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Diana Levine Before The Court This Morning

Posted by Jane Akre
Monday, November 03, 2008 11:03 AM EST
Category: Major Medical, Protecting Your Family
Tags: Diana Levine, Federal Pre-emption, Tort Reform, Wyeth, Phenergan

Diana Levine celebrating the day. 

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

 

It is an issue that is discussed behind law school doors, but it is an issue that citizens in a democracy need to understand.

NPR, National Public Radio, provides one of the best explanations of the Diana Levine case before the court this morning and if you think some obscure legal notions have nothing to do with you - think again.

Basically the U.S. Supreme Court, the highest court in the land, will render the final decision on whether corporations that make devices and products we use every day have immunity from prosecution, if those products harm us.  

That is the far reaching implication. Wyeth, the drug company that brought the issue to the high court, says the decision will just affect Wyeth and Levine, a departure from what the company said in its legal brief to the high court.

Injuryboard has provided extensive coverage of Diana Levine and the issue of federal pre-emption. 

Here are the basics to consider.

John Adams, one of our founding fathers writes in 1774, “Representative government and trial by jury are the heart and lungs of liberty. Without them we have no other fortification against being ridden like horses, fleeced like sheep, worked like cattle, and fed and clothed like swine and hounds.

In other words, being able to take a defective product to trial is an important American right. (Adams is also referring to the court system to right any wrong, such as being accused of a crime when you are innocent).

Diana Levine, a Vermont musician lost part of her right arm after a botched drug injection. The drug, Phenergan, is made by Wyeth and nowhere on its label does it say it should not be administered by IV push, a rather forceful way to inject medication. In this case, the IV push punctured the vein and caused her arm to turn gangrenous.

Levine, and her attorneys say that Wyeth should have carried the warning against IV push on its label. 

Her story convinced a Vermont jury that awarded her $6.7 million. Wyeth appealed to the Vermont Supreme Court, which upheld the jury award.

Not satisfied, Wyeth took the issue before the court. Many eyes are watching their argument.

Basically, Wyeth says its hands are tied when it comes to any label changes. The Food and Drug Administration must decide on label changes, therefore consumers should not be able to sue under state law.

Even FDA officials of late, as well as medical editors of the New England Journal of Medicine, have stated that the FDA is not capable of guaranteeing the safety of drugs. 

There are too many drugs approved; often drug makers do no disclose all adverse findings in bringing a drug to the FDA to market; and the majority of the post-marketing negative reports are issued to the drug companies, therefore they have the better vantage point when it comes to label changes and formulation changes to make drugs and devices safer. 

Even past FDA regulators, such as David Kessler, say that lawsuits are a vital part of the balance of issuing new drugs and consumer safety.    

Vermont and 46 states are urging the court to uphold the Vermont Supreme Court ruling favoring Levine and consumers rights to sue. 

Diana Levine, meanwhile still hasn’t seen a dime. Levine, who still lives in Marshfield, Vermont, survives on Social Security disability and has to play a guitar with the help of her sister strumming the strings.  #


33 Comments

Anonymous User
Posted by David Christopher
Monday, November 03, 2008 12:13 PM EST

This sounds like a tragic accident that happened to one person in maybe millions who have benefitted from this same drug. Have compassion for this unfortunate lady, but take it as it is, an ACCIDENT.

This is one of our problems in this country that is driving health care costs up for everyone, sue, sue, sue seems to be the answer for everything.

Anonymous User
Posted by collette
Monday, November 03, 2008 12:15 PM EST

In the Diana Levine case there is no "fair" restitution. However, she deserves a settlement that acknowledges her loss. -- Love the John Adam's quote.

Anonymous User
Posted by Clifford Ocheltree
Monday, November 03, 2008 12:22 PM EST

David,

Anonymous User
Posted by tj
Monday, November 03, 2008 12:23 PM EST

Once again as Americans we a being forced to give up the individual rights to the corprate right to make money and not be responsible of their products. It goes way past an accident.

Anonymous User
Posted by Clifford Ocheltree
Monday, November 03, 2008 12:28 PM EST

It's only an accident if Wyeth did not know of the problem. Several years ago I was on a jury that dealt with an OTC drug related injury. The manufacturer knew of the problem, did a series of surveys [at shopping malls]using several proposed package inserts and chose to omit the particular problem because more folks said they would not buy the product with that type warning. Sales won out over safety.

Anonymous User
Posted by Chris H.
Monday, November 03, 2008 12:28 PM EST

In this article the author states "There are too many drugs approved;.." What? How many is too many? The number of drugs approved is not important, the approval process, the full disclosure of all trial results, and post approval monitoring are what is important. If a drug company hides relevant information they should be liable. I don't think this is one of those cases, but let's see what the court says.

Anonymous User
Posted by jrt
Monday, November 03, 2008 12:32 PM EST

As a hospital pharmacist, this problem is well documented. We have severe limitations on the use of promethizine iv usage as to total dose as an IV. There are other safer drugs than promethazine. Having been involved with clinical trial and seeing big pharma doing everything to get there products to market I full hope that the supreme court rules for the plaintiff. Promethazine has some other nasty side effects precluding its use anymore.

Anonymous User
Posted by jr
Monday, November 03, 2008 12:33 PM EST

I'm confused. How is the specific drug or manufacturer relevant? Diana was NOT harmed by the drug, but by a botched IV, which is the fault of whoever administered the IV. How could any drug manufacturer be held responsible for a health care provider's faulty care?

While someone should have the right to sue when they are harmed, Diana's money hungy lawyers are suing the wrong party.

The only reason Wyeth is being sued is because they have deeper pockets. I blame the blood-sucking lawyers in addition to the fool who actually punctured Diana's vein and caused her injury.... :)

Anonymous User
Posted by John Adams
Monday, November 03, 2008 12:36 PM EST

The idea that any consumer product manufacturer is immune to liability is insane. Drug companies should be especially liable for the safety of their products. The FDA, now run by former drug company executives, is another example of deregulation by letting industry regulate itself. When the FDA is nothing more than a drug company puppet where is the consumer safety? It's astonishing to realize how many rights are quietly being eroded away by those who drape themselves in American flags.

Anonymous User
Posted by PAS
Monday, November 03, 2008 12:38 PM EST

Wyeth should be responsible for all of Levine’s medical and legal expenses plus make up for any loss of income due to the disability for the rest of her natural life expectancy. There should also be a fine equal to 10% of the sum of the above also provided to Levine by Wyeth. If and only if this calculated value is less than the $6.7million, should anything less than the $6.7 million be paid to Levine.

Anonymous User
Posted by Pedro
Monday, November 03, 2008 12:41 PM EST

This case is stupid, that lady clearly just injected the iv incorrectly. It's her fault, too bad.

Anonymous User
Posted by !jr
Monday, November 03, 2008 12:43 PM EST

jr,

Anonymous User
Posted by flip
Monday, November 03, 2008 12:44 PM EST

The problem may be that the drug itself was highly caustic and capable of causing tissue damage unless diluted before injection. It's not going to take a genius to realize that in animals testing re: the need to apply via a slow drip when the animals limbs go necrotic after injection.
Basically it should be on the label to protect the individual. If this drug was to be given only by IV (no mention of a "push") and not IM (shot in the arm or butt) it shows that the drug solution was capable of causing undue tissue damage and the company was aware of that fact. But didn't disclose it because it would have hinted at it's tissue damaging effects requiring the need for a more time consuming and expensive doctors office drip system to apply the drug vs a "quick shot".
That is the whole deal right there...
The company wanted to broaden it's market for it's product
it should have been safely applied in a medical office
instead they opted to market it as a easily applied drug to broaden it's appeal and raise sales.
the problem is that the ability for this to destroy a large section of the patients vein (leading to it's going necrotic) was known beforehand and they opted to sweep it under the rug.

If the court decides that the company is NOT responsible for it's lacking in dosage information then it opens the door for ANY company to not give full disclosure on it's medications resulting in MORE people being harmed when such harm would be easily avoided. The FDA is already far too close to many of the major pharma companies, their allowing of companies to go to market without full disclosure of their known harmful effects runs counter to their reason to exist - to protect the public.
instead:
Profit came before people... just like in China.

Anonymous User
Posted by Jillian Galloway
Monday, November 03, 2008 12:44 PM EST

I agree with everything collette said.

But I have to ask, who does the FDA answer to? The interesting thing about the FDA is they can release any statement they want but when they're proven to be 100% wrong no one there faces any sort of retribution whatsoever.

Like in 2006 when they announced that "no sound scientific studies supported the medical use of marijuana", when in reality thousands of studies have found marijuana to be safe and to have very real medical uses.

We need to reform the FDA and LEGALIZE MARIJUANA.

Anonymous User
Posted by Jane Akre
Monday, November 03, 2008 12:45 PM EST

Hello

Levine's case is a failure-to-warn case. Drug companies say they can only go as far as the FDA allows them in producing the label. That was folded into law recently beginning around the time when Daniel Troy was general counsel for FDA. He now works for GlaxoSmithKline. See our Diana and Daniel Troy story that is currently in Popular Posts section.

The case has been heard- more in a moment by the Legal Director for Alliance for Justice, Simon Heller.

Anonymous User
Posted by Brian Murphy
Monday, November 03, 2008 12:45 PM EST

As to Mr. Christopher's comment, sue, sue, sue is not the answer to everything. Litigation is only part of the answer when there is merit to the lawsuit. Clearly, the jury was convinced that Wyeth had enough prior knowledge of the IV push use of phenergan and the dangers that are posed by the drug being administered by this route. In short, Ms. Levine and her attorneys proved their case and Wyeth, and its attorneys, did not. Compensation was arrived at by a jury of common people, who understand pain, suffering, disability and disfigurement (if you have not guessed by now, I am a plaintiffs' attorney). The second part of the answer depends on Wyeth: What will Wyeth do now, or better said, what did it do when it realized that there was credible evidence that its labeling had serious gaps.

Drug cases are about as difficult a case any plaintiff can take on. I am not damning the pharmaceutical companies. The truth is they do not need preemption to rig the system for their benefit. Pharmaceutical companies have the litigation advantage in any of these cases without preemption.

Our jury system works but only when all sides are given access. The profits will always be there for those companies who develop and market safe, effective pharmaceuticals (which happens the vast majority of the time). Governmental agencies can only do so much; in the end, the individual must be allowed to have a company like Wyeth answer if they drop the ball. Premption removes this highly effective check.

Anonymous User
Posted by Bob J.
Monday, November 03, 2008 12:46 PM EST

The injury sustained by Ms. Levine is not altered by the benefits of Phenergan. Wyeth Labs is responsible, as the manufacturer of the drug, for ensuring that all information relevant to the use of this drug is available to those prescribing and administering it. If a common mode of drug administration (IV push) was not to be used with Phenergan this had to be clearly stated, as otherwise there was no way for those administering the drug to know that they should not use this common method of drug delivery. If Wyeth was aware that the use of an IV push delivery could cause problems but did nothing to make this known they are then liable for whatever problems might arise, including Ms. Levine's injury. There was nothing preventing them from going back to the FDA and requesting a label change, and had they done so in a timely fashion they would likely have been found to have no liability in this case, whether or not the instructions accompanying the individual vial of product administered to Ms. Levine had the updated warnings.

Certainly Ms. Levine's case is a tragedy made all the more egregious because her livelihood is so dependent on the use of her hands and arms. However, it is important to recognize that what is at issue here is more than Diana Levine's injury. If anyone is injured by a product, where the producer of the product knew or had reason to know that the product could cause injury, and where the producer failed to make this potential for injury known, then the injured part has the right to go to the courts asking for redress for their injury. That's you, me, and everyone in this country.

Frankly, I don't think Wyeth has a leg to stand on but more to the point, Ms. Levine doesn't have an arm.

Anonymous User
Posted by jr
Monday, November 03, 2008 12:51 PM EST

Flip,

I'll concede if there are properties of this specific drug that make IV application more dangerous, and those properties were known but not disclosed, then the manufacturer has some liability. Whether the botched IV or the drug's likelyhood of adverse reaction when administered via IV was the primary cause of injury has probably already been debated.

The article simply states that the cause of Diana's injury was the punctured vein, not anything to do with this specific drug.

I agree that an individual's right to sue when harmed is of paramount importance. However, I am also concerned about the frivolity or target (i.e. deep pockets rather than primary liability) of many of these lawsuits.

Anonymous User
Posted by Steve
Monday, November 03, 2008 12:52 PM EST

This wasn't simply the result of a mistake by the person who administered the IV. The problem is that Wyeth knew that Phenergan would kill the artery and cause gangrene *if* it comes in contact with the artery. They also knew that IV push makes it far easier for the clinician to acidentally inject into an artery, rather than a vein.

Anonymous User
Posted by Ken
Monday, November 03, 2008 12:58 PM EST

I worry about associating the knowledge of possible problems with liability. This encourages companies to "look the other way" and not try to discover possible side-effects and other problems, because if they never knew of the problems they cannot be sued.

Anonymous User
Posted by flip
Monday, November 03, 2008 1:04 PM EST

JR.
What we need is really some more detailed information
However I believe that there's enough perspective coming from other people in the medical field to full in the blanks here.

I believe that the comment Posted by Steve
Monday, November 03, 2008 12:52 PM EST
nicely says what my thinking is at this point.

Anonymous User
Posted by Mike Shapiro
Monday, November 03, 2008 1:09 PM EST

This story published by the Injury Board (wonder who butters their bread???) does not provide the drug company's position. Fact of the matter is that there are several warnings in the Phenergan product labeling stating that Phenergan should not be given into an artery or exposed to arterial blood. Yet arterial administration of Phenergan is just what happened in the Levine case. The medication was given in a method that was specifically against the manufacturer’s recommendations and caused a specific injury that the manufacturer warned about.

Anonymous User
Posted by flip
Monday, November 03, 2008 1:23 PM EST

mike shapiro,
I don't think that the warnings were on the product or given by the company. IF the drug is supplied in a packaged bottle intended for IV injection without the mention of the NEED for a IV drip and not a "push". then the company is responsible for not supplying all the information. As the jury decided in the lower court.
I've looked up "Phenergan" on the web... seems like they've taken the IV forms off the market and only prescribe it in oral and rectal forms.
where did you get your information that says "n the Phenergan product labeling stating that Phenergan should not be given into an artery or exposed to arterial blood"?

Anonymous User
Posted by Juno
Monday, November 03, 2008 1:30 PM EST

An anti-nausea drug that can lead to loss of limbs??? Sounds like a drug that should never have been brought to market. Many of the drugs that pharma companies rush to market--and sell, sell, sell to the American public--have potentially severe side effects that far outweigh the benefit of taking the drug. This fact, coupled with the recent revelations (Vioxx, etc.) that many pharma companies hide the results of studies that show their drugs have harmful side effects, indicates that a patient's right to legal action needs to be protected, not eliminated.

Anonymous User
Posted by Rabbitwantsaniphone
Monday, November 03, 2008 2:07 PM EST

OMG David, I'm sure you would be singing a different song if it were your arm! I understand that it was an accident. I'm sure the person to gave the injection didn't do it on purpose. But if this drug absolutely shouldn't be given via "IV Push", then it should be clearly marked on the label/bottle.

I've had to have this drug in the past (thank goodness it's available) and I have always received the dose on my buttocks! As well the person that gave her the dose should have known. Accidents DO happen...we are only human. But if the accident requires an arm to be removed, THAT'S SERIOUS! She should be compensated. But who am I...just a rabbit.

Anonymous User
Posted by Rabbitwantsaniphone
Monday, November 03, 2008 2:48 PM EST

OK, I'm a little confused...I was just doing some research on the case and apparently the label on the bottle DOES state a warning based on the info below:

"Phenergan, was first approved in injectable form in 1955. By the mid-1960s, according to court documents and company officials, Wyeth had learned of a dangerous side effect when the drug is administered directly into a vein, a method known as IV-push. If the Phenergan mixes with blood from an artery, it can cause irreversible gangrene.

Wyeth alerted the FDA, which imposed a series of warning labels. At the time Levine was treated, the label instructed doctors to be extremely careful when using IV-push and specified gangrene as a side effect. Court documents said about 20 patients -- out of more than 200 million -- have been stricken with gangrene, a risk that the company and FDA think is minimal enough to keep IV-push as an option for doctors because it gets the drug into the bloodstream immediately."

Someone should be held responsible, but I’m not sure who that should be. Wyeth? The Doctor? The Clinic? That’s why there’s liability insurance right? To compensate people when they are injured accidentally…we are human…to err is human. It seems to me the Wyeth did what they were supposed to do. However, I don’t believe there have been only 20 cases of gangrene out of 200 million.

Anonymous User
Posted by Jane Akre
Monday, November 03, 2008 3:42 PM EST

Hi Rabbit-
Where did you get this warning? Certainly not from the drug label. Did you get it from their website? Please source it.

Wyeth could not reasonably go into court and argue that they can't change the label and then go ahead and change it. The point being that the label did NOT have an IV Push warning in 2000 when Levine was injured.

Anonymous User
Posted by Rabbitwantsaniphone
Monday, November 03, 2008 3:57 PM EST

To Jane Akre:
I got the info from an article By Jerry Markon
Washington Post Staff Writer
Monday, November 3, 2008; 2:44 PM on the Washington Post Website. the Article title "Supreme Court Hears Pharmaceutical Case" page 2.

Hope this helps. I was originally going to list the source but when I went back to the page they required a "free registration" which I declined. But since you inquired I completed the free registration to get the complete source info.

Anonymous User
Posted by Rabbitwantsaniphone
Monday, November 03, 2008 4:44 PM EST

I just want to be clear. I feel that Ms. Levine deserves compensation. Her situation is tragic. However, I'm questioning who the compensation should come from.

I don't think that this drug should be administered via "IV Push" at all if there is such a serious side effect. OR the patient should be forewarned of the side effects prior to administration of the drug via IV Push.

But…then I think, if a patient is warned of the side effects, realize a patient who is in that much pain is not in their right mind and they just want the pain to go away. Can you then blame the patient for accepting the risk?

Anonymous User
Posted by B Montgomery
Tuesday, November 04, 2008 1:21 AM EST

I just found an article about Diane Levine this morning while going through an old issue of AARP. I was in shock when I read what happened to Ms Levine. In May 2006 while hospitalized at Waukesha Memorial Hospital I received an IV push injection of Phenergan. It was one of the most painful experiences I have ever had! It was like a meat grinder was running up my forearm. I asked several physicians and nurses about this since then and no one ever explained that the IV should not have been given with this drug. Perhaps no one knows? I believe Wyeth must be responsible for informing the medical professionals and placing warning labels on their products!

Jane Akre Injury Board Community Member
Posted by Jane Akre
Tuesday, November 04, 2008 11:51 AM EST

Read the Supreme Court transcript, Wyeth v. Levine
LINK

Anonymous User
Posted by Rabbitwantsaniphone
Tuesday, November 04, 2008 8:59 PM EST

Thank you

Anonymous User
Posted by Rabbitwantsaniphone
Tuesday, November 04, 2008 9:00 PM EST

Hi Jane,

Comments for this article are closed.

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