In his song, Send Lawyers, Guns and Money, Warren Zevon sung that he was “an innocent bystander” and that he somehow got “stuck between the rock and the hard place.” Victims of the Medtronic Sprint Fidelis Leads debacle may feel a little like that lately. And they may want to amend Zevon’s song and ask for lawyers, doctors and congressmen to help them out. It doesn’t have quite the same ring as Warren Zevon’s classic, but here’s why leads victims need all three.
Congressmen – We have written extensively about the United State Supreme Court’s decision in Riegel. The Court ruled in that case that patients with faulty medical devices could not go to court and hold the negligent manufacturers responsible for their injuries. Instead, those claims were “preempted” since the medical devices had already been approved by the FDA. This decision directly impacts the victims of the Medtronic Sprint Fidelis Lead debacle — almost 300,000 Americans implanted with a device that was recalled for safety reasons. In fact, the court overseeing the Sprint Fidelis Lead litigation in federal court just formally dismissed hundreds of victims’ cases, based on Riegel, and ruled that those victims have no right to hold Medtronic responsible for their injuries.
Thankfully, some members of Congress are trying to do something about this problem. The Medical Device Safety Act has been introduced in Congress that would override Riegel and return the playing field to where it was before that decision. The principle is very simple. If medical device companies want to reap huge profits by manufacturing and selling their products, they are correspondingly responsible when they manufacture products that hurt people. Seems pretty fair to me.
If you have not done so already, call your U.S. Congressman and U.S. Senator and encourage them to co-sponsor and vote for the Medical Device Safety Act. Here is a link to find your Congressman and here is the link to find your Senator.
Doctors — The Heart Rhythm Society is a group of cardiac surgeons who prescribe and implant medical devices in patients’ hearts. According to an article on MSNBC, the Heart Rhythm Society believes there needs to be more doctors trained and experienced in the removal of leads. The article states that,
Heart Rhythm Society President Dr. Mark Estes said the increased focus on lead performance underscores the need for more reliable products and physicians who are comfortable removing them.
“The number of implantable heart devices continues to grow and as that happens the absolute number of leads that will need to be removed will grow,” Estes said in an interview with the Associated Press. “Lead removal is technically and clinically challenging and there are definite risks associated with it.”
The society warns there are not enough physicians trained in removing leads to keep up with demand. The group states that only medical centers that perform a large number of extractions each year should train physicians to perform the surgery.The group recommends physicians perform at least 40 extractions under expert supervision before operating on their own. Supervising physicians should have performed at least 75 extractions with a high rate of success, the group states.
The Heart Rhythm Society does not believe that potentially defective leads should automatically be removed since the risk of surgery may outweigh the risk of a device malfunction. But the panel did provide examples of when leads should be removed prior to any malfunction. An example the panel gave was a situation where a patient with a dysfunctional lead was also at risk of irregular heart rhythms. Those patients with defective leads need to discuss all of these issues with their physicians. And if it is ever recommended that the lead be removed, the patient should ensure that the surgeon is experienced in that procedure.
Lawyers – The recent dismissal of the Sprint Fidelis cases in federal court does not end the fight. Appeals will follow. In addition, there will be much litigation about the parameters of the Supreme Court’s decision in Riegel. Lawyers for consumers who have faulty medical devices have their work cut out for them. But the fight will go on.
“Lawyers, doctors and congressmen” won’t be a tune that you’ll hear anytime on the radio. But it is exactly what patients with Sprint Fidelis Leads need now.
Richard J. Arsenault, 2011
Very nice. Thanks for this.