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Flatt v. Kantak
Day by Day 2
 

Press Coverage   Flatt v. Kantak/Informed Consent    NY Stowell Case     April GI Rally in DC     Foreign Press     >NOCIRC Current Events    >CIRP  News
 
       

Day to Day 1
Flatt v. Kantak Press Coverage
Flatt v. Kantak, Legal Briefs
George Kaplan's Deposition
Craig Shoemaker's Deposition


The Flatt v. Kantak and Meritcare
legal suit on Informed Consent

Day by Day 2

Wednesday, February 12, 2003.
Craig T. Shoemaker took the stand for the defense. He is presently at the University of California, Davis, Director of Special Care Children's Hospital. He worked at Meritcare in Fargo for 16.5 years starting in 1984. He initiated and drafted the first copy of the booklet, Should Your Infant Son Be Circumcised. He was a member of the American Academy of Pediatrics (AAP) 1996-1999 ad hoc Taskforce on Circumcision.

Did Dr. Kantak meet accepted standards of care? Yes. He said the AAP has 450,000 members from U.S., Canada and central America; that he chaired the AAP Committee on the Fetus and the Newborn when the State of N.D. was sued in 1996 [FGM suit]; was on the N.D. bioethics committee and worked with Attorney General of N.D. on circumcision issues when the State was sued: He wrote an avadavat in relation to that court case in N.D.

Shoemaker said he has performed 1-2 thousand circumcisions since 1976, mostly on newborns and has obtained that many informed consents. He teaches circumcision to pediatric and family practice residents using the Gomco clamp exclusively since he says it is faster, easier to control and achieves better "aesthetics."  Has an historical, theological and ethical interest in circumcision. He is familiar with AAC guidelines on the consent issue and with practice in Europe. There are many ways to discuss circumcision to obtain informed consent.

He is a colleague of Kantak who talked with him many times about the law suit. She was distressed about the suit. Shoemaker said she met the standard of care (was well within the standard of care) when she obtained informed consent during her discussions with parents about the risks and benefits of circumcision. He bases this on the medical record. She properly performed the circumcision because he has seen photos of Josiah's penis.

Anesthesia was documented as being used: Dorsal penile pain block, the recommended method to alleviate or "eliminate" pain. Giving a baby a pacifier dipped in sugar also diminishes pain response before and during circumcision. When asked whether he ever heard of a baby having a collapsed lung or gastric rupture, he said he never heard of these. Is there any injury due to circumcision? Not in any way--this is a medical certainty. The penis functions normally, has good cosmesis, looks "normal." Adhesions are common result of circumcision because of the embryologic epithelial development [i.e., "adhesions" are a normal part of penile maturation].

Vogelwede asked him whether there was any written material for parents before the 1996 booklet he wrote? The booklet on infant care had some information on pages 5-6. Shoemaker said he had a personal interest in the N.D. case mentioned [FGM suit]. He wanted to provide more information for parents. He wrote Should Your Infant Son Be Circumcised. It was adopted before and after its initial printing and approved by the Department of Pediatrics at MeriCare in 12/96.

How does it compare to other hospitals' information? It is more extensive, discusses ethical implications, etc. It is designed to be used at the Family Birth Center and intensive care nursery to establish a platform for discussing circumcision. The booklet is not intended to be comprehensive.

Shoemaker was asked to comment on plaintiff's experts' criticisms of the 1999 AAP statement regarding its use of the lowest figures for circumcision complications and the highest rate found for UTIs in uncircumcised infants (10x those cut). The rate of complications at Meritcare was low, so that figure was used. The AAP selected slightly below median figure for UTIs; he said those advocating circumcision quote a much higher figure.

Shoemaker was asked whether circumcision is common in western cultures. It is common in U.S. and Australia; 50% in Canada. In non-western societies and Asia it is rare. Penile and cervical cancer rates are documented at higher rates in uncircumcised males. Even though the AAP 1999 taskforce said there are no established medical benefits, they did say there are potential medical benefits.

Shoemaker became known to the Committee on Fetus and Newborn because of his involvement with the 1996 N.D. circumcision suit [FGM case], and his knowledge and interest in the subject. He said he reviewed all English-language documents since 1960 which included 119 sited references and two surveys which aren't usually used. The essence of the AAP's conclusion was that there is potential protection from infection of the male over a lifetime, but not enough to recommend all newborns be routinely circumcised. He said all parents should be consulted regarding the potential the medical benefits, and anesthesia should be used.

Asked if circumcision is not essential, why didn't the taskforce conclude it should not be done anymore. He said the benefits of lowering UTIs is lost if circumcision is done after the newborn period, but the benefits last for years. There is little risk, but there is some risk, namely, bleeding and infection: .2-.6%. Most of these are managed without consequence. Other risks? How common? Very rare. Death was not included in the 1999 statement. The last death due to circumcision was in 1979[!]

Exhibit 112 was introduced: The 1989 taskforce's report on Contra-indications, Complications and Informed Consent. Contra-indications include, hypospadias abnormalities; not stable; not feeding normally; temperature not controlled;  infection, bleeding disorder. There were two deaths before 1973. Has not found any deaths since that report. Are adhesions a complication? Can be. How about asymmetry? Can be. Adhesions and asymmetry were not complications according to Shoemaker--they are common occurrences with normal circumcisions.

There are also religious and ethical reasons to circumcise. It also "eliminates" penile cancer and reduces cervical cancer. The structure of the foreskin causes problems and transmits HIV and other STDs. Most literature on HIV and STDs at the time the taskforce was working was from African studies.  Information is better now; it shows a decrease in HIV if men are circumcised. Is circumcision a treatment for UTIs? No. What is the effect of circumcision on penile cancer? Virtually nonexistent in circumcised males.

Van Howe--a known advocate for discontinuing the circumcision of infants who had done a review of the literature--came to the taskforce to offer his opinion and writings on circumcision risks, benefits and complications. His interpretation of the data was different from that of the taskforce. His studies were not controlled. They were skewed in opposition to circumcision, and he used his own studies and was the only observer. His analysis of the complication rate was 100x more than other studies show. He said the alternative to circumcision is not to do it.

Does the foreskin have a function? We are not clear on that entirely. We assume all body parts have a function. The scientific evidence on sexual function shows no change with circumcised men later in life.

Cross examination began at 10 am by Zenas Baer. Shoemaker's deposition was taken a year ago at Davis, CA. Zenas asked whether Shoemaker knew that complications need to be disclosed. Yes. You authored editorial comments after the Laumann JAMA article was published before the taskforce's 1999 statement was released. Yes. The Meritcare brochure implies Western cultures circumcise, but the U.S. stands apart from the rest of the world, including the "Western world" in the number of circumcisions.

You said parents must be fully informed before deciding to circumcised their son. The Laumann article says circumcision may increase STDs. Shoemaker: I have no opinion on circumcision in general, but I have done it for religious reasons for my own family. Who were the pro-circumcision members of the taskforce? Myself and Kaplan. I am pro-circumcision, personally. The taskforce women were generally against circumcision.

Do you profit from circumcisions? Not me, my institution does, but not currently. Infant circumcision is an emotional topic, like ending life. One should not exaggerate either the risks or benefits--shouldn't give biased information. Zenas: But aren't physicians resistant to change? In general, yes. Zenas: The Canadian statement says routine neonatal circumcision should not be done. Shoemaker: "Routine" means all male infants. Parents decide mostly on social rather than medical reasons.

The 1996 Australian statement has guidelines for informed consent that should apply generally, not just to circumcision. Shoemaker was a member of the N.D. bioethics committee; its statement was published in 2000. Here the defense objected to Zenas' implying the standard of care was part of the law. Judge Rothe-Seeger said the court will give cautionary instructions regarding what the law says a doctor must do to get informed consent. The jury will then apply the facts against the law.

Zenas: What are some guidelines or suggestions as to what informed consent should include: Should parents have an explanation of the nature of the ailment or condition? Yes. But Josiah had no ailment. Shoemaker: Circumcision is designed as a potential medical benefit. Zenas: Do you describe for the parent what the foreskin does? Shoemaker: Not if it is not known. Zenas: You need to know what the penis is, don't you? Have you read Taylor and Cold's work? Yes. I do know something regarding the foreskin.

Zenas: So some elements of informed consent would include the ailment or condition (but the newborn is normal with no ailment); the nature of proposed diagnostic steps or treatments (but since the infant is normal, there is no aliment). If the infant is abnormal, you should not circumcise; correct? Yes. But you agree that the existence and nature of the risks involved must be given to be fully informed? Yes.

Kaplan's 1983 treatise says the parents should be informed of alternative methods of treatment. Shoemaker: Alternative treatments should be given, but the alternative to circumcision is to leave it alone. Zenas: You don't think there is value to the foreskin. "I did never say that, Mr. Baer!"

Shoemaker: If one does not have a foreskin, one cannot get an infection of it. But if one does not have a nevis on their arm, they can't get cancer there either. There is a reasonable body of literature that says circumcision after infancy is more painful. (Shoemaker looked, but could not find this statement in Kaplan's article.)
Zenas lists some of Kaplans's complications:
9.5% have circumcision repeated. Yes.
Concealed penis? Very rare. Only seen one in my 25 year career.
Skin bridging? Very rare.
Infection? I have never seen a severe case of infection.
Urinary retention? Yes, it is a risk with certain types of circumcisions, not with others.
Meatitis? It is a risk factor. I (Shoemaker) rely on AAP to tell me what the risks are and on the literature.
Chordee? I don't consider this a complication of circumcision, rather a indication not to circumcise.
Inclusion cysts? They could be there whether or not one is circumcised.
Lymphodemia risk? I've never seen fistula complication. I've read about them; presumably caused by crushing the urethra.
Necrosis? This is expected with Plastibell. Zenas: How about the entire glans penis? Only one report to my knowledge.
Hypo and Epi spadia? These are congenital abnormalities identified by circumcision or caused by being cut during circumcision.
Impotency? I have read literature, but as a pediatrician, it is not my area. But you are looking at a lifetime of improved health. Zenas: Why not look at impotence? It is very rare. I would not describe that to parents. It has psychological issues.
Aesthetic complications:
     Major skin loss? Rare.
     Scalded skin syndrome? Rare.
     Gangrene? Rare.
     General sepsis? Rare
     Meningitis? Rare.
     Permanent disability or death?

Zenas: There is a problem with consent by proxy: Informed consent must be in the best interest of he child. Physician care must be based on what the patient (not parent) needs and not on what someone else asks. Vogelwede: Objection. Sustained.

As a medical doctor, your obligation is to whom? Objection. Sustained. Zenas: Parents need accurate and unbiased information to decide what is best for the life-long health of their child. Do physicians talk about death? They might. How about penile cancer? This is a concern mainly for the elderly. Impotence? I know of no cases where infant circumcision has caused impotence in an adult male. Zenas: You are quoted in Men's Health as saying that many doctors do not provide adequate information.

Consider the function of the foreskin. Is there an immune function? Is the foreskin enervated? There is contradictory evidence regarding the foreskin function. Zenas: You said on page 74 of your Deposition, line 21: "I'm not God. I don't know that anyone knows what the function is."

What about sexual satisfaction? John Taylor, pathologist from Winnipeg, Canada wrote in a 1996 article published in the British Journal of Urology, that there is specialized mucosa in the foreskin which is lost in circumcision. Up to 51% of the penile covering is lost due to circumcision. Shoemaker: I have never seen 51% of the skin of the penis removed in my entire career. When the foreskin is intact, the glans has only "primitive feeling."

Zenas: Is the foreskin heat sensitive? Yes, because the foreskin is normal human epidermis [implying nothing special]. Does the foreskin have light touch receptors--like fingertips and tongue? Zenas uses Chris Cold's drawings to illustrate the maturation and release of the foreskin from the glans penis. Shoemaker: If allowed to "degenerate" [i.e., maturate] it creates a space. Zenas argued that no space is created, rather mobility becomes possible.

Was there injury to Josiah Flatt? No. There was no permanent harm or injury. Zenas: But his foreskin was taken from him. Shoemaker: I am saying exactly that. It was no injury, no permanent injury. Zenas: Would cutting off part of a finger decrease the function of that finger? Yes. But foreskin loss does not affect the function of the penis. Psychological harm could be there? Yes.

Zenas lists some structures lost in circumcision:
removes Misnor's corpusles;
removes frenulum;
removes Dartos facia;
removes immunological mucosa;
removes several feet of microscopic blood vessels.
--So, no injury? Shoemaker: No permanent injury results.
Zenas: Is there a permanent scar? Shoemaker reluctantly agrees.

Zenas shows Exhibit 55 of a cartoon, patent office drawing of a Gomco clamp from 1935. The amount of force this device exerts is 80,000 foot pounds when the screw is tightened. Applying pressure...Objection; sustained.

Zenas: You set the ball in motion for the booklet to be approved by the MeritCare clinic after April 1996 when the need for a circumcision booklet was discussed in the Department of Pediatrics' meetings. Objection. Jury dismissed. Voglewede said using department minutes was unfair. Objection sustained. Zenas wants to ask about pain and injury. Vogelwede said this is a waste of time on peripheral issues.

Jury back. Zeans: You developed the booklet because of a case in N.D. Supreme Court when you wrote your affidavit to the U.S. District Court, Mr. Shoemaker. Shoemaker: I prefer "Dr." There follows a discussion of how many circumcisions Shoemaker has done. He said he couldn't possibly know how many.

Sucrose studies showed a decrease in crying but not in pain as Dr. Tadio's article regarding heart rate, etc. show. As a member of the AAP committee, appointed late 1996, I reviewed a number of articles. The Committee evaluated the scientific basis of the information (evidenced based). The committee reviewed literature but not all of it is described in the final report. The literature at times would conflict on both immunological and sensory data, so they didn't put it into the final statement.

Feb 16, 1996 the Vice President of the Cancer Society wrote a letter saying circumcision does prevent cervical cancer, and now the NEJM says so also. Zenas: Does the medical community still think circumcision prevents gout, clubfoot, epilepsy, and masturbation as a 1876 medical journal states?.

Committee chair wrote and distributed to members for their comments and then published the AAP statement which included the process of obtaining informed consent, namely, requiring complete explanation of the risks and benefits--this was approved by consensus of the committee. Shoemaker: I do not make recommendations to patients. I tell them the medical benefits and risks and they make the decision. Zenas brings up the topic of pierced ears. Objection; sustained.

Does the information in Should Your Infant Son Be Circumcised? and the Infant Care booklet meet informed consent standards? No. Standard of care was met you said. Did you make that assumption based on the medical record? Yes. Zenas: Kantak signed off on the new baby exam. Did she actual do what she said she did? If it was written down, it was done. Zenas: You never heard her talk, or talked to nurses about Kantak's circumcision discussions with parents. Shoemaker: It is well-known that her presentation was detailed. Zenas:  So your testimony is heresay? Shoemaker: Yes.

Standard of care was met because you assume Dr. Kantak provided the information and carried out what she said in the record? I have to assume she followed the guidelines in counseling parents. Informed consent can take place with no written information at all. It was policy to give it to every parent group who had babies in the newborn and intensive care nursery. Zenas: Who printed it? MeritCare printing place.

You read Anita Flatt's deposition. You have to assume she is mistaken? Mistaken or misremembering. Informed consent can be done without written material. The medical record said it was done. I can't speculate on what the mother said. I make the assumption because it was agreed that all doctors will provide the same information.

Before testifying, did you view a video tape? (Zenas wants to show the video of Josiah's penis). Objection; sustained. Are adhesions a complication of circumcision? They are generally minor; some would say they are not a complication, but normal part of circumcision. Asymmetry is even very common in the uncircumcised penis.

Did Dr. Mastell diagnose asymmetry? Not a diagnosis--just an observation--it is in the chart. Dr. Sawchuk evaluated Josiah August 1st or 2nd as having adhesions more on the left than the right, a very common finding after circumcision. He said it could be lysed  in the office or later under general anesthesia.

Zenas: Regarding Van Howe's paper to the AAP, that recommended a moratorium on circumcision until the extent of harm is known. Was it exhaustive research? Yes. But somewhat skewed. He admitted some potential benefits to circumcision. I wouldn't council anyone to have a circumcision. In no way is Josiah Flatt injured either functionally or cosmetically.

2:10 pm. Sherry Stowa takes the stand for the defense. Vogelwede: What is  the protocol for the entry of records into the computer database?  Do you document the time things occur? Yes. How is the decision made to circumcise? Anyone who has a son, makes the decision. Kantak tells the parents there is controversy over the issue of circumcision, that parents have been sued; there is diminished pleasure. She hands them the booklet and lets them read it. Vogelwede: What is the parents' response and reaction. Zenas: Objection. Sustained. Stowa: No pediatrician at MeritCare uses the Plastibell. I have never heard Dr. Kantak say, "I'm going to circumcised your son," ever.

Before the jury came back, Vogelwede complains to the judge that nurses have been waiting for 2-3 days to testify at Mr. Baer's connivance and they are still waiting. Can they be sent home? Zenas responds that instead of subpoenaing them, he is letting them come at their convenience (as had been agreed on earlier) to accommodate the nurses schedule.

Sunita Kantak took the stand. Under Zenas' questioning she said she began working at MeritCare July of 1988; that she was trained in India, but not in pediatrics. She never did circumcisions in India. She doesn't remember March 6-7th. The 8th was a Saturday and she was at home. When asked whether Anita asked her to be Josiah's pediatrician when she came into the hospital, Kantak said it doesn't go that way. Whatever doctor is on duty takes over.

Zenas points out that there is no record of Kantak being in Anita's room prior to the circumcision; that Josiah was a healthy, stable baby; that Kantak removed Josiahs's foreskin without a diagnosis of disease. "I [Kantak] did not diagnose a disease." Kantak said she was on call 4 to 5 weeks a year. The pediatricians rotate a week at a time. They go in a 8 or 9 am depending on how many babies are in the nursery. The babies are examined first, then they are circumcised. Kantak could not remember whether the nursery was busy that day.

Do you use anesthesia? Yes. Do you use the Gomco clamp. Yes. Do you put trauma to the penis when you circumcise? No. Kantak said she uses dorsal nerve penile block, not a pudendal block. Zenas asked whether she wanted to change her testimony from the deposition that said pundendal block. Kantak said she misspoke during the deposition. Always wait 2 minutes after you crush foreskin with a hemostat before making the dorsal slit? She goes on to say that she applies the hemostat to the foreskin, waits 2 minutes before removing it and making a dorsal slit where the hemostat was applied.

She use only the Gomco clamp and Lidocane injected into the dorsal nerve. Zenas pointed out that such an  injection would not deaden the ventral nerve, but Kantak said the dorsal penile nerve block affects the foreskin. She said circumcision is a minor procedure.

Kantak described the procedure she uses when circumcising: The baby is put in a Circumstrait. Rather than strapping the arms down like the legs, she tightly swaddles the arms. The baby is given a pacifier. The babies do pretty good in the restraint. She cleans the genitals with alcohol swabs before injecting anesthesia, Lidocane, 1% solution. She sticks the penis once, but moves the needle to both sides of the penis. Babies sometimes don't even cry.

Kantak scrubs herself for a minute, cleans genital area with Betadine and drapes the infant. A forceps is applied a 3 o'clock and another at 9 o'clock. Objection by defense on lack of relevance. Sustained. Zenas again tries to get a description of how the Gomco clamp is applied. Objection. Approached the bench.

Zenas: Does the foreskin have nerves, rich enervation. Kantak: It is like any other skin, not bad pain, like sticking a finger. Local anesthesia works really good. When you apply the forceps, if the baby is nicely calmed down, he is ok. 2nd foreceps. Used local anesthesia, not 100% effective, but pretty good. Baby will possibly feel some pain when "adhesions" are removed. I don't "tear" away the facia from the glans.

Zenas: Do you ever get bleeding? I have never had bleeding when I do a circumcision. Zenas: To remove the adhesions, don't you have to use a forceps of hemostat and go down to the coronal ridge? I very gently, slowly push in and gently open the adhesions. Not 100%, but I get good effect. Zenas: When the adhesions are removed, you then take another forceps and crush... Objection. Sustained. Z: Do some babies respond differently? K: Most are pretty good. Are all the same? I can't answer that? Recess.

 

 

 

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