According to a Wall Street Journal article published July 2015, LiNA Medical AsP settled Scott Burkhart’s morcellator claim for an undisclosed amount. Mr. Burkhart’s wife Donna died of cancer after a morcellator was used in her surgery. Reporter Jon Kamp wrote that the settlement, reached sometime the previous weak, was still awaiting approval from the US District Court for the Eastern District of Pennsylvania. Mr. Burhkart told the Journal he was glad the case didn’t have to go to trial, and that his main goal was to make others aware of the risks.
Morcellators spreads Cancer
Power morcellators are widely believed to have spread or worsened undiagnosed uterine cancers.
A month after the Burkhart lawsuit was filed, J&J’s Ethicon division announced it would stop promoting and selling power morcellators worldwide. Ethicon’s decision came days after FDA released a rare medical device safety advisory, a statement that pinpointed the serious risks of morcellation and warned physicians to avoid using the devices in the majority of women undergoing hysterectomies and other procedures for the removal of uterine fibroids.
FDA updates Morcellator Warnings
FDA also announced it had instructed all power morcellator makers to review their current labeling for accurate risk information for patients and providers. On November 24, 2014, the FDA updated the warning with news that it had asked all companies producing morcellators to add “two contraindications and a boxed warning in their product labeling.” According to the press release, the new information “warns against using laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy and recommends doctors share this information with their patients.”
Three more Morcellator Lawsuits
Before the FDA released its strengthened warnings, at least three more morcellator lawsuits had been filed in the interim by cancer patients and their loved ones.
Woman Files Suit Five Months Before Dying
Brenda Leuzzi et al. v Ethicon Endo Surgery et al. was filed in the US District Court for the Western District of New York May 1, 2014, under case number 6:14-cv-06218. See the complaint
George and Brenda Leuzzi claimed she underwent a hysterectomy procedure in September 2012, after University of Rochester Medical Center doctors found uterine fibroids causing abnormally heavy blood flow. According to court documents, Ms. Leuzzi was soon diagnosed with uterine cancer, a disease which she alleged morcellator surgery had spread and “upstaged.” Less than two months after surgery, Ms. Leuzzi was battling stage-4 cancer with chemotherapy and radiotherapy.
In their complaint, the Leuzzis claim Johnson & Johnson and Ethicon made an unsafe product and failed to warn patients.
Brenda Leuzzi died in October 2014, five months after filing her lawsuit, and her husband amended the complaint to include information pertinent to her death.
Oncologist calls for Morcellator Ban
Mrs. Leuzzi’s uncle, Gene Manley, had testified at a hearing convened four months earlier by the FDA to review the potential dangers of morcellation and determine regulatory action. An oncologist at Walter Reed National Military Medical Center, Craig Shriver, advocated for a complete ban on power morcellators at the same hearing. Dr. Shriver testified that “there is at present no safe way to offer laparoscopic power morcellation as part of any minimally invasive surgery.”
University restricts Morcellator Use
In May, the same month Leuzzis’ lawsuit was filed, the University of Rochester announced it would restrict the use of power morcellators in hysterectomy procedures, explaining:
“Given concerns for spread of occult [ie unsuspected] cancer, intraperitoneal power morcellation will only be allowed inside of containment bags. If this is not technically possible, specimens can be removed from the abdominal cavity using non-power morcellation or intact through larger incisions in the abdomen or vagina.”
The FDA ultimately decided against issuing a full recall of all power morcellators. Another option, requiring surgeons to use so-called surgical bags that many key industry players have argued could drastically minimize the risk of spreading cancer, was dismissed as well. The FDA’s advisory panel concluded that surgical bags would not make power morcellation any safer. The FDA panel ultimately determined that there is no way to eliminate morcellation’s risks.
Plaintiff says she was informed of Morcellation Risks only after Uterine Cancer Diagnosis
Sarah Salem-Robinson et al. v Richard Wolf Medical Instruments Corporation et al. was filed in the US District Court for the Northern District of California May 13, 2014, under case number 5:14-cv-02209-EJD. See the complaint
The Robinson family alleges Richard Wolf’s power morcellator caused his wife, Sarah, to suffer from severe intensification of an undetected leiomyosarcoma.
According to her complaint, Salem-Robinson underwent a hysterectomy to remove what were believed to be benign uterine fibroids on May 18, 2012. The power morcellator used on her was made by Richard Wolf Medical Instruments, a German company with operations in Illinois. Ms. Salem-Robinson says that “prior to [her surgery], there was no evidence that she had disseminated or metastatic cancer.” Twelve days later, Salem-Robinson was told one her “fibroids” had in fact been a cancerous tumor. Only at this stage, according to the complaint, was she informed of the “significant risk that cancer cells had been freed within her peritoneum by the Wolf Power Morcellator.”
Ms. Salem-Robinson is now undergoing “aggressive treatment and therapy” to treat her condition, according to court documents. Since her initial diagnosis, four lesions have been found in her lung, which her physicians believe to be metastatic leiomyosarcoma. Plaintiffs claim Richard Wolf knew of the procedure’s risks but did not warn patients and surgeons adequately.
New Revelations J&J Knew Risks
New revelations came to light one month after the Salem-Robinson family filed suit. Pittsburgh Business Times obtained documents which showed Dr. Robert Lamparter, a former pathologist in Pennsylvania, had alerted Johnson & Johnson (which had then captured more than 70% of the global morcellator market) to the power morcellator’s significant risks as early as 2006. E-mail correspondence with Dr. David Robinson, an executive in charge of Ethicon’s Women’s Health division, Lamparter urged J&J to “reconsider the [morcellator’s] risk to the patient” and suggested that, from his clinical experience, around one 1 of every 350 women undergoing a fibroid removal procedure in harboring unsuspected uterine cancer. Dr. Lamparter stressed the near impossibility of distinguishing benign fibroid from cancerous tumors prior to surgical removal. Dr. Lamparter’s complaint, which Ethicon dismissed in May 2006, was sent to Ethicon’s World Wide Customer Quality department.
Nine years later, the FDA would review the existing scientific literature and report roughly the same risk ratio, 1 out of 352, in its safety advisory released in April of 2014. The FDA’s estimate would soon be substantiated by an article published in the Journal of the American Medical Association September 24, 2014. Using insurance records from a total of 232,882 women who had undergone morcellator hysterectomies, researchers at Columbia University found that more than 1 out of every 370 of these women were subsequently diagnosed with uterine cancer.
J&J recalls Morcellators
In July 2014, Johnson & Johnson, under increasing public pressure, instructed doctors worldwide to return their Ethicon power morcellators to the company.
First Morcellator Lawsuit
The first power morcellator lawsuit, the Burkhart case which settled this past summer, was filed in March 2014 in the United States District Court for the Eastern District of Pennsylvania, under case number 5:14-cv-1557. Donna Burkhart had undergone a laparoscopic hysterectomy to treat uterine fibroids. Nine days after her surgery, doctors informed her that one of the fibroids contained a uterine sarcoma known as leiomyosarcoma. Doctors attacked the cancer with chemotherapy and radiation treatments, and Donna died in February 2013.
Filed a month after Donna Burkhart’s death, the complaint alleged that when a morcellator was used, it spread undetected uterine cancer throughout her body. The leiomyosarcoma then metastasized (allegedly) at a faster rate than it would have otherwise, spreading to organs that would otherwise have remained unaffected.
A month after this lawsuit was filed, the FDA published a safety warning that urged surgeons to stop using the morcellator during gynecological surgeries. The FDA warning stated:
When used for hysterectomy or myomectomy in women with uterine fibroids, laparoscopic power morcellation poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus. Health care providers and patients should carefully consider available alternative treatment options for symptomatic uterine fibroids. Based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.
30 Morcellator Lawsuits
Today, more than 30 lawsuits have been filed against companies such as Johnson & Johnson, Richard Wolf GmbH, Karl Storz GmbH, and Gyrus ACMI.
Morcellator Lawsuit Update
The first lawsuit was scheduled for trial November 3, 2015, before the parties reached a settlement agreement for an undisclosed amount. To date, this is the only morcellator lawsuit that has been settled. All other complaints are set for trial, pending the decision of the Judicial Panel on MultiDistrict Litigation. If the panel agrees to the request to consolidate all morcellator lawsuits submitted by the plaintiffs, all trials will be tried in one federal district court – or MDL court.
• Morcellator Lawsuit Update