Everyone has a right to control their body. And to properly exercise this autonomy, people need to understand the risks of any medical procedure, including alternatives that might be less risky.

Without informed consent, people might agree to a medical procedure unwillingly. In Pennsylvania, it is solely the physician's duty to obtain informed consent from patients. Our Philadelphia medical malpractice lawyers take a closer look at informed consent and why it is important.

When Informed Consent is Required

Our state's law on informed consent is located at Pennsylvania Act 135, also called the Medical Care Availability and Reduction of Error Act of 2002. The Act requires informed consent before performing any of the following:

  • Giving a blood transfusion

  • Giving chemotherapy or radiation

  • Performing surgery

  • Inserting a surgical device

  • Giving or using an experimental device or drug

  • Using an approved drug or device in an experimental way

The obligation to obtain informed consent does not exist during emergencies. For example, a doctor can help a person who is unconscious or choking without needing to worry about informed consent.

What Constitutes Informed Consent

Now that we know when a doctor must obtain it, let's consider the information a patient must receive to make an informed choice. The law requires the following:

  • A description of the proposed procedure

  • A description of the benefits and risks of the procedure

  • The alternatives to the proposed treatment, as well as the benefits and risks of these alternatives

  • Any other information a reasonably careful patient would find meaningful

Information should also be presented in plain language, using common terms, so that a patient can understand it.

Of course, the amount of medical information a doctor could give might be unlimited. Procedures could have countless risks and benefits. However, the state only requires that doctors inform patients of those that would matter to a reasonable patient in a similar situation.

Who May Give Informed Consent

The most obvious person is the patient about to receive the medical procedure. However, in other situations a child's parent would give informed consent, or a family member, such as when a patient is incapacitated.

Written Informed Consent

Patients usually sign a form stating they are giving their informed consent. This paperwork is helpful, but it does not decide whether informed consent was given. Instead, the question is always focused on what information a patient received. It's possible a patient signed a form without receiving adequate disclosures of the risks and alternatives. In other words, a signed piece of paper does not determine whether a patient's consent was informed.

What Happens when Informed Consent is Lacking

If a patient does not receive adequate information to give informed consent, then they have not consented to the doctor touching their body. In effect, this is a battery under Pennsylvania law, which is an intentional tort. Anyone who is touched against their will has a possible lawsuit against the person who did the touching. And any injury they suffer-including emotional distress-warrants compensation.

These are thorny issues, and we encourage patients to meet with a doctor to discuss whether informed consent was lacking.