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.
“Blocking such lawsuits, in my view, would do great harm to the public health,” Dr. Aaron S. Kesselheim, an internal medicine physician at Brigham & Women’s Hospital in Boston and an instructor at Harvard Medical School, said in a statement.
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.
On Wednesday, Curfman 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 stated 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.
“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 Healthcare made efforts to change the drug’s labels after three infants at a hospital in Indianapolis died in September 2006. This was the same mix-up that threatened the life of the twins of actor Dennis Quaid. But Baxter’s efforts to warn hospitals and submit label changes to the FDA progressed slowly and Baxter failed to recall the bottles still on the market with the old labels.
“Like many Americans, I believed that a big problem in our country was frivolous lawsuits,” Quaid testified before Congress. “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.”