In early stages of pregnancy, Methotrexate is typically administered to a female by injection. Abbreviated as MTX, Methotrexate, a known teratogenic agent, is an antimetabolite and antifolate drug that can be used to stop the rapid growth of dividing embryonic, fetal and early placenta cells. Examples of MTX use are to end early ectopic pregnancy, prevent growth of cells and as part of an induced abortion.

Under Pennsylvania’s doctrine of informed consent, it is unclear whether a physician who administers an injection of MTX to end early fetal development is saddled with the duty to inform the patient of the risks and alternatives to the MTX treatment. Stated differently, a physician in Pennsylvania may not owe a pregnant patient the duty to inform her of all the benefits, risks and costs of known alternative treatment options prior to administering into her body a medical substance intended to terminate fetal development. Here, MTX is used demonstratively to highlight the nature and effect of medical substances given through injection.

This article provides a brief exploration of the scope of Pennsylvania’s doctrine of informed consent as it pertains to the use of needle injections to administer medical substances, specifically MTX. Pennsylvania’s current application of the informed consent doctrine improperly excludes a population of patients who receive medical substances through the administration of transdermal needle penetration. Beyond MTX administration, examples of the affected, disenfranchised patient population include without limitation dialysis patients, diabetic insulin patients, pain management patients and patients receiving the intravenous administration of saline, antibiotics and gastrointestinal medications, to name a few.

Historically, under common law principles, Pennsylvania determined that the duty to inform required that the medical treatment at issue involve a requisite level of touching. (See Gray v. Grunnagle, 223 A.2d 663, 667 (Pa. 1966) (founded the state’s surgical requirement; physician’s failure to obtain patient’s informed consent to surgical procedure constitutes a technical battery).) Thus, a battery was committed if valid consent did not exist prior to surgery. "The duty to obtain informed consent is rooted in the rule that any touching of a patient by a physician is technically a battery unless it is done with the patient’s knowing consent," the court held in Boyer v. Smith, 497 A.2d 646 (Pa. Super. Ct. 1985) (prescribing oral medication did not involve touching, did not amount to battery, and did not require informed consent).

The breadth of informed consent remained unknown, despite the surgical requirement enunciated in Gray. Various claims involving non-surgical medical treatments challenged the scope of the doctrine of informed consent. (See, e.g., Sinclair v. Block, 633 A.2d 1137 (Pa. 1993) (use of forceps during delivery did not constitute operative procedure because labor is inevitable and patient has no choice to make during the natural delivery process); Morgan v. MacPhail, 704 A.2d 617, 620 (Pa. 1997) (invasive nature of surgery gave rise for need to achieve a patient’s consent; intercostal nerve block resulting in pneumothorax did not "rise to the same level of bodily invasion as surgery"); Wu v. Spence, 605 A.2d 395 (Pa. Super. Ct. 1992) (administration of intravenous antibiotics was insufficient level of touching where medicine created the harm rather than the insertion of the needle); Karibjanian v. Thomas Jefferson University Hospital, 717 F. Supp. 1081, 1084 (E.D. Pa. 1989) (duty to provide informed consent can exist where patient challenges the need for the injection prior to its administration).)

Then, in 1996, Pennsylvania’s Health Care Services Malpractice Act abrogated the common law surgical requirement. The act expanded the informed consent doctrine to include non-surgical-related treatments involving, among other forms of medical treatment, injections. The act solidified a physician’s duty to obtain a patient’s informed consent for "surgery and the related administration of anesthesia." It also expressly extended the doctrine to include radiation, chemotherapy and non-surgical-related blood transfusions, all of which were previously excluded under common law. Significantly, the act did not contain any language limiting the physician’s duty to provide informed consent to the enunciated treatments.

The act effectively abolished the rule that the duty to obtain informed consent was based upon a requisite level of touching or invasiveness. By adding chemotherapy and blood transfusions, for example, the act’s informed consent provisions now force courts in Pennsylvania to address issues involving the insertion of the needle as well as the effects of the medicines. Herein rests the conundrum: If the patient’s reaction to the medication becomes the pretext to requiring informed consent rather than the invasiveness of the procedure itself, then the act contravenes Pennsylvania’s battery approach to informed consent.

Pennsylvania courts must now ascertain and effectuate the intent of the legislature. Perhaps the legislature intended that Pennsylvania finally depart from the minority of states that adheres to the battery approach. Indeed, the act extinguished Pennsylvania’s surgical requirement, extending the informed consent doctrine to the non-operative administration of medications through needle infusion. Perhaps the legislature was inviting the courts to determine what medicines administered through injections impact the patient in such a manner so as to amount to an unwanted touching if given absent valid consent.

The decision in Morgan followed the act’s obliteration of the surgical requirement. In arduous dissent, Justice Russell Nigro identified the conflict created by the act and the battery-based approach to informed consent. Nigro cited lower court decisions finding the surgical/non-surgical distinction to be without basis and artificial. He thereafter identified that the act implicitly rejected any prior distinction between surgical and non-surgical when it opted to include blood transfusions and radiation therapy. For prior precedent, see Hoffman v. Brandywine Hospital, 661 A.2d 397 (Pa. Super. Ct. 1995) (informed consent not required for post-operative blood transfusion) and Dible v. Vagley, 612 A.2d 493 (Pa. Super. Ct. 1982), appeal denied, 629 A.2d 1380 (Pa. 1983) (informed consent not required for radiation therapy).

Nigro’s dissent in Morgan proposed a reconciliation — to abandon a battery theory and adopt a negligence approach to informed consent. "The failure to get informed consent is not a technical battery because the doctor’s omission is not due to a willful intent to injure the patient" and, moreover, the "faulty conduct — the failure to inform — is not a touching." The negligence approach would concentrate on whether a doctor’s duty to disclose the risks of medical treatment to the patient satisfied the duty of reasonable care. Nigro stated: "This view comports with the concept underlying informed consent — that the patient has the right to determine what shall be done to his body."

Notwithstanding the conflict created by the act, the informed consent cases following Morgan have prophylactically applied the surgical requirement or have failed to address the issue. (See, e.g., Valles v. Albert Einstein Medical Center, 805 A.2d 1232 (Pa. 2002) (applying battery principles to hold only the physician who actually performs the surgery obliged to warn the patient of the risks and obtain informed consent); Stalsitz v. Allentown Hospital, 814 A.2d 766 (Pa. Super. Ct. 2002) (relying upon the majority in Morgan in finding intravenous TPA therapy to be non-surgical, thereby not requiring informed consent); Watkins v. Hospital of the University of Pennsylvania, 737 A.2d 263 (Pa. Super. Ct. 1999) (recognizing hospital can be held directly liable for failing to obtain patient’s informed consent where hospital assumes an independent duty to obtain consent).) These decisions have exposed some significant obstacles inherent in the application of the informed consent doctrine, particularly in cases that arose after the act in 1996, continue to apply battery principles and involve non-surgical care.

With the import of modern medicine and the growth of surgical alternatives, patients in Pennsylvania would be deprived of the ability to self-determine whether or not to undergo a significant number of medical treatments if the informed consent doctrine did not apply to treatment modalities that administer medical substances through needle penetration. Absent emergent circumstances, little should outweigh the importance of a patient understanding the benefits, risks and costs of known treatment alternatives and making a fully informed decision whether or not to accept such treatment regardless of the method of administration or the substance being administered.

A physician’s duty to provide informed consent to patients who receive medical substances through needle penetration should be no less than the duty owed to a surgical patient. If necessary to apply justice evenhandedly, Pennsylvania should abandon the battery-based approach to informed consent for the majority’s negligence approach. Then, the critical consideration would rightfully be the patient’s need for information to make a reasonable decision about the course of medical care, regardless of the level of invasiveness.

In the alternative, the act should be amended to require that physicians in this state owe a duty to provide their patients who receive medical substances through needle penetration with all benefits, risks and costs of alternative medical care. Having received such information, those patients can function like patients contemplating surgery, who are statutorily afforded the right to decide whether or not to undergo medical treatment with adequate informed consent.

Informed consent should not be limited to specific medical treatments but should be afforded by the physician to the patient in every non-emergent situation in an effort to provide good health care. This would include imposing upon the physician a duty to provide informed consent to a pregnant female prior to the administration of MTX through non-surgical needle infusion. To find otherwise would negate the purpose of the act, defy Pennsylvania’s social policy strongly recognizing a patient’s right to ensure his or her own safety through self-determination, and permit the uninformed and nonconsensual administration of MTX, a known teratogenic agent, to a woman in early stages of fetal development. •

Julianna Burdo is a partner with Haggerty, Goldberg, Schleifer & Kupersmith. She serves as chair of the firm’s medical malpractice and catastrophic injury group.