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Actor tells House panel of newborn twins' overdose

  • Story Highlights
  • Actor testifies before House committee on newborn twins' brush with death
  • The newborns were given 1,000 times the normal dose of a blood thinner
  • Quaid says pharmaceutical companies must be held accountable through lawsuits
  • Baxter Healthcare said the incident resulted from human error
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WASHINGTON (CNN) -- Actor Dennis Quaid told lawmakers Wednesday how his newborn twins came close to death after an overdose of blood-thinning medication, the fault of a drug company that did not recall easily confused bottles despite previous problems, he said.

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Actor Dennis Quaid says that what is happening in the nation's courts "is no fiction."

The incident occurred last year at a Los Angeles, California, hospital, Quaid told members of the House Committee on Oversight and Government Reform. In The actor also said the "infants nearly died because of a drug company's failure to put safety first."

The panel's hearing focused on the issue of "pre-emption," under which FDA approval guarantees immunity for drug companies against state lawsuits, because federal law supersedes state law.

The Supreme Court is mulling the issue in a Vermont case. Oral arguments are expected in early October.

"I am in the entertainment industry, but what happened to us, and what is happening in the courts of our country, is no fiction," Quaid said in a statement prepared for members of the House panel. "It is all too real. That is why I have decided to speak out and do something." Video Watch Quaid say "Baxter's negligence was an accident waiting to happen" »

The actor's actual statement was abridged, as he and other witnesses were given a five-minute time limit on remarks.

Committee Chairman Henry Waxman, D-California, said, "This is exactly the wrong time for the FDA to say, 'Trust us.' As a result of chronic underfunding and weak leadership, FDA's ability to protect the public is plummeting."

He said the agency has believed that state liability helped the agency regulate drugs and devices but has changed its stance under the Bush administration.

In response to Quaid's testimony, the company that made the drugs involved -- Baxter Healthcare -- issued a statement saying human error was to blame, noting that the finding was supported by the California Department of Public Health.

In November, Quaid's 12-day-old twins, Thomas Boone and Zoe Grace, were undergoing intravenous antibiotic treatment for a staph infection at Los Angeles' Cedars-Sinai Hospital. According to standard procedure, nurses were supposed to clean the infants' IV lines with Hep-Lock, a drug containing a very small dose of the blood thinner heparin, to allow the lines to flow freely.

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However, instead of the 10 units of heparin they were supposed to receive, the twins received 10,000 units, 1,000 times the prescribed amount. The babies survived, apparently with no permanent injury, Quaid told members of Congress, although no one knows whether they will show any long-term effects.

The actor grew emotional as he recalled a 41-hour ordeal in which his infants' blood was the consistency of water and their bodies bore bruises from internal bleeding.

"It made me feel that they had survived for a reason ... that maybe they were going to change the world in a little way," he said.

In researching the incident, Quaid told lawmakers he found that the bottles of 10-unit Hep-Lock and 10,000-unit heparin were "virtually indistinguishable." Both drugs are manufactured by Baxter Healthcare.

He also learned that the labels' similarity led to an overdose of infants at an Indianapolis, Indiana, hospital in 2006. Three babies died and three were injured. Four months after that incident, he said, Baxter sent a warning to hospitals regarding the potential for mistakes. Seven months after that, Baxter received permission to change the labels. However, Quaid said, Baxter failed to recall the previous bottles that were in hospitals.

"They recall automobiles; they recall toasters; they even recall dog food," Quaid said. "Although mistakes did occur at Cedars, the overdosing of our twins was a chain of events of human error -- and the first link in that chain was Baxter."

Baxter, meanwhile, said in its statement that its heparin vials "have been used safely more than 100,000 times a day, a fact that contradicts the implication that two of the company's vials are indistinguishable.

"The two hospitals where tragic errors occurred with Baxter's heparin products reported that these were isolated events resulting from a system failure in the hospital along with human and procedural errors, such as not reading the label."

Quaid and his wife, Kimberly, have filed suit against Baxter in state court. The drug company has filed a motion to dismiss the case, relying on the pre-emption argument, Quaid said.

Baxter spokeswoman Erin Gardner said in the statement that the company did not recall the vials because the medication errors were not related to the safety or efficacy of the product, and "Baxter's vials, even before the label enhancement, were better differentiated than other heparin products on the market."

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The company said it contacted the Quaids' attorney in March to ask whether the couple would partner with them and medication safety experts on a program aimed at reducing medication errors but had not received a response.

"Baxter is hopeful that it can resolve this litigation and partner together with the Quaids for the beneffit of clinicians and patients rather than continue to litigate this matter in the courts," the statement said.

All About Dennis QuaidU.S. House Committee on Oversight and Government Reform

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