Overruled


It “felt as if a cannon was being repeatedly shot at my chest”
February 9, 2009, 11:01 am
Filed under: Ian | Tags: ,

Excellent reporting in the Star-Tribune this weekend on the Supreme Court’s recent decision saying that medical device manufacturers are immune from accountability when their defective devices malfunction:

“Make it stop,” Liz Fossum remembers thinking.

For about an hour early that November morning two years ago, Fossum’s implanted defibrillator repeatedly shocked her heart — 54 times all told. It felt like a horse was kicking her in the chest.

The 68-year-old grandmother from Golden Valley now knows that part of her heart device, an insulated wire made by Medtronic Inc., had been recalled by federal regulators because a small number had malfunctioned, occasionally causing unnecessary shocks.

Months later, physically worn out and emotionally fragile, Fossum decided to sue the Fridley-based medical technology giant in a product liability case.

But a U.S. Supreme Court ruling last year — heralded by the Bush administration and the med-tech industry alike — would have a crushing effect on hundreds of similar lawsuits. The high court restricted legal options for patients who claimed they’ve been injured by a defective device. If the Food and Drug Administration (FDA) approved the device following a rigorous review, the court said, then a suit by an aggrieved patient could not be filed under state laws.

Several hundred cases filed by patients who claim they were injured by the Sprint Fidelis lead were consolidated in U.S. District Court in St. Paul. Last month, a federal judge dismissed them as a result of the Supreme Court’s decision. Cases filed in state court — including Fossum’s by the Minneapolis law firm Zimmerman Reed — remain in limbo.

It was a stinging rebuke. “I feel like I’ve been shocked all over again,” Fossum said.

Read the whole thing, as they say.

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[…] drug companies, erisa, medicial devices When I write about cases where the Supreme Court says that medical device manufacturers are immune to accountability when their defective devices injure or kil…, or that employer-provided health plans can illegally refuse to pay for lifesaving treatments and […]

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