In the Arkansas Reglan lawsuit of Fields v. Wyeth, the tardive dyskinesia lawyer representing Bettye Fields alleges that the black box warning Reglan has should have come sooner:
I.
INTRODUCTION
Plaintiff sued these defendants for their negligent acts, which proximately caused Plaintiff's injuries. This is a failure to warn case. Wyeth and Schwarz Pharma, Inc. claim that they cannot be liable for the warning they crafted, no matter how negligently, because they are neither the manufacturers nor suppliers of the drug Plaintiff ingested. Though they appear not to have manufactured the drug at issue here, Wyeth and Schwarz Pharma, Inc. should remain liable under claims of negligence, fraud and misrepresentation as they relate to failure-to-warn claims. Wyeth and Schwarz Pharma, Inc. are the manufacturers of name-brand Reglan(R), generically known as MCP. Ms. Fields took the generic form. MCP/Reglan(R), typically prescribed for gastroesophageal reflux disease, carries a significant risk of tardive dyskinesia, a severe drug side effect characterized by grotesque involuntary movements of the mouth, tongue, lips, and extremities, involuntary chewing movements, and a general sense of agitation, especially with extended use. Tardive dyskinesia is a terribly debilitating condition. Plaintiff contends that the various defendants failed to adequately warn of the risks of tardive dyskinesia associated with extended use of MCP/Reglan(R), that the drug, by whomever manufactured, ought to carry a black box warning of the risk of tardive dyskinesia with extended use. It was in fact the warning created and sponsored by Wyeth and Schwarz Pharma, Inc., the warning that the FDA approved, that, by law, the MCP consumed by Bettye Fields carried. In fact, as of February, 2009, MCP/Reglan(R) now carries, as mandated by the FDA, just such a “Black Box” warning.[FN1] As a result, Ms. Fields has suffered permanent, disabling and disfiguring injuries.
FN1. The newly required warning says that “Chronic treatment with [MCP] can cause tardive dyskinesia.... [MCP] therapy should routinely be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia .... Prolonged treatment (greater than 12 weeks) ... should be avoided in all but rare cases....” See Exhibit A.
A designer who is not also the manufacturer should share the same duty in design and warning.
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