Power Morcellators Lawsuits

Power morcellators are medical devices used to remove uterine fibroids, which are growths that commonly occur on the surface of the uterus. Although fibroids are usually benign, some can carry undetected cancer. Power morcellators tear these fibroids apart and may spread any existing cancerous cells.

Women diagnosed with uterine cancer after a hysterectomy or myomectomy with a power morcellator are filing lawsuits against the manufacturers of these devices. While many file personal injury claims, some widowed husbands are filing wrongful death claims in their spouse’s names.

Many of these women were diagnosed with late stage cancer because the morcellator spread the cancer throughout their abdomen. There are three main types of uterine cancer that power morcellators can worsen, including:

• Endometrial stromal sarcoma
• Undifferentiated sarcoma
• Leiomyosarcoma

Plaintiffs hold the manufacturers of power morcellators responsible for knowing the risks of these devices. Johnson & Johnson (J&J), through its subsidiary Ethicon, was the largest manufacturer of power morcellators before they recalled their products.

There are many other power morcellator manufacturers that may be held accountable in a court of law for the dangers of their products.

When the dangers of power morcellators became clear, J&J came under scrutiny from the government and the public for marketing and dispensing their devices. Government agencies took J&J to task as the main producer of power morcellators, which is highlighted in personal injury lawsuits.

The FDA Places “Black-box” Warning on Power Morcellators

In 2014, the Food and Drug Administration (FDA) placed a black-box warning on all laparoscopic power morcellators – the strongest warning for medical devices and medications. Additionally, the FDA has rejected power morcellators in favor of traditional hysterectomies that keep cancerous material confined to the uterus. The agency deemed the devices’ risks greater than the benefits based on revealing statistics.

It’s estimated that 1 in 350 women who undergo a hysterectomy or myomectomy with a power morcellator have some form of uterine sarcoma, including leiomyosarcoma. The FDA also stated that approximately 50,000 hysterectomies each year involve a morcellator. By these numbers, roughly 143 women annually could have had undetected cancer made worse by power morcellation.

Another study by Columbia University found that 1 in 368 women undergoing hysterectomies have undetected uterine cancer, which helps back up the FDA’s estimates.

Johnson & Johnson Voluntary Recall

After the FDA placed the black-box warning on power morcellators, Johnson & Johnson stopped selling the products. Shortly after, the company voluntarily pulled their power morcellators off the market.

In 2011, J&J produced approximately 72 percent of the power morcellators on the market. Their decision to pull such a lucrative product is indicative of the risks posed by the devices.

FBI Investigation of Johnson & Johnson

J&J came under further fire in May of 2015 when the Federal Bureau of Investigation started looking into the company’s marketing practices. The FBI suspected that J&J knew the risks of power morcellators since 2006.

According to an article by the Wall Street Journal, one doctor from a small hospital in Pennsylvania contacted Ethicon about the risks of power morcellators in 2006. He shared his concerns about power morcellators spreading cancer eight years before the FDA issued its warning. In light of information released by the FDA and the FBI many women began filing legal complaints.