Young Daughter: 'Mommy's Dying'
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 from Gwynedd, Pa., 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."
Robb recounted her terror before a Senate committee today, saying the electric jolts "felt as if a cannon was being repeatedly shot at my chest at close range."
"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 felt like she was being repeatedly electrocuted.
Making matters worse, when she got to the 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.
Sen. Patrick Leahy, D-Vt., chaired the Judiciary Committee hearing today where Robb retold her story in an effort to have the law changed.
"I think it was a good law that worked very, very well and suddenly the Supreme Court interprets it, I believe, the wrong way," Leahy said. "Either way, it's a duty now of the Congress to try to fix it."
The senator was clearly angered by Robb's physical and legal ordeal.
"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.
Sen. Arlen Specter, R-Pa., put the blame on the FDA which approved the faulty device.
"The FDA has become a joke," Specter said.
Medtronics, the company that makes the defibrillator used by Robb, issued its recall in 2007. But Robb told the committee, "Medtronics never notified me that my lead was recalled and I did not learn of the recall until after this 'life-saving' medical device seriously hurt me."
She told ABC News she found out about the recall in the hospital emergency room.
"I had no idea," Robb said. "I was shocked."
Medtronics told ABC News they sent certified letters to all the patients and their doctors.
Her agony does not entitle Robb to sue or recoup any compensation from Medtronics, experts told ABC News.
"She does not have a right, under the law, to sue because the company did not disobey the FDA," said attorney Robert Weiner.
"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.
The Senate committee also heard the harrowing story of Maureen Kurtek, who suffers from Lupus.
Kurtek, from Pottsville, Pa., told the Senators there was a 53-day delay by her insurance company in deciding that a therapy to boost her immune system was medically necessary. Meanwhile she developed an infection which became septic.
Kurtek described bleeding out from every orifice and nearly dying. She lost five fingertips and half of her right foot.
But her lawsuit against her health insurance plan was dismissed by a judge who ruled that she was barred from suing her health plan. Kurtek testified today that Supreme Court decisions have evolved the so-called ERISA law that Congress passed to protect employer-sponsored health insurance and retirement benefits now protects the health insurance companies.
"The Supreme Court has ignored the intent of Congress in passing these measures, oftentimes turning these laws on their heads, and making them protections for bug business rather than for ordinary citizens," Leahy said. "I hear this buzzword of activist judges and I can't think of anything more activist than these decisions."
Specter, the ranking Republican on the committee, blamed the FDA and the Bush administration. He said the administration's delay in requesting more money for the FDA bordered on "criminal negligence" and was "unconscionable."
Andy Anderson, an attorney who testified on behalf of the U.S. Chamber of Commerce, said that while Kurtek's story was horrible, the Congress should not act to change the ERISA law to undo the Supreme Court's decision and allow state judges and legislatures leeway to tailor eligibility requirements for their particular state, which would also allow Kurtek's lawsuit.
"While a few will benefit, many will lose," he said, arguing that it would be even harder for companies to afford health care plans for their workers.
Tom Shine contributed to this report.