A medical procedure can be performed correctly and still raise questions about informed consent. In Pennsylvania, a patient may have a legal claim if certain procedures go forward without adequate disclosure of their risks and alternatives. The central issue is whether the patient received the information needed to make an informed decision before treatment began.
These cases differ from claims involving a surgical mistake or another error in treatment. Understanding that distinction can help patients evaluate whether what happened before a procedure may support a medical malpractice claim.
Key Takeaways: Can Lack of Informed Consent Be Medical Malpractice in Pennsylvania?
- Lack of informed consent can support a claim involving certain medical procedures, even when treatment was performed correctly.
- Pennsylvania treats the underlying claim as battery rather than ordinary negligence.
- The required disclosure generally includes the procedure’s description, material risks, and alternatives.
- The patient must connect the omitted information to the decision whether to undergo treatment and establish the harm for which compensation is sought.
- A certificate of merit is required for a lack-of-informed-consent claim, expert testimony is generally necessary, and a two-year filing deadline commonly applies.
Can Lack of Informed Consent Be Medical Malpractice in Pennsylvania?
Pennsylvania recognizes lack of informed consent as a distinct legal claim. Although often discussed alongside medical malpractice, it focuses on authorization for treatment rather than whether a physician performed the procedure skillfully.
In Montgomery v. Bazaz-Sehgal, the Pennsylvania Supreme Court explained that lack of informed consent sounds in battery. In this context, battery is a civil legal theory involving unauthorized physical contact; it does not require an allegation that the physician intended to injure the patient.
A patient therefore does not have to prove negligent performance to pursue this type of claim. However, an incomplete conversation does not automatically establish liability or entitlement to compensation.
What Does Informed Consent Require in Pennsylvania?
Section 504 of Pennsylvania’s MCARE Act generally requires informed consent before:
- Surgery, including related anesthesia
- Radiation or chemotherapy
- Blood transfusions
- Insertion of a surgical device or appliance
- Experimental medications or devices, including experimental uses of approved products
For covered procedures, disclosure includes a description of the procedure and the risks and alternatives a reasonably prudent patient would need to decide. The law does not require an exhaustive list of every imaginable complication.
The statutory categories matter. A dispute over routine treatment does not automatically become an informed-consent claim under Section 504, although another legal theory may apply.
The Difference Between Informed Consent and Negligent Treatment
Informed-consent claims concern what the patient was told and authorized. Negligence claims concern whether medical evaluation or treatment met the required standard of care.
For example, a patient might allege that a surgeon failed to disclose a material risk. A separate allegation might be that the surgeon negligently recommended an unnecessarily invasive operation.
The Pennsylvania Superior Court addressed this distinction in McAleer v. Geisinger Medical Center. The court reversed summary judgment because the plaintiffs presented expert evidence supporting claims of inadequate assessment, inappropriate procedure selection, and resulting harm. It rejected treating those allegations as merely an informed-consent dispute.
Depending on the evidence, the same medical episode may support both theories. Each must be evaluated under its own requirements.
What Must a Patient Prove in an Informed Consent Case?
For a disclosure-based claim under Section 504, the patient must show that receiving the omitted information would have been a substantial factor in deciding whether to undergo the procedure. The standard does not require proof that the patient definitely would have refused treatment.
Evidence might address why an undisclosed risk mattered to that patient or how another treatment option would have affected the decision.
Recovering compensatory damages also requires evidence connecting the unauthorized treatment to the harm claimed. That harm may include physical injury or, in appropriate circumstances, emotional harm. As Montgomery explains, expert testimony may be necessary when that connection is beyond an ordinary person’s understanding.
This is why a technically successful procedure does not automatically defeat a claim, but missing information alone does not establish every element of a compensable case.
When Can an Emergency Affect Consent Requirements?
Section 504 expressly recognizes an emergency exception. Whether it applies depends on the circumstances, including whether consent could be obtained without a dangerous delay.
For example, an unconscious patient with life-threatening internal bleeding may need immediate surgery when neither the patient nor an authorized representative can provide timely consent. A scheduled procedure where a required discussion was simply overlooked presents a different situation.
An emergency label does not resolve the issue by itself. Medical records and testimony may help establish the patient’s condition and the time available to obtain consent.
The statute also addresses qualifying human research and circumstances in which informed consent has already been obtained for the procedure.
Special Consent Rules for Certain Examinations
Pennsylvania has additional protections for pelvic, rectal, and prostate examinations performed on anesthetized or unconscious patients in specified medical instruction or clinical training settings.
Section 504.1 of the MCARE Act, codified at 40 P.S. § 1303.504a, generally requires specific informed consent in both verbal and written form for these examinations.
The additional requirement has exceptions when the examination is within the scope of care ordered for the patient or is necessary for emergency diagnosis or treatment when the patient cannot provide specific consent. Those exceptions do not create blanket permission for examinations whenever a patient is unconscious.
What Evidence Can Show That Required Information Was Not Disclosed?
An informed-consent investigation often involves comparing written documentation with accounts of the conversations before treatment.
Relevant evidence may include:
- Signed consent forms
- Medical records and procedure notes
- Documentation of consultations
- Written patient instructions
- Messages between the patient and treating practitioners
- Records of alternatives discussed
- Testimony from the patient, family members, and medical staff
A signed form is relevant evidence, but it does not necessarily establish that all required information was adequately communicated. Likewise, a patient’s later statement that they misunderstood treatment does not automatically prove a legal violation.
An attorney can examine the available evidence through the discovery process and assess how it relates to the claim.
Expert Testimony and Certificate-of-Merit Requirements
Section 504 requires expert testimony to establish whether the procedure falls within the covered categories and to identify its risks, the available alternatives, and the risks of those alternatives. The legal disclosure standard remains centered on the reasonably prudent patient.
Experts must also satisfy applicable qualification requirements under Section 512 of the MCARE Act. These requirements distinguish medical testimony from standard-of-care testimony and permit certain court-approved waivers.
Separately, Pennsylvania Rule of Civil Procedure 1042.3 expressly applies its certificate-of-merit requirement to lack-of-informed-consent claims. The certificate generally must be filed with the complaint or within 60 days afterward, subject to the rule’s extension provisions.
In the usual expert-supported case, the certificate relies on a qualified professional’s written statement supporting the allegations. The rule also permits other certifications, including that expert testimony is unnecessary. Whether that option is appropriate requires careful analysis, particularly given Section 504’s expert-evidence requirements.
A certificate is a procedural requirement. It does not replace the evidence needed to prove the case.
What Deadline Applies to an Informed Consent Claim in Pennsylvania?
Pennsylvania generally applies a two-year filing deadline to personal injury and battery claims under 42 Pa.C.S. § 5524.
The discovery rule may delay the start of that period when, despite reasonable diligence, a patient could not know of the injury and its connection to another person’s conduct. The Pennsylvania Supreme Court discusses this rule in Fine v. Checcio.
The deadline does not necessarily wait until a patient learns that the circumstances may support a lawsuit. Special rules may also affect particular claims, including those involving minors. Prompt review helps determine which deadline applies.
Frequently Asked Questions
Can I bring a claim if the surgery was performed correctly?
Proper performance does not automatically defeat an informed-consent claim. The patient must still establish the claim’s requirements and support the damages sought.
Does signing a consent form prevent a claim?
A signed form can support the defense, but the inquiry may also involve what information was communicated and whether the form covered the treatment actually performed.
Can a nurse or physician assistant obtain informed consent in Pennsylvania?
Current law permits delegation to statutorily qualified practitioners, including physician assistants and certain nurses. Patients may request that the physician personally obtain consent.
When should I speak with an attorney about a consent concern?
Consider seeking a review when treatment exceeded what you authorized or when a material risk or alternative was omitted and the treatment caused harm. Bringing available records and written communications can help an attorney evaluate the circumstances.
Get Help With a Pennsylvania Informed Consent Claim
Questions about consent can be difficult to sort through while recovering from medical treatment. The records may describe one conversation, while your recollection raises concerns about what was explained or authorized.
Brandon J. Broderick, Attorney at Law, can help evaluate whether inadequate disclosure, unauthorized treatment, or negligent medical care may support a claim. An attorney can review the circumstances, identify the evidence needed, and explain the deadlines that may apply.