Published May 14, 2008
WASHINGTON – Actor Dennis Quaid told Congress on Wednesday of a harrowing, near-fatal drug mixup in which his newborn twins were administered 1,000 times the normal dose of a blood thinner.
The actor said his family's brush with tragedy underscores the need to hold pharmaceutical companies accountable through lawsuits, a remedy that is becoming increasingly problematic for injured consumers.
Some 7,000 Americans die every year from medication errors.
At issue before the House Reform and Government Oversight Committee is a move by regulators at the Food and Drug Administration to step into lawsuits on the side of defendant drug companies.
In court, the drug companies argue that federal regulation should pre-empt the filing of lawsuits under state law, a matter that will come before the Supreme Court later this year in a case from Vermont.
The Quaid family is suing drug maker Baxter Healthcare Corp., which is seeking dismissal of the lawsuit on federal pre-emption grounds that the FDA approved the labeling.
"Like many Americans, I believed that a big problem in our country was frivolous lawsuits," Quaid testified. "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."
The committee's ranking Republican, Rep. Tom Davis of Virginia, sympathized with Quaid, saying that if this had happened to the Davis family, "I'd be suing everybody in sight." Apart from Quaid's case, Davis called for balance between total pre-emption and unrestrained litigation.
Committee Chairman Henry Waxman, D-Calif., said that if manufacturers face no liability, all the financial incentives will point them in the wrong direction and that abusive practices will multiply.
Quaid told the committee his family's life-altering story began in November 2007 when twins Thomas and Zoe, at the time 12 days old, developed a staph infection and had to be hospitalized.
The children were mistakenly administered the wrong version of the drug heparin, due to two concentrations of the drug being bottled with similar labels and size. 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 actor asked whether consumers' rights to sue under state law should be blocked just because the FDA approves the drug and its labeling and packaging.
The actor said that under the approach favored by business and the federal government, the FDA handed the drug maker "a get-out-of-jail-free card" when the regulatory agency allowed heparin onto the market.
The Quaids' children recovered, though "we don't know what the longer-term effects will be," said Quaid.