Philadelphia, PA (PRWEB) January 28, 2013
The U.S. Food and Drug Administration’s (FDA) regulatory pathway known as the 510(k) process has allowed dangerous devices to reach and potentially injure thousands of people before adequate testing showed the products’ dangers, according to a recent article by the New England Journal of Medicine.*
The national law firm of Anapol Schwartz applauds the publication’s efforts to reveal serious flaws in the 510(k) approval process for metal-on-metal hip implants, which have 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.”
Using the DePuy ASR XL as an example, the article explains that the elements that make up the ASR XL were never used together in a previously approved hip implant. The implant received 510(k) clearance anyway, because the FDA deemed the separate elements substantially equivalent to those of several different devices. FDA documents trace the ancestry of the ASR XL through 50 years and nearly 100 different devices, some of which were recalled years ago for a high revision risk.* The ASR XL was recalled in 2010, and patients who suffered injuries are filing DePuy hip replacement lawsuits to recover damages for the serious side effects of hip implant failure.
“Because the elements of the DePuy ASR XL were never used together in the same fashion, the 510(k) should never have been applied in this situation,” Anapol said. The ancestry of many defective metal-on-metal hip implants reveals serious flaws in the approval process that allowed clearance of a new hip implant that was never proven to be a safe or effective device.*
About Anapol Schwartz:
Anapol Schwartz is national leader in product liability and pharmaceutical litigation, having successfully litigated thousands of cases in state and federal courts over the last 30 years. The firm has obtained hundreds of millions of dollars in successful verdicts, settlements and judgments on behalf of its clients.