St. Jude, makers of one of America’s leading heart implant devices, faced a major setback last week when The Heart Rhythm Journal refused to retract a recently published article that linked failures in their medical devices with at least 20 deaths.
According to the New York Times, the medical device company did not dispute the occurrence of the deaths, but rather accused the study of being flawed due to incorrect research and bias against St. Jude’s devices. According to representatives of St. Jude, the analysis should have uncovered a similar frequency of deaths associated with the use of devices made by a competitor, Medtronic.
“While I can understand the angst St. Jude is experiencing, I haven’t seen their data and it hasn’t been peer-reviewed,” Dr. Dougals Zipes, the editor and chief of The Heart Rhythm Journal told the Wall Street Journal. “There is no way I can accept what amounts to a press release” over the original article, which was scientifically researched and approved by experts in the field.
The damaging article on St. Jude arose from injury reports pertaining to one of the company’s Riata leads, an older model that was popular in previous years. Evidently, a number of these devices have caused electrical problems, including delivery of shocks at inappropriate times. The electrical malfunctioning results from wiring within the devices coming through the surrounding insulation. According the company, this problem has been corrected in newer models.
When a company produces a flawed, potentially injurious product, how they deal with the ensuing crises will determine much about the future of their relationship with customers. This principle may hold particularly true for a company in the medical industry that produces products on which their customers’ lives literally depend.
In attacking both their competitors and the science behind the accusations rather than dealing with the problem head-on, St. Jude may be doing an even greater disservice to the future of their company that will not easily be undone. According to crisis-management experts interviewed by the Wall Street Journal, this stance that is at the same time defensive and offensive could easily backfire. “They’re calling into question some of the leading lights in the industry,” said Raj Denhoy, an analyst at Jefferies & Co. “That’s not going to sit well with clinicians.”
Despite laws requiring that medical devices that possess a higher risk of injury (such as ventilators and heart implants) undergo studies before they can receive the Food and Drug Administration’s (FDA) seal of approval for distribution, oftentimes problems will arise after the devices are released on the market. According to a recent article in the Online Journal of Issues in Nursing about safe use of medical devices, it is critical that the FDA is able to rely on manufacturers as well as consumers to report problems as they arise.
It is for this reason that it is particularly disturbing to see companies—such as St. Jude—that have manufactured faulty medical devices react to the tragedies that their products have caused with denial and scapegoating. When human lives are at stake, medical companies need to step it up, take ownership of their mistakes, and work with medical professionals, regulating industries, and the public to solve the problem. They certainly owe that much to the families of the 20 or more people who have died due to their defective products.
If you or a loved one has been seriously injured by a medical device, you may be legally entitled to compensation for your pain, suffering and losses. Contact our experienced medical device injury attorneys today, and let them discuss your legal rights and options with you.