The website NewsInferno.com discusses recent lawsuits around the Ortho Evra contraceptive patch:
The New York Post is reporting that Ortho-McNeil has already “settled a dozen lawsuits for millions of dollars in the last few months” for claims arising out of the use of the company’s Ortho Evra contraceptive patch.
Currently, there are over 100 additional cases pending across the U.S. that Ortho-McNeil appears to be interested in resolving and this has prompted attorneys to submit their client’s claims for settlement.
The Post article indicates that the twelve settlements include claims by women between 18 and 47. One settlement is believed to be in excess of $10 million.
The Ortho Evra cases vary from most claims where a prescription drug is the subject of personal injury or wrongful death litigation. Typically, the “victim” was already suffering from a physical or psychological illness, disease, or other health problem that may have actually caused, or at least contributed to, the alleged injuries.
The article goes on to discuss changes to labels on the product:
The FDA medical officer also included the following statement in his comments:
The professional product labeling and information written specifically for women using Ortho-Evra “should reflect the possible increased risk of venous thromboembolism (VTE) [blood clots] associated with this new transdermal combination hormonal contraceptive containing the new molecular entity progestin norelgestromin (17d-norgestimate).”
In addition, the medical officer expressed concern that 211 out of 3,088 women (6.8%) in the pre-approval clinical trials gained 10 or more pounds in the trials and noted that the contraceptive effectiveness of Ortho-Evra was reduced in women weighing more than 198 pounds (90 kilograms).
The rather detailed article can be found at NewsInferno.com.