June 7, 1999

Jim Norris, Esq.

Law Firm of-

Address, ect.

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Dear Mr. Norris:

Thank you for discussing the above matter with me in some detail. As you know, I have spent considerable time over the past few months reviewing voluminous documents and files materials pursuant to this action, taken against Dr. Brian Gale by the North Dakota Board of Podiatric Medicine. This action generally alleges violations of the North Dakota Statutes, under Chapter 43-05, and in specific, 43-05-16 [g.],[k.], & [u.].

This has included:

1. Individual physician files from the office of Dr. Gale in the five cited cases including radiographs pursuant to same.
2. The proceedings & minutes of The North Dakota Board of Podiatric Medicine's deliberations and actions aimed at Dr. Gale and obtained by Dr. Gale's legal counsel.
3. Written "complaints" filed with the Board by two local Bismark orthopedists {all from the same group The Bone & Joint Center-Dr. Bopp & Dr. Hart}, against Dr. Gale relating to various patient care cases.
4. Written complaint from the administrator of the same local orthopedic group, The Bone & Joint Center, specifying generically, "grave concerns" about Dr. Gale's care in "several patient cases" without specifying the nature of those "concerns".
5. Written complaint by one Fargo orthopedist -Dr. Johnson, relating to a patient that Dr. Johnson formerly treated and ultimately was treated by Dr. Gale with surgery- this complaint was filed with a member of the Board.
6. "Excerpted report" information from Dr. Expert- the Board's expert against Dr. Gale in this action, incorporated in the formal Amended Complaint delivered to Dr. Gale. The full report was not provided or available for review. It is noted that Dr. Expert also reviewed at least three other complaints filed by the Board also generated from petition by The Bone & Joint Center, against Dr. Gale and discarded them. After investigation and Dr. Expert's evaluation, no deviation from the standard of care (SOC) nor any violations of the North Dakota Statutes was confirmed, under Chapter 43-05, and in specific, 43-05-16 [g.],[k.] & [u.]. These were all dismissed. This has left five cases incorporated into the present Amended Complaint, subject herein for review and analysis.

In each of these discarded cases, it was noted that the Board failed to consider all available information, and even more reckless failed to obtain additional file information, known to exist, that would have substantiated and justified Dr. Gale's treatments. Equally reckless, the two complainant orthopedists also failed to obtain outside records that would have provided the necessary perspective in these same cases, which were discarded. Such proper diligence would have precluded these complaints from being filed initially. Also notable, only one of the ultimate five complaints dated 12/20/98, filed by the Assistant AG-Douglas A. Bahr, on behalf of the Board against Dr. Gale originated from a patient-Shirley Sailor. This particular complaint was received by the Board on 1/29/98. All others originated from two local orthopedists of The Bone & Joint Center-local competitors. The one exception being an orthopedist from Fargo, Dr. Philip Johnson previously mentioned as a prior care giver of this particular patient. None of these cases involve allegations of malpractice nor are any professional lawsuits pending from these cases nor is there any evidence of factual disability resultant in any of these cases in the records.

All these cases are suspect based on existing file information that would lead the casual observer to conclude a conspiracy to harm Dr. Gale professionally exists both within the orthopedic group -The Bone & Joint Center, the Board and it's President Dr. Olson or both. It should be noted that the President of the Board, Dr. Olson, formerly employed Dr. Gale and subsequently has had a well known adversarial professional relationship. Additionally, it seems clear there is an animus to harm Dr. Gale professionally in his community based in part by anticompetitive considerations with The Bone & Joint Center & a few of it's orthopedic physicians as well as Dr. Olson individually along with others working in concert, within the Board. Even Dr. Johnson in Fargo, another orthopedist, had previously treated the patient in question, Geraldine Parsley and failed to consider all information available, in particular Dr. Gale's records, prior to filing his complaint against Dr. Gale to the Board. Also notable, none of these cases has resulted in professional litigation against Dr. Gale by the involved patients. This is in spite of efforts to provocate same by some of the orthopedists directly with attorneys as evidenced by file correspondence.

Also consider the complaint filed by Dr. Hart (again, of The Bone & Joint Center) related to Gladys Wright. The Board's own expert Dr. Expert, notably indicates that Dr. Hart himself (the complainant in this particular case) demonstrated "lack of competence or judgment" as well as other notable failures in his records. This included failure recognize and document loosened screws and problems with the internal fixation, obvious wrongful flexion position of the fusion site and malunion, in his improper surgery to this patient, which in the opinion of Dr. Expert, will result in the need for further unnecessary risk and surgery!

And finally, as a backdrop, please note that the Dr. Olson, the President of the Board is involved as a care provider significantly in three of the present five cases that have resulted in complaints against Dr. Gale. Two cases- Gladys Wright and Shirley Sailor- were previously operated by Dr. Olson and resulted in serious post operative problems quite apparently due to inappropriate surgery performed by Dr. Olson some years earlier. Both of these cases resulted in destroyed joints that were avoidable by proper technique and surgery. A third case of the five involved in this action against Dr. Gale by the Board, also involved Dr. Olson as a first assistant in surgery to Dr. Gale - Patricia Lautenschlager.

Many of these issues and questions are legal questions, and will be undertaken by Dr. Gale's legal counsel. It is revealing however, to demonstrate the environment in which these proceedings are taking place. There is overt hostility demonstrated between Dr. Olson (Dr. Gale's former employer), The Bone & Joint Center, and in particular, the orthopedists Dr. Hart and Dr. Bopp. Professional discrimination is a frequent general occurrence in the orthopedic community against podiatric surgeons, which is well known professionally and quietly discussed behind closed doors. (See attachment from the American College of Foot & Ankle Surgeon). With this background perspective, I would like to proceed with the individual complaints and allegations made by the Board against Dr. Gale mostly by hostile competitors. The format will address mostly the opinions and "criticisms" by the Board’s expert, Dr, Expert. "The Defense response" will also simultaneously address the formal Board Complaints, which in part, are also included in Dr. Expert's criticisms.

1. The phalangeal component of the implant was in a plantarflexed position after surgery and there was loosening of the distal component.
2. Joint congruity also failed to be kept after surgery.
3. Dr. Gale failed to diagnose loosening of the implant.

This complaint originated again, from The Bone & Joint Center without any specific allegation other than "grave concern". The records were sent from Dr. Hart who is a competing foot and ankle orthopedist in Bismarck. The complaint was filed one year after Dr. Hart’s treatment of the patient. One would wonder why such "grave concern" required so long to address and report? Dr. Hart’s criticisms are:

1. Proximal phalanx portion of the prosthesis has been put in a plantar flexed position.
2. Loosening of the prosthesis.

1. Poor judgment to use an implant in an active 49 year-old female.
2. Implant was installed with a marked plantarflexion.
3. Failed to recognize the plantar flexed distal component.

1. Prosthesis use in a 49 Y/o is not contraindicated- especially a non-silicone variety. The amount of joint destruction present made prosthesis consideration reasonable and as such, is widely practiced.
2. The alignment of the phalangeal component in the phalanx is not perfect-I agree. However, it is not angulated that far off from where it should be if it were considered to be perfect. Moreover, stiff rigid joints are difficult to realign for any experienced surgeon. The articular disk of the prosthesis is seated nicely against the metatarsal component. There is no loosening noted on any films.
3. Dr. Gale did note plantarflexion of the phalangeal component on early radiographs (progress note of 7/17/96), and believed all along this was not problematic for the patient and did not represent the site of the patients clinical pain. The sesamoids and sesamoid adhesions were believed responsible for her pain and arthrofibrosis and loss of motion following prosthesis placement.

Interestingly, this particular case represents a surgical failure of Dr. Olson, who performed the original bunionectomy some 8 years earlier on Ms. Wright. The patient admitted to pain and swelling "ever since the operation". Thus, Dr. Olson never resolved her problem. Interestingly, Dr. Olson, the President of the Board, is involved in this case.

Dr. Gale clearly did recognize that the implant was slightly plantarflexed as noted above, but did not believe it was a contributing factor to the patients post-operative problems and as such required no disclosure. Informed consent was well documented and included the possibility of an exchange prosthesis at a later date or even fusion which is clearly documented. Dr. Gale clearly indicated even these operations would probably not relieve all her pain and problems (4/16/96). Early progress was excellent with notes on 8/8/96 indicating excellent ROM and that the patient was "doing fine" in her own words. Early problems did not really develop until around 11/7/96 when the patient developed some pain around the surgical site. This was believed related to the sesamoids and plantar metatarsal prominence, which would clearly explain the nature of the pain. 11/19/96 documents pain again at the sesamoid region which is well proximal to the phalangeal base region which the Board & Dr. Expert relates as being problematic for the patient. The patient failed to return following her 11/25/96 visit and thus Dr. Gale did not have the opportunity to follow this case or determine if simple orthotics would resolve the problem. The surgery was performed on 7/8/96 (not 6/10/96 as Dr. Expert notes in his report); the bone scan was done on 3/24/97-less than nine months after the implant procedure was performed. This is within the time frame for the bone scan to still be positive normally. Bone scans can be positive after implant arthroplasty for up to years afterwards as described in the article by Herzwurm, et al in Clinical Orthopaedics, March 1997. In another study in Nuclear Medicine Annual 94, page 107, "60% of the femoral components and 90% of the tibial components demonstrate increased periprosthetic activity more than 1 year after surgery". There are not any signs of heterotopic bone formation that is often found when implant loosening occurs. The bone scan report says this can be positive due to normal post-operative changes.

On the subsequent treating surgeon (Dr. Hart) "patient questionnaire form" she states she has moderate and daily pain however she then states her activity level is described as no limitation of any recreational or daily activity, does not require the use of any walking aid. She has some difficulty with uneven ground, looks normal when she walks, wears conventional shoewear without an orthotic or insert and the foot problem mildly interferes with her life and ability to do what she wants.

The alignment according to Dr. Hart’s questionnaire was good and there was good range of motion with no restriction, and the joint was stable. There is another form labeled Foot and Ankle Rating System that has the highest (best) possible rating from Dr. Hart in all areas listed except one. This one is the MTP motion and it is rated as moderate restriction (30-74 degrees). It is confusing why Dr. Hart did not attempt simple orthotic management of this problem initially?

Surgery by Dr. Gale was clearly indicated and the patient was not an athlete or extremely active. There is no reason to suggest that a non silicone implant was an inappropriate choice. The same could be said for any of a number of other procedures chosen for this patient. In Dr. Expert’s text in chapter 28 on page 617 he states several options for this type of problem but doesn’t say implant arthroplasty shouldn’t be done in a 49 year old female. The authors go on to state on page 641 that "In cases of profound arthrosis of the first metatarsophalangeal joint, a double-stem implant is recommended." The radiographs on page 641 are very similar to this patient’s. There is no statement about age when there is profound arthrosis. On page 643 the authors have a case in which they describe "Alternatives to implant arthroplasty: first metatarsal osteotomy for severe hallux valgus. Patient is middle-aged, with good range of motion and only minor crepitation." Gladys Wright had "moderate to severe pain with attempted range of motion and decreased range of motion." In all cases cited in chapter 28 of Dr. Expert’s text the patients either had good range of motion without pain and had non-implant type procedures or they had pain with decreased range of motion and had implant arthroplasty or arthrodesis performed.

Probably one of the most interesting revelations in this entire matter is the commentary and evaluation by the NDBPN expert, Dr. Expert when he makes clear, Dr. Hart - the complainant, demonstrated "lack of competence or judgment" in his operation. Dr. Hart clearly had fused the joint in a plantar flexed position, which is a cardinal error in this procedure. This makes gait extremely difficult and painful. Why have no charges been brought against Dr. Hart in this matter for such a grievous "lack of competence or judgment", as Dr, Expert stated?

There is nothing unreasonable about the care or operative procedure performed by Dr. Gale on this patient. To the contrary, the complainants care and surgery is highly suspect for incompetence.

1. The ankle was in a position of in varus, and the tibia was posteriorly displaced on the talus.

2. Dr. Gale performed a calcaneal osteotomy in March 1994, resulting in residual varus of the foot and pain in the subtalar joint.

This complaint emanated from The Bone & Joint Center without any specific allegations. Dr. Mark Hart was the treating foot & ankle orthopedist. He treats mostly foot and ankle patients. Dr. Aaron Olson referred this case to Dr. Hart. It is difficult to determine Dr. Hart's exact criticisms-they are generic.

1. Dr. Gale undertook a procedure that "appears to have been beyond his competence".
2. The ankle is fused in varus which should have been recognized immediately as the cause of the patients painful condition.
3. Dr. Gale failed to document the cause of the patient's painful concentration on the lateral border of the foot and consult with the patient honestly.
4. Dr. Gale selected a heel osteotomy to correct the varus of the ankle.
5. Dr. Gale damaged the posterior facet of the sub talar joint during osteotomy and which caused jamming of the calcaneus against the back of the talus.
6. Dr. Gale could have performed a triple arthrodesis to solve the residual problem.
7. Dr. Gale could have considered revisional ankle osteotomy to overcome the varus.
8. The SOC requires that an informed clinician of podiatric medicine and surgery be able to recognize such errors and be able to correct or at least refer the patient to someone who can correct them.

1. The extensive training Dr. Gale underwent has qualified him for this operation.
2. Ankle arthrodesis is a known complex and difficult operation with a moderate complication factor. Malposition and malalignments are one of these complications and can occur even with a highly skilled and experienced surgeon. I myself have encountered this complication and problem after performing several hundred of these procedures. He was credentialed and considered qualified by his hospital to perform this procedure as well.
3. Dr. Gale clearly did recognize and document and discuss the problem with the patient and attempted resolution with valgus heel osteotomy.
4. Calcaneal osteotomy can overcome hindfoot/ankle malalignment and is an often-used concept in reconstructive foot & ankle surgery.
5. The calcaneal osteotomy does appear to have entered the posterior process of the talus, which is a non-articular region and should present no significant problem. This was performed as anterior as possible in order to realign as much as possible of the posterior calcaneal tuber into valgus to overcome the deformity.
6. Triple arthrodesis indeed could have been considered as a revision. This however is much more extensive and disabling to the patient and an alternative less invasive operation is not unreasonable as a first attempt, especially when the mid tarsal joint was intact, as in this particular case. Dr. Hart offered the patient a sub talar joint fusion-not a triple fusion, so he obviously also felt a hindfoot procedure could resolve the problem as well. It is also clear the original injury could have initiated the arthritic process in the sub talar joint as noted by Dr. Hart himself when referring to the onset of ankle joint arthritis, post traumatic. The same concept is plausible for the sub talar joint along with mechanical compensation in this joint which occurs naturally following an ankle fusion-this is well known.
7. Agreed-revisional ankle osteotomy could have been considered. Ankle fusion osteotomy on the other hand is a difficult to achieve status compared to calcaneal osteotomy and there is considerable risk of non-union on a second operative attempt that would justify a lesser-involved concept.
8. Dr. Gale did recognize the problem and did attempt a conservative resolute operation. Had the patient remained with Dr. Gale in post op follow up, perhaps it would have become clear subtalar fusion or even triple arthrodesis was required as a more definitive solution and could have been accomplished with no further damage or untoward effects.

Dr. McKenzie was at Q & R Clinic and saw patient after Dr. Hart saw her. He is also an orthopedist. He agreed with Dr. Hart that a subtalar joint (STJ) fusion should help her considerably and states that she had excellent relief from the Marcaine injection Dr. Hart gave her to see how much relief she would get after this type of procedure. The patient questionnaire from The Bone & Joint Center on 12/19/94 states the patient has pain on the outside of her ankle not foot. There is no place in the record where it states the patient is having forefoot pain contrary to Dr. Expert's conclusion in this regard.

The patient was referred from Dr. Gale to Dr. Fanous, another Doctor of Podiatric Medicine, for a second opinion and the patient never returned to Dr. Gale after Dr. Fanous saw her. Dr. Fanous, Hart, McKenzie all told the patient she needed a sub talar joint {STJ} fusion-not triple arthrodesis which was also suggested by Dr. Expert. There is an abundance of literature, which discusses STJ arthritis after ankle fusion at a rate of about 50%. It is indeed reasonable, based on my experience, that this patient probably had the STJ arthritis starting from the original severe fracture injury which subsequently progressed more rapidly after the ankle fusion. Factually, the ankle fusion itself could have accelerated this process as well; this is a known possible complication of ankle fusion. Notable, the ankle arthritis progressed very quickly from the original injury which was around 8/91. Radiographs from Q & R Clinic about 6 month subsequent 2/92 already showed narrowing of this joint. Within 3 months subsequent 5/92, a tomogram demonstrated "severe narrowing". A similar and plausible sequence of events might well have engaged at the sub talar joint in particular, following arthrodesis of the ankle, which quickly accelerates occult problems in the STJ.

Dr. Expert states on page 5 of his report that the best surgeons have problems such as the ones Dr. Gale had during first the varus position of the fusion and then the repositioning of the distal pin. Then on page 8 he states that "The problems he (Dr. Gale) had with those two surgeries suggest he may not be the most proficient surgeon. It simply suggests he may be undertaking procedures beyond his competence". The complexity of these type procedures carries these same risks and complications regardless of which experienced surgeon performs the procedures. As noted early, I have encountered these identical problems after several hundred of these procedures. Clearly Dr. Gale is highly trained and experienced-there can be no question about this. His training records will demonstrate this.

Dr. Expert states on page 5 that Dr. Gale obviously recognized the fixed varus position of the foot. Then on page 8 Dr. Expert states that the standard of care {SOC} does demand that he be able to recognize a complication of fusion of the ankle in a varus position. This clearly is contradictory to the facts noted on page 5 of his report mentioned earlier?

Dr. Expert states on page 8 of his report that "the SOC further requires that he know that to correct a varus positioned fusion of the ankle the forefoot varus must be corrected as well as the heel". Dr. Gale noted in his pre-operative examination of 2/15/93, prior to the original ankle fusion surgery that she has a significant pes planus and heel valgus that she may need a subtalar joint fusion or triple arthrodesis or other surgery in the future, because of the increase strain to the subtalar joint after the ankle is fused. She understood this and desired to proceed with the ankle fusion. This demonstrates that Dr. Gale has the knowledge to understand the procedures and possible complications. There is nothing in the record which states that the patient is bearing weight on her fifth metatarsal base and having pain in this area. Furthermore, the same progress note of Dr. Gale reflects the fact that he injected the ankle joint with local anesthetic and the patient had significant relief however not complete relief of her pain. This suggests that there was other occult pathology and probably occult arthritis starting in other areas of her foot, more than likely at the subtalar joint.

In The Comprehensive Textbook of Foot Surgery, Chapter 43, on page 1090 it states that in one study 56% of the patients had significant limitation of subtalar motion.

Dr. Expert makes several assumptions including that Dr. Gale didn’t explain to the patient that she had a problem with the position of her foot. It is obvious that the patient knew that there was a problem and that the patient and Dr. Gale had several discussions about the varus from the record. The patient underwent surgery to correct the varus problem so she must have understood that there was a problem. Obviously Dr. Gale must have explained the problem to the patient and how he was going to correct it. Dr. Gale knew there was a chance the patient was having arthritis in her subtalar joint however at the time there were minimal to no signs of it radiographically therefore Dr. Gale chose to try to avoid fusion in hopes of maintaining the patient’s motion at the subtalar joint and mid tarsal joint and thus decided against triple or sub talar fusion. The mid tarsal joint has significant inherent compensatory ability in the frontal plane which could have been anticipated to overcome any residual inversion of the forefoot, if it really did exist as Dr. Expert opines.

The subtalar joint was probably damaged at the original injury but not badly enough to cause the arthritis to appear radiographically until after the ankle fusion caused increased stress. The subtalar joint would probably have become arthritic even if ankle fusion had not been undertaken. Recall also that approximately 50% of the ankle fusions will possibly require subsequent subtalar fusion due to compensatory "work overload" arthritis that occurs in the subtalar joint after ankle fusion.

The complaint says "that Dr. Gale failed to treat and care for Patricia Lautenschlager. It says that "as a result of the procedures the ankle was in a position of varus and the tibia was posteriorly displaced on the talus. Dr. Gale performed a calcaneal osteotomy in March 1994, resulting in residual varus of the foot and pain in the subtalar joint".

The chart notes and x-rays from the Q & R Clinic and Bone & Joint Clinic before and after Dr. Gale’s treatment of this patient as well Dr. Gale’s notes and x-rays were reviewed. The patient underwent closed reduction in Idaho and subsequently was treated conservatively by an orthopedist at the Q & R Clinic in Bismarck, ND. Within one year the patient developed a significant arthrosis of her ankle joint. This would indicate that the patient had a bad injury at the time and should have had an open reduction based upon the original x-rays. Dr. Gale treated the patient after two orthopedists had already told her that she would need an ankle arthrodesis. Dr. Gale performed the arthrodesis of her right ankle in March 1993.

Dr. Olson assisted with the procedure. Dr. Gale was an employee of Dr. Olson’s clinic at the time. Both Dr. Olson and Dr. Gale spent a lot of time with the patient preoperatively reviewing the possible complications and problems that could occur post-operatively. Dr. Gale states in his notes that he reviewed the specific possibility of further surgery being necessary such as a triple arthrodesis or subtalar fusion due to increased demands on the joints below the ankle. This is clearly demonstrated and factual.

The patient did have a shift of the medial malleolus post-operatively and because the ankle fusion was in good position, a decision was made to remove the medial malleolar fragment as an alternative to revising the otherwise satisfactory site. The patient healed with fusion from the procedure but continued to have pain. She felt like she was walking on the outer border of her foot and this was felt to be due to the arthrosis that was already occurring in the subtalar joint and it was noted that the subtalar joint range of motion was more limited and the heel was inverted. The ankle fusion was well healed at this point in time and appeared in good alignment. As the next several months pass, aggressive physical therapy, shoe therapy padding, and cortisone injections in the areas of pain were performed with temporary and limited improvement. She then went through a calcaneal osteotomy to evert the heel. She healed from this procedure as well but continued to have pain. The patient was sent to have a second opinion with Dr. Fanous who felt that the appropriate procedure had been done. He thought that if she continued to have pain that she might need a subtalar joint arthrodesis.

Analysis of the case does not reveal any serious technical flaws. The fusion was successfully done posterior on the talus but this is not a serious problem. The damage in the subtalar joint may have been occult and present already from the original injury and/or from the gradual increased stiffness of the ankle joint during the time prior to having the ankle arthrodesis. The fact that the subtalar joint loosened after physical therapy but was still inverted would be a good indication to do the calcaneal osteotomy as a first choice prior to the much more aggressive and major arthrodesis of the subtalar joint. Dr. Gale exhausted several non-operative treatments with temporary and limited results. The patient would have probably benefited from a subtalar arthrodesis but she decided to seek other opinions and "move on" elsewhere which did not offer him the chance for continued care. The patient went on then to seek treatment by Dr. Hart who is a local Foot & Ankle competitor and orthopedist. Dr. Hart has also sent in other complaints about Dr. Gale - this case did not emanate from the patient. Dr. Hart did nothing in regards to treatment of the patient but reviewed and criticized the records for several pages of his own. Some of the criticisms by him are general and vague.

Original Complaint by the Mrs. Sailer

1. Dr. Gale took no x-rays.
2. Her orthotics were unsatisfactory
3. Her big toe was "all screwed up"

1. Pre-operation varus was 15 degrees; final position 20 degrees varus
2. Elevation of the first metatarsal head
3. Dr. Gale failed to recognize shifting of osteotomy from earlier x-rays
4. Loosening of the screw and proximal migration of the capital fragment

1. Didn’t adequately correct hallux varus
2. Failure to recognize and deal with metatarsalgia under the second and third metatarsal heads
3. Failure to record the complications and consult with the patient
4. Bent to treat everything with surgery or steroid injections

1. Clearly, correction was not good in this case - I agree. Additionally, residual varus is apparent on the radiographs. Failure to correct, an iatrogenic hallux varus, however is not a sign of incompetence. This is an extremely difficult to resolve deformity for any experienced surgeon. I would venture to say at least 50% of all revisional hallux varus operations fail to correct the deformity. Even fusion salvage for this difficult condition often results in additional problems including non union and malunion.
2. Dr. Gale did document and recognize the residual metatarsalgia as his records indicate along with his concern for neuroma developing in the 3^rd interspace which also mimics a metatarsalgia in the entire forefoot.
3. Dr. Gale did recognize the residual hallux varus and incomplete correction; he splinted the site; he subsequently treated the neuroma with non surgical conservative care as well.
4. Surgery was entirely appropriate obviously for attempted correction of hallux varus, albeit, unsuccessful in this case. Additionally, abundant evidence of a Morton's neuroma is present in the records and progress notes and was treated initially non surgically through all accepted conventional modalities. Ultimately, excision of the benign neoplasm was accomplished on 6/25/97 and confirmed by pathology report, dated 6/26/97 with an executed signature of the Pathologist-Dr. John Hipp. So, clearly, this is documented and obviously a condition that was factually present and confirmed, contrary to Dr. Expert report that indicates no neuroma was present and no pathology report available to confirm the lesion! Additionally, Dr. Expert indicates in his report, that there is no elevatus, contrary to the Board complaint-in other words, the expert of the confirms no elevatus is present! Additionally, Dr. Expert indicates Dr. Gale's operation made no sense-which is incorrect. He did swivel the metatarsal head back medially to increase the IM angle and open the medial capsule with release, and this clearly improved the deformity on the radiographs which I reviewed after the operation. Factually, the correction did not hold up long term, and the deformity recurred based on later films I reviewed from Dr. Olson's office when Mrs. Sailor ultimately returned back there for care. Failure of an operation to successfully resolve an extremely complex and difficult iatrogenic deformity caused by a prior surgeon, is hardly evidence of wrongdoing or incompetence. All surgeons have these difficulties.

A review of the original patient complaint demonstrates her facts and allegations to be entirely untrue and confused with one exception -the final outcome. Unfortunately, Ms. Sailer is mixed up in her recollections, which is not uncommon. There are several studies in the literature that corroborate the confusion and inability of the typical patient to recall the nature of their informed consents or description and recall of their treatments. Her complaints generally focused on three elements:

1. Dr. Gale failed to take x-rays,
2. that her orthotics were unsatisfactory in some undetermined way and
3. that her big toe was all screwed up.

None of the file material confirms these impressions. To the contrary, clearly Dr. Gale did take both pre and post operative x-rays, clearly he had professional orthotics made by an accepted laboratory and the devices were made to specification. And finally, I guess, one could agree that her toe was "all screwed up" as she states, since the deformity remains, so there is truth to this. However, not due to absolute incompetence but rather the recalcitrance of this deformity and the original surgeon Dr. Olson-the President of the Board, who created the problem and deformity.

The Board allegations are senseless and without factual foundation. Clearly, the deformity was improved considerably after the operation, for some time. Of very interesting significance, again is the Board's own expert, Dr. Expert confirming that the prior surgeon-the President of the Board, Dr. Olson resected too much bone from the medial side of the metatarsal head with a resulting moderately severe hallux varus. Dr. Expert also contradicts the Board allegation of an elevatus! I also reviewed Dr. Olson's radiographs dated 1/18/97 which clearly demonstrate good weight bearing purchase of the ls metatarsal segment on the supporting surface, in his axial radiograph.

Clearly, this case was very unsuccessful for all parties, including both surgeons and unfortunately, Mrs. Sailor. Realistically, there is far more guilt in the surgeon that produced the original hallux varus- Dr. Olson- the Board President, than a subsequent salvage surgeon. - Dr. Gale.

And finally, as far as Dr. Expert's criticism that Dr. Gale was bent to treat everything with surgery and steroids -well, that is what we all do -surgical and non surgical care. His textbook is replete with this type of documentation and dissertation.

This complaint again originated from The Bone & Joint Center without any specific complaint - only generic allegations. The only thing sent was a one page single evaluation of the patient by Dr. Bopp from the Bone & Joint Center. Dr. Bopp’s criticism’s are:

1. Didn’t remove the heel spur.
2. His opinion that the calcaneal branch of the tibial nerve was cut during surgery.

1. Patient left with persistent numbness and pain following surgery on left foot
2. A tarsal tunnel release was not indicated.
3. The procedure was not properly performed in that the medial calcaneal nerve was cut.

1. Surgery not indicated.
2. Tarsal Tunnel Syndrome not diagnosed.
3. No conservative treatment of Tarsal Tunnel Syndrome.

Response:

1. The patient had pain for over one year. Abnormal EMG was documented-although the NCV was normal. This is not remarkable however and many surgeons do not rely on electrodiagnostic studies these days due to the high number of false tests with NCV's. The posterior tibial did demonstrate some abnormality and irritation, according to Dr. James Ragland - neurologist who believed it could be related to a drop in amplitude o the abductor hallucis muscle (see 11/30/94 report p.2). Also noted in this report is a "questionable postive Tinel's sign" on the right which is distinctively negative on the opposite non surgical extremity. Plantar fasciitis is also suggested in his report under "impressions". The neurologist report also confirms the radiation of her pains into the right leg. Dr. Gale's H&P MedCenter One (12/15/94) and initial exam (11/17/94) clearly document that patients problems, complaints with numbness and shooting pains with paresthesia's; there is a record of some form of injection therapy previously by another podiatric physician, but the nature of these injections are not certain. The neurologic examination he performed is entirely consistent with a possible diagnosis of tarsal tunnel syndrome, along with plantar fasciitis. Dr. Gale never makes note that he diagnosed or intended to treat heel spurs, as the NDBMP allege. This was by way if history in Dr. Gale's file provided by the patient in accordance with her prior treating physician, Dr. Fanous. Additionally, the final pathology report from the operation done on 12/15/94 indicates "chronic low grade fasciitis" from the specimen (reported dated 12/16/94 signed by pathologist Dr. D.E. Nelson.
   
2. A presumptive diagnosis of tarsal tunnel syndrome under the circumstances is entirely reasonable and prudent based on the file information when reviewed in totality. Even review of the operation report does confirm constriction in the tarsal tunnel canal as well.
   
3. Prior treatment demonstrates this patient had three injections and x-rays by Dr. Fanous. She had a considerable physical therapy which did not help. She had shoe gear modifications. She had shooting pain in her arches and ankles and it shoots into her calves. She had a history of Congestive Heart Failure and Hypertension which could cause venous canal distention problems leading to tarsal tunnel syndrome {TTS}. Her occupation was consistent with a patient that typically manifests these type problems-she stands several hours daily as a Certified Nurse Assistant at a local nursing home. Neurologic evaluation showed shooting type pain with palpation of the tarsal tunnel. Musculoskeletal evaluation showed severe pain with palpation of the plantar medial tubercle. Neurologic evaluation showed subjectively that the patient had pain in the medial right foot with radiation into the right calf and nocturnal pains. Objective examination showed heel toe walking was impossible on the right foot. Tinel’s sign in the right. The patient was using orthotics from Dr. Fanous and was not improving. The patient refused further injections and conservative treatment and insisted on having surgery to correct the problems. The notes from Dr. Bopp indicate that he took a x-ray and told the patient that she still has her heel spur. He states that "Dr. Gale supposedly removed the heel spur" and that "she was told her calcaneal spur was removed at the surgery". Dr. Bopp did nothing to confirm that Dr. Gales records contained any statements about removing the heel spur, which they don’t. Dr. Bopp states in his notes that cutting the calcaneal nerve branch "is a known complication of plantar fascial release". In fact, many surgeons cut this sensory branch intentionally as part of their operation to provide relief of this intractable condition as the plantar medial tubersity of the heel. Dr. Bopp does nothing to confirm that there is in fact a problem with the calcaneal nerve branch such as have the patient evaluated by a neurologist. Dr. Bopp does nothing to treat the patient other than a custom insert for her shoe which she already had from Dr. Fanous.

Dr. Bopp initiated this complaint without any specific written criticism of his treatment of this patient. The only information received from Dr. Bopp by the Board is the one evaluation of Ms. Pulkrabek without review of any other records, in particular Dr. Gale or Dr. Fanous as best I can tell from this review. His criticism of Dr. Gale not removing the heel spur can be explained by reviewing Dr. Gales chart and observing that there are no statements in the chart or on the surgical consent forms concerning removal of the heel spur. It is common knowledge that patients remember very little and sometimes understand very little of what a doctor says to them. Ms. Pulkrabek could have easily assumed that the heel spur would be removed because she saw it on the x-ray. According to the notes from Dr. Gale’s office there was no specific discussion of the heel spur, no was there indication in the consent that spur removal would be an objective.

Dr. Bopp also documents his opinion about the possible diagnosis and that there is no solution. Dr. Bopp could have had the patient seen by a neurologist. He could have tried one or more cortisone injections. He could have also considered surgery as a last resort to release or excise the entrapped or cut nerve if in fact this was ever definitively diagnosed?

Review of the records and Board minutes make clear, that Board then proceeded with Dr. Bopp’s "complaint" and without considering Dr. Fanous’s records pre-operatively, or any other evaluation of the patient after Dr. Bopp’s, and decided that the patient did in fact have a medial calcaneal nerve that was cut. The fact that Dr. Bopp stated in his own records that this was a common complication didn’t matter to the Board does not seem to be considered by the Board? In fact the Board’s expert Dr. Expert states in his book, "Comprehensive Textbook of Foot Surgery" that he himself edited, and in a chapter that he authored on "Acquired Neuropathies of the Lower Extremity", on page 1114, that "The diagnosis of tarsal tunnel syndrome is based on historical interview and physical findings. The distribution of sensorimotor alteration is the key to accurate diagnosis." He goes on to say "… one should not discount the clinical diagnosis of tarsal tunnel syndrome in the light of negative electro-diagnostic findings. He also references this last statement to an article by Wirth FP in Archives of Surgery in 1970.

Dr. Expert then goes on to state on page 1115 that "Conservative therapy has traditionally revolved around the use of NSAIDs combined with the control of abnormal pronatory forces and possibly shoe modifications. These measures alone have typically met with limited success." He then states that "Surgical decompression of the tarsal tunnel with external neurolysis of the tibial nerve and its branches is often necessary in the recalcitrant case." The patient was in a good shoe and had been using orthotics. She was having severe pain.

On page 1122 Dr. Expert has a section in the same chapter which discusses plantar nerve entrapment. He discusses inferior calcaneal nerve entrapment and states that "Conservative treatment can often be gratifying…" and goes on to list a number of possible treatments which can be attempted. He then points out that if these don’t work then surgery should be performed and if neurolysis doesn’t relieve the symptoms that neurectomy can be performed.

Dr. Bopp didn’t offer this list of possible alternatives to the patient. We don’t know how significant her symptoms were or how she was progressing since Dr. Bopp does not record same? We know she did not return to Dr. Bopp and he did not refer her to any other specialists which would lead one to conclude her problems are not significant at that point in time. Additionally, review of the records failed to demonstrate any petitions for disability benefits.

Dr. Expert states "The records do not indicate Dr. Gale attempted any conservative treatment. In fact the first time Dr. Gale saw the patient he did discuss the options with her as indicated on 11/17/95. Dr. Expert "presumes" the injections that Dr. Fanous gave the patient were of the heel, but there is no statement to definitively show this is true. He also states that there is no indication that there had been a prior diagnosis of tarsal tunnel syndrome or any treatment. This remains unclear but it is possible Dr. Fanous did treat symptoms of tarsal tunnel, but these records were not provided, and I doubt whether the Board reviewed these files as well? On the other hand, the records, diagnostic work up and prior treatment history with therapy and orthotics, and long standing nature of the problem is easily a justifiable premise to proceed with a presumptive diagnosis of chronic plantar fasciitis and TTS. It should be noted again, that often, many surgeon intentionally cut the medial plantar nerve intentionally as part of the plantar fasciitis condition treatment; it should also be noted that this particular interval at the medial plantar fascia is a notorious site of entrapment of another distal portion of the tarsal tunnel, commonly referred to as Baxter's nerve, which would have been released also by Dr. Gales decompression operation of the tarsal tunnel and medial slip 50% of the plantar fascia. Dr. Expert’s own statement indicating most patients need surgery for this condition also should more than adequately justify Dr. Gale’s decision to perform surgery on the patient. And finally, Dr. Gale followed the patient for one month following her surgery because she had healed. She did not return for further follow up after an appointment was made on 11/11/95. The patient stated to Dr. Gale’s nurse who did a follow up call eight days after her surgery that the patient is having "less pain than pre-op". Although desirable to follow these patients longer term, soft tissue procedures such as this can be reasonably followed within this time frame, although not optimal and in this instance, was the result of patient decision.

There are two informed consents; one from the hospital where the surgery was performed and one from Dr. Gale’s office. They both state that there may be complications and that further surgery may be necessary. The consent from Dr. Gale’s office reviews the possibility of unforeseen complications. Dr. Gale's progress note pre-operatively notes that he told the patient about possible recurrent arch, heel, or ankle pain.

It is clear that the allegations contained in the Board complaint failed to consider all information available and are simply wrong. Dr. Gale factually did properly treat and diagnose Ms. Pulkrabek with more than sufficient justification to arrive at a working diagnosis of tarsal tunnel syndrome and chronic plantar fasciitis. Review of the operation report clearly defines a conventional and thorough decompression operation. "Persisting numbness" along the medial calcaneal nerve branch as the Board allege, is a common occurrence after this operation and not entirely undesirable and often intentional by many well known surgeons in this country and abroad.

This complaint was filed by Dr. Philip Q. Johnson- an orthopedist and former treating physician of Ms. Parsley, in Fargo (Orthopaedic Associates of Fargo). The complaint was generated by letter directed to Lee Hofsommer, D.P.M. of the Board, dated 6/12/95. Dr. Johnson’s concern is quoted:

1. "Unnecessary surgery since the post operative diagnosis does not at all support the surgical findings with Ms Bodin".
2. Dr. Johnson states that the patient informed him "she had a torn Achilles tendon, yet indeed at the time of surgery there was no mention of made of a torn Achilles tendon and it appeared to be more of an exploratory of her Achilles tendon at the same time".
3. The surgery was done for a torn Achilles tendon; "she only manifested chronic Achilles tendonitis that was improving while he was treating her, and she had never demonstrated objectively or with any testing a torn Achilles tendon which is what the post operative diagnosis has been rendered as you will find in the operation report".

1. The records do not demonstrate this surgery was appropriate and Dr. Gale's post operative diagnosis did not match the operative findings.
2. Dr. Gale performed a gastrocnemius recession with exploration of the left Achilles tendon on May 2, 1994.

1. Dr. Gale’s records are inadequate to provide a basis to judge whether or not the gastrocnemius recession was justified. That his records had inadequate documentation to take his patient to surgery.
2. "Serious questions as to whether the aftercare following Dr. Gale's surgery was appropriate?
3. Paradoxical query regarding whether or not surgery was really needed, based on Dr. Gale’s records. On the other hand, Dr. Expert clearly indicates under his "observations section" that with a 4 year history of treatment and continuing painful symptoms and Dr. Johnson still reporting tightness in the Achilles that surgery may well have been justified.

1.) It seems crystal clear from Dr. Gale's records that surgery was appropriate for this patient, given the circumstances and nature of Ms. Parsley's condition and complaints and orthopedic findings. Even Dr. Johnson - the complainant- makes this clear several places in his records over an extended period of time. I wonder if we are all reading the same records? I have reviewed the documents specified in the introduction to this document and assume Dr. Expert and the Board have also reviewed these same records. Accordingly, not only is there abundant evidence of this patient's protracted chronic painful condition, with tightness in her heel cord, Dr. Gale's record reflects this. Dr. Johnson's own records repeatedly refer to an original injury of an Achilles tendon rupture, either in part or totally and this is documented in numerous locations in his files and the files of the emergency room (visit of 8/29/92). I carefully read the records of this patient, in particular Dr. Gale and Dr. Johnson and clearly the records from Dr. Gale’s office do not state that the surgery was being done for a torn Achilles tendon. Where on earth the Board and Dr. Johnson obtained this fictitious information is a mystery? Addressing Dr. Expert's and the Board specific criticism regarding lack of documentation for the gastrocnemius recession-Dr. Gale clearly makes note of the only 5 degrees of dorsiflexion with the knee extended which is 5-10 short of normal. It is clear Dr. Gale had a main concern about chronic degeneration or central rupture of the Achilles in addition to the lack of dorsiflexion and associated strain this would place on a compromised prior rupture site in the Achilles which is well documented by prior records of the ER and Dr. Johnson. It should be noted also that Dr. Gale clearly provided informed consent regarding the possible need to lengthen the Achilles (in this case accomplished by gastrocnemius recession) as confirmed in his pre op H & P dated 5/2/94. Thus it becomes more apparent that this could be part of the intended operation as well. It is an accepted practice to alter ones surgical procedure intraoperatively when circumstances present that indicate variation from the original intent. Also, consider the following:

1. The post-operative diagnosis on the operative report was "status post Achilles tendon rupture" not (acute) Achilles tendon rupture.
2. The operative report pre- and post-operative diagnoses may have been misunderstood by Dr. Johnson because the reason for the words "status post" meant chronic not acute. Dr. Gale may have selected a term which Dr. Johnson and the Board do not like, however Dr. Gale never indicated anything in his record about an acute rupture. The Board should have easily recognized this clear information..
3. If Dr. Johnson would have had the complete record from Dr. Gale's office he would have recognized that the documentation was present indicating the procedure performed
4. The operative procedure states "Exploration of Achilles tendon, previous rupture area and soft tissue mass"; it doesn’t say anything about repairing an acute Achilles tendon rupture.

Dr. Johnson treated this patient for a period of Approximately four years for problems associated with an Achilles tendon rupture. Clearly, it is unreasonable to cite Dr. Gale for Dr. Johnson's inability to recall he treated the patient for injury and rupture of the Achilles tendon!

1. Aftercare-the 2^nd criticism-the record clearly demonstrates Dr. Gale treated this patient in the emergency following surgery for an apparent fall and again in his clinic on May 10 & 18^th, 1994. A handwritten note documents that the patient failed to show up for follow up care and appointment subsequently and lost to follow up due to disconnected telephone with no new listing
2. Whether or not surgery was indicated--as noted earlier, Dr. Expert points out in one part of his report that surgery was indicated however subsequently, he questions this need? This is paradoxic and makes no sense since the prolific amount of prior history and record documentation which he must have been provided from Dr. Johnson's office, would have easily made the conclusion for surgery obvious at this point in time. In fact, Dr. Johnson even states she might need surgery. He even documents her improvement following Dr. Gales surgery in his records!

The surgery was appropriate and the records do demonstrate this fact. Ms. Parsley had a long-standing history of Achilles problems starting with a rupture treated by Dr. Johnson and which he fails to recall and is well documented in his records. He clearly noted repeatedly in various file documents and correspondences, that surgery might bed required in the future himself. He already has provided generic documentation for the need for surgery ultimately performed by Dr. Gale and which also resolved the patients chronic condition!

Disconcertingly, Dr. Johnson makes inappropriate and misleading statements to an attorney in his 6/2/95 correspondence to Mr. Al Baker, Esq. in an obvious attempt to stimulate a malpractice action against Dr Gale. The file correspondence from Dr. Johnson to Al Baker, Attorney on February 24^th, 1994 states "Geraldine will probably have problems with this down the line and there is the possibility that exists that it may require further surgical intervention for amelioration of her problems." The surgery was performed by Dr. Gale on May 5, 1994. The records from Dr. Gale do in fact spell out what Dr. Fanous is provide as far as post op care since she ultimately was to follow through with Dr. Fanous- this is very well documented in Dr. Gale's records also.

The Board and Dr. Expert have failed to make their case or validate these allegations contained in the Complaint against Dr. Gale. Quite the contrary, this entire series of events is misdirected and lacks any substance that would substantiate their claims when the record is considered in totality.

Dr. Expert, D.P.M., FACFAS

Harold Vogler, DPM, FACFAS