Lawmakers will hear testimony this week on the proposed Medical Device Safety Act which would legislatively overturn the highly criticized U.S. Supreme Court’s 5-4 Riegel decision barring tort suits for defective medical devices. That decision held that injured patients were preempted from bringing claims for damages because the FDA had approved the medical device.
That hasn’t sat well with the hundreds of victims of Medtronic’s defective Sprint Fidelis pacemaker leads which crack and can shock the patient multiple times. There are also growing concerns over complications following cervical surgery from Medtronic’s INFUSE Bone Graft as well as inflammatory mass growths in patients using Medtronic’s Intrathecal Infusion Pump.
Legislators are being pressured by their angry constituents to even the playing field with these large pharmaceutical manufacturers. A manufacturer should be accountable for the products they make and sell, especially those that are implanted in the human body.
Current law gives the manufacturers immunity from suit and a free pass to sell a defective product if their medical device was approved by the FDA. This proposed Act will provide a powerful deterrent by returning the right of individuals to hold the manufacturer liable for their faulty products and will ensure that medical devices are actually safe to be implanted in our bodies.
Richard J. Arsenault, 2011
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