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Showing posts from February, 2008

If the FDA makes a mistake....

It doesn't matter. Medical device users, such as insulin pumpers, can't sue the pump-maker. Why? The Supreme Court of the United States says so. A court ruling Wednesday sided with devicemaker Medtronic, holding that if federal regulators approved a device, a suit couldn't be filed under state laws. This case stemmed from a New Yorker who was injured after a Medtronic-made catheter burst during an angioplasty procedure 12 years ago. He needed emergency bypass surgery. As a result, he sued the company and alleged design and manufacturing defects in the catheter, as well as inadequate labeling on the device's packaging. The patient later died, but his widow continued the lawsuit on his behalf. The case probed whether manufacturers of sophisticated medical devices approved for sale by the FDA can be sued under consumer-friendly state laws, or whether they are preempted from such lawsuits. Writing for the court, Justice Antonin Scalia called the FDA's current "prem

A price of freedom

News of the shooting at a Missouri city council meeting sent chills down the spine of journalists this week, and sparked memories of council meetings and court hearings I've attended that could have erupted into similar chaos - but fortunately didn't. As I read the accounts of the rampage, which ended with six people dead and several others suffering gunshot wounds, including a reporter, I couldn’t help but think how lucky I am to have never found myself living that nightmare. I’ve sat through hundreds of public meetings myself in the decade I've been newspapering. Most are mundane, boring, to the point where my eyes suddenly slam shut enough to jerk me awake - even temporarily. They all run together in my memories, few standing out. But some do. Like the ones were people get escorted and dragged out by police, those people pointing fingers an screaming at the decision-making government officials. Or the court hearings where a loved one's attacker or murderer doesn