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Friday, March 6, 2009

Protection from Unsafe Drugs but Not "Medical Devices"?

From the Huffington Post
By Nan Aron

Americans won a Supreme Court victory this week that underscored the urgent need for Congress to pass the Medical Device Safety Act that was introduced in both the House and Senate yesterday.

It's a good news, bad news story - and I'll start with the good news.

On Wednesday, the Supreme Court refused to let what will soon be a subsidiary of the world's largest drug company "hit and run." A professional musician from Vermont named Diana Levine had lost her arm because Wyeth Pharmaceuticals, which Pfizer has announced it's acquiring, failed to warn doctors and patients of health damage one of their drugs had caused to at least twenty people.

The company, citing the Bush administration as its authority, argued that it couldn't be sued because the Food and Drug Administration had given permission to market the drug with the original label.

Levine courageously stood up to the drug giant, backed by a public outcry that included public forums, a petition campaign, screenings of a documentary film, opinion pieces in major newspapers, and much more.

The Court upheld Levine's rights. Only three justices voted for the corporation's hit and run theory - including Chief Justice John Roberts, whose legally required disclosure forms showed before the decision that he owned stock in Pfizer.

That's the good news - now the bad. Unless Congress acts, the Court left the door open to the hit and run theory. It said that if the Bush administration had followed better procedures when it tried to protect drug manufacturers from legal accountability, the outcome might have been different.

Worse yet, this same Court ruled a year ago that a manufacturer of a defective heart device could avoid liability. Retiree Charles Riegel needed advanced life support and an emergency coronary bypass procedure because a balloon catheter produced by Medtronic burst. But, in a case brought by Riegel's widow on his behalf, the Supreme Court denied Riegel's right to sue, basing its decisions on a law that governs medical devices rather than prescription drugs.

So the current legal situation is that if you are harmed by a drug you can hold the company accountable in court, but if it was a medical device like a defibrillator, heart pump, or artificial heart valve, hip, or knee, then you can't.

It's now up to Congress to make clear that permission by a federal agency to market a product does not prevent Americans who are harmed from holding the manufacturer accountable. Legislation like the Medical Device Safety Act - introduced by Representatives Waxman and Pallone in the House and Senators Kennedy and Leahy in the Senate -- will not only ensure basic fairness for all Americans but also maintain a strong incentive for companies to make safe products in the first place.


Click here to read the post on Huffington Post.

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