Recent Medtronic Defribrillator Recall
Problems with these recalled pacemakers have resulted in the unfortunate deaths among many patients. When those recalls began, Guidant had the lion's share of recalled products with Medtronic and St. Jude pacemakers following closely behind.
The most recent "recall" is for defective leads manufactured by Medtronic. Medtronic is not calling this a recall; its calling it "suspended sales." The Food and Drug Administration is, however, referring to this as a Class 1 recall1. Medtronic has simply decided to cease sale of the remaining leads it has in stock, and has notified doctors and hospitals not to use the specific leads that they still have and to return the unused inventory to Medtronic. Ironically, the suspension notice was made public on the same day that Medtronic was sued for injuries caused by the defective leads.
Medtronic has suspended sales of the Sprint Fidelis® family of defibrillator leads because of the potential for lead fractures. A lead is a wire that attaches the defibrillator unit, which is implanted under the skin in the upper chest, to the heart. The lead is threaded into the heart muscle where it hooks into the heart. A lead fracture, is just that; a break in the lead. There has been a corporate marketing race to have the thinnest leads, and the leads have been approved by a series of amendments to the original Premarket approval, or PMA, for this product. The thinness of the lead may be the impetus to the fracture. You can tell if your client has these leads by looking at the device card that recipients are given upon implantation. The product numbers in the alert are:
Sprint Fidelis® 6930, 6931, 6948, and 6949 2
So far, children and young adults seem to be the most at risk. These patients seem to be the most active and that may result in stress to the lead after implantation. Also, the thinness of the lead makes is susceptible to damage both during and after implant.
A fracture in the lead can result in several different problems. The Sprint Fidelis leads are used in implantable cardioverter-defibrillator units (ICD) or cardiac resynchronization therapy defibrillator units (CRT-D). The ICD and CRT-D devices are used to treat abnormal heart rhythms that can cause the heart to stop suddenly. They work by shocking the heart to resume a normal rhythm, similar to what we see on medical television shows when electric paddles are used externally to shock someone's heart which has stopped beating. When the leads fracture, it may cause inappropriate shocks, such as numerous, repetitive shocks when heart resynchronization is not needed or has already been obtained. A lead fracture can also result in a loss of therapy, so that a shock is not delivered when one is needed. Further, the lead fracture can also result in a loss of pacing, obviously critical for patients who are pacemaker dependent.
Removal of the lead comes with it own set of risks. A small barb at the end of the lead is designed to hold the lead in the heart muscle. The longer the lead is in place, the more scar tissue has likely grown over the lead. Medtronic is not recommending that patients seek routine or prophylactic removal of the leads as the removal can be more dangerous than the chance of a lead fracture. There are two alternatives to removing the lead3. One alternative is to closely monitor the lead for signs of failure. The second alternative is to add a replacement lead but leave the Sprint Fidelis® in place. If the lead is left in place, the tip must be "capped" similar to capping hot electrical wires. However, not everyone is eligible for the placement of additional leads and everyone's individual doctor should be consulted to determine the best medical intervention for a particular patient.
The Sprint Fidelis® leads have been implanted in approximately 268,000 people worldwide, the majority of which are in the United States. The Sprint Fidelis® lead may have also been used to connect defibrillators manufactured by other companies such as Guidant, Boston Scientific, and St. Jude. Medtronics estimates that approximately three percent of the 268,000 recipients, 4,000 to 5,000 people, will suffer a failure. Others will just have to live in constant fear that any moment, their leads will fail. Many recipients are having their devices set in alarm mode so that if there is any failure, a sound like a smoke detector will go off and people can call 911. There is also a system called CareLink that is set up through a phone system. The patient calls the CareLink system and the ICD or CRT-D unit is checked over the phone line4. One of the issues facing patients is a determination of what costs will be paid for by Medtronic.
The FDA is recommending that patients who have had the Sprint Fidelis® lead implanted should contact their physician immediately, especially if they have experienced multiple shocks, lightheadedness, fainting, or palpitations. Patients describe the shocks like being kicked in the chest by a horse.
Those who intend to file suit against Medtronic should do so cautiously. There will be two key issues in these cases. One issue will center around whether the changes to the Sprint Fidelis® lead, since the original design of the lead, require approvals more like §510k, that do not preempt claims, or PMA. Medtronics is going to assert an aggressive pre-emption defense in this case. Given our current United States Supreme Court and the Buckman Co. v. Plaintiffs' Legal Committee, 121 S.Ct. 1012, 148 L.Ed.2d 854 (U.S. 2001)decision holding that a patient cannot sue the manufacturer of a defective medical device that has gone through the PMA process - even when the manufacturer has lied to the FDA, it is very important the cases be filed with care. Another important issue in these cases will be whether the fracture problem is caused by a manufacturing defect. Medtronic has already taken the position that the fractures may be caused by the insertion technique used by the implanting doctor who causes a kink or bending of the lead5. The United States Supreme Court will hear oral arguments on a similar line of preemption cases6 in early December.
The leads were manufactured in Puerto Rico by Medtronic Puerto Rico, Inc. and Medtronic Puerto Rico Operations Company, wholly owned subsidiaries of Medtronics that were created for tax advantages. Medtronics corporate headquarters are in Minneapolis, Minnesota. Therefore, filing in Minnesota, the 11th Circuit, or Puerto Rico, seems to be the trend.
1.Class 1 recalls are considered to be the most serious type of recall and involve situations in which there is a reasonable probability that use of the products will cause serious injury or death. See, http://www.fda.gov/cdrh/recalls/recall-101507.html
2. http://www.medtronic.com
3. See http://www.fda.gov/consumer/updates/medtronic101507.html.
4. This method of checking the ICD or CRT-D unit is called "interrogation." The system is designed to check the defibrillator to identify any potential problems.
5. http://www.medtronic.com/fidelis/physician-letter.html; see also, The Wall Street Journal, October 30, 2007, p. A1.
6. Riegel v. Medtronic, Inc. wherein the plaintiff sued Medtronic for injuries caused by an exploding balloon catheter which was manufactured by Medtronic. Medtronic claimed preemption barred the plaintiff's claims and the district court agreed and dismissed the case. The United States Supreme Court granted cert. Copies of the parties' briefs can be seen on the Public Citizen website at http://www.citizen.org/litigaiton/forms/cases/CaseDetails.cfm?cID=79. The United States government has also filed an amicus brief in Riegel taking the position that all cases involving PMA approved devices would be preempted unless the case involved the breach of an express warranty or manufacturing defect. See http://www.usdog.gov/osg/briefs/2007/3mer/1ami/2006-0179.mer.ami.html.
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