In Kellogg v. Wyeth, the Reglan attorneys representing Ethel Kellogg in her tardive dyskinesia lawsuit allege that Wyeth knowingly wrote a false and misleading label for Reglan:
23. The package inserts for metoclopramide products, and the PDR monograph for Reglan, contained false and/or misleading statements and omitted information material to the foreseeable and ordinary contemplated uses of the products. These statements and omissions include:
a) The statement that “Like the phenothiazines and related drugs, which are also dopamine antagonists, metoclopramide produces sedation and may produce extrapyramidal reactions, although these are comparatively rare (See WARNINGS).” This statement is false and misleading in light of the manufacturers' knowledge that extrapyramidal reactions are far more common, particularly when metoclopramide is used long-term and their concurrent knowledge that metoclopramide is commonly prescribed for long-term use.
b) The statement that the most common EPS occurred in approximately 1 in 500 hundred patients using metoclopramide. This statement is without scientific evidence of any sort capable of supporting it.
c) The omission of any reference to epidemiological studies and other evidence suggesting that the prevalence of tardive dyskinesia among patients exposed to metoclopramide for six months or longer is as much as 100 times greater than 1 in 500.
d) The statement that use of metoclopramide products for longer than 12 weeks “had not been evaluated” and therefore “cannot” be recommended. The statement misleadingly implies that no evaluation whatever of longer term use has been undertaken, or that use for longer than 12 weeks would be recommended if only formal evaluations or clinical studies for such periods had been performed.
e) The statement that the risk of tardive dyskinesia from exposure to metoclopramide is “believed” to increase with duration of treatment and total cumulative dose. The statement misleadingly implies that the “belief” is not supported, or not strongly supported, by scientific evidence.
f) The omission of any statement that therapy with metoclopramide should not extend beyond three months, which implies, in context, that no scientific evidence suggests, or strongly suggests, that longer term use increases substantially the risks of overexposure.
g) The statement that “Extrapyramidal symptoms, manifested primarily as acute dystonic reactions, occur in approximately 1 in 500 patients treated with the usual adult dosages of 30-40 mg/day of metoclopramide,” which tends to understate concerns about more serious extrapyramidal symptoms such as akathisia and tardive dyskinesia.
24. The dangerous propensities of metoclopramide products, as referenced above, were known or scientifically knowable to the drug company defendants, through appropriate research and testing, at the time they distributed, supplied, or sold the products, and not known to ordinary physicians who would be expected to prescribe the drug for their patients, or their patients.
25. In its dissemination of information to physicians concerning Reglan, Wyeth (and in particular the A. H. Robins Company, Inc. prior to its merger with and into Wyeth) promoted the idea that long-term use of metoclopramide or Reglan was both safe and effective. The promotion of such use included presentations by sales representatives (known as “detail men”) emphasizing the drug's gastroenterological effects, in particular gastric emptying, at the expense of its extrapyramidal effects; the sponsoring of talks and seminars with company sponsored speakers, who would discuss the supposed benefits and safety of longer term use; and the ghost-authoring, company-sponsored publication, and further dissemination of at least one junk science study calculated to “demonstrate” the safety of long-term metoclopramide use. Defendants Wyeth and Schwarz have never repudiated the substance of this promotion or acted to neutralize its effects.
26. Between 5/8/00 and 5/24/04, Plaintiff's physicians prescribed “Reglan” and/or “metoclopramide” for the plaintiff as treatment for gastroesophageal reflux disease (GERD).
