Morcellator Lawyers Tracey & Fox Report California Woman Claims Power Morcellator “Likely” Spread Uterine Cancer To Lungs
June 16, 2015 – – On March 13, 2014, a couple from California filed one of the first lawsuits involving a power morcellator, claiming that the medical device, frequently used to perform fibroid removal procedures, spread an undiagnosed case of uterine cancer. As many as a dozen power morcellator complaints have now been filed, and attorneys at Tracey & Fox, a personal injury firm experienced in dangerous medical device litigation, expect the amount of morcellator lawsuits to grow further.
Filing their complaint in the US District Court for the Northern District of California, under case number 5:14-cv-02209-EJD, Sarah Salem-Robinson and her husband Alan Robinson claim that the Richard Wolf Medical Instruments Corporation failed to warn patients, including Salem-Robinson herself, about the risk of “disseminating” undetected uterine sarcomas posed by its Wolf Power Morcellator.
Salem-Robinson says that she underwent a hysterectomy procedure in 2012 for the removal of what were believed to be benign fibroids. But according to a public Safety Communication from the US Food & Drug Administration, “there is no reliable method for predicting or testing whether a woman with fibroids may have a uterine sarcoma,” a form of cancer that begins in the uterus’ soft tissues. As of November 24, 2014, the FDA now cautions against the use of power morcellators in the majority of women undergoing fibroid removal procedures, but for Salem-Robinson that warning may have come too late.
During her procedure, a Wolf Power Morcellator was used to grind fibroid tissue into small pieces that were then removed through minor incisions in her abdomen. Previous to her surgery, she says “there was no evidence that she had disseminated or metastatic cancer.”
But twelve days later, Salem-Robinson would be informed that one of the growths removed was not in fact a benign fibroid, but a malignant tumor. She was diagnosed with a leiomyosarcoma, an aggressive soft tissue cancer, and told that the use of Wolf’s power morcellator meant that there was a significant risk that cancer cells had been spread within her abdomen. Plaintiff claims that this was the first time she became aware of power morcellation’s dangers.
Salem-Robinson underwent a rigorous course of monitoring immediately after her diagnosis, she writes in court documents. She says that “initial imaging of [her] lungs, abdomen and pelvis did not show any lesions or nodules that were consistent with possible metastatic disease.” Since that time, physicians have identified four lesions in one of Salem-Robinson’s lungs. She says that her medical team believes that these growths “likely represent metastatic leiomyosarcoma.”
Along with her husband, Salem-Robinson claims that the Wolf Corporation failed to “promptly and adequately warn” of their power morcellator’s potential to spread undiagnosed uterine cancer. She says that Wolf concealed its “full knowledge and experience” of the morcellator’s risks from the FDA, medical community and public, thereby preventing patients from making truly informed decisions about the course of their own health care.
After the FDA’s strict warnings were released, entire hospitals announced that they would discontinue use of the device. Many public health advocates have called for a total ban on power morcellation. Johnson & Johnson, the world’s largest morcellator manufacturer, has stopped selling the product, and asked physicians across the globe to return their power morcellators. Many large health insurers have sought to restrict, or drop completely, their coverage of fibroid removal procedures that involve power morcellators.
But other insurers, including Health Care Service Corp., have decided to continue covering morcellator surgeries, reports the Wall Street Journal. And while the FDA now requires all morcellator manufacturers to include its strongest, “Black Box” warning, on their devices, use of the power morcellator in hysterectomy and myomectomy procedures is likely to continue.
In the face of these opposed reactions to what some consider a public health crisis, women diagnosed with uterine cancer after undergoing a power morcellator procedure have begun to file lawsuits. Claims have been brought against many manufacturers, including Johnson & Johnson, and several have been filed by widowers who survive their deceased loved ones. In response, the experienced attorneys at Tracey & Fox are providing free consultations to patients who believe that a power morcellator may have spread or “upstaged” an undiagnosed uterine cancer. For more information on the morcellator litigation and case eligibility, call (713) 495-2333.
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Contact Tracey & Fox:
Sean Tracey
888-427-0543
440 Louisiana Street , Suite 1901
Houston, TX 77002
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