Government
Should FDA regulation bar liability lawsuits?
By Ben Wasserman
May 14, 2008 - 11:08:37 AM

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WEDNESDAY May 14, 2008 (foodconsumer.org) -- The Committee on Oversight and Government Reform today is conducting a hearing entitled, "Should FDA Drug and Medical Device Regulation Bar State Liability Claims?" CNN reported.

Actor Dennis Quaid appeared on Capital Hill on Wednesday telling the House Oversight panel that just because the FDA approves a drug does not mean it is safe.   He was quoted by NECN.com as saying "I used to think lawsuits were frivolous. Now I know the courts are the only path."

In November 2007, the Quaid's twins when they were 14 days old were given doses of the blood thinner Heparin that were 1,000 times higher than the doses they were supposed to receive, leading to a nearly fatal medical accident.

The problem appeared to be with the labels.   The labels of dramatically different doses looked strikingly alike, leading the medical workers to mistakenly believe that the doses they were using were what they were supposed to use.

Baxter, the manufacturer of heparin, made efforts to change the labels, but only after three infants at a hospital in Indianapolis reportedly died in September 2006 of the same mix-up that the Quaids experienced, according to ABC NEWS.

Baxter did not seem to warn hospitals and submit label changes to the FDA quickly enough, according to ABC NEWS.   Baxter did not recall the drugs on the market with the old confusing labels.

ABC News cited Healthgrades, an independent health care ratings company as reporting that 247,662 patients between 2003 and 2005 died from potentially preventable problems.   The Institute of Medicine also estimated that 1.5 million of Americans suffer from medication mistakes every year.

Although people can sue drug companies under state law, the Bush Administration was cited by ABC News as arguing that "states have no right to fault a company for selling a product that has been reviewed and approved by the federal government."

NECN.com also reported that "As of 2006, the Food and Drug Administration said any product that meets its standards for approval is not subject to state liability laws."

"Blocking such lawsuits, in my view, would do great harm to the public health," Dr. Aaron S. Kesselheim at Brigham & Women's Hospital in Boston and an instructor at Harvard Medical School was quoted By ABC NEWS as saying in a statement.

Gregory Curfman, New England Journal of Medicine Editor, also said on Wednesday in a prepared testimony 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."

According to CNN, David Kessler, FDA commissioner from 1990 to February 1997 will tell Congress on Wednesday that FDA approval of a drug or medical device shouldn’t bar states from suing the manufacturers because the FDA is unable to detect emerging risks due to its lack of resources.