Opinion ID: 3163349
Heading Depth: 2
Heading Rank: 2

Heading: Negligence and Informed Consent Claims

Text: Massachusetts law recognizes the right of a competent adult to forgo treatment, and the [k]nowing exercise of this right requires knowledge of the available options and the risks attendant on each. Harnish v. Children's Hosp. Med. Ctr., 439 N.E.2d 240, 242 (Mass. 1982). For a plaintiff to prevail on a theory of informed consent, (1) the physician must have a duty to disclose the information at issue to the patient, and (2) the breach of that duty must be causally related to the patient's injury. Halley v. Birbiglia, 458 N.E.2d 710, 715 (Mass. 1983). Under the duty inquiry, (a) a sufficiently close doctor-patient relationship must exist; (b) the information subject to disclosure must be that which the doctor knows or reasonably should know; (c) the information must be of such a nature that the doctor should reasonably recognize that it is material to the patient's decision; and (d) the doctor must fail to disclose the subject information to the patient. -14- Id. In turn, for the causation inquiry, the plaintiff must demonstrate that had the proper information been provided neither he nor a reasonable person in similar circumstances would have undergone the procedure. Harnish, 439 N.E.2d at 244. A physician need only disclose information that is material to an intelligent decision by the patient whether to undergo a proposed procedure. Id. at 243. Materiality is defined as the significance a reasonable person, in what the physician knows or should know is his patient's position, would attach to the disclosed risk or risks in deciding whether to submit or not to submit to surgery or treatment. Id. (internal citation omitted); accord Precourt v. Frederick, 481 N.E.2d 1144, 1146 (Mass. 1985). In addition to encompassing the risks associated with a particular procedure, material information also includes the available alternatives, including their risks and benefits. Harnish, 439 N.E.2d at 243.
The Bradleys also assert claims of medical negligence. To show medical negligence, the plaintiff must show (1) the existence of a doctor or nurse-patient relationship, (2) that the performance of the doctor or nurse did not conform to good medical practice, and (3) that damage resulted therefrom. St. Germain v. Pfeifer, 637 N.E.2d 848, 851 (Mass. 1994). To establish the -15- appropriate standard of care, a plaintiff typically must present expert testimony to that effect. Pagés-Ramírez v. RamírezGonzález, 605 F.3d 109, 113 (1st Cir. 2010) (In order to determine the applicable standard of care in a medical malpractice action and to make a judgment on causation, a trier of fact will generally need the assistance of expert testimony.).
Rule 702 of the Federal Rules of Evidence governs the admission of expert testimony. Fed. R. Evid. 702. Rule 702 requires that the testimony be (1) 'based upon sufficient facts or data,' (2) 'the product of reliable principles and methods,' and (3) that the witness apply 'the principles and methods reliably to the facts of the case.' Pagés-Ramírez, 605 F.3d at 113 (quoting Fed. R. Evid. 702). When determining whether such evidence is admissible, the judge must determine: 'whether the expert is proposing to testify to (1) scientific knowledge that (2) will assist the trier of fact to understand or determine a fact in issue.' Mitchell v. United States, 141 F.3d 8, 14 (1st Cir. 1998) (quoting Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 592–93 (1993)). A district court enjoys broad discretion when making such evidentiary determinations, id. at 15, and its decision to admit or exclude testimony is reviewed for an abuse of discretion, Pagés-Ramírez, 605 F.3d at 115. But [t]he standard -16- is not monolithic: within it, embedded findings of fact are reviewed for clear error, [and] questions of law are reviewed de novo. Milward v. Acuity Specialty Prods. Grp., Inc., 639 F.3d 11, 13–14 (1st Cir. 2011) (quoting Ungar v. Palestine Liberation Org., 599 F.3d 79, 83 (1st Cir. 2010)). We affirm where the lower court's error [does] not affect the parties' substantial rights and likely [does] not affect the outcome of the case. Martínez v. Cui, 608 F.3d 54, 59 (1st Cir. 2010).
The Bradleys contend that the district court erred in excluding Dr. Putnam's testimony related to the availability of an FNA biopsy, explaining that such testimony was relevant to the standard of care for both their informed consent and medical negligence claims.5 The expert disclosure report identified three opinions that subsequently were excluded: 1. The surgeon departed from the standard of care by failing to perform a less invasive procedure (such as needle biopsy or bronchoscopy), rather than thoracotomy as the first diagnostic procedure. 2. If the surgeon dissuaded the patient from consideration of needle biopsy, an alternative to diagnosis of the superior sulcus tumor and which would modify the patient's treatment options, the surgeon departed from the standard of care. 5 The parties do not dispute Dr. Putnam's professional qualifications on appeal. Rather, their dispute is limited to the relevance of his testimony. -17- 3. If the surgeon did not do so, the surgeon departed from the standard of care by failing to discuss with the patient and family the alternative diagnostic options to wedge resection (such as needle biopsy or bronchoscopy) as part of informed consent.6 The Bradleys contend that Dr. Putnam's testimony regarding Dr. Sugarbaker's failure to discuss the availability of the FNA biopsy was relevant to the available alternatives and the standard of care for the informed consent claims. During the trial, the Bradleys expanded upon Dr. Putnam's expected testimony, which would touch on the general approach of getting informed consent which involves a general discussion of what you're going to do, the risks, the benefits, the reasonable alternatives and the risks and benefits of those. The Bradleys acknowledged that this was not a situation where an FNA biopsy had never been offered -- indeed, one had been scheduled, with another hospital, prior to the PET scan. Nevertheless, the Bradleys contend that Dr. Sugarbaker did not satisfy the standard of care articulated in Harnish by failing to engage in a discussion of the alternate routes of obtaining a biopsy after her PET scan: [Mrs. Bradley] can't possibly have understood that something she was told was not 6 The district court did admit portions of Dr. Putnam's testimony pertaining to Dr. Sugarbaker's failure to discuss Mrs. Bradley's increased risk of complications in light of her previous chest trauma. -18- going to be pursued anymore would have given her the alternate means of obtaining the information she wanted on December 14th [the date of the PET scan]. As to Dr. Sugarbaker's failure to perform a less invasive procedure, Dr. Putnam would have testified that performing an FNA biopsy was relevant to the standard of care for purposes of the medical negligence claim.7 In this respect, the Bradleys intended to have Dr. Putnam testify that an FNA biopsy is less invasive and . . . safer than doing surgery. Dr. Putnam would explain that an FNA biopsy is a standard initial diagnostic procedure that would provide crucial information before an operation would be performed. As to causation, the Bradleys also intended for Dr. Putnam to testify that what happened to Barbara Bradley would not have happened had the standard of care been followed. Dr. Putnam would have explained that, where an FNA biopsy returns negative results, the doctor should discuss with the patient the likelihood that the mass is nevertheless cancerous. In the case of Mrs. 7 During trial, the Bradleys' counsel referred to this testimony as Dr. Putnam's second specific opinion. As listed on the disclosure report, the second opinion concerns whether Dr. Sugarbaker, having allegedly dissuaded Mrs. Bradley from undergoing an FNA biopsy, deviated from the standard of care. The discussion that follows, however, touches on the failure to perform the procedure, which is in fact the first opinion listed on the disclosure report. -19- Bradley, who had suffered previous chest trauma, the doctor would then explain the greater than average risk posed by surgery and query whether other therapy options are available.
Dr. Sugarbaker first contends that the Bradleys did not preserve their evidentiary issue as they failed to comply with Rule 103(a)(2) of the Federal Rules of Evidence, which requires one claim[ing] error in a ruling to admit or exclude evidence to inform[] the court of its substance by an offer of proof, unless the substance was apparent from context. Dr. Sugarbaker contends that the Bradleys did not make an offer of proof with respect to the specifics of the relevant opinion testimony that they sought to elicit from Dr. Putnam. This assertion is unsupported by the record. The Bradleys' proffer included a detailed Disclosure Report from Dr. Putnam as well as a deposition. Indeed, when determining which sections of Dr. Putnam's disclosure report were admissible, the district court methodically analyzed each paragraph of the disclosures. Such specificity is a strong indication that the Bradleys' proffer satisfied Rule 103's requirements. Turning to the merits, we address each of Dr. Putnam's three opinions in turn. -20-
Alternative Diagnostic Options The district court excluded Dr. Putnam's testimony regarding Dr. Sugarbaker's failure to discuss alternatives. It reasoned that, while the FNA biopsy theoretically was an alternative, it was not an alternative in this instance: [the FNA biopsy] was . . . considered an alternative until it stopped being one. The district court noted that this decision was based on the facts of the case, which indicate that an FNA biopsy was not a practical alternative. Dr. Sugarbaker contends that Dr. Putnam's testimony improperly spoke to the materiality of the availability of the FNA biopsy. Under Massachusetts law, [t]he materiality determination is one that lay persons are qualified to make without the aid of an expert. Harnish, 439 N.E.2d at 243. As a threshold matter, a judge will consider the severity of the injury as well as the likelihood that it will occur. Precourt, 481 N.E.2d at 1148. The determination of whether that information is material is then left to the factfinder. Id. at 1148–49. As a matter of law, a negligible risk is not material and need not be submitted to the jury. Id. at 1149.8 In Precourt, the Supreme Judicial Court 8 In Harrison v. United States, 284 F.3d 293 (1st Cir. 2002), we expanded upon Precourt, noting that the caselaw stands for the proposition that there is no duty to disclose negligible risks, not that all non-negligible risks are actionable if not revealed. -21- (SJC) of Massachusetts cautioned, [t]he development of our law concerning risks that as a matter of law may be considered remote, and those that may be left to the determination of a fact finder, must await future cases. Id. As discussed herein, Opinion 3 would have included testimony touching on the general approach to getting informed consent. Dr. Putnam would have explained that Dr. Sugarbaker failed to inform Mrs. Bradley of an FNA biopsy, which would be the easiest, most straightforward, [and] carry the greatest benefit of a diagnostic with the least risk, of any procedure. Contrary to Dr. Sugarbaker's assertions, Dr. Putnam's testimony does not infringe on the jury's materiality analysis. Rather, it would explain the general category of risks and alternatives that a physician must disclose to his patient and the factors relevant to whether an FNA biopsy should have been disclosed as an alternative in this instance. In this way, Dr. Putnam's testimony was relevant to what the standard of care requires when a physician engages in a discussion of alternatives with his patient. In Harnish, the SJC explained, [w]hat the physician should know involves professional expertise and can ordinarily be proved only through the testimony of experts. 439 N.E.2d at 243.9 Likewise, Id. at 300. 9 The Bradleys contend that the district court improperly excluded -22- the manner that a physician discusses a procedure with a patient and the types of information he must include in that conversation are areas where an expert may be necessary to aid the jury. The fact that Harnish does not require expert testimony on what is material does not mean that expert testimony on the available choices that doctors in the exercise of standard care offer to their patients is not relevant. Further, the district court's determination that an FNA biopsy was not available as an alternative is not supported by the evidence adduced at trial.10 Mrs. Bradley recounted a call from this evidence on the theory that it embraced an ultimate issue. See Fed. R. Evid. 704(a) (An opinion is not objectionable just because it embraces an ultimate issue.). To the contrary, the district court stated that the ultimate question of evaluating severity and likelihood is one for the jury, which is an accurate restatement of the law that the issue of materiality is for the jury. Harnish, 439 N.E.2d at 243. 10 The Bradleys contend that the district court improperly usurped the jury's function by deciding this issue of fact. Under Daubert, however, when determining the admissibility of expert testimony, the trial judge must determine at the outset, pursuant to [Federal Rule of Evidence] 104(a), whether the expert is proposing to testify to (1) scientific knowledge that (2) will assist the trier of fact to understand or determine a fact in issue. Daubert, 509 U.S. at 592; cf. Fed. R. Evid. 104(b) (When the relevance of evidence depends on whether a fact exists, proof must be introduced sufficient to support a finding that the fact does exist.). Dr. Putnam's testimony as to whether dissuasion or non-discussion of available alternatives (Opinions 2 and 3, respectively) satisfies the standard of care is only relevant insofar as the Bradleys demonstrated that non-discussion and dissuasion of available alternatives are facts at issue here, and the district court did not err in making this preliminary factual determination. See Bogosian v. Mercedes-Benz of N. Am., Inc., 104 F.3d 472, 476 (1st -23- Dr. Sugarbaker's physician assistant, William Hung, in which he explained that an FNA biopsy was not possible as they would be unable to access the mass using that procedure. In light of that conversation, Mrs. Bradley cancelled her previously scheduled FNA biopsy. Hung does not recall this conversation and his notes from that day do not mention the FNA procedure. At trial, Hung explained that he spoke with a radiologist, Dr. Francine Jacobsen, and that Dr. Jacobsen had recommended against an FNA biopsy. But Hung's notes contain no mention of Dr. Jacobsen's suggestions regarding the procedure. In addition, Dr. Sugarbaker recalled having a conversation with either Hung or Dr. Jacobsen in which they agreed not to proceed with an FNA biopsy given the location of the mass. As Bradley's trial counsel noted, there were no records of these conversations, and Dr. Sugarbaker's testimony regarding his conversation with Dr. Jacobsen is inconsistent with Cir. 1997) ([T]he court performs a gatekeeping function to ascertain whether the testimony is helpful to the trier of fact, i.e., whether it . . . is relevant to the facts of the case.). The Bradleys' reliance on Milward is unavailing. There, this Court determined that, [w]hen the factual underpinning of an expert's opinion is weak, it is a matter affecting the weight and credibility of the testimony -- a question to be resolved by the jury. Milward, 639 F.3d at 22 (internal citation omitted). But Milward concerned the district court's extensive evaluation of the reliability of the scientific theories underscoring the expert's testimony, and not the threshold issue of factual relevance. -24- earlier statements that he did not recall discussing the availability of the FNA biopsy with another medical professional. Moreover, the district court's determination that an FNA biopsy was not an available alternative is further undercut by its decision to admit the testimony of expert Dr. Mark Edelman, Mrs. Bradley's interventional radiologist, who testified to the benefits of the FNA biopsy. At trial, he explained that an FNA biopsy could have been safely performed with respect to Barbara Bradley and opined that the location of the mass did not render it inaccessible by FNA biopsy. He also remarked on the benefit of this non-surgical alternative due to the complications of surgery and difficulty recovering from surgery. Contrary to the district court's determination, such testimony suggests that the FNA biopsy was a viable alternative here.11 Nor can it be said that the risks associated with a surgical biopsy were so minimal that, as a matter of law, Dr. Sugarbaker was not obligated to disclose less invasive alternatives. At trial, Dr. Putnam testified that the risk of complications arising from surgery were heightened due to Mrs. Bradley having sustained significant thoracic trauma just 18 11 In addition, during his deposition, Dr. Ralph Reichle, an interventional radiologist and expert for Dr. Sugarbaker, testified that he could have performed an FNA biopsy on Mrs. Bradley without complication. -25- months or so previously. Dr. Putnam explained that scarring from a previous trauma may increase the risk of bleeding or otherwise complicate the surgery -- potentially requiring a longer procedure or adversely affecting the surgeon's ability to do the operation as efficiently as [he] could without it. Furthermore, Mrs. Bradley's scarring from her chest trauma likely contributed to the apical space12 that formed following surgery. While a physician is not required to disclose all non-negligible risks, Harrison v. United States, 284 F.3d 293, 300 (1st Cir. 2002), Dr. Putnam's testimony demonstrated that the likelihood that complications might arise was far from remote, see Harnish, 439 N.E.2d at 243 (suggesting that a surgeon need not disclose remotely possible risks) and, further, that these risks were not inherent in any operation, id. On the contrary, they were specific to Mrs. Bradley's medical situation. At trial, the jury heard testimony from Dr. Gary Strauss, an oncology expert, that an FNA biopsy, even if negative, would not rule out the possibility of cancer, especially where a patient had a particularly high risk of cancer, and that Mrs. Bradley's computed tomography (CT) and PET scans indicated that she was at 12 An apical space refers to an area where there is no lung immediately after surgery. It can also be described as a nonexpansion of the lung. -26- a high risk. Dr. Strauss also testified that it would not be reasonable for Dr. Sugarbaker to rely upon a negative FNA in this setting where everything else really points to it being cancer to say she didn't have a cancer. This testimony indicated that, under the appropriate standard of care, Dr. Sugarbaker was not required to present an FNA biopsy as an alternative prior to the surgical biopsy. By excluding Dr. Putnam's testimony, the district court effectively prevented Mrs. Bradley from presenting evidence that Dr. Sugarbaker's duty to disclose in a reasonable manner all significant medical information, Harnish, 439 N.E.2d at 243, necessitated a discussion of non-surgical alternatives and therefore from rebutting Dr. Strauss's testimony to the contrary, see Pagés-Ramírez, 605 F.3d at 116 (finding that the district court abused its discretion by refusing to allow an expert to testify in a medical malpractice case where, without [the expert]'s testimony on causation and the standard of care, the plaintiffs were unable to present evidence on two elements of their case). Dr. Sugarbaker argues that the Bradleys cannot demonstrate causation because Dr. Putnam conceded in his deposition that, if the results of an FNA biopsy had been negative, the mass would nevertheless have needed to be removed. But Dr. Putnam made no such cut-and-dried statement. While he acknowledged that removal of the mass was a possibility, he also -27- stated that a discussion of next steps was necessary in light of Mrs. Bradley's previous chest trauma. In particular, Dr. Putnam's testimony would have supported the view that a non-surgical alternative such as watchful waiting was a reasonable option following a negative FNA biopsy. It would make little sense to expand the law of informed consent such that a plaintiff, in addition to demonstrating that she would have chosen an alternate course of treatment, must also delineate the precise plan of action that she would have followed to obtain that treatment . . . . Harrison v. United States, 233 F. Supp. 2d 128, 135 (D. Mass. 2002). Accordingly, we conclude that the district court abused its discretion by excluding Opinion 3. c. Opinion 2: Dr. Sugarbaker Dissuaded Mrs. Bradley from Considering an FNA Biopsy The district court excluded Opinion 2, noting that, at most, there was evidence of nonperformance and perhaps . . . nondiscussion, but not evidence of dissuasion. But there was clear evidence of dissuasion: as described herein, Mrs. Bradley testified that Dr. Sugarbaker's assistant, Hung, told her that surgery likely would be necessary as the mass would be inaccessible by an FNA biopsy. Moreover, Mrs. Bradley's conversation with Hung in fact dissuaded her from undergoing an FNA biopsy. Following the conversation, she cancelled her previously scheduled FNA biopsy at Hartford Hospital because she did not want to go to -28- Hartford to have an FNA done only to find out they couldn't access [the mass] with an FNA. The fact that Dr. Sugarbaker did not personally dissuade Mrs. Bradley does not change the result. Hung served as Dr. Sugarbaker's assistant, and Dr. Sugarbaker's testimony at trial suggested that he was aware of Hung's views that an FNA biopsy would not be feasible for Mrs. Bradley. See Mass. Gen. Laws ch. 112, § 9E (If a physician assistant is employed by a physician or group of physicians, the assistant shall be supervised by and shall be the legal responsibility of the employing physician or physicians.). Nevertheless, Dr. Sugarbaker never recanted Hung's initial recommendations regarding the FNA biopsy. In such an instance, a jury reasonably could attribute the relevant dissuasive statements to Dr. Sugarbaker. Cf. Santos v. Kim, 706 N.E.2d 658, 661–62 (Mass. 1999) (evaluating instances where a physician may be liable for his failure to institute practices and procedures). Accordingly, the district court's factual finding that there was no evidence of dissuasion was clearly erroneous, and the district court abused its discretion by excluding Opinion 2. -29- d. Opinion 1: Dr. Sugarbaker Failed to Perform an FNA Biopsy The district court excluded Dr. Putnam's testimony regarding Dr. Sugarbaker's failure to perform an FNA biopsy because it found that this testimony was not related to an informing obligation but a performing obligation. The district court reasoned that, because Dr. Sugarbaker would not have been the doctor to perform the procedure, the failure [could] have . . . no legal significance. Insofar as this ruling pertained to the informed consent claim, the district court is correct: the informed consent inquiry focuses on the physician's disclosure obligations, rather than how a medical procedure was performed. Harnish, 438 N.E.2d at 154 (describing the informed consent doctrine as relating to a physician's failure to divulge in a reasonable manner to a competent adult patient sufficient information to enable the patient to make an informed judgment). The Bradleys contend that this Court has emphasized that a duty to disclose, if it exists . . . does not necessarily indicate any duty to offer or to perform the procedure at issue. Harrison, 284 F.3d at 301 n.8. But they misconstrue our precedents. It is true that the fact that a physician would not perform a particular procedure will not immunize him from an informed consent claim. Harrison, 233 F. Supp. 2d at 134 ([A] doctor cannot 'save' himself from liability for breach of informed consent by merely arguing -30- that . . . causation is lacking because he himself would have been unwilling to perform that procedure upon the patient's request.). But this legal analysis does not imply that the converse is true, i.e., that the non-performance of a specific procedure will sustain an informed consent claim. Again, informed consent is about disclosure, not performance. The Bradleys also contend that this testimony is relevant to their medical negligence claim, which was brought independent of any of [Mrs. Bradley's] informed-consent claims. Dr. Sugarbaker does not address this argument. The Bradleys assert that the standard of care required that Dr. Sugarbaker perform a less invasive procedure to obtain tissue for the surgical biopsy. As the Bradleys contend, the fact that Dr. Sugarbaker himself would not have performed the procedure will not foreclose a claim in the medical negligence context. Santos, 706 N.E.2d at 663 (explaining that the fact that a doctor would not personally treat a patient does not automatically absolve him of liability). Moreover, a physician's failure to perform a less invasive procedure may speak to whether he deviated from the standard of care. See Emerson v. Bentwood, 769 A.2d 403, 409 (N.H. 2001) (reversing a trial court's directed verdict where [t]he expert's testimony was sufficient for a rational trier of fact to conclude that the defendant should have employed less invasive measures -31- . . . and that said deviation from the standard of care resulted in the plaintiff's injury). Accordingly, the non-performance testimony in Opinion 1 may be relevant to the Bradleys' medical negligence claim. That said, the negligence claim does not appear ever to have reached the jury: the verdict form only references Mrs. Bradley's informed consent claim, and the jury instructions were limited to the elements of informed consent. Indeed, the jury was told that [t]his [case] is about whether there was an adequate consent to the surgery that followed, and not about the manner in which the surgery was performed. Neither party addresses whether these facts support a finding of waiver as to the medical negligence claim. In light of the poorly developed record on this issue, we leave for the district court the question of Opinion 1's relevance to the Bradleys' medical negligence claim.