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Diana Levine Drug Gets Black Box Warning

Posted by Jane Akre
Thursday, September 17, 2009 4:42 PM EST
Category: Protecting Your Family
Tags: Federal Preemption, Tort Reform, U.S. Chamber of Commerce, Diana Levine, Wyeth, Phenergan

The drug that caused Diana Levine to lose her arm and brought the issue to the Supreme Court, will finally get a black box warning.

Dangerous Drug Will Carry Warning


IMAGE SOURCE: Courtesy Charles Eller Studios, Diana Levine under a rainbow

The drug, Phenergan became a household word when Diana Levine’s fight against drug maker, Wyeth, went all the way to the U.S. Supreme Court.

Levine complained that the drug label did not explicitly warn against administering it via the IV push method.

Now it will.

The Food and Drug Administration (FDA) has ordered the companies that make Phenergan, (now generically sold by other companies as promethazine hydrochloride), to slap a “black box” warning on the drug to tell the public the nausea-reliever should not be delivered via an IV push, a method to more quickly deliver the drug into the bloodstream.

Levine wishes it had been there all along.

“I’m thrilled,” she said in a phone interview with the Philadelphia Inquirer, though she wishes ithe FDA ordered an outright ban instead of indicating that the preferred method of administering is through intramuscular injection.

Had the warning been on the label in the spring of 2000, she might not have lost her right arm.

In 2000, Levine had a migraine headache and went to a local clinic in Marshfield, Vermont to be treated.

Because the drug she was given also gave her nausea, she was administered Phenergan via an IV push, also known as intravenous push, method.

The clinician accidentally penetrated her artery with the needle. The drug caused her right arm to be infected with gangrene.

Eventually doctors had to amputate, a devastating injury for a musician who uses her right arm to pay the guitar and make music, her livelihood.

Levine sued the clinic but also Wyeth for failing to adequately warn the public in its label.

At a lower court trial, Levine’s jurors agreed that the drug should have carried a warning against IV push method and awarded her $7 million. But Wyeth argued that federal preemption, or approval by the FDA, shielded the company from product liability lawsuits.

The outcome of this trial would determine whether Americans retained their rights to hold drug makers liable and was closely watched by many.

In March 2009, the high court struck a blow to Wyeth and to supporters of federal preemption. Levine’s lower court ruling stood.

But she told IB News she would rather have her arm.

FDA’s Karen Riley says since the IV method requires such low doses, it would effectively eliminate IV push as an alternative, reports the Philadelphia Inquirer. #

1 Comment

Anonymous User
Posted by Joan Petty
Tuesday, September 22, 2009 12:08 AM EST

Great Going! The FDA put the case in a BLACK BOX, when it should have been a Criminal case to begin with. Not a Product Liability case. Of course there is NO Law to prosecute for loss of an arm.
Only can bring this to the Court as a Product Liability that was incorrectly labeled and administrated. The drug itself is now in a BLACK BOX. If the United States Supreme Court looked at this case without the Preemption of the Law and used Common Sense. It was the Drug that did the damage and not the administration. Great Going Diana As you know by now that Congress omitted the Product Liability for defective Prescription drugs. No Federal Law and No State Law.You could not prosecute them for the Criminal Act. The Legislator should remove the Preemption of the Law and include Prescription drugs and Medical devises in the Healthcare Reform Bill.

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