Congressional hearing

Quaid testifies to Congress about drug mix-ups
"Courts are often the only path to justice," actor says
Wednesday, May 15, 2008


WASHINGTON, D.C. -- Actor Dennis Quaid told Congress yesterday that taking away the right to sue pharmaceutical companies would turn consumers into "uninformed and uncompensated lab rats."

Quaid's comments came as he described a harrowing, near-fatal drug mix-up in which his newborn twins received 1,000 times the correct dose of the blood thinner heparin.

The actor said his family's brush with tragedy underscores the need to hold pharmaceutical companies accountable through lawsuits.

That remedy is becoming increasingly problematic for injured consumers.

The drug maker, Baxter Healthcare Corp., said it regrets that a product intended to save and sustain life was at the center of a medication error.

Beginning with the Bush administration, the Food and Drug Administration has stepped into suits on the side of defendant pharmaceutical companies, arguing that federal regulation of drugs pre-empts state suits.

"The regulatory cop is off the beat," Georgetown University law professor David Vladeck told the House Reform and Government Oversight Committee.

The issue of federal pre-emption of suits against the drug industry will come before the Supreme Court this year in a case from Vermont.

About 7,000 people in the United States die every year because of medication errors.

The Quaid family is suing Baxter Healthcare, which is seeking dismissal of the case on 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."

The committee's top 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 urged a middle ground between total pre-emption and unrestrained litigation.

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.

Quaid's children were mistakenly administered the wrong version of the blood thinner; two concentrations of the drug were 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 said.

The children recovered, though "we don't know what the longer-term effects will be," he said.

Fourteen months earlier, a similar mix-up occurred at an Indianapolis hospital; three infants died. Baxter did not take the similarly appearing packages off the market.

.... Bungee Diving - Living it up when you're going down!
___ Blue Wave/QWK v2.12