The FDA only approved testosterone therapy for one medical condition. Male hypogonadism occurs when the body doesn’t produce enough testosterone. But testosterone manufacturers have tapped into a huge market by appealing to the male ego. Testosterone therapy is advertised on TV and online and even stores offer one-stop-shopping: testing and injecting. “Here in Texas we have these man caves [testosterone supplements stores] where you can sit in a Lazy Boy chair, tune into the sports channel or read the latest edition of Sports Illustrated while waiting for your health care provider to inject you,” says Malik.
“Some places even serve chicken and fries - it really is the crazy wild west!”
But Malik says this situation, which can be laughable on the surface, is as serious as a heart attack. To date, close to a hundred Testosterone injury cases have been filed across the US involving heart attacks, deep vein thrombosis and/or pulmonary embolism.
As for the latest turn of events where Pfizer has asked that its Depo-testosterone injection not be included in multidistrict litigation, Malik doesn’t think this is a good idea for plaintiffs.
“A motion has been filed to bring in all forms of testosterone products and some testosterone makers, such as Pfizer, have balked at that,” Malik explains. “It makes sense to have all the complaints under the same roof because many men have tried all forms of testosterone - shots, gels and creams.”
Malik says testosterone side effects apply to all forms of products, including injection, but Pfizer disagrees: it says its injection should be excluded because not many lawsuits have been filed. Given that up to 60 percent of the market is AndroGel, naturally most lawsuits would involve the gel.
“If Pfizer gets its way, perhaps plaintiffs will have to file in separate venues and separate courts,” Malik says. “Pfizer wants the cases involving both AndroGel and Depo-Testosterone use, for the JPML Panel to sever and transfer the AndroGel claims to an MDL and leave the claims against the Pfizer entities in their present districts. Testosterone Injuries are very similar regardless of the product, so here is the problem: a different venue and different judges coming to a different conclusion is not amenable to resolving these cases. What if some other manufacturer decides to oppose consolidation? It is a setup for confusion and that’s what the manufacturers want.”
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“At the end of the day I think the testosterone claims may be lumped together in one court, to simplify discovery,” says Malik. “Pfizer is always able to participate in discovery and move for federal preemption based on adequate warning labels.”
And the JPML is hearing all arguments in Chicago on May 29. Stay tuned…