Malpractice and Acute Limb Ischemia
Pennsylvania’s Superior Court considers whether endovascular procedures are surgery.
On December 31, 2002, one of Pennsylvania’s appellate courts rendered a decision in a malpractice case involving the endovascular treatment of acute limb ischemia.
FACTS OF THE CASE
In January 1992, William Stalsitz was admitted to Lehigh Valley Hospital (LVH) in Pennsylvania, complaining of pain in his legs and feet. He was a 73-year-old white male, with a history of intermittent claudication, hypertension, and atrial fibrillation. During the preceding 2 to 3 weeks, he had experienced a rapid deterioration of his claudication symptoms, along with cool toes and mild numbness in the distal portion of the toes. His ankle/brachial index was 0.40 on the right and 0.69 on the left. An arteriogram with runoff of the right leg demonstrated total occlusion of the popliteal artery with collaterals that filled the tibioperoneal trunk.1
Gary Nicholas, MD, a peripheral vascular surgeon, evaluated Stalsitz and consulted with James Jaffe, MD, an interventional radiologist. Drs. Nicholas and Jaffe determined that lytic therapy was the most appropriate way to treat Stalsitz's condition. At the time, Dr. Jaffe was participating in a study to evaluate the use of low doses of tPA in lytic therapy to dissolve clots in the lower extremities. The study involved infusing 2 mg of tPA per hour through a catheter placed in the blood clot, until 40 mg had been infused. The protocol also called for the simultaneous infusion of a low dose of heparin (500 to 1,000 units per hour).2 Arteriograms were to be performed 4 hours into the procedure, and thereafter at 8-hour intervals from initiation of the therapy, until the study concluded at 20 hours. Dr. Jaffe explained the procedures involved in the study to Stalsitz, answered his questions, and had Stalsitz sign a consent form for participation in the study.3
The 4-hour arteriogram revealed some lysis of the right popliteal artery clot, but a large degree of residual thrombosis, which extended into the tibio-peroneal trunk, and stenosis at the origin of the trunk.4 In addition, the right anterior tibial artery was now occluded, and there were several focal areas of occlusion in the posterior tibial artery.5
The tPA therapy continued on schedule, but the physicians did not perform another arteriogram until 20 hours after the therapy began. The 20-hour arteriogram revealed that the right popliteal artery and the tibioperoneal trunk were patent, but there was a question of either thrombus or atherosclerosis at the mid-to-distal popliteal artery.6
Accordingly, Dr. Jaffe consulted Alan Berger, MD (Dr. Nicholas' partner), and they decided to perform angioplasty to address the arteriosclerosis. Dr. Jaffe performed a successful angioplasty, but some thrombus embolized into the distal peroneal artery. Drs. Jaffe and Berger then contacted the head of the tPA study and decided to administer additional tPA to dissolve the newly discovered clot. After an additional 22 hours of tPA infusion (42 hours total), another arteriogram was performed, revealing a patent peroneal artery, and the tPA was discontinued. During the next 6 hours, Stalsitz developed tenderness and edema in his right calf. His symptoms worsened, and Dr. Nichols performed a fasciotomy, which revealed blood in the anterior compartment, plus extensive edema of the muscle in the lateral compartment. Two days later, the anterior compartment muscle was dead and noncontractile, and the necrotic muscle was debridged from the anterior compartment, resulting in a right foot drop.7
In April of 1994, Stalsitz filed a medical malpractice action in the Court of Common Pleas of Lehigh County, Pennsylvania. He alleged (1) that the defendants provided negligent treatment for blood clots in his right leg, and (2) that he did not give his informed consent to the endovascular procedures used to treat blood clots. In particular, he claimed that the defendants performed angioplasty upon him during the course of this study without any informed consent and without informing him of the associated risks or alternatives to that procedure, as well as that the defendants failed to inform him of the unproven nature of the tPA procedure for thrombolysis.8
PRE-TRIAL PROCEDURAL HISTORY
The defendants filed Preliminary Objections to the complaint, seeking a declaration from the trial court that, even if the factual allegations in Stalsitz’ complaint were true, one or more of the counts had no legal basis. In response, Stalsitz filed a series of amended complaints. The amended complaints again contained common law claims regarding informed consent, but also added a claim that informed consent was necessary under FDA regulations. The defendants filed preliminary objections to the amended complaints on various grounds.
Prior to trial, the court granted the defendants’ preliminary objection to the informed consent claims, removing them from consideration by the jury. The trial court also dismissed several defendants, and Stalsitz proceeded at trial against LVH, Medical Imaging of Lehigh Valley, and Drs. Nicholas, Berger, and Jaffe.
After a 2-week trial, the jury reached a verdict, concluding that Doctor Jaffe and LVH were negligent in their care of Stalsitz, but that their negligence was not a substantial factor in increasing the risk of harm to him, and therefore there was no liability. The jury found no negligence on the part of the other defendants.
Stalsitz filed an appeal to the Superior Court (Pennsylvania’s mid-level appellate court), asserting that the trial court should have ordered a new trial because (1) the trial court improperly granted the defendants’ preliminary objections to Stalsitz’s informed consent claim, and (2) the trial court should have precluded certain evidence at trial.
Under Pennsylvania’s common law (law that has been created by the courts, but has not been codified by the Legislature), a physician must obtain informed consent from a patient before performing a surgical or operative procedure, but not in cases involving nonsurgical procedures.11 Accordingly, there were five issues before the Superior Court:
1. Did the lytic therapy delivered through a catheter constitute surgery?
2. Did the angiogram constitute surgery?
3. Did the angioplasty constitute surgery?
4. Did the trial court err in removing the informed consent claim based on the FDA study?
5. Did the trial court err in admitting evidence of subsequent lytic therapy?
Is Lytic Therapy Surgery?
To determine whether the procedures were surgical in nature, both the trial court and the Superior Court relied on the Pennsylvania Supreme Court decision in Morgan v. MacPhail.12 In Morgan, the Supreme Court ruled that the injection of a long-acting steroid and the injection of a local anesthetic did not constitute a surgical procedure requiring informed consent. The Court held that “surgery…involved an excision or incision or the use of surgical instruments,” and did not include the mere intravenous administration of drugs.13 Accordingly, the Superior Court held that lytic therapy did not involve surgical or operative procedures, and was akin to the facts in Morgan.14 Therefore, the trial court had properly dismissed the common law claims for informed consent for the lytic therapy.
Is an Angiogram Surgery?
The Superior Court also found that there was no duty to obtain informed consent for the angiogram, because the procedure involves the injection of a dye (similar to Morgan) and is therefore considered nonsurgical.15
Is Angioplasty Surgery?
The Superior Court could not determine whether angioplasty is surgical or nonsurgical. The trial court, relying on Morgan, held that "[a]rteriograms and angioplasty fail to require a surgical cut and the use of surgical instruments that gives rise to the need to inform the patient of risks prior to surgery."16 The Superior Court found other text in Morgan that provided a contradictory conclusion: “It is the invasive nature of the surgical or operative procedure involving a surgical cut and the use of surgical instruments that gives rise to the need to inform the patient of the risks prior to surgery.”17
There was no question that a balloon catheter was inserted into the artery in Stalsitz's leg. The defendants argued that the catheter did not require a surgical cut, because the "balloon wire used for the angioplasty was inserted into the same sheath that had been inserted earlier to permit tPA infusion and infusion of the dye for angiograms."18 In contrast, Stalsitz pointed to various medical dictionary definitions, which seemed to place angioplasty in the surgical category. The testimony of his expert witness, however, indicated that angioplasty is considered a nonsurgical therapy.
The Superior Court held that it could not determine as a matter of law that angioplasty is a nonsurgical procedure, and therefore the trial court improperly dismissed that claim. The Superior Court held, however, that Stalsitz was not entitled to a new trial because he could not show that he was prejudiced by that error. The jury had already found that Dr. Jaffe breached the standard of care, but determined that his conduct was not a substantial factor in causing Stalsitz's harm.
Did the Trial Court Improperly Dismiss the FDA Claim?
In Pennsylvania, the common law rule is that informed consent only applies to surgical procedures, and only to the physicians performing those procedures.19 There is an exception to this rule if the study is part of a clinical investigation for the FDA, because the physician and hospital are bound by FDA regulations to obtain an informed consent from any patient undergoing experimental treatment as part of the study. In the present matter, Stalsitz first raised his FDA informed consent claim in July 1994, 3 months after the statute of limitations had expired. Accordingly, the Superior Court held that the trial court properly dismissed that count of the complaint.
Did the Trial Court Err by Permitting Evidence of Subsequent Angiograms?
Stalsitz also contended that the trial court should have excluded evidence that he received additional lytic therapy and angioplasty at LVH in 1997, because that evidence was irrelevant. As noted in the trial testimony above, Stalsitz’ subsequent therapy revealed that the original treatment had a patency of more than 5 years. The Superior Court held that evidence of the 1997 lytic therapy and angioplasty on Stalsitz's leg was relevant because it supported the defendants' contention that the 1992 angioplasty was an appropriate method of treating the stenosis and did not represent a deviation from the standard of care.
Last month, Stalsitz filed a Petition for Allocatur20 to the Pennsylvania Supreme Court. If the Supreme Court grants allocatur, the state’s highest court will decide these issues.
The facts and holding in Stalsitz are of interest to endovascular specialists as a snapshot of one case involving endovascular procedures, limb ischemia, and informed consent. The application of Stalsitz, however, is limited to these particular facts, this jurisdiction, and even this panel of the Superior Court.21 You should consult an attorney familiar with the jurisdiction(s) where you practice to ensure that your informed consent procedures are adequate and customized for the various procedures you perform. If you are participating in an FDA study, you must ensure that you and your hospital have complied with all additional requirements of that study, or your failure to do so may become a separate basis for liability.
1. Report of Plaintiff’s expert, Timothy R S Harward, MD.
3. Stalsitz v. Allentown Hospital, et al. (Superior Court of Pennsylvania, December 31, 2002).
4. Report of Defendants’ expert, Anthony J. Camorota, p 2.
5. Harward, supra, p 2.
6. Camorato, supra, p 2.
7. Id at 3-4.
8. Stalsitz, supra.
9. Harward, supra.
10. Camorato, supra.
11. In 1996, the Pennsylvania Legislature amended the Health Care Services Malpractice Act (the Act) which codified and expanded the common law doctrine of informed consent to require informed consent for the following procedures: (1) Performing surgery, including the related administration of anesthesia; (2) Administering radiation or chemotherapy; (3) Administering a blood transfusion; (4) Inserting a surgical device or appliance; (5) Administering an experimental medication, using an experimental device or using an approved medication or device in an experimental manner. Health Care Services Malpractice Act, 40 P.S. 1301.811-A(a)(1)-(5), effective January 25, 1997. Because this incident occurred in 1992, the Act does not apply to this case.
12. Morgan v. MacPhail, 550 Pa. 202, 704 A.2d 617 (1997).
13. Id at 206, 704 A.2d at 619.
14. Stalsitz, supra.
18. Stalsitz, supra.
19. Stalsitz, supra., citing Valles v. Albert Einstein Medical Center, 569 Pa 542, 805 A.2d 1272 (2002).
20. A Petition for Allocatur is a request for permission to file an appeal. As with the US Supreme Court, there is no absolute right to a review by the Pennsylvania Supreme Court.
21. There are multiple panels of the Superior Court in Pennsylvania, and they are not bound by each other’s decisions. A different panel could arrive at a very different conclusion.