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Power Morcellator Lawsuits Coordinated in Kansas Federal Court

court houseHarris Martin reports that the JPML has granted plaintiff’s requests to centralize some 20 power morcellator lawsuits for more efficient pretrial proceedings. The complaints center on allegations that that the devices, which are commonly used in laparoscopic fibroid removal and hysterectomy procedures, can inadvertently spread occult cancer cells throughout surrounding tissue, and that manufacturers knew of these inherent risks yet failed to warn the public or medical community.

In an order dated October 15, 2015 the panel appointed Senior Judge Kathryn H. Vratil to preside over the product liability multidistrict litigation in the District of Kansas.

The motion will transfer at least 20 actions pending against defendants including Ethicon Inc., Johnson & Johnson, Karl Stortz Endoscopy-America Inc. and Richard Wolf Medical Instruments Corp. Plaintiffs say they believe additional federal actions will be filed in the coming months, which may then be transferred to Kansas City for shared pretrial proceedings.

Multidistrict litigation established for morcellation claims

The complaints filed by plaintiffs who had morcellation-assisted gynecological surgeries all contained common questions of fact concerning the safety and overt dangers of the medical devices when used for their intended purpose. The JPML decided to consolidate all actions before one judge to “… serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation.” Additionally, consolidated litigation helps prevent inconsistent pretrial rulings while conserving resources of the parties, their counsel and the courts.

The defendants stand accused of strict products liability-failure to warn, design defect and other causes of action relating to the uterine cancer risks posed to women who had myomectomy or hysterectomy procedures with morcellation.

Ethicon, along with the other defendants, opposed the formation of an MDL, arguing that specific factual questions regarding claimants will eclipse common issues of fact. The JPML disagreed on the basis that all of the 20 morcellation cases revolved around the testing, design, manufacture and marketing of the defendant’s morcellators, as well as the accompanying warnings.

Power morcellators and cancer risk

According to allegations raised by plaintiffs thus far, Ethicon and other manufacturers of morcellators have known for more than two decades that uterine and fibroid tissue broken up by the devices is frequently left behind, and can embed into surrounding organs and tissues. Considering that some women have undiagnosed cancer before these operations, this poses a grave risk of disseminating cancerous tissue around the body, thus reducing the patient’s chance of long-term survival.

In 2014, the FDA warned against the use of morcellators in the majority of patients having surgery for fibroid removal, given the increased risk of spreading uterine sarcoma.

Despite their safety communication regarding cancer risks, health regulators have not banned the use power morcellators in the U.S., though J &J has voluntarily recalled its devices.  Given the increased publicity about sarcoma risks and FDA warning, a large number of hospitals have stopped using power morcellators in laparoscopic myomectomies and hysterectomies, and several insurance chains will not cover the procedure, stating the risks do not outweigh the benefits.

Each of the lawsuits joined under MDL 2652 will share in pretrial processes that are helpful for streamlining early proceedings among similar cases. However, if settlements do not materialize, the claims will be remanded back to their original court of filing for resolution.

  1. Harris Martin, JPML Grants Plaintiffs’ Request to Consolidate Power Morcellator Actions in Kansas

  2. FDA, UPDATED Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication