Statement of Ophthalmological Expert Witness Dr. John D. Sheppard, President, Virginia Eye Consultants, Hampton, Virginia

 

When the trip to Bethesda ultimately was arranged the appointment was set for April 26, 2010.

At around 9:00 AM Fred Reed arrived at Dr. Stanley’s office at Bethesda Naval Hospital.  Dr. Stanley briefly examined him with a slit lamp and stated, “It’s been more than a year and the cornea is transparent and healthy so we might as well take them all out.  But we need to make sure that removing the sutures will resolve the problem.  If it won’t help the vision there is no reason to do it.”  To this end he had a corpsman take Fred Reed to another room and fit him with a hard contact lens and read an eye chart to check his vision.  It was explained that the lens covers the wrinkles in the cornea which fill with tears negating the astigmatism.  This was the only time a contact lens had been tried as a solution to the problem.  The results were excellent as the letters were sharply defined and clear, and Fred Reed easily read the 20/80 line and was reading the 20/60 line when an employee of the hospital interrupted stating, “Dr. Stanley is ready for you.”  Mr. Reed was ushered back into the office where Dr. Stanley was.

As he was being seated back before the slit lamp Dr. Stanley produced a permission form for him to sign.  Fred Reed specifically inquired as to what the risks in fact were because of the important consideration that he only had one eye with useful vision.  In response to this inquiry Dr. Stanley gave Fred Reed the unmistakable impression that he regarded this suture removal as very minor stating that, “removing the sutures somewhat weakened the cornea and you should avoid being punched in the face.”

Dr. Stanley then numbed the eye with drops, positioned Fred Reed at the slit lamp again and went around the periphery of the cornea, cutting the sutures. Mr. Reed indicates that he knows that was what was done because Dr. Stanley stated that was what he was going to do and as Dr. Stanley proceeded it was obvious that was what he was in fact doing. He then tried to pull the sutures out, at one point stating that he wanted to use other instruments and going into another room to get them. According to Mr. Reed, Dr. Stanley pulled harder and harder, which Mr. Reed could easily feel.  Dr. Stanley stated that the stitches were, “very tight,” “tight,” and verbatim “I’ve never seen this before.”  Mr. Reed states that soon Dr. Stanley was pulling hard enough that he, “could feel the eye moving out of position” a fact Dr. Stanley commented on that he then, “felt a distinct pain in the back of the eye.”  From time to time He heard a tiny “pop” and the eye would “settle back into position.”  Fred Reed recalls thinking, “This can’t be right it feels as if he is going to pull the front of the eye out.”

Dr. Stanley then said, “We may have a leak” followed a few minutes later by an assertion, that there is, “definitely a leak.”  Mr. Reed felt liquid running down his cheek and asked if it were tears or aqueous humor pouring from the eye.  Dr. Stanley responded aqueous and left saying he had to get a gurney and make arrangements for assistance, and an OR. 

Mr. Reed was left sitting at the slit lamp with no bandage contact lens or other intervention being taken to prevent loss of aqueous and stabilize the Seidle positive wound, nor was he provided with a clear shield, or other protective measure or protective bandage placed over the eye.  No topical antibiotics were given to prevent infection, or cycloplegics to prevent pain or ciliary spasm.  In addition no admonitions were given to Mr. Reed not to strain, bend, blink, squeeze, cough, eat, drink or touch the eye.  In about five or ten minutes by Mr. Reed’s recollection a gurney was brought in and Mr. Reed was placed flat on his back on the gurney or head support.  He was not placed in a seated or reverse Trendelenberg position to reduce venous pressure to the orbit despite having an open globe. There he lay for an extended period of time while attempts were being made to assemble the necessary personnel to undertake surgery to close the wound dehiscence complication.  In about another half hour or forty-five minutes Dr. Stanley put drops in the eye and suddenly Fred Reed felt the most intense pain he had ever experienced and someone said, “There’s blood coming from the eye.”  Fred Reed’s had suffered a choroidal hemorrhage.  This hemorrhage has left Freed Reed totally blind.

According to the record the hemorrhage occurred prior to any speculum having been placed.

There is absolutely no doubt that the open globe following suture removal on 4/26/2010 resulted in a painful choroidal hemorrhage that rendered Fred Reed totally blind. Thus this case turns on whether the physician breached the standard of care on that day.
There are in fact multiple areas where the standard of care was breached which are:

  1. The decision to remove sutures was a breach of the standard of care because it was reached without performing a full evaluation of the patient in accordance with the standard of care.
  2. The sutures were removed without obtaining the full informed consent of the patient in accordance with the standard of care.
  3. The suture removal was attempted in a fashion that breached the standard of care.
  4. The standard of care was breached in the manner in which wound dehiscence was responded to once it occurred.

Each of the above breaches of the standard of care will be addressed:
THE DECISION TO REMOVE SUTURES WAS A BREACH OF THE STANDARD OF CARE BECAUSE IT WAS REACHED WITHOUT PERFORMING A FULL EVALUATION OF THE PATIENT IN ACCORDANCE WITH THE STANDARD OF CARE.

The evaluation of Mr. Read was inadequate based on the fact that there was no assessment made regarding wound integrity or the state of his healing from the corneal transplant.  There is no assessment at all in the note by Dr. Stanley that addresses this issue on April 26, 2012.  Full thickness corneal transplants require between 14 and 30 sutures to hold the grafted donor tissue in place until full healing can occur. Because the cornea is an avascular tissue, the healing process can take many months or years to completely restore the maximum wound strength possible. Many factors affect wound healing speed: the patient’s age, general health, nutrition, occupation, and adherence to medication regimes. In addition, inflammation may accelerate wound healing, while aggressive application of topical steroids to reduce inflammation may also concomitantly delay healing.  Young patients heal very quickly but are more prone to injuries. Older patients heal very slowly, but are more likely to adhere to their recommended medication regime, avoid trauma, and requires less anti-inflammatory therapy. Vessels in the donor bed or at the graft host interface would significantly accelerate healing and wound adhesion . Where trauma has occurred as part of the patient’s history, the host bed is more likely to be abnormally thin and will likely require far longer to adhere to the donor tissue.  In an essentially one eyed patient such as Mr. Reed a conservative bias is required by the standard of care in making the required evaluation and subsequent logical decisions as to whether wound healing is sufficient to permit suture removal. The statement by Dr. Stanley that it has been over a year and the cornea is transparent and healthy falls far short of meeting the standard of care and the record contains nothing to indicate that a significant number of the additional assessments required by the standard of care to be included in making the determination to proceed with suture removal were ever made, these include:

  1. There is no description of the health and thickness of the host bed.  In an eye that has been subjected to multiple traumas such as Mr. Reed’s this is an assessment that the standard of care clearly requires to have been made in order to proceed with suture removal.
  2. There is no description of whether or not vessels are present in the graft host interface.
  3. There is no indication as to whether or not sutures were, tight, lose, inducing vascularity or irritating.
  4. An incomplete refraction was performed and thus there was no assessment of the best potential visual acuity, with or without glasses or a hard contact lens.
  5. There is no description of aphakic contact lens fit, centration, irritation, compatibility, retention, or comfort.
  6. No manual keratometry was performed prior to suture removal.
  7. No automated digital topography was performed prior to suture removal.
  8. There is no assessment whatever of the sutures that are contemplated being removed. Sutures that are loose can cause irritation, infection, or even rejection and may no longer be contributing to structural wound integrity, while sutures that are tight can induce astigmatism. Some sutures may remain in the cornea indefinitely if they are not causing irritation, vessel growth, distortion, or irregularity and thus do not need to be removed to address astigmatism.  Many patients have sutures in their eyes for decades without untoward effects.
  9. There is no rationale set forth in the record for single or multiple suture removal let alone total removal of all sutures.  It is beyond question that a wound is weakened more when multiple sutures are removed.  It is also quite true that the results are less predictable when multiple sutures are removed and the risks involved with multiple suture removal are higher. Sequential single suture is a prudent, more predictable, conservative and safe practice for most transplant patients.

THE SUTURES WERE REMOVED WITHOUT OBTAINING THE CONSENT OF THE PATIENT IN ACCORDANCE WITH THE STANDARD OF CARE.
Dr. Stanley had indicated to Fred Reed that it was his intention to remove all of the sutures.   Fred Reed eye had been subjected to multiple traumas and surgeries, his history was complex, and his case complicated.  In a case such as Mr. Reed’s the predictability of astigmatic changes following suture removal is less reliable than in most.  Of even greater importance, is the fact that the risks of complications arising from suture removal including major complications such as wound dehiscence, as in fact occurred, are increased and are even greater with multiple suture removal, or as Dr. Stanley intended in this case the removal of all of the sutures.  None of this was explained to Mr. Reed so it cannot reasonably be  contended that he gave his consent to the removal of any sutures, much less an attempt to remove  all of them. The standard of care required that Fred Reed be informed of the increased risk that was associated with the decision to proceed to remove sutures and that he give his consent to proceed with full and complete knowledge of the risks involved.  In that regard the standard of care likewise required that he be given the alternative option that was available to him to choose to wear a contact lens to correct the astigmatism in the eye.  At this point he had never had an adequate trial of a contact lens and the results that were obtained with the partially completed eye test were quite good. The choice with regard to whether that was how he wanted to address the astigmatism belonged exclusively to Fred Reed.  Given that he only had one eye that is the choice he would have made rather than to take any risk of ending up totally blind which is in fact what occurred when Dr. Stanley choose to make his choice for him.
THE SUTURE REMOVAL WAS ATTEMPTED IN A MANNER THAT BREACHED THE STANDARD OF CARE.
The Standard of care requires that sutures be removed by cutting one or at the most two at a time with a fine sterile surgical blade and then removing each suture with a jeweler’s forceps.  It also requires that an assessment be made following the removal of each suture, evaluating the results and making a determination of whether or not it is appropriate to remove an additional suture.  This assessment clearly was not made after each suture was removed.  The record is devoid of any description of what occurred during the attempted suture removal and the only evidence we have is what Fred Reed recalls.  From his statement it is clear that Dr. Stanley breached the standard of care an initio as he predetermined that he was going to remove all of the sutures.  The manner in which he proceeded going around the cornea cutting multiple sutures shows that he was carrying out his stated intention.  On occasion a suture may be difficult to remove as a buried knot can induce excessive resistance to suture movement out of the corneal transplant and host rim tissues.  When this occurs it is of great importance that the physician not exert an excessive amount of tension on the cut suture in attempting to accomplish its removal.  From Fred Reed’s statement as to what he recalls it appears that excessive tension was applied on multiple occasions in attempts to remove sutures with immobile buried suture knots and ultimately Dr. Stanley pulled the wound apart.
THE STANDANDARD OF CARE WAS BREACHED IN THE MANNER IN WHICH WOUND DEHISCENCE WAS RESPONDED TO ONCE IT OCCURRED.
Once again the medical record is totally devoid of any description as to what was done to protect Fred Reed’s eye once wound dehiscence took place.  That in itself is a violation of the standard of care.  From Fred Reed’s description he was left sitting at the slit lamp while Dr. Stanley attempted to make arrangements for assistance and an OR.  According to Fred Reed in about five or ten minutes a gurney was brought in and he was placed flat on his back upon it.  There were no efforts whatever to provide appropriate protective measures. About half an hour or forty-five minutes later with no further intervention having taken place the choroidal hemorrhage occurred and Fred Reed was thereafter rendered totally, irreversibly blind. There were multiple breaches of the standard of care during this period of time increasing the risk of choroidal hemorrhage which were:

  1. Fred Reed was placed flat on his back when he was moved to the gurney.  The standard of care required that he be left in a comfortable sitting position with the head elevated.  Placing him flat on his back increases intra-ocular and orbital venous pressure and subsequently the risks that have been created by this emergency including further loss of aqueous, corneal wound instability and choroidal hemorrhage.
  2. A bandage therapeutic soft contact lens was not placed.  This intervention would have served to stabilize the eye, prevent further loss of aqueous, or ingress of bacteria.
  3. No cyanoacrylate tissue glue was applied to the gaping wound.  This is a quick and temporizing commonly utilized measure to attempt to close the wound until a surgical repair can be accomplished, prevent loss of aqueous, and hemorrhage.
  4. No clear shield was placed over the eye.  This would have served to protect the eye  from further trauma.
  5. No instructions were given the patient to avoid touching the eye, squeezing, coughing, eating, drinking or otherwise increasing the risk of raising the intraocular pressure or venous pressure, thereby increasing the risk of aqueous loss or choroidal hemorrhage. Imminent general anesthesia requires that the patient remain NPO, that is without food or liquid ingestion.
  6. No topical antibiotics to prevent infection, or topical cycloplegics to prevent pain and ciliary spasm were given.
  7. There was an unacceptable delay in getting Mr. Reed into surgery where a full surgical repair could be accomplished.  The records are devoid of any information as to how long the delay was or why it occurred.
  8. There was a failure to obtain an immediate consultation with a vitreo-retinal specialist. It was recognized that this was an emergency and the standard of care required that this be one of the first things that is done in dealing with this emergency.