Diana & The Supremes
If you lose part of your arm due to a medical error, and you sue, and you win, and the drug company you’ve sued appeals and succeeds in taking your case all the way to the Supreme Court, what’s the upside?
“I have an opportunity to talk to people. Millions are now paying attention to the situation. I’m up on my soapbox and I’m going to create awareness. Hopefully, that’ll lead to change.”
Those are the words of Diana Levine of Plainfield, Vermont. And today the e-Alert is her soapbox. Listen carefully, because any one of us could easily end up standing in her shoes, to find ourselves with absolutely no legal recourse against drug company negligence.
Standing at the crossroads
Diana is a musician – a pianist, guitarist, and songwriter – who makes a living giving music lessons to kids and sometimes performing with her husband and sister.
About eight years ago, Diana went to her local hospital and checked into the ER. This wasn’t an unusual drill for her. Diane has a history of debilitating migraine headaches, which she’s usually able to manage on her own. But sometimes the pain is so excruciating that she requires Demerol (a powerful narcotic painkiller), along with a shot of Phenergan to prevent nausea caused by the Demerol.
Typically, the Phenergan was simply given by intramuscular shot. But on this particular visit a push IV was used to administer the drug in her right arm.
When she woke up, she was surprised to find she was still in severe pain. But the pain was in her right hand, not her head. About three weeks later her doctors ran out of options and were forced to amputate her forearm due to gangrene caused by using Phenergan with a push IV.
Needless to say, this was a disastrous turn for Diana’s musical career.
Diana sued Wyeth – the maker of Phenergan – for failing to supply an adequate warning with the product packaging. She won, and was awarded nearly $7 million. When Wyeth appealed, the Vermont Supreme Court upheld the ruling, agreeing that the drug label warnings were insufficient.
End of story? Not quite. The case is now on the U.S. Supreme Court’s docket for November.
You keep me hanging on
The Chicago Tribune calls “pre-emption” the “most important legal issue you’ve never heard of.”
Pre-emption simply means that in areas where the federal government claims full regulatory power (such as the FDA’s regulation of drugs), state courts cannot act independently. This concept would prevent someone like Diana Levine from suing Wyeth for negligence.
Wyeth argues that the FDA approved the Phenergan drug label. They’re not arguing that the warning label was sufficient, they’re arguing the technicality, sort of like a child might claim that touching a certain tree makes him safe from being tagged.
According to a National Public Radio report, the FDA maintains that a label approved by the agency represents the minimum required of a drug company. Beyond that, the company is free to provide more information and warnings. And in the past, the FDA has generally viewed lawsuits as an additional check on the drug industry.
Will the Supreme Court agree? We’ll know the answer next month sometime. But the prospects don’t look good. Over the past couple of years, the court has sided with corporations over individuals, barring most investor lawsuits against Enron, for instance. And in one case last term, the court held that lawsuits could not be filed against manufacturers of medical products approved by the FDA.
I think Goliath may walk away with this one. And if he does, many many “Davids” like you and me and Diana Levine will be the losers.
Stay tuned – I’ll give you an update in November.
“Consumer Issues Top Supreme Court’s Docket” Nina Totenberg, Morning Edition, National Public Radio, 10/6/08, npr.org
“Preemption and Amputation: Diana Fights Wyeth” Ed Silverman, Pharmalot, 2/20/08, pharmalot.com
“Drama Again on the Supreme Court Docket” James Oliphant, Chicago Tribune, 10/6/08, chicagotribune.com