If the U.S. Supreme Court rules in favor of barring lawsuits against Food
and Drug Administration-approved medications, pharmaceutical companies
will be quite pleased. Earlier this year the Supreme Court reinterpreted
a 1976 amendment that had originally been intended to protect the public
against dangerous medical devices by requiring the FDA to review and approve
such devices before they could be sold to the masses. The reinterpretation
led the Supreme Court to bar lawsuits against FDA-approved medical devices.
Now the Supreme Court may extend this ruling to FDA-approved drugs. If
this happens, some tens of thousands of lawsuits will be dismissed, and
the public will have no recourse or protection when harmed by pharmaceuticals.
Pharmaceutical companies and their advocates argue that the FDA is filled
with experts, and the decision as to whether a medication is safe or dangerous
should be left to them. Juries, they argue, are made up of lay people,
who most likely would not be able to make informed decisions about a prescription
medication’s safety. Consumer rights groups, on the other hand,
argue that the public deserves added protection and that lawsuits can
bring to light new dangers or issues that the FDA was not aware of.
The case the Supreme Court will rule on on November 3, 2008, involves a
Vermont woman who suffered from severe headaches. She went to a clinic
with a headache and was given Demerol for pain relief and Phenergan for
nausea. Phenergan’s warning label indicates that extreme caution
must be exercised if the drug is given via injection. Hitting an artery
can cause extreme damage. The patient was given Phenergan via injection,
and an artery was struck. As a result, the patient lost part of her arm
and her hand due to gangrene. She filed a lawsuit against Wyeth, the maker
of Phenergan, arguing that the company should have warned against injecting
Phenergan in any situation. The case went to trial in Montpelier, Vermont,
and the jury found in favor of the plaintiff. Wyeth, however, appealed,
and that is the appeal on which the Supreme Court will rule.
For more information, see
this article in the Los Angeles Times.