Widower sues medical-device maker over hysterectomy

Posted: March 19, 2014

The husband of a Berks County woman who died of a rare uterine cancer following a minimally invasive hysterectomy is suing the maker of the device used in her surgery at Reading Hospital.

The lawsuit, filed Friday in federal court in Philadelphia, adds to controversy over electric tissue-cutting "morcellators." The devices let doctors remove tissue through tiny abdominal incisions, shortening patients' hospitalization and recovery. In rare cases, the process can disseminate an aggressive uterine cancer, leiomyosarcoma, that routine diagnostic tests usually miss.

In October, that scenario upended the lives of husband-and-wife physicians in Boston, leading them to campaign for a ban on power morcellators in gynecology. The Food and Drug Administration and gynecological groups are reviewing the matter.

In the suit, Scott Burkhart of Reading alleges that his wife, Donna, had no evidence of metastatic cancer before she underwent a hysterectomy with power morcellation to treat uterine bleeding in March 2012. She was not warned "about the possibility of seeding an undiagnosed sarcoma" throughout her abdominal cavity and thus worsening her prognosis, the suit says.

Less than a year later, in February 2013, she died at age 53 of metastatic leiomyosarcoma.

Burkhart's attorney, Francois Blaudeau of Birmingham, Ala., calls the case "the first major federal product liability lawsuit involving a uterine morcellator manufacturer."

Blaudeau said he was waiting for Reading Hospital to precisely identify that manufacturer. In the meantime, the legal complaint names three manufacturers known to sell to the hospital - Ethicon Inc., Blue Endo, and Lina Medical - as well as generic defendants.

A spokeswoman said the hospital could not comment on pending litigation. The companies did not respond to requests for comment.

In addition to being a lawyer, Blaudeau is an obstetrician-gynecologist who has performed many minimally invasive operations.

"Surgeons collectively claim they aren't breaching the standard of care because surgeons across the nation are using morcellators this way," he said. "So because a bunch of doctors are doing the wrong thing, it's OK to do the wrong thing."

That standard-of-care argument has been attacked by Amy Reed, 41, the Boston anesthesiologist and mother of six who has stage 4 leiomyosarcoma, and her husband, cardiothoracic surgeon Hooman Noorchashm.

The couple - both trained in Philadelphia and affiliated with Harvard Medical School - also spurred a review of the medical literature that has led to a reestimation of the risk of dispersing a leiomyosarcoma during morcellation. Previously, doctors told women the chance was one in 10,000; now it is believed to be between one in 400 and one in 1,000.

But Blaudeau disagrees with the couple about the need to ban gynecological morcellation.

"Hooman's position is it should never be done, period. I don't think eliminating morcellation completely is something that academic medicine and the industry will accept. But we think we can effect change without that. I think this case is a bellwether case. It has all the ingredients to force something to be done."

Blaudeau said gynecologists have ignored certain factors that put women such as Burkhart at higher risk of sarcoma, including being menopausal and having a very large uterine fibroid.

Gynecologists say those factors are too common to be useful. Middle-aged women with abnormal bleeding caused by fibroids account for most of the 430,000 hysterectomies done annually in the United States.

About 11 percent of hysterectomies involve electric morcellation, according to the American Congress of Obstetricians and Gynecologists.


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