The national law firm of Anapol Schwartz applauds New England Journal of Medicine’s (NEJM) recent article about serious flaws in the 510(k) approval process for metal-on-metal hip implants, a system that has endangered the lives and health of thousands of people.

“The article clearly outlines how manufacturers manipulated the presentation of facts to the FDA in order to get a fast track approval,” said Tom Anapol, partner and shareholder of Anapol Schwartz. “It’s rather ironic that the ‘new’ solution callously marketed to younger arthritic patients is based on technology that’s a half century old and didn’t work particularly well then.”

The press release by Anapol Schwartz outlines important points in the NEJM article that show the weaknesses of an approval process that allowed clearance of new devices that were never proven to be safe or effective.

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