, when in fact, the
products reportedly provide little or no benefit for men without
hypogonadism, and the drugs can cause cardiovascular issues and death.