[Mb-civic] NYTimes.com Article: Blocking Medical Product Suits

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The article below from NYTimes.com 
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Blocking Medical Product Suits

August 1, 2004
 


 

It is disheartening that the Bush administration has been
intervening in court to block lawsuits filed by people
seeking compensation from manufacturers for harm allegedly
caused by drugs or medical devices. As described by Robert
Pear in last Sunday's Times, the administration has argued
in several cases that individual consumers have no right to
sue for such injuries if the products have been approved by
the Food and Drug Administration. If the Bush
administration's campaign proves broadly successful, people
injured by drugs or medical devices may be left without
legal recourse, no matter how just their complaints. 

In a recent ruling, a federal appeals panel in
Philadelphia, after seeking the administration's views,
threw out a lawsuit filed by the widow of a man whose heart
pump failed. Whatever the legal merits of this close
two-to-one decision, which turned on the degree to which
the F.D.A. can pre-empt state laws and court decisions,
most fair-minded Americans would probably think that the
widow got a bum deal. The facts of the case as alleged in
court documents suggest that the heart pump, though
approved by the agency, was designed poorly. 

The device had several components connected to each other
by screw rings or other threaded connections that were
vulnerable to loosening because of motions within the body.
The model inserted into the Pennsylvania man used a
factory-installed suture to prevent such loosening, but
that suture apparently broke because it rubbed against the
breastbone, allowing the joint to separate and an air
bubble to travel to the brain. The precise role of the
heart pump in causing the man's death may never be known
because the case was aborted before it went to trial. But
the manufacturer subsequently designed a self-locking screw
ring that required no sutures and would very likely have
prevented this accident. 

The administration argues that allowing consumers to sue
the manufacturers would undermine federal regulation of
drugs and devices by encouraging lay judges and juries to
second-guess the experts at the F.D.A. The result could be
a hodgepodge of conflicting judgments around the country as
to the safety of a product and the need to change warning
labels. Skittish manufacturers might then remove good
products from the market or issue scary warnings that would
discourage their use. 

These concerns seem overblown and are offset by other
considerations. The F.D.A. is not infallible. It seems poor
policy to assume that once the agency has judged a product
safe enough to use, the manufacturer should be insulated
forever from lawsuits that could force improvements. Simple
justice suggests that victims harmed by a product should be
able to seek compensation. If a manufacturer has acted in
good faith and received the agency's approval, the
likelihood of huge punitive damages - the real bêtes noires
of the tort reformers - seems slight. 

Angered by the F.D.A.'s intervention on the side of
manufacturers against consumers in several cases,
Representative Maurice Hinchey, Democrat of New York,
persuaded the House to amend an appropriations bill to
strip $500,000 from the agency's legal budget as a penalty
and use it instead to police the accuracy of drug
advertising. If the Senate finds that approach too
punitive, it might forgo the financial penalty and simply
direct the agency not to intervene in product liability
cases unless it is asked to do so by the courts. Or perhaps
Congress should devise a new compensation fund so that
victims who are blocked from suing can nevertheless be
compensated for any damage they have suffered. Meanwhile,
if the administration wants to "reform'' the tort system it
should tackle the problem broadly, not piecemeal through
individual suits. 

http://www.nytimes.com/2004/08/01/opinion/01sun1.html?ex=1092378847&ei=1&en=dc2ba69600c4b186


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