In 2007, Charles Riegel and his wife sued a medical device manufacturer, Medtronic. Charles had a catheter produced by Medtronic placed in his coronary artery after he suffered a heart attack. However, during his heart surgery part of the catheter burst. Charles and his attorney claimed that because of the malfunction he suffered other health problems. Charles and his wife sued the catheter manufacturer, claiming that Medtronic was negligent in the production and distribution of the medical device. In turn, Medtronic argued that because the Food and Drug Administration had determined that Medtronic's manufacturing and design of the devices complied with existing safety standards, it was protected from suit for product liability. The district courts and the Second Circuit both sided with Medtronic. The Riegels appealed, and the case went to the Supreme Court.

1. Does Justice Scalia see the general tort duties as imposing duties different from those requirements imposed by the rigorous FDA review process?
Clue: For the Court to have decided that the Riegels' claim was preempted by the MDA, what would the Court have had to believe about the requirements imposed by a potential tort action against the defendant?
2. The Court claims that the Riegels and their attorney have misread the MDA. This disagreement emphasizes the importance of reading comprehension. What ambiguity are the plaintiffs claiming that the Court says is not present?
Clue: Reexamine the dispute about the meaning of the word requirement.