According to the Wall Street Journal, Johnson & Johnson (J&J) the world’s largest medical device and pharmaceutical company is settling personal injury and product liability lawsuits alleging that its now-recalled hysterectomy device injured women by spreading an undetected hidden cancer.
Court documents note that there are about 100 cancer spread cases after hysterectomy cases have either been filed or readied for filing against the J&J’s Ethicon unit, a subsidiary. The litigation is centered around a medical device known as the laparoscopic power morcellator.
According to sources J&J has settled nearly 70 cancer injury cases over the past few months, and several are in settlement discussions. J&J’s final settlement pay out on the cases will end up way past the hundred million dollar mark, by the time it is all said and done.
What are Power Morcellator Devices?
Power morcellators grind up fibroids which are benign growths in the uterus, so doctors can remove the chopped up or morcellated tissue through small incisions during a laparoscopic hysterectomy. Laparoscopic hysterectomy is a very popular procedure in the United States with several hundred thousand cases being performed annually.
Gynecological surgeons routinely used the devices before April 2014, when the U.S. Food and Drug Administration warned that women undergoing fibroid operations have a 1 in 350 chance of a uterine sarcoma that can’t be reliably detected before the procedure.
The FDA said that power morcellators can broadcast undiagnosed uterine cancer tissue within the abdomen and pelvis, significantly worsening a woman’s chances of long-term survival. Women who developed uterine cancer after hysterectomy, in many cases are facing a death sentence with an appalling 5 year survival, despite aggressive chemotherapy regimens which is usually ineffective.
Doctors used power morcellators in hundreds of thousands of hysterectomy procedures cases per year. J&J’s Ethicon unit had the largest morcellator share of the market, with over 70% of units used.
J&J Ethicon Morcellator Wrongful Death Claims
The plaintiffs have filed wrongful-death and product-liability claims against J&J’s Ethicon division alleging that the medical device giant company knew or should have known that the surgical tools sprayed undiagnosed cancer cells but didn’t take adequate action, and that the products were essentially a defective design because of the difficulty of differentiating a fibroid from a uterine sarcoma.
FDA Reluctantly Investigates
The FDA began looking into possible risks of laparoscopic hysterectomy surgery with the device after a 40-year-old anesthesiologist Amy Reed, went public in a Wall Street Journal article detailing her worsened cancer after a hysterectomy using the device.
Dr Reed has sued another morcellator maker, Karl Storz GmbH, in a case pending in a Massachusetts state court, as well as the Boston hospital and doctors involved in her care. Dr Reed, a mother of six who now lives in Philadelphia, has had multiple recurrences and continues to fight advanced metastatic cancer.
According to several medical experts, many women never had the chance to discover why they developed the deadly cancer and those they left behind have no idea what happened to them. There must be be hundreds of grieving families who to this date have not made the connection to the death of their loved one from post hysterectomy cancer and the deadly morcellator device.
Sad Stories of Unfinished Lives
One case that settled involved Molly Minihan, a Colorado woman who underwent a laparoscopic surgical procedure in April 2013. “During this surgery,” according to the lawsuit, “cancerous tissue was cut, shredded and spread throughout her body.”
According to Mrs Minihan’s attorney, “By December 2015, her uterine leiomyosarcoma had recurred twice despite chemotherapy, and she worried administrative delays would hurt her client and rob her of her day in court.”
In a separate case, Mona Eldin, a family doctor in Michigan, confirmed settlement of her case. Ms. Eldin, who is in her 40s, said that when she had a laparoscopic hysterectomy with morcellation for fibroids, her doctor never mentioned the possible risks of a hidden cancer.
The pathology of the macerated uterine tissue initially came back benign. Later retesting of the original tissue, after Ms. Eldin developed a malignant tumor, found that the tissue had been sarcoma all along, demonstrating another danger of morcellation, that the process of morcellation alters tissue samples. This alteration of the tissue during the grinding process can make the pathological diagnosis difficult.
Shezad Malik is an Internal Medicine and Cardiology specialist, a Texas Medical Doctor (retired) and Defective Medical Device and Dangerous Drug Attorney. Dr. Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.
One Comment
eric rugart
This is crazy! Some idiot in accounting just signed off on harming a generation of women…if Ethicon won’t fight bad science, who will?
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