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RINGSTAFF v. EAKIN, A-5445-11T3. (2014)

Court: Superior Court of New Jersey Number: innjco20140221416 Visitors: 14
Filed: Feb. 21, 2014
Latest Update: Feb. 21, 2014
Summary: NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION PER CURIAM. Plaintiffs — the estate of Melissa Ringstaff (Melissa) and her parents, Randall Ringstaff and Ann Ringstaff (Mrs. Ringstaff) — appeal from a no cause verdict on their medical negligence complaint. Plaintiffs' principal claim of error concerns the trial court's failure to instruct the jury on informed consent. They claim defendants failed to inform Melissa of the symptoms associated with potentially life threatening
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NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION

PER CURIAM.

Plaintiffs — the estate of Melissa Ringstaff (Melissa) and her parents, Randall Ringstaff and Ann Ringstaff (Mrs. Ringstaff) — appeal from a no cause verdict on their medical negligence complaint. Plaintiffs' principal claim of error concerns the trial court's failure to instruct the jury on informed consent. They claim defendants failed to inform Melissa of the symptoms associated with potentially life threatening post-surgical blood clots thus depriving her of the opportunity for earlier intervention that may have saved her life. Because we are satisfied the trial court erred, as a matter of law, in declining to submit plaintiffs' informed consent claim to the jury, we reverse and remand for a new trial on that claim.

I.

We begin by summarizing the most pertinent trial evidence. Nineteen-year-old Melissa first consulted defendant Enrico Marcelli, D.O. of Academy Orthopaedics1 on January 26, 2006, about ten days after she injured her right knee in an accident while operating an all-terrain vehicle (Quad).

At the time of the initial office visit, Melissa completed a medical history questionnaire. Upon reviewing the form, Dr. Marcelli noted information about Melissa's weight (250 pounds), and birth control usage that he considered risk factors for deep venous thrombosis (DVT).

Dr. Marcelli scheduled an MRI for Melissa and a follow-up appointment. The MRI revealed an anterior cruciate ligament (ACL) tear. Dr. Marcelli recommended conservative treatment and sent Melissa for physical therapy. When Melissa's pain did not respond to therapy, Dr. Marcelli recommended surgery.

On March 30, 2006, Dr. Marcelli saw Melissa for a pre-operative consultation. According to Dr. Marcelli, he explained that ACL surgery was optional and Melissa could live a "normal life" with continued physical therapy, but an adjustment of lifestyle may have been necessary. Dr. Marcelli also explained the types of surgeries available, including autograft and allograft reconstructions,2 to repair an ACL tear. Prior to Melissa's surgery, Dr. Marcelli had performed 400 to 500 arthroscopic ACL surgeries. Other than Melissa, Dr. Marcelli indicated he had made the diagnosis of DVT in only one other post-operative arthroscopic ACL patient, although he frequently suspected the possibility:

Q: Doctor, ... please give us your best estimate ... how often you suspected the possibility of a DVT in a post-op patient? A: ACL or altogether? Altogether, hundreds and hundreds. Probably in ACL surgery, I would think somewhere between 30 and 50 percent of the people that come back in post-surgery, after the operation, we suspect the possibility and send them for ultrasounds.

According to Dr. Marcelli, Melissa selected an allograft reconstruction and he informed her "[w]ith an [allograft] ... there's a risk of AIDS and hepatitis. A very small risk, it's calculated out to about one in five million[.]" He also explained that with an allograft there is an "increased risk of failure where that graph ruptures more frequently than your own," as well as informing her of general risks such as infection, fevers, chills, drainage, blood loss, blood clots in the calf, swelling, neurovascular injury, DVT, pulmonary embolism and death. In a report to Melissa's family doctor, Dr. Marcelli indicated he discussed with her the procedure and its goals, and explained possible complications, including infection, blood loss, neurovascular injury, DVT, pulmonary embolism, and even death. When asked how he explains the risk of DVT and pulmonary embolism to a patient, he replied:

A: Well, I don't think most people would understand DVT necessarily, but it would be a blood clot. And a blood clot can break off and go to your lung. It's called a pulmonary embolism, but it's a clot in your lung and that can cause you to die. .... Q: Did the patient have any questions? A: I don't recall any specific long discussion after we spelled out those things. I really don't remember.

On April 25, 2006, Melissa signed a consent form authorizing Dr. Marcelli to perform the ACL reconstruction surgery, which stated:

My physician has explained to me the material risks and possible complications such as severe loss of blood, infections, cardiac arrest and possibly death, that are associated with this procedure, and I have had an opportunity to discuss them. I am aware that the practice of medicine and surgery is not an exact science, and I acknowledge that no guarantees have been made to me about the results of the procedure.

On May 30, 2006, Dr. Marcelli performed Melissa's arthroscopic ACL reconstructive surgery using general anesthesia. He stated "[t]he surgery went well." He explained that he usually discusses discharge instructions with the patient after the patient has had time to recover and typically performs the next surgery to allow the patient time to recover in the recovery room; however, following Melissa's surgery, "by the time I got finished the next surgical procedure there was nobody to talk to.... But there [were] written instructions given by the surgical nurses." Those written instructions provided Melissa with information related to diet, activity, medication, conditions she should report, and specific instructions for the care of her knee.

Melissa's sister Ranne Dunnet (Ranne) brought Melissa home after surgery and testified that, at the time of discharge, she received a carbon copy of the discharge instructions. Ranne asked the nurse on duty "is there anything that I need to look for[?]" The nurse replied "no" since Melissa would be seeing the doctor in two days.

Regarding the post-operative instructions provided to Melissa, the following exchange occurred on direct examination of Dr. Marcelli:

Q: What was your understanding, Doctor, as to the postoperative instructions that you wrote down on this sheet that was given to the patient, with regard to activities, what to do? A: Well, this was pretty much a routine, if there's any such thing as a routine operation. I mean there was nothing special that had to be done.... Melissa was able to put weight on this. She was able to do the ankle pumps, ice the knee, which is routine, and basically, those postoperative instructions, if there is anything changed, to call the office.

The night of her surgery, Melissa experienced excessive bleeding from her surgical site, causing her bandages to become soaked with blood from her knee to her ankle. Misreading the discharge instruction to say "Call ER," Mrs. Ringstaff took Melissa to the emergency room where Melissa informed the doctor she had pain in the back of her leg. The doctor initially advised her to "double up" on her medicine; he rescinded this instruction, however, upon learning of her medication, Percocet 10.

Two days later, on June 1, 2006, Melissa had her first post-operative examination. Dr. Marcelli explained he likes to see his patients "within 48 hours [of surgery] so I can explain what I did and what to look for." Dr. Marcelli asked Melissa to raise her leg and Melissa raised her leg about an inch and a half. Dr. Marcelli re-wrapped Melissa's leg, at which time he physically examined Melissa by taking her leg in his hands and placing her calf on his thigh. This allowed him to wrap underneath the knee while feeling the temperature of the leg and determine whether any swelling or excessive tenderness existed. He found none.

Mrs. Ringstaff testified that Dr. Marcelli asked about red marks approximately the size of a nickel on Melissa's calf, and Melissa replied that the red marks could be from her heating pad usage. Although Dr. Marcelli did not recollect observing red marks on Melissa's calf, he said they may have resulted from her heating pad usage, the surgery or dressings. In any event, Dr. Marcelli stated that such marks are not typically indicative of DVT. Dr. Marcelli recalled that Melissa had routine pain associated with her surgery, with no unusual pain or condition noted. Dr. Marcelli instructed Melissa to continue straight leg raises and extension exercises with ankle pumps. Regarding this office visit, the following exchange occurred on direct examination of Dr. Marcelli:

Q: Do you have an opinion, Doctor, as of June 1st, 2006, from your evaluation of this patient, as to whether or not she had a DVT present? A: She had no signs of a DVT on the 1st. Q: At the end of the visit do you give the patient any instructions or do you reinforce any instructions to the patient? Q: Well, my usual routine is I usually will tell a patient, at the end of my visit, you have to come back in, in a week or two or three or whatever it might be. And the usual instructions are I'll see you in two or three weeks. If there's any fevers, chills, drainage, swelling, calf pain, shortness of breath, give me a call. If not, I'll see you in a couple of weeks. And that's the end of it and that's what I've been telling people for 26 years. Q: And is that just for people with ACL surgeries? A: It holds up with anybody. I mean that's what I do with everybody.

Mrs. Ringstaff said Melissa's complaints of discomfort decreased with pain medication usage following the June 1, 2006 office visit; on June 5, however, Melissa woke up in pain as she had run out of pain medication. Mrs. Ringstaff testified Melissa called the office and advised of her leg pain and that she was out of her pain medication. She was told that Dr. Marcelli was unavailable. Ranne and Mrs. Ringstaff testified that Melissa stated the staff was rude and instructed her to go to the emergency room for her pain medication prescription.

An hour later Mrs. Ringstaff called the Stratford office and was informed that Dr. Marcelli was in the Washington Township office. When Mrs. Ringstaff called that office she informed the receptionist that Melissa was "crying with pain in the back of her leg" and was out of pain medication. Mrs. Ringstaff was told Dr. Marcelli would be informed and she would be contacted shortly. Within an hour, the Washington Township office called Mrs. Ringstaff and told her Dr. Marcelli will have a prescription for her at the Stratford office. When Mrs. Ringstaff called the Stratford office to learn the time she could pick up the prescription, she claimed she was "very rudely and nastily" told "4 o'clock." According to Mrs. Ringstaff, she was not offered an appointment during any of her conversations with the two offices.

Dr. Marcelli recalled receiving the message regarding Melissa's call and stated he instructed the receptionist in the Washington Township office to tell Melissa to come in if she had a problem. When Dr. Marcelli received the message, he did not inquire into the location or severity of Melissa's pain.

A former receptionist at the Washington Township office for Academy Orthopedics testified as to the normal office procedures of the practice. Receptionists were trained to ascertain certain information from patients when they called. If post-operative patients called for renewal of pain medication, the receptionist would ask when the surgery took place, what type of pain they were having, and would they like to come in to see a doctor. If a patient specifically indicated calf pain, swelling or redness, the receptionist would tell the patient to come in immediately. Receptionists were required to pay special attention to leg pain, especially calf pain in orthopedic post-operative patients because they were trained that that is an indication of a possible blood clot, requiring immediate medical attention. Making a patient wait four hours for a prescription was a violation of the office procedure; generally, the office policy required addressing a patient's pain complaint within one hour.

Dr. Eakin testified he was in the Stratford office on June 5 and received a message from the receptionist that a "patient was out of pain medication and needed a prescription written." According to Dr. Eakin, the patient "had contacted Dr. Marcelli and Dr. Marcelli had requested that I write a prescription." At that point, he assumed that Dr. Marcelli had already determined the location and type of pain; "the way that it was related to me [was] that that message had already been addressed and I was just doing a convenience factor." He did not speak to Melissa. He later learned that Dr. Marcelli also did not speak to Melissa that day.

Mrs. Ringstaff filled the Percocet prescription and from June 5th to June 9th, she said Melissa "wasn't crying and howling like she was on the 5th. It was — I guess it was just like a surgery pain. It hurt, but it wasn't like it was severe." Melissa walked around, used the steps, and continued her exercises as instructed. However, Mrs. Ringstaff noticed Melissa getting paler and not eating around June 7th and 8th; these changes were not reported to any doctor.

On June 9th, Melissa had her second post-operative visit. According to Mrs. Ringstaff, a medical assistant removed Melissa's stitches and then Dr. Marcelli came in and

checked his [work]. He walked to the bottom of the table ... to see how high she could lift her leg ... [H]e went back up ... and talked to ... Melissa. And, he told her that the leg lifting was okay.

He turned around to leave to go — I guess he was going to get tape or something from the other side of the room. And she said, "Excuse me?" And he stopped and he turned around. And she said, "Why do I have pain in my calf up?" She put her hand on her calf, to the inside of her knee up into her groin area. "Why do I have pain there?" And he said, ... "You just won yourself a ticket across the street for an ultrasound." He said, "If it's a blood clot, they'll keep you 24 hours hooked up to heparin."

Mrs. Ringstaff immediately took Melissa to the hospital where an ultrasound revealed Melissa had a blood clot; she was informed that the blood clot could break away and hit the heart and lungs. The hospital called Dr. Marcelli and he ordered that Melissa be admitted immediately for treatment. Moments later, Melissa suffered a pulmonary embolism and lost consciousness and collapsed on the gurney. She never regained consciousness. On June 13, 2006, Melissa was taken off life support and died shortly thereafter.

On cross-examination of Dr. Marcelli, plaintiff's counsel reviewed the information and instructions contained in the written post-operative discharge instructions Melissa received:

Q: Academy Orthopedics chooses this form of discharge instructions to give [its] patients, is that right? A: Correct. Q: And this is sort of a canned or preprinted form, is that right? A: The preprinted part is. .... Q: And ... this area here which is preprinted which talks about what's to be reported by the patient, that's a general statement. That's not specific to knee surgery, is it?

A: It's not specific to knee surgery.

Q: And in fact, by talking about unusual bleeding from the vagina, that has absolutely nothing to do with knee surgery, is that true? A: That's correct. Q: Bleeding from the rectum would have absolutely nothing to do with knee surgery, is that true? A: That's correct ... Q: So what we're looking at is a general form, not a specific form to knee surgery, is that right? A: That's correct. Q: So when it comes to knee surgery, the important items for discharge instruction for the patient would be listed, handwritten, or typed up like this one here, is that true? A: That would be the additional instructions other than the ones that are preprinted that also include any unusual circumstances. .... Q: So if a patient has a pain after surgery in her knee or leg, is that unusual because the leg was just operated on? .... A: Pain in the knee would not be unusual. Q: So a patient is supposed to know that pain in the leg is an unusual condition after surgery on the leg, is that what you're saying? A: It's possible. .... Q: So can pain in the calf be life threatening? Yes or no. A: Can it be? It's possible.

Plaintiff's orthopedic expert, Dr. Ronald Byank, did not have any criticism of the surgery performed by Dr. Marcelli. He noted that Melissa was at an increased risk for a DVT because of her size (5'4" and 250 pounds) and the fact she was on birth control pills. Dr. Byank testified that in patients with an increased risk of DVT, the physician should always be looking for signs of complications, even if the patient has no complaints of calf pain or swelling. Dr. Byank stated that if Dr. Marcelli noticed a red spot on Melissa's calf on June 1, the standard of care required him to inquire about the red spot and physically examine the area. Dr. Byank further opined that Dr. Marcelli had enough information at the time of the June 1 post-operative examination to send Melissa for an ultrasound to determine whether she had a blood clot forming.

Dr. Byank testified that, based on his review of the medical records, neither the consent for surgery forms nor the post-surgical instructions communicated to Melissa or her family that calf pain could be a symptom of a life-threatening blood clot. He further indicated that the record of Melissa's first post-operative visit on June 1 contains no reference to any discussion about DVT or the significance of calf pain.

Dr. Byank testified that "[m]ost people will have knee pain after surgery" but if "somebody has calf pain, then that's a ... different animal ... Yeah, that's a light going on. That's something that needs to be looked at." Dr. Byank acknowledged that Mrs. Ringstaff's deposition testimony played a big role in his opinion that there were deviations in the case. Dr. Byank indicated his belief Melissa had a symptomatic DVT on June 5 that was causing her pain in the calf and back of the leg.

Dr. W.O. Scott, defendants' orthopedic expert, testified it takes "many days" or about one week for DVT symptoms to develop. Dr. Scott did not believe there was any deviation on June 5, because of the lack of documentation that anyone reported calf pain, even though there were many people involved in the conversations that took place that day. Dr. Scott stated a blood clot could potentially form during surgery or the day after surgery. During cross examination, plaintiffs' counsel engaged in the following colloquy with Dr. Scott regarding his teaching of medical residents:

Q: Would it be accurate to say that when you teach the residents, you tell them calf pain can be life-threatening symptoms after ACL surgery? A: It can be. .... Q: And ... you teach the residents that fact because you want to make sure that those residents have that medical knowledge to protect their patients, is that right? A: Correct. Q: By the same token, patient education can be equally important for a patient to know what is a life-threatening symptom and what is not a life-threatening symptom?

At that point, Dr. Marcelli's attorney objected, stating that plaintiffs' counsel was not "entitled to start making an argument about a potential new theory that's not supported by expert testimony." Plaintiff's counsel responded:

The way this case has been defended, it's been defended on the fact that the patient was comparatively negligent for having failed to follow discharge instructions. It is clear that.... the defense has turned this into an informed consent case. The informed consent means it's not an expert driven issue; it's what a reasonably prudent patient would want to know and attach significance to.... the door has been opened wide by blaming the patient for having failed to report certain things such as being pale and not eating.

After further argument, the judge ruled in favor of plaintiffs on the objection and the colloquy continued:

Q: The other way you protect a patient is by patient education after surgery, is that true? A: That's true. Q: And after surgery, discharge instructions like this, these are the post-operative after surgery treatment plan of a doctor, is that right? A: That's correct. Q: And one of the issues in a post-operative treatment plan would be patient education to make sure that the patient is aware of any life-threatening potential, is that right? A: Well it's — that's not entirely true. What we try to have the patient be aware of is that they should contact us when there's change. I would prefer that a patient not make their own decision what is life-threatening and what is not. When there's a change, I would prefer to be notified of that.

With this disputed evidence before the jury, we turn to the trial court's decision to deny plaintiffs' request to charge the jury as to informed consent. Relevant to this issue, defendants requested a mitigation of damages charge based upon their contention that Melissa acted unreasonably after her surgery by not alerting her doctors when she became pale and stopped eating. Over plaintiffs' objection, the judge ruled that he would charge mitigation of damages. Plaintiffs requested an informed consent charge based on defendants' failure to provide proper post-surgical instructions citing Niemiera v. Schneider, 114 N.J. 550 (1989). Plaintiffs' counsel explained why the informed consent charge was required:

Informed consent in this case is not whether somebody is going to forego or not forego [treatment]. She's being charged with contributing to her own demise.... But she wasn't told calf pain could be life threatening. ... [S]he needs to be warned about the symptoms in a way that a reasonably prudent patient would want to be warned [.]

The court rejected plaintiffs' contention that defendants placed informed consent in the case by asserting claims that Melissa was responsible for her own injuries and death because she failed to follow discharge instructions. The court agreed with the defense argument that the holding of Niemiera did not apply:

[T]he [c]harge is not appropriate, as I read Niemiera.... Even though [the Court talks] about pre-shot and post-shot kind of designation, it ... [does not] seem to me to [set up] anything different than the consent that is secured prior to treatment. I think this would be creating something new, not — I think it actually may be appropriate under certain circumstances. But I don't think that the [t]rial [c]ourt is the place for that to happen.

We disagree with the trial court's interpretation of Niemiera and conclude the factual underpinnings of the case are present here. We are convinced this case presents a factual pattern where both theories of liability, deviation and informed consent should have been presented to the jury.

II.

A proper charge is essential to a fair trial. Pressler & Verniero, Current N.J. Court Rules, comment 3.3.2. on R. 2:10-2 (2014). In clear understandable language, the jury charge should explain the law that applies to the issues at trial. Toto v. Ensuar, 196 N.J. 134, 144 (2008). The charge "is a road map that explains the applicable legal principles, outlines the jury's function, and spells out how the jury should apply the legal principles charged to the facts of the case at hand." Ibid. (citation and internal quotation marks omitted).

"[A] claim based on the doctrine of informed consent is predicated on the patient's right to self-determination." Canesi v. Wilson, 158 N.J. 490, 503-04 (1999). "Choosing among medically reasonable treatment alternatives is a shared responsibility of physicians and patients[,]" and physicians "have a duty to evaluate the relevant information and disclose all courses of treatment that are medically reasonable under the circumstances." Matthies v. Mastromonaco, 160 N.J. 26, 34 (1999). The doctrine of informed consent obligates a doctor to disclose material risks inherent in a procedure or course of treatment so that the patient can make an informed decision. Id. at 36.

The doctrine of informed consent, a type of medical negligence, is based on a physician's duty to provide patients with sufficient information to enable them to "`evaluate knowledgeably'" the available options and their respective risks before submitting to a particular procedure or course of treatment. Perna v. Pirozzi, 92 N.J. 446, 459 (1983) (quoting Canterbury v. Spence, 464 F.2d 772, 780 (D.C. Cir. 1972), cert. denied, 409 U.S. 1064, 93 S.Ct. 560, 34 L. Ed. 2d 518 (1972)). "Plaintiff is required to show only that the warning was inadequate and that the harm would have been prevented by an adequate warning." Draper v. Jasionowski, 372 N.J.Super. 368, 373-374 (App. Div. 2004).

The standard governing the required disclosure is what a reasonably prudent patient would deem material to make an informed decision about undergoing the recommended treatment. Largey v. Rothman, 110 N.J. 204, 211-12 (1988). See also Blazoski v. Cook, 346 N.J.Super. 256, 267 (App. Div.), certif. denied, 172 N.J. 181 (2002). This is an objective standard, relating to the patient's needs and not the physician's judgment. Blazoski, supra, 346 N.J. Super. at 267 (citing Largey, supra, 110 N.J. at 211; Niemiera, supra, 114 N.J. at 565 n.4).

An informed consent claim is established not through a physician's error in diagnosis or treatment, but by failing to provide the patient with "adequate information regarding the risks of a given treatment[.]" Farina v. Kraus, 333 N.J.Super. 165, 179 (App. Div. 1999) (quoting Eagel v. Newman, 325 N.J.Super. 467, 475 (App. Div. 1999)). The informed consent doctrine is founded in negligence and is based on a physician's duty to disclose information to a patient that will "enable [the patient] to evaluate knowledgeably the options available and the risks attendant upon each before subjecting that patient to a course of treatment." Matthies, supra, 160 N.J. at 35 (quoting Perna, supra, 92 N.J. at 459) (internal quotation marks omitted).

Information is material "when a reasonable patient, in what the physician knows or should know to be the patient's position would be likely to attach significance to the risk or cluster of risks in deciding whether to forego the proposed therapy or to submit to it." Adamski v. Moss, 271 N.J.Super. 513, 519 (App. Div. 1994). The reasonably prudent patient standard focuses on what information the patient would find significant, given the risks, to make an informed decision regarding the course of treatment. Acuna v. Turkish, 192 N.J. 399, 415 (2007) (citing Howard v. Univ. of Med. & Dentistry of N.J., 172 N.J. 537, 547 (2002); Matthies, supra, 160 N.J. at 36). "It is now settled that a physician has a legal duty to disclose to the patient all medical information that a reasonably prudent patient would find material[.]" Ibid.

In addressing the issue of informed consent, the standard against which Dr. Marcelli's communication with Melissa should be measured is not a legal issue to be defined by this court. Nor is it established by expert testimony. See Largey, supra, 110 N.J. at 213-14. See also Kimmel v. Dayrit, 301 N.J.Super. 334, 352-353 (App. Div. 1997) aff'd in part and modified in part, 151 N.J. 465 (1997) ("[T]he duty to inform a patient of all reasonable options is a standard of care well within the understanding of a lay jury and requires no expert testimony."). Rather, "[w]henever non-disclosure of particular risk information is open to debate by reasonable-minded [people], the issue is one for the finder of facts." Largey, supra, 110 N.J. at 213 (quoting Canterbury, supra, 464 F.2d at 788). Therefore, while both parties are free to present testimony of experts deemed qualified by the trial court to testify and express an opinion, the finder of fact ultimately will be required to address that debate in the context of the reasonably prudent patient standard.

Regulations in effect at the time of Melissa's surgery recognized the importance of providing the patient with relevant information. N.J.A.C. 8:43G-15.2 (j), mandates that "[a]ny consent form for medical treatment that the patient signs shall be printed in an understandable format and the text written in clear, legible, nontechnical language." N.J.A.C. 8:43G-32.5(a) addresses same-day surgery patient services, and requires "[t]here shall be documentation of perioperative patient education."

In addition to providing instructions regarding diet, activity, and medication, the discharge instructions stated in preprinted language: "REPORT severe pain, high fever, changes or discharges from the wound, vomiting, unusual bleeding from wound, vagina, rectum, etc., or any unusual condition or problem, to your doctor immediately." The form included a section labeled "ADDITIONAL INSTRUCTIONS" that included handwritten notes that instructed Melissa to:

— Elevate right knee intermittently — Ice to right knee intermittingly — Keep brace in extension until seen [at] office — Take medications as prescribed — Follow up with Dr. Marcelli on Thursday — Call office for time.

In Niemiera, a two-month-old infant, Gregory Niemiera, suffered a convulsive episode, one week after receiving a DPT vaccine, which left him severely brain damaged. Niemiera, supra, 114 N.J. at 552. The plaintiff's expert witness believed the infant's brain damage was caused by an adverse reaction to the pertussis component of DPT3 vaccine. Ibid. Following the inoculation, a nurse gave Mrs. Niemiera, Gregory's mother, a printed paper describing the possible reactions that could occur. Id. at 555. Seven days later, the infant was found "unresponsive, running a high fever, and suffering periodic seizures. At one point he stopped breathing." Id. at 556.

Earlier in the week following the vaccination, the infant was no longer nursing and was running a low-grade fever. Id. at 555. Additionally, Mrs. Niemiera testified she reported the symptoms to Dr. Schneider's office, a contention the doctor disputed. Ibid.

Mrs. Niemiera also testified that she called Dr. Schneider's office again on April 9, 1982, because the baby's condition had worsened. Gregory was now vomiting, crying uncontrollably, and still did not want to eat. Dr. Schneider prescribed pedialyte, a medication to replace body fluids, and told Mrs. Niemiera to call again if Gregory had blood or mucus in his stool. This phone call was received by Dr. Schneider and noted in his office chart. [Ibid.]

Despite the infant's symptoms, neither Dr. Schneider nor any member of his group examined Gregory on April 9, or at any time before his convulsive episode three days later. Id. at 555-56.

Mrs. Niemiera sued Dr. Schneider for malpractice, on her son's behalf, alleging that Dr. Schneider failed to warn of the vaccine's side effects.4 Id. at 552. At the close of all the evidence, the trial judge granted Dr. Schneider's motion to dismiss Gregory's failure-to-warn claim. Id. at 557. The Court reversed, finding that as a learned intermediary, Dr. Schneider had a duty to give proper warning of the dangers or side effects of the DPT vaccine. Id. at 559-60. The Court determined that the objective "prudent patient" standard applied to the duty of informed consent, which Dr. Schneider owed to Gregory's mother. Id. at 563. The Court stated that "the threshold of information that makes the product safe to market needs to be disclosed[,]" and in a case involving treatment of a minor child, this means "information a good mother would need to attend to the health of her child." Id. at 563-64.

The Court noted that "the question was ... whether the failure to warn the patient deprived her of the opportunity to avert the medical catastrophe that can occur[.]" Id. at 565-66. The Court noted "there was slim but competent evidence that an adequate warning could have prevented the harm[,]" based on the testimony of plaintiff's expert that the problems "of several days later with extremely high fever, seizures and the anoxia or the lack of oxygen to the tissues, particularly the brain, this could have been avoided had it been picked up earlier." Id. at 567. The Court then held that

[r]easonable minds might have concluded, on the basis of this evidence, that insulating a prudent patient from knowledge that convulsive brain disorders were a potential side effect of DPT vaccine could, to a reasonable degree of medical probability, have substantially increased the risk of harm that eventually befell the patient. Specifically, by not alerting the mother to the gravity of the consequences of her child's symptoms, the physician deprived the child of the opportunity for early intervention that could have saved him from that fate. If she had been adequately warned, she might have been more aggressive in seeking appropriate treatment. [Id. at 567-68.]

In Niemiera, "[t]he exact cause of the convulsive illness was disputed[,]" although at "one time Dr. Schneider ... had rendered an opinion that the episode was caused by the vaccination."5 Id. at 556.

The doctrine of avoidable consequences "proceeds on the theory that a plaintiff who has suffered an injury as the proximate result of a tort cannot recover for any portion of the harm that by the exercise of ordinary care he could have avoided." Ostrowski v. Azzara, 111 N.J. 429, 437 (1988). The doctrine applies to medical malpractice claims. Id. at 432-35. "The underlying rationale is that once a patient comes under a physician's care, the law can justly expect the patient to cooperate with the physician in their mutual interests." Cohen v. Cmty. Med. Ctr., 386 N.J.Super. 387, 400 (App. Div. 2006) (citing Ostrowski, supra, 111 N.J. at 445). The doctrine "limits consideration of a plaintiff's fault to the time period that begins after a defendant's wrongful conduct." Del Tufo v. Twp. of Old Bridge, 147 N.J. 90, 120 (1996) (citing Ostrowski, supra, 111 N.J. at 438).

Notwithstanding the Court's holding in Ostrowski, there are cases where the doctrine of avoidable consequences arguably does not apply. As we noted in Geler v. Akawie, 358 N.J.Super. 437, 461 (App. Div. 2003):

We have strong reservations as to whether the doctrine of avoidable consequences has applicability in any "informed consent" context.... The doctrine of informed consent presupposes essential ignorance on the part of the patient with respect to medical issues. The duty to inform arises from that ignorance, and from the patient's need to obtain information sufficient to make the right of self-determination in medical matters meaningful. Even if the patient is partially informed at the onset of the physician-patient relationship, it is the physician's duty to fill any informational gaps that preclude a meaningful exercise of the patient's self-determinative right.

III.

Plaintiffs argue the trial court erred in failing to instruct the jury on the issue of informed consent because Melissa was not fully informed of the symptoms associated with potentially life threatening post-surgical blood clots, and thus, was unable to make an informed decision about her post-surgical treatment. Plaintiffs further assert that by failing to alert Melissa as to the severity and consequences of her symptoms, she was deprived of the choice to pursue another course of treatment, such as seeking treatment elsewhere.

Defendants argue the trial court did not err in failing to instruct the jury on informed consent because plaintiffs never asserted a claim based on informed consent. Defendants further assert that Melissa fully consented pre-operatively to the surgery and was fully informed of the risks, and thus, the informed consent claim was properly not submitted to the jury.

By its verdict, the jury obviously resolved credibility issues regarding the claims of deviation against plaintiffs. The only claims considered by the jury concerned whether defendants' conduct deviated from the accepted standard of care based upon Melissa's June 1 office visit with Dr. Marcelli or the handling of Melissa's pain complaints on June 5. Much of the focus of the trial was upon Melissa and Mrs. Ringstaff, and what they did, and what they failed to do. This focus was highlighted when the jury received the mitigation of damages charge without an informed consent charge.6

While plaintiffs did not specifically plead a lack of informed consent in their complaint, the underlying facts giving rise to such a claim were sufficiently established at trial to entitle plaintiffs to submit the question of whether Dr. Marcelli failed to provide Melissa "with adequate information regarding the risks of a given treatment." Eagel, supra, 325 N.J. Super. at 476. The error in denying plaintiffs' request to charge the jury on informed consent was "clearly capable of producing an unjust result," Rule 2:10-2, and requires reversal.

Applying Niemiera to the case under review, reasonable minds might have concluded, on the basis of the evidence, that failing to provide Melissa with knowledge that calf pain could represent a symptom of a life-threatening DVT, rather than simply ordinary post-surgery pain, could, to a reasonable degree of medical probability, have substantially increased the risk of harm that Melissa eventually realized. Specifically, by not alerting Melissa to the gravity of the consequences of her symptoms, Dr. Marcelli arguably deprived his patient of important information that could have saved her life. If she had been adequately warned, she might have been more aggressive in seeking appropriate treatment.

Similar to Niemiera, Melissa received written information from her doctor which failed to provide a complete picture of the risks involved. In Niemiera, the warnings of the drug manufacturer

detailed seven possible severe adverse side effects, including convulsions, collapse, inconsolable crying, and temperatures in excess of 105 degrees.... In contrast, the warnings to Mrs. Niemiera, as recited on the information sheet given to her after the shot was administered, included only the less severe side effects: local redness or swelling, restlessness, and temperature between 100 and 102 degrees F. [Id. at 564.]

Also similar to Niemiera, the judge in the case under review refused to charge informed consent, and plaintiffs were no caused. Id. at 552 In Niemiera, the Court found that, "although the jury resolved all issues in the defendant-physician's favor concerning other aspects of professional treatment, the jury was not permitted to consider whether the patient was adequately informed of the risks of the vaccine." Ibid. The Court concluded this was reversible error and ordered a new trial against the doctor. Ibid.

Regarding causation, the trial testimony of the medical experts and defendant doctors all confirmed DVT is a treatable condition once diagnosed. On direct examination, Dr. Eakin agreed that one of the reasons that there are so few deaths from DVTs is because the condition is recognized and then treated. Dr. Marcelli testified that he explained to Melissa, if her ultrasound was positive, "they would let me know that and we'd have to admit you to the hospital for treatment for that clot, which will be anticoagulation, blood thinners." The record contains "competent evidence that an adequate warning could have prevented the harm." Niemiera, supra, 114 N.J. at 567.

[W]hen there is evidence [in medical malpractice cases] that a defendant's negligent act or omission increased the risk of harm to one in the plaintiff's position and that harm was in fact sustained," the finder of fact is entitled to determine [on the basis of competent proof] whether or not that increased risk was a substantial factor in producing the harm. [Ibid. (alteration in original) (citations and internal quotation marks omitted).]

Unfortunately, Melissa did not receive the post-operative oral instructions Dr. Marcelli typically provides to his patients because she had left by the time Dr. Marcelli finished his next surgery. While a nurse provided Melissa with written discharge instructions, those instructions failed to provide Melissa with the important information relevant to this case. Inexplicably, none of the written discharge instructions mentioned DVT, nor the important symptoms of DVT (calf pain, swelling, redness), even though these symptoms are critical signposts of a potentially life-threatening condition.

We note the written post-operative discharge instructions provided to Melissa were of a general nature applicable to knee surgeries. Dr. Marcelli testified he likes to see his patients within forty-eight hours of surgery so he can explain what he did and what symptoms "to look for." He explained his "usual routine" at the end of the first post-operative visit is to advise the patient "[i]f there's any fevers, chills, drainage, swelling, calf pain, shortness of breath, give me a call."7 Of these six symptoms, only one (fever) appears on the written discharge instructions provided to Melissa. Again, nothing indicated these were symptoms of a life-threatening condition.

We note that clear and specific written discharge instructions would likely reduce the possibility of doctor-patient miscommunication which, in turn, would decrease the possibility of a poor outcome for the patient and resulting litigation for the doctor. Where warnings and instructions are "accurate, clear, and unambiguous," we have not hesitated to find them "adequate as a matter of law."8 In Banner v. Hoffmann-La Roche Inc., 383 N.J.Super. 364, 382, 384 (App. Div. 2006).

The record reflects defendants provided training to their receptionists relating to DVTs and their symptoms. The obvious purpose of this training relates to patient health and safety. By providing basic information regarding certain complications, like DVT, defendants enable their receptionists to assist in the early identification of patients who need immediate attention. While the record indicates defendants' receptionist possessed this critical information, the record does not clearly show that Melissa ever received it; the record is inconclusive on this issue. It will be for the jury, at the retrial, to determine whether Dr. Marcelli provided Melissa with the information a reasonably prudent patient would deem material. Largey, supra, 110 N.J. at 211-12.9

To summarize, we conclude the trial court erred in failing to submit plaintiffs' informed consent claim to the jury. Melissa had a right to know about the risks posed by DVT and pulmonary embolism, to enable her to exercise reasonable care to protect her own health post-operatively. The failure to give the informed consent charge was clearly capable of producing an unjust result. From defendants' records, it is not clear what information Melissa received post-operatively; the trial testimony indicates the nature and extent of information Dr. Marcelli provided orally was seriously disputed. Certainly, Melissa's conduct would tend to indicate she was not aware the symptoms she was experiencing following her surgery were potentially life threatening.

Dr. Eakin only wrote a prescription for Melissa as a convenience to Dr. Marcelli and did not play a role in the informed consent aspects of Melissa's care; therefore, we discern no basis to disturb the jury verdict in his favor. We find none of the other issues raised by the parties to have sufficient merit to warrant discussion in a written opinion. R. 2:11-3(e)(1)(E).

The judgment in favor of Dr. Eakin is affirmed. The judgments in favor of Dr. Marcelli and Academy Orthopaedics are reversed, and plaintiffs' claims against those defendants are remanded for retrial.

Affirmed in part, reversed and remanded in part.

FootNotes


1. In 2006, Academy Orthopaedics was an orthopedic practice with offices in Sicklerville, Stratford and Washington Township. The group consisted of Dr. Marcelli, Dr. David Eakin, and two other orthopedists.
2. In an allograft reconstruction, the surgeon uses a harvested cadaver tendon. In an autograft reconstruction, the graft is taken from the patients themselves and used as the new ACL.
3. The tri-fold components of the DPT vaccine "protect against diphtheria, pertussis (whooping cough), and tetanus." Ibid.
4. Mrs. Niemiera also sued Wyeth Laboratories (Wyeth), the manufacturer of the vaccine, asserting it had an independent duty to warn that DPT had potentially devastating side effects. Before trial, Wyeth successfully moved to dismiss the plaintiff's complaint for failure to warn on the basis of the "learned intermediary" doctrine.
5. In contrast, the record indicates no dispute regarding the fact that a pulmonary embolism from the DVT caused Melissa's death. Nor does the record reflect any evidence to challenge the contention that the delay in the diagnosis increased Melissa's risk of harm.
6. Because plaintiffs were alleging both deviations and informed consent, a properly tailored mitigation charge may have been appropriate at the initial trial, despite the dicta in Geler, supra, 358 N.J. Super. at 461. In a case where a jury considers claims of deviation and informed consent, and there is evidence of post-deviation unreasonable conduct of the plaintiff, the jury could be charged that the mitigation of damages charge would only apply if the jury found against the plaintiffs on the informed consent claim but in favor of plaintiffs on the deviation claim.
7. The record contains no documentation that Dr. Marcelli followed this normal routine with Melissa.
8. Providing accurate, clear, and unambiguous instructions would also be consistent with applicable regulations. See N.J.A.C. 8:43G-15.2(j) and N.J.A.C. 8:43G-32.5(a).
9. Because the retrial will be limited to the issue of informed consent relating to post-operative instructions, we caution the court against providing the mitigation of damages charge unless the trial evidence presents compelling reasons not contemplated in our discussion in Geler, supra, 358 N.J. Super. at 461.
Source:  Leagle

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