Preventing informed consent malpractice claims

By Joan M. Roediger, JD, LLM & Gary M. Samms, Esq.

The medical malpractice litigation crisis throughout this country continues to grow. Whether it is frivolous lawsuits, runaway verdicts, the rising cost of insurance or even the availability of insurance, physicians must continually be aware of new developments in the law. One of the most recent and troubling developments in Pennsylvania and other states is the expansion of the Doctrine of Informed Consent.

As we are all aware, the Doctrine of Informed Consent is the sole responsibility of the physician. In most jurisdictions as a matter of law, a hospital or other health care facility lacks the control over the manner in which the physician performs his duty to obtain informed consent so as to render the facility directly or vicariously liable. This, in turn, leaves the physician as the sole target in a case involving failure to obtain informed consent.

Traditionally, the Informed Consent Doctrine requires the physician to advise the patient of the risks of the proposed surgery. While doctors are not required to disclose “all known” information, they are required to “advise the patient of those material facts, risks and complications a reasonable person in the patient’s situation would consider significant in deciding whether to have the procedure performed.”

In Pennsylvania, as a response to the litigation malpractice crisis, the legislature recently passed the Medical Care Availability and Reduction of Error Act (MCARE). While beneficial to physicians by finally codifying the circumstance of when informed consent must be obtained and what information must be provided to the patient, it unfortunately has also expanded the scope of what information falls under the umbrella of informed consent. The expansion of the doctrine will almost certainly increase the number of claims under informed consent theories. Pennsylvania now imposes liability on physicians for failing to obtain proper informed consent if the physician knowingly represents to the patient his or her professional credentials and/or training; this is in direct response to a Pennsylvania Supreme Court decision in Duttry v. Patterson where the Supreme Court held that this was beyond the furthest of boundaries of informed consent. There is also an early indication that other jurisdictions are considering similar language in new legislation dealing with informed consent issues.

While no physician supports intentionally misleading patients about their qualifications and expertise, and the language on its face is harmless, it nevertheless remains dangerous.

The legislation has now created another avenue for plaintiffs and creative plaintiffs’ counsel to argue in which the doctor was deficient. The most troubling aspect of this is that, unless there is proper documentation of the informed consent, a communication may be misinterpreted, misunderstood or misconstrued by the patient, and ultimately, a jury. Particularly if there is a bad outcome, it is not uncommon for a patient when there is a bad outcome to suffer from a revisionist or convenient memory and their creative lawyer to seize upon this in filing a malpractice action based upon alleged informed consent issues.

The Act does not require physicians to voluntarily, however, provide their background and experience as part of the discussion on informed consent, but does require forthright responses regarding the same if questioned by the patient. Failure to understand this legal standard could lead to the admission of improper evidence in a trial or the creation of a faulty jury charge in response to failure to understand this legal distinction.

Recently in California, a physician was found liable under the informed consent doctrine for failing to persuade a patient to undergo a pelvic exam. In this case a woman saw her physician for her yearly gynecological exam. When the physician requested to do a pap smear the patient refused. The physician stressed and documented why a pap smear was important. The next year the patient returned for her annual exam and a pap smear was requested/suggested again by the physician. Again the physician stressed why a pap smear should be done and why it was in the patient’s best interest. Despite this information, the patient refused. Approximately six months later the patient was found to have cervical cancer. She soon filed a suit and, shockingly, a jury found the physician liable for failing to have done more to stress why the pap smear should have been done. While certainly this is a ridiculous example of why making sure a patient is properly informed, it is used to illustrate the fundamental concern that physicians face.

What then becomes the appropriate way to deal with informed consent and related issues in the current environment in light of these changes? First, you must be aware of all circumstances in which informed consent must be obtained. It is not just for surgery anymore. Almost universally, a physician must obtain informed consent in the following five circumstances:

· Performance of surgery, including the related administration of anesthesia.

· Administration of radiation or chemotherapy.

· Administration of a blood transfusion.

· Inserting devices and/or appliances under the skin.

· Administering experimental devices or medication.

Second, in addition to knowing when consent must be obtained, it is strongly suggested that physicians apply their common sense as well as their medical knowledge and training when obtaining informed consent. In this vein, you may want to consider discussing the following items with patients when obtaining consent:

· Explain generally why the operation or procedure is necessary and how it is to be performed.

· Explain the alternative treatments available to the patient and why the surgery or your treatment is recommended.

· Explain the likely result of the procedure, trying not to alarm or mislead the patient.

· Explain the material risks of the procedure.

· Explain to the patient what to expect during the recovery period and hospitalization.

· Explain any other residual effects from the procedure.

· Encourage and welcome the patient to ask questions.

· Document these discussions.

In addition to addressing the above directly related to the procedure, have the patient sign an informed consent form. Many physicians and surgeons dismiss the importance of these documents since they are usually pre-printed forms created by the hospital or surgery center. In Pennsylvania and other limited jurisdictions, a physician is not required to have the informed consent in writing. As anyone, however, who has been through a trial can attest, it is easier to prevail when you can show documentation to a jury regarding informed consent than to allow the case to deteriorate to a “he-said, she-said” scenario. If you do not have documentation and there is a bad outcome, a jury may have a tendency to want to believe the patient just to award them damages as a result of the bad outcome. Furthermore, it will only strengthen your case if you also make a hand-written progress note regarding the consent. To ensure that this note is as supportive as possible, it is suggested that this note be made contemporaneously to the obtaining of the consent.

If feasible, you should have a nurse, other medical professional or other employee or witness present at the time of the informed consent process to further avoid any “he-said, she-said” situations and to ensure that it was clear that the patient understood the information being supplied by the physician. This witness should also sign the informed consent form to establish their presence when the informed consent was given.

Many physicians in their practice have a resident obtaining the consent. If this is the case, it is imperative that the physician takes the time to make sure the resident knows all the proper risks of the procedure. At a minimum, it is good practice to have the resident recite a sample informed consent session to ensure he or she is well versed and will obtain proper informed consent on your behalf. It is incumbent upon the physician to also make sure the resident has sufficient knowledge regarding the physician’s experience and training. It is just as important that the physician not exaggerate their credentials or experience and training during any of these discussions and when explaining the procedure, should try to avoid all unnecessary medical nomenclature and whenever possible, use common, everyday language. This again will help decrease any potential misunderstandings.

While the legislature and courts are finally taking action regarding medical malpractice issues, a practicing physician must not assume that all changes are for the better, and with the expansion of the Doctrine of Informed Consent the physician must be more vigilant than ever in obtaining the informed consent. If, unfortunately, a malpractice claim is filed against you based upon informed consent or other legal grounds, make sure to promptly notify your malpractice carrier. If you have an established relationship with a malpractice defense lawyer, make sure to request with your insurance carrier that this individual represent you in your legal action. If the insurance company, instead, appoints a lawyer on your behalf, make sure to verify that the lawyer has experience in defending these types of malpractice cases.

Joan M. Roediger, JD, LLM, and Gary M. Samms, Esq, are partners with the law firm of Obermayer Rebmann Maxwell & Hippel LLP in Philadelphia, Pa. Ms. Roediger is a member of Obermayer’s Health Law Department, and Mr. Samms is a member of Obermayer’s Litigation and Health Law Departments.