Court: Federal Rules Don't Protect Drugmakers From Consumer Lawsuits (3/4/09 - Major Ruling)

[Hepburn]

Source: The Washington Post



(Picture Caption: In this Oct. 7, 2008 file photo, Diana Levine sits at her home in Marshfield, Vt. The Supreme Court on Wednesday upheld a $6.7 million jury award to a Levine, who lost her arm because of a botched injection of an anti-nausea medication. The court brushed away a plea that it limit lawsuits against drug makers. (AP Photo/Toby Talbot, File) (Toby Talbot - AP))

The Supreme Court today ruled in favor of a woman who had her arm amputated after an improper injection of an antinausea drug and said drugmakers could not rely on federal regulation to protect them from lawsuits brought under state consumer protection laws.

The court ruled 6-3 that Congress did not mean to shelter drugmakers such as Wyeth Pharmaceuticals from the kind of lawsuits brought by Diana Levine of Vermont, who developed gangrene after a physician's assistant injected the drug Phenergan into an artery.

The opinion by Justice John Paul Stevens said that even though the Food and Drug Administration had approved label warnings about complications from the drug, the company could have done more to prevent what happened to Levine, a children's musician who played guitar.

Wyeth contends that "once the FDA has approved a drug's label, a state-law verdict may not deem the label inadequate, regardless of whether there is any evidence that the FDA has considered the stronger warning at issue," Stevens wrote. "The most glaring problem with this argument is that all evidence of Congress' purposes is to the contrary."



Read more: http://www.washingtonpost.com/wp-dyn/content/article/2009/03/04/AR2009030401407.html?hpid=moreheadlines

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About time that the BIG coporations start answering for the damage they do. Of course, no amount of money is going to replace the missing arm of a guitarist...but at least the pharmaecutical coporation got held liable and could not hide behind the federal government.

[Hepburn]

1. Leahy responds to Supreme Court ruling on Vt. musician

His statement:

“This decision to uphold the Vermont Supreme Court’s ruling in Wyeth v. Levine has far-reaching effects on the ability of countless Americans to seek justice in their courts. Diana Levine’s life and career have suffered irreparable – yet preventable – damage. The Court’s decision soundly rejects the anti-consumer position of the Bush administration, and reaffirms Congress’ primacy concerning the extraordinary power to preempt state law. Most of all, the decision reclaims for all American citizens the ability to seek justice in their courts of law.

“In the 110th Congress, the Senate Judiciary Committee held several hearings to examine the way in which federal agencies have overstepped their authority in the area of preemption, and, given what I viewed as an untenable position by the drug maker and the former administration, I filed an amicus brief with the United States Supreme Court in Ms. Levine’s case. I am gratified that the Court has spoken so clearly on this issue. While recent Supreme Court decisions have shielded big business from accountability and have undermined stronger state consumer protections, this ruling alters that earlier course and affirms that Congress never intended to preempt state laws in the way claimed by Wyeth and the Bush-Cheney administration, claimed. This is a clear victory for Ms. Levine, and for all American consumers. It is also a clear vindication for our own laws and courts in Vermont.”

Edit for link:

http://www.burlingtonfreepress.com/article/20090304/NEWS02/90304034

[pleah]

2. K&R

[happyslug]

3. Duplicate Subject AND source

http://www.democraticunderground.com/discuss/duboard.php?az=view_all&address=102x3766828

[crimsonblue]

4. ok, so how is the drug company responsible for the woman losing her arm?

Just thought I'd ask that. Was it a tainted drug, or was it an inexperienced, unqualified individual performing a procedure in which he did not understand the potential side effects and complications?

[4lbs]

5. Supposedly the warning from the drug company about injecting it into arteries was almost nonexistent

While the FDA said the warning was sufficient, this was the Bush FDA, which pretty much let everything go without much scrutiny.

EDIT:

For example, warning "injecting this drug into an artery may cause an adverse reaction" versus "injecting this drug into an artery will likely cause gangrene of the surrounding tissue".

[crimsonblue]

6. ok, then.

looks like Wyeth is liable.

[WriteDown]

7. When have you ever seen a label that says "likely"

to anything? Most list "possible" side effects. This is a good ruling in general, but a bad case. The fault was with the tech who improperly injected the drug in the first case. If the drug had been injected properly, then there would be no problem.

This is akin to a doctor putting the bone saw blade in backwards and then the patient suing the bone saw manufacturer.


edited to add thought.

[4lbs]

8. The warning label on cigarettes.

"SURGEON GENERAL’S WARNING: Smoking Causes Lung Cancer, Heart Disease, Emphysema, and May Complicate Pregnancy"


Regarding the tech. What if no one told the physician's assistant not to inject it into an artery because they themselves weren't told about it by the drug company?

So, they read the warning label and it says "may cause an adverse reaction". What the heck does that mean? May cause teary eyes? Sneezing? Sniffles? Slight fever? Gas? Stomach cramps? Itching at the injection site?

They should have mentioned "gangrene" in the warning somewhere since that was a likely consequence of improper use.

We need to know just how much the physician's assistant who administered the injection knew about the dangerous side effects.

[WriteDown]

9. By that logic....

If a physician decided to inject botox directly into an eye to see if it cleared up allergies, should that be covered on the label and what should it say? There are proper ways of doing things and improper. What if a physician decided to use a sharp kitchen knife to do surgery? There are no labels on those.

As I stated above, what if a bone saw blade was put in backwards, but was clearly labeled as "insert this way." Is the bone saw blade manufacturer then liable.

[4lbs]

10. Your attempts at analogy fail because there are many drugs that are designed to be injected into

arteries, others into veins.

This was a drug that was designed to be injected into the veins, and not the arteries. It wasn't clearly labeled as such. That's why the drug manufacturer was responsible.

However, you are certainly free to find any Botox injections designed to be injected into patients' eyes, or kitchen knives that have a blurb stating that they are good scalpels.

[WriteDown]

12. And some intra-muscularly...

What did the label say on this drug?

[WriteDown]

13. And some intra-muscularly...

What did the label say on this drug?

[WriteDown]

14. I imagine your having trouble finding it.

:)

[4lbs]

15. Doing some more research on this drug yields some startling findings.

Phenergan is the brand name of promethazine.

Promethazine has been widely documentated in research to cause tissue necrosis (AKA gangrene) when extravasation occurs. This supposedly has been known since the 1960s.

What is extravasation? That's when the drug goes through the blood vessel into the surrounding tissue. What type of drug administering mostly causes extravasation? IV. Why? Because frequently the needle insertion often allows some of the drug to enter the surrounding tissue.

Promethazine is also listed as a vesicant. A vesicant is a substance that causes either irritation or damage upon contact with skin and muscle tissue.

Because of this, the drug manufacturer should have declared that using Phenergan (promethazine) via IV injection would cause tissue necrosis (gangrene) if not done properly.

When the plantiff was administered this drug via IV injection, no such warning label was present. A lesser one was there instead. Since this incident, the label has been changed accordingly.


I also found a discussion about this case and the drug in question among various nurses:

http://www.iv-therapy.net/node/2180

<snip>
We had our own problem here at U of L not to long ago. A patient in the ER had an IV site in the right brachial vein in the bend of the arm (ER's favorite place to put um) that extravasated after a push of phenergan (diluted like it should be, not that it actually helps) and ate through the brachial artery at the same time. We tried to save the arm, but she ended up losing it anyway. The hospital is fianally listening to us, but that is what it took to make them listen. The patient has become a great advocate for others.

We also just got rid of Dilantin. It only took us 3 years and multiple law suites . The patients want the phenergan, the doc's say it works so well, and it is cheap. It's been a long battle, but I think it is FINALLY coming to an end. Thank God!
<snip>

<snip>
One of our IV RNs testified as an expert for this case. I am familiar with Diana - through a close friend, and I sang in an a capella group with her sister. It's had a big impact in our small Vermont communities.

I'm grateful not for her tragedy, but am grateful that it has gained national attention. Because of it, it seems that all of the ISMP alerts about phenergan that I hand out to MDs and RNs are having more of an impact. We may be able to remove the IV route from formulary.

I pray the Supreme Court does the right thing, and that the precedent that will be set by this decision will be on the side of the consumer - not the drug manufacturer. Perhaps the labeling issues r/t heparin this year will help decide this case.



Mari Cordes, BS RN

Nurse Educator IV Therapy
Fletcher Allen Health Care, Burlington VT
Educator, Bard Access Systems
<snip>

<snip>
The IV injection of promethazine has had reported risk documented as far back as the 1960's when accidental arterial injection was reported. My first case involving promethazine extravasation was in 1996 and I found this statement in the book Intravenous Medications, published annually be Mosby even back then - "Determine absolute patency of the vein. Extravasation will cause tissue necrosis." I also published articles in Nursing99 and Nursing2002 listing promethazine as a vesicant.

In August of 2006, ISMP published their warning about this drug which was based on numerous lawsuits that had been published in regular newspapers. This was truly not the beginning of the problem. It was the first time that a nationally recognized organization published anything calling attention to this problem.

It is my firm belief that each facility must take a hard look at all of their anti-emetic practices with a strong policy created. Promethazine IV must be treated with the same high level of respect that all other antineoplastic agents receive. A literature search will produce numerous articles about the benefits of promethazine as an antiemetic, however there is almost nothing in the professional literature about the horrible outcomes with this drug when the correct nursing actions are not taken.

When I look at a case, I consider what the nurses did to prevent the problem as outlined in the INS standards of practice, how quickly did they recognize that an infiltration/extravasation was happening, and what interventions did they use to mitigate the problem.

The national standard has always been that the nurse must know the drugs they are giving and the possible problems and how to administer them safely. This is not anything new.

Lynn Hadaway, M.Ed., RN, BC, CRNI

www.hadawayassociates.com

<snip>

[WriteDown]

16. Still no details on what the label actually said....

Which I find particularly odd. Actually, many types of drugs including chemo drugs are vesicants. Its not uncommon and there are ways of dealing with it.

[ArcticFox]

11. The companies must be scared

No longer can they shield themselves from liability by lobbying a single federal agency. Fifty states are a bit harder to control.

Now, if only somebody would overturn the federal arbitration act, consumers might have a fighting chance.