Supreme Court rules States cannot add to FDA regulations says Henry Greenspan, Ph.D

2008-07-29 15:18:42 (GMT) (WiredPRNews.com - Law)

WiredPRNews.com wishes to correct the story entitled, “Supreme Court rules States cannot add to FDA regulations,” which was posted on July 27, 2008. We thank Dr. Henry Greenspan, Ph.D, of Integrative Medicine, University of Michigan who gave us timely correction to this news.

In fact, the Supreme Court, which is currently in recess, will not hear the Wyeth v. Levine case until this Fall. This past spring, the Court did rule on a related case, Riegel v. Medtronic, which concerned the issue of whether FDA approval should shield a manufacturer of medical devices from civil liability (lawsuits).. In that instance, the Court did support the manufacturer by a vote of 8-1.

The question of “FDA preemption” - whether FDA approval should constitute a shield against liability - has been of great concern to many. There have been hearings on the issue in both the U.S. House and Senate, and editorials have appeared in national newspapers as well as in the New England Journal of Medicine and elsewhere.

Until the current Bush administration, FDA explicitly stated that it did not see its regulations as preempting state civil liability law in most instances. Lower courts have been divided on whether FDA’s new position ought to trump its earlier views. The Supreme Court’s decision in Wyeth v. Levine will be a critically important milestone.

Henry Greenspan, Ph.D.
Faculty Scholar, Integrative Medicine, University of Michigan Ann Arbor, MI