November 25, 2009, 06:00:00PM. By Gordon Gibb

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Wheeling, WV: A recent lawsuit against Reglan alleges that the drug caused the plaintiff to develop tardive dyskinesia and other Reglan side effects. The innovators of Reglan were excused from liability, given that the plaintiff had used only the generic version of the product.

The plaintiff in the case, Shirlean Meade, sued Wyeth and Schwarz Pharma after she developed symptoms of tardive dyskinesia and akathisia following the issuance of a prescription for metoclopramide (Reglan) to treat reflux disease.

Meade alleged that a doctor had prescribed the Wyeth and Schwarz Pharma version of the drug, but that her pharmacy had given her a generic version of Reglan produced by another manufacturer.

Claim: If It Originated with the Innovator, the Innovator Must Bear Liability

The plaintiff argued that even though she had consumed the generic version of Reglan, the innovators of the drug that allegedly caused her tardive dyskinesia (Wyeth and Schwarz) should bear responsibility for alleged inaccuracies and deficiencies in the safety version of the generic version, given that generic versions of a drug are permitted to rely on the warnings originally coming from the manufacturers of the original brand-name product.

However, the US District Court for the Southern District of West Virginia, in a summary judgment, dismissed that argument. In its ruling, the court cited several similar cases that determined a company controlling the manufacturing and the labeling of a product—and thereby collecting the profits—should bear legal liability for any resulting injury.

Ruling: The Manufacturer of a Generic Bears Liability, Not the Innovator

The November 18 issue of Drug Industry Daily notes that this past March, a federal judge found that Virginia state law does not compel either Wyeth or Schwarz, as innovators of Reglan, to warn patients about potential risks associated with generic versions of Reglan manufactured, distributed, and marketed by other companies.

The innovators of Reglan are therefore off the hook for any legal liability in the state relating to generic versions of its drug, leaving the plaintiff with no recourse but to pursue the companies that actually manufactured and marketed the product.

It is not known if the pharmacy that dispensed the generic form of Reglan to the plaintiff did so at the plaintiff's request, or made the substitution on its own.

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