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Proposed Premarket Approval Process Could Shield Metal-on-Metal Hip Manufacturers from Liability

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The American Association for Justice (AAJ) is asking the Food and Drug Administration (FDA) to prohibit metal-on-metal hip implant makers from taking advantage of a proposed change to the approval process that could shield manufacturers from personal injury liability.

This became an issue since the FDA announced that it may shift toward a more intensive approval process for all-metal hip replacement devices. The new approval process would require metal hip implant manufacturers to go through a stringent safety review process in order to continue selling the hip replacement devices, or to bring new devices to the open market.

You may be thinking, “Wait, they don’t already have a stringent review process?” Unfortunately, no. The current process allows metal hip replacement device manufacturers to obtain approval by showing that their all-metal designs are similar enough to those on the market that they don't have to submit clinical studies, according to Reuters.

It’s good to see the FDA take some action, but it should not result in consumers losing their ability to sue the hip implant manufacturers for their injuries.

"It would be absolutely unfair … if these claims all of a sudden were thrown into jeopardy solely because the government determined that the products needed additional safety testing before being marketed to consumers again," wrote AAJ president Mary Alice McLarty.

Mrs. McLarty has a good point. There is a risk that a metal hip device manufacturer could obtain premarket approval for an existing metal-on-metal hip implant device. After that, the manufacturer could use that approval to shield itself from liability – even for injuries that occurred before the device met the new, stringent approval process.

Our law firm is in total agreement with the AAJ and strongly encourage the FDA to include language in its final rule that would prevent metal hip implant manufacturers from attempting to take advantage of the premarket approval process to retroactively defeat personal injury claims that were filed prior to the proposed review changes.