OPINION
BAKER, Judge.
After their newborn daughter was diagnosed with a heart defect, was given a Guidant pacemaker, and tragically passed away at the age of fourteen months, the appellants filed a state law complaint against Guidant. Among other things, they argue that Guidant should have put specific warnings on the pacemaker labeling related to its implantation into pediatric patients. Because the label had been preapproved by the Food and Drug Administration...
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