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Diana Levine Reflects On High Court Decision

Posted by Jane Akre
Thursday, March 05, 2009 12:27 PM EST
Category: Major Medical, Protecting Your Family
Tags: Federal Preemption, Tort Reform, Diana Levine, U.S. Chamber of Commerce, Wyeth, Baxter

Diana Levine talks one day after the Supreme Court ruling in her favor.

Diana Levine



IMAGE SOURCE:  NPR image of Diana Levine NPR Web site


Injuryboard spoke to Diana Levine at her 150-year-old farmhouse in Marshfield, Vermont this morning, one day after the U.S. Supreme Court ruled 6-3 in her favor that people like her who are injured by drugs do have a right to file a lawsuit in state court.

It seems basic, but consumers came dangerously close to losing that American right before this case concluded.

Levine won a failure-to-warn lawsuit against Wyeth in Vermont state court, saying the drug label did not contain explicit enough information that would have warned a physician assistant from injecting her arm with the anti-nausea drug, Phenergan, through the IV push method directly into her bloodstream in 2000. Levine, a musician, lost the lower half of her right arm to gangrene. She was awarded $6.7 million in damages.

Drugmaker, Wyeth had tried to overturn Levine’s award arguing that the authority of the Food and Drug Administration precludes or preempt hers and other consumer lawsuits that are brought at the state level.

If the FDA approves the label, that should be the final word, the company argued. The authority of the FDA should have shielded the company from Levine’s lawsuit.

Levine did sue and settle with the clinic that administered the Phenergan into her artery causing the gangrene. The bigger issue became the lack of adequate and specific instructions on the Wyeth drug label.

After the media left last night Levine, 63,  decided to be alone to take in what had happened.  Cameras had filled her white farmhouse all day and she did numerous press conferences. When she was alone it hit her, she would have to live with the loss of her right arm forever.   

Levine:  “I’m so relieved and so happy, and so proud, and so grateful. Nobody was all that encouraging at first when the court decided to hear it.  Not only did it come also surprise but we were also surprised (Justice) Roberts didn’t recuse himself. 

“It was just all day, the minute I heard, the emotions, the press, in between friends and strangers, everyone was so grateful and happy. It was all positive energy flooding in on me.”

“After everybody left it was really poignant what happened. My sister and I went for a walk so I could breathe, and she asked me what I needed. I said I really needed to be alone, to contain myself.

“I said this occasion merits a margarita! Unknowingly,  I had just bought a bottle of rum juice that morning, so I got out my bottle of lime juice. I could not open the bottle of lime juice!  It just brought it so home to me. Nobody caught the footage of me trying to open this bottle so I could celebrate this victory.   

“I burst into tears partly from the emotion that you’re alone with this and this continues. Justice has been done and the dark side has been defeated, I felt all those things too.

“In the end we’re alone. I’d trade it all for my arm back.  I loved that arm. I’m so grateful I had 30 years of music playing the base, the guitar and piano. It was my friend. It helped me make music."

The Future- A Better Prosthetic Arm

Levine: “Now that I have that settlement, I’m going to aggressively pursue that (prosthetics).  When I first went I got a cosmetic and then a robotic one but it broke and the battery wore out.  They’ve made a lot of improvements. I’m going to go to Atlanta to meet with someone called Lefty who was born this way and he invented something for himself."

She also has plans to fix her garage and do many household improvements that will allow her to more easily function with one arm.

Rebop Records

Diana Levine founded Rebop Records 20 years ago with her late husband. The company has 14 releases and a Web site that sells CDs of the mostly music made for children.   Levine had been living on sales from Rebop and a monthly disability check.

Levine: “I feel so much more of a positive impetus to make things happen. Now I feel even that there are more possibilities. This year is the 20th anniversary with Rebop Records. With this victory I can celebrate on both fronts. I can celebrate Rebop records.  I’ll continue to do music with kids.  “

“I’m producing for the Eco-Center on Lake Champlain that Patrick Leahy got it started. There is a science museum and an aquarium.  I’m putting that all together.  I’m working on a food and music show geared toward teens. I’m doing things. TV is way more challenging that I expected. We started a partnership with New England Culinary Institute and Video Visions, and Rebop Records." 

Levine Will Never Tell Lawyer Jokes Again

Levine: “I just feel for one thing so amazed at both my lawyers. My Vermont lawyer, Richard Rubin, he just didn’t give up.  He found David Frederick and he’s brilliant.  I’m in awe every time he explains things. There are just such good people I will never tell a lawyer again.”

Jassamine Levine

Diana Levine’s daughter, 26-year-old Jassamine works in a child care center and lives nearby, helping her mother by bringing her food.

Levine: “Everyone was so skeptical they (the justices) were not going to do the right thing and they did.   They just saved a 26-year-old from being a cynic for the rest of her life.  She was really suffering and borderline cynical about our system. She graduated from Smith and when she came in the door I told her it was  6 to 3 in my favor she looked in this quizzical look. She said ‘do I get to be really excited at this time?’  “

“She was so discouraged before, but she was great. It’s great having that young blood around. And because of this case, it will continue to work to keep checks and balances is in place.”

Future Drug Development

In a company statement, Wyeth said, “When lay juries are permitted to second-guess the experts at FDA on the benefits and risks of particular medicine, the result is uncertainty for patients and doctors alike about how and when to use prescription drugs.”

Erik Gordon, a professor at the University of Michigan’s School of Business told NPR that industry will have to weight how prevalent the side effect is versus how much money can be made from the drug by helping people.

“This is like blood in the water for plaintiff lawyer sharks,” and will encourage more lawsuits, Gordon said to NPR.

Levine:  “Their arguments were so farfetched, that because of the conflict between the state and federal government (FDA) they couldn’t make the change.  They’ll continue to say that. They have to not admit they’re wrong.  Hopefully they’ll change the label.”   

In the future will this ruling hurt drug development?  Diana Levine says no.

Levine: “It’s ridiculous. It’s going to keep them honest and more diligent and careful and they’ll make changes will be made quicker.”

Label Change?

Doug Petkus, a Wyeth spokesman said, “We believe the product is appropriately labeled. That’s been our position all the time.”

But Petkus adds that Phenergan is now off patent, sold generically and made by other companies. Wyeth divested itself of the injectable version, which hurt Levine, to Baxter Pharmaceuticals in 2004 and divested the syrup form of Phenergan to ANI Pharmaceuticals in 2003.

Petkus says reviewing drug labels for accuracy and safety is an ongoing process. “We work with the FDA all the time because labels are determined by science and the science changes.” 

Baxter Healthcare's Corporate Communications officer Erin Gardiner was working on an answer at the time of publication.   # 


Posted by Chrissie Cole
Thursday, March 05, 2009 1:04 PM EST

Great post, Jane!

While I know the victory is bittersweet for Diana Levine I am so happy the Supreme Court ruled in her favor - and for ALL OF US.

Posted by Jane Akre
Thursday, March 05, 2009 8:36 PM EST

Erin Gardiner, Corporate Communications for Baxter Healthcare says when Wyeth quit selling injectable phenergan in 2002, about five companies began selling the generic form.

If there is any class label change it must now start with TEVA Pharmaceuticals, though Gardiner says Baxter can make “modest adjustments” to the label.

The label has undergone changes which are updated continually on the label and package insert (warning label), she tells IB News.

So label changes can be made? No you just can't change a label, she said.)

Does there exist today a warning specifically against the IV Push method of delivery? Not exactly.

“There have been continual updates as recently as December about the appropriate route of administration which is deep intramuscular use, which is preferred. Proper intravenous administration is well tolerated, but the use of this route is not without hazards. It is not for subcutaneous administration and not for intra-arterial administration.”

So without saying don’t use it in an IV push, the label says to avoid the artery.

But Gardiner adds there is no prohibition against using the IV push method, but with the lower doses only.

“In this case the inappropriate administration of the drug was delivered by a clinician and is not due to a lack of information.” #

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