From hospital bed, cancer patient presses device suit that blames N.J. doctors, manufacturer

From the article on NorthJersey.com.

Viviana Ruscitto, the mother of a toddler, is fighting for her life in a New York hospital bed. She is suffering from a highly aggressive form of cancer that, she believes, was spread by a device used during what was supposed to be a routine hysterectomy.

A surgical tool called a power morcellator was used to cut and shred tissue so it could be sucked out through a tiny opening during the minimally invasive operation. Ruscitto, 43, believes it spattered cancer cells through her abdomen.

In a lawsuit filed in federal court in Newark, she contends it should never have been used for her surgery at The Valley Hospital in Ridgewood last fall. Six months before her operation to remove a large fibroid, the federal government had discouraged health-care professionals from using morcellators because of the risk of spreading undetected cancer cells. The largest manufacturer of the device had already suspended sales.

"My sister's prognosis is poor, and I do not know how much longer she can continue fighting this cancer that is attacking her body so fiercely," Mirian Rivera told a judge last week in a sworn statement. "Our mother and I take turns staying with her at the hospital, while our father is at home taking care of her 2-year-old son, Maximo."

Ruscitto has been diagnosed with Stage 4 leiomyosarcoma, a rare and aggressive cancer.

She has sued the device maker, her doctors and Valley, charging that they should have known about the risk posed by the device.

A judge in federal district court agreed last week to her attorney's request to take her testimony immediately - in her room at Memorial Sloan Kettering Cancer Center, if necessary. She may not live to attend the trial, the attorney, Demetrios Stratis, said.

The metastases have spread quickly, obstructing her intestines and causing so much swelling she looks nine months pregnant, Rivera told the court. Ruscitto, who lives in Upper Nyack and has been the radiology director of a Westchester County radiology facility, is no longer undergoing chemotherapy to fight the disease. She is receiving oxygen, morphine and anti-nausea medication.

Ruscitto's suit is the third filed in U.S. District Court for New Jersey involving cancer that was allegedly spread by a morcellator, and it is one of nearly two dozen around the country. The others - against four device makers, including Karl Storz Endoscopy-America Inc., which is named in Ruscitto's suit, and Ethicon, a subsidiary of Johnson & Johnson - are being considered by the Judicial Panel on Multidistrict Litigation for consolidation.

Karl Storz Endoscopy did not respond to requests for comment.

Ruscitto's case is different from the others, her lawyer says, because it includes malpractice claims against the hospital and her doctors, Howard H. Jones, a gynecologic oncologist; Eugenia C. Kuo, a gynecologist; and Celeste A. Telfeyan, an anesthesiologist.

Stratis argues that when Ruscitto had surgery Oct. 17, there had already been so much publicity about the potential dangers of power morcellators that the health care providers should have known, informed her and secured her consent before the surgery.

She "specifically told him [Jones] that she had tremendous anxiety of ovarian cancer," the lawsuit said.

Maureen Curran Kleinman, a spokeswoman for The Valley Hospital and its related medical group - where Jones and Kuo are employed - said, "We will not be commenting on this matter."

Bergen Anesthesia Group, which employs Telfeyan, did not respond to requests for comment.

On Friday, Rep. Bill Pascrell Jr., a Paterson Democrat, joined 11 other members of Congress in asking the U.S. comptroller general to investigate how the power morcellator was approved by the federal Food and Drug Administration in the first place, and what's being done to make sure it is safe enough to remain on the market.

"The power morcellator is only one of many medical devices to raise serious concerns about safety and efficacy," said Pascrell, who has pushed for improved tracking of devices and reporting of adverse events.

Ruscitto's lawsuit contends that months before her surgery, the government advised health professionals about the danger of spreading previously undetected cancer when the device was used. Other methods of doing the procedure were available, the lawsuit says, and her doctor should have done a biopsy before opting for morcellation.

An estimated 600,000 hysterectomies are performed a year. The FDA first approved power morcellators in 1991, making it possible for surgeons to do minimally invasive hysterectomies. Traditionally, the procedures were performed via an incision in the abdomen or pubic area. With the device, surgeons promised a faster, easier recovery, with less chance of infection, and considered the risk of spreading cancer to be extremely rare.

Recently the FDA revised its assessment of the cancer risk. It now says that one in every 350 women who undergoes a hysterectomy for fibroids has a cancer that may not have been detected but could be spread by morcellation.

The high-speed, spinning blades of a morcellator cut and shred tissue into smaller fragments that can be removed through small incisions. When it minces the tissue, some fragments may be left behind, attaching to the intestines or the abdominal wall, or even traveling to other areas of the body through blood vessels or lymph. If the tissue contains cancer, the dispersed cells cause the cancer to spread, or metastasize, and change it from an early-stage cancer to a much higher stage. Stage 4 leiomyosarcoma is considered incurable.

"Hundreds, if not thousands, of women in America are dead" because the device was used on them in a laparoscopic hysterectomy, the congressional contingent wrote in Friday's letter. "This device can take a Stage 1 treatable cancer immediately to a Stage 4 terminal cancer. For too many women, this routine procedure ended with a death sentence."

In Ruscitto's case, she was diagnosed with Stage 4 cancer within weeks of her operation.

The first public attention to potential problems with the device came in December 2013, when a Boston anesthesiologist, Amy Reed, and her husband, a heart surgeon, spoke about her battle with metastatic leiomyosarcoma in The Wall Street Journal. Their story, about her diagnosis following a routine hysterectomy performed with a power morcellator, appeared on the front page. Reed's husband, Hooman Noorchashm, started an online petition at change.org to stop the use of power morcellators in minimally invasive gynecologic surgery. His one-man campaign reached the FDA and federal lawmakers.

In April 2014 the FDA issued a "safety communication" discouraging use of power morcellators for uterine fibroids and told health care professionals to discuss the risks and benefits of the treatment with their patients. That month, Johnson & Johnson, the device's largest manufacturer, suspended sales of new morcellators. Many health systems also suspended their use.

An FDA panel held two days of public hearings about morcellators in July 2014.

That same month, Johnson & Johnson asked its customers to return the devices and withdrew from the market. The Journal of the American Medical Association published a study showing that the risk of spreading a hidden uterine cancer was much higher than the 1-in-10,000 previously estimated.

Ruscitto's surgery took place in October. She returned to work soon after, according to another of her attorneys, Michael Gunzburg.

On Nov. 24, the FDA issued an official warning against the use of power morcellators for "the majority of women." It told manufacturers to place a black-box warning about the risks of the device on their products. Many insurers subsequently limited their coverage of procedures that use the device.

By that time, Ruscitto had received her diagnosis of leiomyosarcoma and was getting ready for treatment at Memorial Sloan Kettering.