Gabriel Mejia, Esq.: September 2009 Archives

September 29, 2009

FDA Orders Black Box Warning for Generics of Wyeth's Phenergan

The U.S. Food and Drug Administration (FDA) has ordered manufacturers of the promethazine hydrochloride injection to include a black box warning regarding potential dangers associated with the administration of the drug.  Promethazine hydrochloride was formally manufactured by pharmaceutical giant Wyeth under the name Phenergan.  Promethazine is used to treat nausea, vomiting, and pain after surgery and anesthesia, as well as allergy symptoms, motion sickness, and other ailments.

According to the FDA, the warning only applies to the injectable form of the drug which presents a serious risk of tissue damage if improperly administered.  The FDA warns that gangrene and other tissue injuries can be caused by administering promethazine in an artery or under the skin.  Because Phenergan, or promethazine, can potentially leach out of a vein and damage surrounding tissue during intravenous administration, the drug should be injected deep into muscle according to the FDA.

The black box warning label ordered for promethazine follows a March 4, 2009, U.S. Supreme Court decision in the landmark case Wyeth v. Levine.  In Levine, Diana Levine, a musician, had her arm amputated after Phenergan was injected into her vein using the "IV-push" method, entered her artery, and caused gangrene.  A state jury found that Wyeth failed to provide adequate warning of the dangers of such administration and awarded Ms. Levine $6.7 million in compensatory damages.  Wyeth appealed claiming that federal law pre-empted Levine's claim because the warning label had been approved by the FDA and it would be impossible to comply with both state and federal law.  The Supreme Court found against Wyeth and upheld the state court decisions in favor of Ms. Levine.

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September 14, 2009

Repeat Drunk Driver Charged with Killing Florida Motorcyclist

A Miramar, Florida, driver has been charged with killing a Davie, Florida, resident while driving drunk.  According to reports, the intoxicated driver was taking his 9-year-old daughter to school when he struck the Davie motorcyclist and dragged him 180 feet before coming to a stop.  When the drunk driver was apprehended after fleeing the scene of the accident, breathalyzer results showed his blood alcohol content to be .236 -- nearly three times the legal limit.   This was not the first time the driver has been charged with drunk driving according to the South Florida Sun-Sentinel.  According to their report, the intoxicated driver was wanted in Maryland for failing to appear for a court proceeding after violating his probation for driving under the influence with another charge of DUI.

Unfortunately, motorcycle accidents have been on the rise for the past nine years according to Florida's Department of Highway Safety and Motor Vehicles.  In 2008 alone, there were 9618 motorcycle crashes in Florida which caused the death of 502 motorcyclists and 30 passengers and contributed to over 9000 injured riders.  These numbers include 37 motorcycle accident deaths in Broward County, 44 in Miami-Dade County, and 34 in Palm Beach County.  Drug and alcohol related fatalities in Florida sadly exceeded 1,400 people in 2008.

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