Promethazine Hydrochloride Injection
Earlier this year, the pharmaceutical industry suffered a crushing defeat at the hands of the Federal Supreme Court. In a 6-3 decision, the Supreme Court upheld a Vermont court’s decision awarding 6.7 million in damages to Ms. Levine for the defendant pharmaceutical company’s (Wyeth’s) failure to provide sufficient warnings for its promethazine hydrochloride injections. The narrow issue for the court to decide was whether federal drug labeling laws “preempt” or prevent an injured plaintiff from suing a drug firm in state court. The court held that it does not.
In Wyeth v. Levine, a Vermont court found the pharmaceutical giant, Wyeth, responsible for the loss of Ms. Levine’s arm caused by an intravenous injection of Phenergan using the IV-drip method. Phenergan is the brand name for promethazine hydrochloride, which is an antihistamine often used to treat nausea. It can be administered either intramuscularly or intravenously using either the IV-push or IV-drip method.
Apparently, the IV-drip method presents a danger of gangrene because Phenergan is corrosive to arterial walls, and the IV-drip method presents greater risk of accidental arterial injection. This is what happened to Ms. Levine.
Counsel for Ms. Levine argued that Phenergen’s labeling lacked sufficient warnings and, due to the lack of sufficient warning, the clinician administering the drug wasn’t aware of the risks of using the IV-push. In fact, nothing in the labeling contained any specific warning connecting the IV-push method with the increased risk of gangrene to extremities. As such, Wyeth should have contraindicated intravenous use even though the FDA had not required the drug maker to indicate as such.
According to Jeff Grand, the decision to hold the drug company responsible for its defective product despite the manufacturer’s compliance with FDA labeling “reflects a clear recognition by the Supreme Court that the responsibility to provide adequate information about the risk associated with prescription drugs lies with the manufacturer and not the FDA.”
On September 16, it seems the FDA got the message that its labeling requirements for Phenergen (promethazine hydrochloride) were insufficient when it notified healthcare professionals that a Boxed Warning is being added to the prescribing information for promethazine hydrochloride products, “describing the risks of severe tissue injury, including gangrene, requiring amputation following intravenous administration of promethazine.” The new warning will remind practitioners that the preferred route of administration of Phenergen is deep intramuscular injection.
Who says private litigation isn’t an effective enforcer of the public good?
Sources: http://pharmexec.findpharma.com/pharmexec/Regulatory/Wyeth-Loses-Preemption-Battle/ArticleStandard/Article/detail/584710; http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm182500.htm
