June 29, 2015 – – In at least 22 individual lawsuits, women and widowers from across the country have claimed that previously-undiagnosed uterine cancers were spread and exacerbated by the use of power morcellators, devices often used to perform “non-invasive” gynecological procedures. According to the dangerous medical device attorneys at Tracey & Fox, a couple from Sandy Springs, Georgia added their voice to this growing litigation on April 7, 2015.
Filing their lawsuit in the US District Court for the Northern District of Georgia, Atlanta Division, Eva and John Galambos bring their claim for compensation against the multinational medical giant Johnson & Johnson. Once the world’s largest manufacturer of power morcellators, Johnson & Johnson pulled their devices from the market after a series of safety announcements from the US Food & Drug Administration cautioned surgeons to avoid the use of power morcellators in most uterine fibroid removal procedures. But now Johnson & Johnson faces a number of legal claims from former patients and survivors who, like the Galambos’, claim that the company failed to warn women and physicians of the morcellator’s significant risks.
Eva Galambos, 86, served as Sandy Springs’ first-ever mayor between the years of 2005 and 2013. During her unprecedented tenure, Galambos underwent a laparoscopic hysterectomy in Atlanta, according to the complaint. During the procedure, intended to remove “benign” uterine fibroids, Johnson & Johnson’s Gynecare Tissue Morcellator was used. As surgeons increasingly turn to “non-invasive” options, the use of power morcellators, which can be inserted through small incisions in the abdomen, has become more common. The medical devices use a spinning blade to grind uterine and fibroid tissue into small pieces for easier removal. And while fibroids are assumed to be non-cancerous, there is currently no medically acceptable way of telling whether or not a woman with fibroids is in fact harboring an aggressive form of cancer known as a uterine sarcoma. According to the FDA, these undetected, and near undetectable, cancers can be spread and “upstaged” if the occult cells are ground by a morcellator’s blade.
In her lawsuit, Galambos writes that a biopsy of the morcellated tissue revealed evidence of a previously undetected cancer: endometrial stromal sarcoma / leiomyosarcoma. Plaintiff says that she underwent treatment, and was subsequently deemed cancer-free. But on April 10, 2013, more than two years after her fateful hysterectomy, Galambos returned to her doctor’s office with an unexplained “abdominal wall mass.” She claims that she underwent a CT scan, then a biopsy and finally an exploratory laparotomy. Pathological examination revealed that her cancer had returned, in a more virulent form. She was diagnosed with metastatic endometrial sarcoma, “involving the pelvis and left anterior abdominal wall through the peritoneum.”
Galambos claims that her undiagnosed cancer was spread and worsened by the use of Johnson & Johnson’s power morcellator. She says that she was not warned of the morcellator’s dangerous potential, and had no knowledge of the device’s capacity to spread occult cancers prior to undergoing her procedure. Plaintiff claims that Johnson & Johnson “knew or should have known that […] Laparoscopic Power Morcellators could cause occult malignant tissue fragments to be disseminated and implanted in the body.” She points to years of medical research indicating the morcellator’s dangers, and accuses the manufacturer of failing to respond adequately. Johnson & Johnson “failed to provide a reasonable, sufficient or adequate warning about [the power morcellator’s] true risks,” plaintiffs write.
In filing their complaint, the Galambos’ join a growing body of patients and widowers who believe that power morcellation significantly worsened undetected cases of uterine cancer. Plaintiffs claim that morcellator manufacturers’ alleged failure to adequately warn the public has shortened prognoses and, in some tragic cases, ended lives prematurely. If these allegations are true, any woman who underwent a gynecological procedure involving morcellation and was subsequently diagnosed with a uterine cancer may be eligible to file a claim.
The experienced attorneys at Tracey & Fox are providing free consultations to any patient or survivor who believes they may have a morcellator claim of their own. For more information, and a free case eligibility evaluation, call 713-495-2333.
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Contact Tracey & Fox:
Sean Tracey
713-495-2333
440 Louisiana Street , Suite 1901
Houston, TX 77002
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