Your opinions on this lawsuit...

Lawsuit Filed Over Woman Who Died in AIDS Drug Trial
Wednesday, December 29, 2004

MEMPHIS, Tennessee — The family of a pregnant woman who died while taking experimental AIDS (search) drugs to protect her baby from getting the disease is suing the doctors, drug makers and hospitals involved in the study for $10 million.

Joyce Ann Hafford's (search) mother and sister allege in the suit filed Tuesday that doctors continued to give Hafford the drug regimen despite signs of liver failure. The suit also claims doctors didn't warn the 33-year-old HIV-positive woman of the trial's dangers. The family is seeking $10 million in damages.

'She trusted doctors to treat her, and they failed her,' said Rubbie King, Hafford's sister.

Family members said they did not learn the National Institutes of Health (search) had concluded the drug therapy most likely caused Hafford's death until The Associated Press obtained copies of the case file this month.

For the past year, family members believed Hafford died from AIDS complications.

NIH officials quickly suspected the drug regimen because it included nevirapine (search), an antiretroviral AIDS drug known to cause liver problems. Hafford's death in August 2003, less than 72 hours after her son Sterling was born prematurely, halted the federal government research program of nevirapine.


Hafford learned she was HIV-positive when she became pregnant in spring 2003, and shortly after started the NIH-funded clinical trial of the drugs Combivir and nevirapine, also known as Viramune, hoping to block transmission to her son.

The baby was born HIV-negative.

The family first filed a wrongful death suit in June, but withdrew it in September because lawyers felt they didn't have enough evidence.

Among the defendants named in the suit are several doctors and nurses who treated Hafford, the Regional Medical Center and drug makers GlaxoSmithKline and Boehringer Ingelheim Pharmaceuticals.

A message at British manufacturer GlaxoSmithKline's American offices said they were closed for the holidays. Boehringer Ingelheim is based in Germany.

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Posted by kptoys

'She trusted doctors to treat her, and they failed her,' said Rubbie King, Hafford's sister.

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I don't know how they can make this statement, when she was taking an 'experimental' drug
I'm sure there are stack of waivers to be signed and was advised of the risks.

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Posted by Kate

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Posted by kptoys

'She trusted doctors to treat her, and they failed her,' said Rubbie King, Hafford's sister.

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I don't know how they can make this statement, when she was taking an 'experimental' drug
I'm sure there are stack of waivers to be signed and was advised of the risks.

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I agree. Plus, if the purpose was to protect her baby from getting the disease, then the drug succeeded...

I'm going to take the other side. Yes, complications are expected with an experimental drug, BUT, if the Dr.'s were aware, or should have been aware, that the drug could cause liver failure, the patient should have been made aware and expressly consented to that particular risk. There is no way of knowing whether the mother would have reconsidered if she knew of the risk of liver failure...

Well a few of my clients are Pharmaceuticals and I see a lot about their clinical trials. It seems to me that this woman’s main goal was to save her child’s life. To see that her child was born HIV negative.

I am sure she must have signed paperwork indicating that she understood the risks involved with taking this drug therapy. If I were a mother I’d drink acid for 9 full months if it meant my child would live a healthy life.

There’s a LOT missing in this story. I would go with the general feeling that the drug therapy may have been the direct cause of death, but I feel perhaps the doctors have more responsibility than the drug company. It is a doctor’s professional obligation to care for their patients. I’m not one for malpractice lawsuits (which I feel are rampant) but this is one of those situations when I feel the doctors actions should be reviewed. What really happened?

Frankly, I’d settle this claim out of court for the cost of education and such for the child. I am very sickened by the idea of any family trying to make a buck off the death of a relative. These doctors saved the child’s life. The mother volunteered. That has to be taken into factor.

I find it odd they didn’t have enough evidence for wrongful death. It sounds fishy. If what they say is true they had just ‘enough’ evidence for a wrongful death suit. Seems like these folks went for the bigger pockets.

It’s a toughie. One I’d love to be on the jury of to truly see what can be brought to surface. This is also why I feel more Americans should be honored to be on jury duty. Especially those so quick to judge based on media warped stories.

While I agree that she most likely consented to the risks involved in a clinical trial, there are plenty of instances where patients have been withdrawn from trials b/c of life-threatening side effects.

In this case, I would need to know more. Did her doctors explicitly tell her that she was in end-stage liver failure, and did she say 'fine with me, as long as my baby lives'?

(edited for typo)

My father took part in an experimental drug study for his cancer - he had to sign all these releases and waivers in order to take part.

I do not agree with this lawsuit. I would assume that the attorneys withdrew the suit because of this woman would have had to sign the same releases and waivers or those similar to the ones my father did. The family would have better chances going after the doctor for not explaining the risks to the patient, but even that would be difficult to prove.

This is very sad, I feel badly for the family.

However, I am very sure that if this study got IRB approval from wherever it was being run, that this woman was given a very long, very detailed consent form informing her of all possible risks including the liver damage. They then asked her questions to be sure she understood the risks and the consent form before shewas allowed to begin the study. It is still very sad, but I wonder how the family is going to do in court given the large number of waiver/consents needed to be signed by participant to be in a study like this.
If the researchers did something shady, then that's a different story.

Either way, a sad story for all involved.