The United States Supreme Court will soon decide whether state tort actions against drug companies will be "pre-empted" by the FDA’s pre-market regulation of new drug products. The case, Wyeth v. Levine, arose out of a Vermont action by a musician, Diane Levine, who was injected with Wyeth’s anti-nausea drug, Phenergan during hospital treatment for migraine headaches. The drug was mistakenly injected into Ms. Levine’s artery resulting in the necessary amputation of her right arm. Many observers believe the Supreme Court will follow the logic of its recent decision in Riegel v. Medtronic, to pre-empt state law tort actions against drug companies where the drug has received FDA approval.
The FDA does not itself test new drugs, but rather relies on reported results of pre-market studies performed by the drug companies themselves. It may not surprise anybody to learn that these self-reports are not always complete and candid. Further, an overextended and underfunded FDA is not always on top of its game in investigating weaknesses in the studies presented to it.
Continue reading "FDA Review to “Pre-Empt” State Pharmaceutical Litigation?" »
Wilcox Memorial Hospital in Kauai, Hawaii announced last month that a relative of a patient arrived at Wilcox with a horse to cheer up a patient at the hospital. The visitors reached the lobby where the front desk personnel had retired for the evening. The relative and the horse called from the lobby to announce their arrival and intention to visit the patient. They boarded an elevator and proceeded to the 3rd floor where they were met with security. Security seems to be a problem at Wilcox at a number of different levels. Back in 2005, the hospital informed 120,000 past and current patients that their names, addresses, Social Security numbers and medical records had been placed on an USB Flash Drive and was missing.
Continue reading "AND THE HORSE YOU RODE IN ON!" »
The Indiana Court of Appeals, in McSwane v. Bloomington Hospital and Healthcare System, Ind. App. ct.,No 53A04-075-cv-243 (March 12, 2008) reversed a summary judgment granted in favor of Bloomington Hospital in a claim, that the hospital negligently discharged Malia Vandenneede into the custody of her estranged husband, Monty Vandeneede, following her treatment for apparent martial abuse. The hospital treated Mrs. Vandeneede for laceration puncture wounds and arm and wrist pain
which Mrs. Vandneede herself related to falling off of a horse onto a pile of debris. The plaintiff in the case, Mrs. Ava McSwane, was Mrs. Vandeneede's mother,who advise a hospital nurse that Mr. Vandeneede had beaten his wife with a fireplace poker.
Continue reading "NEGLIGENT DISCHARGE?" »
