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Morcellation Media Monitoring 05/21/2015
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Olympus Sued In Pa. Over FDA-Flagged Uterine Surgery Tool
May 18, 2015 | Law360.com
By Dan Packel
Medical device manufacturer Olympus America Inc. was hit Thursday with two lawsuits in Pennsylvania state court alleging that a device used in gynecological surgery was responsible for the spread of cancer-causing cells. -
Lawmakers Push FDA for Stricter Power Morcellator Approval
May 19, 2015 | TopClassActions.com
By Melissa LaFreniere
Two Pennsylvanian lawmakers are urging the FDA to reexamine its 510(k) program, which allows medical devices like the controversial power morcellators to have a fast-track approval process.
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Olympus Sued In Pa. Over FDA-Flagged Uterine Surgery Tool
May 18, 2015 | Law360.com
By Dan Packel
Medical device manufacturer Olympus America Inc. was hit Thursday with two lawsuits in Pennsylvania state court alleging that a device used in gynecological surgery was responsible for the spread of cancer-causing cells.
A Georgia woman and a Kentucky woman said in their largely identical suits that the company should have been aware of the cancer risks associated with its PKS PlasmaSORD Bipolar Morcellator before it was used on them in surgeries in 2009 and 2010.
“Although evidence was available to defendants for years before plaintiff’s surgery, defendants failed to respond to multiple published studies and reports describing the risk of disseminating and upstaging or worsening occult cancer with laparoscopic power morcellator use, and failed to design their laparoscopic power morcellators, including the defendants’ PKS PlasmaSORD Bipolar Morcellator, in a manner to reduce this life-threatening risk,” both women said in their filings.
The U.S. Food and Drug Administration issued a warning in November that laparoscopic power morcellators, gynecological tools used to perform hysterectomy or uterine fibroid removal, should not be used in surgery that involves cancer or fibroids. The agency said that uterine tissue may contain unsuspected cancer and that using the morcellators may spread the cancer and decrease long-term patient survival.
But Betty Dobson of Georgia and Anita Whittaker of Kentucky both argued that Olympus had good reason to know that its devices could cause cancer to spread far earlier. They pointed to medical journal articles dating to the mid-1990s discussing the use of the morcellators, along with a patent issued in 1991 that described the potential for morcellator use to spread malignant tissue fragments.
The women both also argued that their claims, although filed after the expiration of the two-year statute of limitations for product liability cases in Pennsylvania, were valid because they had no way to discover their injuries. They emphasized both that Olympus, through its misrepresentations, made it harder for them to recognize the risks they to which they had been exposed and that the use of the device itself created obstacles in diagnosis.
“Defendants knew or should have known that when malignant tissue undergoes laparoscopic power morcellation, the resultant tissue specimens can delay diagnosis because their condition can prevent the pathologist from properly identifying and staging cancer, which can further worsen a patient’s prognosis and treatment outcomes,” the women said in their complaints.
The women say that Olympus’ disregard for the available information, along with with its misrepresentations, makes the company subject to punitive damages.
Both women, along with their spouses, filed separate product liability lawsuits against Olympus on Friday, although these two suits did not include formal complaints, but simply summonses.
An attorney for both women did not immediately respond to a request for comment, nor did a representative for Olympus.
The company’s morcellator currently comes with a warning advising doctors of the cancer risks of the product, according to an Olympus website.
Other companies have taken more vigorous measures. Johnson & Johnson unit Ethicon Endo-Surgery Inc. executed a worldwide recall of its Morcelex brand devices in July, after having suspended sales of the devices in April 2014.
Of the 500,000 hysterectomies performed every year, about 11 percent are done using laparoscopic power morcellators, according to the FDA.
Both plaintiffs are represented by Rosemary Pinto of Feldman & Pinto PC and Sean Tracey, Rebecca King and Andrew Rubenstein of Tracey & Fox.
Counsel information for the defendants was not immediately available.
The complaints are Whittaker v. Gyrus Acmi LP et al, case number 150401310 and Dobson v. Gyrus Acmi LP et al, case number 150401312, both in the Philadelphia County Court of Common Pleas. -
Lawmakers Push FDA for Stricter Power Morcellator Approval
May 19, 2015 | TopClassActions.com
By Melissa LaFreniere
Two Pennsylvanian lawmakers are urging the FDA to reexamine its 510(k) program, which allows medical devices like the controversial power morcellators to have a fast-track approval process.
Senator Robert Casey and Representative Michael Fitzpatrick have addressed the FDA with concerns that the program allows manufacturers to get approval on medical devices without pre-market testing as long as they can prove the product is “substantially equivalent” to other devices already on the market. This medical device approval policy is concerning to lawmakers, as recent studies have linked the use of a power morcellator in hysterectomy procedures to an increased risk of developing uterine fibroid cancer.
Power Morcellator Cancer Risks
Power morcellator are used in hysterectomies in order to provide patients with a shorter post-operative recovery time when compared to traditional abdominal hysterectomies. While the medical tool provides a less invasive procedure for patients, researchers have found that using the power morcellator on unsuspected cancer tissues may cause the cancer to spread throughout the abdomen. Since there is no real way to detect if uterine sarcoma exists prior to having surgery, this uterine cancer danger has made power morcellator use in laparoscopic hysterectomy procedures a serious health risk for women.
Studies show that 1 in 350 women who undergo a morcellation hysterectomy or myomectomy procedure are eventually diagnosed with uterine sarcoma. Due to these recent findings, some of the largest health insurance companies in the United States, including Cigna, Aetna and UnitedHealth Group Inc., are choosing not to cover the use of a power morcellator because of the high uterine cancer risk.
The FDA has issued power morcellator warnings in a recent report that encourage physicians, patients, and manufacturers to take the following actions:Doctors have been asked to “carefully consider alternative treatment options for the removal of symptomatic uterine fibroid” and to limit the number of laparoscopic incisions that use a power morcellator.Patients are urged to find out if a doctor plans to use a power morcellator if they recommend a laparoscopic hysterectomy or myomectomy procedure.Manufacturers are strongly urged to include the strongest caution issued by the FDA called a “black box” warning on all new and existing power morcellators. The black box warning is the final step before the FDA will take a product off the market.
Lawmakers think the FDA could be doing more. Congressman Fitzpatrick states that the agency needs to not let medical tools like the power morcellator slip through the approval process so easily. Likewise, Senator Casey would like to know how the FDA decides if it needs to force a power morcellator recall or encourage the makers to do so on their own.
Power Morcellator Lawsuits
Johnson & Johnson, one of the leading power morcellator manufacturers, has already decided to stop selling the medical tool until its connection to spreading cancer is better understood. Johnson & Johnson is not the only maker of the medical tool, and since a full recall has not been ordered, other companies will continue to produce the potentially cancer-causing product.
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