The FDA and the Wall Street Journal: Dumb and Dumber

Dan Frith

Contributor

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The Wall Street Journal ran an editorial yesterday (August 13) titled, "Devices for Lawyers." The piece was very critical of trial lawyers in America for lobbying Congress to pass the "Medical Safety Device Act," which would overturn the U.S Supreme Court's decision in Riegel v. Medtronic.

The U.S. Supreme Court's decision in Riegel has, and will, do more damage to the rights of Americans than any other case in recent history. You see, the Court held that if the Food and Drug Administration approves a new drug or medical device as safe...then an individual who is injured or killed by such drug or medical device cannot hold the manufacturer of the product responsible in state court. The Court believes the FDA can be the protector of the American public! Right!

Do you remember such FDA fiasco's with the approval of Digitek (digoxin), the Ortho Evra Patch, Fosamax (alendronate), Bextra (valdecoxib)...? All are medicines initially approved by the FDA and then later serious problems arose...even recalls....but how many people were injured or killed in the interim? Should they have a right to hold the manufacturer accountable?

How about the FDA's other fiascos with approval of medical devices like the Medtronic Sprint Fidelis Defibrillator Leads, Sunrise Medical Power Wheelchairs, Baxter Healthcare Infusion Pumps, Guidant Pacemakers, and the list of previously approved then recalled devices goes on and on and on....

So, the Wall Street Journal believes the trial lawyers in America are wrong for lobbying Congress to pass a law to hold manufacturers of previously FDA approved medicines and devices accountable when those medicines and devices prove to be a danger.

That is criticism I can live with.