Cengage Advantage Books: Foundations of the Legal Environment of Business 2nd Edition by Marianne Jennings, Albert Napier, Marianne Jennings

Exercise 9

Gladys Mensing and other patients took the generic version of metoclopramide over a long period a time, something that resulted in serious neurological damage. Ms. Mensing and others filed suit against the generic manufacturers under the Louisiana Products Liability Act. They alleged that despite mounting evidence of the connection between long-term use of metoclopramide and neurological damage, the manufacturers did not change their labels to provide warnings. The generic drug manufacturers argued that federal statutes and FDA regulations require generic manufacturers to use the same safety standards and labeling as their brandname counterparts. They argued that it was impossible to simultaneously comply with both federal law and any state tort-law duty that required them to use a different label. What section of the U.S. Constitution will be used to resolve this issue? How will the court decide whether the manufacturers can be held liable? [ PLIVA, Inc. v. Mensing , 131 S.Ct. 2567 (2011).]