330. 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
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.
331. Refer to Fact Pattern 19-1. After Frank had his accident, other people who were taking Reduceo reported seeing
spots and becoming disoriented. If many people taking experience this side effect, what enforcement activities
could the FDA use?
a. the agency may order the drug off the market
b. the agency may sue the manufacturer for breach of contract
c. the agency may seize shipments of the drug
d. the agency may order the drug off the market and seize shipments of it
e. none of the other choices