June 6, 2012 – Johnson and Johnson has announced that its Ethicon unit will end sales of most of its vaginal mesh implants which are the subject of hundreds of lawsuits claiming the implants are defective and dangerous. It is expected that it will take several months for the products to come off the market and the company has asked the FDA for 120 days to end sales. In addition, Johnson and Johnson says Ethicon will also discontinue or revise, as appropriate, all marketing materials during this time. These marketing materials form the basis of claims that patients and physicians were not appropriately warned of the risks of vaginal mesh implants. Ethicons agreement to change or stop using the marketing materials is an important victory for the lawyers and clients pushing for changes in how these implants are made and sold.
June 1, 2012 – American Association for Justice Trial Magazine June 2012
Drugs & Devices: How Big Pharma Puts Patients at Risk
“Bad Actos” by Howard L. Nations and John M. Restaino
“The safety of Actos, an oral diabetes drug that increases the body’s sensitivity to insulin, has been increasingly called into question since 2010. That was when the FDA announced that it was “reviewing data from an ongoing, 10-year epidemiological study designed to evaluate whether Actos (piolitazone) is associated with an increased risk of bladder cancer.” Read the rest of the article in Trial Magazine.
By Amber Stanford
May 26, 2012 – The FDA has recently recognized a new study released in the issue May 17, 2012 of the New England Journal of Medicine that reports a small increase in cardiovascular deaths, and in the risk of death from any cause, in persons treated with a 5-day course of azithromycin (Zithromax) compared to persons treated with amoxicillin, ciprofloxacin, or no drug at all. The FDA intends to further review this research any findings.