Real-World Wrangling Surrounding St. Jude Heart Valve

Minneapolis, MNIt has been the basis for many a night terror and many a movie plot: the ticking time bomb that is either in the throes of being diffused or the attempt to escape from one. The slow motion run as the potential victim tries to distance himself from the pending explosion the audience knows is about to happen, but when? In fact, the foregoing is a metaphor summarizing the lives of individuals implanted with the st jude heart valve.

The silzone mechanical heart valve was recalled in 2000 after it became apparent that a silzone coating, derived from silver, appeared to be fostering leakage that could lead to serious heart consequences.

However, at the time of the recall, the manufacturer advised that the defective heart valves should only be replaced if it was medically safe for the patient—or if the risk to the patient inherent with the valve leak was greater than any risk associated with attempted removal.

Such is the rub with the medical device industry and the potential for devices to fail or become problematic. Replacing a defective part, such as a defective heart valve, is not as easy as swapping out a wonky computer module in a modern car. Medical devices such as defibrillator heart leads, which are affixed directly to the heart muscle, can be the source of tremendous risk surrounding any attempt to remove and replace such a lead due to a defect.

Hence, the ticking time bomb metaphor with the silzone mechanical heart valve. How does a patient live with such an ongoing risk, constantly waiting for the other shoe to drop? How does that affect peace of mind and quality of life?

Should there be compensation for that? And does the regulatory process play a role?

The US Food and Drug Administration (FDA) has been widely criticized for not properly vetting the pros and cons of a medical device prior to approval. A regulatory loophole that allows for a substantial shaving of time and testing given that a proposed device is substantially similar to an existing device doesn't help.

In the case of the troublesome silzone mechanical heart valve, the FDA originally took nine months to consider the device application. Was nine months long enough to vet potential problems that eventually emerged with this particular st jude heart valve? Health advocates will say it wasn't nearly long enough, although to the FDA's credit, the agency stipulated a number of conditions before the heart valve was approved.

In comparison, according to a legal paper published by Mondaq in January (1/25/12), Health Canada approved the silzone heart valve in just 52 days.

A number of lawsuits have been launched against manufacturer St. Jude Medical Inc., including a class action originating in the Canadian province of British Columbia.

The manufacturer, meanwhile, found itself embroiled in a dispute with an excess insurer that threatened coverage for potential claims against its allegedly defective heart valves in October 2010. According to Health Law Week (10/15/10), American Insurance Co. (AIC) at the time sought a declaration that it had no obligation to St. Jude Medical Inc. for claims arising from the silzone mechanical heart valve.

Of an eight-layer liability coverage program protecting St. Jude against product claims, AIC provided the sixth layer. St. Jude, it was reported, countered that AIC had breached its obligation. The US District Court for the District of Minnesota sided with St. Jude, declaring that AIC must cover St. Jude for claims arising from allegedly defective heart valves.

Such claims alleging a defective silzone mechanical heart valve may indeed continue, as patients either experience physical health issues related to valve leak or emotional issues stemming from having to live with a potential time bomb…