Louisiana Woman Claims Morcellator Spread Her Cancer

A Louisiana couple has filed a lawsuit against Karl Storz Endoscopy-America, Inc., claiming that the company’s morcellator products are defective.

Audrey Radford had a laparoscopic supracervical hysterectomy with uterine morcellation on Dec. 15, 2014. Very shortly afterwards, she found out that she had uterine cancer. Prior to the procedure, there were no signs of disseminated and/or metastic cancer. However, several weeks after finding out she had cancer, she was given reason to believe that the morcellator had enhanced the spread of cancer throughout her body.

Since learning that she has cancer, the plaintiff has been forced to undergo aggressive treatment and therapy. The morcellator injury lawsuit claims that the defendants were aware that morcellation could disseminate an occult uterine leiomyosarcoma throughout the peritoneal cavity, but failed to warn patients and the medical community.

Couple sues defendants on 7 counts

Audrey and Darryl Rayford are suing the defendants on seven counts, including:

• Liability of Defendants Under the Louisiana Products Liability Act
• Strict Products Liability on Behalf of Audrey Rayford
• Breach of Express Warranty
• Breach of Implied Warranty on Behalf of Audrey Radford
• Breach of Warranty: Fraudulent Misrepresentation and Omission
• Loss of Services on Behalf Darryl Rayford
• Punitive/Exemplary Damages Under California Law and/or Massachusetts Law

FBI investigates J&J morcellators

In early 2015, the FBI launched an investigation into Johnson & Johnson’s knowledge of the device’s ability to spread cancer in women. The company’s Ethicon division was the largest manufacturer of morcellators until 2014, when it advised doctors to stop using the devices and took them off the market. FBI investigators are trying to determine what the company new about the role of the device in spreading cancer.

Before Ethicon withdrew its morcellators from the market, approximately 60,000 procedures were performed with the devices each year. One of the patients adversely impacted by the device reached out to the FBI to share her story. Dr. Amy Reed underwent a hysterectomy with a morcellator in 2013. Soon after, follow-up tests revealed that the cancer had spread through her abdomen.

Aetna stops covering routine morcellator use

On May 15, Aetna spokeswoman Cynthia Michener announced that the nation’s third-largest insurance company would no longer cover routine use of the morcellator — in most circumstances. The insurer now requires doctors to receive approval prior to performing any procedure involving the device. Doctors are able to request exceptions for women who are pre-menopausal who want to remain fertile and for those whose best option is morcellation.

“The policy takes into account the latest FDA warnings about the risk that morcellation can spread unsuspected uterine sarcoma in the abdomen and pelvis,” said Michener.

Aetna said it is encouraging doctors to discuss the risks and benefits of morcellation with their patients and possible alternatives to the procedure. The company is the largest managed-care organization to speak out against the devices, but it isn’t the only one. Aetna and other health plans — including the fourth-largest U.S. insurer, Health Care Service Corp. — that collectively cover approximately 93 million Americans have reduced the use of morcellators or are considering putting limitations in place.

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