Pathologist Warned J&J of Morcellator Cancer Risks 9 Years Ago, Report Tracey & Fox Lawyers

Attorneys at Tracey & Fox have reported that a doctor from Pennsylvania notified Johnson & Johnson of concerns that power morcellators present a risk of spreading undetected uterine cancer more than nine years ago.

At the time, Johnson & Johnson was the world’s largest manufacturer of power morcellators, a medical device frequently used in minimally invasive hysterectomies and myomectomies. Through its Ethicon subsidiary, Johnson & Johnson would go on to capture an estimated 72% of the laparoscopic morcellator market by 2011. But Ethicon stopped selling its devices, and then asked physicians worldwide to return them to the company, after a 2014 FDA safety advisory warned physicians to avoid morcellation in the majority of gynecological procedures.

For many public health advocates, including Dr. Robert Lamparter, Johnson & Johnson’s response may be too little, too late. Lamparter, a former pathologist, contacted Ethicon director David Robinson in February of 2006, asking Johnson & Johnson to “reconsider [the power morcellator’s] risk to the patient.” Morcellators are used to grind fibroid and uterine tissue into small pieces for easier removal. The devices promise patients shorter recovery times and less trauma, but come at a serious risk.

As Lamparter noted in his email to Robinson, while the majority of uterine fibroids are assumed to be benign, or noncancerous, preoperative “screening [...] misses a certain number of malignancies.” According to the US Food & Drug Administration, as many as 1 in every 350 women who undergo a morcellation procedure are in fact harboring unsuspected uterine sarcomas, a rare and aggressive form of soft tissue cancer. Under the morcellator’s spinning blade, undiagnosed cancer cells can be spread throughout a patient’s abdomen and pelvis, “upstaging” the disease and significantly worsening prognosis.

Lamparter became alerted to the risks of morcellation at the Pennsylvania hospital where he worked for 28 years. As a pathologist, he inspected body tissues after surgical removal for signs of malignancy and other medical conditions. And even at his small hospital, where only around 300 hysterectomies were performed every year, Lamparter was finding at least one unsuspected cancer in morcellated fibroid tissue every year. In his email, Lamparter presented his own conclusion clearly: “if a morcellation is done, the patient’s survival is jeopardized.”

Robinson responded quickly, saying he had submitted Lamparter’s concerns to Ethicon’s World Wide Customer Quality department as a complaint. But in May, 2006, the complaint was dismissed and Lamparter’s subsequent attempts at correspondence went unanswered.

Lamparter would have to wait nine years before public outcry brought his early warnings into the spotlight. In an interview with the Wall Street Journal, Lamparter now says that he has been approached by the Federal Bureau of Investigation (FBI). According to the WSJ, the FBI has begun investigating the risks of power morcellation, with a focus on what manufacturers, including Johnson & Johnson, knew about those risks years before public pressure forced Ethicon to recall its devices and drove many insurance companies to stop covering routine gynecological procedures in which power morcellators are employed.  

Several public health advocates have also been contacted. Doctors Hooman Noorchashm and Amy Reed say they were approached by federal investigators as well. After a hysterectomy for what her doctors had concluded were “clearly benign” fibroids in 2013, Reed was diagnosed with leiomyosarcoma, a form of uterine cancer. Along with husband Noorchashm, Reed has become one of the most vocal proponents of a complete ban on the use of power morcellators in fibroid removal procedures. A Change.org petition that she started has received more than 88,000 signatures in support.

Meanwhile, patients who were diagnosed with metastatic uterine cancer after morcellation procedures have begun to file legal claims against the manufacturers of these devices. In as many as a dozen complaints, plaintiffs claim that power morcellators are defective in design and that companies failed to adequately warn patients and surgeons of the risks of morcellation. Several wrongful death lawsuits have been filed by widowers who survive their loved ones.

The attorneys at Tracey & Fox are providing free consultations to patients and families who believe that a morcellation procedure may have spread or worsened an undiagnosed case of uterine cancer. Patients can learn more about their own case eligibility at no cost by calling (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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