...OF HOW THE ONLY RECOMMENDED, (PROFIT-MOTIVATED) TREATMENT FOR
...HOW PODIATRIST AMY L. DUCKWORTH THEN PRESCRIBED OVER 1,400 NARCOTIC PILLS IN 90 DAYS TO MASK SEVERE PAIN SHE CAUSED
 |
...HOW IT TOOK FIVE MORE UNSUCCESSFUL SURGERIES TO AVOID AMPUTATION and ATTEMPT TO REPAIR THE DAMAGE... |
13 YEARS LATER, the bone remains mangled, and the victim, now over age 30, remains in chronic pain and treatment for PTSD. Duckworth's
NEGLIGENT PRESCRIPTIONS
ultimately were equally devastating.
ultimately were equally devastating.
My son's only objective was pain relief. The damage from podiatrist AMY DUCKWORTH's "experiment" not only made the pain exponentially worse, it is irreparable. The full story follows.
This post was updated as events unfolded. If reading seems long, try living it: in 2023, it is still not over. At least scroll through and see the final results.
In a kick boxing accident early in 2009, my then-18-year-old son fractured the distal medial aspect of the left great toe proximal phalanx. His PCP, Dr. Ron Sockolov of Sacramento, recommended no treatment. A year later, he continued to experience pain with movement.
My son has an extensive medical history that includes a diagnosis of ulcerative colitis in 1999 (age 7), a total colectomy (removal of the entire large bowel) with 5-month hospitalization for post-surgical complications in 2000 (age 9), cholecystectomy (large laparotomy for gall bladder removal) in 2002 (age 12), and chronic sinusitis. By 2010, he had undergone six major abdominal surgeries and three extensive sinus surgeries (ages 11, 13 and 16) and had been under general anesthesia for various procedures 25 times. During most of his almost-5-month hospitalization at age 9, he was dependent on IV morphine via PCA.
This post was updated as events unfolded. If reading seems long, try living it: in 2023, it is still not over. At least scroll through and see the final results.
2009
My son has an extensive medical history that includes a diagnosis of ulcerative colitis in 1999 (age 7), a total colectomy (removal of the entire large bowel) with 5-month hospitalization for post-surgical complications in 2000 (age 9), cholecystectomy (large laparotomy for gall bladder removal) in 2002 (age 12), and chronic sinusitis. By 2010, he had undergone six major abdominal surgeries and three extensive sinus surgeries (ages 11, 13 and 16) and had been under general anesthesia for various procedures 25 times. During most of his almost-5-month hospitalization at age 9, he was dependent on IV morphine via PCA.
January, 2010
In January, 2010, a new primary care physician, Kuo Ooi of Rocklin, ordered x-rays, diagnosed a non-union fracture, and referred him to orthopedic surgeon Roy Pottinger at the Northern California Orthopedic Clinic (name later changed to Summit Orthopedic Specialists) in Carmichael, CA.
March, 2010
After ordering studies and examining him twice, on "There is no evidence of fluid along the suspected fracture margin to indicate nonunion...REMOTE FRACTURE ALONG THE DISTAL MEDIAL ASPECT OF THE GREAT TOE PROXIMAL PHALANX WITH NO MRI EVIDENCE OF NONUNION. [At the time, we did not read or understand this and continued to believe it was the previously diagnosed "non-union."] Plantar subchondral cystic and reactive changes in the great toe proximal phalangeal head...likely secondary to altered ambulatory mechanics. Diffuse bone marrow edema in the great toe proximal phalanx and mild bone marrow edema along the base of the distal phalanx, as well as interphalangeal joint effusion..."
My son's PCP later explained that these basically were typical arthritic changes caused by the injury. A year later, another consulting podiatrist viewed the x-rays and testified to the Podiatry Board in writing that the apposition of bone appeared good and marginally articular, and the remainder of the joint space appeared clear.
March 5, 2010, at my son's first appointment with the "foot specialist," Amy Duckworth, D.P.M., she told him the pain was unlikely to resolve. Her clinical notes state:
"I advised them that the conservative options are quite limited."
(The other podiatrist who later provided his written opinion to the Podiatry Board listed numerous examples of conservative options Duckworth did not suggest. These included: immobilization, cortisone injections, modified shoes, physical therapy, oral medications, topical medications, transdermal medication, ice, compression, rest, and modified activity.
As a surgical option, Duckworth likewise did not suggest removal of only the fracture fragment, which the testifying practitioner said he would have tried. Had all the above failed to adequately relieve pain, only then would the testifying podiatrist have proceeded to fusion--not mutilation.)
Duckworth's clinical notes continue:
"We reviewed the surgical options today, and I discussed [ONLY] two options in detail with them.
1. Resection of the head of the proximal phalanx (site of the "old fracture") and replace the joint with a tissue imposition. They understand that this procedure is "experimental" and could fail. [She did not define or describe "failure" or any specific risks.] However, the advantage and goal is to (a) eliminate the pain and (b) lessen the stress on the MPJ—vs. fusion of the IPJ, as he would have increased stress and "early arthritis " in the MPJ if we fused him at this age. That being said, if this procedure fails, he is looking at having to undergo the fusion anyways [sic].*
*QUESTION: Does this statement not indicate that fusion would remain a viable option?? (Note: never let someone who writes "anyways" perform surgery.)
2. Fusion/arthrodesis of the IPJ. They understand that this is certainly the definitive procedure, but poses problems in the future as the MPJ will have "early arthritis."
My son's only objective was pain relief. His medical history was disclosed. Given only these two options and the seemingly important goal of maintaining flexibility of the joint in order to avoid "early arthritis"--and with apparently nothing to lose, since he still could "undergo the fusion anyways [sic]"--he consented to the podiatrist's experiment.
A year later, an orthopedic foot specialist flatly contradicted the contention that fusion of the IPJ causes "early arthritis" in the MPJ. He told us, "We fuse this joint all the time, and people get along just fine." In the three years following, NO orthopedic foot specialist supported Duckworth's contention that fusion of the IP joint causes "early arthritis" in the MP joint.
July, 2010
At a pre-surgical appointment on July 6,2010, Duckworth wrote a prescription for 90 10/325 hydrocodone tablets--Norco--for post-surgical pain. She stated that healing would take six to eight weeks.
For the severe pain that followed and NEVER RESOLVED, in the first 90 days post surgery, Duckworth prescribed
800 Norco's and 500 Tramadol's
--an average of 14.5 narcotic pills per day.
800 Norco's and 500 Tramadol's
Her pre-surgical clinical notes state:
"I personally reviewed the consent form including the most common risks and/or complications involved, as well as oral and written explanations of the surgery."
The only risk or potential complication she underlined on the standard surgical consent form was "infection." She did not discuss the type of "tissue" she intended to implant nor disclose any specific risks associated with it, much less her intended off-label usage of it, which the manufacturer specifically recommended against. When I asked what type of tissue it was, she said only that it was equine pericardium. She had no qualms about using this product despite our disclosure of my son's pre-existing auto-immune conditions.
Duckworth performed her "experiment" on July 9, 2010. Her clinical notes state:
Duckworth performed her "experiment" on July 9, 2010. Her clinical notes state:
"...there were no contraindications to the proposed procedure."
"MATERIALS IMPLANTED: Pegasus soft tissue graft to the proximal interphalangeal joint."
No doctor we have since consulted has ever seen or heard of the removal of this much bone for this purpose, nor of implanting this mammalian tissue in a joint space.
My son's multiple autoimmune and hyper-immune issues had been disclosed to Duckworth during his first appointment. A 2011 study (link) concludes, "Several soft-tissue dermal fillers have been reported to provoke immunogenicity [creating an immune response] and may cause adverse reactions despite claims regarding their safety."
In the year following implantation of horse tissue in his joint, swelling and inflamation never resolved. Three months later, Duckworth told him the swelling might NEVER resolve--and apparently found this outcome acceptable. In subsequent surgeries, once this foreign tissue was removed, post-surgical swelling and inflammation DID resolve, even when the bone did not heal.
Two years later, thanks to comments by the podiatrist who wrote to the Podiatry Board documenting his opinion of numerous departures from the standard of care, I learned more about the tissue used in the joint space--the Pegasus OrthAdapt bioimplant.
After hearing that he and others had long since abandoned using mammalian grafts for their intended purpose of tendon repair because of rejections, I found:
- that Duckworth's use of the implant as a spacer in the joint was "off-label" and contraindicated;
- that in a letter to the editor in the December 2010 edition of the American Journal of Sports Medicine (link), orthopedic surgeons Andreas H Gomoll, Tom Minas, Dr. Christian Probst and Sonal Sodha write,"...several surgeons commented on trying the abandoning the use of the OrthAdapt membrane (Pegasus Biologics, Irvine, California) because of foreign body reactions and synovitis." In other words, tissue rejection.
- that the FDA has 198 Adverse Event reports (link to a few) on file for the Pegasus OrthAdapt implant;
- that in adverse events in which the implant is used as a spacer, failure is attributed to the product being used "contrary to its intended use" ; (Read case #1895496 (link), which is a similar surgery.)
- that an online discussion among pharmaceutical reps (link--and switch to "view oldest first") cites multiple problems, a 17% failure rate, and calls it a POS. (For the uninitiated, that's a "piece of shit");
- and that after being acquired by Synovis in 2009, the Pegasus OrthAdapt implant has been discontinued and is no longer on the market.
"If surgeons use a product for an indication not in the approved or cleared labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain awareness of the product’s use and effects. Surgeons should appropriately counsel patients about the benefits and risks of the proposed treatment, and alternative treatments that might be available."
Apparently PODIATRISTS have NO similar policy.
From the Adverse Event reports, it appears that at the time of Duckworth's experiment, numerous other similar "experiments" already had been performed, and substantial evidence showed that on multiple occasions they had FAILED.
The Results
July, 2010
Post-surgical pain was severe, and my son continued to take the maximum prescribed dosage of Norco. When we expressed extreme concern about this, at the second post-op visit Duckworth prescribed Nucynta "to use either in combo or in place of the Norco." Blue Shield HMO denied Nucynta, a newer medication, and it was replaced with Ultram 50 mg--Tramadol.
In April, 2010, the FDA had issued a safety warning (link) for Tramadol. It states, "The strengthened Warnings information emphasizes the risk of suicide...Tramadol may be expected to have additive effects when used in conjunction with...other opioids..."
My son continued to have severe chronic pain and to take the maximum quantity of prescribed narcotics. He began his junior year as a transfer student at UC Davis and excelled, becoming a Dean's Honor Student in his first semester despite constantly being high on the prescribed narcotics and/or in pain.
August, 2010
While stargazing with friends, my son wandered away from the group, dangled his legs over the side of the 730-ft. Foresthill bridge, and for no apparent reason seriously considered jumping.
October, 2010
Three months post-op. From Duckworth's clinical notes, 10/1/2010:
[The patient] returns for a postop visit. He still notes a great deal of pain in the toe. He relates that with activities, the pain can get up to an 8/10 [on the pain scale].
He is taking 6 Norco 10/325 a day.
The MS Contin [a third narcotic she had added] not only did not help the pain, but made him "sick" in that he had headaches, felt dizzy, noted stomach pain and generalized fatigue and anxiety.
Regarding the surgical site, I advised [the patient] and his mother that the toe is still healing and even though he is out of the initial post op period (3 months) the tissue graft is still incorporating and the overall healing process can take a full year to recover from. [A dramatic departure from the "six to eight weeks" she originally predicted when selling us this surgery.] He is to expect some pain with increased activities and will continue to "listen" to the foot and rest/ice/elevate as needed.
Certainly he should be more improved, i.e. less pain than an 8/10 with activities, at this point.
We discussed [the patient's] need for increased Norco, and although he is not opiate shy due to his childhood morphine use [while hospitalized], there is concern that this is not appropriate. [OUR concern, expressed in a number of phone calls, but apparently not hers.] He does need some oral analgesic medication, but Ultram did not help and MS Contin made him ill. Therefore we will keep him on the 6 Norco 10/325 per day until he can be seen/treated by a pain management specialist."
A referral to pain management was first suggested to us and finally made by his PCP, who called and, according to Duckworth, was somewhat "angry" with her regarding her prescriptions.
Following a move from one apartment to another, pain increased significantly. A September 12 x-ray showed why. At this point, we had not seen the clinical notes indicating any question as to whether or not the graft had incorporated and assumed it was healing. Clearly a regular shoe was not sufficient protection, nor were vague warnings to protect the foot sufficiently emphasized.
December, 2012
At the post op appointment in March, x-rays showed that another accidental bump had broken two more screws. The graft was still in place, but still showed no bone growth.
At this point, he was still in pain management and had graduated to a daily combination of methadone and Percocet.
June 7, 2012 – My son was authorized for one consultation at UC Davis, but was told he was not a candidate for Dr. Lee's bone marrow trials. He was referred to Dr. Eric Giza, UCD’s brilliant and compassionate orthopedic foot specialist, whose first available appointment was September 13, 2012.
August 8, 2012 – Dr. Lee unexpectedly agreed to a consultation. X-rays showed broken screws were beginning to back out, which is common when a graft does not incorporate. He said that although my son was not a candidate for his trials (because they involve only long bones), the bone marrow aspirate could be used in his foot. However, Dr. Giza, the foot specialist, would have to determine the possibility of and perform any surgery. Dr. Lee agreed that healing the bone likely would resolve much of the pain.
September, 2012
We discussed [the patient's] need for increased Norco, and although he is not opiate shy due to his childhood morphine use [while hospitalized], there is concern that this is not appropriate. [OUR concern, expressed in a number of phone calls, but apparently not hers.] He does need some oral analgesic medication, but Ultram did not help and MS Contin made him ill. Therefore we will keep him on the 6 Norco 10/325 per day until he can be seen/treated by a pain management specialist."
A referral to pain management was first suggested to us and finally made by his PCP, who called and, according to Duckworth, was somewhat "angry" with her regarding her prescriptions.
November, 2010
November 18, 2010, Duckworth' clinical notes: "I spoke to him and his mother about the pain management issue and at this point I am not sure it is necessary to pursue this option... [The patient] is to return to the office as needed with any further questions or concerns as we are releasing him from our care." [At this point, she couldn't wait to get rid of him.]
From Sept-Nov, my son had referred to her as "the pill fairy."An internal note from the secretary to Duckworth indicates that she likely was flippant and dismissive of our multiple calls regarding the prescribing issue. (12/10/2010: "Happy friday. Pt's mom called here and is requesting to speak to you due to [the physician group denying a pain management authorization and] stating we need to f/u.") Duckworth refused--and so ends her file.
From Sept-Nov, my son had referred to her as "the pill fairy."An internal note from the secretary to Duckworth indicates that she likely was flippant and dismissive of our multiple calls regarding the prescribing issue. (12/10/2010: "Happy friday. Pt's mom called here and is requesting to speak to you due to [the physician group denying a pain management authorization and] stating we need to f/u.") Duckworth refused--and so ends her file.
The Aftermath
January, 2011
My son continued to have swelling and inflammation from the unresorbed bioimplant, accompanied by severe chronic pain. In January the insurance company finally authorized his referral to pain management. Treatment continued with Percocet, Neurontin and Tramadol.
February, 2011
Four months post-op. We consulted an orthopedic foot specialist in Sacramento. He told us that at this point he did not think any further improvement was likely. His letter to my son's PCP states, in part:
"On examination of the left foot there is diffuse swelling about the great toe. There is a L-shaped incision by the IP joint dorsally...[x-rays] demonstrate resection of the IP joint of the great toe with soft tissue interposition keeping the bones separated about 1 cm.
The patient has failed the procedure that was attempted to relieve his great toe pain on the left. We talked about that and discussed options...I don't think that there are any particular braces that will help...We talked about cortisone injection to see if it would give him relief, and also discussed surgery. The surgical treatment would be a takedown of his arthroplasty, with fusion of the IP joint using iliac crest bone grafting.
Today I injected the IP joint of the left great toe with a mixture of Marcaine, lidocaine and Kenalog. He will keep track of the response to the injection, and if it is satisfactory he may want to have injections until they become not helpful. If he would like to have surgical treatment he could have it done at any time."
Pain relief from the injection was only partial and lasted only a few days. My son decided to wait until summer, when school was out--the podiatrist's "full year"--to have revision surgery.
March, 2011
I began contacting malpractice attorneys regarding potential litigation on my son's behalf. None told me his complaint was without merit, but none would accept the case. The statute of limitations is one year from the date of surgery--ironically the exact length of time the podiatrist had advised him to wait for "complete healing."
April, 2011
An attorney finally explained why I was unable to find representation:
"The basic reason that I will not move forward with your case is because the deck is stacked heavily in favor of the defendants in medical malpractice cases. This is due to several things. First, the Northern California Orthopedic Clinic has a nearly unblemished record of returning defense verdicts in medical malpractice cases. [I wonder how many there have been.] Second, in 1975, the legislature reacting to pressure from the doctors and threats of cessation of medical care, passed an act that makes doctors, hospitals and other health care providers a privileged class in California.
Among the special provisions they received was a limitation cap on general damages, to the amount of $250,000. This means that the most you can collect is the present value of your future medical bills [minimal when one is insured], any lost wages [none when one is a student], and $250,000. [And that's even (or maybe only?) if the patient DIES.] This limitation takes the risk out of the case for the malpractice insurance carriers, so they are forcing nearly every one of these cases to trial. In most cases, expert witnesses would have to be hired to testify before a jury. Typically, by the time a jury goes out on a medical malpractice case, the plaintiff's side has spent somewhere between $50,000 and $100,000 preparing the case for trial. This makes many good medical malpractice cases economically impossible to pursue.
It is my hope that the Legislature and Governor will change these unfair laws in the future. Unfortunately, this special form of alleged "tort reform" has left victims like yourself without any real remedy. I wish that I could help you, but do not believe that I can."
DO YOU APPROVE, FELLOW CALIFORNIANS?
See more about 1975's Medical Injury Compensation Reform Act (MICRA) and it's disgusting effects HERE
May, 2011
I filed a complaint against Duckworth with the Medical Board of California. The Board's brochure How Complaints are Handled (link) explains:
"When you file a complaint it is assigned to a Consumer Services Analyst. If it is determined an investigation is needed, the case will be referred to a district office in the area where the complaint originated."
6-24-11 My son had revision surgery to fuse the joint, with bone harvested from his iliac crest used to fill the gap. "The pseudoarthrosis tissue [i.e., the POS] at the resection arthroplasty site was identified and excised and sent to pathology. Foot and hip wounds were dressed; the foot was not splinted." Afterward he remained hospitalized for two nights.
June, 2011
July, 2011
"[The patient] is back 11 days after surgery...He has had fairly significant pain after surgery. He is on a pain contract through pain management, and has used up all of his medications...I removed his dressings. The wounds in his foot and at the iliac crest donor site look like they are healing well. I took out the staples at the hip and the stitches in the foot. He really should use his post-op shoe for the next four weeks. I will check him routinely with x-rays. I gave him a refill today for Percocet 10/325 #150. Following that he will have to get further refills from his pain management doctor."
August, 2011
Letter from the Medical Board of California, accompanied by the Board's brochure, Questions and Answers About Investigations (link):
"Based upon the information you've provided, your complaint is being forwarded to the Board's Sacramento District Office for further investigation."
It is my understanding that an investigation by the Medical Board costs taxpayers $10,000 and up--so full investigations are not undertaken lightly.
August 11, 2011, post-op appointment notes:
"[The patient] is now six weeks after surgery to fuse the left IP joint with iliac crest bone graft. He has had improvement of his discomfort but still has soreness. He is down from 11 Percocet each day to taking 5 now. He is walking in a regular shoe.
"[The patient] is now six weeks after surgery to fuse the left IP joint with iliac crest bone graft. He has had improvement of his discomfort but still has soreness. He is down from 11 Percocet each day to taking 5 now. He is walking in a regular shoe.
On examination there is diffuse swelling that I think looks normal The alignment is fine. There is diffuse tenderness about the toe. He had x-rays done, and the position of the screw has not changed. I can see the bone graft, but can not say that it has incorporated yet. I think the x-ray appearance is as I would expect at this point.
He needs to protect this still, and if he can do that in a regular shoe, that is fine.
September, 2011
At an appointment the following day, the options presented were:
- Living with it--clearly not an option due to severe pain and the radiologist's finding, "The possibility of a superimposed infection is raised in this patient, given these findings."
- Redoing the graft. The surgeon's notes state, "The repeat operation would require debriding this and removing the shank of the screw and possibly the threaded portion. He would require further grafting and then fixation. The problem will be what would be adequate fixation. I would favor using longitudinal threaded pins that protrude out the tip of the toe and are kept in place for three months. I would try to not cross the MTP joint, although it could be necessary if the bone was not adequate in the proximal phalanx to hold that." He explained that crossing the MTP joint with pins could eventually damage that joint--the podiatrist's rationale for the original surgery coming true, though for a completely different reason.
- Amputation.
In anticipation of another surgery, my son dropped a half-completed, $1,200 Law School Admission Test prep course. He reduced his university status to part time, hoping to complete one Fall course.
October, 2011
Dr. Loretta Chou, the talented orthopedic foot specialist at Stanford, did not think amputation was appropriate and thought she could fix the toe. In a surgery she described as "technically challenging," she took a second graft from the iliac crest and placed it, along with BMP (bone morphogenic protein) to promote bone growth. She predicted that healing would take 3-12 months and that he would be in a cast for much of that time. Pain again was severe in both the toe and hip--more so because of scarring from the previous surgery. Post surgical instructions were for him to be non-weight-bearing on the foot and to keep it elevated above heart level as much as possible.
Due to severe pain, cognitive impairment from high levels of prescribed narcotics, reduced mobility, and the requirement to keep his foot more-or-less constantly elevated, my son was unable to complete his one remaining class. In December he retroactively withdrew from the Fall quarter.
In late December, despite the cast, he tripped and bumped the toe.
January, 2012
Januany 11, 2012 radiological findings: "Fracture of the middle screw. No significant incorporation of the bone graft. Increased disuse osteopenia." The graft was still in place, but there had been no bone growth. The cast was replaced.
After missing a week of school due to an unexpected GI infection, for the second consecutive quarter, he was forced to withdraw from all classes.
February, 2012
At his fourth post-op appointment, Dr Chou told him there was still no bone growth, and that healing could take up to 12 months to begin. She ordered an ultrasound bone stimulator for twice daily treatments at home.
After years of medical torture, this situation was the straw that broke the camel's back. Alone in his apartment and disenrolled for a second term, my son became severely depressed and self-destructive. Back at home, on Feb 19 he attempted suicide with medication. He spent 10 days in the hospital and psychiatric hospital and continues in treatment indefinitely for major depression.
March, 2012
At this point, he was still in pain management and had graduated to a daily combination of methadone and Percocet.
April, 2102
A friend emailed us a television interview of Dr. Mark Lee, a researcher at the UC Davis Institute for Regenerative Medicine who is conducting trials in which he facilitates bone healing and growth to fill bone gaps by inserting stem cells contained in concentrated bone marrow aspirate. Dr. Chou said she could not use this product but supported anything that might heal the bone.
May, 2012
After as many delays possible by Duckworth and her malpractice attorney, the Medical Board finally interviewed her and and completed its investigation. However, although the Medical Board conducts the investigations, they do not regulate podiatrists. Podiatrists are not medical doctors and are therefore self-regulated by the California Board of Podiatric Medicine. The Podiatry Board reviewed the Medical Board's findings, then sent them to their outside consultant--not a doctor, but another PODIATRIST-- for review. Most Asked Questions About Medical Consultants. (link)
June, 2012
X-rays still showed no bone growth. The Stanford surgeon told us the longest she has seen successful healing take to begin is 18 months. We had begun working on referral and insurance authorization to see Dr. Lee at UC Davis.
On June 15, 2012 the Medical & Podiatry Boards notified me of their decision:
"...during the investigation, medical and pharmacy records were obtained, and interviews were conducted, which included an interview of [the podiatrist]. During the course of the investigation, the case was reviewed by a podiatrist medical consultant. Additionally, the case was sent to an outside podiatrist expert for review. The case was also reviewed by a legal professional with specific experience in filing administrative actions against health care professionals.
Based upon the totality of our investigation...it has been determined that the Board of Podiatric Medicine would be unable to establish grounds for discipline against the licensee. Therefore this case is closed with no further action anticipated at this time."
I contacted Beth Gaines, my CA State Assemblywoman, whose staff advised that if I could submit any new information and/or a respected doctor's opinion that Duckworth's surgery departed from the standard of care, I could request that the board re-open and re-examine the case. I obtained and submitted both: a letter from a far more experienced podiatrist documenting his opinion of various departures, as well as my newly-discovered information about the off-label use and multiple documented failures of the Pegasus bioimplant.
On June 15, 2012 the Medical & Podiatry Boards notified me of their decision:
"...during the investigation, medical and pharmacy records were obtained, and interviews were conducted, which included an interview of [the podiatrist]. During the course of the investigation, the case was reviewed by a podiatrist medical consultant. Additionally, the case was sent to an outside podiatrist expert for review. The case was also reviewed by a legal professional with specific experience in filing administrative actions against health care professionals.
Based upon the totality of our investigation...it has been determined that the Board of Podiatric Medicine would be unable to establish grounds for discipline against the licensee. Therefore this case is closed with no further action anticipated at this time."
I contacted Beth Gaines, my CA State Assemblywoman, whose staff advised that if I could submit any new information and/or a respected doctor's opinion that Duckworth's surgery departed from the standard of care, I could request that the board re-open and re-examine the case. I obtained and submitted both: a letter from a far more experienced podiatrist documenting his opinion of various departures, as well as my newly-discovered information about the off-label use and multiple documented failures of the Pegasus bioimplant.
July, 2012
At the 8th post-surgical follow-up at Stanford, there still had been no apparent change. He continued in severe chronic pain and pain management. He was willing to wait a few more months but was ready to have the toe amputated in order to relieve pain. However, Dr. Chou said if the graft failed to heal, she would not remove any of the hardware and also refused to amputate, as she thought this now had only a 50-50 chance of resolving the chronic pain.
August, 2012
Dr. Giza ordered a CT scan to determine whether there had been any bone growth whatsoever and agreed to attempt a third revision, utilizing bone marrow aspirate from my son's hip. If one more revision failed, he thought amputation would have a 75% chance of resolving the pain and would be willing to do it. My son agreed to undergo one more attempt to save the toe, but pain relief was now the paramount objective.
September 24, a Medical Board investigator emailed me,saying, "the materials you provided will be further evaluated by the Expert in this case."
September 24, a Medical Board investigator emailed me,saying, "the materials you provided will be further evaluated by the Expert in this case."
October, 2012
October 18, Dr. Giza performed a third arthrodesis--and kept him hospitalized for several nights. He said one end of the graft had begun to incorporate, but the other had formed only fibrous scar tissue and never would have fused. He successfully removed the plate, seven screws and broken fragments; re-positioned and re-plated the graft, and extracted bone marrow and a small core of bone from the hip. This was placed in the gap, along with allograft and more BMP. He also re-positioned the tendon. The foot/leg was splinted. He said healing again would be slow and still was not guaranteed. If it has not healed "in a year or two" he will amputate.
The initial narcotic prescriptions paled in comparison to post-surgical needs after this surgery.
October 18, Dr. Giza performed a third arthrodesis--and kept him hospitalized for several nights. He said one end of the graft had begun to incorporate, but the other had formed only fibrous scar tissue and never would have fused. He successfully removed the plate, seven screws and broken fragments; re-positioned and re-plated the graft, and extracted bone marrow and a small core of bone from the hip. This was placed in the gap, along with allograft and more BMP. He also re-positioned the tendon. The foot/leg was splinted. He said healing again would be slow and still was not guaranteed. If it has not healed "in a year or two" he will amputate. The initial narcotic prescriptions paled in comparison to post-surgical needs after this surgery.
October 24, I inquired and received my final response from the Medical Board via email:
"The Board of Podiatry was to notify you of the final outcome. [That's nice--they didn't.] I do not know the status of their communication. I can tell you that the expert reviewed all the additional materials that you provided. The expert’s original opinion was not altered. As I mentioned in a previous conversation, the outcome of the procedure in question is not always related to whether the standard of care was met or not. You could have a very severe outcome with no or a simple departure from the standard of care, or a relatively minor outcome that has an extreme departure from care.
Note:
This is actually the SECOND time a podiatrist had proposed an aggressive surgery for my son. The first (12 years prior) was an ankle surgery, which thankfully was strongly discouraged by an orthopedist from whom we sought a second opinion and who instead referred us to Shriner's. This time we failed to get a second opinion, because we already were IN an orthopedic clinic and foolishly thought we were getting multiple opinions and good care.
In other states, podiatrists are more restricted in what they do, in some less (link). In California, they are lobbying the legislature for the right to perform surgeries even further up the leg.
Infection had originated in the nail bed, not the graft, but the near-by metal plate was now involved. The area was flushed and IV antibiotics started. He was hospitalized for a week, while lab work determined the type of bacteria and most effective antibiotic. The bone appeared to be healing, so the hope was to control infection long enough for the graft to incorporate before the plate had to be removed. My son went home with a PICC line (peripherally inserted central catheter, of which he previously had five inserted during his UCSF stay at age nine) and IV antibiotics, which were to be administered in 90-minute infusions every eight hours daily for SIX WEEKS.
"The Board of Podiatry was to notify you of the final outcome. [That's nice--they didn't.] I do not know the status of their communication. I can tell you that the expert reviewed all the additional materials that you provided. The expert’s original opinion was not altered. As I mentioned in a previous conversation, the outcome of the procedure in question is not always related to whether the standard of care was met or not. You could have a very severe outcome with no or a simple departure from the standard of care, or a relatively minor outcome that has an extreme departure from care.
Therefore, this case will remain closed."
At that point, for 2.5 years and counting, my son's life had been destroyed by the mutilation of A TOE.
This is actually the SECOND time a podiatrist had proposed an aggressive surgery for my son. The first (12 years prior) was an ankle surgery, which thankfully was strongly discouraged by an orthopedist from whom we sought a second opinion and who instead referred us to Shriner's. This time we failed to get a second opinion, because we already were IN an orthopedic clinic and foolishly thought we were getting multiple opinions and good care.
In other states, podiatrists are more restricted in what they do, in some less (link). In California, they are lobbying the legislature for the right to perform surgeries even further up the leg.
December, 2012 Update: A BONUS ROUND
After seven weeks of apparent healing, on the night of December 5, the toe developed swelling, redness and oozing pus. We rushed to the ER at 2:00 a.m. By 10 a.m., my son was back in surgery.
Infection had originated in the nail bed, not the graft, but the near-by metal plate was now involved. The area was flushed and IV antibiotics started. He was hospitalized for a week, while lab work determined the type of bacteria and most effective antibiotic. The bone appeared to be healing, so the hope was to control infection long enough for the graft to incorporate before the plate had to be removed. My son went home with a PICC line (peripherally inserted central catheter, of which he previously had five inserted during his UCSF stay at age nine) and IV antibiotics, which were to be administered in 90-minute infusions every eight hours daily for SIX WEEKS.
On December 10, the Board of Podiatric Medicine finally saw fit to notify me of their final decision. It reads in part:
"California law imposes a very high burden of proof upon the Board by requiring that we establish 'clear and convincing evidence' that a violation of the law occurred before pursuing administrative action. This is a higher standard of proof than that of most civil proceedings, including malpractice lawsuits, which only require a 'preponderance of the evidence.' 'Clear and convincing evidence' is only slightly less rigorous than the 'beyond a reasonable doubt' standard required in criminal proceedings. Consequently, the Board must have more compelling evidence to initiate disciplinary proceedings against a podiatrist than a patient must have to bring a successful malpractice suit against a podiatrist."
[However, as explained above, "bringing a successful malpractice suit against the podiatrist" is virtually impossible--so this statement is misleading and only
emphasizes California
"All of the relevant materials were reviewed by an expert consultant for the Board, who determined that Dr. Duckworth had departed, with one act of simple negligence, from the standard of care in how she handled your son's pain management. An educational letter was sent to her. However, this one simple departure does not constitute repeated negligent acts or gross negligence, that would allow the Board to pursue disciplinary action under the Medical Practice Act.
On August 9, 2012, you provided an appeal to the Board's final decision. All of the material you provided in this correspondence was reviewed by the Board's expert consultant. After the review, the final disposition of this case remains the same.
The expert consultant has found the one same simple departure from the standard by Dr. Duckworth, and the Board has again determined that this does not constitute grounds for disciplinary action under the Medical Practice Act, which requires findings of repeated simple negligence or at least one finding of gross negligence.* Therefore this case will remain closed."
*A point of law: If the Board of Podiatric Medicine's "Expert (INDUSTRY) Consultant" had agreed with our experienced consulting podiatrist, Medical Board staff, and various orthopedic surgeons in finding the experimental procedure to be a departure from the standard of care, that departure combined with the second act of simple negligence (over-prescribing of narcotics) would have allowed the filing of an accusation of gross negligence.
January, 2013
January 11: After five weeks, IV Vancomycin was discontinued , because it was making him feel terrible . The toe was looking OK, and we hoped the infection was gone. But three days later, the the morning the nurse arrived to remove the PICC line, the toe was again beginning to swell and turn red. IV antibiotic treatment was resumed with Daptomycin.
January 21: A small wound opened up at the site of the original infection, oozing fluid and revealing the plate below. He was admitted via the ER and spent another night in the hospital for wound assessment and possible surgery. Because the rest of the toe looked OK, and CT showed additional bone bridging, it was decided that the wound would be kept covered and IV antibiotic treatment continued. It was thought if he could stay on antibiotics and infection could be confined to the toe for 30-60 more days, the graft incorporation might become strong enough to survive imperative removal 0f the infected plate.
February, 2013
Infection was barely controlled. Antibiotics were reducing the inflammation, but the opening was larger, with the screw and plate holding the bones visible. Throughout the month, he continued nightly infusions, which made him fatigued and sick most of the time.
February 26: Another CT scan and x-rays were done, and we waited for Dr. Giza's assessment. It had been three months, and the infectious disease doctor was not willing to continue IV antibiotics much longer, because sooner or later the PICC line would become infected. If the plate could not be removed within the next couple of weeks, he would have to switch to an oral antibiotic--and hope it was effective enough while we continued to wait.
March, 2013
March 8: Dr. Giza finally called. After consulting with the radiologist, he thought there was a little additional "bridging" since the last scan and that the plate must come out. Surgery was scheduled for March 27. He would make an intra-operative decision about whether to replace the large plate with a smaller one (another infection risk) or splint and later cast the foot and hope more bone would grow. If everything failed, amputation remained a possibilty. With any outcome, the chances of my son ever being pain free were uncertain. There was no choice but to continue the IV antibiotics until surgery, despite the side effects of body pain and extreme fatigue that kept him in bed much of the time. Psychologically he was nearly hopeless and barely hanging on. At that point, he wasn't sure it was worth it even if they saved the toe.
March 27, 2013--The Glass Half Full: We remained in limbo. There was slightly more bridging, but still no big "tube" of strong bone. The graft was only partially incorporated, still somewhat flexible, and fragile. No one knew exactly why. Because of infection risk, the chance of smaller hardware breaking again, and the possibility that metal contributed to the pain, after removing the infected plate Dr. Giza decided not to reinforce the area with a smaller plate. He roughened the bone ends and inserted more BMP. IV antibiotics continued for a 17th week, until April 8, now with an infusion pump that ran 24/7. So again we waited. Dr. Giza thought the chances of sufficient bone growth over the next few months were 50:50--that was 20% less than he gave it before his re-do of the graft. The chances of my son ever having significantly less pain were unknown.
April 8, 2013 - Dressing removed 12 days after plate removal, surgery #6--the fifth incision through nerves and sensitive scar tissue. Sutures were removed, and it was cleaned and re-bandaged. He still had to keep it dry and change the dressing every other day. He could not tolerate the IV antibiotic for a single day more, so we stopped it on 4/7, and the line was removed 4/8. We hoped the infection was gone and that bone growth would continue.
April 29 - x-ray. I didn't need a doctor to tell me that the gap remained unfused. However, the skin was healed, and the implanted BMP still in place, so we continued to wait. As Dr. Giza says, bone healing is like watching paint dry. Next appointment was in 2 months. He continued to protect it, wear the orthopedic boot and use the knee walker, which he had been using for a year and a half--and to take narcotic pain medication.
January 21: A small wound opened up at the site of the original infection, oozing fluid and revealing the plate below. He was admitted via the ER and spent another night in the hospital for wound assessment and possible surgery. Because the rest of the toe looked OK, and CT showed additional bone bridging, it was decided that the wound would be kept covered and IV antibiotic treatment continued. It was thought if he could stay on antibiotics and infection could be confined to the toe for 30-60 more days, the graft incorporation might become strong enough to survive imperative removal 0f the infected plate.
February, 2013Infection was barely controlled. Antibiotics were reducing the inflammation, but the opening was larger, with the screw and plate holding the bones visible. Throughout the month, he continued nightly infusions, which made him fatigued and sick most of the time.
February 26: Another CT scan and x-rays were done, and we waited for Dr. Giza's assessment. It had been three months, and the infectious disease doctor was not willing to continue IV antibiotics much longer, because sooner or later the PICC line would become infected. If the plate could not be removed within the next couple of weeks, he would have to switch to an oral antibiotic--and hope it was effective enough while we continued to wait.
March, 2013
March 8: Dr. Giza finally called. After consulting with the radiologist, he thought there was a little additional "bridging" since the last scan and that the plate must come out. Surgery was scheduled for March 27. He would make an intra-operative decision about whether to replace the large plate with a smaller one (another infection risk) or splint and later cast the foot and hope more bone would grow. If everything failed, amputation remained a possibilty. With any outcome, the chances of my son ever being pain free were uncertain. There was no choice but to continue the IV antibiotics until surgery, despite the side effects of body pain and extreme fatigue that kept him in bed much of the time. Psychologically he was nearly hopeless and barely hanging on. At that point, he wasn't sure it was worth it even if they saved the toe.
March 27, 2013--The Glass Half Full: We remained in limbo. There was slightly more bridging, but still no big "tube" of strong bone. The graft was only partially incorporated, still somewhat flexible, and fragile. No one knew exactly why. Because of infection risk, the chance of smaller hardware breaking again, and the possibility that metal contributed to the pain, after removing the infected plate Dr. Giza decided not to reinforce the area with a smaller plate. He roughened the bone ends and inserted more BMP. IV antibiotics continued for a 17th week, until April 8, now with an infusion pump that ran 24/7. So again we waited. Dr. Giza thought the chances of sufficient bone growth over the next few months were 50:50--that was 20% less than he gave it before his re-do of the graft. The chances of my son ever having significantly less pain were unknown.
April, 2013
April 8, 2013 - Dressing removed 12 days after plate removal, surgery #6--the fifth incision through nerves and sensitive scar tissue. Sutures were removed, and it was cleaned and re-bandaged. He still had to keep it dry and change the dressing every other day. He could not tolerate the IV antibiotic for a single day more, so we stopped it on 4/7, and the line was removed 4/8. We hoped the infection was gone and that bone growth would continue.April 29 - x-ray. I didn't need a doctor to tell me that the gap remained unfused. However, the skin was healed, and the implanted BMP still in place, so we continued to wait. As Dr. Giza says, bone healing is like watching paint dry. Next appointment was in 2 months. He continued to protect it, wear the orthopedic boot and use the knee walker, which he had been using for a year and a half--and to take narcotic pain medication.
June through November, 3013
Despite all our waiting and attempted optimism, there was little more bone growth. In November, Dr. Giza declared it a "stable non-union", prescribed orthotics to take some of the pressure off the toe, and said he would wait a year to x-ray again.
Meantime, in July, he was hospitalized for two days when medications taken for pain (methadone) and ongoing fatigue (Adderall) caused withdrawal, a possible partial seizure, and triggered a delusional episode.
2014
My son, now 23, continued in pain management and psychiatric treatment--possibly for life. His once-promising future was now uncertain. As far as I knew, the podiatrist, whose "experiment" and narcotic prescriptions precipitated all of these events, continued to practice.
9/11/14 Update: I learned that the podiatrist had not worked at the orthopedic clinic--re-named "Summit Orthopedics"--since November, 2013. The clinic address was still listed on her license information, but Summit would provide no forwarding information, and no other practice location was listed anywhere online.
12/30: Duckworth's LinkedIn profile (since removed) read:
"I do enjoy practicing medicine and performing surgery. However... I elected to return to school [and]...In August 2014, I will graduate with a health care MBA degree. During the course of this recent education, I have discovered my strong affinity for the health care business realm.
I am currently in transition from practicing medicine to a healthcare business."
3/23: The mother of a prospective surgical patient found an online review and called me. Apparently Duckworth recently had been hired at Kaiser Permanente in Roseville and was advocating to perform surgery on her pre-teen child.
9/11/14 Update: I learned that the podiatrist had not worked at the orthopedic clinic--re-named "Summit Orthopedics"--since November, 2013. The clinic address was still listed on her license information, but Summit would provide no forwarding information, and no other practice location was listed anywhere online.
12/30: Duckworth's LinkedIn profile (since removed) read:
"I do enjoy practicing medicine and performing surgery. However... I elected to return to school [and]...In August 2014, I will graduate with a health care MBA degree. During the course of this recent education, I have discovered my strong affinity for the health care business realm.
I am currently in transition from practicing medicine to a healthcare business."
3/23: The mother of a prospective surgical patient found an online review and called me. Apparently Duckworth recently had been hired at Kaiser Permanente in Roseville and was advocating to perform surgery on her pre-teen child.
October 2014
FINAL OPTIONS--NONE GOOD:
1. Rigid, graphite orthotic to prevent movement (which causes pain in arch, due to pre-existing plantar faciitis and/or plantar fibromatosis), and narcotic pain management, possibly for life.
2. MORE SURGERY to insert allograft "cushion" between bones (essentially repeating the initial surgery, but with a material that will not cause TISSUE REJECTION--another painful surgery with no guarantee of resolving pain.)
3. AMPUTATION--with the significant risk of causing phantom limb pain, which can be even more difficult to manage
September, 2015
Everything status quo, he continued in pain management.
February, 2016
Everything status quo, no change anticipated.
June, 2017
NO CHANGE. EVER.
--though psychiatric problems now outweigh chronic pain. PTSD a significant factor.
(He finally discontinued narcotic pain meds on his own.)
August, 2018
Still in struggling, still in pain.
June, 2017
NO CHANGE. EVER.
--though psychiatric problems now outweigh chronic pain. PTSD a significant factor.
(He finally discontinued narcotic pain meds on his own.)
August, 2018
Still in struggling, still in pain.
2021
His life still enormously impacted. Medical trauma identified as the primary issue.
2023
After two years of intensive trauma therapy, treatment is ongoing.
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