Personal Injury Law

Levine Case Pits Corporations Against Consumers

By Jane Akre

Diana Levine lives in Marshfield, Vermont. She is 62, tall, elegant and missing much of her right arm, a tragedy for a musician, all due to a medical and medication mistake.

In November, the U.S. Supreme Court will listen to her case brought by drug maker Wyeth, which lost a $6 million verdict to Levine for failure to adequately warn about one of its drugs. 

Wyeth believes that the case should be pre-empted, a doctrine that bars consumers, such as Levine, from suing in state courts when a product has met federal standards.

Not a dry legal argument, the case has significance for every consumer of medical products.

Increasingly manufacturers and the government are trying to shield liability from injury lawsuits over every consumer product from cars to mattresses. Business usually backs pre-emption while injury lawyers and consumers, particularly those who have been injured, oppose pre-emption since it blocks the path to a remedy found in a courtroom.

It will also be an indication of where the Roberts court is heading, as more pre-emption cases are slated to follow.

"Federal pre-emption is the fiercest battle in products liability law today," Catherine M. Sharkey, a law professor at New York University tells the Times.  "The court clearly recognizes this, as it has agreed to hear so many cases and seems eager to give clarity to what has been, to date, an undisputable muddled area of law."

In the Levine case, she received the Wyeth drug Phernergan in the emergency room in the spring of 2000. She also received Demerol for the pain.

"Nothing wrong with either drug," says Ms. Levine, adding they're safe when given as directed.  But in this case, Phernergan was not.

When exposed to arterial blood, it causes swift and irreversible gangrene, that's why it is usually given in the muscle.  It can also be administered by an IV drip, which is almost entirely safe.

But in the emergency room, a physician's assistant used a third method, injecting the drug presumably into a vein in something called an "IV push."  Unfortunately she missed the vein.  Ms. Levine's hands and forearm turned purple then black in the following weeks. It had to be amputated in two stages.

She sued Wyeth. The drug's label, approved by the FDA. While it warned that "inadvertent intra-arterial injection" can lead to gangrene requiring amputation. It did not warn against the IV push method of administration.   

The question then is should Wyeth have warned in its label against the IV push method?

"The benefit-risk is just outrageously ridiculous, " Ms. Levine said to the Times. "Any child could figure this out."  Faster relief from nausea is just not worth the risk of losing an arm, she says.

"All they had to do was change the label and say, "Don't give it this way" she says to the paper. 

But lawyers for Wyeth says the company could not change Phenergan's label "to comply with Vermont law without violating federal law," they write in the brief, even though someone in Nevada could be subject to the same harm.   

Wyeth and the FDA argue the company cannot follow federal label law and the jury's verdict, which punished the company for not using a different label.

That conflict, according to Wyeth is "implied pre-emption."

Most personal injury lawsuits against drug companies are brought in state court.

In affirming Levine's verdict in 2006, the Vermont Supreme Court ruled that federal law, "provides a floor, not a ceiling, for state regulation." That state Supreme Court upheld Levine's $6 verdict.

The federal pre-emption is just the latest chapter in the tort reform movement that purportedly aims to rein in expensive lawsuits. Plaintiff's lawyers argue that actions brought to court are of merit- the cost of litigation is too expensive for frivolous actions and judges have the discretion to dismiss baseless claims.

The U.S. Supreme Court is set to hear the case November 3^rd. 

The community response to the NYT is just as interesting as the story and covers the gamut from those who believe in stricter regulation to those who do not.   #  

Full post as published by InjuryBoard on September 19, 2008 (boomark / email).