ATTUNE KNEE CONTROVERSY: WHAT YOU DON’T KNOW ABOUT MEDICAL DEVICES CAN HURT YOU
Roughly ten percent of Americans carry a medical device of some kind implanted in their bodies, ranging from pacemakers and artificial joints to surgical mesh and birth-control devices. Over the past half century we have gradually become a bionic culture; some procedures, such as knee replacement, have become so common that more than 600,000 people undergo the surgery every year in this country, usually to relieve chronic pain from arthritis.
But even as our reliance on medical devices has increased, so have reports about manufacturing defects and bad designs, costly recalls and painful “revision” surgeries – in some cases, replacing a failed replacement with yet another, “new and improved” model. Such misfires can end up causing misery for thousands and even hundreds of thousands of patients.
One current controversy concerns the Depuy Synthes Attune Knee System, a knee replacement developed by a company that is part of Johnson & Johnson’s medical devices group. Since Depuy began marketing the device in 2013, the Food and Drug Administration has received numerous reports of “adverse events” involving the product. In 2017 an article in the Journal of Knee Surgery, authored by several orthopedic surgeons, remarked on what they considered to be an unusual number of early failures of the Attune Knee System, a phenomenon that the authors attributed to a “high rate of debonding” between the tibial component and the bone cement used to hold it in place. The publication of that article was soon followed by the filing, in Alabama, of the first of what could turn out to be hundreds of lawsuits claiming that the product is defective.
The researchers who conducted the study reviewed clinical and radiographic data for patients who were implanted with the Attune system and later required revision surgery. They found 21 reports over a two-month period of tibial loosening at the implant-cement interface in the Manufacture and User Facility Device Experience database, or MAUDE, a government storehouse of medical device reports, and “numerous” other reports of tibial failure that weren’t specific about the mechanism of failure. The authors believed that the complication was probably underreported.
Patients who experienced the “debonding” problem— in some cases, within two years of having knee replacement surgery — complained of pain, swelling, inflammation, and difficulty walking. They also faced the prospect of a painful revision surgery, followed by weeks or months of physical therapy and rehabilitation. In two case studies cited in the article, the doctors who performed the revision surgeries examined the devices that they removed and found no evidence that the cement had ever adhered to the tibial plate.
Depuy responded to the article with its own white paper, challenging the authors’ methods and conclusions. The company has strongly denied any defects in its knee system; at the same time, it has launched a new version of the tibial base plate, the Attune S+, that is supposed to offer improved bonding ability.
This isn’t the first time Depuy has felt the need to retune, so to speak, its Attune technology. In 2015 it launched a global recall of 3,474 units of its Attune Knee Tibial Articulation Surface instrument, a device used to measure a patient’s “fit” prior to implanting an artificial knee. According to the recall notice, there was potential for a small wire spring on the device “to become damaged and disassociate (come off).” If that happened, it was possible that the spring would be left inside the patient after the surgery.
The company has also faced litigation from thousands of patients over certain artificial hip implants. One, a metal-on-metal device known as the ASR XL, began to generate complaints not long after it hit the market in 2005, including reports of the device shedding debris and causing infection, injury, nerve damage, and metallosis, a type of metal poisoning that can lead to bone loss, tissue damage, and other serious complications. Despite mounting adverse reports, DePuy didn’t stop selling the model until 2010. (The company blamed poor sales, not a product defect, for the decision.) Thousands of lawsuits against that product and a subsequent DePuy hip implant, the Pinnacle, are now underway, including 9000 cases filed in multidistrict litigation in the Northern District of Texas. The most recent bellwether trial over the Pinnacle implants resulted in a $247 million jury award for six patients who had to have their hips surgically removed; two previous trials resulted in jury verdicts of $502 million and $1.04 billion (later reduced to $150 million).
The hip lawsuits are among a series of claims involving products offered by DePuy’s parent company, Johnson & Johnson, that earned J&J a place on the list of “Worst Corporate Conduct of 2017” compiled by the American Association of Justice, an advocacy organization comprised largely of trial attorneys. (Other Johnson & Johnson products that have generated lawsuits and controversy include the blood thinner Xarelto, the antipsychotic drug Risperdal, pelvic mesh, and talc products that may contain asbestos.) But the DePuy litigation is also a glimpse into the particular hazards of the high-stakes medical device industry, which receives far less scrutiny from federal regulators than most consumers realize.
“Many people assume that the Food Drug Administration requires rigorous testing of medical devices before they are approved,” notes Jeanne Lenzer, author the The Danger Within Us, in a recent opinion piece in the New York Times. “In fact, most high-risk devices on the market, including implants, have undergone no clinical testing at all.”
Lenzer observes that medical device makers can skirt clinical testing by representing that their products are “substantially equivalent” to ones already in the marketplace or that they contain only minor modifications. But if those changes result in a dangerous defect or failure, it’s often not detected until after the device has already been implanted in many patients, a population that effectively becomes “unwitting guinea pigs.” Partly as a result of the ease with which such devices now reach the marketplace, the number of Class 1 device recalls (the most serious form of recall) has soared to more than ten times what it was in 2003.
If you have suffered injuries or undergone revision surgery as a result of a defective medical device, you may be entitled to compensation. The product liability attorneys at Franklin D. Azar & Associates are currently investigating several devices associated with recalls, adverse events, or possibly inadequate warnings issued to doctors and patients, including Pinnacle Hips, Attune Knee Systems, St. Jude Defibrillators, and faulty shoulder replacements. Contact us for a free, no-obligation consultation.