LOS ANGELES: Lawsuit against Mogen clamp maker

And about time too!


Law 360
April 22, 2015

Circumcision Clamp Makers Sued Over Amputated Penis

by Y. Peter Kang
Los Angeles (April 22, 2015, 4:00 PM ET) -- Companies associated with the production of a clamp used in performing circumcisions were hit with a product liability suit in Pennsylvania state court on Wednesday alleging that the medical instrument's poor design led to the amputation of the tip of an infant's penis.

California resident Victoria Hoekstra, the mother of a minor child, filed the suit against Misdom-Frank Corp. and related entities Sklar Corp. and Medco Group Inc., accusing the Pennsylvania-based companies of negligence and product liability in connection with the partial amputation of her week-old infant's penis in 2010 in what was supposed to be a routine circumcision procedure, according to the complaint.

Hoekstra says that the companies' product, known as a Mogen clamp, has a design defect that does not provide any protection for the head of the penis, unlike other circumcision clamps, and contains a second defect that does not allow for the doctor to be able to visualize the head of the penis when applying the scalpel to the foreskin.

These design defects "are well known and have long been identified and published in medical literature," according to the complaint.

"The Mogen clamp, unlike other circumcision devices, has a long history of penile amputations," Hoekstra alleges. "Defendants have misrepresented the efficacy and safety of their Mogen clamp through various means and media, actively and intentionally misleading the medical community, patients and the public at large."

[The Mogen Company went out of business in 2012 after losing two lawsuits to the value of $18.3 million. A subsequent suit was worth $4.6 million.]

Hoekstra says that her son has sustained permanent injury and will require future corrective surgeries and brings claims for strict liability, negligence and breach of warranty against the companies, seeking more than $50,000 in damages.

An attorney for the plaintiff told Law360 on Wednesday that the clamp should be pulled from the market.

"Circumcision is an ancient ritual that has been performed safely for centuries without incident [BS!]," said co-lead counsel Daniel Balaban of Los Angeles-based Balaban & Spielberger. "This case is about a defective product that has left our client mutilated and maimed. This dangerous device should be pulled off the market or fixed before another infant is harmed."

...

--Editing by Stephen Berg.

JOHANNESBURG: Man seeks redress for botch

Daily Sun (South Africa)
June 11, 2014

Justice for my 4-5!

(June 11 2014) - He had the circumcision because his wife kept fighting with him to do it. But the operation was a mess, and now his wife is fighting with him because of his damaged penis.
NOT ONLY COULD HE LOSE HIS 4-5, BUT HIS WIFE HAS MOVED OUT OF THE HOUSE AS WELL.

The sad businessman (30) from Germiston, east of Joburg was perfectly happy with his sex life, but his pregnant wife wasn't. She said it would make sex for her much better if he went to the clinic to have a circumcision done.

But if he didn't do it, she said, he would be without a wife. In the end the man agreed, so he went to the Johannesburg Men's Clinic on 21 May. He paid R750 [$US 69.75] and went home the same day.
"I was not in any pain. I had a bandage wrapped around my penis and I couldn't see the cut," he said. But a few days later his wound became very painful and he took off the bandage.

"I could not believe my eyes," he said. "My foreskin had been cut off and it had been stitched back on again!" He immediately went back to the clinic but says they refused to give him the name of the doctor who did the operation. The man came to South Africa from Rwanda during the war in that country without being circumcised. "Last year I visited my family and they told me I had to be circumcised by a traditional healer. I ended up crying and telling my parents I was old and I was afraid things would go wrong," he said. "Then my wife started complaining. She said real men were circumcised." He said he couldn't sleep and he hadn't gone to work.

"My wife has taken our seven-year-old son and left the house. They are living in our other house in Vanderbijlpark," he said. "I am worried they may never come back."

The man is sleeping in the Wendy House outside so he doesn't disturb the other people in the house. "I have made peace with the fact that I may lose my penis. I am even prepared to fly to England to have it removed," he said. "But when I come back, that doctor will suffer." Clinic spokesman, Phumlani Dladla confirmed the doctor who did the operation made a mistake. It appears the patient had a lot of excess skin and the doctor didn't cut off enough.

Then he realised his mistake and cut off some more, but this time he cut off too much and sewed some skin back on again. He said the man may not have followed the doctor's instructions and that is why he ended up with a septic penis. [Yes, blame the victim.] "We have offered to do a second operation to rectify that," said Dladla. "We are willing to fix the problem if the man co-operates." "We know it will hurt but the problem will be fixed." The man has lodged a complaint against the doctor with the Health Professional Council of South Africa, which requested the name and practice number of the doctor.

DENMARK: Baby in coma after circumcision

BT (Denmark) May 23, 2014 Læge: Omskæring gik helt galt i Nordvest - baby i koma Af: Silla Bakalus En lille baby er kommet så slemt til skade i forbindelse med en omskæring på en privatklinik på Nørrebro, at han er blevet lagt i koma. Sådan forlyder det i et facebook-indlæg, der de seneste dage er blevet spredt med lynets hast på facebook. Bl.a. har personer som Suzanne Bjerrehus samt den kendte overlæge og forsker i seksuel sundhed, Morten Frisch spredt indlægget. Sidstnævnte bekræfter, at historien er sand overfor BT. - Jeg kan bekræfte, at historien er sand. For jeg har talt med lægen, der har udført indgrebet, og han bekræfter, at drengen ligger i respirator, siger Morten Frisch. Ifølge indlægget, der angiveligt er skrevet af et familiemedlem til den lille dreng, havnede babyen i koma, efter han tirsdag blev omskåret på en privatklinik i Københavns Nordvest-kvarter. Efterfølgende måtte drengen indlægges på Hvidovre Hospital, hvor han altså blev lagt i koma. - Inden omskæringen gav han (lægen, red.) bedøvelse, desværre kom den amatør til at give babyen for meget bedøvelse ca. 8ml. (Han burde højst give 3ml. da babyen kun vejer 3 kg.) Kort efter omskæringen og mens babyen stadig var på klinikken begyndte han at havde svært ved at trække vejret og farven i ansigtet ændrede sig samtidig med der kom væske ud af munden på babyen, lyder ordlyden i indlægget... Dansk Folkepartis Liselott Blixt stillede i torsdag følgende spørgsmål til sundhedsminister Nick Hækkerup (S). - Kan ministeren af- eller bekræfte den historie, der florerer i medierne, om en baby der har fået for meget bedøvelse i forbindelse med en omskæring og nu er indlagt på Hvidovre Hospital? Liselott Blixt oplyser fredag formiddag til BT, at hun endnu ikke har fået svar Nick Hækkerup. ...

Bing translation (edited) May 23, 2014 Doctor: Circumcision went badly wrong in the Northwest - baby in a coma By: Silla Bakalus A little baby has suffered so badly in connection with a circumcision at a private clinic in Nørrebro, that he has been put into a coma. This was reported in a Facebook post that has gone viral. People like Suzanne Bjerrehus and the well-known consultant and researcher in sexual health, Morten Frisch, among others, have spread the story. He confirms the story to BT. -I can confirm that the story is true. For I have spoken with the doctor who performed the surgery, and he confirms that the boy is on life support, says Morten Frisch. According to the post, allegedly written by a family member of the little boy, the baby ended up in a coma after he was circumcised on Tuesday at a private clinic in the Northwest District of Copenhagen. Subsequently the boy was hospitalized at Hvidovre Hospital, where he was put into a coma. -Before circumcision, [the doctor] gave him too much anesthetic, about 8ml. instead of the maximum of 3ml. for a 3 kg baby. Shortly after circumcision and still at the clinic, the baby had difficulty breathing, the color of his face changed and fluid was coming out of his mouth, according to the initial post... Danish people's Party member Liselott Blixt asked to health minister Nick Haekkerup (Social Democrat) on Thursday: - -Can the Minister of-or confirm the story, which is rife in the media, about a baby who has gotten too much anesthesia for a circumcision and now is hospitalized at Hvidovre Hospital? Liselott Blixt told BT on Friday morning that she has not yet received a reply from Nick Hækkerup. ...

TENNESSEE: Clinic uncooperative after botched circumcision

WMCTV (Tennessee)
February 6, 2014

Shelby Co. commissioner seeks answers in botched circumcision case

by Nicole Harris and Janice Broach
(WMC-TV) - A mother is finally getting closer to answers after her son's botched circumcision last August.

"We want to make sure that they have a plan in place to make sure this does not happen ever again to another child. This was a horrible thing,' said Shelby County Commissioner Henri Brooks.

Brooks wants answers about how Christ Community Health Services allegedly botched the circumcision of three-month-old Ashton Rhodes.

Back in November, Maggie Rhodes told Action News 5 that she took her son to the clinic for a circumcision in August. She felt something was wrong because she could hear her son's cries through the closed door.

"When he was in the room, he was screaming like life and death; like there wasn't no tomorrow," said Rhodes.

Commissioner Brooks says Rhodes, one of her constituents, contacted her. Brooks set up a meeting with commission Chairman James Harvey in his office.

"We have invited Christ Community Center representatives, as well as asked them to bring documents that will include certification of the credentials for staff also the health care professionals involved in this procedure," said Brooks.

Christ Community Health Services, who has a health care contract with Shelby County, declined the invite for the meeting on Thursday.

Brooks says she was traumatized when she found out about Ashton's situation.

"It was a baby. Can you imagine the pain a baby having to go through that kind of pain?"

Christ Community did not respond to Action News 5's request for comment about the meeting, but the first person who answered the phone cited HIPAA laws.

Earlier story

STOCKHOLM: Swedish doctors want tighter rules for circumcision

Information (Denmark)
26. januar 2014

Svenske læger vil skærpe regler for omskæringer

Det kirurgiske indgreb burde erstattes af en symbolsk omskæring, mener lægeforening. Minister er afvisende.

Den svenske lægeforening mener, at omskæringer kun skal udføres efter samtykke fra drengen.
Anbefalingen støttes af samtlige medlemmer af foreningens etiske udvalg, skriver Svenska Dagbladet.

Hvis politikerne vælger at følge forslaget, vil det være en skærpelse af de nuværende regler for at omskære drengebørn.

Lægeforeningen begrunder sin indstilling med, at risikoen for bivirkninger ved det kirurgiske indgreb er urimelig høj.

Drenge skal tidligst blive omskåret i 12-13 års alderen. Indgrebet, hvor forhuden bliver fjernet, skal foretages på et hospital og først efter, at der er givet information om smerten og de eventuelle risici, som det kan medføre, mener rådet.

At gå så vidt helt at forbyde omskæringer, hvilket diskuteres i Finland, anses ikke for at være realistisk her og nu, skriver Svenska Dagbladet.

Men grundlæggende mener Läkarförbundet, at det kirurgiske indgreb bør erstattes af en symbolsk omskæring. For eksempel i form af en ceremoni af en eller anden slags.

Den mulighed vil lægerne nu drøfte med med jurister og muslimske repræsentanter.

- Vi er ikke religiøse eksperter, men af medicinske grunde kan vi ikke give vores opbakning til et indgreb, hvor man fjerner væv på kønsorganet, når der er så stor en risiko for alvorlige komplikationer, siger Thomas Flodin fra foreningens etiske råd.

Dansk forskning viser, at der opstår komplikationer i fem procent af samtlige omskæringer - også selv om indgrebet er foretaget af sundhedspersonale på hospitaler.

- At en ud af 20 personer lider af en infektion eller blødninger, er en alt for stor risiko. Især når indgrebet ikke er udført af medicinske grunde, siger Thomas Flodin.

Integrationsminister Erik Ullenhag fra Folkpartiet mener, at den gældende lovgivning er tilstrækkelig.
- Jeg har aldrig mødt en voksen mand, der oplevede omskæringen som et overgreb, siger han til avisen.

(Microsoft translation)
26 January, 2014

Swedish physicians will sharpen rules for circumcision

The surgical procedure should be replaced by a symbolic circumcision, doctors believe. Minister is dismissive.

The Swedish Medical Association believes that circumcision [should be] performed only after consent from the boy.

The recommendation is supported by all the members of the Association's Ethics Committee, Svenska Dagbladet writes.

If politicians choose to follow the proposal, it will be a tightening of the rules currently in force [concerning] circumcising of baby boys.

The Danish Medical Association justifies its recommendation [on the basis] that the risk of side effects from the surgery is excessive.

Boys may be circumcised [at] 12-13 years of age, at the earliest. The procedure, in which the foreskin is removed, must be carried out at a hospital and only after [parents are] given information about the pain and the possible risks it can cause, according to the Council.

To go so far as to completely prohibit circumcision, [being] discussed in Finland, is not considered to be realistic here and now, Svenska Dagbladet writes.

But the Medical Association fundamentally believes that the surgery should be replaced by a symbolic circumcision, for example, in the form of a ceremony of some sort.

They will now discuss the option with doctors, lawyers and Muslim representatives.

"We are not religious experts, but for medical reasons, we cannot give our backing to an intervention where one removes tissue from the genital organ, when there is such a high risk of serious complications," says Thomas Flodin from the Association's ethical Council.

Danish research shows that there will be complications for five percent of all circumcision, even if the procedure is carried out by health care professionals in hospitals.

"For one in 20 people to suffer from an infection or bleeding is too great a risk, especially when the surgery is not performed on medical grounds," says Thomas Flodin.

Integration minister Erik Ullenhag of the Liberal Party believe that the existing legislation is adequate.

"I have never met an adult man who experienced circumcision as an assault," he told the newspaper.

SUSSEX, ENGLAND: Circumcision-botch doctor turns amateur

BBC News
November 17, 2013

Circumcision doctor in GMC investigation to quit NHS

by Nicola Dowling
A doctor under investigation by the General Medical Council after circumcising a child says he is resigning from the NHS.

Dr Muhamad Siddiqui, a hospital surgeon, had conditions imposed on his GMC registration after a complaint by the parents of the toddler.

The doctor, who carried out the procedure at the child's home, denies all the allegations.
Dr Siddiqui operated his own mobile circumcision service outside the NHS.

The GMC investigation was launched after a complaint by Kelly Braiha and her husband Ghali, from Littlehampton in West Sussex.

They claim their 23-month-old son Najem was left traumatised and suffered an infection because Dr Siddiqui, who works at University Hospital Southampton NHS Foundation Trust, did not take hygienic precautions.

Mrs Braiha says she believes home circumcisions should now be banned.

Dr Siddiqui is also accused of failing to obtain indemnity insurance for his private work and of carrying out regulated procedures without the necessary Care Quality Commission registration.
He denies all the allegations against him.

After an initial investigation by the GMC, the case has been referred to a fitness-to-practise hearing.
In the meantime, the GMC issued an interim order banning Dr Siddiqui from carrying out circumcisions anywhere other than in a hospital or clinical setting.

Regulatory loopholes
But when researchers from the BBC Radio 5live Investigates programme contacted him this week, days after the interim order came into force, he said he would be happy to carry out a circumcision at a private address in Southampton.

After the arrangements for the procedure were agreed, the programme contacted Dr Siddiqui again and told him the call had been made by a researcher posing as the father of a boy he wanted circumcised.

Dr Siddiqui said he wanted to continue performing home circumcisions but he was in the process of resigning from his NHS job and surrendering his GMC registration.

This would mean he would not be able to practise as a doctor but because of regulatory loopholes he would be able to carry on performing circumcisions privately.

[In fact anyone at all, with no qualificaitons whatsoever, may genitally cut a boy.]

Asked why he had agreed to carry out a home circumcision when there was a GMC order preventing him from doing so, he said he would not have carried out the procedure until his resignation had been formalised.

Dr Siddiqui said: 'I don't agree with the limitations the GMC has imposed on me. I don't want to be at odds with the GMC."

Healthcare workers have to be registered with the CQC if they want to perform home circumcisions but Dr Siddiqui felt he did not have to be.

Those who have no formal medical training, however, are not required to be registered with any of the regulators.

5live Investigates has also spoken to consultants who have told the programme they are concerned about the number of children they are seeing with medical complications after some home circumcisions.

They are now calling for tighter controls.

'Children have died'
Consultant surgeon Feilim Murphy, secretary of the British Association of Paediatric Urologists, said: "The biggest issue is there are a number of children who are circumcised by people who are not experienced and don't understand what is required, and there can be significant complications with that."

He said this could include bleeding, which is particularly dangerous for babies, pain, damage to the penis and loss of the top of the penis.

[Circumcision always causes damage to the penis....]

He added: "Unfortunately children have died in the last number of years in Britain and Ireland from circumcision-related complications.

"It does make sense that everybody should register, that everybody should be on the same playing field.

"It makes sense for the child it makes sense for the family it makes sense for everyone."

[What would make sense for the child is not being genitally cut before they could give informed consent.]

MEMPHIS, TENNESSEE: Another botch, penis cut off

WMCTV
November 7, 2013

Mother claims doctor disfigured son after 'botched' circumcision

by Janice Broach
(WMC-TV) - Circumcision for newborn boys is considered one of the most common medical procedures in the world. [No, it is rare except in the USA and Israel. Most circumcision is done later, and most of the world does not circumcise.] But one Memphis mother says her son was mutilated during the common surgery.

Maggie Rhodes' son Ashton was three months old when she had him circumcised at a local low-cost clinic.

"When he was in the room, he was screaming like life and death like, like there wasn't no tomorrow," she said. "When she pulled back the cloth, like the thing was like gone. She cut up instead of down, instead of cutting around the top of the penis."

Rhodes says her son now screams when he urinates. He will need reconstruction work to correct what she considers a botched procedure.

Ob/Gyn Doctor Kent Lee did not perform Ashton's circumcision nor has he ever met Ashton or his mom. Lee says most circumcisions are safe, but he says mistakes do happen.

"I've been doing this for 20 years, and I have never ever seen anybody with everything completely cut off," said Ob/Gyn Dr. Kent Lee. "Actual penectomy is extraordinarily rare." [Unfortunate choice of words.]

According to the American Academy of Pediatrics 1 in 500 newborn boys experience significant acute complications as a result of circumcision. [Even that figure - wherever they got it - means one significant acute complication of circumcision every 3 hours and 40 minutes in the USA.] The procedure typically takes five to 30 minutes.

Rhodes says her son was in surgery for nearly three hours.

"While he was screaming, I asked her, I kept asking was everything OK?" said Rhodes. "She was like uhh, 'I don't know if he's too large to get did inside the clinic, but I am going to do it anyway.' "

Another Ob/Gyn says some people have their child go through the procedure in the hospital.
"Some people do it within the first week or two," said Dr. Charles Ryan.

Ryan says the sooner a newborn receives the procedure the better, but circumcisions can still be done up to three months after birth with no problems.

Rhodes did not have her son circumcised in the hospital because she was unable to be present for the procedure. Also, her son had a cold during his six-week-checkup. The doctor said wait.

"You try to be the best mom you can be, but it's like the attack of the enemies is always there," said Rhodes. "I feel like I failed my son."

Studies suggest circumcision decreases the likelihood of certain diseases and infant urinary tract infections. but medical opinions vary.

The percentage of newborn boys circumcised in the U.S. dropped to 54 percent last year. Rhodes wishes she had not had her son circumcised and wonders what she will tell him when he gets older.

She is devastated. Rhodes' story is far from over as she is currently talking to a lawyer.

"I feel in my heart, I felt like I couldn't do nothing but cry," she said.
...

SOUTH AFRICA: R2.2M for botched circumcision

IoL News (South Africa)
June 20, 2013

R2.2m for boy's botched circumcision

by Sharika Regchand

Durban - The parents of a boy whose circumcision was botched at a Vryheid hospital were awarded R2.2 million [$US 195,900] to be paid within 14 days by the provincial Health Department, Deputy Judge President Achmat Jappie ordered in the Pietermaritzburg High Court on Wednesday.

Judge Jappie also ordered that the department pay all the family’s legal costs.

The mother of the child, now nine, sued the department on behalf of her son following his circumcision in October 2009. [They asked for five times as much.]

He suffered severe burning, infections and a loss of his normal penile tissue after the procedure.

Plastic and reconstructive surgeon Paul McGarr said in a report before the court that he was “completely amazed by the inertia, lack of a sense of urgency and lack of sensitivity shown by the doctors” who initially managed the child.

McGarr went into detail as to how the child’s injury had occurred and commented that the standard of practice and aftercare at the hospital constituted gross negligence by staff who had failed to follow the most basic principles of surgery.

“The words lazy, incompetent and disinterested accurately describe the treating doctor’s actions,” he said.

“In essence, nine minutes of a rushed, incompetent circumcision has significantly and severely impacted on the child for the rest of his life.”

Attorney Sonette Boning said the boy’s parents were happy that the matter had been finalised after four years.

She said they were not on medical aid and had found it difficult to get him the best medical and psychological treatment.

He would also need to have further surgery.

The mother previously told The Mercury that it was difficult for her son and there had been a big change in his life.

“He went through a lot of anxiety, fear and psychological trauma. He also lost his self-confidence,” she said, recalling days when her son had panic attacks and times when she could do nothing to help him feel better.

Earlier story

TEL AVIV: Botched baby in critical condition

Times of Israel
May 30, 2013

Baby in critical condition after circumcision

by Stuart Winer

Barely breathing boy rushed to hospital following ritual

A baby boy slipped into unconsciousness during a circumcision ceremony and was taken to hospital in a critical condition on Thursday.

The eight-day-old infant underwent the brit milah ritual at the Pinhas Lavon synagogue in Holon when he stopped breathing and lost pulse.

The family made desperate calls to Magen David Adom for an ambulance and to the Hazalah first response organization.

Medic Yehuda Mizrahi was first to arrive on the scene.

“When I arrived, the baby was completely blue, not breathing and with no pulse,” he told Channel 2, and described how he began resuscitation techniques, including massages to try to restart the boy’s vital systems. Finally an ambulance arrived and the infant was rushed to Wolfson hospital.

Doctors began investigating what might have caused the incident, including excessive blood loss, a congenital disease, or infection. [Hmm, I wonder. How about that wound on his penis?]

ZIMBABWE: Father, son, another in hospital after botched circumcisions

Nehandra Radio (Zimbabwe)
October 3, 2012

Father and son hospitalised after horror circumcision

THREE Gweru men, among them a father and son, were reportedly admitted to Gweru Provincial Hospital after they reacted by bleeding profusely after being circumcised at the hospital’s circumcision clinic.

In an interview, one of the men said he had taken his son, aged 16, to the hospital circumcision clinic when they suffered the complications. He said he was hospitalised in the same ward with his son for three days following the anomaly.

“We spent three days admitted to the hospital following the incident and we were later discharged on Thursday last week. We discovered that there was another man in the same ward who had also suffered some complications after being circumcised,” said the man.

He said they were not in the light on whether the complications they faced were as a result of the doctor’s failure to properly conduct the operations.

“I was very disappointed because I am the one who persuaded my son to undergo circumcision only for us to develop the complication. We believe the doctor might have failed to conduct his duties properly. This is because we later discovered that there was another patient in the same ward who also experienced problems after being circumcised,” he said.

Gweru Provincial Hospital medical superintendent Dr Fabian Mashingaidze, however, said it was common that circumcision patients could develop “adverse complications” after circumcision. He said the number of patients who responded negatively after being circumcised was, however, minimal.

“These particular cases were not brought before my attention maybe because they were not serious or common adverse events. This can happen when a patient develops normal complications after undergoing circumcision. Remember, this is an operation and these incidences do happen but they are very minimal,” he said.

Dr Mashingaidze said the Gweru circumcision clinic has conducted many circumcision cases and had not recorded any serious complications in the process.

“In fact, globally the chances of one getting complications after getting circumcised is one out of 100 and according to a national audit, which was conducted recently, only two percent of the circumcised population had complications meaning that the chances of one getting complications like bleeding or infections is very low in the country.

“Some of the challenges that might arise are due to failure to take care of the wound on the part of the patient,” he said. The Chronicle