A common but highly-unwelcome occurrence for women is the development of uterine fibroids, small generally-benign tumors that cause considerable pelvic and abdominal pain, getting worse as they grow. Uterine fibroids occur when muscle tissue in the uterus begins to grow abnormally, though science is not yet certain of the reason for this ailment.
Fibroid tissue is thought to occur in around 80 percent of women by the time they turn 50. In such circumstances, the most practical option to address it is a minimally-invasive surgical extraction of the offending fibroids, called a myomectomy. However, if they occur in sufficient numbers or sizes, or grow in inaccessible locations, the only solution may be partial or total hysterectomy--that is, surgical removal of all or part of the uterus. The surgery can also include removal of the ovaries and fallopian tubes.
In one form of these surgeries, physicians make use of an instrument called a power morcellator. Research conducted after many years of using this device has suggested that rather than fully remove cancerous tissue, it may actually cause the additional spread of cancer in a patient's body. Quite rightly, this has caused a legal uproar among women who underwent the procedure only to have their condition worsen afterward.
A Quick Intro to Power Morcellators
Employed in health care since the early 1990's, the power morcellator is a surgical instrument used in abdominal procedures, such as laparoscopic hysterectomies and myomectomies, and liver/spleen surgeries.
As you can see, the device looks a bit like a drill with sharp blades at the tip. It may appear sort of alarming, but don't worry--a lot of modern medical instruments look more imposing than they turn out to be.
During the procedure, doctors make small incisions (less than 2 cm apiece) in the abdomen, then insert the tubal portion of the device. The blades then morcellate (literally "cut into smaller pieces") the damaged tissue and vacuum it out of the body through the tube.
Doctors perform roughly 600,000 hysterectomy procedures a year. Given that a standard hysterectomy is fairly invasive and involves a three- to seven-inch incision in the abdomen through core stomach muscles, morcellation has for some time been a preferred alternative. Surgery and recovery time are both drastically improved by the device, as well as major reductions in wound-complication incidents like infection.
With that said, recent facts have come to light about the hazards of morcellator use that have called into question their use for the last 20+ years.
The Controversy Behind Morcellation
Morcellators are still used for surgical procedures across the country, and given the description above, it's easy to see why. If they had been perfected, they would be an obviously superior method of conducting this kind of surgery. They mark a distinct stride forward in medical technology, but like many such advances, a negative side of the procedure went undetected for a length of time before studies brought it to public attention.
According to an alert released by the Food and Drug Administration (FDA) in April of 2014, further use of laparoscopic power morcellators is discouraged because of the possibility that they could miss some of the small pieces of tissue they create while cutting up a tumor. Again, fibroids tend to be benign, but it is not impossible that they contain active cancer cells; when such a phenomenon occurs, the fibroid is considered an occult tumor, where the cancer is present but its source is not immediately obvious. If a morcellated fibroid contains malignant cells and they are left behind and missed by the morcellator's vacuum, the cancer can take hold again in the patient's body and metastasize.
Obviously, a device designed to remove tumors that can proliferate cancer constitutes a huge design flaw.
The most prevalent form of cancer attributed to these incidents is leiomyosarcoma, which translates from Greek as "smooth muscle connective tissue tumor." While a fibroid tumor is similarly named a leiomyoma, the two are unrelated beyond their origin in the same tissue. Leiomyosarcoma is highly malignant, and far more difficult to remove from an afflicted patient. If morcellation causes these cancer cells to become metastatic, the five-year survival rate for the patient drops from 50 to a maximum of 16 percent.
Those who have not endured cancer may have difficulty grasping the idea that small parts of a tumor can be as dangerous as the whole if left unchecked. Try this analogy: Imagine that your child finished playing with a tub full of assorted Legos and then wandered off. You peek into her play area and wisely determine that no matter how nice the spaceship she made is, the unused Legos still spread around the carpet constitute a minefield of opportunities for pain. Sighing, you drop to all fours and scoop up handfuls of the blocks, dumping them back in their bucket. You gingerly set the spaceship on a nearby shelf, in case it turns out to be her Sistine Chapel.
Invigorated by completing your task, and briefly ignoring the glass of Pinot Grigio calling your name from the kitchen, you step a little further into her room to straighten her bed.
In that moment, the malevolent stars align. You obliviously bring your full body weight down onto a bare foot, which manages to locate the corners of a small square piece you didn't notice during your sweep. As your eyes widen and the first syllable of your response forms, we end the scene.
We've likened a crippling and life-altering disease to an inconvenience to your foot for the sake of a reductive metaphor, but virtually any attempted parallel would fall short of the anguish that is cancer. In this analogy that left-over piece, unnoticed during a larger and highly-necessary removal procedure, ruins your evening. Now multiply that evening by your whole life, and you'll start to understand what's at stake.
The procedure can actually have a range of unwelcome side effects, of which cancer is just the most severe. A patient can also suffer any of the following, and beyond:
- Bleeding or infection
- Bowel obstruction
- Fibroid reoccurrence
- Oozing at incision site
- Organ damage
- Pelvic and abdominal pain
- Abscesses (a swollen or infected area within the body)
I Had Complications after a Morcellation Procedure. What Can I Do?
If you or a loved one has been diagnosed with leiomyosarcoma or another pelvic/abdominal problem after undergoing a morcellation procedure, you may have grounds to pursue a personal injury claim.
After research kicked into higher gear about this potential issue in 2013, the medical-industry giant Johnson & Johnson recalled several models of morcellator it produced through its Ethicon subdivision. Ethicon produced three major types of morcellator at the time of the recall, and all were used in laparoscopic hysterectomies during when the devices' hazards were beginning to surface:
- Gynecare X-Tract Tissue Morcellator
- Gynecare Morcellex Tissue Morcellator
- Morcellex Sigma Tissue Morcellator System
Johnson & Johnson has a checkered track record of injury to its consumers. Morcellators aside, they are also embroiled in a number of legal battles across the spectrum of their considerable catalog of products, including antipsychotic medication and talcum powder. While the company as a whole creates a wide range of goods, by spreading its influence so widely it creates responsibility for its subsidiaries' cost-cutting measures, which inevitably reflect poorly on the parent corporation itself.
They're not the only ones on the hot seat, but considering how often "Johnson & Johnson" seems to be synonymous with "product liability lawsuit," they are a major face of the lawsuit.
According to FDA estimates, laparoscopic morcellators are used in something like 10% of the procedures where they could reasonably be employed. That's about 60,000 surgeries a year, and that number was expected to keep climbing. However, with the rise of these studies and the evidence of "left over" cancerous tissue escaping the morcellator's suction, that number has gradually declined.
"Awareness," however, only does so much good. Part of the goal of any product liability litigation is to protect future victims from suffering the same fate. That means that it's critical to make those who suffered such circumstances whole, so the company recognizes and honors its obligations instead of gingerly stepping around them for profit's sake.
In order to force them to do so, injured parties will need the help of skilled product liability attorneys. The idea will be to establish that the maker of the used morcellator failed to apply all of the care required when creating a product designed to promote and protect patient health.
The Elements of a Morcellator Claim
Let's say a very nice lady had surgery to remove her painful fibroids. She required a partial hysterectomy to rid her of their effects. She was shortly thereafter diagnosed with leiomyosarcoma and some abscesses near the surgical site. Based on the published findings from the device's critics, the patient learns that the device is responsible for her injuries, and chooses to sue the manufacturer.
To pursue a product liability claim against a company, the main allegation will usually be that it produced or manufactured something for end-use that caused harm previously undeclared by the company. This idea is constituent to a negligence claim--particularly that of a failure to warn. Many such cases have been filed against the manufacturers of laparoscopic morcellators. Beyond Johnson & Johnson's Ethicon, here are some further companies on the hot seat and their products:
- Karl Storz GmbH & Co.: Swalhe II SuperCut Morcellator
- Olympus: PKS PlasmaSORD, VarioCarve Morcellator
- Ethicon of FemRx: Diva Morcellator
- Lumenis, Ltd.: VersaCut+ Tissue Morcellator
- Richard Wolf GmbH: Morce Power Plus
- Cook Urological, Inc.: Cook Tissue Morcellator
- KSE America: KSE Steiner Electromechanic Morcellator
- Blue Endo: MOREsolution
- LiNA Medical: Xcise Morcellator
Once the responsible company is identified, a product liability attorney will need to prove some important facts for a claim to be accepted by a court or jury:
It's important for the attorney to establish that a manufacturer owed a duty to the public not to hurt them with their created products. It's true that morcellators are not home-use goods, and none of these companies sell their products directly to consumers, but to intermediaries in the health care industry for surgical use. However, because in the end it is patients who experience the actual use of the products, the manufacturers do have implicit obligation to them to exercise a reasonable standard of care when making medical equipment that will be used on them. This means that adequate research should be conducted on the possible side effects that could occur from the use of the product. The fact that nothing was said by any of these companies related to morcellation and cancer spread suggests one of a couple of uncomfortable options:
- They didn't know, and they damn well should have. The FDA registered power morcellators as "Category II," meaning that clinical trials weren't mandatory when they first hit the market in the 90's. Cook Medical, who put the first morcellators on the market, was rapidly followed by several other manufacturers, and now the FDA recognizes about two dozen companies with registered morcellator products.
- They knew, but played the odds. This happens an uncomfortable amount of the time; the "odds" of the injury (which current estimates place at about 1 in 350) are determined not to be worth corrective measures. The company determines internally (and never admits) that the cost of settling with injured parties will cost it less than a cumulative recall to fix the faulty products and/or release updated ones. After doing that math, they decide to ride out any legal backlash instead of taking proactive measures.
No matter which explanation is correct, the failure of these companies to address the damages caused by their products is a breach of their obligation to patients and health care providers. Thanks to the twists and turns of the FDA's approval process, the manufacturers didn't necessarily commit any legal wrongdoing by failing to perform clinical trials, but once the American College of Obstetricians and Gynecologists (ACOG) released a statement about the comparative hazards of laparoscopic versus vaginal hysterectomy in 2009, the companies could no longer justifiably feign ignorance. When given knowledge of their products' flaws, it's not unreasonable to think that the companies could have taken corrective action--this would have been expected as part of a reasonable standard of care.
Given that the company failed in its duty to create products free of hazard, or at minimum to adequately warn the public of known dangers, it could be held liable for their injuries if plaintiffs can prove that the morcellator was in fact the proximate (direct) cause of their injury. In essence, that means proving that the patient did not suffer from malignant uterine cancer (such as leiomyosarcoma) before her morcellation procedure. This can likely be proven through the patient's medical records--a cancer-free history on one side of the procedure, and a diagnosis of cancer on the other. With only the morcellator in between, and the published findings suggesting exactly this kind of problem, it would not be hard to argue causation.
In order to collect damages, a patient must have demonstrable injuries. These can run the gamut from mental anguish (yes, that is real, ignore tort reformers and ignorant TV lawyer shows that dismiss the concept) to extensive physical damages, or even death. When a patient is diagnosed with cancer, she is hit hard in a variety of ways. Both the disease and the treatment are painful, time-consuming, and exhausting. Medical bills can be a tremendous financial burden, and in this case the cost of the cancer treatment would closely follow the already-exorbitant bills from the initial fibroid surgery. The duration of this affliction involves extensive mental and emotional damage to both the patient and her loved ones, and it would be difficult to say if she would be able to re-join the workforce for a considerable length of time, meaning there would be a need to recoup lost wages.
Given the circumstances, it seems clear that patients who have suffered similar injuries should seek a skilled products liability attorney, as the maker of a laparoscopic morcellator may owe them compensation for their pain. It is a poor substitute for ethical and compassionate business practice and pre-emptive safety precautions, but having failed to provide those, these companies owe many women an apology, and that language is spoken with money.
I Have Fibroids. Should I Not Get a Morcellation Procedure?
Anyone who is not a doctor, myself included, should not offer medical advice. That would be a breach of personal and professional ethics. I can only relate facts about laparoscopic morcellation that have been determined through careful research by qualified individuals and groups, but I cannot advise anyone better than a doctor about her best health-care options.
In the interest of relating more facts, I encourage anyone with this problem to discuss her options with a physician. An alternate form of power morcellator, called a hysteroscopic morcellator, is gaining prevalence among doctors because it reduces the risks involved with the procedure. One of its primary differences from the laparoscopic method is that a "collection pouch" is inserted into the surgical area, which catches any errant tissue and makes for safer, more complete extraction.
Further surgical options also exist, in the form of vaginal or abdominal hysterectomy or myomectomy. It is not afforded the technological advantages of morcellation, but given the hazards of using the device, some women prefer one risk over another.
Again, I cannot stress enough that you should draw your conclusions after conferring with a qualified medical professional.
Grossman Law Truly Believes in Helping the Injured.
As with most nationwide product liability claims, the motivation behind the morcellator lawsuits isn't only the collection of financial damages. Our attorneys hear every day from people who are reluctant to make use of the legal system because they do not want the reputation of being "money-hungry" or litigious in nature. We understand this sentiment, but try to convey to them that there are additional considerations beyond payment, and that's part of why our attorneys are so passionate about justice.
Without injury litigation to keep them in check, very little prevents manufacturers from ignoring their obligations to the consuming public. "Accidental" omissions in quality control and loophole-filled government oversight give them many opportunities to release items that are not 100% ready for public use. When these products inevitably hurt the public that purchased and/or used those items in good faith, it is important that the negligent manufacturers be held accountable.
Helping injured parties obtain the resources they are owed to make them whole and able to continue living comfortably is very important. The ultimate goal, however, is the lesson that the lawsuits impart to manufacturers: We see you trying to bend the rules to squeeze in a few more bucks. You are not going to get away with it.