Wednesday, February 20, 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 "premarket" method for approving sophisticated devices "rigorous." The agency spends an average of 1,200 hours reviewing each company's application, which includes studies testing devices on real-world subjects to prove they are safe and effective.

One of the lawyer's involved said this ruling is "particularly scary after hearing recent reports that say the FDA isn't up to the job of protecting the public from dangerous drugs and medical devices. We know that people will be injured as a result, and some of them will have no remedy."

Hmm. Does this ruling do more harm than good? Some people sue these medical devicemakers for no adequate reason, making unreasonable claims that shouldn't be in court to begin with. Sure, they're frivolous. But that's why we have the court system - to weed out those frivolous cases and let those warrant court action to get that far. When the Supreme Court lays out a blanket rule disallowing any of these claims, they're also doing away with the ones that may be legimate and taking away state courts' power to judge the validity. This is a business-friendly ruling that flies in the face of a logical law. Bummer.

Friday, February 8, 2008

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't get a tough enough penalty. Many topics can spark these raw emotional scenes - crimes, property taxes, rivers or parkland being paved over for a new drugstore on the corner... The list goes on.

As a reporter, I've been on the receiving end a number of times. Officials pointing their fingers at me, silently threatening my livelihood because of something I'd written or somehow "allowed" to get into the paper. Regardless of the factual accuracy, I called them out on it. Or the family members who've shoved and lunged at me inside and outside a courtroom, after my news accounts covering their beloved daughter - a mother herself who stabbed her newborn in the head with a steakknife and then left her for dead in a bathroom closet. In those times, I've gone into court hearings and public meetings wondering if I was going to have to defend myself, verbally or physically.

Fortunately, I've never witnessed anything such as the Kirkwood City Hall shooting on Thursday night. When that double-edge sword of routine public meetings and open comment comes back with a bullet-packing punch. In a local city hall - a place as close to home as anyone can get, where they tackle issues for the people, and are charged with making decisions for the people. Handling issues such as whether people should have to get a gun permit at city hall or the polcie station, and then if people should have to go through the hassle of metal detectors or not to simply talk to their leaders. Talk to their leaders at a public meeting, where those very decisions are made. It all connects somehow.

We have this opportunity for greatness, simply by attending these meetings and being informed, responsible citizens. But so easily it can go bad. My heart goes out to those people who lost their lives, those who attended the meeting that night and witnessed this, those who'll never be the same. They were doing something everyone should - whether performing public service or being a citizen or j0urnalistic watchdog to keep officials accountable. And they paid dearly for it. They paid the price of freedom, in a land where everyone can do everything and anything they want. Until someone challenges that right, and public meetings and courtroom hearings are held. Routine and not-so-routine.

When does that price get too high? Is there a balance? Who decides? The elected official, or the gun-toting citizen who wants them to listen? (Does this ring a bell - Wasn't it just a couple months ago that someone tried a similiar stunt at a presidential candidates campaign office????!?) If not either of those, then do people just hit the streets and ghettos with their weapons, putting bullets into those that've crossed them?

What a world - what a web we've weaved.