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QUESTION

In Riegel v. Medtronic, Inc. , the Court heard an appeal of a case involving a defective medical device called a balloon catheter.

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In Riegel v. Medtronic, Inc., the Court heard an appeal of a case involving a defective medical device called a balloon catheter. The Court had to decide whether or not the injured party could continue with his legal cause of action.

  1. What were the relevant facts of this case? (Please focus on the injury of the defendant and keep this part of your discussion to less than 1/3 of your total post).
  2. Did federal law apply in this case? What source of federal law was applied by the court?
  3. Was state law relevant in this case? What sources of state law were applied by the court?
  4. What does the term "common law" mean? Why did the Supreme Court rule that the Medical Device Amendments (MDA) barred common-law product liability claims for FDA-approved medical devices?
  5. Should the fact that the medical device passed the Food and Drug Administration's approval process exempt the manufacturer from state law negligence, strict liability, and implied warranty claims?
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