Indiana plaintiffs who filed a testosterone replacement therapy lawsuit may have their case tried in federal court in Illinois, where 281 similar lawsuits reside. The U.S. Judicial Panel on Multidistrict Litigation on Friday transferred to U.S. District Court for the Northern District of Illinois a lawsuit against Abbvie, Abbott Laboratories and unnamed physicians consistent with a decedent's use of AndroGel.
The physicians must defend malpractice claims. But the pharmaceutical corporations face product liability claims that the use of their product led to the heart attack death of a 59-year-old patient in October 2012.
The lawsuit, which the surviving spouse filed on behalf of herself and the estate of her husband, was originally filed in November 2014. It claims that the corporations were negligent in numerous respects, including:
- Placing a product "into the stream of commerce that was defective and dangerous in ways not contemplated by consumers" such as the decedent
- Misrepresenting the drug's "safety for low testosterone treatment"
- Misleading the public about "the prevalence and symptoms and the safety and effectiveness" of the drug
- Failing to "warn consumers of the risks of heart attack and death" associated with the product and failing to warn about the contra-indications for its use
- Failing to protect users and consumers "from the product's serious and even deadly side effects"
- Failing to "properly package or label" the drug so as to provide "reasonable warnings"
The widow and estate further claim that the defendants should have "reasonably foreseen" that the decedent - whose preexisting conditions included diabetes, obesity and "chronic pulmonary and chronic cardiac conditions" - was subject to "the harm caused by the defective and dangerous condition of their product, AndroGel."
The testosterone therapy replacement lawsuit alleges that the widow suffered a loss of earnings, care and the benefits of companionship.
As it sent the case to the multidistrict litigation court, the panel of judges held that all of the nearly 300 centralized testosterone replacement therapy lawsuits share "factual questions arising from allegations that the use of one or more testosterone replacement therapies caused plaintiffs or their decedent to suffer injuries such as heart attack, stroke, deep vein thrombosis, or pulmonary embolism ... This action involves allegations that use of AndroGel caused plaintiff's decedent's fatal heart attack and clearly falls within the MDL's ambit."
Federal regulators are monitoring the alleged risks of using testosterone products. Roughly a year ago, the U.S. Food and Drug Administration announced its investigation of "the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products."
The agency further explained, "We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. We are providing this alert while we continue to evaluate the information from these studies and other available data, and will communicate our final conclusions and recommendations when the evaluation is complete."
The FDA then clarified the types of testosterone drugs that it has approved.
"Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition," the agency wrote in January 2014. "Examples of these conditions include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy. Other examples include problems with brain structures, called the hypothalamus and pituitary, that control the production of testosterone by the testicles. None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition."
Further, in a separate June 2014 statement, the FDA announced that it was "requiring manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins. Blood clots in the veins, also known as venous thromboembolism (VTE), include deep vein thrombosis (DVT) and pulmonary embolism (PE)."
Very important: The FDA wrote in 2014, "Patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their health care professionals."
Testosterone replacement therapy patients who suffered a stroke, heart attack or a serious blood clotting issue may be entitled to compensation. The same applies to a surviving family member of someone whose death can be linked to the use of the therapy. The way to find out whether a victim has a viable case is to contact one of the product liability attorneys at Reich & Binstock. The consultation is free, and the law firm operates in all 50 states.
Contact Reich & Binstock either by calling the toll-free number below or by submitting an electronic message through the form located on this web page.