Lawyer Comments on FDA's Lapdog Authority

Jane Akre
July 12, 2012

Prolift from J & J website

Generally speaking, lawyers avoid talking to reporters. But in a July 10 press release (here), Henry G. Garrard III of Blasingame, Burch, Garrard & Ashley, P.C., an Athens, Georgia law firm, recounts what he’s told to Bloomberg News in a June 26, 2012 story (here).

The story – how Johnson & Johnson continued to sell its Gynecare Prolift mesh even when the company had been ordered to stop by the U.S. Food and Drug Administration (FDA).

In a 2007 letter, the FDA wrote to J & J to stop selling the Gynecare Prolift after it found the company had bypassed seeking any FDA approval. According to the 2007 letter, the FDA wanted time to determine if it was indeed “substantially equivalent” to other medical products on the market. That is the only standard required to sell a device under the 510(k) approval process but J&J had not even submitted paperwork to seek a 510(k) approval.

J & J just kept on selling the device. Finally it was cleared for market in May 2008 with no sanctions on the company. Garrard says this lack of authority raises questions about the FDA’s ability to protect patients.

“Companies know the FDA has little enforcement ability and scarce resources,” Garrard, the managing partner of the Athens, Georgia-based law firm of Blasingame, Burch, Garrard & Ashley, P.C., tells Bloomberg.

In other words a lapdog instead of a watchdog.

Technically the company could have been found in violation of the Federal Food, Drug and Cosmetic Act. In the case of a nutrition supplement maker found facing similar violations, the FDA will threaten the manufacturer with sanctions and having the product forcefully removed from store shelves.

Garrard is Co-Lead Counsel for Plaintiffs in the multidistrict litigation consolidated in Charleston, West Virginia that names four manufacturers – Bard, J & J’s Ethicon, American Medical Systems, and Boston Scientific.

Gynecare Recall?

Gynecare Prolift was one of four meshes that Johnson & Johnson’s Ethicon division announced in early June it was removing from the market over the next 90 days, even though it still had confidence in the product.

The J & J website still advertises the Prolift (here) with no mention on the main page about the product withdrawal.

The MDND story on the withdrawal is here.

The other meshes to be withdrawn by the Gynecare division of J & J are:

TVT Secur

Prosima Pelvic Floor Repair System

Prolift MTM Pelvic Floor Repair System #

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