WASHINGTON The Supreme Court has granted review to Wyeth in regards to a case where the state of Vermont awarded a $6.8 million verdict to a woman whose arm had to be amputated after being injected with the company’s anti-nausea drug Phenergan, according to published reports.
This will be the second case heard by the Supreme Court regarding the Food and Drug Administration’s approval of drug labeling and whether that preempts state law. In the first case, Warner-Lambert v. Kent, patients who claimed to have suffered personal harm from the Type 2 diabetes drug Rezulan alleged that the drug company concealed the safety information from the FDA.
Wyeth is stating that it should not have been subjected to the lawsuit because the company had approval from the FDA for the warning label that accompanied the drug.
Wyeth has even said the company recommended a label change to the FDA, but the agency told it to keep the existing language.
Lawyers for the drug industry have said that the FDA and not jurors should have the role of deciding when drugs can be used safely.