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J&J’s Woes Continue – Sale of Gynecare Prolift Vaginal Mesh Continued

Posted Jun 27 2012 2:50pm

In August 2007, the U.S. FDA ordered Johnson & Johnson’s Ethicon unit to stop selling its Gynecare Prolift vaginal mesh product until the agency had evaluated its equivalency to other marketed products (J&J’s Gynemesh was the reference product).  So, what are you to do as America’s most distressed pharmaceutical company?  You ignore the FDA order.

And that’s just what J&J did.  The company ignored the August 24, 2007 letter from the FDA.  The company ignored the 16 identified potential product deficiencies, and kept right on selling the device.

J&J’s Gynecare Prolift has been a mess for company.  The FDA has noted numerous instances of “organ perforation” – or punctured vaginas with the product.  If you’re a male senior leader sitting in New Brunswick, it may not seem like a big deal.  But it is.
Now, the men in New Brunswick sitting atop the glass ceiling feel they were justified.  Nearly 10 months later, the FDA did ultimately clear the vaginal mesh implants.  However, J&J clearly lost another important round in the court of public opinion – consumer’s faith in its products.
It’s worth noting that J&J faces over a 1,000 lawsuits of women who claim to have suffered perforated vaginas and other impairments as a result of the product.  Trial lawyer Adam Slater noted in an interview:  “If a company knows the FDA tells them, ‘Don’t sell a device,’ they’re supposed to not sell it.  It’s egregious that J&J was selling the device without clearance.”  And that just about sums it up.

J&J’s corporate spokesperson Matthew Johnson has said:  “Throughout this process, our actions were responsible, appropriate and consistent with FDA regulations.”

This looks like another big settlement that J&J’s shareholders get to pay for.
Source:  Bloomberg
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