White House and High Court decree FDA infallible

[Guest guest]

We had heard mutterings the pharmaceutical industry lawyer implants

at the U.S. Justice department were vectored into state courts with

the dunce-initiated nuance of " nanny-nanny boo-boo, if it's FDA-

approved, you can't sue " .

http://news./s/ap/20080220/ap_on_bi_ge/scotus_medical

WASHINGTON - The Supreme Court on Wednesday made it harder for

consumers to sue manufacturers of federally approved medical devices.

In an 8-1 decision, the court ruled against the estate of a patient

who suffered serious injuries when a catheter burst during a medical

procedure.

The case has significant implications for the $75 billion-a-year

health care technology industry, whose products range from heart

valves to toothbrushes.

In a recent three-month span, federal regulators responded to over

100 safety problems regarding medical devices.

At issue before the Supreme Court was whether the estate of

Riegel could sue a company under state law over a device previously

cleared for sale by federal regulators.

Under federal law, a company must substantiate the safety and

effectiveness of a medical device before the U.S. Food and Drug

Administration will approve it for the marketplace.

State lawsuits are barred to the extent they would impose

requirements that are different from federal requirements, said the

ruling by Justice Antonin Scalia.

In dissent, Justice Ruth Bader Ginsburg said that Congress never

intended " a radical curtailment of state common-law lawsuits seeking

compensation for injuries caused by defectively designed or labeled

medical devices. "

But Scalia, in response, said, " It is not our job to speculate upon

congressional motives. "

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One must wonder aloud, " has the highest court had eight of it's nine

collective heads collectively stuck in the sand? " Declaring the FDA

infallible is the same as declaring Adolph Hitler an admirable genius.

The U.S. Food and Drug Administration - The new mock pontiff of

medico-secularism mock papacy.

Lawyers representing these poor victims should re-sue for producing

a product which failed to comply with the reasonable performance and

consistently expected by the FDA approval criteria.

Congress should create a medical device " lemon " law just to spite

Bush.