Product Liability Attorney Blog

One of the most difficult matters in deciding pharmaceutical cases is determining where fault lies in the production of generic medications. Plaintiffs injured by generics often feel they have a right to pursue the originators of the formula in question. After all, the original manufacturer and developer came up with the medicine, testified it was safe for common use to the FDA and got FDA approval, all long before secondary manufacturers began producing the generic equivalent in bulk. Thus, regardless of whether it was the original formula or a generic copy, the theory argues that a certain amount of blame can be placed on the original producers.

For the time being, however, the Federal courts do not seem to agree. In a recent decision, Federal judge Marcia Crone ruled that because plaintiff Judith Finnicum only took a generic formulation of the drug Reglan, produced wholly by Actavis-Elizabeth, then she could not sue the manufacturers of the original medication. Finnicum's suit against Actavis-Elizabeth may proceed as planned, but the drug's original development/manufacturing companies, Wyeth and Schwarz Pharma, are excluded.

People like Judith Finnicum who have been prescribed the medication have developed a movement disorder known as Tardive Dyskenesia. This disorder is characterized by uncontrollable muscle tics and movements that can be distracting and exhausting, and in some cases painful to live with.

This decision is one of the latest that presents a major setback for plaintiffs complaining of the disorder after taking Reglan. In 2009, a suit sought to consolidate all the ongoing Reglan cases into one major case. The judgment in that case went against the plaintiffs, however, so each Reglan case must proceed on its own merits and be resolved individually.

The risks from Reglan are not new, and have in fact been well-documented. It is one of a select few drugs with a black box warning from the FDA, which is the agency's strongest possible warning criteria.