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The choice to use a synthetic bladder-support sling — instead of one made of natural substances — is not necessarily a surgical-method decision, and thus a Philadelphia trial court properly permitted a lawsuit against a surgeon for not informing his patient of the increased risk of infection related to that form of urinary system repair. In Allen v. Kilstein, a Pennsylvania Superior Court panel acknowledged that the doctrine of informed consent’s umbrella does not encompass surgical methods or techniques. But the judges, in a nonprecedential decision, ultimately decided to uphold a jury’s decision to award Deborah Allen $739,000 in her action against Lancaster, Pa., physician Bruce Kilstein. In its argument as to the impropriety of Allen’s informed consent theory at trial, the defense cited the Pennsylvania Supreme Court’s 2002 decision in Valles v. Albert Einstein Medical Center. In that decision, which stemmed from a case in which the plaintiff had been informed of the risks of catheter surgery but was not told how the surgery would be performed, the court concluded that the informed consent doctrine does not apply to a physician’s surgical methods. But the judges in Allen ruled that Philadelphia Common Pleas Judge Joseph I. Papalini had been right to rely on the Superior Court’s 1993 opinion in Stover v. Association of Thoracic and Cardiovascular Surgeons, in which the court held that a doctor should have advised a patient about the risks of having a mechanical heart valve installed as opposed to one made from natural tissue. “We are not persuaded that the choice of the type of sling used in this case is necessarily a decision of surgical method simply because Dr. Kilstein testified to that effect,” the opinion states. “On the contrary, we find the trial court properly relied on [ Stover] in ruling on this issue… . [The defense suggests] that this court’s rationale in Stover is flawed and contrary to our Supreme Court’s decision in Valles. We cannot agree.” The panel in Allen consisted of Judges Joan Orie Melvin and Richard B. Klein and Senior Judge Frank J. Montemuro Jr. Kilstein performed surgery on Allen in January 1998 after she had been suffering from urinary stress incontinence. A synthetic sling was inserted to help prevent leakage and relieve her symptoms, according to the opinion. Allen subsequently developed an infection and needed two surgical procedures to remove the sling and correct further injuries related to its insertion. She and her husband, Lloyd, filed suit against Kilstein and his corporate practice group, as well as Boston Scientific Corp., which manufactured the sling. The claims against Kilstein involved negligence and lack of informed consent. (The Allens settled with Boston Scientific in fall 2003 for an undisclosed sum.) At trial, the plaintiffs offered testimony that Kilstein had improperly implanted the sling and introduced evidence that Kilstein had failed to inform Allen about an increased risk of infection related to synthetic slings, according to the opinion. “[The jury] determined that Dr. Kilstein failed to obtain Mrs. Allen’s informed consent for the surgical procedure performed in January 1998 and that her receipt of additional information about the surgery would have been a substantial factor in her decision to undergo the procedure,” the opinion states. In addition to damages awarded to Deborah Allen, Lloyd Allen was awarded $50,000 on a consortium claim. On appeal, Kilstein requested JNOV or a new trial. In addressing the defense’s arguments, the panel stressed the similarities between Allen and Stover. “Here, as in Stover, the question was whether Dr. Kilstein informed Mrs. Allen of the risks attached to the specific type of sling implanted, not the manner or method of doing so,” the opinion states. “The trial court recognized the precedential authority in Stover and, as such, properly determined this was not a clear case which would entitle [the defense] to judgment n.o.v.” Plaintiffs’ attorney William Atlee of Atlee Hall & Brookhart in Lancaster said that delay damages in the case totaled roughly $94,000. “The important thing [in cases like this] I think is that there are different levels of risk depending upon what specific type of implant is being used, and that was basically the testimony at this trial,” Atlee said. Kilstein was defended by attorneys from Marshall Dennehey Warner Coleman & Goggin. Calls to the firm seeking comment were not immediately returned.

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