On February 3, 2015, John Ostrander, a widower from Greenville, South Carolina brought a legal claim against Johnson & Johnson, the manufacturer of a medical device that Ostrander says exacerbated his wife’s previously undetected uterine cancer. Ostrander says that a power morcellator, used to grind fibroid tissue into small pieces, spread an undiagnosed leiomyosarcoma throughout his wife’s abdomen, cutting her prognosis tragically short and ultimately leading to her death.
A copy of his complaint, filed in the US District Court for South Carolina, Greenville Division under case number 6:15-cv-00516-MGL, can be read here.
According to the dangerous medical device attorneys at Tracey & Fox, Ostrander’s claim is one of more than twenty lawsuits to be filed against power morcellator manufacturers since March 2014. Ostrander himself is one of four widowers to file on behalf of deceased loved ones. To find a comprehensive timeline of the morcellator litigation visit Tracey & Fox’s website.
Suffering from severe uterine bleeding, Mrs. Ostrander underwent a hysterectomy on October 2, 2012, her husband writes. The procedure, intended to remove what were believed to be benign fibroids, involved the Gynecare Morcellex power morcellator manufactured by Johnson & Johnson. Prior to her procedure, plaintiff claims that Mrs. Ostrander underwent “all reasonable and standard procedures for detecting cancer.” According to court documents, no evidence of leiomyosarcoma, an aggressive form of soft tissue cancer, was found. Ostrander was deemed cancer-free and cleared for surgery, her surviving husband writes.
During her operation, surgeons used Johnson & Johnson’s morcellator to grind “three large fibroid specimens.” These small fragments of tissue were then removed from the patient’s abdomen through minor incisions. But after pathological scrutiny, it was determined that the morcellated tissue also contained samples of cancer. Mrs. Ostrander received her diagnosis: “leiomyosarcoma cancer.” Plaintiff claims that his wife’s cancer had remained completely undetected until after her morcellation procedure. According to a recent US Food & Drug Administration safety announcement, cautioning against the use of power morcellators, “there is no reliable method for predicting or testing whether a woman with fibroids may have a uterine sarcoma.”
A subsequent examination would confirm that Ostrander’s cancer had spread beyond her uterus. Cancer cells were identified in her vaginal cuff, “at areas around her ureters, and throughout the omentum,” a portion of the stomach. Malignancies were also noted in areas of her abdomen, as well as within her lymphatic system. After a two year battle against leiomyosarcoma, Ostrander died on September 25, 2014, her widowed husband claims.
Writing that the company “knew, or should have known” that its device posed the danger of spreading undiagnosed cancers, Mr. Ostrander accuses Johnson & Johnson of “failing [...] to properly warn of the [power morcellator’s] risks.” He says that his wife’s passing “was completely avoidable and would have been avoided but for [Johnson & Johnson’s] breaches of duties.” And while the FDA has cautioned surgeons against using morcellators as of April 2014, Ostrander claims that Johnson & Johnson was notified of the device’s risks as early as 2006. He says that the company “failed to notify the FDA of this notice and danger, and [...] took no action to warn surgeons [...] and did nothing to make the device safe for use.”
Johnson & Johnson was once the world’s largest morcellator manufacturer. Since the FDA’s warning, the company has issued a “market withdrawal,” asking physicians across the world to return their power morcellators immediately. According to the Wall Street Journal, Johnson & Johnson has come under FBI investigation, with federal officials attempting to determine what Johnson & Johnson knew about the morcellator’s dangers before pulling the device from the market. But for many patients, including John Ostrander’s wife, the company’s newfound caution may have come too late.
Experienced power morcellator attorneys at Tracey & Fox note that an estimated 60,000 women undergo gynecological procedures involving power morcellators every year. And while increased regulatory pressure may have limited the medical device’s use to some degree, many hospitals continue to employ morcellators in fibroid removal procedures. The lawyers expect many patients to step forward in the coming months.
Tracey & Fox is currently offering free consultations to anyone who believes that a power morcellator may have spread or “upstaged” an undiagnosed case of uterine cancer. For more information, including a case eligibility evaluation, call 713-495-2333.
###
Contact Tracey & Fox:
Sean Tracey
888-427-0543
440 Louisiana Street , Suite 1901 Houston, TX 77002
