A Vermont woman was awarded more than $6 million when a jury ordered Wyeth, a pharmaceutical company, to pay her for failing to warn her about the risks of one of its drugs.
But this case was appealed all the way to the US Supreme Court and the Court is set to hear arguments this November.
This case concerns “Federal Pre-emption,” a legal doctrine that can prevent plaintiffs from suing in state court when the products that injured them had met federal standards.
In early 2000, Ms. Levine had a migraine attack and she visited a clinic for treatment: Demerol for the headache and Wyeth’s drug Phenergan for nausea.
Both medications are safe when given the right way. But if Phenergan is given arterially, it causes swift and irreversible gangrene. A physician’s assistant injected the drug into what she thought was a vein. Shortly afterwards, Ms. Levine’s hand and forearm became gangrenous and were amputated in two stages.
The drug’s label, approved by the FDA, had warned that “inadvertent intra-arterial injection” can result in “gangrene requiring amputation.”
Ms. Levine filed and settled a lawsuit against the clinic, and she went to trial against Wyeth. She alleged Wyeth should have added a stronger warning to the label that the FDA had approved.
This is the issue: does the FDA set minimum safety standards that States are free to add to? Or do they rule on the balance between risks and benefits that States must follow?
Wyeth and the FDA claim that there is a conflict; Wyeth could not comply with both federal law, given its requirement that the agency approve drug labels, and the jury’s verdict, which punished Wyeth for not using a different one. That conflict, they say, amounts to “implied pre-emption.”
The Vermont Supreme Court rejected that argument; Federal law, they ruled provides a floor, not a ceiling, for state regulation.
Legal Analysis: Tough case, bottom line irrespective of the labelling on the medication, this drug cannot be given intra-arterially without dire consequences. This is a simple case; botched up and negligent injection leads to amputation. The argument about the FDA, labels and Wyeth is a red herring. Is Wyeth ultimately liable because they did not put on a stronger warning? I doubt it.