“How big will my scar be?” As modern surgical techniques have improved over the last few decades, this is a question finally being answered to the delight of many patients. Whereas certain surgeries historically involved extensive scarring and long recovery times, the advent of newer technologies has rendered some of those surgical procedures minimally invasive.
One of the more recent surgeries to be transformed is the laparoscopic hysterectomy. Until recently, the uterus was simply too large to be removed laparoscopically. The same goes for uterine growths known as fibroids, that sometimes reach the size of various fruits and account for 40 percent of all hysterectomies. In the mid-1990s, however, physicians began using something called a morcellator – a device designed to remove larger organs and tissues by essentially “eating” them.
Small enough to be inserted through the standard laparoscopic “keyhole” incision, a morcellator is akin to a large straw with a grinder inside. The instrument is able to suction, grind up, and extract the uterus – including the often-large fibroids – while inside the body. Unfortunately there’s a recently discovered catch: while the tissue is being pulled through the strawlike extension, microscopic pieces of the tissue can escape the pull of the grinder and be cast off into the body. This is not a problem unless that microscopic tissue happens to be cancerous. When it is, morcellation of fibroids could potentially “seed” the body with cancer. Each year, approximately 50,000 women in American hospitals undergo morcellation as part of their hysterectomies, and roughly one in 350 women have cancerous fibroid cells. Assuming those figures, nearly 150 women per year may be at risk of having their early-stage cancer spread through morcellation.
For manufacturers and distributors of morcellators, the future is uncertain. A major manufacturer that previously controlled 75 percent of the morcellator market voluntarily recalled its three devices last July after first halting sales in April. In November, the FDA issued a boxed warning on morcellators, noting the potential to spread cancer. Lawsuits have been filed in several states, and plaintiffs’ firms are circling the waters. Could this be the next big wave of medical device litigation, with commercials and other solicitations bombarding the airwaves? We thought we would look into our crystal ball and make some general predictions about the future of this sort of litigation.
As plaintiffs’ lawyers assess cases coming in the door, a number of possible obstacles could surface. In a state like Alabama, a two-year statute of limitations could limit the exposure for manufacturers, as many plaintiffs may not manifest cancerous symptoms until more than two years after surgery. In states like Florida, where the statute of limitations is four years, the prospect of timely lawsuits increases.
Another key issue for manufacturers will be whether the physician has assumed the mantle of “sophisticated user” or “learned intermediary” – being informed and then informing patients about the risks when obtaining consent for surgery and for the use of the morcellator. Given the relative obscurity of the cancer risk until recently, however, physicians may not have been warning their patients about those risks.
A third possible defense for manufacturers will be physician misuse of the product. Most morcellators were approved for sale in the U.S. under the FDA’s 510k process. Under 510k, a new device does not have to be supported by extensive science and testing, it just has to be “substantially equivalent” to a previous medical device – a “predicate device” in FDA-speak – that received FDA clearance. Many morcellators were approved under 510k by reference to predicate devices which were intended to be used with a “bag” that would enclose and hold the tissue being consumed. But as the Wall Street Journal recently reported, “[m]ost gynecologists didn’t end up using bags with morcellators.” If a given morcellator was approved and marketed for use with a bag, but the bag was not used, manufacturers may enjoy a defense that the physician misused the product.
Obviously any morcellator litigation will involve profound questions of causation, as well as whether the product was actually defective in design or manufacture. Both of those issues will spur the now-familiar battle of the experts.
One can also expect the narrative of morcellator litigation to subtly inveigh against “the system.” Like the “unsinkable” Titanic, the FDA has implemented various systems and programs designed to quickly detect and prevent adverse events from the use of pharmaceuticals and medical devices. The FDA also enjoys significant oversight authority to probe companies which have received 510k approval. Because of the relative ease of demonizing any agency’s streamlined approval procedures, coupled with the emerging bad outcomes, arguments that “the system failed” will be a recurring theme of litigation. Although themes of a conspiracy, or of a “good old boy network,” might not directly implicate manufacturers, it may be suggested to incense a jury. In response, manufacturers will need to be prepared to defend not only their products but also to explain to the fact-finders the very reasonable bases for fast-tracking approval of certain devices through the 510k program. Distancing themselves from the system could be riskier than embracing it and defending it as good for everyone.
In Alabama, one group can likely breathe easy. Recent legislation immunizes most distributors, retailers and other middlemen who have not had a role in packaging, labeling or other related activities that modify or change the product before reaching the end user. Many other states have enacted similar defenses, such as Georgia and Tennessee, but others, such as Florida, have not. Thus, even non-manufacturing distributors of morcellators may require a vigorous defense in the Sunshine State.
Morcellator litigation is in its infancy. It may turn out to be the newest wave of intense nationwide litigation, or it may fizzle out and yield only a handful of lawsuits. One thing is clear: manufacturers and distributors have a variety of plausible defenses at their disposal, and any eventual litigation presents an excellent opportunity to defend the innovation and ingenuity behind morcellators and other devices.