Medical Devices Can Sometimes Result in Loss of Life
Steven E. North, Esq. and Laurence M. Deutsch, Esq.
A doctor who had campaigned against using a medical device called a power morcellator to remove uterine fibroids laparoscopically, died in May from widespread uterine cancer caused by improper use of that device.1
In 2013, Dr. Amy Reed, an anesthesiologist, had a routine hysterectomy for what her doctors thought were benign uterine fibroids. The power morcellator, which facilitates minimally invasive surgery, had been in use for some 20 years in the gynecologic community. As its name implies, the device is a surgical power tool used for, among other things, removal of uterine fibroids in pieces, which is faster and easier than manual dissection techniques.
The power morcellator was promoted throughout the medical community as an advance that would decrease surgery complication rates. Intuitively, some physicians (and patients) feared that breaking up small growths of unknown origin in the uterus could, if they turned out to be malignant, result in the spread of cancer cells throughout a patient’s body. Such claims were dismissed for many years with reference to the FDA’s approval process for medical devices during which no evidence of such increased cancer fatalities were seen.
Dr. Reed learned after her procedure that she had small but cancerous growths on the uterus that had been spread by use of the power morcellator. She was quickly diagnosed with Stage 4 cancer which in most instances is fatal. In the remaining years of her life, Dr. Reed became a strong advocate for a stricter approval process for devices such as the power morcellator and succeeded in prodding the FDA to change its rules for use of the device.
After further inquiry, the FDA formally announced in 2014 that use of a power morcellator should be severely restricted, most notably among women who are menopausal or perimenopausal and have growths of an unknown origin. As a practical matter, the prohibition covered the vast majority of women who formerly were subjected to the power morcellator procedure. Therefore, the FDA was in effect telling the medical community that the power morcellator was unsafe for use on the vast majority of women, except perhaps those at extremely low risk of undiagnosed uterine cancer.
Regardless of damning press coverage, it is notoriously difficult to sue a medical device manufacturer. "Safe harbor" laws protect medical device manufacturers who have gone through the device approval process, even if a devices turn out to be dangerous. Doctors, too, prior to the FDA revised rules in 2014, were often shielded from medical malpractice suits, even if they used a morcellator thought by many in the community to be unreasonably dangerous. This is because a physician using an FDA-approved device could usually be said to be following the community "standard of care" even if the community standard of care turns out to have been dangerous.
However, since the FDA updated its rules in 2014, a physician who improperly uses a power morcellator and therefore spreads cancer may now be held liable in a malpractice suit.
The elements of proof would include evidence that the doctor used the device on a patient who did not meet the appropriate criteria according to the more updated FDA rules. Formally, an FDA rule does not necessarily define a medical standard of care. However, this particular rule and the amount of coverage it has received in the medical community establishes a de facto standard of care.
Accordingly, it is our belief that if a physician improperly uses a power morcellator, e.g., on a menopausal or perimenopausal woman with fibroids of unknown origin, and use of that morcellator results in a spread of cancer, we believe there may be a strong basis for a malpractice suit.
Dr. Reed’s advocacy and the history of the power morcellator hold many lessons for doctors and patients. Physicians need to know that even if a practice is in wide use, they need to apply common sense and err on the side of caution. If a procedure appears to be dangerous, a good physician may want to look further into his or her own practices.
Similarly, patients need to question doctors closely to determine whether a planned procedure or the manner in which it is planned is for their benefit or to maximize convenience for the doctor.
There are many examples of this in medicine. Women are, for example, routinely scheduled for an induction as opposed to a more natural timing of childbirth. While there are often good reasons for a planned induction or scheduled C-section, too often procedures are scheduled to suit the needs of the delivering obstetrician rather than for a real medical reason. When scheduling for convenience causes harm to a patient, there is sometimes a basis for a medical malpractice suit.
For all of us, the power morcellator chapter carries the overall lesson that what is "quick and easy" is not always best for the patient.