Bridget Robb Can't Take Legal Action Because Device Was FDA-Approved
By YUNJI DeNIES, SHEILA EVANS and STEPHANIE DAHLE
June 11, 2008

As her 6-year-old daughter watched in horror, Bridget Robb screamed in
pain.

"Am I dying?" Robb asked the 911 operator. "I'm young. I don't wanna
die."

On Dec. 17, 2007, Robb's implanted defibrillator malfunctioned,
shocking her heart a total of 31 times in the span of a few minutes.

During the seven-minute phone call, Robb was shocked 11 times.

The single mother pleaded with the operator to send help quickly.

"You don't understand how this hurts," Robb, 34, screamed with each
shock. "God, please don't take me."

"Mommy's dying," her daughter said as she hugged her cat, helplessly
watching her mother writhe in agony.

A faulty wire caused the malfunction under her skin, which meant Robb
feel like she was being repeatedly electrocuted.

Making matters worse, when she got to the Pennsylvania hospital, Robb
found out the defibrillator had been voluntarily recalled two months
earlier.

"It was the worst day of my life," Robb told ABC News. "It was just
horrific."

Though she survived the horror, she has had two surgeries to correct
the problem and a blood transfusion, and she now suffers from severe
anxiety. Robb said she had the device for two years because she has
congestive heart failure.

But Robb can't take legal action against the maker of the faulty
wire.

That is because the United States Supreme Court recently ruled that
once the Food and Drug Administration approves a medical device, a
consumer can't sue the manufacturer, even if they are injured by it.

"I think it was a good law that worked very, very well and suddenly
the Supreme Court interprets it, I believe, the wrong way," said Sen.
Patrick Leahy, D-Vermont.

"Either way, it's a duty now of the Congress to try to fix it," said
Leahy, chair of the Senate Judiciary Committee.

"She does not have a right, under the law, to sue because the company
did not disobey the FDA," said attorney Robert Weiner.

"Here's a woman who is basically being electrocuted, by a device that
had been recalled by a company that didn't even tell her," said
Leahy.

Medtronics, the company that makes the device used by Robb, told ABC
News they sent certified letters to all the patients and their
doctors.

But Robb said she did not know her defibrillator had been recalled
until she arrived at the hospital's emergency room.

"I had no idea," Robb said, "I was shocked."

"Consumers can't get any compensation for their injuries, even for
their deaths, at the hands of fault or defective medical devices,"
said Brian Wolfman, director of Public Citizens Litigation Group.

Lawmakers will hear from Robb, who will speak of her excruciating pain
and her frustration at the legal system. Along with another victim,
she will ask Congress to change the ruling prohibiting legal action.

Congress could change the medical device amendment and override the
Supreme Court's decision, allowing victims to receive compensation,
according to Wolfman.

The hearing will be about consumers and their legal rights, according
to Robb, but she is hoping her horrific case will help spur change.

"I don't think that there are words to sum up what I went through,"
said Robb. "I want to make sure that this does not happen to anybody
else."

Tom Shine contributed to this report.

http://abcnews.go.com/GMA/OnCall/story?id=5044693&page=1