FBI Investigates Power Morcellator Manufacturer

Last year, after a surgical device was determined to raise the risk of spreading aggressive forms of uterine cancer, one manufacturer recalled all of its power morcellators used to remove uterine fibroids. Now, it’s reported that the FBI has been investigating the company, Johnson & Johnson and its Ethicon subsidiary, over the timing of when it knew about the dangers of its product.

Power morcellation surgery had been popular because it was a less invasive way to remove fibroids in the uterus than traditional surgery. Performed laparoscopically (a small incision is made into which the device is inserted), morcellation surgery broke up fibroids into tiny bits that were removed through the incision.

But after it was learned that many women had contracted advanced cancer after undergoing the procedure, the FDA issued morcellation warnings.

Last month, AboutLawsuits.com summarized a story that originally appeared in the Wall Street Journal. Reportedly, “a number of sources close to the company and familiar with uterine fibroid surgical device cancer risks say they have been interviewed by the FBI in recent months.”

When Ethicon recalled its power morcellators and stopped making and selling them, it was commanding about three-quarters of that medical device market. The decision to exit the market was made because the company and an FDA panel believed that there was no way to make the devices safe.

But “[r]eports suggest that Johnson & Johnson may have been warned nearly a decade ago about the risks of upstaging undiagnosed cancer with morcellation during uterine fibroid removal surgery,” according to AboutLawsuits.com. (“Upstaging” means to deem a cancer at a higher, or more invasive, critical level than before.)

That was the opinion of Dr. Robert Lamparter, a pathologist interviewed by the FBI in May, according to the Journal. Lamparter had warned Ethicon in 2006, eight years before the recall, that power morcellators could be life-threatening because they could spread cancer cells that had been unknown to doctors or patients previous to the laparoscopy. “The manufacturer acknowledges he warned them,” said AboutLawsuits.com, “and say they responded by trying to change the instructions on the devices to make them safer.”

In November, the FDA announced that it would allow hysterectomy morcellators to remain on the market, but would require substantially stronger warnings about the risk of cancer and indicate that they would be appropriate treatment for fewer patients than had composed the market before the cancer risk was known. As we blogged, it wasn’t a very popular move by the feds.

Since last year, many hospitals have refused to perform procedures using power morcellators, and several insurance companies now decline to cover such operations.

As you might expect, the number of lawsuits over cancer diagnoses after morecellation procedures has grown. They claim that inadequate warnings were provided for consumers and the medical community.

And now, it seems, the FBI is lending credibility to those allegations.

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