In an 8-1 decision, the Supreme Court overrode tough state regulations, claiming that makers of medical devices, such as breast implants or defibrillators, are now immune from liability for personal injuries if the device in question had premarket approval from the F.D.A. This is a victory for the Bush administration and big business that have been looking for ways to get around state regulations that usually award vast sums in damages to injured patients. The Bush administration reversed the federal policy in 2004, arguing that the F.D.A.’s premarket approval of new medical devices overrides claims for damages given by the states.
This came to light with the Riegel v. Medtronic Inc. case on Wednesday, February 20. In 1996, Charles R. Riegel went in for an angioplasty procedure. During the angioplasty, a catheter burst while being inserted into his coronary artery, injuring Riegel. The F.D.A. gave the device premarket approval in 1994. Though Riegel died after the lawsuit was filed, his widow carried on with the case. Riegel’s case also concerns the Medical Device Amendments of 1976. Though the F.D.A. sends products to market through a different process now, the F.D.A. has found them to be “substantially equivalent” to product marketed before the Amendments law took effect.
Antonin Scalia Speaks
Writing for the majority, Justice Antonin Scalia said that, though state juries might impose liability on companies who make approved medical devices, this “disrupts the federal scheme,” since the F.D.A. evaluates the risks and benefits of new devices. It is their responsibility to find that the devices are safe and effective for use. Scalia goes on, saying, the jury will only look at the injured patient, weighing only the dangers of the device. The juries don’t look at the device’s benefits or those patients who have not had any problems. He bases this on the premarket approval process laid out by the Medical Device Amendments of 1976.
Ruth Bader Ginsburg and the Dems Respond
As the sole dissenter, Justice Ruth Bader Ginsburg claims that the court has misinterpreted Congress’s original intent with the 1976 law. Justice Ginsburg claims the original law was to keep individual states from applying their own premarket approval process to medical devices, and that was all. Democratic lawmakers seem to agree with Justice Ginsburg. Senator Edward Kennedy of Massachusetts sponsored the 1976 law, and said Congress didn’t mean for the F.D.A.’s approval to give “blanket immunity” to manufacturers of medical devices. Representative Henry Waxman of California said this decision strips consumers of rights we’ve had for decades. He also claims Congress will pass legislation to “fix this nonsensical situation.”
Until then, hope you don’t have to sue a manufacturer for a faulty heart pump, artificial heart valve, or prosthetic knee. The Bush administration and seven of eight Supreme Court Justices claim they’re immune if the F.D.A. approved their product before it even hit the market. However, if you find yourself involved in a product liability case, please contact an experienced injury lawyer.
