Holland & Hart Healthcare Law Blog

FDA DRUG LABELING: A FLOOR OR CEILING ON PHARMACEUTICAL LIABILITY?

In April of 2000, Diane Levine was a professional musician in Vermont when she suffered two amputations, one to her right hand and a second to her right arm, following the IV administration of the Wyeth drug Phenergan at Northeast Washington County Community Health, Inc.  Her doctor administered the drug to treat migraine headaches resulting from nausea.  She received two injections.  The first was by intermuscular injection.  She received the second dose by a direct intravenous injection procedure known as an “IV push.”  This last resulted in the inadvertent injection of Phenergan into an artery.  The artery turned gangrenous and the amputations followed.  Litigation following the amputations resulted in a 6.4 Million Dollar verdict against Wyeth which the Vermont Supreme Court affirmed in 2005. The trial centered on the adequacy of Wyeth’s warnings on the Phenergan label.

PHYSICIAN PRIVACY SUITS DUMPED

Two recent federal district court cases that raised physician concerns about privacy were unceremoniously rejected on motion.  In William Andrew Rinell, M.D. and Alan B. Whitehouse, M.D. v. Private Healthcare Systems and The Capella Group, Civil Action No. 106-176 (S. Dist. of Georgia, Augusta Div. 2007), the Plaintiff physicians sought damages in tort against a Preferred Provider Organization (“PPO”) with whom they had entered provider contracts and a discount card company who had purchased provider information and discount data from the PPO.  The physicians argued that their agreements with the PPOs did not contemplate the sale of their information to a purchaser who was not an insurance company and that the sale of such information was a breach of privacy or of some other kind of tort arising out of the contractual duties created by the physicians’ contracts with the PPO.  The court refused to recognize a claim sounding in tort and held that any claim arising out of the contract was fundamentally a contract claim and that since the Plaintiffs did not include a contract claim in its complaint, the complaint must be dismissed.

Ketek Attack At FDA.

In the April 19, 2007 edition of The New England Journal of Medicine, David B. Ross, M.D., Ph.D.,, a clinical assistant professor at George Washington University School of Medicine and Health Sciences took the FDA to task for its approval of Ketek, a ketolide antibiotic manufactured by Sanofi-Adventis, for use in respiratory tract infections.  The drug underwent three rounds of review by the FDA and followed an unusual structure of review and approval that may suggest outside interference in the process.