When Elizabeth Conte went to the pharmacy to fill her acid reflux drug prescription, she accepted a generic in place of the Wyeth-branded drug her doctor had prescribed, as has become common practice in California and the many other states that allow such substitutions.
After nearly four years of taking generic Reglan, or metoclopramide, Conte developed tardive dyskinesia, an irreversible neurological disorder that causes uncontrollable bodily movements--and a known side effect of long-term use of metoclopramide. Conte sued three generic drug manufacturers and Wyeth, claiming the manufacturers knew or should have known that physicians tend to prescribe Reglan (and its generic versions) for long-term use, and that its product information understates the risk of serious side effects that long-term use can cause.
According to a December report from IMS Health Inc., generic products now make up 63.7 percent of the U.S. pharmaceutical market, with generic prescriptions up 5.4 percent last year.
History & Hindsight
The pioneer drug companies themselves may have paved the way for Conte.