On March 12, 2008, the Petitioner, the Board of Registration in Medicine, issued a Temporary Order of Suspension prohibiting the Respondent, Suzanne Rothchild, M.D. from practicing medicine pending a hearing on the merits of the allegations of misconduct described below. Rothchild appealed the Suspension Order and I heard the appeal on March 18, 2008 at the office of the Division of Administrative Law Appeals, 98 North Washington Street, Boston, MA 02114. Fourteen exhibits were marked and there is a transcript of the hearing and one tape of the arguments on the Board's Motion In Limine, which was filed at the hearing.
For reasons discussed below, I deny the Motion In Limine and recommend that the Temporary Order of Suspension be upheld.
A. Procedural History
There are two disciplinary matters pending against Rothchild. The first, BRM Adjudicatory Case No. 2006-021, DALA Docket No. RM-06-241 ("Rothchild I") concerns an April 12, 2006 Statement of Allegations in which the Board contends that Rothchild rendered substandard care in six cases (Patients A - F). A hearing in Rothchild I took place over 6 days, beginning on February 15, 2007 and ending March 27, 2008, while the summary suspension matter was under advisement.
The second disciplinary matter was brought on January 9, 2008. The Board's Statement of Allegations asserts that Rothchild rendered substandard care in two additional cases (Patients G and H). BRM Adjudicatory No. 2008-002, DALA Docket No. RM-08-28 ("Rothchild II").
On March 12, 2008, the Board amended the Statement of Allegations in Rothchild II, bringing new allegations concerning (1) the care of an eighth patient (Patient I) during labor on March 10, 2007, (2) restrictions which Winchester Hospital has placed on Rothchild's privileges there and (3) the imminent termination by Rothchild's current malpractice insurer on her coverage for liability arising out of obstetrics practice and other specified procedures. The Summary Suspension order issued shortly after the new charges were added.
B. The Record on Summary Suspension
The record offered by the Board in support of the Summary Suspension is voluminous. It includes, inter alia, various of Rothchild's license and license renewal applications; medical records of the labors, deliveries and autopsies in the cases in issue; and numerous insurance and peer review records evaluating Rothchild's treatment in these cases. Also before the Board is the written record of proceedings in Rothchild I through March 20, 2007 (the last date of hearing before the Summary Suspension was heard). This includes the transcripted testimony of Rothchild and the medical expert who reviewed the cases at issue for the Board, as well as all of the exhibits offered in that case.
1. The following facts are not in dispute.
a. On December 23, 2000, Patient A was admitted to Winchester Hospital in labor. Rothchild assumed care and coverage of the patient on the morning of December 24, 2000 and performed a caesarian section at approximately 2:33 p.m. that afternoon. The baby suffered meconium aspiration and an entrapped fetal head and died. Answer to Statement of Allegations in Rothchild I ("Answer"), ¶¶ 9 - 13.
b. Rothchild cared for Patient B throughout her pregnancy and admitted her to Winchester Hospital in early labor on December 1, 2002. After birth, the baby required transfer to Children's Hospital. Answer, ¶ 24.
c. In July 2002, Patient C was at 19 weeks gestation. An ultrasound showed that her fetus had a two-vessel umbilical cord. A Maternal Fetal Medicine Physician at Winchester Hospital recommended close fetal surveillance during pregnancy. At 37 weeks, Rothchild discovered that the fetus was in breech position. Rothchild attempted external version of the fetus in her office instead of the operating room. The procedure was unsuccessful. Answer, ¶¶ 30, 33, 34, 35 and 46.
d. Rothchild cared for Patient D, a 16-year old woman with a past medical history significant for depression, asthma, smoking and drug use, throughout her pregnancy and delivery. The patient presented in Rothchild's office in premature labor in May 2003. Answer ¶¶ 50, 51, 54 and 55.
e. On May 11, 2003, Patient E's baby was delivered with cyanosis, muscle flaccidity and no respiratory effort. The baby required chest compressions and positive pressure ventilation. ¶¶ 68, 70.
f. Patient F came to Winchester hospital in labor on or about April 9, 2000. Rothchild augmented labor with pitocin. The baby suffered a brachial plexus injury. Answer, ¶¶ 80-81.
g. On or about April 13, 2001, Rothchild began obstetrical care for Patient G, a 30-year old, insulin-dependent diabetic woman. The patient was at 36 6/7 weeks gestation on or about October 20, 2001. During labor and delivery on October 19th and 20th, the patient had intrapartum fever, nausea, vomiting and diarrhea. She delivered a deceased fetus at 23:43 on the 20th. Answer to Statement of Allegations in Rothchild II ("Answer II"). ¶¶ 4, 5, 12.
h. During the delivery of Patient H's baby on May 13, 2004, Rothchild encountered a shoulder dystocia. Answer II, ¶ 31.
Expert Opinion Testimony
2. The Board also had before it the reports and testimony of an expert in obstetrics and gynecology ("OB/GYN Expert" or "the Expert") who reviewed the medical records and treatment issues at hand. The Expert is a physician licensed in Massachusetts, a Fellow in the American College of Obstetrics and Gynecology and has served on the Executive Board of the American College of Obstetrics and Gynecology in another state, among other qualifications presented.
3. With respect to Patient A, the Expert opined that Rothchild failed to meet the standard of care in several respects throughout her management of the patient, from the morning on the date of admission through the time the baby was delivered that afternoon. Garison Affidavit, Ex. 33 at pp. 18-19. In the Expert's view, Rothchild failed to diagnose adequately and act on a nonreassuring fetal monitoring strip, resulting in delayed delivery.
4. According to a Professional Liability Insurance Interim Report of Closed Claim submitted to the hospital by Rothchild's insurer, Patient A's baby was stillborn and could not be resuscitated. Garison Affidavit, Ex. 11.
5. With respect to Patient B, the Expert opined that Rothchild fell well below the standard of care in that she failed to diagnose and act on a nonreassuring fetal heart strip and failed to timely intervene to deliver the baby. Garison Affidavit, Ex. 33, Transcript of Expert Testimony, pp. 58-98.
6. The patient's medical records, which the Expert reviewed, indicate that the baby was born hypotonic and cyanotic with poor respiratory effort. Patent B Records at p. 9, Ex. 26 to Garison Affidavit.
7. With respect to Patient C, the Expert opined that Rothchild fell below the standard of care of an average board certified obstetrician in attempting external cephalic version in her office rather than a hospital and under circumstances which presented significant contraindications for proceeding with this course of action. Transcript of Expert Testimony at pp. 100 - 141, Ex. 33 to Garison Affidavit.
8. As to Patient D, the Expert testified to concerns that Rothchild fell below the standard of care with the fetal heart monitoring strip, in failing to intervene early on in the course of the labor given a strip indicating the baby had been showing signs of distress for a period of time. Transcript of Expert Testimony at pp. 142 - 144, Ex. 33 to Garison Affidavit.
9. The Expert prepared a report to the Board based upon his review of the cases of Patient G and H. As to Patient G, he opined that Rothchild handled a difficult situation, i.e. a moderate shoulder dystocia encountered during delivery, well, with proper maneuvers and documentation. He also noted concerns about poor documentation of other information regarding the labor and delivery. Garison Affidavit, Ex. 39.
10. With respect to Patient H, the Expert noted concerns that Rothchild did not attend adequately to managing the patient's diabetes and the risks and potential complications associated with diabetes during pregnancy and delivery. Garison Affidavit, Ex. 39.
11. According to Patient I's records, she suffered a placental abruption and her baby was born flaccid and pale with no signs of respiratory effort and with the umbilical cord flat and empty of blood. The baby was transferred to Children's Hospital. Garison Affidavit, ¶ 43 and Ex. 50.
12. The Expert opined that Rothchild failed to take appropriate measures in response to a drastic and sudden change in the baby's status during Patient I's labor, as indicated by fetal monitoring, a disproportionate increase in the patient's pain and changes in uterine tone and
13. frequency. The Expert opined that these changes can represent a catastrophic event such as abruption, uterine rupture or cord prolapse, and that was in fact what was indicated in this instance. Garison Affidavit, Ex. 53.
14. The Expert further noted that a nursing incident report documents that the nurse caring for Patient I had to call repeatedly for Rothchild's assistance and reportedly, several times, Rothchild did not come when asked for assistance. Id.
15. According to the Expert, "…it appears that the family asked for the physician to come several times and the nurse relayed their desire for attention to the doctor. The physician seems to have been resistant to aiding the nurse when called several times to evaluate the fetal heart tracing, the patient's pain." Id.
16. The Expert noted further that "the nurse appears to have asked for internal fetal monitoring, but the physician never performed this procedure. The nurse also states that the physician was unkind to this family." Id.
17. The Expert opined that Rothchild had fallen below the standard of care in several respects in the case of Patient I, including a failure to properly monitor the patient; failure to respond to many of the calls from the nurse who was concerned for the patient and baby and needed the physician's aid to assess and plan for their care; and 'failure to rescue,' i.e. delaying appropriate, timely intervention. Id.
18. In concluding his review of Patient I's case, the Expert reported:
This physician continues to act in a vacuum, not working with the nursing staff so critical to proper care in the Labor and Delivery Suite, the physician lacks the insight to react and intervene when sudden, drastic changes occur in the course of her patients [sic] labors, hence the description "failure to rescue", so critical in the practice of Obstetrics.
19. In summarizing his conclusions about the care of patients A - H, the Expert opined that Rothchild lacks the critical thinking, required judgment and ability to care properly for obstetrical, surgical and gynecological patients. Garison Affidavit,
20. In her Answers to the Statements of Allegations, Rothchild denies the allegations that she rendered substandard care in these matters. In her testimony under oath in Rothchild I, she generally characterized her decisions as reasonable and medically appropriate under the circumstances, with certain exceptions. See Garison Affidavit, Ex. 32.
21. Regarding Patient B, Rothchild questioned her course of action. She testified that she had concerns about recurrent variables and lack of variability in the baby's heart rate at certain points during the labor, which concerns persisted over a span of several hours. She conceded that she did not handle those concerns as well as she would have liked, explaining:
What I normally would have done and I can't explain why I didn't do it in this case was rupture the membranes to see what color this amniotic fluid was…. If the fluid showed meconium, then I would have been more likely to go for a Caesarean. Why I didn't do that in this case, I cannot explain.
Transcript of Rothchild Testimony at p. 93, Garison Affidavit, Exhibit 32.
22. When Rothchild did rupture the membranes she did observe meconium. At that point the lack of variability in heart rate still persisted. Id. at p. 93. She did not proceed with a Caesarean section, but rather delivered the baby approximately three hours later. Id. at p. 95.
23. Rothchild also admitted that she failed to recognize the nonreassuring fetal strip. With respect to this lapse, she testified "…I can't tell you why because when I looked at the strip the next day, I couldn't believe that I sat on it, and I have no explanation."
24. Rothchild's license renewal applications as well as reports of closed claims from her malpractice insurer document a series of settled claims, in amounts ranging from $200,000.00 - $1,000,000.00. Garrison Affidavit, Exhibits 2 - 13.
Peer Review Records and Winchester Hospital Disciplinary Action
25. In November 2007, a Winchester Hospital peer review committee in the case of Patient I found that Rothchild failed to monitor the patient properly during labor, failed to take the necessary steps to perform appropriate fetal monitoring, failed to take the time to review the fetal monitoring, and failed to provide the appropriate level of assistance to the nurse. Garison Affidavit, Ex. 23.
26. The 2007 review notes that similar concerns were identified in a 2003 peer review which led the hospital to require Rothchild to attend a fetal monitoring course and to obtain consultation from another physician on all obstetrical admissions. "Despite those measures, Dr. Rothschild's clinical practice in this case raises concerns that her clinical practice has regressed to the 2003 level which led to the clinical practice monitoring and fetal monitoring course requirements." Garison Affidavit, Ex. 43.
27. As a consequence of this review, in November 2007, Winchester Hospital required Rothchild to have all labors co-managed by another physician and to attend (again) a fetal monitoring course. Health Care Facility Disciplinary Action Initial Report. Garison Affidavit, Ex. 23.
28. The Board received notice of the November 2007 disciplinary action, (based on Rothchild's conduct in the Patient I's labor and delivery in March 2007) in January 2008. Garison Affidavit, ¶ 27. Garison investigated the action and reviewed related records pursuant to a subpoena for records issued by the Board on January 15, 2008. Id. at ¶ 41 et seq.
29. In February of 2004, Rothchild's current malpractice carrier, the Medical Professional Mutual Insurance Company ("ProMutual") took remedial action which required her to limit her practice to one hospital only. In addition, "[f]or reasons of patient safety," ProMutual required Rothchild to restrict deliveries to a maximum of 10-12 deliveries per month. Garrison Affidavit, Exhibit 14.
30. On September 30, 2007, ProMutual imposed additional restrictions which required Rothchild to resign obstetrical privileges at any facility where she practices by August 1, 2008 and refrain from accepting any new obstetrical patients or performing any deliveries or other specified procedures after September 20, 2007. Garrison Affidavit, Exhibit 15.
31. Effective August 1, 2008, ProMutual will no longer insure Rothchild for OB/GYN major surgery. Garrison Affidavit, Ex. 16.
The Board has express statutory authority to regulate the practice of medicine "in order to promote the public health, welfare, and safety…" G.L. c. 112, § 5. Under c. 112, the Board is authorized to revoke or suspend a physician's license after a hearing pursuant to G.L. c. 30A. Id. The Board is also authorized to suspend a license prior to a hearing on the allegations underlying the proposed disciplinary action if the Board determines that a licensee is "an immediate and serious threat to the public health, safety, or welfare." 243 CMR 1.03(11)(a). In such cases, the licensee may seek a hearing on the necessity for the summary action within seven days after suspension. Id.
1. The Board's Motion In Limine
At the hearing Rothchild offered a series of Affidavits and letters from various people who identified themselves as current and former colleagues and patients of Rothchild. In addition, Rothchild offered the Affidavit of Alan Pinshaw, M.D., a Board Certified Obstetrician who attests that he is familiar with the allegations raised by the Board and the records produced in the Rothchild matters. He further attests, "upon my review of materials and information known to me, I attest that Dr. Rothchild does not pose an immediate or serious threat to the public health, safety or welfare." Further, regarding the testimony of the OB/GYN Expert who testified in Rothchild I, Pinshaw states "at no time in the proceedings before the Division of Administrative Law Appeals has [the OB/GYN Expert] ever indicated that Dr. Rothchild is an immediate and serous threat."
The Board has moved to exclude this evidence on the grounds that that whether the Respondent poses an immediate and serious threat is a matter of documentary evidence within the exclusive purview of the Board and is in the first instance a question of law." Petitioner's Motion In Limine at p. 1.
Board counsel correctly notes that whether a licensee is a serious threat to the public health, safety or welfare is a determination which rests exclusively with the Board. The regulation is silent, however, on whether opinion evidence offered by the licensee at a summary suspension proceeding is prohibited. To rule that there is a per se exclusion of an entire class of evidence must be balanced against due process considerations, which are a key feature of the disciplinary scheme which the Board has established. The hearing on the merits which follows a summary suspension hearing must comply with G.L. c. 30 A, and in that proceeding, the licensee would presumably be permitted to present the type of evidence the Board seeks to exclude here. See G.L. c. 30A, § 11(3) ("Every party shall have the right to call and examine witnesses, to introduce exhibits…and to submit rebuttal evidence."). Although the scope of a summary suspension proceeding is more narrow, I am not inclined to exclude outright any and all opinion evidence. There may be cases in which, for example, the licensee presents evidence which demonstrates to the Board that a summary suspension was issued in error.
Assuming without deciding that the proferred opinions are admissible, I find that they are entitled to no weight. The Pinshaw Affidavit lacks any foundation to suggest that the doctor is more competent than the Board to weigh the risks to the public in light of the evidence, including extensive expert analysis, which was before the Board. Nor is it clear that Pinshaw had before him the same evidence which the Board did. Even it he did, the Board is the agency mandated to "protect the life, health and welfare of the people at large." Giving appropriate deference to the agency's experience and expertise in executing these statutory obligations, and even by the most generous reading of the Pinshaw affidavit, the latter is plainly insufficient to overcome the Board's determination in this case.
Similarly, the affidavits and letters from Rothchild's colleagues and patients can fairly be described as testimonials attesting to her skill in assisting in obstetric procedures, her competence as a surgeon, her compassion, caring, dedication and willingness to help. None addresses the specific cases at issue in any respect; they do not show, on their face, that they are in any respect credible or reliable evidence on the question of public safety before the Board.
2. Summary Suspension
The board may suspend a license pending hearing on the question of revocation "if the health, safety or welfare of the public necessitates summary action." 243 CMR 1.03(11)(a). Rothchild argues that the Board cannot enter a summary suspension here because there is no expert opinion that she is a threat to public health, safety or welfare. The suggestion that the Board cannot make this determination seems at the least, counterintuitive when considered in the abstract. In view of the plain language of the applicable regulation, it is simply wrong. This argument confuses the medical issues, as to which expert opinion may be appropriate and necessary, with the assessment of risk to public health, safety and welfare. Plainly, the board can make the latter determination, aided with whatever appropriate resources and information it deems necessary. If it were otherwise, summary suspension proceedings could easily devolve into a battle of experts; the regulation was clearly written to avoid just such a result.
It is true as counsel for Rothchild points out that the Board "cannot use its expertise as a substitute for evidence in the record." Arthurs v. Board of Registration in Pharmacy, 383 Mass 299, 305 (1981). More to the point however in this case is the other part of the holding in Arthurs, that is that within these limits, "the Board is free to evaluate evidence in light of its expertise…) Id. (emphasis supplied) Here, the record is replete with evidence supporting the Board's conclusion .
In this context, it bears noting that the suspension order in this matter is temporary. Under the tenets of due process, what process is due turns on the nature, duration and other relevant circumstances of the deprivation at stake. See e.g. Milligan v. Board of Registration in Pharmacy, 348 Mass. 491 (1965). Rothchild is entitled to a full hearing on the merits of the Board's allegations. This additional safeguard is more than adequate to guard against the risk that the temporary suspension of her license was erroneous. See also Board of Registration in Medicine v. Peter F. Giraud, Division of Administrative Law Appeals Docket No. RM-95-584 (a standard of reasonable cause or substantial evidence, rather than a 'preponderance of evidence' standard, is appropriate to summary suspension/a pre-deprivation proceedings on a temporary suspension).
There is substantial evidence to support the agency's decision in this case. See e.g. Wang v. Board of Registration in Medicine, 405 Mass 15 at 21 (1989) (in consideration of entire record, taking into account whatever detracts from weight of agency's opinion, agency findings must stand so long as there is substantial evidence to support the findings). The record is replete with evidence sufficient to support the conclusion that Rothchild poses an immediate threat to the public health, safety, and welfare. There is evidence of a clear and consistent pattern of a physician making the same errors repeatedly, including failure to make use of and properly evaluate diagnostic tools, and repeated instances of poor judgment and apparent inertia in crisis situations, which put her patients and their babies in peril. In several of these cases, death and serious injury resulted, and in at least one instance, Rothchild herself admitted that she failed to identify dangers that later appeared obvious.
Rothchild's argument that there is insufficient of an immediate threat also fails. The impending changes in Rothchild's coverage for malpractice liability alone suffice to support the Board's determinations in this respect. Moreover, the timing of notice to the Board of restrictions on Rothchild's practice imposed by the hospital adds additional support to the finding that there is a risk of imminent harm. Notice of restrictions were imposed in November of 2007 and which were apparently prompted by her conduct in a labor and delivery which took place several months earlier (March of 2007), did not reach the Board's attention until January of this year.
Rothchild will have a further opportunity to challenge the Board's evidence at a hearing on the underlying allegations. Until then, however, given the record in this case, the Board is well within its rights to proceed in a way that minimizes any further risk of harm.
DIVISION OF ADMINISTRATIVE LAW APPEALS
Chief Administrative Magistrate
DATED: April 7, 2008