September 24, 2008 Vermont woman faces off against pharmaceutical giant Play video

(Anya Huneke, NECN: Marshfield, VT) - A Vermont woman heading to Washington to face off against a pharmaceutical giant. Diana Levine - a professional musician - won a suit in a Vermont court four years ago against Wyeth pharmaceuticals... After a routine drug injection left her disabled. The company appealed the ruling all the way up to the US Supreme Court... And some worry if Wyeth wins. Consumers could pay the price with their lives.

When Diana Levine sits down to play music, she often chooses one of the hundreds of songs she's written through the years.

Since the 1970s the Marshfield, Vermont, woman has produced about a dozen CDs - many of them for children. She’s played bass in a number of bands... And started her own record label, Rebop records.

She speaks about her musical career in the past tense because that's when it was at its peak. It Happened eight years ago-- tragically and unexpectedly. it all started with a headache. Levine, who had suffered many migraines before, went to a nearby clinic.

Diana "I went in expecting treatment - which I got: Demerol for the pain, and Phenergan to curb the nausea that goes with the headache."

Phenergan is typically administered by intramuscular injection. But this time clinicians used a method called an "iv push"-- to send the drug directly into her vein and give her faster relief. The needle, however, penetrated her artery-- and gangrene set in over time. Doctors tried to save her arm.

Diana "6 weeks later, 2 amputations later, I left Dartmouth Hitchcock Hospital with no arm and no identity."

The risks of gangrene and amputation were listed on the drug's label... But the label did not warn against the iv push method. So Levine says she was not prepared for what happened...

Diana "It's nausea versus losing a limb- and it's an easy choice. Of course, I knew nothing about this. But Wyeth knew- and they failed to change the label. When I found out this could've all been prevented, it was just insult to injury."

Levine got in touch with an attorney. And they started building a case - first, against the clinic, with whom she settled - and then against Wyeth pharmaceuticals, the maker of Phenergan. In 2004 .. The case went to trial in Montpelier... And a jury awarded Levine almost 7-million dollars.

Rubin\Levine's Attorney "Did you think that was going to be the end?" "We did think that was going to be the end. Wyeth didn't seriously contest the amount of money that was owed, or seriously contest, in my opinion, that they were responsible."

"Not satisfied with that decision .. Wyeth appealed to the Vermont Supreme Court... which ultimately ruled in favor of Levine as well. So .. the pharmaceutical company has taken its case to the U.S. Supreme Court-- where it will be heard in November."

Bert Rein\Wyeth Atty "That was a very large judgment entered against Wyeth - the largest in Vermont history - and that's the principle and primary reason why Wyeth pursued its appeal."

Wyeth counsel Burt Rein says the company should not be held responsible in this case because its product's label was approved by the food and drug administration - a federal body... Therefore Wyeth can't *change* the label to comply with state law.

Burt "Under federal law, Wyeth was required to maintain Phenergan's label that was put under attack in the state court. The state court said Wyeth was at fault for not changing the label when federal law requires it maintain the label. It was an impossible position for company."

Wyeth maintains its FDA-approved label provided adequate warning... And rein adds- even with sufficient warning, not all human errors can be prevented.

He hopes the Supreme Court will validate the relationship between drug companies and the FDA.

But Levine’s attorney, Richard Rubin, warns a Wyeth verdict would cause a sea change for consumers- by leaving victims of medical disasters like this little recourse.

Richard "If this is adopted, it will strip all Americans of the right to sue for unsafe products approved by the FDA. Never has that been the law."

Rubin feels this issue should not be decided by the Supreme Court, but rather by congress. He also believes, for Wyeth, it boils down to money.

Richard "Billions of dollars are at stake here, because lots of lawsuits are outstanding-- tens of thousands of Americans injured by unsafe drugs- their cases are now in the courts. If this case is successful by the drug companies, those Americans will never receive a penny."

So far .. Levine has not seen a penny from Wyeth... She says she's still learning how to get by with one arm... Though doing the things she loves - making pottery, baking pies... And, of course, playing music - is much less fulfilling.

Diana "It's been a long rebuilding process- I'm kind of renovating Diana here."

She heads into this potentially precedent-setting trial, she says, as one woman- with a universal story.

Diana"I'm trying to impress on people- I know you don't think it can happen to you - and maybe *this* won't - but something could - just as drastic, the result of a drug gone awry."

She says getting her due compensation from Wyeth would be a big help... But she has started to see this case through a much wider lens.

Diana: "It's almost like it's way bigger than me." The big picture is vastly more important- because I don't want this to happen to my daughter, my daughter's kids, friends of hers... and for her to be told 'Don't bother suing- remember Wyeth vs. Levine? Well, Levine lost, you're out of luck.'"

She says this trial should be renamed 'Wyeth vs. We the people'... And she's only half joking.

She is learning to cope with her loss. But worries a Wyeth win will leave countless others much worse off.