One of my favorite actors, Dennis Quaid, made a noteworthy appearance before a Congressional Committee last month. With his newborn twins steadily recovering from a grave medical error that nearly cost them their lives, Quaid assured lawmakers that his fight wasn’t over. Quaid was among several people telling the House Oversight & Government Reform panel that, just because the FDA approves a drug, it doesn’t mean it is safe. The actor is arguing for the right to sue the drug maker of the blood-thinner heparin after his twins almost died from an overdose shortly after their birth. As has been reported In November 2007, the Quaids’ twins were given doses of the blood thinner 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 similar.

The Quaids are suing Heparin maker Baxter Healthcare Corporation 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 wants the lawsuit dismissed on the grounds of “federal preemption,” which, if allowed, would bar state lawsuits over drugs that have FDA approval. Quaid told lawmakers in his testimony:

The overdosing of our twins was a chain of events of human error. And the first link in that chain was Baxter. Baxter’s negligence, the cause of that, was an accident waiting to happen. Like many Americans, I have always believed that a big problem in this country has been frivolous lawsuits. But now I know that the courts are often the only path that families have that are harmed by drug companies’ negligence.

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 is trying to sell a bill of goods to the courts saying 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. Dr. Aaron S. Kesselheim, an internal medicine physician at Brigham & Women’s Hospital in Boston and an instructor at Harvard Medical School, observed:

Preempting, or blocking such lawsuits, in my view, would do great harm to the public health. Some drug and device companies have hidden and manipulated important safety data.

Committee chairman Henry Waxman (D-CA), who has been a real champion of consumer rights and a critic of both the drug industry and the FDA, added:

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.”

New England Journal of Medicine Editor Gregory Curfman cited the case of Vioxx, the infamous drug approved by the FDA in 1998, even though it could cause heart attack, stroke or cardiovascular problems, as a prime example of why the court system is important. In 2002, the Vioxx label was revised to reflect those risks and in 2004, it was pulled from the market. Dr. Curfman told the committee 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.” Vioxx is a classic example of how the partnership-type relationship between the drug industry and the FDA results in bad things happening to consumers.

Dr. 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. Dr. Curfman also said that The New England Journal of Medicine’s Web site was publishing a large clinical trial showing that Trasylol results in higher mortality in patients undergoing high-risk heart surgery. He pointed out that “it’s 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.”

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. Meantime, Baxter didn’t recall the bottles still on the market with the old labels. Maybe the courageous acts by the Quaids in filing suit and then going public with their case will alert the public to what federal preemption is all about and how it hurts people.

Source: ABC News

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