Following the FDA’s announcement that it will be reassessing the safety of prescription testosterone products, Abbot Laboratories Inc. and AbbVie Inc., the companies that manufacture AndroGel (a prescription testosterone gel) are facing five lawsuits, all filed in Illinois federal court on Tuesday.
The suits allege that the companies failed to provide proper warnings to consumers.
The lawsuits come just days after the FDA’s announcement, itself prompted by two recent studies that showed a marked increase in heart attacks in older men who took the so-called “low T” therapies. Men who were over the age of 65 or who were younger and had a history of heart problems were shown to have two times the risk of suffering a heart attack when using prescription testosterone products (See FDA Investigates Testosterone Products Over Heart Risks).
The suits allege that the companies failed to provide proper warnings to consumers about the side effects of testosterone treatments, and accuse Abbott of negligence, breach of implied warranty, breach of express warranty, fraud and negligent misrepresentation. The suits are seeking compensation for, among other things, loss of earnings, medical expenses both past and future, mental and emotional distress, and damages for loss of care, comfort, society and companionship.
AndroGel has been marketed and sold since 2010 and the company insists that “known therapeutic risks [are] well documented in the prescribing label.”
We’ll see what the FDA has to say about that.
One complaint, which you can read here, accuses Abbot and its spin-off company, AbbVie, of “an aggressive unbranded ‘disease awareness’ campaign to alert men that they might be suffering from ‘low T’”, going on to accuse Abbot of “disease-mongering” and misleading consumers as to the drug’s safety and efficacy. Abbot’s advertising and use of a doctor-penned “Do I Have Low T?” quiz are also heavily criticized, with Dr. John Morely, the questionnaire’s author, quoted as calling it “crappy.” The plaintiff, Kenneth Aurecchia of Rhode Island, is said to have been caused “physical and emotional impairment” after using AndroGel, including a myocardial infarction (heart attack). Mr. Aurecchia was 63 when he was first prescribed the treatment and had no prior history of cardiac events.
In essence, the complaint makes two main accusations: that AndroGel was aggressively promoted and marketed, often to men who in reality had no real need for low T therapy, and that the medication itself failed to carry adequate warnings about the link between prescription testosterone medications, heart problems and strokes.
The FDA, meanwhile, is urging health care professionals and patients to report side effects involving prescription testosterone products to the agency’s MedWatch program.
Hardly comforting news for the thousands of men who used these products.
You can expect to hear a lot more about this in the coming months. If Abbott and other prescription testosterone product manufacturers have promoted dangerous medications without providing adequate warnings, they have broken the most basic trust between consumers and companies. The FDA won’t take kindly to that – and neither, of course, should patients.