American actor Dennis Quaid went to Capitol Hill today, Wednesday, and told a panel of lawmakers at the House Committee on Oversight and Government Reform about how his baby twins Thomas and Zoe nearly died when they were accidentally given a dose of the blood thinner heparin that was 1,000 times bigger than it should have been when they were 12 days old.
Quaid and his wife, Kimberly Buffington, found out later that the mix up occurred because there were two similar looking doses of the blood thinner sitting on the same shelf and the wrong one was used.
This was in November last year when the Quaid twins developed a staph infection and had to be hospitalized. Quaid told the panel how a bottle containing 10 units of heparin was sitting on the shelf next to a dark blue 10,000 unit bottle that looked very similar, especially when turned slightly so the writing on the label was not directly visible.
Baxter Healthcare Corporation who make the drug had already submitted label changes to the US Food and Drug Administration, and had sent out warning letters to hospitals, but they did not recall the products that were still on the shelves. Quaid and his wife are suing Baxter for not doing so. He told the Committee that his fight was not over yet, according to a report from ABC News.
Quaid described to the panel how his children were affected by the overdose. He said the heparin caused them to “bleed out”, and that their “water-thin blood was flowing out of every place that they had been poked and prodded”.
The actor told the panel how his two babies were screaming in pain, “God only knows what they were feeling,” he said. They were facing the possibility of brain damage or organ failure due to the high risk of hemorrhaging through a vein or artery, he added, according to a report by the Associated Press.
The House Oversight panel is hearing testimony from a number of witnesses today, in a hearing titled “Should FDA Drug and Medical Device Regulation Bar State Liability Claims?”
At the moment, Americans can bring damage lawsuits against drug companies and medical device manufacturers under state law, but the Bush administration is arguing that a company cannot be held liable for selling a drug or device that has been approved by a federal regulator.
The issue before the panel is whether this move should go ahead. Another witness was Gregory Curfman, editor of the New England Journal of Medicine, who related the case of the arthritis drug Vioxx, which gained FDA approval in 1998, but patients later found out it raised the risk of heart attack and other cardiovascular problems. The drug was eventually pulled from the market in 2004.
In his testimony, Curfman said that “”preemption of common-law tort actions against drug and medical device companies is ill-advised and will result in less safe medical products for the American people,” reported ABC News.
Many drug companies also support the view that federal regulation should pre-empt lawsuits filed under state law. Baxter is arguing in the case of the Quaids, that their state-based lawsuit should be dismissed because the label was approved by the FDA.
If all lawsuits were to be pre-empted said Quaid, then “it will basically make us uninformed and uncompensated lab rats,” reported the Associated Press.
The position favoured by the regulators and drug companies effectively means the FDA gave the heparin manufacturer a “a get-out-of-jail-free card” when it approved the label, said Quaid.
Medical errors are the fifth leading cause of deaths in the US, with up to 98,000 deaths annually, according to a report by the Millennium Research Group (MRG) published nearly a year ago.
The Quaid twins have recovered, but as their father told the panel, “we don’t know what the longer-term effects will be”.
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Sources: ABC News, Associated Press, .
Written by: Catharine Paddock, PhD