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.