Circumcision Clamps Lead To Medical Malpractice and Product Liability Claims

Almost all circumcisions in the U.S. are performed with a Mogen clamp, a Gomco clamp or a device called the Plastibell. However, the safety of these devices is being called into question, as is the skill of the doctors in using these devices.

As reported in The Los Angeles times Melanie Hall sued both the doctor and the distributor of the Mogen clamp he had used to circumcise her now 8-year-old son, Terrel, after the doctor had cut off most of the tip of Terrel’s penis. While the claim for Medical Malpractice against the physician was dismissed, Miltex Inc. and its parent company, Integra Life Sciences Holding Corp., agreed this summer to a $4.6-million settlement.

The Mogen clamp’s name derives from the Hebrew word “magain,” or shield. It was invented in 1954 by Rabbi Harry Bronstein, a Brooklyn mohel who wanted to standardize circumcision equipment then in use by both doctors and mohels without medical training who perform the procedure in private homes and other locations. A user first loosens the foreskin, then pulls it through the clamp and clips it off with a single cut.

See the video of a circumcision with the clamp:

There have been numerous reports in recent years of patients being injured by the Mogen clamp, which is much less popular than the other two types of circumcision devices, which are two-part systems that protect the tip of the penis.

As far back as August 2000, the U.S. Food and Drug Administration issued a public health notice about the Mogen and Gomco clamps after receiving about 20 injury reports a year since 1996, including lacerations, hemorrhaging, penile amputation and urethral damage. Instead of recalling the devices, the FDA advised users to make sure they were using the correct size Mogen clamp and that the space between the clamp’s jaws met manufacturer’s specifications. The agency also cautioned against using replacement parts on the Gomco clamp, which led it to malfunction.

But complications continued. In the 11 years between the FDA warnings and the Hall settlement, the agency has received 139 additional reports of problems related to circumcision clamps, including 51 injuries, said spokeswoman Amanda Sena. Twenty-one of those reports were related to Mogen clamps, all but one of which involved injuries.

Miltex, one of several Mogen clamp manufacturers, stopped distributing the devices in 1994. “Although no obvious defect has been found with the clamp’s design or manufacturing we have concerns over the possible mishandling of the instrument by practitioners and our inability to ensure the instrument’s proper use,” Miltex’s then-president Saul Kleinkramer wrote in a letter announcing the decision.

But some of its devices are still in use. That troubles some medical experts, who say the Mogen clamp, unlike others, has a critical design flaw: It does not allow doctors or mohels to see what they are cutting.

In 2000, Miltex reached a confidential settlement with a North Hollywood couple whose newborn was injured during circumcision. Last year, a New York judge awarded $10.8 million in damages to a Florida couple whose son lost the head of his penis when he was circumcised with a Mogen clamp. The maker of that device, Mogen Circumcision Instruments of New York, already was in default on a $7.5-million judgment in Massachusetts.

Only about 10% to 20% of doctors use the Mogen clamp, according to Dr. David Tomlinson, who teaches family medicine at Brown University in Providence, R.I., and serves as the World Health Organization’s chief expert on circumcision. But the clamp is popular with mohels because some orthodox Jews recognize only circumcisions performed with devices based on the traditional design, according to Dr. Fred R. Kogen, a mohel in Los Angeles.

Kogen has performed circumcisions with the Mogen, the Gomco and the Plastibell. He said he prefers the Mogen, which he has used on more than 7,000 babies, including his son.

With the Mogen clamp, a circumcision requires just one cut and is over in minutes. The Gomco and Plastibell devices require doctors to make multiple incisions, which takes more time and causes more pain, according to studies cited in the April issue of the Journal of Family Practice.

“In my mind, it was less traumatic to the child” to use the Mogen clamp, Kogen said. “I felt comfortable with it.”

The clamps appear to be defective both in design and manufacturing, thus leading to claims for Products Liability. Products liability claims, unlike Medical Malpractice claims do not place a cap on pain and suffering damages.

In order to prevail on a claim for medical malpractice, the injured party must prove that the treatment by the doctor was below the standard of care. This is done by the expert testimony of a doctor who specializes in the same field of medicine as the doctor who is being sued. In the Hall case, the claim against the doctor was dismissed-It may be that the doctor testified that the product was defective, and because of that defect the injury occurred. Perhaps in exchange for the favorable testimony, the claim against the doctor was dropped.