Eichhorn & Eichhorn Attorneys At Law

Claim:

Edwards is a medical device manufacturer and a long-time client of the law firm. It manufactures an annuloplasty ring to treat myxomatous heart disease and mitral valve regurgitation. This “myxo” ring was actually conceived and designed by one of the co-defendants, the plaintiff’s cardiac surgeon. During surgery to repair the plaintiff’s myxomatous disease and mitral valve regurgitation, the co-defendant selected the “myxo” ring in question among various other myxo ring options. But the plaintiff suffered a heart attack during the surgery, possibly due to the placement of a surgical stitch on one of the valve leaflets, a known complication of the surgical repair. The plaintiff’s surgical repair was a success; the myxo ring remains in place and the plaintiff’s heart valve continues to operate properly. But because of the heart attack, the plaintiff has decreased heart strength.The plaintiff claimed that the size and shape of the ring was a proximate cause of her heart attack, along with surgical error. While she did not contend that the ring was itself defective, she claimed that it was not properly cleared by the FDA and should have been disclosed to her as an “experimental” device. According to the plaintiff, had she been warned that the Edwards myxo ring was “experimental,” she would not have agreed to its use. She also contended that, by allowing her cardiac surgeon to use the myxo ring, another co-defendant hospital had engaged in an undisclosed experimental study.

Outcome:

Edwards obtained summary judgment on the basis that proper FDA clearance was to be decided solely by the FDA, which had never found the myxo ring to be non-compliant with its procedural requirements. Edwards also obtained summary judgment on the basis that it had no obligation to warn either the plaintiff or her “learned intermediary” cardiac surgeon of the regulatory status of the myxo ring. The co-defendants also obtained a jury verdict in their failure as to the plaintiff’s medical negligence and failure to warn theories.The Illinois Appellate Court affirmed the entry of summary judgment for Edwards after oral argument by Mr. Jensen, finding that FDA compliance is within the FDA’s exclusive jurisdiction, and that Edwards had no duty to the plaintiff to warn her or her “learned intermediary” cardiac physician of the regulatory status of the myxo ring. The court also found no trial error with regard to the jury verdict in favor of the co-defendants. As a result, the court then also agreed with Edwards that the jury’s verdict in favor of the co-defendants was “estoppel by verdict” as to all of the plaintiff’s theories against Edwards, including her allegations of a failure to warn and proximate causation due to the shape and size of the myxo ring. The plaintiff then chose not to seek review of these outcomes with the Illinois Supreme Court.