NEW YORK, Dec. 10, 2014 /PRNewswire/ -- A new investigation by The Wall Street Journal has raised serious questions about the financial ties between certain U.S. Food & Drug Administration (FDA) advisors and the manufacturers of power morcellators http://www.morcellatorlawsuit2015.com) , Bernstein Liebhard LLP reports. According to a December 9th report, the FDA did not disclose that Keith Isaacson, a doctor who served on the agency's morcellator panel in July, had been paid $12,000 in consulting fees from Johnson & Johnson in 2013, which until recently had marketed morcellators via its Ethicon, Inc. unit. Dr. Isaacson also received payments of about $9,500 from Johnson & Johnson from 2010 through 2013. From 2009 to 2013, he was paid $148,400 in consulting fees and other compensation from Karl Storz, another manufacturer of power morcellators.*
This is not the first time The Wall Street Journal has uncovered financial ties between morcellator manufacturers and FDA advisors. As the December 9th article notes, Dr. Andrew Brill recused himself from the FDA's panel just days before the July morcellator meeting, after the Journal revealed that he had received $100,000 in consulting fees from Johnson & Johnson in 2013.
"FDA advisors often make recommendations that could have adverse financial consequences for device manufacturers. As such, advisors' financial ties to those device manufacturers should at least be disclosed before a panel hearing," says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is providing free legal consultations to women who were diagnosed with advanced uterine cancers following uterine morcellation.
Power Morcellators and Cancer
Power morcellators are used in laparoscopic hysterectomy and fibroid removal procedures to shred tissue so that it may be removed via a small abdominal incision. In a new morcellator cancer warning issued on November 24th, the FDA cautioned against using morcellators in women who are entering menopause, as well as those who have already been through menopause. The FDA also advised against such procedures for women who are good candidates for intact removal of the uterus, either through the vagina or via a procedure known as a mini-laparotomy. These contraindications would apply to the vast majority of women who require hysterectomy or fibroid removal, the FDA said.
In its latest alert, the FDA noted that there is no reliable way to screen for malignancies before a woman undergoes uterine morcellation, and dissemination of cancer cells via a power morcellator can upstage the disease and greatly reduce a woman's chance of long-term survival. The agency estimated the prevalence of unsuspected uterine sarcoma in patients undergoing hysterectomy or fibroid removal surgery is 1 in 352, while the prevalence of unsuspected uterine leiomyosarcoma is 1 in 498..
As The Wall Street Journal article notes, Dr. Isaacson was among the FDA panel members who questioned the FDA's data regarding the prevalence of uterine sarcoma among women with fibroids.*
Women who allegedly experienced the spread of uterine sarcoma or other cancers due to a power morcellator may be able to take legal action against the manufacturer of the device. To learn more about the risks potentially associated with uterine morcellation, please visit Bernstein Liebhard LLP's website. To obtain a free legal review, please call (888) 340-4807.
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993. As a national law firm, Bernstein Liebhard LLP possesses all of the legal and financial resources required to successfully challenge billion dollar pharmaceutical and medical device companies. As a result, our attorneys and legal staff have been able to recover more than $3 billion on behalf of our clients. The Firm has been named by The National Law Journal to the Plaintiffs' Hot List, recognizing the top plaintiffs firms in the country, for the past 12 consecutive years. Bernstein Liebhard LLP is the only firm in the country to be named to this prestigious list every year since it was first published in 2003.
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