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The Federal Trade Commission has initiated legal action against the makers of three “Low-T” drugs, alleging that the drug companies have conspired to delay generic versions of their drugs from hitting the market. This comes as legal scrutiny is mounting over the safety of these drugs.
On September 8, the FTC annouced it was filing a lawsuit alleging AbbVie, Teva Pharmaceuticals, and Belsins Healthcare Inc. worked together to delay the release of generic AndroGel, a drug designed to increase testosterone levels in men. According to the FTC’s AndroGel lawsuit, this move was designed to increase profits from AndroGel by delaying competition from generic competitors as long as possible, costing the American healthcare system millions. The FTC’s lawsuit seeks to recoup these costs.
Allegedly, the agreement involved AbbVie and Besins Healthcare filing meritless patent infringement lawsuits, and subsequently agreeing to a settlement that would ultimately delay generic AndroGel from hitting the market. Such an action could violate antitrust laws designed to protect consumers from companies manipulating prices by avoiding competition.
This comes as the drugs in question are coming under increased scrutiny. Allegedly, these drugs are linked to an increased risk of developing blood-clot related problems. Clotting is a normal part of the healing process in humans. But when the process misfires, blood clots can form within the body. These clots can block the blood vessels that feed critical tissues and organs, such as the brain, heart, and lungs. This can cause stroke, heart attack, and pulmonary embolism. Lawsuits have been filed alleging that AndroGel and similar drugs are dangerous, and that drug makers were aware — or reasonably should have been aware — of the serious risks linked to the drugs.
Additionally, testosterone product lawsuits over AndroGel and related drugs allege that the makers of these drugs have aggressively promoted them, to the point that many men taking these allegedly dangerous drugs may not even need them. One study found that a quarter of users of testosterone products had never had their testosterone levels examined.
The legal action over the safety of low-T drugs like AndroGel has taken the form of multidistrict litigation, or MDL. MDLs are a type of group legal action in which similar individual cases are combined into a single coordinated action. This is intended to streamline the legal process by coordinating tens, hundreds, or even thousands, of individual cases, simplifying the legal system and avoiding duplicated efforts.
The AndroGel MDL is In Re: AndroGel Products Liability Litigation, MDL No. 2545, in the U.S. District Court for the Northern District of Illinois.
In general, testosterone products lawsuits are filed individually by each plaintiff and are not class actions.
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