Drug Makers Getting Closer to Legal Shield
An
excellent New
York Times story from yesterday details what will (hopefully) become a hot legal
issue later this year. The story details how court decisions could effectively shield
drug makers from personal injury lawsuits – even when the companies intentionally
misrepresent data about their products to the public.
The
Supreme Court, which granted similar protection to medical device producers
earlier this year, is set to hear and decide a case on this topic later this
year. The argument for this corporate protection, which the Bush administration
whole-heartedly supports, is simple: The FDA, in all its effectiveness and
glory, is the only governmental department with enough expertise to decide
whether a drug is safe enough to hit the market (i.e., whether society benefits
from its availability). Its authority, therefore, should not be ‘second-guessed’
by lawsuits from hurt patients. This legal argument is known as ‘pre-emption.’ 
But
the NY Times article does an excellent job of illustrating why this is a truly
a terrible idea. The story details one case before lower courts right now,
involving a Johnson & Johnson birth control patch that released a much greater
amount of estrogen than it claimed it did. Higher amounts of estrogen lead to
blood clots and stroke. From the article:
Documents and e-mail
messages from Johnson & Johnson, made public as part of the lawsuits
against the company, show that even before the drug agency approved the product
in 2001, the company’s own researchers found that the patch delivered far more
estrogen each day than low-dose pills. When it reported the results publicly,
the company reduced the numbers by 40 percent.
So
we know the company knew of the increased health risks, and failed to act on their
data. It doesn’t take a genius to figure out why. Furthermore:
The F.D.A. did not warn the
public of the potential risks until November 2005 — six years after the
company’s own study showed the high estrogen releases. At that point, the
product’s label was changed, and prescriptions fell 80 percent, to 187,000 by
last February from 900,000 in March 2004.
So
from the time the company originally knew of the problem to the time the FDA
alerted the public, six years
had passed. During that time, at least 50 deaths have occurred (allegedly) as a
result of the drug’s use. But the article goes on:
Last month, at a trial over
the schizophrenia drug Zyprexa, Dr. John Gueriguian, a scientist who worked at
the F.D.A. for two decades, testified that the agency did not always ask for
strong warnings even if it believed a drug was risky. Companies typically
oppose warnings, and the agency knows it must compromise on its requests or
face years of delay, Dr. Gueriguian said.
-- Dylan Blaylock
*Photo courtesy of Tom Varco
Comments