WASHINGTON Actor Dennis Quaid told Congress on Wednesday 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 drugmaker, 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 lawsuits on the side of defendant pharmaceutical companies, arguing that federal regulation of drugs pre-empts state lawsuits.
"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 lawsuits against the drug industry will come before the Supreme Court this year in a case from Vermont.
Some 7,000 people in the United States die every year from 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.
The committee chairman, Rep. 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.
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. That event was brought up at the hearing by Rep. Dan Burton, R-Ind.
Baxter did not take the similarly appearing packages off the market.
In its statement, the company said that after learning of the deaths involving heparin in Indianapolis in late 2006, Baxter consulted with the FDA. The company broadly distributed a medication safety alert to clinicians across the United States to notify them that its heparin vials had been involved in a medication error.
Baxter says that before the Indianapolis case, it had never received a single customer report about a perceived similarity between the two versions of the heparin packaging.
More recently, Baxter recalled the blood thinner, which was made from ingredients from China, after the drug was connected to 81 deaths and 785 severe allergic reactions.
The FDA found the drug was contaminated with oversulfated chondroitin sulfate, which mimics heparin and thus was not detected in routine testing.