.jpg "Dennis Quaid told lawmakers that citizens should not lose their ability to sue because the FDA cannot assure safety of all drugs and medical devices.")
Sometimes it takes a celebrity to bring an issue to the American conscience.
Actor Dennis Quaid talked to lawmakers today about medical errors that almost cost his newborn twins’ lives last year.
With medical errors at an all-time high, an average of one per patient per day that lead to 100,000 deaths a year, Quaid warned lawmakers not to remove the courts as a remedy.
“Like many Americans, I believed that a big problem in our country was frivolous lawsuits. But now I know that the courts are often the only path to justice for families that are harmed by the pharmaceutical industry and medical errors.”
Quaid and his wife Kimberly Buffington are suing Baxter Healthcare Corporation for not pulling vials of the drug in question Heparin, while it was fixing problems with labeling that had already led to the 2006 deaths of other three other infants.
Baxter tried to throw out the Quaid lawsuit under something called “Federal Preemption”.
That is favored by the Bush administration and offers blanket immunity to drug and device makers citing approval by the Food and Drug Administration (FDA). Preemption is favored by the drug industry and device makers to avoid the cost of lawsuits.
Quaid, among others is telling the House Oversight Committee that just because a drug has been approved by the FDA doesn’t mean it’s safe.
Quaid told lawmakers "Their now water-thin blood was flowing out of every place that they had been poked and prodded," he said. "They faced the very real possibility of hemorrhaging through a vein or artery, causing massive brain damage or failure of one of their vital organs ... They were both screaming in pain, and God only knows what they were feeling."
The twins have since fully recovered.
Are FDA approved drugs always safe? A former FDA Commissioner should know. David Kessler was commissioner from 1990 to 1997, and even he told lawmakers that FDA approval shouldn’t bar lawsuits because the agency does not have enough resources to eliminate all risk.
“Even if the FDA’s funding were doubled or tripled, its resources and abilities to detect emerging risks on the thousands of marketed drugs and devices would still be dwarfed” by the resources of the drug companies, he said today in a prepared statement.
Last November, the hospitalized twins, Thomas and Zoe, were given a dose 1,000 times higher than recommended because the low dose and high dose vials have similar blue labels. Since then Baxter has changed the labeling.
Some hospitals are changing their medication dispensing system, putting a bar code on the patient’s wrist band and the drugs and ensuring they match before dispensing.
That move alone might have saved the twins from the massive bleed-out in the hospital which the Quaids only discovered upon a visit one morning to their shock.
Healthgrades says the Quaids are not alone. The independent company that rates health care and facilities reports that between 2005 and 2005, 247,662 patients died from potentially preventable problems. And the Institute of Medicine estimates that 1.5 million patients suffer medications mistakes.
People can sue under state law for mistakes and medical malpractice. But the Bush administration, at the urging of pharmaceutical companies and medical device manufacturers, says the states have no right to fault a company.
This hearing before the Committee on Oversight and Government Reform is directed at that question, entitled, “Should FDA Drug and Medical Device Regulation Bar State Liability Claims?”
The editor of the New England Journal of Medicine says consider the recent record of the FDA, it’s far from stellar.
- Vioxx - used to treat arthritis. The FDA approved the drug in 1998 but it was later linked to an increase in heart attacks and stroke. In 2004 it was pulled from the market.
- Avandia- approved by the FDA in 1999 for treating Type 2 diabetes and later for controlling bleeding during heart surgery. Even though it’s been associated with an increased risk for heart problems, it remains on the market.
- The makers of Trasylol would like to return their drug to the market. A trial on the drug had to be halted in Canada for ethical reasons after many patients died of heart attacks, stroke, kidney failure and death.
60 Minutes recently profiled a patient who was given Trasylol during heart surgery, only to die eight months later after a series of organ failures. In 2006, drug maker Bayer, allegedly withheld vital internal information on higher mortality results from an FDA panel reviewing the drug’s safety. (Correction: Bayer makes Trasylol not Merck).
One panel member said he would have liked to have that information.
The New England Journal of Medicine Editor Gregory Curfman illustrated his prepared statement to lawmakers with these drug examples saying, “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.”
Henry Waxman, D-CA, the House Government Reform and Oversight Committee Chair said in an opening statement, about preemption, it would take away “one of the most powerful incentives for safety – the threat of liability.” #