Fact Pattern 19-1 In 1999, the Drugs-R-Us Began Testing Its New Drug, Reduceo

question 433

Multiple Choice

Fact Pattern 19-1
In 1999, the Drugs-R-Us began testing its new drug, Reduceo, a medicine to help people lose weight. Tests looked promising and, in 2006, the company applied to the FDA for approval to market Reduceo as a prescription drug. In March 2009, the FDA granted Drug-R-Us approval to market Reduceo. Reduceo was sold with some "diet enhancing" cookies that contained no drugs but were claimed to help dieting with Reduceo.
Frank saw an ad for the new drug. The Reduceo ad stated that it was a "wonder drug" and "tests prove it is the safest weight reduction drug on the market today!" Frank was interested and made an appointment to see his doctor.
Frank's physician prescribed the new drug for his patient. Frank had no success using other weight-loss drugs, and dieting and exercise seemed ineffective. Frank took Reduceo from June until the end of August and lost 25 lbs. He also ate Reduceo's cookies. He was delighted with his weight loss, but was concerned because dots appeared before his eyes, causing disorientation. One day, the dots appeared before Frank's eyes while he was driving. He became disoriented and hit a tree and was seriously injured. He sued Drugs-R-Us, alleging negligence in manufacturing and inadequate warning of possible effects, as well as for deceptive advertising.
-Refer to Fact Pattern 19-1. What would be the most likely outcome of Frank's suit against Drugs-R-Us if the company argued that prior FDA approval shielded it from tort liability?

• A) the company's argument would not be accepted
• B) the company would win because FDA approval implies that a product is safe
• C) the company would win because FDA approval of Reduceo for sale indicates a high level of care, so a negligence case would be impossible
• D) Frank would lose because weight-loss drugs are covered by the Delaney Clause, which restricts such lawsuits
• E) none of the other choices

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Definitions:

Unaffected Side

The side of the body or the part of an organ that remains normal or is not impacted by disease or injury.

Inguinal Lymph Nodes

These are a group of lymph nodes located in the inguinal (groin) area, which filter fluid and potentially harmful particles from the legs and groin area.

Palpable

Something that can be felt with the hands or fingers, such as a lump or mass within the body.

Mobile

Capable of moving or being moved freely or easily, often used to describe the status of body structures in medical evaluations.