Posts Tagged ‘supreme court decision’

Mr. Goodheart had been suffering chest pains because of an erratic heartbeat for a number of years. His cardiologist decided it was best if he had a pacemaker inserted which was done. Several weeks after the insertion of the pacemaker, Mr. Goodheart passed out while in a grocery store.

The first medics on the scene actually experienced being electrically shocked when they touched Mr. Goodheart. As it turned out, the pacemaker was shorting out because of the fact that it was malfunctioning. Unfortunately, for Mr. Goodheart, he would not survive the ordeal.

Mr. Goodheart’s family would bring a lawsuit against the manufacturer of the pacemaker. As it turned out, a number of the pacemakers that the manufacturer had supplied were defective, and the serial numbers on those defective pacemakers had, in the past, been sent out. Notice of the defective nature of Mr. Goodheart’s pacemaker, though, had not been distributed.

Mr. Goodheart’s family decided to bring a lawsuit against the manufacturer of the pacemaker.

Question: Will they be successful?

Answer: Based upon a recent United States Supreme Court Decision, Mr. Goodheart’s family will not be successful in pursing a lawsuit against the manufacturer of the defective pacemaker. Before the manufacturer was allowed to place the pacemaker into commerce where it could be used, it had to have acquired FDA approval. The pacemaker had, in fact, achieved such a status. Our Supreme Court has taken the position that once the FDA gave an approval, defects in the product such as the pacemaker which are inserted in the body, even though ultimately defective, cannot be the basis for a lawsuit.

This situation is different than the lawsuits involving the drug, Vioxx, because it was learned that some of the studies done prior to FDA approval by that manufacturer showed that Vioxx may lead to serious complications. Those particular results were not provided to the FDA at the time that that manufacturer was seeking approval.

This most recent decision is another indication of the highest court siding with large manufacturing companies over the interests of consumers.