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FBI Pursues Investigation Into Johnson & Johnson’s Knowledge About the Cancer Risk Associated With Power Morcellators

David W. Hodges
Partner at Kennedy Hodges LLP practicing pharmacy error, medical malpractice and personal injury law
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In addition to the many lawsuits being filed against Johnson & Johnson over its laparoscopic power morcellator device, the company Would use a medical device that had known cancer risks?now has another worry: how it handled the device’s potential link to the spread of cancer in some patients. The Federal Bureau of Investigation is looking into whether the company had knowledge of the link before the U.S. Food and Drug Administration (FDA) issued its warning about the risk in November 2014. The FDA’s warning stated that the device should not be used in the majority of women due to the risk that its use could spread undetectable malignancies in patients, making their outcome worse. The “black box” warning issued for the device is the strongest warning that the agency uses.

5 Facts About the FBI Investigation Regarding Power Morcellators

With lawsuits pending, the FBI’s involvement is a new development. The following is an overview of what is happening:

  • The Federal Bureau of Investigation’s Newark, New Jersey office is overseeing the investigation.
  • The FBI interviewed Robert Lamparter, a former pathologist at Evangelical Community Hospital in Lewisburg, Pennsylvania, regarding correspondence that he had with Johnson & Johnson’s subsidiary in 2006. Lamparter expressed concern to the company about the power morcellator potentially spreading undetected cancer in patients.
  • Lamparter came to this conclusion after his hospital performed 292 hysterectomies in 2005.
  • In the years following, gynecologists discovered an unexpected malignancy at least once per year, causing further suspicion with regard to the device.
  • Johnson & Johnson admitted that the 2006 correspondence with Dr. Lamparter prompted the company to revise the instructions for the laparoscopic power morcellator.
     

If you were injured by a power morcellator, it is important to take the proper steps to protect your legal rights. We can help. We encourage you to contact us today for a consultation at 888-526-7616.

 

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