Appeal from the Order of the Superior Court, No. 1448 EDA 2004, entered on December 13, 2005, affirming the order of the Court of Common Pleas of Philadelphia County entered on May 3, 2004, at No. 2642.
The opinion of the court was delivered by: Mr. Chief Justice Castille
CAPPY, C.J., CASTILLE, SAYLOR, EAKIN, BAER, BALDWIN, FITZGERALD, JJ.
The primary issue in this appeal is whether a patient, seeking to prove a lack of informed consent claim in a medical malpractice case, may rely solely upon circumstantial evidence to demonstrate that the information that the physician allegedly failed to disclose would have been a substantial factor in the patient's decision to undergo the procedure. Specifically, we consider whether the substantial factor element of the claim may be established solely through testimony of the patient's spouse.*fn1 The trial court and the Superior Court panel majority answered that question in the negative. For the following reasons, we determine that the testimony of the patient's spouse may be sufficient to prove the substantial factor element. For the reasons we explain below, we vacate the Superior Court's order and remand to that court to consider appellants' evidentiary claim, which the panel did not reach.
The evidence adduced at trial, viewed in the light most favorable to appellants as verdict winners, revealed the following. Appellant Carol Fitzpatrick was born in 1953, and was diagnosed with multiple sclerosis ("MS") when she was nineteen years old. MS is an incurable condition that attacks nerve fibers in the brain, spinal cord, and eyes, resulting in progressive physical deterioration that is often attended by muscle spasticity or flaccidity that eventually necessitates the use of a wheelchair. The progression of the disease is marked by "flare ups" of varying frequency that leave the patient progressively more disabled. Carol married appellant Thomas Fitzpatrick when the two were in their early twenties.
There are three types of treatment available to patients diagnosed with MS: (1) treatment for the "flare ups"; (2) symptomatic treatment; and, relevant to this case, (3) treatment to reduce disability. This third treatment typically involves the use of disease-modifying drugs that slow the progression of the disability, but do not eliminate it.
By 1977, Carol's MS had progressed to the point where she required a cane to walk, and was prescribed daily oral doses of Baclofen, an anti-spasticity drug. In 1990, due to the continuing progression of her disease, she was forced to terminate her employment and was hospitalized on numerous occasions. In 1994, Carol began using a Rascal motorized scooter. In 1998, Carol became a patient of Dr. Howard Natter, a neurologist at Meadowbrook Neurology. While taking her medical history, Dr. Natter noted that Carol was having difficulty walking, and had some incontinence, intermittent pain, and other symptoms. Instead of oral doses of Baclofen, Dr. Natter suggested that Carol consider undergoing surgery to have a subcutaneous pump implanted that would administer Baclofen continuously and uniformly. Dr. Natter provided appellants with manufacturer-produced information on the Baclofen pump, which included a videotape and pamphlet that outlined the use of the pump, as well as the benefits and risks associated with it.
At Carol's next appointment, Dr. Natter again suggested having the Baclofen pump implanted and appellants were receptive, agreeing to consider the procedure. In December of 1998, Dr. Natter referred appellants to appellee Dr. Michael Munz,*fn2 a neurosurgeon who performed pump implantation procedures. Appellee examined Carol, discussed the risks and benefits of the implantation with appellants, and stated that Carol was potentially a good candidate for the surgery, but would first have to undergo a test dose of Baclofen to gauge her reaction to the medication. After again reviewing the information they had received from the Baclofen pump manufacturer and discussing the surgery, appellants decided that Carol had "nothing to lose and everything to gain" from the procedure.
Carol signed two consent forms, one prior to undergoing the test dose, and a second prior to the surgery itself. The parties disputed later what occurred following the test dose procedure: Dr. Munz testified that, while Carol experienced some hypotonia, i.e., extreme muscle flaccidity, her spasticity and function began to return within twelve hours and her walking was improved for several days after the test dose. Thomas testified that Carol had a severe reaction to the test dose, experiencing extreme hypotonia that robbed her of all function and lasting several days, well after her discharge from the hospital. Thomas testified that despite this reaction, Carol's ability to walk was improved after four to five days. Dr. Munz opined that Carol's response was favorable and confirmed that she was a good candidate for the procedure.
On May 12, 1999, Carol underwent surgery for the implantation of a Baclofen pump. After being discharged from the hospital, Carol was referred to physical therapy. While her condition improved for a period of time, in August of 1999 Carol was diagnosed with a urinary tract infection and, following the infection, her ability to walk decreased until she ultimately became wheelchair bound. Carol's condition continued to deteriorate to the point where she became paraplegic, incontinent, and wholly dependent upon Thomas for caretaking. In 1999, Thomas left his job to care for Carol full-time.
In 2001, appellants filed a civil action against Dr. Natter, Meadowbrook Neurology,*fn3 the Brain and Spine Institute at Temple University Hospital,*fn4 and appellee. Appellants claimed professional negligence or a breach of the standard of care, battery or a lack of informed consent, and loss of consortium.
A jury trial commenced on February 23, 2004, but limited to the claims of lack of informed consent and loss of consortium. Thomas testified that he and Carol made all medical decisions jointly and that, had the risks of the surgery been fully disclosed, Carol would not have undergone the procedure. Carol was present in the courtroom for most of the proceedings, but did not testify. While appellants now assert that Carol did not testify due to her deteriorated condition and cognitive dysfunction, Appellants' Brief at 11, 24, the record does not support that assertion. Appellants did not present any explanation or evidence at trial that Carol's failure to testify was due to her physical incapacitation. Meanwhile, appellee argues that Carol's failure to testify was strategic. Appellee notes that it was only after the defense case began and the court was considering a motion for compulsory non-suit that appellants asked to re-open their case to present Carol's testimony. That request was denied by the trial court. In its opinion, the trial court found that appellants had made a conscious and strategic decision not to present Carol's testimony. The trial court found that the request was untimely and prejudicial to the defense. Trial Ct. Op. at 10, 19-21.
In order to prove the first element of the informed consent claim, that is, the undisclosed risk or alternative, appellants attempted to present two expert witnesses, an anesthesiologist and a neurologist. The trial court refused to permit the anesthesiologist, Dr. Atlas, to testify on informed consent, reasoning that an anesthesiologist was not qualified to testify against a neurosurgeon such as appellee. The neurologist, Dr. Grenell, was also barred from testifying as to the informed consent issue, the trial court reasoning that a neurologist was not necessarily qualified to testify regarding the benefits, risks, or complications associated with pump implantation surgery. Further, the trial court found Dr. Grenell unqualified to testify on this point because he had never personally performed a surgery, had never secured a patient's consent for surgery, and had no experience with the Baclofen pump. Both experts were permitted to testify concerning the negligence case against Dr. Natter.
Thomas testified that he had questioned Dr. Munz about potential risks and side effects of the pump implantation, and that Dr. Munz had told him that it was an "extremely simple procedure." Thomas also stated that his understanding was that patients with MS should never undergo any procedure near the spinal cord, and that Dr. Munz had "shrugged that off," and stated that that was "a very conservative way of thinking" and that "none of [Dr. Munz's] patients ever suffered an attack or exacerbation; that's not something to worry about." Notes of Testimony ("N.T."), 2/24/04, at 26. Thomas testified that, prior to the procedure, Dr. Munz did not inform him and Carol that the pump implantation might not be successful in controlling Carol's spasticity, that it might cause weakness, or that it might exacerbate her incontinence.
Appellee testified at trial as to the risks of pump implantation. Appellee testified that the risks that should be disclosed to a patient before the surgery are the general risks associated with anesthesia and surgery, the risk that the procedure may not help the patient, and the risk of increased perceived weakness due to the decrease in spasticity brought about by the medication. Appellee testified that hypotonia and temporary loss of function are recognized potential side effects of Baclofen, but that those side effects were caused by the medication, and so could be dealt with by "turning the Pump off" and thereby ceasing the administration of the medication.
On February 27, 2004, the defense rested. During closing arguments, appellants argued that the undisclosed risks of the pump implantation were loss of the ability to walk due to too large a dosage of Baclofen, and that the procedure may not work due to an inability to correctly calibrate the dosage. As part of its jury charge, the trial court submitted a verdict sheet with seven questions to the jury. Questions three, four, five, and seven addressed the case against Dr. Munz. Question three asked: "Do you find that [Dr. Munz] failed to obtain the informed consent of Carol Fitzpatrick for the operative procedure which he performed?" Question four read: "Do you find that the failure of [Dr. Munz] to obtain the informed consent of [Carol Fitzpatrick] was a substantial factor in her decision to undergo the implantation procedure?" Question five asked for a calculation of damages for the informed consent claim, and question seven for a calculation of damages on the loss of consortium claim.
On March 1, 2004, the jury answered yes to questions three and four, finding that appellee failed to obtain Carol's informed consent before performing the pump implantation surgery and that the missing information would have been a substantial factor in Carol's decision whether to undergo the surgery. The jury awarded damages in the amount of 1.5 million dollars on the informed consent claim, and 1.7 million dollars on the loss of consortium claim. Both awards were against Dr. Munz only.*fn5
Dr. Munz filed post-trial motions for, inter alia, a new trial and judgment N.O.V. The trial court granted the motion for judgment N.O.V. In its Opinion, the trial court found that the informed consent claim failed on three distinct grounds. First, the trial court opined that the claim failed as a matter of law because the informed consent statute, 40 P.S. § 1301.811-A, required the patient herself to testify that the allegedly undisclosed information would have been a substantial factor in her decision to undergo the procedure. The trial court noted that Carol was present throughout the trial and capable of testifying, yet appellants instead strategically chose to rely solely on Thomas' testimony to establish the lack of informed consent. Without Carol's testimony, the trial court reasoned, the jury could only speculate what her ...