Discovery for Morcellator Cases Involving Plaintiffs Suffering Extreme Health Problems Given Priority

With women continuing to suffer deteriorating health or dying as a result of uterine cancer spread by the use of a laparoscopic morcellator, the federal court presiding over all product liability case pending against one of the leading manufacturers of the surgical device has established a procedure that gives priority to discovery in cases filed by women who are suffering extreme health problems.

A growing number of morcellator cancer lawsuits continue to be filed throughout the federal court system against Johnson & Johnson’s Ethicon subsidiary, alleging that the company sold an unreasonably dangerous and defective medical device that has been used in thousands of minimally invasive hysterectomy and uterine removal surgeries in recent years.

Power morcellators are surgical devices used to cut up and remove the uterus or fibroids through a small incision in the abdomen, which is designed to reduce the risk of infection and shorten recovery times. However, the tools have largely been abandoned by the medical community since it was discovered that morcellation may cause hidden cancers contained within the uterus to be spread throughout the body, rapidly upstaging the cancer.

Ethicon previously manufactured about two-thirds of all morcellators used in hospitals nationwide, before announcing in July 2014 that they would no longer sell the devices because there was no way to make them safe.

Given the similar allegations raised in dozens of lawsuits filed against Ethicon by women and families of those who had aggressive uterine cancers rapidly disseminated, the U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized the cases last year before one judge in the District of Kansas for coordinated discovery and pretrial proceedings.

In an order (PDF) issued last week, U.S. Magristrate Judge James P. O’Hara established a procedure for discovery for cases involving living plaintiffs who are in extremis, which is a legal term describing individuals who are in a dire health condition or near death.

“Case-specific discovery for in extremis cases has priority and may commence any time on or after January 11, 2016,” the Court indicated in the order. “A person will be considered ‘in extremis’ when she is expected to reach, within the next twelve months, a state or condition of difficulty in testifying competently in a deposition or being no longer capable of testifying competently in a deposition and is unlikely to recover sufficiently to provide competent testimony at a later date.”

The order underscores the severity of health problems facing women with advanced stage endometrial stromal sarcoma or other uterine cancers that were allegedly spread by use of a morcellator.

Power Morcellator Cancer Concerns

Each of the lawsuits against Ethicon involve similar allegations that the medical device manufacturer knew or should have known about the risk that laparoscopic morcellation may disseminate uterine cancer, yet failed to adequately warn the medical community or women deciding to undergo a minimally invasive procedure instead of a traditional hysterectomy or myomectomy.

The litigation has emerged since April 2014, when the FDA estimated that one out of every 350 women undergoing surgery for symptomatic uterine fibroids may actually have undiagnosed and unsuspected sarcoma contained within the uterus.

Two FDA advisory panels were convened by the agency, which determined that there was no safe way to use power morcellators for uterine fibroid removal. However, the panels could not agree on whether to recommend that the agency demand a power morcellator recall or simply add a black box warning.

Shortly afterwards, Ethicon, who previously dominated the power morcellator market, decided that it will no longer manufacturer the devices, essentially issuing an Ethicon power morcellator recall after acknowledging that there is no way to make the devices safer.

While the FDA has allowed laparoscopic morcellators to remain on the market, with much stronger warnings about the potential cancer risks, many hospitals and doctors have announced that they will no longer perform hysterectomy or myomectomy procedures with morcellation, indicating that there is no way to justify the risk.

In addition to cases over Ethicon morcellators, similar lawsuits have been filed against other manufacturers of the hysterectomy surgical devices, including Karl Storz, Richard Wolf Medical Instruments, and Gyrus ACMI.

As part of the coordinated proceedings in the Ethicon morcellators MDL (Multi-District Litigation), if the manufacturer fails to settle or otherwise resolve cases, it is expected that the Court will schedule a series of “bellwether” trials to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.

The next status conference on February 10 is expected to cover more case-specific discovery issues, such as surgeons and facilities disclosure orders, as well as case-specific discovery and common discovery served by defendants on the plaintiffs’ steering committee.