Pharmaceutical

Testim testosterone side effects trial scheduled for January

Low T1 Testim testosterone side effects trial scheduled for JanuaryPhiladelphia County Court of Common Pleas Judge Mary Colins denied Auxilium Pharmaceuticals Inc.’s request to worm out of an upcoming trial over alleged testosterone side effects linked to its hormone replacement drug Testim. Auxilium had cited federal preemption as a grounds for summary judgment.

The trial involves the case of Alabama resident Robert Hoehl and his wife Kathleen. Hoehl sued Auxilium in 2014 alleging that in October 2011, at the age of 62, he was prescribed Testim to treat fatigue and erectile dysfunction related to low testosterone. But in July 2012, Hoehl suffered a stroke, which he believes was caused by his use of Testim.

Hoehl’s lawsuit claims that Auxilium did not adequately warn users or doctors that use of its testosterone replacement therapy increased the risk of cardiovascular events, including heart attacks, strokes, blood clots, and death.

Auxilium tried to wiggle out of the lawsuit in October as well, claiming that the Food and Drug Administration’s (FDA) approval of the drug made it impossible for the company to warn about heart risks, or change its alleged negligent design. Judge Colins rejected this motion.

Auxilium filed a second motion in October, this time claiming Hoehl’s accusation that the drug company was negligent did not stand up considering his doctor stood by his decision to prescribe Testim to Hoehl. Furthermore, there was no evidence to suggest that Hoehl was lured by advertising to ask for the drug or that he even read the safety label to check for side effects.

Judge Colins did side with Auxilium and rejected a claim under the Alabama Deceptive Trade Practices Act in which litigants are prohibited from bringing claims under state law if they are also pursuing common law fraud claims. But the remainder of the Hoehls’ claims remained intact.

The Hoehls’ case is scheduled to go to trial in January.

Source: Law360