Friday, February 22, 2008


Supreme Court Shields Medical-Device Makers

On Wednesday, by an 8-1 margin, the U.S.
Supreme Court ruled to protect “the makers of medical devices that have passed the most rigorous federal review standards from lawsuits by consumers who allege that the devices caused them harm.”

The case was brought by the wife of a man who was seriously injured when a balloon catheter burst during an angioplasty in 1996. The man died three years ago. The wife alleged that the device’s design was faulty and its labeling deficient.

Okay, so the reason this case caught my eye was that four months ago I had an implantable cardioverter-defibrillator (ICD) installed in my chest to keep my heart from beating too fast or too slow. When I read the lead, “Supreme Court Shields Medical-Device Makers,” I didn’t automatically begin to think about how tort lawyers were getting what’s coming to them. My first thoughts were more along this line: what if my ICD malfunctions because of faulty design or construction and I become a vegetable or die because of it? What happens to my family? My device seems to be working fine, but it was more than self-interest that prompted me to pay attention to the decision.

Concern for others might have prompted me to read further because this case has
significant implications for the $75 billion-a-year health care technology industry, whose products range from heart valves and ICDs to toothbrushes: "In a recent three-month span, federal regulators responded to over 100 safety problems regarding medical devices."

After my first thought, a second rushed to fill the void and that was despair about what has happened to the Supreme Court in the past eight years. Justice Antonin Scalia wrote the majority decision, saying that federal law preempts the imposition of liability under state laws for devices that have undergone the Food and Drug Administration's pre-market approval process, the most rigorous of the FDA's testing procedures. I wonder if Justice Scalia has any idea of how oxymoronic “the most rigorous of FDA’s testing procedures” sounds to many U.S. citizens.

Justice Ruth Bader Ginsburg was the lone dissenter. She wrote that Congress did not intend the preemption clause “to effect a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical device.”

Need I remind you that Ginsburg was first appointed a Judge of the United States Court of Appeals by President Carter in 1980 and in 1993 nominated as an Associate Justice of the Supreme Court by President Clinton in 1993? In a Senate made up of 56 Democrats and 44 Republicans, the vote on Ginsburg was 97-3, the three in opposition being Republicans Don Nickles (OK), Robert C. Smith (NH), and Jesse Helms (NC). The vote had everything to do with a nominee who was genuinely qualified.

My third thought was how important it is for us not only to elect a Democrat as President but also increased Democratic majorities in the Senate and House. Ending the war depends on both; re-instituting the rule of law depends on both; restoring confidence in our judicial system and our tattered reputation abroad depends on both; dealing with global warming and other critical environmental issues depend on both; and, yes, manufacturer accountability depends on both.

I’m glad I got that off my chest. I feel better already! That’s good because we have a lot of work to do in the next eight months.
- Milo

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