Patients’ medical records might soon include the make or model number of any medical device used in their treatment, thanks to the efforts of a Pennsylvania lawmaker. According to The Wall Street Journal, Rep. Mike Fitzpatrick, (R., Pa.), sponsored an amendment in the recently-passed “21st Century Cures Act” which calls for the inclusion of unique device identifiers in medical records to better facilitate the tracking of adverse events.

Rep. Fitzgerald, who is himself a cancer survivor, said he was driven by the recent controversy swirling around power morcellators and cancer. “What happened with the power morcellator should never be allowed to happen again,” he said during a July 10th hearing of the House Rules Committee, just before the Act passed the U.S. House of Representatives.

The Congressmen was inspired to propose several other amendments to the Act, including one that called on the Government Accountability Office to investigate medical-device safety reporting regulations, “focusing on reporting problems involving power morcellators.” Unfortunately, those amendments did not make it into the final version of the legislation.

It remains to be seen whether or not any part of the “21st Century Cures Act” will ever become law. A similar bill has yet to be introduced in the U.S. Senate, and it’s unclear if any such version would include an amendment like the one sponsored by Rep. Fitzgerald.

FDA Morcellator Regulation

Power morcellators are used in laparoscopic hysterectomies and myomectomies to cut tissue into small pieces so that it can be easily removed through a small abdominal incision. Since April 2014, the U.S. Food & Drug Administration (FDA) has issued two warnings regarding their potential to spread and upstage undetected uterine cancer cells, with the most recent warning advising against the use of power morcellators in most women who require hysterectomy or fibroid removal. According to the agency, more women than previously thought may have undiagnosed malignancies within uterine fibroids, and dissemination of those cells beyond the uterus during morcellation greatly reduces a woman’s chances of long term survival.

Court documents indicate that at least 22 morcellator cancer lawsuits have been filed in U.S. courts since early 2014. While one of those cases was settled for an undisclosed amount earlier this month, the remaining lawsuits are still pending. On July 6th, a group of morcellator plaintiffs asked the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate all federal claims in a single court for coordinated pretrial proceedings. Several defendants, including Johnson & Johnson’s Ethicon subsidiary, Karl Storz, Richard Wolf Medical Instruments, and Gyrus ACMI, are opposed to the creation of a multidistrict litigation for these claims.

Bernstein Liebhard LLP is evaluating potential product liability lawsuits on behalf of women whose cancer may have been spread by a power morcellator. To learn more, please call 877-779-1414 to discuss your case with one of our attorneys.

Published July 22, 2015 by