Pharmaceutical

Patient asks that new AndroGel side effects trial be on all claims

androgel pump 435x435 Patient asks that new AndroGel side effects trial be on all claimsJesse Mitchell asked an Illinois federal court to order a new trial on all his claims against testosterone manufacturer AbbVie Inc., instead of just one claim in the first bellwether in a multidistrict litigation accusing makers of testosterone replacement therapies of misrepresenting their products and failing to warn that their treatments were linked to cardiovascular risks.

Jurors in that case did not find Abbie’s AndroGel as the cause of Mitchell’s heart attack, but did find the company guilty of fraudulently misrepresenting the testosterone treatment through alleged off-label marketing. As a result, they awarded Mitchell no compensatory damages, but did award him $150 million in punitive damages.

In December, U.S. District Judge Matthew Kennelly overturned the verdict, finding it was “internally inconsistent” because no compensatory damages were awarded. He ordered a new trial on just the fraudulent misrepresentation claim. Mitchell asked the court to hold a new trial on all three claims of strict liability, negligence and fraudulent misrepresentation.

Mitchell suffered a heart attack and in 2014, filed a lawsuit against AbbVie alleging it was caused by use of the company’s AndroGel testosterone gel. He cited studies that showed use of testosterone replacement therapies increased the risk for heart attacks, strokes and blood clots, and accused AbbVie of failing to warn consumers of these cardiovascular risks.

Instead, Mitchell alleged, the company fraudulently misrepresented the product when it launched an aggressive marketing campaign targeting middle-aged men like Mitchell claiming AndroGel could treat a made-up condition called “Low T.” The symptoms, Mitchell alleged, were just typical signs of aging and that the Food and Drug Administration (FDA) never approved AndroGel for this use.

Source: Law360