1. Discuss potential claims by Mr. Diaz

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

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Discuss Potential Claims by Mr. Diaz Against the Noflux Manufacturer for Manufacturing Defect

INSTRUCTIONS:

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.

CONTENT:

Noflux Drug: Case Study Student: Professor: Course title: Date: Noflux Drug: Case Study The scenario involves a Doctor who administered Nofluxdrug to one of her patient. The drug resulted to affecting the patient`s health severely. The patient in the case was Mr. Jorge Diaz who went to seek treatment from Dr. Gloria Gonzalez with an attempt of getting urgent medical treatment from the gastro-esophageal disease. The package of the drug warned the user of the side effects and suffering that he faced after using the drug. In addition, the manufacturers of the drug had run advertisements on Spanish cable television network, where the company had complied with advertising rules, guidelines and regulations from FDA, which is the relevant advertising body in the country. However, the company failed to make a summarized copy in relation to its product, which is the Noflux drug. B

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