Friday, March 23, 2012

Bloomberg: J & J Marketed Vaginal Mesh Without Approval

According to Bloomberg News writers David Voreacos and Alex Nussbaum, Johnson & Johnson sold a vaginal mesh implant for three years before U.S. regulators approved the device.

J&J’s Ethicon unit introduced the Gynecare Prolift device in March 2005, touting it in an annual report as an “innovative and effective surgical option” for weakened pelvic muscles.

Here is the problem. The U.S.Food and Drug Administration said it learned of the Prolift in 2007, when J&J sought approval for a related product. The FDA cleared both devices in May 2008.

Johnson & Johnson’s unauthorized sales might cost it more to resolve lawsuits over the product.

J&J’s unauthorized sales might cost it more to resolve lawsuits over the product. J&J already has endured recalls of artificial hip implants and over-the-counter drugs. Three J&J units have pleaded guilty in the past two years to bribery or illegal marketing of drugs. A fourth agreed to plead guilty in a marketing case.

This type of conduct again raises questions about the FDA’s approval process, which lets companies introduce products without human testing if the agency decides they’re similar to devices already for sale, or so-called predicates.

An FDA report in July found a fivefold jump in deaths, injuries or malfunctions tied to vaginal mesh for prolapsed organs. In September, an advisory panel urged the FDA to reclassify such mesh as “high-risk” devices needing human testing.

In Atlantic City, patients’ lawyers are seeking to interview more than 70 company witnesses, including Gary Pruden and Sheri S. McCoy, the leader of J&J’s pharmaceutical and consumer products unit. Both Pruden and McCoy previously served as company group chairman and worldwide franchise chairman of Ethicon.