A new milestone was hit recently in court — with over 5,000 cases filed against manufacturers of Testosterone Replacement Therapy (TRT), a hormone replacement therapy. The claims assert that the makers of Androgel®, Axiron and Testim all failed to issue adequate warnings about the health risks of the product.
Allegations include an increased risk of heart attacks, stroke, deep vein thrombosis (DVT), pulmonary embolism (PE), and other serious medical conditions.
The manufacturers are fighting the accusations. However, on March 3, 2015 the FDA announced that all testosterone replacement therapies must have their labels updated to reflect the possible increased risk of heart attacks and strokes associated with its use, after the agency reviewed several studies that suggested men using the “Low T” therapies are at an increased risk for heart attacks and strokes.
While the FDA originally gave the OK to TRT for some medical conditions, such as male hypogonadism, a condition where low testosterone levels can lead to disorders in the testicles, pituitary gland, or brain; TRT was also prescribed to lessen the effects or delay the onset of normal male aging.
U.S. District Judge Matthew F. Kennelly in the Northern District of Illinois, where the cases have been consolidated as part of an Multidistrict litigation (MDL), has ruled the first set of eight cases will go on trial starting June 2017. While June 2017 seems like a long time away much work needs to be completed by then.
While the trial buzz is on, affected claimants are still contacting law firms to associate with the MDL. Intaking cases is of utmost importance to a law firm, at the same time validating them by way of a thorough review of records to ascertain Proof of Usage (POU) and Proof of Injury (POI) is of equal significance. Here we recommend not to compromise at all; every dime spent to validate these claims will be a wise investment for sure. Primarily, since you wouldn’t want to house and spend on cases that claim but don’t meet the qualifying criteria, but most importantly because at the 11th hour of submissions you wouldn’t want to be burdened by those frivolous claims.
Medical Record Review and claim validation of Testosterone case should take an experienced MD approximately 2 hours in most instances; however, this approximation may vary in cases based on the actual volume of records. Evidence to be looked for in potential Low-T cases
- Indication of Testosterone usage in Medical Records
- Evaluation of Risk and Confounding factors from Past Medical History
- Pharmacy records indicating usage of Testosterone
- Sticker labels of Testosterone gels
- Duration/Formulation of Testosterone usage
- Follow up complications and their treatment after initiation of Testosterone therapy in medical records