Remember Wyeth v. Levine, U.S. Supreme Court decision that held federal approval of labels drug warning labels does not preclude lawsuits under state law claiming inadequate warnings? Well, the government, through the FDA, has now added a final chapter to that story.
The drug at issue in Wyeth v. Levine was Phenergan, an antihistamine. The drug was administered using a method known as an “IV push,” however the drug was inadvertently injected into Dina Levine’s artery. She developed gangrene, the arm had to be amputated (Diana Levine is a musician, and the tragedy of her injury is simply incomprehensible. See John Bratt’s blog post).
The label originally warned that the IV push method could lead to inadvertent injection into arteries, but the label did not expressly forbid that procedure. Now, after the conclusion of the Wyeth case, the FDA has allowed the Court’s decision to lead the way, and has amended the label to include a black box warning: “due to the risks of intravenous injection, the preferred route of administration is a deep muscular injection and that subcutaneous injection is contraindicated.”
Can anyone doubt that if Wyeth was truly concerned with patient safety, it would provide full warnings as soon as possible? Unfortunately, it seems as though the almighty dollar is the reason for holding back on warnings, with the fear that fewer patients will take drugs when the risks are appropriately disclosed. It is a game of “hide the ball.” The results: ask Diana Levine’s.