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.
The Wall