Supreme Court immunity for defective medical devices costs government billions

Professor Dennis Tolley, an actuary hired by lawyers handling Sprint Fidelis defective lead cases, argues that the Supreme Court's surprising grant of immunity to manufacturers of FDA-approved medical devices, has created a windfall for manufacturers and a heavy burden for State and Federal governments. Citing the pacemaker leads manufactured by Medtronic as a prime example of what the decision costs Medicare and others, Tolley points out that the leads were recalled as defective in 2007, and that they have a failure rate of 3.75 percent per year, for a cumulative failure rate that is escalating, currently, somewhere above 12 percent. Medicare is paying more than one BILLION dollars per year in additional medical expenses associated solely with Medtronic Sprint Fidelis lead failures: under traditional negligence law, the manufacturer would be responsible for paying the cost of replacing a defective product. In the case of medical devices, however, governments, health insurers and patients end up footing the bill. The specific flaw in the Medtronic leads relates to the use of a wire of diminished size which was "grandfathered" under the approval of prior wire leads. Thus, the actual defect leading to the recall [the overly-brittle under-sized wire] was never examined during the FDA-approval process, yet the Supreme Court's decision is so broad it protects the manufacturer from a duty to stand behind its product.