As noted in our Medtronic heart lead recall blog, the New York Times has issued a story that the U.S. FDA “has revealed that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees,” an approval it is now revisiting. As the Times reports, over many years the agency’s scientific reviewers repeatedly and unanimously decided that the device, known as Menaflex, was unsafe because the device often failed, resulting in patients having to have an additional knee operation.

Nevertheless, after receiving what an FDA report described as “extreme,” “unusual” and persistent pressure from four NJ Democrats, agency managers overruled the scientists and approved the device for sale in December. All four legislators began their pushing within a few months of receiving significant campaign contributions from the manufacturer of the patch.

This only highlights the importance of passage of the Medical Device Safety Act, which would restore the right of patients injured by faulty medical devices to hold manufacturers accountable. The safety of millions of Americans with medical devices cannot and should not be put in the hands of one person at the FDA. The civil justice system provides an independent check and balance on corporations to ensure that their products are safe for consumer use.