One way the big manufacturers were going to avoid any liability for their actions was to stack the courts to rule that State courts could not interfere (with jury verdicts) in areas where the Feds have regulated. Unfortunately for their diabolic plans, some of the conservatives put on the Supreme Court actually believe in keeping the Feds out where the States can do a better job of protecting the public. While Bush’s appointments tend to be corporate lapdogs who will do whatever the largerst corporation wants in a given case, I expect diehards like Scalia to stand by their principles and stop this whole “preemption” nonsense. Note the latest move by the Supreme Court:
The U.S. Supreme Court agreed to consider giving patients the right to press product-liability lawsuits against Medtronic Inc. and other medical-device makers.
The justices today agreed to hear an appeal by a New York man who says he suffered permanent injury when a Medtronic-made catheter burst during an angioplasty. A lower court said Medtronic couldn’t be sued because its product was cleared for sale by the U.S. Food and Drug Administration.
The issue has arisen in scores of lawsuits against Fridley-based Medtronic and other medical-device makers, with most lower courts shielding the companies from suit.
Injured consumers are now “without any remedy in many parts of the country,” patient Charles R. Riegel and his wife, Donna, argued in their appeal, filed in Washington.
The Bush administration’s top courtroom lawyer, U.S. Solicitor General Paul Clement, told the justices they shouldn’t take up the appeal. He said suits challenging an FDA-approved medical device “would undermine the regulatory scheme established by Congress.”
Medtronic similarly urged the high court not to get involved, saying the New York-based 2nd U.S. Circuit Court of Appeals reached the right conclusion. The Supreme Court had rejected five similar patient appeals since 2001.
Charles Riegel underwent an angioplasty to dilate his coronary artery in 1996. When the device burst, he lost consciousness and developed a complete blockage, forcing emergency bypass surgery.
Medtronic says the surgeon failed to follow guidance on the device’s FDA-approved label not to use the catheter on patients with calcified arteries.
The legal question is when the “pre-emption” provision in the 1976 Medical Device Amendments kicks in to bar state-law suits that claim a product is defective or that a manufacturer failed to warn of risks. The federal law says pre-emption applies when the U.S. government imposes a “requirement,” though it doesn’t specify whether that term includes FDA approval.
In 1996 a divided Supreme Court permitted a suit against Medtronic over a pacemaker lead that was approved under the FDA’s more streamlined “grandfather” rules. That process provides for fast-track review of new devices that are similar to those already on the market.
The Riegel case involved “pre-market approval,” a more extensive FDA procedure that typically takes years.
The justices will hear arguments in the nine-month term that starts in October.
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