Pharmaceutical

AndroGel’s label did not warn of cardiovascular risks

androgel pump 435x435 AndroGels label did not warn of cardiovascular risksAbbVie Inc., never mentioned on the safety label of its testosterone replacement therapy AndroGel that users were at an increased risk of cardiovascular events, including blood clots like those that lodged in the lungs of a man suing the drug company, his attorneys said in opening arguments to an Illinois federal jury this week.

Robert Nolte’s case is the third bellwether trial AbbVie has faced in a multidistrict litigation of consisting of about 7,500 cases of men alleging testosterone treatment makers did not adequately warn doctors or consumers that their products were linked to an increased risk of heart attacks, strokes, blood clots and death. In Nolte’s case, his blood clots traveled to his lung, a life-threatening condition called pulmonary embolism.

Instead, the label on AndroGel said that doctors needed only to monitor patients’ red blood cell counts for signs of blood clots. But, Nolte’s attorneys argued, AbbVie knew but didn’t mention on the drug’s label that AndroGel could increase a man’s risk of blood clots through other mechanisms. Nolte was already prone to blood clots due to a previous medical condition. But his doctor believed that he was safe as long as his blood cell count was monitored.

AbbVie is also being accused of fraudulently misrepresenting and marketing the drug for uses for which it is not approved. Testosterone replacement therapy is only indicated for men with hypogonadism, a condition in which men do not produce enough of the male hormone due to defect, injury or disease.

But AbbVie launched aggressive marketing campaigns promoting the drug for symptoms of so-called “Low T,” such as low sex drive, weight gain and muscle loss. Yet, the drug was never found safe or effective for this use, Nolte claims.

The two previous bellwether trials against AbbVie ended with nearly $300 million in damages. U.S. District Judge Matthew Kennelly tossed one of the $150 million punitive awards after the jury opted not to award compensatory damages finding the drug company was not liable for the man’s heart attack. That case will be retried this spring.

Source: Law360