Representing Guidant Corp. in a suit alleging that a pacemaker failed, Shook attorneys argued that medical records showed that the pacemaker had always worked properly. The plaintiffs' experts conceded that they had no evidence showing any pacemaker inadequacies. The battery was still new and worked properly, and medical records also suggested an alternate cause of death. After a two-week trial, the jury returned a defense verdict. McGookin v. Guidant Corp. (Super. Ct., St. Joseph Jud. Dist., Ind. 2009).
The plaintiffs appealed the decision, asserting that the court should have allowed them to argue that the pacemaker required a different label. The appeals court affirmed the lower court's decision, finding that a U.S. Food and Drug Administration regulation that allowed Guidant to add to its approved warnings did not indicate that the approved warnings alone were inadequate. McGookin v. Guidant Corp., 942 N.E.2d 831 (Ind. Ct. App. 2011).
In a blog post for Drug and Device Law, Scott Kaiser discussed the court's conclusion:
The decision is a straightforward affirmation of two familiar themes: that Riegel (not Wyeth or other non-medical device cases) provides the preemption rules governing Class III medical devices; and that “may” does not mean “must” when determining what constitutes a federal requirement under the MDA’s express-preemption clause.