Facts

Jorge Diaz suffered serious injuries after ingesting Noflux, a recently approved prescription drug indicated for the treatment of gastroesophageal reflux disease. The package insert included a warning about the adverse event that he suffered.

The Noflux manufacturer aggressively promoted the drug in television advertisements on Univision, a Spanish language cable television station. These spots complied with the FDA`s guidance on broadcast advertising (excerpted in Chapter 4(B)(2) of your book), except that the company did not make a copy of the brief summary available in Spanish.

Mr. Diaz (who is not fluent in English) saw these ads, and so did his physician (Dr. Gloria Gonzalez). During an appointment with Dr. Gonzalez, Mr. Diaz specifically asked Dr. Gonzalez to prescribe him Noflux.

After taking a cursory medical history, Dr. Gonzalez (who is fluent in English) gave her patient several samples of Noflux that one of the drug manufacturer`s detail reps had given her.

Assume that the highest court in your jurisdiction has cited the Perez and Ramirez cases with approval.

Assignment

1.            Discuss potential claims by Mr. Diaz against the Noflux manufacturer for manufacturing defect.

2.            Discuss potential claims by Mr. Diaz against the Noflux manufacturer for design defect.

3.            Discuss potential claims by Mr. Diaz against the Noflux manufacturer for failure to warn.

In answering these questions, be sure to address:

1.            How Dr. Gonzalez`s actions or inactions may affect his claims against the drug manufacturer.

2.            How the FDA`s approval of Noflux and its regulations and guidance statements on drug advertisements to consumers affect Mr. Diaz` s claims against the drug manufacturer.

Your answers should explain the legal standards for each claim and apply the facts in the fact pattern to the legal standards to reach a conclusion about each potential claim.