Anyone following this topic is aware that the U.S. Supreme Court ruled last year that manufacturers of medical devices, even if the devices are defective, are immune from liability if the product was approved by the FDA. The rationale was that the scientists at the FDA should not be second guessed by juries across the nation in determining if a product is defective or safe. This would be true even if the manufacturer voluntarily or involuntarily recalls the product, acknowledging its defective condition. As a result of the Supreme Court’s decision, courts throughout the nation have begun dismissing cases against Medical Device manufacturers on grounds of Federal Preemption.
Since the closing days of the Bush administration, we have learned that the scientists at the FDA themselves understood that they did not have the capacity to fully test and "certify" the safety of medical devices being passed through the agency. In fact, the scientists were being threatened with criminal sanctions for demanding an opportunity to perform more testing and scientific analysis before approval. From these developments it is obvious that the manufacturers of these devices have now been placed in the perfect position of being able to push products through the FDA without significant scrutiny, to then become insulated from liability once the FDA’s "good housekeeping" seal of approval was obtained.
However, today the tides may have changed and, as sports broadcaster Lee Corso is ever ready to say, "Not so fast my friend!"
In a story in the New York Times following the case of a young widowed mother whose husband was killed during a surgery to remove a defective electric lead on a heart difibrillator, it was reported that two House Democrats, Henry Waxman of California and Frank Pallone, Jr. of New Jersey, were reintroducing new legislation to nullify the Supreme Court ruling. This would allow state courts to act as a "second screening" device to insure the safety of these products.
We hail the efforts of these two Congressman, as well as Senators Edward Kennedy, Massachusetts, and Patrick Leahy, Vermont, who intend to introduce similar legislation in the Senate. The safety and reliability of these types of products that become part of the patient’s own body must be paramount. We certainly cannot assure that safety will remain the paramount concern when the wolf is left to guard the hen house!