Actor Dennis Quaid lent his star power on Capitol Hill Wednesday to raise awareness of potential problems with FDA-approved drugs and technology.
Quaid told lawmakers how his twin infants received near fatal drug overdoses when hospital staff mistakenly gave them an overdose of the blood-thinning drug heparin.
The two versions of the drug had similar packaging and labeling, apparently causing the mix up.
The Quaid family is suing drug maker Baxter Healthcare Corp. But the company is seeking dismissal of the lawsuit on federal pre-emption grounds that the FDA approved the labeling.
"Our feelings are they recall automobiles, they recall toasters, they even recall dog food, but Baxter failed to recall a medication that due to its labeling had already killed three infants and severely injured three others just a year earlier," Quaid testified.
Critics say the rule lets drug manufacturers off the hook. But backers say without it, medical innovation and new technologies would be impeded by fear of frivolous lawsuits.
"Like many Americans, I believed that a big problem in our country was frivolous lawsuits," Quaid told the House Reform and Government Oversight Committee. "But now I know that the courts are often the only path to justice."
Quaid said that if all lawsuits are pre-empted, "it will basically make us uninformed and uncompensated lab rats."
Quaid told the committee his family's story began in November 2007 when twins Thomas and Zoe, at the time only 12 days old, developed a staph infection and had to be hospitalized.
The children were mistakenly administered the wrong version of the drug heparin, because of two different dosages in similar labels.
When rotated slightly as they often are when stored, the light blue 10-unit bottle and the 10,000-unit dark blue bottle are virtually indistinguishable, Quaid told the panel.
The Quaids' children recovered, though "we don't know what the longer-term effects will be," said Quaid.
Source: The Associated Press