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."
Medical Mistakes Not Uncommon
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.
New England Journal of Medicine Editor Gregory Curfman noted the case of Vioxx, a drug used to treat arthritis pain. Vioxx was approved by the FDA in 1998, but people later learned it could cause heart attack, stroke or cardiovascular problems. In 2002, the Vioxx label was revised to reflect those risks and in 2004, it was pulled from the market.
Curfman today said that "preemption of common-law tort actions against drug and medical device companies is ill-advised and will result in less safe medical products for the American people."
Curfman also testified that the drugs Avandia, approved by the FDA in 1999 for treating Type 2 diabetes, and Trasylol, approved in 1993 to control bleeding during heart surgery, also show how researchers sometimes find out after the fact what's wrong with the drugs.
Avandia remains on the market — with altered warning labels — since researchers found in 2007 that it is associated with an increased risk of cardiovascular events.
In 2006, the FDA re-examined Trasylol after a study in the New England Journal of Medicine suggested it was associated with an increase in heart attack, stroke, kidney failure and death.
Curfman said that this evening that the New England Journal of Medicine's Web site will publish a large clinical trial showing that Trasylol results in higher mortality in patients undergoing high-risk heart surgery.
"It is essential that a drug's safety continue to be carefully monitored during the post-marketing period, because we know that serious safety issues may come to light only after a drug has entered the market," Curfman said.
In the case of Heparin, Baxter made efforts to change the drug's labels after three infants at a hospital in Indianapolis died in September 2006 of the same mix-up that the Quaids experienced. But Baxter's efforts to warn hospitals and submit label changes to the FDA progressed slowly. Meanwhile, Baxter didn't recall the bottles still on the market with the old labels.
"Like many Americans, I have always believed that a big problem in this country has been frivolous lawsuits," Quaid said. "But now I know that the courts are often the only path that families have that are harmed by drug companies' negligence."
ABC News' Brian Hartman contributed to this report.