J&J Lawsuit Sheds Light on Link Between Doctors and Device Makers

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Johnson & Johnson

One lawsuit taking legal precedence on Johnson & Johnson’s (NYSE:JNJ) docket dates back to March 2005, when the pharmaceutical giant’s Ethicon unit introduced the Gynecare Prolift transvaginal mesh device. Several years later, the company’s 2007 annual report touted the device as an “innovative and effective surgical option” for weakened pelvic muscles.

The problem was the U.S. Food and Drug Administration did not approve the device for another three years after its initial release. At the time, the company said it could market the Prolift without approval because it was so similar to an approved device called the Gynecare Gynemesh, FDA spokeswoman Morgan Liscinsky told Bloomberg in a March 2012 email. In 2007, the federal agency became aware of the Prolift when Johnson & Johnson sought regulatory approval for a related device. By May 2008, both devices had been cleared.

But while Gynecare Prolift was eventually approved by the FDA, lawsuits streamed in nonetheless. However, the implications of Johnson & Johnson marketing the device without government approval are not just limited to the lawsuits — although this is not to say that devices or drugs that have been approved by the FDA never cause widespread problems.

Ethicon’s conduct raised questions about the FDA’s approval process and contributed to the storm of criticism raining down on the federal agency for recent high-profile recalls of devices like Johnson & Johnson’s hip prosthetics, also prompting Congress to consider changes to the system. But more important is what the unapproved release of the device says about the importance of relationships between pharmaceutical companies and doctors in marketing products: Doctors can be vital in providing or influencing the information consumers hear about medical products.

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