1. Ira H. Rex, III, M.D., d.o.b. 1/25/1961, graduated from Brown University School of Medicine in 1987. He has been licensed to practice medicine in Massachusetts since 1992 under certificate number 76995. He is board-certified in plastic surgery. He has privileges at Charlton Memorial Hospital, St. Anne's Hospital and the Same Day SurgiClinic in Fall River. He has an office in Fall River. (Tr. X, 953-956; Ex. 50.)
2. Patient A, d.o.b. 5/8/1965, is a transgendered male to female. She is married to Charles Baham. Mr. Baham accompanied Patient A to all of her visits to Dr. Rex. (Tr. III, 69, 81; Tr. VI, 581.)
3. Patient A first consulted Dr. Rex on June 13, 1996 because she was concerned with hollowing of her cheeks, an increase in her nasal labial folds and lines on her forehead as the result of weight loss. Dr. Rex discussed with Patient A three methods of correcting the nasal labial folds, including placement of Goretex under the skin, the use of collagen and the use of fat harvested from the patient (autologous fat). (Tr. X, 960-961; Exs. 25, 26, 6/13/1996.)
4. Dr. Rex discussed with Patient A at the June 13, 1996 visit the risks and complications of this surgery. His office note states: "Will be swollen, may have contour deformity, swelling, pain, bruising. Wants to proceed. May lose result over time and req[uire] further procedure." ( Tr. X, 961-963; Exs. 25, 26, 6/13/1996)
5. Patient A elected to proceed and on August 8, 1996 Dr. Rex performed liposuction on Patient A's abdomen and injected autologous fat into Patient A's face. On August 22, 1996, Dr. Rex saw Patient A in follow-up and noted "good result face, wants more lateral correction now." Patient A was interested in cheek implants for more lateral projection in that area, and she wanted to discuss breast implants. (Tr. X, 963-964; Exs. 25, 26, 8/8/1996, 8/22/1996; Ex. 2, pp. 20-30.)
6. At the August 22, 1996 visit, Dr. Rex examined Patient A with respect to her desire for breast implants. Dr. Rex noted in his office note that Patient A's chest wall was wide, and there was a small amount of breast tissue. A wide chest wall makes it difficult to fill up the chest wall and create cleavage. A paucity of breast tissue means that a lot of what will be seen post-operatively will be the implants. (Tr. X, 964-966; Exs. 25, 26, 8/22/1006.)
7. Dr. Rex discussed with Patient A on August 22, 1996 the risks of breast implantation surgery outlined in the McGhan booklet that is put out by the F.D.A. His office note indicates that he discussed with Patient A "pain, swelling, infection, deflation, displacement, wrinkling, other. Scar will result." (Tr. X, 969-970; Exs. 25, 26, 8/22/1996.)
8. Dr. Rex discussed with Patient A on August 22, 1996 the possibility of intra-operative bleeding that could result in a hematoma, that is, a collection of blood around the implant that might or might not require surgical drainage.
(Tr. X, 970-971.)
9. Dr. Rex discussed the possibility of wrinkling of the implants with Patient A on August 22, 1996. Wrinkling is a common problem with implants and will be more obvious when there is very little breast tissue covering the implants. (Tr. X, 971-972.)
10. Dr. Rex noted in his office note for August 22, 1996 that Patient A would require a note from her transgender counselor to be certain that it would be healthy for Patient A to acquire breasts. (Tr. X, 972; Exs. 25, 25, 8/22/1996.)
11. Patient A visited Dr. Rex again on October 3, 1996 to discuss breast implant surgery. Patient A told Dr. Rex that she wanted large implants with cleavage, without too much step-off of the upper pole. Dr. Rex discussed with Patient A the fact that large implants had more of a tendency to have a significant step-off in the upper pole and might look unnatural in that area, and the fact that the weight of the implant could lead to early sagging that might require a corrective procedure. Dr. Rex explained that he might not be able to produce the kind of cleavage that Patient A wanted. (Tr. X, 973-976; Exs. 25, 26, 10/3/1996.)
12. Patient A decided to proceed with breast implants knowing the risks of large implants and the fact that she might not be able to obtain the cleavage that she desired. Dr. Rex performed bilateral breast augmentation on Patient A on October 11, 1996 using 450cc implants over-filled to 460cc. The surgery went smoothly. (Tr. X, 976; Exs. 25, 26, 10/3/1996, 10/11/1996; Ex. 2, pp. 32-48.)
13. Patient A returned to see Dr. Rex on October 24, 1996 for a follow-up visit. Dr. Rex noted that Patient A was happy with the implants, but wanted fuller and wider cheekbones. They discussed cheek implants and further fat injections. Dr. Rex informed Patient A that cheek implants would be inserted through the mouth, and that infection and displacement of the cheek implants was a possibility that could require corrective surgery. (Tr. X, 979-981; Exs. 25, 26, 10/24/1996.)
14. Patient A returned to see Dr. Rex on December 26, 1996 about facelift surgery that Dr. Rex said would serve her better than cheek implants. Physical examination of Patient A by Dr. Rex revealed coarse nasal labial folds and labial mandibular folds (also known as marionette lines), and loose skin on the cheeks and upper neck. (Tr. X, 981-982; Exs. 25, 26, 12/26/1996.)
15. Dr. Rex discussed with Patient A facelift surgery, "including extent of surgery, recovery, scars in scalp/around ear, possibly ugly scarring, poor results, asymmetry, contour deformities, motor nerve damage, numbness, hematoma, pain, swelling, infection, other." (Exs. 25, 26, 12/26/1996; Tr. X, 985-986.)
16. Dr. Rex informed Patient A that a facelift is major surgery that requires long incisions that Dr. Rex demonstrated through a pamphlet. He described for Patient A a SMAS (superficial musculoaponeurotic system) tightening facelift that would last about ten years rather than five years. Dr. Rex informed Patient A that there is a difficult recovery after facelift that requires the head to be elevated and requires the patient to avoid bending, lifting weights and sex to prevent blood pressure from rising. He explained that there would be post-operative visits for suture and staple removal. (Tr. X, 983-984.)
17. When Patient A pulled her facial skin up to tighten it, Dr. Rex told her that he could not produce that result and he demonstrated for her a less dramatic result. (Tr. X, 984-985.)
18. Patient A did not go ahead with a facelift at that time. Her next visit to Dr. Rex was on April 15, 1998 when she presented with a complaint of wrinkling of her breast implants. (Tr. III, 73; Tr. X, 997; Exs. 25, 26, 4/15/1998.)
19. On April 15, 1998, Dr. Rex and Patient A discussed the nature of wrinkling, the difficulty of eliminating wrinkling, and ways to eliminate wrinkling, including manipulation of the scar tissue around the implants and over-inflation of the implants. They also discussed the risks of surgery. (Tr. X, 998; Tr. III, 73; Exs. 25, 26, 4/15/1998.)
20. Dr. Rex's office notes for April 15, 1998 states, "Will plan overinflation by about 10%. May not eliminate all wrinkles or help at all. Wants larger implants." (Exs. 25, 26, 4/15/1998.)
21. Patient A decided not to attempt to remove the wrinkling by overinflation of the implants in April 1998 because Dr. Rex told her that overinflation would make the implants very hard. (Tr. III, 73.)
22. Patient A next visited Dr. Rex on December 29, 1999, when she returned to discuss implant size again. Patient A was not satisfied with her breast implants because of wrinkling, and because she felt the implants were not wide enough and did not fill in the middle area between her breasts. (Tr. III, 74 -76; Tr. X, 999; Ex. 1.)
23. During the visit of December 29, 1999, Patient A indicated that she wanted 900cc implants. Dr. Rex explained that because of the size and weight of those implants, there could be premature sagging that would require surgical correction. His office note for that date indicates, "She doesn't mind and is willing to accept multiple risks. Reviewed FDA risks. Will not be symmetric." (Tr. X, 999-1001; Exs. 25, 26, 12/29/1999.)
24. On January 7, 2000, Patient A cancelled surgery to replace her breast implants with larger implants. (Exs. 25, 26, 1/7/00; Tr. X, 1001; Tr. III, 84-86.)
25. Patient A's next visit to Dr. Rex was on April 7, 2004 to discuss an exchange of breast implants and a rhinoplasty. Patient A indicated that she was also interested in a facelift after Dr. Rex told her that cheek implants would not address her concerns about the folds that go from the nose to the corner of the mouth. (Tr. III, 77-78; Tr. X, 1001; Exs. 25, 26, 4/7/04.)
26. During the visit of April 7, 2004, Patient A said that she wanted larger, high profile implants that have more projection when filled. Dr. Rex reviewed with Patient A the booklet of risks issued by the implant manufacturer, Mentor. (Tr. X, 1004, 1008-1010; Exs. 25, 26, 4/7/04; Ex. 51, pp. 9-12.)
27. During the visit of April 7, 2004, Patient A said that she wanted a more feminine looking nose which required refinement of the bulbous tip and narrowing of the dorsum. (Tr. X, 1011; Exs. 25, 26, 4/7/04.)
28. Dr. Rex noted in his office note that he had a limited ability to refine the tip of Patient A's nose and narrow her dorsum because Patient A had thick, oily skin at the tip of her nose. When a plastic surgeon performs surgery on the underlying cartilage of the nose, he is not able to get the same type of re-draping of the skin that can be achieved in a patient with thinner skin. It is more difficult to narrow a wide dorsum because of the thickness of the bone. (Tr. X, 1012-1013; Exs. 25, 26, 4/7/04.)
29. Dr. Rex discussed the risks of rhinoplasty with Patient A on April 7, 2004, including bleeding, infection, asymmetry and dissatisfaction with the results. Dr. Rex reviewed with Patient A a pamphlet on rhinoplasty. (Tr. X, 1013;
30. Patient A returned to see Dr. Rex on April 26, 2004 to discuss facelift surgery. Dr. Rex performed a physical examination of Patient A's face that revealed jowl laxity, neck laxity, and good skin tone. He wrote in his office note, "improvement expected but will be modest secondary to early changes. Wants to feel younger and more feminine. Pulls skin tight - unable to produce this effect entirely." (Tr. X, 1016-1017; Exs. 25, 26, 4/26/04.)
31. Dr. Rex expected only modest improvement because Patient A was a relatively young person so the expectations with respect to facelift surgery were more modest than the expected results of performing a facelift on a 70-year old person. By the end of the April 26, 2004 visit, Dr. Rex believed that Patient A understood his expectations with respect to each procedure that they
discussed. (Tr. X, 1018.)
32. Dr. Rex discussed the risks of facelift with Patient A on April 26, 2004, including infection, tissue loss, hematoma (the risk of which is greater in a genetic male), asymmetry, pain, numbness and scars that could require further touch-up surgery. (Tr. X, 1019-1020; Exs. 25, 26, 4/26/04.)
33. Dr. Rex reviewed a pamphlet with Patient A about facelift and gave the pamphlet to Patient A. In his notes Dr. Rex wrote, "Reviewed brochure and scars at length. Wants to proceed." (Tr. X, 1020-1023; Ex. 53.)
34. Dr. Rex told Patient A that there was a risk associated with anesthesia, but he left it to the anesthesiologist to explain the risks to Patient A and obtain informed consent from her. (Tr. X, 1024-1025.)
35. Patient A asked Dr. Rex whether she should have breast implant exchange, rhinoplasty and facelift in three separate operations rather than in one procedure. Dr. Rex told Patient A that it was less dangerous to be anesthetized once rather than three times, and she would have to pay the SurgiCenter and the anesthesiologist only once. Patient A agreed with that. (Tr. III, 88.)
36. A few days before the procedure a nurse from the SurgiClinic called Patient A and asked her whether she had discussed her planned surgery with Dr. Rex because "This is a lot of surgery." Patient A called Dr. Rex and told him what the nurse said. Dr. Rex asked Patient A to come in and see him. Patient A went to see Dr. Rex and he was angry and wanted the name of the nurse. Dr. Rex relieved Patient A's anxiety by telling her that he performed these procedures often. (Tr. III, 91-94.)
37. Patient A's surgery, including breast implant exchange, rhinoplasty and facelift went forward on April 29, 2004 at the Same Day SurgiClinic in Fall River. (Tr. X, 1026; Ex. 2, pp. 49-69; Exs. 25, 26, 4/29/04.)
38. Prior to surgery Patient A signed a Procedure Consent form for all three procedures, and a Consent for Anesthesia form. (Ex. 2, pp. 50-51.)
39. The surgery went smoothly. Anesthesia began at 8:10 a.m. The first incision was made at 8:30 a.m. The surgery was finished at 1:10 p.m. (Tr. XII, 1284-1285; Ex. 2, p. 54.)
40. Dr. Rex exchanged Patient A's breast implants for Mentor Smooth Round High Profile implants with a nominal fill volume of 630cc and a maximum fill volume of 750cc. He filled both implants to 840cc. (Ex. 21; Tr. X, 1075.)
41. After the surgery was completed, the blood had to be washed out of Patient A's hair, and she was bandaged. After Dr. Rex left the operating room, the anesthesiologist, Henry Crowley, M.D., asked Dr. Rex to return to the operating room to re-evaluate Patient A's bandages, and check an area of ecchymosis in Patient A's lower neck. Dr. Rex observed a minimal amount of staining on the bandages at the site of incisions that were stapled in the hairline above the top of the ear and in the hairline behind the earlobe. Dr. Rex's findings appeared to him to be normal and expected. (Tr. X, 1042-1044; Tr. XII, 1286-1287; Ex. 2, p. 56.)
42. Dr. Crowley did not have any concern that Patient A was actively bleeding or that Patient A was developing a hematoma. (Tr. XII, 1286-1287.)
43. Patient A was moved to the Post-anesthesia Care Unit and then to the Recovery Room at 2:10 p.m. (Ex. 2, p. 64; Tr. XII, 1288.)
44. Patient A was discharged from the SurgiCenter at 4:50 p.m. in the care of her husband, Mr. Baham, who was then her significant other. Her vital signs were stable, she had minimal discomfort, and there was no nausea or vomiting. Patient A could verbalize and ambulate; she was jovial. (Ex. 2, pp. 54, 64; Tr. XII, 1290-1291.)
45. Mr. Baham was given written discharge instructions with a phone number to call if help was needed. The printed instructions read in part: "If you should experience difficulty in breathing, bleeding that you think excessive, increased swelling, persistent nausea or vomiting, an increase in any discomfort or pain, or develop a fever, please call your physician. In the unlikely event that you cannot locate your physician, or the individual on call for the practice, go to a hospital emergency room." (Ex. 2, p. 68.)
46. Dr. Rex's handwritten instructions were as follows: "Don't do anything to elevate your blood pressure. Keep head elevated on 2-3 pillows or sleep in chair. Expect drainage tonight. Keep compression dressing in place until tomorrow. May remove dressings in AM, shower, and replace compression garment. Keep nasal splint dry and in place. Wear bra except to shower. Follow up 5-7 days." (Ex. 2, p. 68.)
47. Mr. Baham drove Patient A to their home to Malden where they arrived almost two hours later. (Tr. VI, 603.)
48. Mr. Baham tried to make Patient A comfortable by seating her upright on the couch surrounded by pillows. He used bags of frozen vegetables to help Patient A when she said she felt "warm." It then seemed to Mr. Baham that Patient A looked more swollen that he thought she should look, and he saw more blood than he thought he should see. Blood had started to drip down Patient A's neck onto her chest, and her bandages were starting to get wet with blood around the surface of Patient A's head. (Tr. VI, 605.)
49. Mr. Baham took pictures of Patient A at Patient A's request sometime between 8:30 and 10:30 p.m. (Tr. VI, 605-607; Exs. 3, 16, 42, 43, 44.)
50. Mr. Baham started to see blood not only around the top of Patient A's head, but around the back of her neck and around her cheek. He called the phone number listed on his discharge instructions and reached Dr. Rex's answering service. Within a few minutes Dr. Rex called Mr. Baham. (Tr. VI, 607-608.)
51. Mr. Baham told Dr. Rex, that Patient A "was really looking swollen and I was seeing signs of blood." Dr. Rex said it was normal to see a little trickling blood. Mr. Baham said it seemed like more than a trickle. Dr. Rex asked whether the swelling was over the entire face or on just one side. Mr. Baham said it was the entire face. Dr. Rex asked whether Patient A was in pain. Dr. Rex advised Mr. Baham to make Patient A relax, keep cold compresses around her, not let her move much, and give her a couple of pain pills. Dr. Rex said to call him immediately if there were any changes. (Tr. VI, 608-609; Tr. X, 1050-1053.)
52. Dr. Rex inquired about whether Patient A's swelling was over her entire face or only on one side, and whether Patient A was in pain, because pain and unilateral swelling are "significant indicators of facial hematoma." (Tr. X, 1051.)
53. Mr. Baham tried to make Patient A comfortable. A short time later Patient A said she was having trouble breathing. Patient A's face was swollen to two to three times its normal size. Mr. Baham tried to loosen the bandages that went from the top of Patient A's head to the bottom of her chin. He could see incisions and a lot of blood. Mr. Baham made a second call to Dr. Rex's answering service about one hour after his first call. (Tr. VI, 609-612.)
54. The answering service operator told Mr. Baham that she would give a message to Dr. Rex and have him get back to Mr. Baham. (Tr. VI, 613.) Dr. Rex did not get a call from the answering service. He did not hear from Mr. Baham again until early the next morning. (Tr. X, 1057.)
55. Mr. Baham did not get a call from Dr. Rex. Mr. Baham decided to take Patient A to the emergency room at New England Medical Center (NEMC) in Boston. (Tr. VI, 619.)
56. Upon arrival at NEMC Patient A was taken directly from the emergency room to the operating room for fiberoptic intubation by the ENT service, and evacuation of a hematoma by the Plastic Surgery service. (Ex. 39, p. 90.)
57. When Patient A was taken to the operating room, Mr. Baham made another call to Dr. Rex's answering service. The service told him that they would get a message to Dr. Rex and Dr. Rex would be in touch on Monday. Mr. Baham explained that he was at NEMC with a patient on whom Dr. Rex had operated that day. Five minutes later Dr. Rex called Mr. Baham. (Tr. VI, 621-622.)
58. Patient A was noted by the ENT service to have severe swelling of the face, lips and eyelids with a tense hematoma. An intra-nasal exam revealed inferior turbinate laceration on the right side, and diffuse mucosal bleeding on the left. Both nasal cavities were packed with surgifoam which controlled the bleeding. (Ex. 39, p. 92.)
59. The Plastic Surgery service then performed evacuation of the hematoma and ligation of bleeding vessels, including a left temporal artery branch and a vessel in the right neck. Patient A lost approximately 1.5 liters of blood. (Ex. 39, p. 89.)
60. While the Plastic Surgery service was evacuating the hematoma, the ENT service was called back in because of further nasal bleeding. Surgifoam was again packed into both nostrils which stopped the nasal bleeding. (Ex. 39, 94, Tr. VIII, 845.)
61. When Donald J.Morris, M.D., the plastic surgeon on call at NEMC first saw Patient A, he observed the most facial swelling he had ever seen. When Patient A's airway was safe, Dr. Morris removed all of the sutures and staples placed by Dr. Rex during the facelift and evacuated 500-700cc of blood. Dr. Morris found it "almost impossible to control the bleeding." He feared that Patient A would not survive. (Tr. VIII, 818.)
62. After Dr. Morris got Patient A's bleeding under control, he placed a drain on each side behind the ear and closed the wounds back up again. The drains were in the cheek, but did not go through Patient A's cheek. Dr. Morris did not make any new incisions, although it is possible that ENT or anyone assisting could have extended the existing incisions. (Tr. VIII, 826, 846-847; Ex. 39, p. 95.)
63. Patient A was transferred to the Intensive Care Unit. She was kept intubated for airway protection. On May 3, 2004, Patient A was extubated. On May 4, 2004, Patient A's drains were removed and she was transferred to the floor. On May 5, 2004, Patient A was discharged home. (Ex. 39, p. 89.)
64. After Dr. Rex spoke with Mr. Baham in the early morning of April 30, 2004 and learned that Patient A needed emergency care for a hematoma, Dr. Rex immediately called the Chief Resident. Dr. Rex made three calls to NEMC on April 30, 2004 to check on Patient A's condition. He was informed that she was doing well, was ventilated and agitated. (Tr. X, 1058-1059; Exs. 25, 26, 4/30/04.)
65. After April 30, 2004, Dr. Rex called NEMC at least twice a day to check on Patient A's status. He spoke with the ICU nurse caring for Patient A. Then he learned that Patient A had been discharged. Patient A called Dr. Rex's office on May 7, 2004 for medication. (Tr. X, 1060-1061; Exs. 25, 26, 5/7/04.)
66. Patient A went to Dr. Rex's office on May 10, 2004. Dr. Rex noted that she was healing normally except for an area behind her right ear that was necrotic. He noted moderate swelling. He removed sutures and noted that Patient A's nose was corrected. (Tr. X, 1064-1065; Exs. 25, 26, 5/10/04.)
67. During the visit of May 10, 2004, Mr. Baham expressed his anger at Dr. Rex's answering service for not allowing him to speak with Dr. Rex on his second call to Dr. Rex on April 29, 2004. Mr. Baham told Dr. Rex that the service advised him to go to the emergency room. Dr. Rex wrote a complaint to the answering service. (Tr. X, 1062-1063.)
68. Patient A's next visit to Dr. Rex was on May 18, 2004. Dr. Rex removed the staples and noted that Patient A's scalp was healing well. He noted decreased swelling and that all surgical sites were healing normally. Dr. Rex noted that Patient A's breasts were softening and were of a good size with good placement. He believed Patient A's nose showed good correction. (Tr. X, 1065-1066; Exs. 25, 26, 5/18/04.)
69. Patient A's next visit to Dr. Rex was on May 24, 2004. Patient A was concerned that the skin on her face was not tight enough. Dr. Rex could not pull the skin any tighter; a lot of skin had been removed in the surgery. Dr. Rex thought the result was as he had anticipated. Significant swelling after a facelift lasts about six weeks and continues to get better over six months. (Tr. X, 1067-1069; Exs. 25, 26, 5/24/04.)
70. Patient A's last visit to Dr. Rex was on June 14, 2004. She was still concerned about her facial skin not being tight enough. Dr. Rex told her he did not think further correction was possible. Patient A was concerned that one breast appeared bigger than the other, although Dr. Rex had put equal amounts of fluid in each implant during surgery. Dr. Rex explained that he could do a revision, but it was too early to make a decision on that. He noted that Patient A's face was healing well. (Tr. X, 1069-1070; Exs. 25, 26, 6/14/04; Tr. III, 126 - 137.)
71. Sometime in June 2004, Patient A had a telephone conversation with Dr. Rex in which she outlined her complaints about the outcome of her surgery. Patient A felt that Dr Rex was unresponsive to her concerns and she decided to contact Cynthia Hines, M.D., the CEO of the SurgiCenter. (Tr. III, 145-146.)
72. On June 25, 2004, Patient A consulted Jaromir Slama, M.D.at Beth Israel Deaconess Medical Center about a revision of her facelift and breast augmentation. She was advised that revision surgery only two months after a facelift was not advisable. She was told that the earliest to consider revision surgery was six to eight months after the initial surgery. Patient A was told of the low likelihood of improving the appearance of her nasal labial folds.
73. In or about the end of July 2004, Patient A wrote to Dr. Hines asserting that she had been trying for a month to get her medical records from Dr. Rex, and she had just learned from someone in the SurgiCenter records department that there was no operative note for the April 29, 2004 procedures. (Ex. 41.)
74. By letter of August 4, 2004, Patient A requested that Dr. Rex provide her with her medical records. (Exs. 17, 19.)
75. On August 4, 2004, Dr. Rex dictated his operative note for the procedures done on April 29, 2004. The note was transcribed on August 9, 2004. Dr. Rex did not dictate his operative note until he was informed by the SurgiCenter that there was no operative note in Patient A's chart. (Ex. 2, pp. 65-67; Ex. 55; Tr. X, 1073-1074.)
76. Dr. Rex's operative note contains an error. He did not insert 700cc implants filled to 840cc. He inserted 630cc implants filled to 840cc. (Tr. X, 1075.)
77. About three months after the surgery, Patient A had photographs taken. (Exs. 8-15; Tr. III, 126-137.)
78. By cover letter of August 11, 2004, Dr. Hines mailed to Patient A her medical records, including Dr. Rex's operative note. (Ex. 20.)
79. By letter of September 27, 2004, Patient A requested that Dr. Rex provide her with pre-operative pictures taken at his office. The photographs were provided to Patient A on or about October 18, 2004. (Ex. 18; Exs. 4-7.)
80. In November 2004, Patient A consulted Michael Yaremchuk, M.D. about having a chin reduction and a midface lift with reduction of the mandibular angles. Dr. Yaremchuk indicated that the combined procedures would cost $11,500.00 plus $350.00 to stay overnight. (Ex. 30; Tr. IV, 348.)
81. By letter of January 5, 2005, Patient A demanded that Dr. Rex return to her the money she had paid him for the procedures of April 20, 2004 which totaled $15,900.00. (Ex. 31; Tr. IV, 349.)
82. Dr. Rex responded by letter of January 25, 2005 agreeing to reimburse Patient A $15,900.00 if she would withdraw her complaint against him at the Board of Registration in Medicine with the following proviso: "The Board of Registration in Medicine must agree that it is appropriate to fully resolve this dispute with a monetary transaction and that no ethical or moral codes are thusly infringed." (Ex. 24; Tr. IV, 351-352.)
83. In May 2005, Patient A consulted Sheldon J. Sevinor, M.D. regarding revision surgery to her face, nose and breasts. Dr. Sevinor noted, "She states that at NEMC they had to extend the incision across the entire scalp and she was in the ICU for six days." Dr. Sevinor did not recommend revision surgery. He suggested Restalyne for the nasal labial folds and marionette lines. (Ex. 28.)
84. In an undated letter to Dr. Rex probably mailed sometime in May 2005, Patient A asked Dr. Rex to call her to bring the dispute between them to an end. (Ex. 23, Tr. IV, 356.).
85. In an undated letter to Dr. Rex, probably sent sometime in June 2005, Patient A expressed her desire to end her relationship with Dr. Rex. She stated. "You had Kim call my home and make an offer and a commitment, and then I never heard from you again." (Ex. 32; Tr. IV, 354)
86. Dr. Rex's office note from June 20, 2005 indicates that someone in Dr. Rex's office called Patient A and said Dr. Rex would be amenable to returning $19,000.00 to her. Patient A was to think about the offer and call back on June 23, 2005. The note also indicates that Dr. Rex told Patient A it would be improper for him to refer her to another plastic surgeon for revision surgery. (Exs. 25, 26, 6/20/05.)
87. Sometime after June 30, 2005, Patient A forwarded to Kim in Dr. Rex's office Dr. Yarmechuk's estimate for revision surgery prepared in November 2004. (Ex. 33, Tr. IV, 358.)
88. Dr. Rex's office notes for June 28, August 25 and August 29, 2005 indicate that Patient A had not returned phone calls to Kim with respect to Dr. Rex's offer of settlement. (Exs. 25, 26, 6/28/05; 8/25/05; 8/29/05.)
89. By letter of September 14, 2005, Dr. Rex mailed to Patient A a Mutual Release and Settlement Agreement. (Ex. 34.)
90. Patient A did not sign the Release. She wrote one more letter to Dr. Rex in or about October 2005, asking him to "refrain from initiating any and all communication with me." (Ex. 35, Tr. IV, 365-367.)
91. On February13, 2007, Patient A consulted Sumner Slavin, M.D. about revision surgery. Dr. Slavin opined that Patient A was a good candidate for revision of the facelift, but would continue to have severe scars. He suggested the use of gel implants with the use of AlloDerm to smooth the take off from the chest wall of the breast implants. Dr. Slavin referred Patient A to Mark B. Constantian, M.D. for rhinoplasty revision. (Ex. 37.)
92. On February 26, 2007, Patient A consulted with Dr. Constantian about revision of her thinoplasty. Dr. Constantian opined that he would not recommend a secondary facelift because he did not believe sufficient improvement could be obtained. He suggested Restalyne to correct the asymmetry of the nasal labial folds. (Ex. 29.)
The Board of Registration in Medicine has not met its burden of proving, by a preponderance of substantial evidence, that Ira H. Rex III, M.D.'s care of Patient A was substandard, except for the fact that he failed to produce an operative note until four months after surgery.
Risk of multiple surgical procedures performed at one time
The Board's expert witness, Sumner Slavin, M.D., testified that there is a difference of opinion among plastic surgeons about the increased risk of performing several plastic surgical procedures at one time. He opined that full disclosure of the risk of each procedure must be communicated to the patient, verbally and in writing. (Tr.V, 442-445; 495-496; Ex. 38, p. 2.)
Dr. Rex's expert witness, Kenneth A. Marshall, M.D., testified that the risk of performing several procedures at once is the risk of increased anesthesia. Otherwise, multiple procedures can be done safely in patients who are not otherwise compromised by significant systemic illness. (Tr. IX, 913-914; 934-935.)
I conclude that because there is a difference of opinion among plastic surgeons about the risks of multiple procedures, I cannot conclude that Dr. Rex's care of Patient A was substandard because he did not specifically speak with her about the increased risk of multiple procedures or the increased risk of longer anesthesia. Dr. Rex did advise Patient A extensively about the risks of breast implants, rhinoplasty and facelift as documented in his office notes. Furthermore, he provided Patient A with brochures that outlined the risks of each procedure.
Although both Patient A and Mr. Baham deny that Dr. Rex advised them of the risks of each procedure, and deny that Dr. Rex provided Patient A with a pamphlet relative to each procedure, I conclude that Dr. Rex's office notes made contemporaneously with Patient A's visits to him beginning in 1996 are more reliable than the respective memories of Patient A and Mr. Baham from more than 12 years ago. I have no doubt that Patient A and Mr. Baham testified truthfully. I believe their memories are faulty. I do not believe that Dr. Rex purposely put misinformation into his office notes and I relied upon his office notes in making my findings of fact.
Informed consent signed by Patient A
Patient A signed one consent form on April 29, 2004 relative to all three procedures. (Ex. 2, p. 51.) Dr. Slavin opined that this form is inadequate. (Tr. V, 444.) Dr. Marshall opined that it is not necessary for a patient to sign a different consent form for each procedure. (Tr. XI, 1158-1160.) Both experts agree that Dr. Rex disclosed to Patient A the risks of all three procedures as evidenced in his office notes.
The first paragraph of the consent form Patient A signed reads, "I have been made aware, to my complete understanding and satisfaction, of the nature and the purpose of the operation. Possible alternative methods of treatment, and the risks and consequences that are commonly associated with the procedure(s) or surgery described above."
The consent form Patient A signed contemplated that her doctor had already disclosed the risks of the procedures to her, as, in fact, Dr. Rex had.
In view of the fact that the experts disagree on whether the consent form is adequate, and in view of the fact that Patient A had been made aware of the risks of each procedure and acknowledged that she had been made aware when she signed the form, I conclude that Dr. Rex did not breach the standard of care by using this one consent form for all three of Patient A's procedures. It was not necessary for the consent form to reiterate all of the risks of all of the procedures of which Patient A had already been informed.
Failure to arrange for overnight care/traveling home
Dr. Slavin testified that he recognizes differences of opinion among plastic surgeons with respect to whether a genetic male, after undergoing facelift, rhinoplasty, and breast implant replacement requires overnight hospitalization. (Tr. V, 445-446.)
Dr. Marshall opined that Dr. Rex's postoperative care of Patient A met the standard of care because Patient A was stable at the time of discharge. There was no indication at the time of discharge that would require Patient A be kept in Fall River. There are good facilities close to Malden in case of an emergency, and Patient A was released into the care of Mr. Baham. (Tr. IX, 915-920; Tr. XI, 1192-1193.)
Dr. Marshall also opined that a patient should be informed that she has the choice to stay in a hospital after day surgery and pay for hospitalization if she so chooses. (Tr. XI, 1166-1167.) There is no evidence that Dr. Rex ever made Patient A aware of this choice, nor is there evidence that Patient A would have chosen to stay in a hospital in Fall River at her own expense if she had been informed of the choice. Neither expert testified that failure to offer this choice to Patient A was a deviation from the standard of care.
I conclude that Dr. Rex did not breach the standard of care on April 29, 2004 by allowing Patient A to return home in the care of Mr. Baham, in view of the fact that she was stable, and there were no indications that she was developing a hematoma at the time of discharge.
Mr. Baham's first telephone call to Dr. Rex on April 29, 2004
Mr. Baham told Dr. Rex that that "Patient A looked swollen and he was seeing signs of blood." Dr. Rex told Mr. Baham that trickling blood was to be expected. Mr. Baham said he thought it was more than a trickle. Mr. Baham did not testify that he told Dr. Rex he saw a "flow" of blood, or that blood was "flowing," or that Patient A was "actively bleeding," or that there was "blood coming out of a wound."
Dr. Rex inquired about the location of the swelling and the presence of pain because he was aware that unilateral swelling and pain could be an indication of a facial hematoma.
Dr. Slavin opined that if an observer who is not medically trained reports to a plastic surgeon that he sees a "flow" of blood, or "blood coming out of a wound," the surgeon ought to refer the patient to the emergency room for evaluation. (Tr. V, 448; 472.)
Dr. Marshall testified that it is not unusual to see swelling and staining of the bandages within the first twenty-four hours after a facelift, and that mere staining of the bandages is not an indication of major bleeding. (Tr. IX, 921-926; Tr. XI, 1168-1169.) Dr. Marshall reviewed the photographs Mr. Baham took of Patient A on the evening of April 29, 2004 (Exs. 3, 42, 43, 16) and opined that there was nothing visible in the pictures indicative of anything other than expected post-operative findings, and no indication of a hematoma. Dr. Marshall opined that the information provided to Dr. Rex by Mr. Baham during his first telephone call would not require the average qualified plastic surgeon to conclude that a hematoma was forming, or that Patient A should be directed to the emergency room at that time. (Tr. IX, 921-926.)
I conclude that Dr. Rex did not breach the standard of care by failing to recognize that Patient A was forming a hematoma based on the information provided to him by Mr. Baham. If Mr. Baham had said the blood was "flowing," or that there was "active bleeding," or that there was "blood coming out of a wound," I would reach a different conclusion. But based on the information provided to Dr. Rex, I accept the opinion of Dr. Marshall that there was insufficient information to form the conclusion that a hematoma was forming.
Dr. Rex's availability to Patient A during a postoperative crisis
Dr. Rex was available to Patient A by telephone on the night of her surgery. Dr. Rex called Mr. Baham back immediately after receiving the message from his answering service. Dr. Rex never received Mr. Baham's second message. Dr. Rex called Mr. Baham back immediately when he received Mr. Baham's call to the answering service from NEMC early on the morning of April 30, 2004.
Dr. Marshall opined that a doctor cannot be held responsible if an answering service does pass on a message to him. (Tr. IX, 927.)
Dr. Slavin opined that a doctor or his associates must be available to care for a post-operative patient as needed, and provide care "24/7.". (Tr. V, 477.)
I conclude that Dr. Rex was available to Patient A during her postoperative crisis, but his answering service negligently failed to pass on Mr. Baham's second call to Dr. Rex. I do not believe Dr. Rex can or should be held responsible for the failure of his answering service. I have no reason to believe that Dr. Rex would not have contacted Mr. Baham immediately if he had received the message, in light of the two telephone calls from Mr. Baham returned immediately upon receipt. Dr. Rex did not breach the standard of care.
New scars and deformities
Patient A has a small scar on her right cheek that was not there prior to surgery. (Compare, Exs. 5 and 10.) She has extensive scarring in her scalp. (Exs. 9, 13) She complains of pixie ears. She is not happy with the appearance of her nose. She is disappointed that her nipples are lateralized, and she feels her breast implants are too big.
Dr. Slavin testified that he does not know whether the scar on patient A's cheek was done at NEMC. (Tr. V, 503.) Dr. Marshall testified that the scar on the cheek could have occurred from any damage to the skin, any intentional incision in that area, or from an untoward surgical complication. He opined that the injury could occur from underneath the skin with electrocoagulation or a pressure bandage. He opined that the scar is a recognized complication of both the original procedure as well as the NEMC emergency procedure. (Tr. IX, 933-934.)
Because it is unclear when and how this scar appeared, and in view of the fact that the scar could have resulted from Patient A's emergency procedure at NEMC, I conclude that there is insufficient evidence to conclude that Dr. Rex created this scar. I cannot conclude that Dr. Rex's care of Patient A was substandard based on the scar on her cheek.
Dr. Slavin testified that he has never seen facelift scars extend all the way around the back of the neck to join at the nape, and the scarring on top of Patient A's head is more extensive than he is familiar with. (Tr. V, 437-438.) He acknowledged that opening the original incisions at NEMC can affect the cosmetic result of the facelift. (Tr. V, 504.)
In Dr. Sevinor's letter of May 24, 2005, he indicated that Patient A told him that her incisions had to be extended across her entire scalp at NEMC. (Ex. 28)
Dr. Morris, who performed the NEMC surgery, testified that he did not extend the existing facelift incisions, but he acknowledged that the ENT service or anyone assisting in the surgery could have extended the existing incisions. (Finding #62.)
I conclude that Patient A's facelift scars, although extensive, are not as the result of substandard care provided by Dr. Rex. It is likely that the scars were extended over Patient A's scalp at NEMC, as Patient A reported to Dr. Sevinor. I cannot conclude that the extensive facelift scarring was caused by Dr. Rex's substandard care.
Dr. Slavin testified, based on a review of pictures marked as Exs. 7, 10, 11 and 12 that Patient A does not have a pixie ear deformity in the pictures taken about three months after surgery. He noted some abnormal scarring of the lobe to the face which he opined was within the standard of care three months after surgery. (Tr. V, 452-453.)
I conclude that the condition of Patient A's earlobes are not as the result of substandard care provided by Dr. Rex.
Patient A's nose
After review of pictures of Patient A's nose before and after surgery (Exs. 5, 10, 11, 12), Dr. Slavin opined that he did not have an opinion regarding the appearance of Patient A's nose after surgery. (Tr. V, 465-466.) He noted in his consultation with Patient A that she had a line of demarcation on the profile of her nose between the tip area and other area that gave her a moderate supratip deformity, a fullness above the anatomy of the tip itself. He also noted the presence of a ridge on the profile. (Tr. V, 466-467; Ex. 37.)
Dr. Slavin acknowledged that the attempts made at NEMC to stop Patient A's bleeding from the hematoma, and the packing of SurgiFoam into the nose could disrupt what Dr. Rex accomplished during the rhinoplasty. (Tr. V, 489-492.)
Because Patient A's nose was packed with SurgiFoam on two occasions while Patient A was at NEMC, and because Dr. Slavin acknowledged that this can disrupt the cosmetic outcome of the rhinoplasty, I cannot conclude that the supratip deformity on Patient A's nose is the result of substandard care by Dr. Rex.
Dr. Slavin testified that if the nipples are lateralized prior to surgery, then placement of a new implant that continues that appearance is reasonable. (Tr. V, 556-557.) A review of the pre-surgery pictures with the post-surgery pictures reveals that Patient A's nipples were lateralized prior to the implant exchange. (Exs. 1, 14, 15.) There is no evidence in Dr. Rex's office notes that Patient A ever complained to him about lateralization of her nipples after the first surgery. I cannot conclude that lateralization of her nipples after the implant exchange is as a result of substandard care by Dr. Rex.
Patient A feels that the new implants are too large, but a review of Dr. Rex's office notes indicates that Patient A requested and agreed to larger implants as a way to remove the wrinkling. Dr. Rex explained to Patient A prior to surgery the disadvantages of large implants. (Findings 20, 23, 26)
There is no evidence that Patient A's dissatisfaction with the appearance of her breasts is as the result of substandard care provided by Dr. Rex.
Documentation of implant size
Dr. Rex dictated his operative note four months after Patient A's surgery. He incorrectly stated that he used 700cc implants overfilled to 840cc when he in fact used 630cc implants overfilled to 840cc.
Dr. Slavin testified that the standard of care requires that notations in a chart should be "as accurate as possible." (Tr. V, 461.) He did not testify that Dr. Rex's care of Patient A was substandard as a result of this error in the operative note. There is no evidence that Patient A was in any way harmed by this error.
I cannot conclude that Dr. Rex's error in his operative note rises to the level of substandard care.
Overfilling the implants
Dr. Rex used implants with a nominal fill volume of 630cc and a maximum fill volume of 750cc. He overfilled the implants to 840cc. He overfilled the implants by 90cc which is 12% of 750cc. (90 divided by 750 = .12 = 12%)
Dr. Marshall testified that overfill in measured in relation to the maximum fill leve. (Tr. IX, 937.)
Dr. Slavin opined that overfilling breast implants is not a deviation of the standard of care, and that in general "we overfill ten percent and when there is some ambiguity here, up to twenty percent is considered pretty much the maximum." (Tr. V, 463.) Dr. Slavin opined, "although we've been taught that ten percent is correct, there is a gray zone of a few extra percent." (Tr. V, 558.)
I conclude that Dr. Rex did not breach the standard of care by overfilling Patient A's implants by 12%.
Failure to dictate operative note for four months
I found as fact that Dr. Rex did not dictate his operative note until four months after Patient A's surgery based on Dr. Rex's letter of January 4, 2005 to the Board in which he wrote, "The operative note was not dictated on the date of surgery which is my standard." (Ex. 55.)
Dr. Marshall opined that an operative note should be dictated within 24 hours, and that dictating an operative note four months after surgery is not "good practice." (Tr. XI, 1177.)
Dr. Slavin opined that it is not within the standard of care to dictate an operative note four months after surgery. (Tr. V, 462.)
I conclude that Dr. Rex deviated from the standard of care by failing to dictate his operative note until four months after Patient A's surgery.
I recommend that the Board impose appropriate discipline.
DIVISION OF ADMINISTRATIVE LAW APPEALS