Who’s liable when medical devices don’t work?

When a potentially life-saving medical device fails, who should be held responsible? Should patients or their families be able to sue the manufacturer when the device is faulty?

These are questions Congress is expected to consider in the months ahead, following a 2008 Supreme Court ruling involving Medtronic that gave device manufacturers immunity from most product-liability lawsuits.

The Star Tribune has a story today about personal efforts to support the Medical Device Safety Act, which would reverse the Supreme Court precedent and make device companies vulnerable to lawsuits again when products malfunction.

The device industry opposes the bill and says litigation money would be better spent on developing new and better products. Your thoughts?

Comments (1)

  1. Submitted by Greg Kapphahn on 08/17/2009 - 01:22 pm.

    Without some type of sufficiently-expensive liability for situations where a faulty medical device injures a person upon whom it’s used or in whom it’s installed, it is inevitable, by human nature as it’s currently expressed, that the market will be increasingly flooded with products of dubious value or poorly-manufactured products that, while continuing to cost a great deal, are far more likely to provide little-or-no benefit if not outright harm.

    Even reputable companies will be pressured by Wall Street to lower their manufacturing and materials standards if it costs them nothing when those lower standards lead to patient harm. Perhaps we’ll even start seeing competing pacemakers or angioplasty catheters advertised on TV (I’m surprised we don’t already – “Be sure to tell your doctor you’ll take nothing less than a Boston Scientific Catheter for your angioplasty.”

    This situation, created when loopholes were revealed (or created) in current law by the Supreme Court, absolutly needs to be corrected.

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