With his newborn twins steadily recovering from a medical error that nearly cost them their lives, actor Dennis Quaid appeared on Capitol Hill today and assured lawmakers that his fight isn't over.
Quaid was among several people who told the House Oversight and Government Reform Committee today that a drug isn't necessarily safe just because the U.S. Food and Drug Administration approves it.
The actor is arguing for the right to sue the maker of the blood-thinner heparin after his twins almost died from an overdose shortly after their birth.
In November 2007, the Quaids' twins were given doses of heparin that were 1,000 times larger than the doses they should have received. They later learned that the labels of the dramatically different doses looked strikingly alike.
The Quaids are suing heparin maker Baxter Healthcare Corp. for not pulling the labels from the shelves while it was fixing the problem. The company warned hospitals and submitted label changes to the FDA, but did not recall the bottles still on the market. Baxter says the lawsuit should be dismissed on the grounds of federal preemption, which bars state lawsuits over drugs that have FDA approval.
"I am not even sure a lab rat had ever received such a high dose of heparin that was causing them to bleed out," Quaid told lawmakers in his testimony.
"The overdosing of our twins was a chain of events of human error," Quaid said. "And the first link in that chain was Baxter. Baxter's negligence, the cause of that, was an accident waiting to happen."
According to HealthGrades, an independent health care ratings company, 247,662 patients studied between 2003 and 2005 died from potentially preventable problems. The Institute of Medicine estimates that 1.5 million patients every year suffer from mistakes with medications.
People can sue for damages under state law if they're harmed by drugs and medical products, but the Bush administration argues that states have no right to fault a company for selling a product that has been reviewed and approved by the federal government.
A panel of medical experts testifying alongside Quaid agreed that a policy of federal preemption would harm drug safety. Later this year, the Supreme Court is expected to examine the issue of federal preemption as it relates to drug labeling.
"Preempting, or blocking such lawsuits, in my view, would do great harm to the public health," said Dr. Aaron S. Kesselheim, an internal medicine physician at Brigham & Women's Hospital in Boston and an instructor at Harvard Medical School.
"Some drug and device companies have hidden and manipulated important safety data," said committee chairman Henry Waxman, D-Calif. "Some have failed to report serious adverse events. And some have failed to disclose even known defects. If manufacturers face no liability, all the financial incentives will point them in the wrong direction and these abusive practices will multiply."
"This is exactly the wrong time for the FDA to be saying, 'Trust us,'" Waxman added.
But Rep. Brian Bilbray, R-Calif., holding back tears, said he blamed an excess of lawsuits on the death of his son years ago. He said he believes his child died because the product he needed wasn't available because of greed trumping science.