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MDL Court Orders AbbVie to Produce Files Related to 269 Adverse Event Report

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All federal testosterone replacement therapy lawsuits were consolidated in one court in June 2014. They are now proceeding in the Northern District of Illinois, before District Court Judge Matthew Kennelly.

Both sides have been preparing a small group of cases for early trial. These are referred to as “bellwether trials” and will be used to evacuate the response of juries to the evidence, and may help facilitate future settlement negotiations. Because the majority of the cases involve the testosterone replacement product “AndroGel,” Judge Kennelly determined that only AndroGel cases are eligible to be considered for early trial.

AndroGel is the most widely used testosterone product on the market, and is manufactured by AbbVie Inc. Recently, in a June 22, 2016 order, Judge Kennelly required AbbVie and former parent company Abbott Laboratories to produce drug safety and investigation files related to 269 adverse event reports that the company received.

Court Orders AbbVie to Produce Materials Related to Adverse Event Reports

The order came in response to a motion filed by the plaintiffs on May 27, 2016. Plaintiff’s asked the court to compel the defendant to produce.

In a response filed June 22nd, the court noted that the back-up materials for the reports to the FDA were “relevant regarding, if nothing else, what defendants knew about adverse events potentially associated with their products and when they knew it.”

Indeed, this very question is pertinent to most testosterone replacement lawsuits. Plaintiffs in these lawsuits typically assert that the manufacturer was aware of the risks associated with their drugs, including the increased risk for heart attack, stroke, and other blood-clot related health issues, but failed to provide doctors and patients with adequate warnings about them. They also alleged that the companies overpromoted their products to men, creating a disease (of low-T) where there wasn’t one to encourage men to ask their doctors for prescriptions of the drugs.

The court explained that the defense would need to redact patient-identifying and some other information on the supporting documents, but that the burden wasn’t undue “given the relevance of the information to the overall scope of this litigation.”

The court added that whether the material will actually turn out to be admissible evidence in trial “is a separate matter that the Court need not now address.”

Manufacturers Misled Men Into Believing They Needed Prescriptions

Currently, there are over 6,000 testosterone replacement lawsuits pending, in which plaintiffs claiming that the products were unsafe as designed, and should have been tested more completely before being released onto the market.

The FDA approved testosterone drugs to treat “hypogonadism,” a condition in which men suffer from a deficiency of the hormone because of a medical condition, such as a pituitary gland problem or a testicle malfunction. A true testosterone deficiency can cause loss of sex drive and erectile dysfunction.

Testosterone drug manufacturers, however, expanded the use of their drugs to men who were often suffering from common symptoms of aging, such as fatigue, lower muscle mass, and reduced libido. They created questionnaires on their websites asking men if they were suffering from these innocuous symptoms, and then encouraged them to ask about prescriptions. In a 2014 study published in the Journal of Clinical Endocrinology & Metabolism, 40.2 percent of men did not have a testosterone test in the 180 days before beginning therapy, and 50 percent had only one test. (Doctors typically recommend that patients receive than one test to obtain a more accurate assessment of patients’ testosterone levels.)

Later studies, however, indicated that the drugs could be dangerous. In 2013, researchers reported that men taking Testosterone drugs were at an increased risk of heart attacks and strokes. In  2014, another study found that the use of testosterone therapy doubled the risk of heart attack in men over the age of 65. Young men with a family history of heart disease had three times the risk of suffering a heart attack if taking testosterone therapy.