A new study postulates that the American taxpayer will have to pony up amounts in excess of $1 billion to monitor and replace defective heart pacemakers, specificially Medtronic’s Sprint Fidelis leads. 

The report authored by H. Dennis Tolley, PhD, ASA, and funded by product liability lawyers, argues that these massive costs are the result of the 2008 U.S. Supreme Court Riegel v. Medtronic decision, in which the high court ruled that manufacturers could not be held liable for FDA-approved devices with the Class III designation (i.e., any device which is used to support or sustain human life or for a use which is of substantial importance in preventing or impairment of human health.) Instead Medicare will have bear the costs, which the report claims will total more than $1 billion by the year 2017.

The pacemaker leads in question were subject to a 2007  recall because they were prone to fracture and sent off false shocks. Leads are installed from the pacemaker to veins connecting to the heart, which provide the link between the heart and pacemaker.

The report concludes as follows:

This examination of the cost to Medicare for the defective Sprint Fidelis lead shows how a single defective life supporting or life sustaining medical device can cost patients and their insurance companies hundreds of millions of dollars. Because of the Court decision in Riegel, the manufacturer of the device is protected from any responsibility to pay for the damage their defective device causes. People on Medicare are 65 or older and have more life supporting or life sustaining medical devices than the general population. This increases the likelihood that someone on Medicare will be the recipient of a defective device and thus increases the cost to Medicare to provide additional medical care, because of damage caused by the defective device. The Medicare program, in its struggle to remain solvent, can ill afford to assume this expense.

The Medical Device Safety Act pending in Congress would expand liability for manufacturers of faulty medical devices. A Medtronic spokesman told FairWarning.com (which publicized the report) that the study’s methodology contained serious flaws.

FairWarning is an online, nonprofit publication that seeks to provide robust, public interest journalism on issues of health, safety and corporate conduct.


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