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In the year
2000, Diane Levine presented herself to a clinic with a migraine, where she was given
a treatment she had already taken several times before for the same ailment: Demerol
and Phenergan. The latter, a product of the Wyeth pharmaceutical
company, is used to prevent motion
sickness, nausea or vomiting and is generally administered by intramuscular
injection, since exposure of the drug to arterial blood causes irreversible
gangrene. An intravenous drip is as safe as the latter method. The nurse that
gave Ms. Levine the medication chose to inject the Phenergan through
intravenous therapy, but she unfortunately missed the patient’s vein.
Consequently, Levine’s arm had to be amputated within few weeks, after it
turned purple and then black.
The woman
filed a lawsuit against the Madison-based company, claiming that the drug’s FDA-approved
label should have contained stronger warnings with regards to the risk of inadvertent
intra-arterial injection, since it did not say anything concerning administration via an
IV push, the method used in Levine’s case.
Diane Levine, 62, is scheduled to present her arguments to
the Supreme Court in November, followed by the latter’s decision whether the
woman should keep the $6 million that a Vermont jury ordered the pharmaceutical
company to pay her.
Levine’s
legal action falls into the category of pre-emption cases, which is a legal
theory stating that consumers can be prevented from filing lawsuits in state
court when the products that they claim injured them are compliant with federal
standards, the federal law trumping the state one.
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