This is just too cool…

In a Shift, Bush Moves to Block Medical Suits
Robert Pear, The New York Times, Published: July 25, 2004

Here’s the deal -

The Bush administration has been going to court to block lawsuits by consumers who say they have been injured by prescription drugs and medical devices.

The administration contends that consumers cannot recover damages for such injuries if the products have been approved by the Food and Drug Administration. In court papers, the Justice Department acknowledges that this position reflects a "change in governmental policy," and it has persuaded some judges to accept its arguments, most recently scoring a victory in the federal appeals court in Philadelphia.

Allowing consumers to sue manufacturers would "undermine public health" and interfere with federal regulation of drugs and devices, by encouraging "lay judges and juries to second-guess" experts at the F.D.A., the government said in siding with the maker of a heart pump sued by the widow of a Pennsylvania man. Moreover, it said, if such lawsuits succeed, some good products may be removed from the market, depriving patients of beneficial treatments.

You see the logic.  If the government says it works – and the “it” might be a medical device or medication – then it does.  And you cannot complain.  If you do you just hurt other folks.  So stop it, damn it!

Got it?

Pear notes that at a 2002 legal symposium the Bush administration outlined plans for "FDA involvement in product liability lawsuits," and it has been “methodically pursuing” that strategy.  This is all part of tort reform – stopping personal liability attorneys like John Edwards from destroying healthcare as we know it.  Bush doesn’t like trial lawyers - personal liability attorneys – because, he says, they impose a huge burden on the economy and drive up health costs.

Pear quotes Representative Maurice D. Hinchey, a Democrat (of course) from New York, saying the administration had "taken the FDA in a radical new direction, seeking to protect drug companies instead of the public."

Really?  What would make you think Bush the guys want to protect drug companies?  Would it be the new Medicare Prescription Drug Program that expressly forbids the government from negotiating bulk discounts on drug price, and, in fact, expressly forbids the government from seeking any discount of any kind from the pharmaceutical companies – and expressly forbids purchases from any place like (gasp!) Canada?  It might be that.  Oh, and as you recall, that Medicare Prescription Drug package passed narrowly when the White House assured Congress it would cost four hundred billion dollars over ten years – and threatened to fire the fellow who was asked by congress how much it would really cost and was going to tell them.  Five hundred and thirty-five billion was the actual projected cost.  They knew.  And the fellow kept his mouth shut.  Ah, just a little fib and a little intimidation.

What about this Pennsylvania case?  That was last Tuesday.  The appeals court threw out a lawsuit filed by one Barbara Horn, who said her husband had died because of defects in the design and manufacture of his heart pump.  A crybaby, of course.  The Bush folks argued that “federal law barred such claims because the device had been produced according to federal specifications.”  Yes, in its briefs the administration conceded that "the views stated here differ from the views that the government advanced in 1997," in the United States Supreme Court.

But times change.  Then the Bush team argued the FDA sets the minimum standard, and now they argue that the FDA’s approval of a device "sets a ceiling as well as a floor."

Huh?

The Bush folks are holding that no one now has a right to sue – and this benefits consumers.

Why?  Because the threat of lawsuits, "can harm the public health" by encouraging manufacturers to withdraw products from the market or to issue new warnings that overemphasize the risks and lead to "underutilization of beneficial treatments."

I suppose.  The federal appeals court in the Pennsylvania case said the FDA was entitled to “great deference” because the agency was "uniquely qualified" to determine when federal law should take precedence.  And the Bush folks said well, gee, all they were trying to do… well it wasn’t that they wanted to shield drug companies.  They wanted “to vindicate the federal government's authority to regulate drug products.”

They did.

Pear trots out some cases of interest in this matter, using a popular feel-good drug as an example of where this is leading –

Kimberley K. Witczakof Minneapolis said her husband, Timothy, 37, committed suicide last year after taking the antidepressant drug Zoloft for five weeks. "I do not believe in frivolous lawsuits," Ms. Witczak said, "but it's ridiculous that the government is filing legal briefs on the side of drug companies when it's supposed to be protecting the public. My husband would be alive today if he had received adequate warnings about the risk of self-harm." Ms. Witczak sued Pfizer, the maker of Zoloft, in May. The government has not intervened in her case.

Thomas W. Woodward of North Wales, Pa., whose 17-year-old daughter committed suicide last year after taking Zoloft for a week, said, "I've been sickened to see the government taking the side of pharmaceutical companies in court." Mr. Woodward has not filed a suit.

Mr. Hinchey said that F.D.A. lawyers, led by the agency's chief counsel, Daniel E. Troy, had "repeatedly interceded in civil suits on behalf of drug and medical device manufacturers."

Ms. Witczak, Mr. Woodward and Mr. Hinchey said Mr. Troy had a potential conflict of interest because Pfizer was one of his clients when he was a lawyer in private practice.

What?  The FDA Chief Counsel used to work for Pfizer?  Imagine that.

More fox-guarding-the-hen-house detail?

The administration has also joined Pfizer in opposing a lawsuit filed by Flora Motus, a California woman who said her husband had committed suicide after taking Zoloft. Mrs. Motus argued that Pfizer had not adequately warned doctors and patients that the drug could increase the risk of suicide.

But the Bush administration said that when federal officials approved Zoloft, they saw no need for such a warning, and that a false or unnecessary warning could "deprive patients of beneficial, possibly life-saving treatment." Susan B. Bro, a spokeswoman for Pfizer, said this week, "There is no scientific evidence of a causal relationship between Zoloft and suicide."

Likewise, the administration intervened in a California case to help GlaxoSmithKline fend off consumer demands for restrictions on the advertising of Paxil. The government said the restrictions "would overly deter use of a life-improving medication."

Patients had persuaded a federal district judge to order a halt to television advertisements that declared, "Paxil is non-habit forming." The administration joined the manufacturer in challenging that order. …

Oh well.  Most people know better.  The government cannot protect all fools.

But seriously, let’s put this in terms of personal responsibility.

It is the job of government to assure the economic health of the country.  That means it is the job of the government to make sure businesses flourish and the economy grows.  Prosperity benefits everyone.  If you hurt a business, any business, you hurt us all.  And that’s what claims of defective products actually do – they hurt the economy.

It is your personal responsibility to keep yourself healthy.  You may take a particular drug or submit to some medical procedure, or have some sort of medical device implanted – on the urgent order of your doctor – but that’s YOUR choice.  YOU decided to do that.  If you are harmed by that drug, procedure or device – if it is truly defective - well, it’s your own damned fault.  You should have known better.  Caveat Emptor.  Don’t hurt us all by filing some frivolous lawsuit claiming it was defective, even if it was.  The government isn’t your Mommy.  And YOU were the one who trusted your doctor.  Your problem, you fool.

Or at least that’s the conservative, Republican view of the matter.

And the counterargument is…?