Power Morcellator Lawsuits Putting the FDA's Medical Device Approval Process Under Fire

Following escalating concerns that the use of laparoscopic power morcellators is causing cancer, the health insurance industry is advocating for the Food and Drug Administration (FDA) to enforce stronger regulations regarding medical device approvals. A power morcellator is a medical device used during minimally invasive surgeries including hysterectomies and myomectomies; however, in November of 2014, the FDA warned that the procedure can cause undetected cancer to spread. Lawsuits have been piling up throughout the country by, and on behalf of, women who were diagnosed with advanced stages of cancer following a routine uterine morcellator surgery. [wsj.com/articles/health-insurers-call-for-stronger-rules-on-medical-devices-1429129995} WSJ April 15 2015]

Manufacturers of the product, including Ethicon, LiNA, and Blue Endo, have been named in the lawsuits as responsible for the injuries or deaths caused by the spread of cancer after the device was used; however, many are looking for fault beyond the manufacturer. In particular, the insurance industry alleged that the FDA’s fast-track approval process for medical devices has wrongfully allowed for dangerous medical devices, including the power morcellator, to enter into the market . In early April, the insurance industry’s national political advocacy and trade association, America’s Health Insurance Plans, sent a letter to Senator Robert Casey pointing to weaknesses in the FDA’s 510(K) pre-market approval program for medical devices, noting specifically the power morcellator as an exemplar of dangerous medical devices that have harmed scores of patients. [wsj.com/articles/health-insurers-call-for-stronger-rules-on-medical-devices-1429129995} WSJ April 15 2015]

A power morcellator is a surgical device that has been used since the early 1990s to remove fibrous cysts during hysterectomies or myomectomies. While treating fibrous cysts, the power morcellator is used to break apart and remove the fibroid growths; however, the procedure has also been found to spread cancerous tissue within the abdomen and pelvis, increasing a woman's risk of uterine sarcoma -- a dangerous form of cancer that doctors are unable to detect prior to the procedure. [nytimes.com/2014/11/25/health/fda-issues-caution-on-use-of-uterine-surgery-device-that-can-spread-cancer.html?_r=0 NYTimes Nov. 24, 2114]

The FDA recently determined that women undergoing a procedure that employs a power morcellator have a higher risk of uterine sarcoma than had previously been understood. According to the FDA, out of an estimated 350 women undergoing gynecological surgery, one woman will have an unsuspected cancerous uterine fibroid. Due to the FDA’s report, the largest manufacturer of the device, Ethicon – a Johnson & Johnson subsidiary – recalled the device, stopping its sale and distribution. Still, morcellators are available for use. [wsj.com/articles/doctor-who-pushed-to-curb-hysterectomy-procedure-says-cancer-has-returned WSJ March 4 2015 ]

The power morcellator, like all U.S. medical devices, reached the market through the FDA’s pre-market approval process. In particular, they reached the market through the 510(k) process, which states that a new device need not undergo pre-market approval if the device is “substantially equivalent” to another device exempt from pre-market approval. § 360(c)(f)(1). The FDA’s review of devices for substantial equivalence has come under scrutiny as many argue the pre-market approval process is focused on equivalence to pre-existing devices rather than safety. Many devices approved under the 510(k) process do not demand clinical studies on humans to confirm their safety and effectiveness. [wsj.com/articles/health-insurers-call-for-stronger-rules-on-medical-devices-1429129995} WSJ April 15 2015]

Organizations started to look closely into the cancer risks of morcellators after lawsuits were filed nationwide. Cases, including Sanders v. Ethicon, Inc. [Case No. 14-7253] and Leuzzi et al v. Ethicon Endo Surgery, Inc., et al [Case No. 6:14-cv-06218] alleged defendant device manufacturers, knew or should have known of the harmful effects caused by using the power morcellator and failed to adequately warn of those potential harms. [Leuzzi et al v. Ethicon Endo Surgery, Inc., et al, Complaint filed May 1, 2014]

This is not the first time the FDA’s 510(k) process has come under scrutiny. Over the past couple of years, many have been questioning the effectiveness of the approval process for substantially equivalent devices. A panel at the Institute of Medicine, which advises Congress on important health issues, maintained that the 510(k) process does not determine that a cleared device is safe or effective and; therefore, is an unreliable pre-market screen for medical devices, as detailed by the Wall Street Journal. Still, the FDA and other medical associations are advocating for the approval processes’ review. [iom.edu/Reports/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years/Report-Brief.aspx Institute of Medicine July 29, 2011]

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